NATIONAL PHARMACEUTICAL CONTROL BUREAU (NPCB)

(Drug Regulatory Agency of Malaysia)

Ministry of Health Malaysia

Trans-Pacific Partnership Agreement (TPPA)

18. Intellectual Property Rights

The provisions in Intellectual Property Rights (IPR) chapter is to:

o Promote technological innovation and the transfer and dissemination of technology

o Promote mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare;

o balance of rights and obligations of producers and users of technological innovation

Definitions : intellectual property refers to all categories of intellectual

property that are the subject of Sections 1 through 7 of Part II of the TRIPS Agreement.

Objectives

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Section A : General Provisions Section B : Cooperation Section C : Trademarks Section D : Geographical Indications Section E : Patents/ Undisclosed Test or other data Subsection A : General Patents Subsection B : Data Protection for Agriculture and Chemical Products Subsection C :Measures relating to pharmaceutical /regulated products Section F : Industrial Designs Section G : Copyright and related rights Section H : Enforcement Section I : Internet Service Providers Section J : Final Provisions

Structure of the IPR Chapter

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Subsection C :Measures relating to pharmaceutical /regulated products

i. Patent term adjustment ii. Patent linkage iii. Pharmaceutical data protection/ Protection of

undisclosed Test or other data - small molecules (other than biologics medicines) - biologics

IPR and Pharmaceuticals Key Provisions

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i. Patent term adjustment

In the TPPA Malaysia is obligated to make available a patent term adjustment to compensate the patent owner if there is a delay in the medicines marketing approval process.

Patent protection for pharmaceutical drugs remains at 20 years, in accordance to TRIPS. Only in the event there is an unreasonable delay, would the patent period be extended

Ministry of Health’s (MOH) client’s charter for registration of medicines by the Drug Control Authority (DCA) is 245 working days, which is comparable to many other countries.

Since the processing time is within the current international practice, the likelihood of an extended period should not arise.

Key Obligations and Flexibilities

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ii. Patent linkage The patent linkage obligation for Malaysia is different from that which is practiced by others such as US FDA where the agency must ensure that there is no infringement of patent before the agency can approve marketing of a generic. In the TPPA, Malaysia is obligated to provide a notification system to a patent holder that the generic or biosimilar company is seeking to market an approved pharmaceutical product during the term of a patent. This system will not be a burden to MoH.

Key Obligations and Flexibilities

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iii. Protection of test data / Data Exclusivity (DE) for (a) small molecules (other than biologics medicines) In Malaysia, the DE Directive, which has been in force since 2011, allows the protection of pharmaceutical test data of innovator products for a period of five years. During that period, health authorities will not be able to rely on innovator test data to grant marketing approval of generics. In the TPPA, Malaysia will continue to provide test data protection for pharmaceuticals for five years.

Key Obligations and Flexibilities

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iii. Protection of test data / Data Exclusivity (DE) for (b) Biologics

Agreement on biologics gives two options for TPP Parties: countries to offer 8 years market protection for Biologics; or

alternatively countries to provide effective market protection

through the implementation of Articles 18.50.1(Protection of undisclosed test or other data) and 18.50.3 mutatis mutandis for a period of at least 5 years from the date of first marketing approval of that product in that Party, through other measures, and recognizing that market circumstances also contribute to effective market protection

to deliver a comparable outcome in the market

Key Obligations and Flexibilities

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iii. Protection of test data / Data Exclusivity (DE) for (b) Biologics… (continued) Malaysia is taking the second option of a minimum standard of 5-year exclusivity and other measures. The shorter period of exclusivity will enable cheaper biosimilars to reach the market more quickly. The biologics agreement also provides a review to be undertaken 10 years after entry into force of the TPPA

Key Obligations and Flexibilities

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continued …iii.Protection of data / Data Exclusivity (DE) Flexibility: The TPP will not affect Malaysia’s ‘access window’ (application for marketing approval must be submitted within 18 months from the date first approved in any other country), which is a condition before any data protection is granted This ‘access window’ is fundamental, and will ensure that new pharmaceuticals/biologics would enter into Malaysia early, thus enable Malaysians to have access to these life saving products.

Key Obligations and Flexibilities

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continued …iii.Protection of data / Data Exclusivity (DE)

Flexibility:

Member states of The World Trade Organization (WTO), including Malaysia is obligated to provide patent protection to innovator products for 20 years.

Granting pharmaceutical test data protection within the patent term of the product will not delay access of generics and biosimilars to the public as protection of the patent and test data is within the patent term and not near the patent expiry.

Imposing the ‘access window’ condition will avoