Top 15

Patent Cases of 2015 in India

Exclusively for SJP Associates and Clients

Compilation of Notable Judgements and Orders of the Indian High Courts in the Patent Matters for the year 2015

STRATJURIS PARTNERS PATENT AND TRADEMARK ATTORNEYS

Dear Readers, The year that just concluded was an eventful year for Patent Ecosystem in India. Not only the reforms were kick-started by the Government at the Indian Patent Office by notifying the new posts for examiners and tabling an IP policy for the long term benefits, the Indian Judiciary also delivered numerous Patent Owner Friendly Judgments and orders throughout the year 2015. The year 2015 will not only be remembered for speedy and time bound trials at the Hon’ble Delhi High Court but also for the remarkable pro Patent owner judgements like Roche vs Cipla and Merck Sharp and Dohne (MSD) vs Glenmark. While the year 2015 is at its end, we at StratJuris Partners (SJP) decided to compile 15 most interesting Judgments and Orders that were delivered by the various Judicial forums in India. We are also distributing 500 Print Copies of this book on the occasion of Global IP Convention the largest gathering of IP stakeholders in India. We have intentionally kept the text, short and crisp in order to maintain this compilation in the form of a pocketsize book. We however recommend our readers to read the full versions of the Orders and Judgements. Authors from Stratjuris Partners:

Priyank Gupta Partner

Vithika Sharma Partner

Abhijeet Gidde Partner

CONTENTS

# Parties to the Case High Court

Decision Date

Pg. No

1 Cipla Ltd. Vs Hoffmann-La Roche Ltd. & Anr.

Delhi 27th Nov 2015

1

2 CTR Manufacturing Industries Limited Vs. Sergi Transformer Explosion Prevention Technologies Pvt. Ltd. & Ors.

Bombay 23rd Oct 2015

7

3 Merck Sharp & Dohme Corporation & Anr Vs. Glenmark Pharmaceuticals Ltd.

Delhi 7th Oct 2015

11

4 Telefonaktiebolaget LM Ericsson Vs. Best It World (India) Private Limited (i-ball)

Delhi 2nd Sep 2015

15

5 Bata India Limited Vs. Vitaflex Mauch Gmbh

Delhi 24th Aug 2015

17

6 Shilpa Medicare Limited Vs. Bristol-Myers Squibb Company and Ors.

Delhi 30th Jul 2015

18

7 Novartis AG Vs. Union of India, Wockhardt Limited and The Deputy Registrar, IPAB

Madras 28th Jul 2015

21

8 S. M. Anand Vel Vs. Union of India, CGPDTM (Mumbai), CGPDTM (Chennai), Assistant Controller Patents

Madras 20th July 2015

23

9 Bristol-Myers Squibb Company & Ors Vs. Mr J.D. Joshi & M/s MJ Chempharm Pvt. Ltd. (BDR Lifesciences Pvt. Ltd.) and Mr. D. Shah & Anr

Delhi 29th Jun 2015

25

10 The Delhi Network of Positive People Vs. Union of India & Ors.

Delhi 7th May 2015

30

11 Darius Rutton Kavasmaneck Vs. Gharda Chemicals, Keki Hormusji Gharda & Ors.

Delhi 7th Apr 2015

32

12 Merck Sharp and Dohme Corporation and Anr. Vs Glenmark Pharmaceuticals

Delhi 20th Mar 2015

34

13 Telefonaktiebolaget LM Ericsson Vs. Intex Technologies (India) Limited

Delhi 13th Mar 2015

39

14 Symed Labs Ltd Vs. Glenmark Pharmaceuticals Ltd. and Anr.

Delhi 19th Jan 2015

45

15 Novartis Ag & Anr Vs Cipla Ltd

Delhi 9th Jan 2015

47

16 Important Provisions of the Patents Act 1970 51

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S. No. #1

Case No.: RFA (OS) Nos.92/2012 & 103/2012 Court: High Court of Delhi

RFA(OS) 92/2012 F. Hoffmann-La Roche Ltd

(Petitioner) Vs.

Cipla Ltd. (Respondent)

RFA (OS) No. 103/2012 Cipla Ltd.

(Petitioner) Vs.

F. Hoffmann-La Roche Ltd (Respondent)

Judge: Hon'ble Mr. Justice Pradeep Nandrajog and Hon'ble Ms. Justice Mukta Gupta Appearance for Petitioner (F. Hoffmann-La Roche Ltd): Mr. Pravin Anand, Advocate with Mr. Shrawan Chopra, Ms. Prachi Agarwala, Ms. Archana Shanker, Mr. Mahabir and Mr. Vibhav Mithal Appearance for Respondent (Cipla Ltd.): Mr. Arvind Nigam and Ms. Prathiba M. Singh, Sr. Advocates instructed by Ms. Bitika Sharma, Ms. Jaya Mandella and Ms. Anusuya Nigam, Advocates Judgement Delivered on: November 27th, 2015 and revised on December 8th, 2015 (Since the Law intern associated with the Bench copied few paragraphs of an Article summarizing the order of the single judge and these copied paragraphs were introduced in the November 27th judgement). What is it about? The dispute started when the case was filed in January 2008 by Roche based on media reports that Cipla has an intention to launch Erlocip, a generic version of Roche's drug Tarceva based on Roche's Indian Patent 196774. Roche approached Delhi HC seeking to injunct Cipla from marketing Erlocip. Roche's plea for interim injunction against Cipla was dismissed by Single Judge on March 19th, 2008, Roche's appeal to the Division Bench against the order passed by the Single Judge was dismissed on April 24th, 2009. Roche's subsequent escalation of the matter on special leave before the Supreme Court was also denied and the case moved to trial.

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The trial was completed by Single judge and Judgement was pronounced on September 7th, 2012 in favour of Roche so far as the validity of the Patent was concerned. Apart from the ancillary issues the main issues addressed in the judgement were:

1) Whether Roche's patent stands to be revoked? and 2) Whether the Cipla's manufacture of Erlocip infringes Roche's

patent? The single judge held that Cipla was not infringing Roche's patent and refused to grant any injunction against Cipla. The single judge had also refused to revoke the patent of Roche as sought by Cipla. Cipla’s defence to the charge of infringement was essentially based on the claim that Roche’s Patent is for Polymorphs A+B of Erlotinib Hydrochloride, whereas Tarceva i.e. Roche’s product is just Polymorph B, which corresponds to a US Patent ‘221 (and the rejected Indian Patent Application DEL’507). Hence Cipla urges that while the patent sought to be enforced is for Polymorphs A+B, the product actually under manufacture by both Roche and Cipla is Polymorph B which ought to be assumed to be in the public domain and hence Cipla’s activities are non-infringing in nature. Whereas Roche’s argument was that suit patent was not confined to any polymorphic form of Erlotinib Hydrochloride and hence as long as Erlotinib Hydrochloride is present in Cipla’s product Erlocip, it infringes the suit patent. The Judgement captured here decides two appeals from the Judgement of the Single Judge. The first one filed by Roche was partially allowed and the second one filed by Cipla was dismissed. While allowing the Roche’s appeal for reversing the judgement of single judge on infringement the bench held that it is apparent that the Learned Single Judge has referred to two distinct things i.e. Claim 1 of 774 Patent and Tarceva, interchangeably, to determine the infringement question and comes to what appears to us to be an erroneous conclusion. It is an incorrect analysis of product patent infringement in a case like the present, to use methodologies like X-Ray diffraction to ascertain whether the competing products are identical in nature. The correct test of infringement in this case is to map Cipla product against the Roche’s patent claims, which we find has not been done by the learned Single Judge, and this is the third infirmity on this aspect of the dispute. (Para 76)

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Division bench ruled in favour of Roche after noting that Cipla's lung cancer medicine, Erlocip, was one polymorphic form of the Erlotinib hydrochloride compound, which may exist in several forms, and Roche's patent claim was not limited to any one such version. The Bench held that Cipla would be liable to render accounts concerning manufacture and sale of Erlocip, for which purpose suit filed by Roche against Cipla is restored and directed Joint Registrar who would record evidence pertaining to the profits made by Cipla concerning the offending product. What is interesting here?

1. Product vs. Substance dichotomy Interestingly in this judgement the division bench explained the product vs. substance dichotomy in the Act. The bench held that legislative intent appears clearly to demonstrate that all ‘substances’ may not qualify as ‘products’ under the Act, where the latter are only those substances that are patent eligible. In fact, Section 2(1) (ta) provides the bridge between Section 3 and Section 2(1)(j), in that, it defines a ‘pharmaceutical substance’ as any new entity involving one or more inventive steps. Thus, the discovery of an entity or substance may not involve an inventive step. Insofar as there is no inventive step involved in its formation it is merely a substance even though its structural form may be hitherto unknown. A new chemical entity (NCE) that is structurally dissimilar but functionally similar to an existing chemical entity is thus merely a substance under Section 3(d). If the substance has an added layer of enhanced efficacy, then it would be treated as a ‘new product’ and would be eligible for assessment under Section 2(1)(j) to ascertain whether its formation involved an inventive step. If the new product involved one or more inventive steps, then it would qualify as a pharmaceutical substance. (Para 29)

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The product vs. substance dichotomy in the Act

2. Similar derivatives of known substance under Section 3 (d)

On Section 3 (d) with respect to structurally similar derivatives of a known substance the bench held that section 3 (d) provides that if the new form of the known substance is found despite a structural similarity to demonstrate a better functionality i.e. ‘enhancement of the known efficacy’, it would qualify for assessment under Section 2(1)(j) as if it were a new product involving an inventive step and it would thereafter be up to the applicant for the patent to demonstrate the patentability of this substance in accordance with Sections 2(1)(j) and (ja). This provision is not a patent term extension or an evergreening provision but in fact recognizes incremental innovations in pharmaceutical patents. (Para 29) The Bench said, a product essentially comprises a substance (active ingredient) or composition (combination of active ingredients). A product patent protects the product in any form however it is made, or however it is formulated. Many different drug products may be marketed with the same active moiety and the same product can thus have various structural forms. Thus Section 3(d) envisages a variety of derivatives of known substances (Para 31) some illustrative types could be as under: -

i. A compound which is not active in itself but is metabolized in the body to form an active drug known as prodrug. For e.g., chloramphenicol succinate ester is used as an intravenous prodrug of chloramphenicol, because pure chloramphenicol does not dissolve in water.

ii. A composition (combination of two or more active ingredients or combination of a pharmaceutical carrier with a compound not used as a drug before).

Substance

S. 3(d)

New Product

S. 2(1)(j)

Pharmaceutical

Substance

S. 2(1) (ta)

Enhanced Efficacy Inventive Step

5

iii. A drug delivery system which is a composition that its constituents enable to be administered in a particular way.

3. Patentability of Polymorphs under Section 3 (d)

If there are polymorphs, which improve only the non-therapeutic properties, then there may be a difficulty in obtaining a patent for the same in India (Para 52). It is for this reason that the other Indian polymorphic patent application IN/PCT/2002/00507/DEL filed by Roche was partly rejected. Section 3(d) came in the way of the product claims as there was no data to support that the polymorphic versions were therapeutically more efficient than the basic compound. Division bench was not persuaded with Cipla’s argument to shoot down the main compound because of the polymorphs rejection under 3(d).

4. Person skilled in the art and Reliance on Overseas Jurisprudence for determining inventive step

Interestingly in a previous decision for the same matter, Single Judge in his judgement stated that no special understanding of inventive step under the Patent Act, 1970 is necessary qua pharmaceutical patents, discarding any reliance on any jurisprudential qualifications of inventive step for pharmaceutical products in other jurisdictions. The learned Single Judge has said that the person skilled in the art as a competent craftsman and a skilled worker but nothing further;

5. Section 8 is a directory Rule and substantial compliance may be enough

Division bench held that Section 64(1) is directory in nature and thus noncompliance of Section 8 would not automatically result in revocation of the patent, the use of the word ‘may’ in Section 64(1) itself indicates the intention of the legislature that the power conferred thereunder is discretionary and consequently it is necessary for the Court to consider the question as to whether omission on the part of the applicant was intentional or whether it was a mere clerical and bona-fide error. The doctrine of substantial compliance is a judicial invention, equitable in nature, designed to avoid hardship in cases where a party does all that can reasonably be expected of it, but failed or faulted in some minor or inconsequent aspects

6

which cannot be described as the essence or the substance of the requirements. Like the concept of reasonableness, the acceptance or otherwise of a plea of substantial compliance‖ depends on the facts and circumstances of each case and the purpose and object to be achieved and the context of the prerequisites which are essential to achieve the object and purpose of the rule or the regulation (See (2011) 1 SCC 236 Commissioner of Central Excise, New Delhi Vs. Hari Chand Shri Gopal & Ors.). The bench held that noncompliance of Section 8 under Section 64(1)(m) was no reason to revoke the suit patent.

6. Registration of Deed of assignment

The Registration Act does not envisage a deed of assignment of a trademark/copyright or patent to be compulsorily registered not being an immovable property.

***

7

S. No. #2

Case No.: Motion No. 497 Of 2014 in Suit No. 448 of 2012 Court: High Court of Bombay

Plaintiff CTR Manufacturing Industries Limited

Vs. Defendants

Sergi Transformer Explosion Prevention Technologies Pvt. Ltd. & Ors.

Judge: Hon'ble Justice Gautam Shirish Patel Appearance for Plaintiff: Mr. Navroz Seervai, Senior Advocate, with Mr. H.W. Kane, Ms. Gulnar Mistry, Mr. Atul Singh, Mr. Amit Jajoo & Ms. Anaisha Zecharia, i/b M/s. PKA Associates Appearance for Defendant: Mr. I.M. Chagla, Senior Advocate, with Mr. Pradeep Sancheti, Senior Advocate, Mr. Pravin Anand, Mr. Vivek A. Vashi, Mr. Aditya Gupta, Mr. Jehangir Jeejeebhoy, Mr. Aditya Sikka, Mr. Krishnendu Satya & Ms. S. Madraswala, i/b M/s. Bharucha & Partners. Order Pronounced on: 23rd October 2015 What is it about? The Plaintiff (“CTR”) had Indian Patent No. 202302 granted on 3rd August 2006 for an explosion and fire detection technology for use in electrical transformers. As per the facts provided in the Judgement this appears to be a very strange Patent for the following reasons: (1) The Patent was granted on 3rd August 2009 (within 8.5 months of filing) but grant inadvertently had not been notified under Section 43(2) of the Patents Act by the Patent office until January 2010. (2) Clueless about the status of the Patent the defendant filed a Pre-Grant and Post-Grant opposition on the same day on 20th January 2010. (3) Finally the grant of CTR's Patent No. 202302 was published in the Official Journal on 16th April 2010. (4) On 27th January 2012, The Controller of Patents informed that he did not take Sergi's pre-grant opposition on record because of some pending documents. Sergi filed Writ Petition No. 2308 of 2011 at High Court of

8

Bombay against that decision, also urging that CTR's Patent had been granted with uncommon despatch. At the hearing of that petition, Sergi placed the order before Division Bench which allowed Sergi to file those documents within two weeks. (5) While the Infringement matter was being heard in the Thane District court, Sergi on 19th June 2012, filed a revocation application (ORA Nno.42/12/PT/MUM) at Intellectual Property Appellate Board ("IPAB"). To the surprise of the judge, it was precisely the situation that the Supreme Court (in Aloys Wobben & Anr. v Yogesh Mehra) said was unlikely ever to arise: where there are, pending all at once, a post-grant opposition (and also a pre-grant opposition, it seems), a Counter-Claim and an application for revocation. Now coming back to the judgement, Plaintiff (CTR) claimed that Sergi’s product, the SERGI 3000, is an infringement. Sergi says it is no such thing, and its product uses a different technology. Sergi claims it has a license to manufacture fire systems in accordance with another Indian Patent No.189089 granted on 14th December 2002. CTR earlier filed a case for suit for infringement at Thane District court and was granted ex parte ad-interim reliefs against the defendant restraining the defendant from selling its product to DTL (a company who floated a tender for the same product). DTL opened the price bids. Sergi (defendant) was declared to be the lowest bidder, Sergi wrote to DTL saying it looked forward to receiving a purchase order and DTL placed a purchase order on Sergi. Later Thane District Court allowed CTR’s application for interim relief and defendant appealed. The Appeal Court found that the ad-interim and interim orders (the first ad-interim order) and (the final order) of the Thane District Court in fact continued in force and survived; and that both orders were in the nature of subsisting and binding ad-interim orders. The judgement and order was stayed for four weeks, subject to Sergi not entering into a fresh contract with another party in respect of the products in question. It was clarified that the stay was to enable Sergi to execute the contract with DTL. CTR filed Special Leave Petition before the Supreme Court against the order(s) of the Thane Court. A leave was granted in both Special Leave Petitions and these were disposed of with several directions. The matter was heard in the High Court and was decided in favour of Plaintiff, CTR, the judge held that the pith and marrow of CTR’s invention is

9

the two integers working interdependently to produce what is, prima facie, a dramatically improved result at the stage of an explosion detection (not fire extinguishing or fire detection and prevention); it was held that Sergi has entirely abandoned its patent and has adopted CTR’s; Sergi could not have met the DTL bid without such an infringement. It was held that Sergi cannot possibly be permitted to continue with what was found to be a clear case of infringement. Why it is interesting here?

1. Infringement of Combination Patent

The invention pertained to a Combination Patent and the court held that the principles one may legitimately draw in a combination patent infringement case are these:

(i) The invention cannot be a mere arrangement or rearrangement of previously known integers all functioning independently in a known way; These integers, though all themselves previously known, may be combined in a previously unknown way, acting inter-dependently, each of them essential, to produce a new and improved result.

(ii) Each of the integers must be essential. If anyone can be taken out without affecting the final result, it is not essential.

(iii) If a patent claim is overbroad, and for that reason, includes in the sweep of the case for infringement the defendant’s invention, i.e., by including every single non-essential and essential addition, then the patent may be prima facie invalid for want of novelty. No person can claim such a monopoly as would result in a bar to future improvements. If the patent is, on the other hand, so narrow that it excludes the addition of another essential integer, then there is no infringement.

(iv) Where a patent has been granted on the patentee disclaiming a particular integer, i.e., by saying it is not essential to his product, then the addition of that nonessential integer does not, per se, defeat the claim for infringement. It must be shown that the additional integer is essential, required and returns a result that is as or more efficient than that produced by the patent.

10

(v) Adding something superfluous to the essential integers does not defeat an infringement claim. It must be shown that what is added is also essential and that it satisfies the previous tests of interdependency, producing as good a result or a new and improved result.

(vi) The patent must be read in a purposive manner to determine what constitutes its ‘pith and marrow’.

2. Ad-interim injunction and validity

At an interim stage, a Court is not required to examine the validity of a patent so much as its vulnerability; and this is to be tested not on a mere say-so, but with the aid of cogent and persuasive technical and scientific material, including reliable expert opinions and other data. The fact that a patent has been granted is not wholly immaterial at an interim stage. While the grant is not a complete answer to a charge of prima facie invalidity or vulnerability, it is still a factor to be considered and given appropriate weight; just how much is fact dependent. The speed of grant of a patent is wholly irrelevant, particularly if it is made without a substantiated (and substantial) case on illegality and malafide.

***

11

S. No. #3

Case: CS(OS) 586/2013 & CC No. 46/2013 & I.A. Nos. 9827/2013, 8048/2014 & 13626/2015 Court: High Court of Delhi

Plaintiff Merck Sharp & Dohme Corporation & Anr

Vs. Defendant

Glenmark Pharmaceuticals Ltd. Judge: Hon'ble Justice Mr. A.K. Pathak Appearance for Plaintiffs: Mr. Pravin Anand, Ms. Archana Shankar, Ms. Tusha Malhotra, Ms. Udita M Patro, Ms. Nupur Maithani and Mr. Devender Rawat, Advs. Appearance for Defendants: Mrs. Pratibha M Singh, Sr. Adv. With Ms. Saya Choudhary, Ms. Manika Arora, Ms. Archana Singh, Mr. Aditya Jayaraj, Ms. Mitali Agarwal and Mr. Shobhit Choudhary, Advs. Order delivered on: 7th October, 2015 What is it about? Plaintiffs filed this suit against the defendant for permanent injunction in respect of Sitagliptin Phosphate Monohydrate or any other salt of Sitagliptin in any form, alone or in combination that infringes the claimed Plaintiff’s Patent No. 209816. The defendants were selling Sitagliptin Phosphate monohydrate under the brand ZITA and Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride under the brand name ZITA –MET. Defendant had filed written statement-cum-counter claim wherein, had prayed for revocation of the suit patent. Defendant has alleged that it does not infringe the suit patent since:

I. it lacks inventive step II. invention claimed lacks industrial applicability within the meaning

of section 64(1)(g) of the Act. Invention disclosed was physically and chemically unstable in nature and was incapable of being used in solid dose formulations;

III. Disclosure was insufficient within the meaning of Section 64(1)(h) as complete specification was not disclosed regarding the

12

preparation of Sitagliptin base so as to enable a person in India, possessing average skill and knowledge to work the invention,

IV. Any claim of the complete specification is not fairly based on the matter disclosed in the specification, thus, violated section 64(1)(i) of the Act.

V. Patent was obtained on a false suggestion or representation and was liable to be revoked under Section 64(1) (j) of the Act.

VI. Applicant failed to comply with Section 8 of the Act resultantly patent is liable to be revoked under Section 64 (1) (m) of the Act.

Following Issues were framed accordingly:

I. Whether the plaint has been signed, verified and filed by a duly authorized person?

II. Whether the plaintiff is the proprietor of Indian Patent No. 209816?

III. Whether the plaintiff is not the owner of the patent no. 209816? IV. Whether the defendants have been infringing patent No. 209816

of the plaintiff? V. Whether the defendant has misrepresentations on the product

packaging and package insert? VI. Whether the license agreement between plaintiff No.1 and plaintiff

no. 2 has not been executed in accordance with law? VII. Whether the registration/recordal of the license agreement

between the plaintiffs qua the suit patent has not been done in accordance with Indian law?

VIII. Whether the plaintiffs have suppressed material facts and documents, if so, its effect?

IX. Whether the defendant’s product ZITA and ZITA-MET infringe the patent of the plaintiff?

X. Whether the patent No. 209816 is invalid? XI. Whether the Dihydrogen Phosphate Salt of Sitagliptin is covered,

enabled and disclosed in the suit patent? If so, its effect? XII. Relief

The judge held that onus to prove that invention in the suit patent was obvious to a person skilled in the art was on the defendant, in which defendant has failed to discharge by leading a positive evidence on record. Mere comparison of chemical structure is not sufficient, inasmuch as, picking up parts of chemical structures of different patents and clubbing

13

them will also not be sufficient, as it appears to have been done, keeping in mind the molecular structure of the suit patent, as a hindsight analysis. A direct question was put to Defendant’s witness 2, that the methodology followed by him was typically referred to as hindsight analysis and is a prohibited methodology in patent law to which he answered “I have no comments”. He has not denied this suggestion. Instead has given a vague answer which is deemed admission on this point. Hindsight analysis is not permissible. Even otherwise, not much reliance can be placed on this witness. Above all, PW4 inventor of the suit patent, was not confronted with these prior arts nor was any question put to her that, in view of the patent’s cited, invention was obvious. Furthermore, Plaintiff Witness 2, for the detailed reasons, has categorically stated that suit patent was not obvious to a person skilled in the art. This contention of defendant was, thus, rejected. In the judgement the defendant was restrained by a decree of permanent injunction from making, using, selling, distributing, advertising, exporting, offering for sale or dealing in Sitagliptin Phosphate Monohydrate or any other salt of Sitagliptin in any form, alone or in combination with one or more other drugs thereby infringing the suit patent no. 209816 of the plaintiffs. What is interesting here?

1. Authenticity of $1 Consideration Agreements The defendants challenged the authenticity of license between Merck Sharp & Dohme Corporation and MSD International GMBH recorded in the register since value of assignment was juts US $ 1. The Judge held that, inadequacy of consideration will not be sufficient to doubt the license agreement. In Wonderweld Electrodes (Pvt.) Ltd. & Ors. Vs. Ahura Welding Electrodues Manufacturing Limited & Ors. 2003 (26) PTC 37 (DB) (Mad), it has been observed thus: According to them, trade mark can be assigned even for a nominal consideration of Rs. 1 or US $ 1.

2. Section 8 again The Judge held that having regard to the fact that section 8 is a mandatory provision and its noncompliance is a ground for revocation of the patent under section 64(1)(m), the world ‘may’ employed in section 64(1) should be construed to mean imperative. This argument has been rejected by the

14

Division Bench in FAO (OS)16/2004 Tilted Maj. (Retd.) Sukesh Bhel & Anr. V. Koninklijke Phillips Electronics. It is further held that revocation would follow only if the court is of the view that omission to furnish the information was deliberate. No evidence has been led by the defendant to show that such non-disclosure of the information was deliberate and for malafide reasons. Accordingly, this argument is rejected.

***

15

S. No. #4

Case No: I.A. No.17351/2015 in CS (OS) 2501/2015 Court: High Court of Delhi

Plaintiff Telefonaktiebolaget LM Ericsson

Vs. Defendant

M/S Best It World (India) Private Limited (i-ball) Judge: Hon'ble Mr. Justice Manmohan Singh Appearance for Plaintiff: Mr. C. S. Vaidyanathan, Sr. Adv. & Ms. Pratibha M. Singh, Sr. Adv. with Ms. Saya Choudhary & Mr. Ashutosh Kumar, Advs Appearance for Defendant: Mr. Amit Sibal, Sr. Adv with Mr. Dev Robinson, Mr. Ajit Warrier, Mr. Naval Chopra, Mr. Aashish Gupta, Mr. Aman Sethi, Mr. Jogeshwar Mishra, Ms. Shreya Munoth, Advs. Orders delivered on: 2nd September, 2015 & 29th October 2015 What is it about? This matter was a suit for permanent injunction restraining infringement of patents, damages, rendition of accounts, delivery up etc. against the defendant. Two orders of this matter are summarized here.

(1) On 2nd September the defendant’s counsel sought time to take instructions from his client as to whether the defendant is willing to sit with the representative of the plaintiff and discuss the matter about the execution of FRAND agreement. When the matter was taken up later in the day, plaintiff informed that no communication was received from the defendant for the purpose of discussion of the matter. Therefore, an order was pronounced (on 2nd September). The defendant was restrained from importing of mobiles, handsets, devices, tablets etc. that were infringing in nature until the next date.

(2) The second order of 29th October 2015 is in the same matter is for

disposal of suit, since the parties entered into a Global Patent License Agreement dated 20th October, 2015 and by virtue of the same, the defendant had accepted a worldwide non-transferable

16

and non-exclusive patent license. Parties shall be bound by the terms and conditions of the agreement.

This is relevant since this case shows how more and more Mobile Phone companies are settling the matters with Telefonaktiebolaget LM Ericsson and signing SEP Agreements on FRAND Terms. What is interesting here? It is interesting to see how Ericsson is able to achieve the SEP Enforcement in other similar matters filed by at the Delhi High Court:

Party/Case No. Stage and Remarks (as on 15th December when this book went to press)

Micromax Informatics Ltd CS (OS) No. 442 of 2013

In this matter by an order dated 12th November 2014 the Single Judge directed payment of the royalty to the plaintiff (Ericsson) for sales made in India at the rates ranging from 0.8-1.3% of the net selling price during final trial in the suit. Later Developments (15th December 2015) Currently an appeal in contempt of Court’s order is being heard in this matter since Mercury Electronics and Micromax were found to be selling infringing goods without royalty through Yu Televentures (their Subsidiary).

Gionee Communication Equipment Co. Ltd. CS(OS)No. 2010/ 2013

Gionee is paying royalty to Ericsson since consent order dated 31st October, 2013. Gionee is required to pay royalty ranging from 1.25% to 2% which is higher than 0.8% to 1.3% being paid by Micromax, on account that Gionee has sales outside India as well.

Kingtech Electronics CS(OS) No. 68/ 2012

KingTech has given an undertaking that it will not import in India any mobile phone using AMR Speech Codec Technology as claimed by Ericsson.

Lava International Limited CS(OS) No. 764 /2015

Parties are negotiating settlement during the pendency of a matter.

***

17

S. No. #5

Case No: CS(OS) No. 1112/2006 Court: High Court of Delhi

Plaintiff Bata India Limited

Vs. Defendant

Vitaflex Mauch Gmbh

Judge: Hon’ble Justice Mr. Valmiki J. Mehta Appearance Plaintiff Through: Ms. Tusha Malhotra, Advocate Appearance Defendant Through: None Date of Pronouncement: 24th August, 2015

What is it about?

Defendant served a Legal Notice dated 3rd April 2006 on Plaintiff. Plaintiff sought declaration that the threats made by the defendant through the notice with respect to the shoes being manufactured by the plaintiff being an infringement of the trade mark or patent rights of the defendant were unjustified and wrongful. Plaintiff also sought the relief of injunction to restrain the defendant from issuing the groundless, unjustifiable or wrongful threats to the plaintiff and also from circulating threats through circulars or advertisements or by communications (oral or written) to the plaintiff or any other person, in this regard. Plaintiff also sought damages of Rs. 20 lacs on account of the unjustifiable and wrongful threats issued by the defendant. Defendant, Vitaflex Mauch Gmbh was proceeded ex parte order and never appeared in any proceedings thereafter. Suit is decreed in the favour of Plaintiff. What is interesting here? Onus was on the defendant to show that the defendant had a right in the reflex/pressure points depiction as a trade mark including by registration thereof or that the defendant had a valid patent and which as per the defendant was being infringed by the plaintiff

***

18

S. No. #6

Case No.: FAO (OS) 96/2014 Court: High Court of Delhi

Appellant Shilpa Medicare Limited

Versus Respondents

Bristol-Myers Squibb Company and Ors.

Judge: Hon’ble Justice Mr. S. Ravindra Bhat and Hon’ble Justice Mr. V.K. Shali Appearance: Appellant Through: Sh. Vivek Sarin and Sh. Ashok Kumar Singh, Advocates. Respondents Through: Sh. Sudhir Chandra, Sr. Advocate with Sh. Pravin Anand, Sh. Nishchal Anand and Sh. Aman Taneja, Advocates, for Respondent Nos.1 and 2. Sh. Gaurav Barathi, Advocate, for Respondent No.3. Date of Order: July 30th 2015 What is it about? This matter was a result of an appeal by the second defendant who is an appellant in this case (“Shilpa Medicare”) against the order of a single judge dated 11th October 2013 dismissing its application for challenge of the jurisdiction. Shilpa sought an order seeking return of the plaint to the Plaintiff for presentation in the appropriate court. A little background of the matter: Pursuant to a request made to the Drugs Control Department of Karnataka under the Right to Information Act, 2005, the Plaintiffs learnt that Shilpa Medicare had applied for and had been granted a manufacturing license by the Drug Controller and Licensing Authority, Karnataka for manufacturing Dasatinib™ bulk drug. In addition, Shilpa Medicare, in its website, had listed Dasatinib™ in their product list as 'Under Development Oncology Active Pharmaceutical Ingredients’. The plaintiff’s (Respondents here) expressed apprehensions, consequently about the threat of the first two defendants (Appellants in this case) entering into arrangement with Natco Pharma, to manufacture and sell Dasatinib™ (API) and that respondent also believed

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they “are soon going to sell and/or offer for sale Dasatinib™ (API) to various generic pharmaceutical companies located in India including but not limited to Defendant No. 3 (Natco Pharma). Defendants Nos.1 & 2 are further likely to increase their revenue by exporting bulk quantities of Dasatinib™ (API) to various international pharmaceutical companies located abroad." Bristol-Myers Squibb (Respondent in this case) filed a quia timet action in the Delhi High Court. After notice and summons were issued, Shilpa, inter alia, filed an application (IA No. 10403/2013) for return/dismissal of the plaint. It claimed that the manufacturing license that has been granted to it by the State Drugs Control Department of Karnataka is for its manufacturing unit located in district Raichur, Karnataka. Shilpa averred that it neither has a registered office nor a branch office in Delhi and, therefore, the Court does not have any territorial jurisdiction to entertain the suit. It was alleged that the Plaintiffs have indulged in forum shopping and, therefore, the plaint must either be rejected or returned. In reply to the said application, Bristol Myers submitted that a part of the cause of action has arisen in Delhi, as Shilpa has customers, consumers, buyers and a host of other persons for various aspects of their business activities in Delhi and thus have purposefully availed jurisdiction of Delhi. Thus Plaintiffs invoked the jurisdiction of Delhi on the basis of the threat or apprehension that the actions of the Defendant within the territorial jurisdiction of Delhi High Court are likely to cause prejudice to the Plaintiff. The Plaintiffs urged that the Court can entertain such action, even if the threat has not culminated into a reality. So, one of the issues that arose for determination was whether, in the facts and circumstances of the present case, based on the averments made in the plaint, it can be said that the Court has territorial jurisdiction to entertain the suit. Particular to the present case, the question that arises is whether the mere apprehension of the Plaintiff or its perception of a threat of infringement by the Defendants of its patent occurring within the local limits of this Court is sufficient to attract the jurisdiction of this Court. The single judge said, it is not necessary at this stage, for the Plaintiff to name the particular customers of Defendants to whom the product is to be sold since what is expressed is only an apprehension of "offer for sale". At this stage, the Plaintiff can at best refer to the fact that Defendant supplies oncology APIs to various generic companies and that the said APIs are sold in Delhi. The apprehension that such oncology APIs may in the near future

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include the infringing product which is also an oncology API cannot, in the circumstances, be characterised as lacking credibility and having been asserted merely to attract the jurisdiction of the Court. The above averments in the present plaint, which is in a quia timet action, are prima facie sufficient to show that Defendant (Shilpa) "carries on business" in Delhi and that the prima facie [sic] the cause of action arises within the jurisdiction of this Court. The bench in its order noticed that …. impugned order has taken note of the plaint averments, particularly Paras.…that Shilpa intends to supply API to various generic manufacturers in India and abroad. It was stated that the plaintiff was not obliged to name specific customers of the defendants‟ products and the assertion that the latter offered oncology APIs which could include infringing products in the future, were sufficient averments to constitute cause of action, within territorial jurisdiction of this court. For the above reasons, it is held by the bench that there is no infirmity with the impugned order of the learned single judge rejecting the Appellant’s application What is interesting here? Apprehended injury the court confines to pleadings for the answer In quia timet action, which visualize apprehended injury the most prominent contention for the plaintiff is to show that the burden of proving such apprehension is heavy. Yet, the fact remains that the suit is based to a large extent on the threat. Now how does a court evaluate a threat to adjudge if it is justified, in the context of a dispute about its territorial jurisdiction? This is to be seen from the requirements of what has to be pleaded in a plaint, and what can legitimately be seen when a dispute (with regard to the territorial jurisdiction) arises. The court necessarily has to confine its gaze to the plaint and the documents filed with it.

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S. No. #7

Case No: W.P. No.15736 of 2015 Court: Madras High Court

Petitioner

Novartis AG Vs.

Respondents Union of India, Wockhardt Limited and

The Deputy Registrar, Intellectual Property Appellate Board

Judge: The Hon'ble Mr. Sanjay Kishan Kaul, Chief Justice and The Hon'ble Mr. Justice T. S. Sivagnanam Appearance: For Petitioner: Mr. Arvind P. Datar Senior counsel and Mr. Hemanth Singh and Ms. Mamta Jha for Mr. Sathish Parasaran For Respondents: Mr. T. V. Ramanujam Senior counsel for Mr. Arun C. Mohan for R2, Mr. D. Ramesh Kumar ACGSC for RR1&R3 Date of Pronouncing the orders: 28th July 2015 What is it about? Writ Petition was filed by the Petitioner to Challenge the alleged arbitrary exercise of discretion of power vested with the IPAB to entertain a Miscellaneous Petition (in a matter numbered ORA/21/2013/PT/CH) for reception of additional documents and raising additional grounds. It was submitted that the IPAB relied on Section 92(2) of the Trade Marks Act, 1995, and observed that it is vested with enormous and unambiguous power to deal with the Miscellaneous Petitions on the basis of principles of natural justice and powers conferred under Section 92(1) (2) &(3) of the Trade Marks Act, 1999 and this finding of the Tribunal is erroneous, since already the IPAB (Patent Procedure) Rules, 2010, were framed under Section 92 of the Trade Marks Act and the said Rules did permit additional grounds to be raised apart from the grounds initially raised in Form-1 of the Revocation Application and therefore, the reliance placed on Section 92 of the Trade Marks Act is contrary to law.

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The bench held that in terms of sub-section (1) of Section 92, though the appellate Board shall not be bound by the procedure laid down in the Code of Civil Procedure, it shall be guided by principles of natural justice and subject to the provisions of the Act and Rules made under and the appellate Board shall have powers to regulate its own procedure including the fixing of places and times of its hearing. Sub-section (2) of Section 92, states that the appellate Board shall have the same power as vested in a civil Court under the Code of Civil Procedure, while trying a suit in respect of matters (a) receiving evidence; (b) issuing commissions for examination of witnesses; (c) requisitioning any public record; and (d) any other matter which may be prescribed. Thus on a conjoint reading of Section 92(1), 92(2)(a) of the Trade Marks Act and 107B of the Patents Act, the bench said that we have no hesitation to hold that the appellate Board is vested with powers to regulate its own procedure as it is vested with the same powers of a Civil Court under Code of Civil Procedure, more particularly for the purpose of receiving evidence. Thus, the Appellate Board was fully justified in entertaining the Miscellaneous Petition filed by the second respondent. In the light of the above discussion…. the order impugned passed by the IPAB was held valid and was not interfered. Accordingly, the Writ Petition failed and was dismissed.

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S. No. #8

Case No.: W.P.No.4662 of 2014 & M.P.No.2 of 2014 Court: Madras High Court

Petitioner S. M. Anand Vel

Vs. Respondent

Union of India, Controller General of Patents Designs & Trade Marks (Mumbai), CGPDTM (Chennai), Assistant Controller Patents (Chennai)

Judge: The Hon’ble Mr. Justice T. S. Sivagnanam Appearance: For Petitioner Mr. Niranjan Rajagopalan for M/s G. R. Associates, For Respondents: Mr. L. Murugan, CGSC (R1 to R4) Order Pronounced on: 20th July 2015 What is it about? Petitioner was not heard by the controller before passing order for refusal of Patent as per Section 15 of The Patents Act. The Controller only after hearing the petitioner can pass a speaking order as per Section 15 of Act. The petitioner challenged the impugned order of the Controller, in fact, a rejection of the application for the grant of patent, which could be done inconsonance with Sections 14 and 15 of the Patent Act. Brief History of the matter: A First Examination Report was issued by the Controller on 30th November 2010 and thereafter, the petitioner amended the claims on 25th May 2011. Consequent thereto, the Controller re-examined the matter and issued another Examination Report on 2nd August 2011. In the said Report, certain queries were raised, giving an opportunity to the petitioner to put forth his objections. Accordingly, the petitioner put forth his objections by a communication dated 6th August 2011 followed by further communication dated 9th August 2011, which was received by the Patent Office on 10th August 2011 and the seal was also affixed on the said communication.

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Once again, another Examination Report (Third one) dated 13th October 2011 was issued by the Controller. On a perusal of the said Report, it is seen that the objections pointed out in the said Report were new set of objections, which did not find place in the Examination Report dated 2nd August 2011. On receipt of the same, the petitioner put forth his submissions vide reply dated 13th December 2011, which also contained an annexure. Thereafter, the impugned proceeding has been passed by the fourth respondent on 09th March 2012. Submission of the counsel appearing for the petitioner was that the application could not have been rejected on the ground of abandonment under Section 21(1) of the Act, especially, when the Examination Reports dated 02nd August 2011 and 13th October 2011 contained two sets of fresh objections and not the same objections and therefore, the petitioner's application could not have been rejected as abandoned. The Hon’ble Judge remanded the matter to the Controller for a fresh consideration and for passing a reasoned order under Section 15 of the Act as expeditiously as possible. The court directed that petitioner shall be given an opportunity of personal hearing before passing an order for refusal of Patent. What is interesting here? This order has again reinforced the fact that before rejecting the Patent application and issuing the order under Section 15, the controller must give opportunity for the Applicant to be heard once.

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S. No. #9

Case No: I.A. No.15720/2009 in CS(OS) No.2303/2009, I.A. No.5910/2013 in CS(OS) No.679/2013 Court: The High Court of Delhi

Plaintiff

Bristol-Myers Squibb Company & Ors versus

Defendants Mr J.D. Joshi & MJ Chempharm Private Limited (BDR Lifesciences Pvt.

Ltd.) Mr. D. Shah & Anr.

Judge: Hon’ble Justice Mr. Manmohan Singh Appearance: Plaintiffs Through: Mr. Pravin Anand, Adv. with Mr. Nishchal Anand and Mr. Aman Taneja, Ms. Archana Shanker, Advocate, Ms. Priyanka Dubey Advs. Defendants Through: Ms. Rajeshwari H., Adv. Order pronounced on: 29th June, 2015 What is it about? Two suits for permanent injunction restraining infringement of Indian Patent No.203937 and for damages against the defendants were filed before the Delhi High Court. Both suits were quia timet actions. Plaintiffs had reasonable apprehension that the defendants were going to launch the generic product which would infringe the claims of IN 203937 and they may violate the exclusive rights of the plaintiffs granted under Section 48 of the Indian Patents Act, 1970. Let’s go back in the history of the matter, the first suit, it was stated by the plaintiffs that around December 2008, they received information that defendant No.2 (“M.J. Chempharma Pvt. Ltd.”) had applied to the DCGI for the marketing approval for Dasatinib. The plaintiffs sent a ‘cease and desist’ letter dated 12th January 2009 to defendant No.2 asking them to restrain from infringing IN 203937. (For a long time, no response was received from the Defendants), In the meantime, plaintiffs also filed a Right to Information (“RTI”) Application with the DCGI on 12th May 2009 enquiring as to whether

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the Defendants-Company had filed an application seeking marketing approval for Dasatinib. The plaintiffs received a reply from the DCGI on 25th June 2009 which stated that two companies have applied for the marketing approval for Dasatinib but did not disclose the name of the companies. The plaintiffs thereafter sent a reminder to its letter dated 12th January 2009. A response was received from the defendants on 6th August 2009 in which it admitted to have applied for a marketing approval for Dasatinib. In view of the apprehension that the defendants may not infringe the plaintiffs’ exclusive right of the patent, the plaintiffs filed a suit being CS(OS) No.2303/2009 in the nature of a quia timet action against the defendants on 3rd December 2009 for the infringement of IN 203937. The defendant No. 2 (Name Changed to BDR Lifesciences) admitted in their written statement that the defendant is intending to launch the generic version of Dasatinib only if the DCGI grants licence to the defendant to manufacture under the provisions of DCA. During the pendency of the first suit, in the meantime, on 2nd February 2012 another group company of defendant No.2, BDR Pharma (not BDR life Sciences) wrote to the plaintiffs requesting for a voluntary license for IN 203937 to manufacture and market Dasatinib. The plaintiffs responded on 13th March, 2012 asking for certain details (listed below) to evaluate its decision to grant the voluntary license. a) Facts which demonstrate an ability to consistently supply high volume of the API, DASATINIB, to the market; b) Facts showing your litigation history or any other factors which may jeopardize Bristol-Myers Squibb's market position; c) Facts showing any history of not honouring patents or other intellectual property; d) Capability of handling the ultimate demand for DASATINIB; e) Facts showing your ability to supply API for other Anti-Cancer Drugs; f) Your ability to meet timelines; g) Quality related facts and in particular compliance with local regulatory standards and basic GMP requirements; h) Demonstrated successful technology transfer and filings; i) Quality Assurance Systems Due Diligence (having quality management systems that include Change Control, Deviations, Validations, Qualifications, Training, Packaging, Labelling and Laboratory systems to include QC Testing capability and COA management);

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j) Ability to formulate and distribute; k) Established relationships with NGOs and local Governments and experience in navigating through emerging market bureaucracy; l) Ability to develop new and more efficient chemistry; m) Financial transparency; n) Pricing proposals; o) Commercial supply terms; p) History of working with pharma innovators; q) Robust IP protection and compliance policies; r) Safety and environmental profile; s) Risk of local corruption; t) Any other relevant issues that might enable us to form a business decision. BDR Pharma did not respond to the Patent Holder the details asked in the letter for over 14 months. In the meanwhile, during this period and without informing the plaintiffs or the Court, BDR Life Sciences applied and obtained a manufacturing license for Dasatinib Tablets from the Food and Drug Control Administration Maharashtra on 18th January, 2013. BDR Life Sciences applied for a manufacturing license for Dasatinib BULK to Food and Drug Control Administration Gujarat on 18th January, 2013 and obtained the same on 13th March, 2013. BDR Life Sciences did not inform the Court of the same. On 4th March, 2013, BDR Pharma applied for a compulsory license for IN 203937 before the Patent Controller. BDR Pharma did not inform the plaintiffs of the compulsory licensing application but as per the plaintiffs, they got to know about the same from newspaper reports. In the same period BDR also started advertising and offering for sale of Dasatinib Tablets under the head “Finished formulations” on its website. The above said acts of BDR Pharma and BDR Life Sciences created further apprehension in the mind of the plaintiffs that BDR Pharma or BDR Life Sciences intend to circumvent the ad-interim injunction granted in the first suit and they may introduce the drug by infringing the suit patent. The plaintiffs immediately filed fresh action being a suit bearing CS(OS) No.679 of 2013 against the defendants in the nature of a qui timet action for the infringement of IN 203937 (“Second Suit”) on 11th April, 2013. The two suits were consolidated later on 12th October 2015 after this order and issues were also framed.

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In the meantime, on 5th May, 2013 the Patent Controller considered the compulsory license application filed by BDR Pharma and opined that the BDR Pharma had not made out a prima face case for grant of a license as the applicant/ BDR Pharma did not make efforts to obtain a licence from the patentee on reasonable terms and conditions and relegated the applicant/ BDR Pharma to approach the plaintiffs for voluntary licence. Thereby, the learned controller by his order dated 29th October, 2013 rejected the application filed by BDR Pharma seeking compulsory licence holding that BDR Pharma did not follow the due procedure in law prior to making the application under Section 84 and thus the occasion to entertain application seeking compulsory licence has not arisen. In the meantime, BDR Pharma again contacted the plaintiffs to revive its negotiations for a voluntary license with the plaintiffs. After analysing the defendant’s arguments challenging the validity of the Patent the Court held that defendant have not been able to establish prima-facie credible defence, and the case of infringement is made out. Under the said circumstances, public interest is an exception to the patent, otherwise the rights granted under Section 48 by the Sovereign towards monopoly would be undermined. The plea of public interest may be invoked once the Court would find that prima-facie the case of credible defence is made out. In the present case, the defendants have not made any representation to the Central Government by raising the plea of public interest, expensive drug and fully non-availability of the drug in question to the patients, nor has the Government exercised its discretion under Section 66 of the Act. The ad-interim injunction has been operating against the defendants since 4th December 2009. It was an admitted position that the defendants have not yet launched the generic version of Dasatinib commercially in the market. No application for vacation has been filed by the defendants for the last more than five years. No request was made by the defendants to the Court during this period to know their interest or intent to launch the product. The court said that Proxy war in the Court at this stage cannot be permitted to allowed. The conduct of the parties was obviously paramount. Thus, the balance of convenience tilted in favour of the plaintiffs otherwise. Appeal was dismissed. What is interesting here?

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Challenge on Utility grounds under Section 64(1) g at ad interim stage It is argued that Markush Claims lists billions of compounds and leaves the “utility” or “evidence of usefulness” to the imagination of a person skilled in the art. There was not a single sentence or whisper as to how the billions of compounds claimed in claim 1 or other claims were useful for treatment of blood cancer or leukaemia. The Judge however said that challenge as to utility is such which cannot be by mere asking of the defendants be assumed to be raising a doubt as to the validity of the patent till the time answers to relevant concerns/questions are provided during the trial. Therefore, the Judge said, I prima facie do not find the plea of the lack of utility as convincing to raise any credible challenge to the validity of the suit patent though it may be a defence, which is yet to be substantiated with more facts during the course of the trial.

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S. No. #10

Case No: W.P.(C) No.2867/2014 Court: High Court of Delhi

Petitioner The Delhi Network of Positive People

Vs. Respondent

Union of India & Ors. Judges: Hon’ble The Chief Justice Hon’ble Mr. Justice Rajiv Sahai Endlaw Appearance: Petitioner: Through: Mr. Anand Grover, Sr. Adv. with Mr. Saurabh Chauhan, Mr. Varun Jain & Ms. Apurba Kundu, Advs Respondents Through: Mr. Vikram Jetley, Adv. with Ms. Chitra, Adv. for UOI Date of decision: 7th May, 2015 What is it about? Petitioner filed Public Interest Litigation (PIL), to secure the rights of persons living with HIV/AIDS, pleading practice adopted by pharmaceutical companies to keep the patent applications pending i.e. of filing a divisional patent application based on an earlier filed patent application – this helps keep a patent application over a particular medicine alive and creates uncertainty over the patent status of the medicines; such uncertainty is against public interest. Petitioner said Pharma Companies are misusing the system of filing divisional application with claim which are identical to the claims of the parent application; petition sought: (a) a direction to the respondent no.1 Ministry of Industry and Commerce to prevent abuse of process in filing of divisional patent applications, including by amending Form-I of the Patents Act, to require a declaration from the patent applicant at the time of filing such divisional application that the parent application discloses multiple inventions not constituting one single inventive concept and that the claims of the divisional applications are not identical to that of the parent applications; (b) a prohibition against the respondent no.2 Controller General of Patents and respondent no.3 Joint Controller of Patents & Designs from proceeding with examining and processing divisional patent applications on merits until

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the existence of jurisdictional fact and their maintainability as divisional patent applications are first determined; (c) a direction to the respondent no.2 Controller General of Patents to reject in line all divisional applications with claims identical to that of the parent applications, without hearing the applicant on substantive issues of patentability; (d) a direction to the respondent no.2 Controller General of Patents to identify patent applicants who have abused the process and take action against them; and, (e) a direction to the respondent no.2 Controller General of Patents and respondent no.3 Joint Controller of Patents & Designs to ensure that in every patent application there is an undertaking that there is no other application filed in respect of the same inventive concept and in the event of the divisional applications to decide without issuing notice whether claim is related to same inventive concept and if so, to reject such an application What is interesting here? Court cannot be approached in vacuum The bench held that in exercise of powers of judicial review, the court cannot legislate or even give direction to legislate. Though Section 158 empowers the High Courts also to make rules but only as to the conduct and procedure in respect of proceedings ‘before it’ under the Act and not in respect of proceedings before the Patent Office. Moreover, the bench said that petitioner has sought the relief in vacuum, without reference to any particular divisional application filed in abuse of Section 16 of the Act. Though instances of two such abuses have been given but the patent applicant who had indulged in such abuse has not been made a party to the petition. It is the settled principle that the Court cannot be approached in vacuum, without a cause of action. the circumstances, though the bench found considerable merit in the grievance urged by the petitioner as well as in the suggestions made to allay the same, but found hands to be tied and accordingly disposed petition with a direction to the respondents to, within a period of six months, treating the writ petition as a representation, take a decision whether any further amendment in the Patents Rules is necessary to address the malady if any and if so, to take appropriate steps therefor.

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S. No. #11

Case No: A. No. 54 of 2015, in NM No. 3567 Of 2011 In Suit No. 2932 Of 2011 Court: High Court of Bombay

Apellant Darius Rutton Kavasmaneck

Vs. Respondent

Gharda Chemicals, Keki Hormusji Gharda & Others Judge: Hon’ble Judge Mr. Naresh Patil Appearance: For appellant: Dr. Virendra Tulzapurkar, Senior Advocate with Mr. Mayur Khandeparkar, Mr. Shriraj Dhru, Ms. Meenal Desai i/b. Dhru and Co. for the appellant For Respondent: Mr. P. Chidambaram, Senior Advocate with Mr. Mustafa Safiyuddin, Mr. Suhas Tulzapurkar, Mr. Sumeet Rane i/b. Legasis Partners for respondent Nos. 2 and 3. Mr. Nishad Nadkarni with Mr. Vaibhav Keni for respondent i/b. Legasis Partners for Nos.1, 4 and 5. Order Pronounced on: 7th April 2015 What is it about? The suit was filed for derivative action by the appellant- plaintiff as minority shareholder. The plaintiff's grievance, in brief, was defendant No.2 (Dr. Gharda) who had obtained several patents in his own name whereas the patents ought to have been applied and obtained in the name of defendant No.1 (Gharda Chemicals Limited). Appellant asserted that the defendant No.2 has been using the infrastructure facilities and investment made by the company in the research and development department to carry out research invent. Defendant No.2 was a full-time Managing Director and in employment of defendant No.1. Appellant said Defendant No.2 has used the Research and Development department and laboratory of the company for doing research. The invention, if at all made by defendant No.2, was made in the laboratory of defendant No.1 and not in his mind. It was contended by the respondent that in the capacity of Managing Director, it was not the duty of defendant No.2 to invent. There was,

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therefore, no fiduciary duty cast on defendant No.2 to register the patents in favour of defendant No.1. The last contract clarifies that he is the owner of all the inventions that he had devised. The said contract has been approved by the shareholders of the company in general meeting by a requisite majority as well as approved by the Central Government. It was alleged by the Appellant that defendant No.2 is likely to transfer the patents in the name of company i.e. GMATF (holding 57% shares of defendant No.1- Company). The court held that the plaintiff's/Appellant’s case for interim relief is based on apprehension. …. We are of the prima facie view that whatever serious apprehension the plaintiff may have, cannot be a ground to grant relief in favour of the plaintiff considering the serious consequences of the same. In the facts of the case and considering the record and submissions advanced, we are not convinced to hold that the balance of convenience lies in favour of the appellant i.e. original plaintiff. Judge dismissed the appeal by rejecting the prayer for grant of interim injunction in view of facts and circumstances. Why it is interesting here? No intention to assign and non-utilization of other remedies affects the judgement of court in cases of injunction The court observed that plaintiff has an alternate efficacious remedy before specialized forum i.e. Controller of Patents. The plaintiff could have initiated proceeding for pre-grant of patents under section 25(1)(a) of the Patents Act or could have resorted to proceeding by filing petition/application under section 64(1)(a)(b) of the said Act. The Court also observed that subject patents were registered since the year 2008 onwards. So far nothing is placed on record which would fairly indicate that defendant No.2 is selling, transferring or in any way creating third party interest in respect of patents registered in his name. This is apart from the question as to whom the patents belong to. There has not been any assignment of the patents by defendant No.2 in favour of defendant No.1. So prima facie material and evidence on record show that the patents are registered in the name of defendant No.2 and the plaintiff has failed to make out a case that defendant No.2 is going to sell or transfer or create third party interest in respect of subject patents or act in such a manner that would jeopardize the interest of the company.

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S. No. #12

Case No: FAO (OS) 190/2013, C.M. APPL. 5755/2013, 466/2014 & 467/2014 Court: High Court of Delhi

Appellant Merck Sharp and Dohme Corporation and Anr.

Vs. Respondent

Glenmark Pharmaceuticals Judge: Hon'ble Mr. Justice S. Ravindra Bhat and Hon'ble Mr. Justice Najwi Waziri Appearance: Appellant Through: Sh. T.R. Andhyarujina, Sh. Kapil Sibal, Sh. Parag Tripathi, Sr. Advs. with Sh. Pravin Anand, Ms. Tusha Malhotra, Ms. Udita. M. Patro and Sh. Salim Inamdar, Advocates. Mr. Michael Fysh, QC SC and Ms. Archana Shanker, Advocate. Respondent Through: Dr. Abhishek Manu Singhvi, Ms. Prathiba. M. Singh, Sh. Rajiv Virmani, Sr. Advocates with Ms. Saya Choudhary Kapur, Ms. Anusuya Nigam and Sh. Saurabh Anand, Advocates. Order Pronounced on: 20th March 2015 What is it about? The appellant – Merck Sharp & Dohme (hereafter “MSD”) – was aggrieved by the dismissal of its application for an ad interim injunction restraining the respondent/defendant Glenmark Pharmaceuticals for selling Sitagliptin phosphate monohydrate salt covered by their Patent IN209816. By the order dated 2nd April/5th April 2013, learned Single Judge in paragraph 22 was of the opinion that a minor variation in the combination in Glenmark’s product (phosphate with Sitagliptin) could not mean that there was no infringement; trifling variations had to be ignored. However, he went on to notice that MSD, as patentee of Sitagliptin was not marketing Sitagliptin alone as a product and was marketing Sitagliptin in combination with phosphate, just like Glenmark. Nevertheless, he noticed that interim relief and the pleadings did not suggest that Sitagliptin Phosphate made by Glenmark was with the same object as MSD’s patent; equally he noted that

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there was no pleading that the mere addition of phosphate to Sitagliptin did not embody an inventive advancement. The impugned judgement, therefore, concluded that the plaintiff did not prove the case it ought to have i.e. how Sitagliptin Phosphate is merely a new form of Sitagliptin that was medically equivalent to Sitagliptin, thus rendering the interim injunction unwarranted. MSD argued that the suit patent is infringed because Sitagliptin and any of its acceptable salts are covered by its claims, thus resulting in the making, using or offering for sale, importing into India etc. of Sitagliptin or any of its salts or any form amounting to infringement of the suit patent. patent is for “Process for the preparation of R. Sitagliptin and its pharmaceutical salts”. MSD’s counsel placed reliance on Glenmark’s US Process Patent No. US8334385 which clearly admits that Sitagliptin is developed for the treatment of T2DM and is the active free base. It also gives the full description of the process for preparing Sitagliptin freebase in the patent specification which is Scheme “6” in Merck’s patent; reliance is placed on MSD’s US patent for Sitagliptin in support. It was stressed that Glenmark’s ZITA (Sitagliptin Phosphate Monohydrate) and ZITA-MET (Sitagliptin Phosphate Monohydrate and Metformin) infringe the suit patent because Sitagliptin is made and used by Glenmark in ZITA and ZITA-MET when it makes salt Sitagliptin Phosphate Monohydrate. It is underlined that the phosphoric acid salt of Sitagliptin was disclosed in the suit patent itself as one of the pharmaceutically acceptable salts. Glenmark’s Counsel, Dr. A.M. Singhvi states that ZITA has Sitagliptin Phosphate Monohydrate as the active pharmaceutical ingredient for which no patent protection exists because Application No. 5948/DELNP/2005 was specifically abandoned. It was also argued that ZETAMET is a combination of Sitagliptin Phosphate and monohydrate and Metformin Hydrochloride which is not subject matter of any patent and application No. 2710/CHENP/2008 is awaiting examination before the Patent office. Accordingly, for the above reasons, this Court held that the order of the learned Single Judge dismissing the application for grant of an interim injunction is liable to be and is set aside. The interim injunction claimed for by the plaintiff MSD in IA 5167/2013 is granted. Additionally, the following directions were issued: i) MSD shall furnish an affidavit undertaking (to be filed by its director duly authorised by its Board of Directors) in the pending suit, that in the event the suit is dismissed, it would compensate Glenmark

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for the damage or loss caused, including but not limited to loss of earnings. The affidavit shall be filed in two weeks. ii) Glenmark shall furnish an undertaking to comply with the injunction within two weeks from today in the suit. iii) Glenmark shall file a detailed account of its earnings (including gross turnover figures) from the products, from the date of the filing of the present suit; the account shall be accompanied by an affidavit of one of its Board of Directors authorized directors, which shall also undertake to pay such damages, if any- which may be decided by the court if the ultimate result of the suit is a decree in favour of the plaintiff MSD. The statement shall be filed with a supporting affidavit of its duly authorized director, within four weeks. The statement of account shall be accompanied by the certificate of a chartered accountant verifying its genuineness. iv) It is clarified that the defendant Glenmark is permitted to sell the products in question which are already in the market (i.e. with its distributors, retailers etc.). However, in compliance with the injunction granted in favour of the plaintiff/MSD – it shall not henceforth further sell, distribute or in any manner take any steps towards placing in the market the drug in question, Zita and Zitamet and such of the pharmaceutical products which are covered by the claim for interim injunction in the suit. If any stocks of such goods are in its factory premises or awaiting the distribution channel, a true and correct account thereof shall be given to the Court along with the affidavit to be filed in compliance with directions (iii) above. What is interesting here? Six Equitable principles The Court notes six equitable principles that come into play in this case and must be considered. First, and this principle is now well established in Indian jurisprudence, the Court must look at the public interest in granting an injunction, as access to drugs, especially one for a condition as prevalent as diabetes, is an important facet of the patent regime. Here, the price difference between the commercial products sold by Glenmark and MSD is not so startling as to compel the court to infer that allowing Glenmark to sell the drug, at depressed prices would result in increased access. Permitting Glenmark to operate would not necessarily result in lowering of market prices. Importantly, whilst lower prices may result from competition amongst two competitors, no allegation has been made that MSD today sells its drugs at a relatively high price that hinders access to the drug. MSD has reduced its

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price by 1/5th from the United States, which shows some receptivity to the Indian market; Second principle, which is whether the Court can overlook the public interest in maintaining the integrity of the patent system itself, so that a legitimate monopoly is not distorted. The Court must be mindful – especially in a case where a strong case of infringement is established, as here – there is an interest in enforcing the Act. It may be argued that despite this no injunction should be granted since all damages from loss of sales can be compensated monetarily ultimately if the patentee prevails. This argument though appealing, is to be rejected, because a closer look at the market forces reveal that the damage can in some cases be irreparable. Third principle, which is where an infringer is allowed to operate in the interim during the trial, it may result in a reduction in price by that infringer since it has no research and development expenses to recoup – most revenue becomes profit. The patentee however can only do so at its peril. Importantly, prices may not recover after the patentee ultimately prevails, even if it is able to survive the financial setback (or “hit”) during the interim, which may take some time. In the present case, given the size of the diabetes drug market in India, and the sheer number of patients, from all economic strata of society, the demand for low-priced medicines will remain, rather than any distortion of demand due to brand loyalty or a first mover’s advantage to MSD. As noticed earlier, the price differential between MSD’s drug and the infringing products is 30%, a significant portion of which is due to the customs duty paid by MSD. Learned senior counsels appearing for MSD had stated that it would compensate Glenmark for loss of earnings if the suit were to be dismissed. Thus this arrangement not only ensures that Glenmark will – if successful – be able to return to the market without any handicap, but moreover, it will be compensated at market value for the period for which it was excluded. The balance of convenience thus clearly lies in favour of MSD Fourth principle operative in this case – is that of the chronology of events and Glenmark’s decision to release Zita without first challenging Januvia or Janumet. Undoubtedly, the Act creates a right to oppose patents even after grant. There is no obligation to only utilize the pre or post grant opposition mechanisms. Neither does a patent benefit from a presumption of validity if it is challenged in the course of an infringement suit. However, if a

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defendant is aware that there may be a possible challenge to its product, but still chooses to release the drug without first invoking revocation proceedings or attempting to negotiate, that is surely a relevant factor. The defendant’s legal right to challenge the patent at any point in time is intact, but that does not mean that this factor cannot determine the interim arrangement. This is more so where Glenmark today argues that MSD ought to have disclosed international patent applications for SPM and Sitagliptin plus Metformin since they were the “same or substantially the same” as the suit patent under Section 8. That is Glenmark’s stated position. Such being the state of things, it is surely reasonable for Glenmark to detect the possibility to challenge, when a US patent application for SPM filed by it was opposed by MSD. Despite this, Glenmark released the drug without initiating revocation proceedings under the Act, which is also a right vested in Glenmark that would have obviated the need for the interim arrangement was under consideration of court. This does not mean that Glenmark’s right to question the validity of the patent in an infringement is affected, but the manner of challenge is a relevant factor against it at the interim stage. Ultimately, the Court must look to the combination of the three primary factors. A strong case can in some instances offset an equal balance of conveniences between parties. In this case, MSD has established a prima facie case of infringement, an interim arrangement that secures the interests of both parties and which maintains the public interest involved is available, which also ensures that the possibility of irreparable harm to the patentee is removed. Fifth principle (not expressly mentioned) Further the fact that the patentee was already dealing in the market on the basis of the patent weighed in as a factor in granting the interim injunction. Sixth Principle (not expressly mentioned) Ultimately, the Court must look to the combination of the three primary factors. A strong case can in some instances offset an equal balance of conveniences between parties. In this case, MSD has established a prima facie case of infringement, an interim arrangement that secures the interests of both parties and which maintains the public interest involved is available which also ensures that the possibility of irreparable harm to the patentee is removed.

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S. No. #13

Case No: I.A. No. 6735/2014 in CS(OS) No.1045/ 2014 Court: High Court of Delhi

Plaintiff Telefonaktiebolaget LM Ericsson

Vs. Defendant

Intex Technologies (India) Limited Judge: Hon'ble Mr. Justice Manmohan Singh Appearance for Petitioner: Mr. C. S. Vaidyanathan, Sr. Adv. & Mrs. Prathiba M. Singh, Sr. Adv. with Mrs. Saya Choudhary Kapur, Mr. Ashutosh Kumar, Mr. B. Prashant Kumar, Mr. Saurabh Anand and Mr. Vihan Dang, Advs. For Respondent: Mr. Saikrishna Rajgopal, with Mr. J. Sai Deepak, Ms. Savni Dutt & Ms. Rachel Mamatha and Mr. Subhajit Banerji, Advs Date of Order: 13th March, 2015 What is it about? The plaintiff - Ericsson had filed the suit for permanent injunction restraining infringement of rights in eight patents registered in India along with damages/rendition of accounts and delivery up etc. against Intex Technologies. Ericsson argued that 8 granted patents are Standard Essential Patent’s (SEPs) and any device (Mobile, Handset and Tablet) that incorporates these features of AMR, EDGE or 3G automatically infringes upon its suit patents. In support of its case Plaintiff said that suit patents (related to AMR, EDGE and 3G technologies) correspond to the standards issued by ETSI related to the aforesaid 2G and 3G technologies. The Department of Telecommunications, India has recognized ETSI standards as approved standards for GSM, WCDMA/ UMTS network and equipment providers and as a consequence the same are required to be complied with by various device importers, manufacturers, sellers etc. It is apparent from a bare perusal of the Unified Access Services License Agreement. Every telecom service provider in India has to enter into a UASL agreement with the Government.

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Brief Background:

Plaintiff on 16th December, 2008 addressed a letter intimating the defendant about the fact that the telecommunication products being sold by it infringe various SEPs held by the plaintiff

In reply, the defendant, vide its e-mail dated 7th January, 2009, stated that it is not aware about any significant portfolio of plaintiff’s patents in India that are essential for compliance by the defendant, however, the defendant agreed to meet on this aspect.

The plaintiff asked the defendant to sign a Non-Disclosure Agreement (“NDA”) so as to facilitate exchange of confidential information (claim chart mapping, infringement analysis etc.) in entering into a FRAND license with the plaintiff. The defendant initially refused to enter into an NDA despite which the plaintiff held various meetings with the defendant to discuss its FRAND licensing program. But despite meeting, the defendant did not enter into the NDA.

The plaintiff, thereafter by its letter dated 16th December, 2011, again requested the defendant to enter into a licensing agreement with the plaintiff on FRAND terms for the SEPs portfolio of the plaintiff. The defendant in its reply letter dated 19th January, 2012, at the first instance, submitted before the plaintiff that the defendant was not a manufacturer of mobile phones as it is merely selling/ trading them under its brand name and thus cannot be held liable for infringement of patents.

The plaintiff in its reply letter dated 26th January, 2012 clarified that the defendant is legally liable to obtain a license from plaintiff despite the fact that it is not manufacturing the infringing products but was selling the same and the defendant was invited to negotiate a license agreement on FRAND terms with the plaintiff.

After repeated attempts by the plaintiff, on 11th April, 2013, the defendant finally signed the NDA (after a lapse of over four years).

The plaintiff thereafter supplied the term sheet to the defendant vide email dated 23rd April, 2013 prior to their meeting dated 29th April, 2013. During the course of another meeting which was held between both the parties on 23rd May, 2013, the plaintiff explained its SEP portfolio, Thereafter, the Plaintiff drafted a written offer based on the discussion held on 23rd May, 2013, and provided the same to the defendant.

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In reply, the defendant, however, proposed a counter offer which was different, as per the plaintiff, from the in-principle agreement reached in the meeting between both the parties on 23rd May, 2013.

Multifarious proceedings were initiated by the defendant against the plaintiff before the Competition Commission of India (CCI) and the Intellectual Property Appellate Board (IPAB) in the months of August-September, 2013, for revocation of the plaintiff’s suit patent.

By its order dated 16th January, 2014 the CCI had ordered an investigation against the plaintiff on the basis of allegations made by the defendant in its complaint before the CCI. Said Order was challenged by the plaintiff by filing a writ petition, being W.P (C) No.1006/ 2014, before Delhi High Court on inter alia the ground that the order passed by the CCI was arbitrary in nature and without jurisdiction. That on 17th February, 2014 the Writ Court directed that whilst the Director General (D.G) of the Competition Commission of India (“CCI”) may call for information from the plaintiff, no final report shall be submitted by the Director General and no final orders shall be passed by the CCI. The Writ Court also directed that no officer of the plaintiff Company, stationed abroad, shall be called upon by the D.G for the purpose of investigation. The Writ Court also ordered that the observations made by the CCI in its order dated 16th January, 2014 shall not come in the way of the plaintiff negotiating with the third parties or in the adjudication proceeding filed by either of the parties.

Thereafter, the defendant had filed a Letters Patent Appeal i.e. LPA No.255/ 2014 challenging the Single Judge order dated 17th February, 2014. The said appeal was disposed of by the Division Bench of the Court vide its order dated 24th March, 2014 whereby the Single Judge’s order was modified to the extent that the D.G. was permitted to call any officer of the plaintiff Company, stationed abroad, for the purpose of investigation in India.

Defendant asserted that since the plaintiff has not been able to establish that the Suit Patents are indeed standard essential, the defendant’s compliance with ETSI standards cannot be used to prove infringement. Defendants also submitted that since the plaintiff’s Suit patents claim computer programmes per se, which is ineligible subject-matter of patent

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protection under Section 3(k) of the Act, the plaintiff needs to establish that the source code employed in the defendant’s products is the same as the plaintiff’s source code. Inter alia the following objections were raised by the defendant: (i) Section 8 compliance (Foreign filing details through Form 3) (ii) Non-patentability of computer programmes under Sections 3(k) and 3(m) (iii) Whether Suit Patents are indeed SEP’s (iv) Novelty and Inventive Step in view of prior art (v) defendant’s pending complaint with CCI and (vi) Activities/Discussions that have happened between Ericsson and Intex on FRAND License before the suit. The Court refused to look in the minute details with regard to the validity of the claims at interim stage also in view of pending revocation petitions with IPAB. The court also observed that in its Counter Affidavit filed by defendant in the W.P(C) 1006/2014 (filed by plaintiff against the CCI’s order dated 16th January, 2014) it has been specifically admitted by defendant that it requires a license in respect of plaintiff’s eight standard essential patents. Even in its revocation petitions filed before the IPAB for plaintiff’s eight patents, the defendant has admitted that all the said eight patents “directly relates to the business of applicant”. On one hand defendant gave the impression to plaintiff that it wanted to obtain a license for plaintiff’s essential patents which were being used by it in various telecommunication devices (mobile handsets/tablets/dongles etc.) being imported and sold by defendant in India, and on the other hand it filed Complaint/Information before the CCI and Revocation Petition before the IPAB (taking two different self-serving stands). The said conduct of the defendant would show that there was no bonafide intention on part of defendant. Court said, from the entire gamut of the matter, it appears to the Court that the suit patents are valid, they are corresponding patents in other countries. The defendant has infringed the same. Unless the suit patents are declared as invalid in revocation petitions filed by the defendant, the same cannot be allowed to be infringed by the defendant who is also unwilling to execute a FRAND licence. For the aforesaid reasons, the Court is of the considered opinion that the defendant has prima facie acted in bad faith during the negotiations with plaintiff, it has even approached various fora and has made contrary statements in order to get monetary benefit. Ericsson was granted an injunction against Intex for any devices that infringed on the eight Standard Essential Patents that are part of Ericsson’s portfolio. The Court also ordered Intex to pay 50% Royalty, to be calculated as per

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Micromax Order in in CS(OS) No.442/2013 (0.8%-1.0% of net selling price to be escalated up to 1.3% during pendency of the trial) from date of filing of suit till 1st March, 2015 within four weeks. For the remaining 50% amount, court asked the defendant to furnish the bank guarantee within the same period with the Registrar General of this Court who would invest the said amount in FDR. What is interesting here?

1. Pleading affects pleading It is a well settled principle of law that an admission made by a party in a pleading, even in a different proceeding, can be used as evidence against such party in another proceeding. The suit patents are “Standard Essential Patents” even as per the admissions of the defendant who had been corresponding with the plaintiff for many years. From the previous conduct of the defendant at the relevant time, the defendant was aware about the rights of the plaintiff

2. Patentability of Software Inventions in India One interesting part of this order is the position the Court has taken on patentability of computer software. The Court dismissed the arguments of the defendants on the count of the non-patentability of computer programmes under Sections 3(k) and 3(m) of the Act. Plaintiff’s counsel provided a detailed analysis of the position of the law in the European Union, the United Kingdom and the United States, analysing the ‘technical features/character’ and ‘significantly more’ tests used in these countries. Though the judge did not go in the details of the provision (since the validity of the Patents have been challenged at IPAB and the matter is pending). The Judge said “it is appears to me prima facie that any invention which has a technical contribution or has a technical effect and is not merely a computer program per se as alleged by the defendant and the same is patentable”.

3. Section 8 Further the Court has given the clarifications on Section 8 non-compliance. It is necessary for the Court to consider the question as to whether the omission on the part of the plaintiff was intentional or whether it was a mere clerical and bonafide error.

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4. Chipset vs Net Selling Price At one point during the case the defendant explored possibility to pay the royalty on the basis of chipset price, however the Judge did not accept it considering that the plaintiff’s practice of charging Royalty on the device price is Non-Discriminatory. Plaintiff’s Counsel placed on record a recent case of China, wherein the Chinese Competition Authority (National Development and Reform Commission) in respect of Qualcomm’s Standard Essential Patents for 3G, 4G technologies has directed that Royalty for 3G Patents should be calculated as 3.25% of the net selling price of devices and for 4G Patents at 2.275% of the net selling price of devices.

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S. No. #14

Case No: CS (OS) NO. 678/ 2013 Court: High Court of Delhi

Plaintiff Symed Labs Ltd

Vs. Defendant

Glenmark Pharmaceuticals Ltd. and Anr.

Judge: Hon'ble Mr. Justice G.P. Mittal Appearance: Plaintiff Through: Ms. Shwetasree Majumdar, Advocate with Mr. Prithvi Singh, Advocate and Mr. Rajeshwar, Advocate Defendant through: Mr. Rajeev K. Virmani, Senior Advocate with Ms. Rajeshwari H., Advocate, Mr. S. Hariharan, Advocate, Mr. Tahir Abdul Tabbur, Advocate, Ms. Anindita Mitra, Advocate and Ms. Aparna, Advocate Order Pronounced on: 19th January, 2015 What is it about? Plaintiff seeks an ad interim injunction restraining the Defendants, their agents, etc. from manufacturing, selling, offering for sale, advertising or directly or indirectly dealing in the product Linezolid manufactured in a manner so as to result in infringement of the Plaintiff’s registered patent IN213062 (IN ‘062) and the registered patent IN213063 (IN ‘063). It is urged that novel intermediate compounds claimed in the suit patents are exclusively formed/ generated and used in the processes for the production of Linezolid as claimed in the suit patents whereas those intermediates are not formed (indeed, there is no possibility of them forming) in the prior art processes for preparing Linezolid. Thus, the presence of any of the aforesaid compounds in the final product (Linezolid) would be indicative of the fact that the said product has been prepared by using the patented processes of the Plaintiff. Defendants have contested the suit by way of filing a written statement to the plaint and reply to the injunction application stating that the processes as well as the intermediates claimed in the suit patents are not the novel. It is claimed that the suit filed by the Plaintiff and the prayer

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of ad interim injunction is misconceived as mere presence of Zodiac-4 and PHPFMA in the final product of the Defendants cannot be indicative of infringement of the Plaintiff’s patents as these compounds can be found even if other processes of prior art are followed for manufacturing Linezolid. Court granted an ad interim injunction restraining the Defendants in the production of Linezolid manufactured in a manner so as to result in infringement of the Plaintiff’s registered Patents IN ‘063 and IN ‘062 till the disposal of the suit. What is interesting here? Infringement of Process Patent It may be noted that the case relates to the infringement of the patent processes. Presence of CHFA, PHPFMA and Zodiac-4 is a strong indicator of the fact that the Plaintiff’s patented processes have been used because the Defendants have not come forward explaining the process which they have used to obtain Linezolid API. It was further held that although initially the burden of establishing the case of infringement rests upon the Plaintiff, the burden to prove the Defendant’s process would be upon the Defendant as it is impossible for the Plaintiff to know the same.

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S. No. #15

Case No: I.A. No.24863/2014 IN CS(OS) 3812/2014 Court: High Court of Delhi

Plaintiff Novartis Ag & Anr

Vs. Defendant Cipla Ltd

Judge: Hon'ble Mr. Justice Manmohan Singh Appearance: For Plaintiff: Mr. Gopal Subramanium, Sr. Adv. with Mr. Hemant Singh, Ms. Mamta R. Jha, Ms. Shilpa Arora & Mr. Talha Rahman, Advs. For Defendant: Through Mr. P. Chidambaram, Sr. Adv., Mr. Sandeep Sethi, Sr. Adv. and Mrs. Prathiba M. Singh, Sr. Adv. with Ms. Bitika Sharma, Ms. Anusuya Nigam & Mr. Vihan Dang, Advs Order delivered on: 9th January, 2015 What is it about? The plaintiffs have filed a suit for permanent injunction restraining infringement of Patent no. 222346. The INDACATEROL (International Non-Proprietary Name), the new chemical entity and compound, as well as its maleate salt, namely INDACATEROL Maleate in which INDACATEROL is the active moiety, are both protected. The case of the defendant in reply is that the plaintiff No. 1 has failed to make the product available to the patient population in India. The imports, if any, by the Plaintiff No. 1, directly or through its licensees. It is suggested by the defendant that the Defendant may be put to terms for depositing of a royalty rate i.e. a percentage of its sales in the court subject to the trial of the suit. The defendant has also referred the decision of Bombay High Court wherein it was held that importation can only constitute working provided sufficient justification is provided. In the said attendant circumstances, wherein the prior arts are unexplained and the defendant is taking inconsistent position and also goes on to state that the product under patent which is INDACATEROL Maleate is highly efficacious in curing the COPD and thus desirable by the defendant

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when the defendant is itself making the other drugs for curing COPD which according to the defendant’s own saying are not adequate (which stand is required to be tested before the relevant forum.), it can be said that the plaintiff is able to establish a case of prima facie valid patent on record. It is settled law that an interim injunction may be granted if the defendant has applied for a compulsory licence but he infringes the patent during a period when his application is still pending. It is also settled law that an injunction may be granted in respect of a single claim even though other claims in the specification are not prima facie valid. The Defendant cannot be permitted to infringe the patent unless the approval of the Controller for seeking compulsory licence. As far as reasonable price of the drug in question is concerned, there is National Pharmaceutical Pricing Authority, an organization of the Ministry of Chemicals & Fertilizers, Government of India established inter alia to fix / revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of medicines in the country under Drugs (Prices Control) Order issued from time to time. The defendant is restrained by in directly or indirectly dealing in Active Pharmaceutical Ingredient (API), pharmaceutical products, compound or formulation containing INDACATEROL, specifically its Maleate salt, … as may amount to infringement of Indian Patent No.222346 of the Plaintiff No.1 until the determination of the pleas raised by the defendant for seeking the compulsory licensing if so filed shall be determined on merit and after hearing of parties in favour of defendant, otherwise, it would continue during the pendency of the suit. If such an application is filed by the defendant, under those circumstances, the directions are issued to the controller or to the relevant authority to decide the application for seeking compulsory licensing within the period of six months from the date of filing the application within two weeks from the pronouncement of the order. What is interesting here?

1. Whether to “Make in India” for Satisfying the working requirement

It is not essential that the patent must be worked by manufacturing the patented product in India. The Act does not mandate that no patent protection would be granted to a patentee unless the local manufacture is undertaken.

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It is clear that the grounds which are available for the person interested while seeking an application for the compulsory licensing or revocation of the patent on the ground of non-working of the patent could be urged before the relevant authority which will consider the matter and cannot be imported as a matter of defence to the suit for infringement as the civil court hearing the suit for infringement cannot transgress within the domain of the authority/ controller/ central government which are distinct functionaries having their powers and considerations specifically defined under the specific provisions of the Act.

2. Public Interest Unless there is a credible challenge to the validity of the patent itself, the Courts will not include any alleged public interest as a factor to exercise discretion. Therefore, to say that public interest is a complete exception to the patent would not be correct as otherwise the rights granted by the sovereign towards monopoly would be undermined by too broadly interpreting the public interest. The ground of public interest can be invoked once the court finds that damages is adequate relief which has been held in the line of authorities emerging from US where the courts have imposed heavy sums upon the defendants towards permitting the usage of patents. The public interest doctrine guides the cases of the patents as well especially in the cases wherein the innovations involve the lifesaving drugs or pharmaceutical preparations which would have bearing upon the life of the general public in the disputes involving the making of the lifesaving drugs affecting the lives of the larger segment of the public. The reason is very simple and plain which is that the manmade inventions cannot be said to be taking precedence over the life of the mankind. Therefore, some mechanism is devised by the courts so that the rights of the patentee is respected and simultaneously the public interests is equally not affected by balancing out the two militating interests. Thus, the balanced approach is adopted by the courts by imposition of the terms in the form of royalty to be paid by the third party to the patentee than to absolutely prevent the making of the patented product in the form of injunction where the disputed question of facts arise as to whether the invention is adequately worked in the country or not or where there exists a link between the patented product and the far reaching effect of the medicines upon the public health and wellbeing of the public of the country in a case of such nature is made by the defendant.

3. Public Interest Doctrine in USA

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The public interest doctrine has been invoked by the US courts number of times in the cases involving the patent infringement including but not limited to pharmaceutical disputes involving the lifesaving drugs. One of the cases which was decided by the US Supreme Court is the case of eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 389 (2006) which is relating to business method patents. The Court established that a plaintiff must demonstrate: (1) that it has suffered an irreparable injury; (2) that remedies available at law, such as monetary damages, are inadequate to compensate for that injury; (3) that, considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted; and (4) that the public interest would not be disserved by a permanent injunction. The US Court remanded the matter before the district court for reconsideration and thereafter the District Court again after hearing the matter came to the conclusion that the public interests favour against the grant of the injunction. This element of the 4th factor of public interests evolved by the US Court which in my opinion was always present on weighing the case of the parties on the balance of convenience became the point of larger debate in US and across the globe in relation to decision in patent matters of diverse nature.

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Relevant Provisions of “The Patents Act 1970”

Section 2 Definitions and interpretation (1) In this Act, unless the context otherwise requires, - …… (ac) "capable of industrial application", in relation to an invention, means that the invention is capable of being made or used in an industry; …. (f) "exclusive licence" means a licence from a patentee which confers on the licensee, or on the licensee and persons authorised by him, to the exclusion of all other persons (including the patentee), any right in respect of the patented invention, and exclusive licensee shall be construed accordingly; …. (j) "invention" means a new product or process involving an inventive step and capable of industrial application; (ja) “inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art; (k) "legal representative" means a person who in law represents the estate of a deceased person; (l) "new invention" means any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of patent application with complete specification, i.e., the subject matter has not fallen in public domain or that it does not form part of the state of the art; ….. (t) "person interested" includes a person engaged in, or in promoting, research in the same field as that to which the invention relates; (ta) "pharmaceutical substance" means any new entity involving one or more inventive steps;

Section 3 What are not inventions The following are not. inventions within the meaning of this Act, — (a) an invention which is frivolous or which claims anything obviously contrary to well established natural laws;

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(b) an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment; (c) the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature; (d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy; (e) a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance; (f) the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way; (g). (omitted) (h) a method of agriculture or horticulture; (i) any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products. (j) plants and animals in whole or any part thereof other than micro­ organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals; (k) a mathematical or business method or a computer programme per se or algorithms; (l) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematographic works and television productions; (m) a mere scheme or rule or method of performing mental act or method of playing game; (n) a presentation of information;

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(o) topography of integrated circuits; (p) an invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components.

Section 8 Information and undertaking regarding foreign applications (1) Where an applicant for a patent under this Act is prosecuting either alone or jointly with any other person an application for a patent in any country outside India in respect of the same or substantially the same invention, or where to his knowledge such an application is being prosecuted by some person through whom he claims or by some person deriving title from him, he shall file along with his application or subsequently within the prescribed period as the Controller may allow— (a) a statement setting out detailed particulars of such application; and (b) an undertaking that, up to the date of grant of patent in India, he would keep the Controller informed in writing, from time to time, of detailed particulars as required under clause (a) in respect of every other application relating to the same or substantially the same invention, if any, filed in any country outside India subsequently to the filing of the statement referred to in the aforesaid clause, within the prescribed time. (2) At any time after an application for patent is filed in India and till the grant of a patent or refusal to grant of a patent made thereon, the Controller may also require the applicant to furnish details, as may be prescribed, relating to the processing of the application in a country outside India, and in that event the applicant shall furnish to the Controller information available to him within such period as may be prescribed.

Section 15 Power of Controller to refuse or require amended applications, etc., in certain case Where the Controller is satisfied that the application or any specification or any other document filed in pursuance thereof does not comply with the requirements of this Act or of any rules made thereunder, the Controller may refuse the application or may require the application, specification or the other documents, as the case may be, to be amended

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to his satisfaction before he proceeds with the application and refuse the application on failure to do so.

Section 48 Rights of patentees Subject to the other provisions contained in this Act and the conditions specified in section 47, a patent granted under this Act shall confer upon the patentee— (a) where the subject matter of the patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing for those purposes that product in India; (b) where the subject matter of the patent is a process, the exclusive right to prevent third parties, who do not have his consent, from the act of using that process, and from the act of using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India:

Section 64 Revocation of patents (1) Subject to the provisions contained in this Act, a patent, whether granted before or after the commencement of this Act, may, be revoked on a petition of any person interested or of the Central Government by the Appellate Board or on a counter-claim in a suit for infringement of the patent by the High Court on any of the following grounds, that is to say— (a) that the invention, so far as claimed in any claim of the complete specification, was claimed in a valid claim of earlier priority date contained in the complete specification of another patent granted in India; (b) that the patent was granted on the application of a person not entitled under the provisions of this Act to apply therefor: (c) that the patent was obtained wrongfully in contravention of the rights of the petitioner or any person under or through whom he claims; (d) that the subject of any claim of the complete specification is not an invention within the meaning of this Act; (e) that the invention so far as claimed in any claim of the complete specification is not new, having regard to what was publicly known or publicly used in India before the priority date of the claim or to what was

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published in India or elsewhere in any of the, documents referred to in section 13: (f) that the invention so far as claimed in any claim of the complete specification is obvious or does not involve any inventive step, having regard to what was publicly known or publicly used in India or what was published in India or elsewhere before the priority date of the claim: (g) that the invention, so far as claimed in any claim of the complete specification, is not useful; (h) that the complete specification does not sufficiently and fairly describe the invention and the method by which it is to be performed, that is to say, that the description of the method or the instructions for the working of the invention as contained in the complete specification are not by themselves sufficient to enable a person in India possessing average skill in, and average knowledge of, the art to which the invention relates, to work the invention, or that it does not disclose the best method of performing it which was known to the applicant for the patent and for which he was entitled to claim protection; (i) that the scope of any claim of the complete specification is not sufficiently and clearly defined or that any claim of the complete specification is not fairly based on the matter disclosed in the specification; (j) that the patent was obtained on a false suggestion or representation; (k) that the subject of any claim of the complete specification is not patentable under this Act; (l) that the invention so far as claimed in any claim of the complete specification was secretly used in India, otherwise than as mentioned in sub-section (3), before the priority date of the claim; (m) that the applicant for the patent has failed to disclose to the Controller the information required by section 8 or has furnished information which in any material particular was false to his knowledge; (n) that the applicant contravened any direction for secrecy passed under section 35 or made or caused to be made an application for the grant of a patent outside India in contravention of section 39; (o) that leave to amend the complete specification under section 57 or section 58 was obtained by fraud. (p) that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention; (q) that the invention so far as claimed in any claim of the complete specification was anticipated having regard to the knowledge, oral or

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otherwise, available within any local or indigenous community in India or elsewhere. (2) For the purposes of clauses (e) and (f) of sub-section (1)— (a) no account shall be taken of personal document or secret trial or secret use; and (b) where the patent is for a process or for a product as made by a process described or claimed, the importation into India of the product made abroad by that process shall constitute knowledge or use in India of the invention on the date of the importation, except where such importation has been for the purpose of reasonable trial or experiment only. (3) For the purpose of clause (1) of sub-section (1), no account shall be taken of any use of the invention— (a) for the purpose of reasonable trial or experiment only; or (b) by the Government or by any person authorised by the Government or by a Government undertaking, in consequence of the applicant for the patent or any person from whom he derives title having communicated or disclosed the invention directly or indirectly to the Government or person authorised as aforesaid or to the Government undertaking; or (c) by any other person, in consequence of the applicant for the patent or any person from whom he derives title having communicated or disclosed the invention, and without the consent or acquiescence of the applicant or of any person from whom he derives title. (4) Without prejudice to the provisions contained in sub-section (1), a patent may be revoked by the High Court on the petition of the Central Government, if the High Court is satisfied that the patentee has without reasonable cause failed to comply with the request of the Central Government to make, use or exercise the patented invention for the purposes of Government within the meaning of section 99 upon reasonable terms. (5) A notice of any petition for revocation of a patent under this section shall be served on all persons appearing from the register to be proprietors of that patent or to have shares or interests therein and it shall not be necessary to serve a notice on any other person.

Section 83 General principles applicable to working of patented inventions

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Without prejudice to the other provisions contained in this Act, in exercising the powers conferred by this Chapter, regard shall be had to the following general considerations, namely; — that patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay; that they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article; that the protection and enforcement of patent rights contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations; that patents granted do not impede protection of public health and nutrition and should act as instrument to promote public interest specially in sectors of vital importance for socio-economic and technological development of India; that patents granted do not in any way prohibit Central Government in taking measures to protect public health; that the patent right is not abused by the patentee or person deriving title or interest on patent from the patentee, and the patentee or a person deriving title or interest on patent from the patentee does not resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology; and that patents are granted to make the benefit of the patented invention available at reasonably affordable prices to the public.

Section 84 Compulsory licences (1) At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds, namely: — (a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or (b) that the patented invention is not available to the public at a reasonably affordable price, or

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(c) that the patented invention is not worked in the territory of India. (2) An application under this section may be made by any person notwithstanding that he is already the holder of a licence under the patent and no person shall be estopped from alleging that the reasonable requirements of the public with respect to the patented invention are not satisfied or that the patented invention is not worked in the territory of India or that the patented invention is not available to the public at a reasonably affordable price by reason of any admission made by him, whether in such a licence or otherwise or by reason of his having accepted such a licence. (3) Every application under sub-section (1) shall contain a statement setting out the nature of the applicant's interest together with such particulars as may be prescribed and the facts upon which the application is based. (4) The Controller, if satisfied that the reasonable requirements of the public with respect to the patented invention have not been satisfied or that the patented invention is not worked in the territory of India or that the patented invention is not available to the public at a reasonably affordable price, may grant a licence upon such terms as he may deem fit. (5) Where the Controller directs the patentee to grant a licence he may, as incidental thereto, exercise the powers set out in section 88. (6) In considering the application field under this section, the Controller shall take into account, — (i) the nature of the invention, the time which has elapsed since the sealing of the patent and the measures already taken by the patentee or any licensee to make full use of the invention; (ii) the ability of the applicant to work the invention to the public advantage; (iii) the capacity of the applicant to undertake the risk in providing capital and working the invention, if the application were granted; (iv) as to whether the applicant has made efforts to obtain a licence from the patentee on reasonable terms and conditions and such efforts have not been successful within a reasonable period as the Controller may deem fit: Provided that this clause shall not be applicable in case of national emergency or other circumstances of extreme urgency or in case of public non-commercial use or on establishment of a ground of anticompetitive practices adopted by the patentee,

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but shall not be required to take into account matters subsequent to the making of the application. Explanation. —For the purposes of clause (iv), "reasonable period" shall be construed as a period not ordinarily exceeding a period of six months. (7) For the purposes of this Chapter, the reasonable requirements of the public shall be deemed not to have been satisfied— (a) if, by reason of the refusal of the patentee to grant a licence or licences on reasonable terms, — (i) an existing trade or industry or the development thereof or the establishment of any new trade or industry in India or the trade or industry of any person or class of persons trading or manufacturing in India is prejudiced; or (ii) the demand for the patented article has not been met to an adequate extent or on reasonable terms; or (iii) a market for export of the patented article manufactured in India is not being supplied or developed; or (iv) the establishment or development of commercial activities in India is prejudiced; or (b) if, by reason of conditions imposed by the patentee upon the grant of licences under the patent or upon the purchase, hire or use of the patented article or process, the manufacture, use or sale of materials not protected by the patent, or the establishment or development of any trade or industry in India, is prejudiced; or (c) if the patentee imposes a condition upon the grant of licences under the patent to provide exclusive grant back, prevention to challenges to the validity of patent or coercive package licensing; or (d) if the patented invention is not being worked in the territory of India on a commercial scale to an adequate extent or is not being so worked to the fullest extent that is reasonably practicable; or (e) if the working of the patented invention in the territory of India on a commercial scale is being prevented or hindered by the importation from abroad of the patented article by— (i) the patentee or persons claiming under him; or (ii) persons directly or indirectly purchasing from him; or (iii) other persons against whom the patentee is not taking or has not taken proceedings for infringement.

Section 92A

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Compulsory licence for export of patented pharmaceutical products in certain exceptional circumstances (1) If the Central Government is satisfied, in respect of any patent in force in circumstances of national emergency or in circumstances of extreme urgency or in case of public non-commercial use, that it is necessary that compulsory licenses should be granted at any time after the sealing thereof to work the invention, it may make a declaration to that effect, by notification in the Official Gazette, and thereupon the following provisions shall have effect, that is to say— (i) the Controller shall on application made at any time after the notification by any person interested, grant to the applicant a licence under the patent on such terms and conditions as he thinks fit; (ii) in settling the terms and conditions of a licence granted under this section, the Controller shall endeavour to secure that the articles manufactured under the patent shall be available to the public at the lowest prices consistent with the patentees deriving a reasonable advantage from their patent rights. (2) The provisions of sections 83, 87, 88, 89 and 90 shall apply in relation to the grant of licences under this section as they apply in relation to the grant of licences under section 84. (3) Notwithstanding anything contained in sub-section (2), where the Controller is satisfied on consideration of the application referred to in clause (i) of sub-section (1) that it is necessary in— (i) a circumstance of national emergency; or (ii) a circumstance of extreme urgency; or (iii) a case of public non-commercial use, which may arise or is required, as the case may be, including public health crises, relating to Acquired Immuno Deficiency Syndrome, Human Immuno Deficiency Virus, tuberculosis, malaria or other epidemics, he shall not apply any procedure specified in section 87 in relation to that application for grant of licence under this section: Provided that the Controller shall, as soon as may be practicable, inform the patentee of the patent relating to the application for such non-application of section 87.

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Section 104: Jurisdiction No suit for a declaration under section 105 or for any relief under section 106 or for infringement of a patent shall be instituted in any court inferior to a district court having jurisdiction to try the suit: Provided that where a counter-claim for revocation of the patent is made by the defendant, the suit, along with the counter-claim, shall be transferred to the High Court for decision.

Section 104A: Burden of proof in case of suits concerning infringement (1) In any suit for infringement of a patent, where the subject matter of patent is a process for obtaining a product, the court may direct the defendant to prove that the process used by him to obtain the product, identical to the product of the patented process, is different from the patented process if, — (a)the subject matter of the patent is a process for obtaining a new product; or (b)there is a substantial likelihood that the identical product is made by the process, and the patentee or a person deriving title or interest in the patent from him, has been unable through reasonable efforts to determine the process actually used: Provided that the patentee or a person deriving title or interest in the patent from him first proves that the product is identical to the product directly obtained by the patented process. (2) In considering whether a party has discharged the burden imposed upon him by sub-section (1), the court shall not require him to disclose any manufacturing or commercial secrets, if it appears to the court that it would be unreasonable to do so. (1) Compulsory licence shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory licence has been granted by such country or such country has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India. (2) The Controller shall, on receipt of an application in the prescribed manner, grant a compulsory licence solely for manufacture and export of

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the concerned pharmaceutical product to such country under such terms and conditions as may be specified and published by him. (3) The provisions of sub-sections (1) and (2) shall be without prejudice to the extent to which pharmaceutical products produced under a compulsory license can be exported under any other provision of this Act. Explanation —For the purposes of this section, 'pharmaceutical products' means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems and shall be inclusive of ingredients necessary for their manufacture and diagnostic kits required for their use.

Section 105: Power of court to make declaration as to non-infringement (1) Notwithstanding anything contained in section 34 of the Specific Relief Act,1963 (47 of 1963), any person may institute a suit for a declaration that the use by him of any process, or the making, use or sale of any article by him does not, or would not, constitute an infringement of a claim of a patent against the patentee or the holder of an exclusive licence under the patent, notwithstanding that no assertion to the contrary has been made by the patentee or the licensee, if it is shown— (a) that the plaintiff has applied in writing to the patentee or exclusive licensee for a' written acknowledgements to the effect of the declaration claimed and has furnished him with full particulars in writing of the process or article in question; and (b) that the patentee or licensee has refused or neglected to give such an acknowledgement. (2) The costs of all parties in a suit for a declaration brought by virtue of this section shall, unless for special reasons the court thinks fit to order otherwise, be paid by the plaintiff. (3) The validity of a claim of the specification of a patent shall not be called in question in a suit for a declaration brought by virtue of this section, and accordingly the making or refusal of such a declaration in the case of a patent shall not be deemed to imply that the patent is valid or invalid. (4) A suit for a declaration may be brought by virtue of this section at any time after the publication of grant of a patent, and references in this section to the patentee shall be construed accordingly.

Section 106

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Power of court to grant relief in cases of groundless threats of infringement proceedings (1) Where any person (whether entitled to or interested in a patent or an application for patent or not) threatens any other person by circulars or advertisements or by communications, oral or in writing addressed to that or any other person, with proceedings for infringement of a patent, any person aggrieved thereby may bring a suit against him praying for the following reliefs, that is to say— (a) a declaration to the effect that the threats are unjustifiable; (b) an injunction against the continuance of the threats; and (c) such damages, if any, as he has sustained thereby. (2) Unless in such suit the defendant proves that the acts in respect of which the proceedings were threatened constitute or, if done, would constitute, an infringement of a patent or of rights arising from the publication of a complete specification in respect of a claim of the specification not shown by the plaintiff to be invalid the court may grant to the plaintiff all or any of the reliefs prayed for. Explanation—A mere notification of the existence of a patent does not constitute a threat of proceeding within the meaning of this section.

Section 107: Defences, etc., in suits for infringement (1) In any suit for infringement of a patent every ground on which it may be revoked under section 64 shall be available as a ground for defence. 2) In any suit for infringement of a patent by the making, using or importation of any machine, apparatus of other article or by the using of any process or by the importation, use or distribution or any medicine or drug, it shall be a ground for defence that such making, using, importation or distribution is in accordance with any one or more of the conditions specified in section 47.

Section 107A Certain acts not to be considered as infringement For the purposes of this Act, — (a) any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in

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force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product; (b) importation of patented products by any person from a person who is duly authorised under the law to produce and sell or distribute the product, shall not be considered as an infringement of patent rights.

Section 108: Reliefs in suit for infringement (1) The reliefs which a court may grant in any suit for infringement include an injunction (subject to such terms, if any, as the court thinks fit) and, at the option of the plaintiff, either damages or an account of profits. (2) The court may also order that the goods which are found to be infringing and materials and implements, the predominant use of which is in the creation of infringing goods shall be seized, forfeited or destroyed, as the court deems fit under the circumstances of the case without payment of any compensation.

Section 109 Right of exclusive licensee to take proceedings against infringement (1) The holder of an exclusive licence shall have the like right as the patentee to institute a suit in respect of any infringement of the patent committed after the date of the licence, and in awarding damages or an account of profits or granting any other relief in any such suit the court shall take into consideration any loss suffered or likely to be suffered by the exclusive licensee as such or, as the case may be, the profits earned by means of the infringement so far as it constitutes an infringement of the rights of the exclusive licensee as such. (2) In any suit for infringement of a patent by the holder of an exclusive licence under sub-section (1), the patentee shall, unless he has joined as a plaintiff in the suit, be added as a defendant, but a patentee so added as defendant shall not be liable for any costs unless he enters an appearance and takes part in the proceedings.

Section 116: Appellate Board (1) Subject to the provisions of this Act, the Appellate Board established under section 83 of the Trade Marks Act, 1999 shall be the Appellate Board

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for the purposes of this Act and the said Appellate Board shall exercise the jurisdiction, power and authority conferred on it by or under this Act: Provided that the Technical Member of the Appellate Board for the purposes of this Act shall have the qualifications specified in sub-section (2). (2) A person shall not be qualified for appointment as a Technical Member for the purposes of this Act unless he— (a) has, at least five years held the post of Controller under this Act or has exercised the functions of the Controller under this Act for at least five years; or (b) has, for at least ten years functioned as a Registered Patent Agent and possesses a degree in engineering or technology or a master’s degree in science from any University established under law for the time being in force or equivalent; or (c) [Omitted

117A. Appeals to Appellate Board— (1) Save as otherwise expressly provided in sub-section (2), no appeal shall lie from any decision, order or direction made or issued under this Act by the Central Government, or from any act or order of the Controller for the purpose of giving effect to any such decision, order or direction. (2) An appeal shall lie to the Appellate Board from any decision, order or direction of the Controller or Central Government under section 15, section 16, section 17, section 18, section 19, section 20, sub-section (4) of section 25, section 28, section 51, section 54, section 57, section 60, section 61, section 63, section 66, sub-section (3) of section 69, section 78, sub-sections (1) to (5) of section 84, section 85, section 88, section 91, section 92 and section 94. (3) Every appeal under this section shall be in the prescribed form and shall be verified in such manner as may be prescribed and shall be accompanied by a copy of the decision, order or direction appealed against and by such fees as may be prescribed. (4) Every appeal shall be made within three months from the date of the decision, order or direction, as the case may be, of the Controller or the Central Government or within such further time as the Appellate Board may, in accordance with the rules made by it allow.

117B. Procedure and powers of Appellate Board.

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The provisions of sub­sections (2) to (6) of section 84, section 87, section 92, section 95 and section 96 of the Trade Marks Act, 1999 (47 of 1999) shall apply to the Appellate Board in the discharge of its functions under this Act as they apply to it in the discharge of its functions under the Trade Marks Act, 1999.

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Notes

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Disclaimer

This compilation is intended to present the Indian Patent case laws of the year 2015. Every effort has been made to assure accuracy in the information contained in this book. However, due to the broad scope of the case laws and the fluid nature of statutory laws and case laws, StratJuris Partners cannot guarantee complete accuracy of the material presented. This document is intended to provide a general overview of the case laws. For more detailed and up-to-date information, the reader is encouraged to review the relevant laws and judgements directly. A great deal of material was covered in the writing of this book and during the research and preparation processes it is possible that something was omitted or misquoted. Any such omissions or misquotes or typing errors are not the responsibility of StratJuris Partners. The publishing of this compilation does not constitute the rendering of legal advice in any jurisdiction.

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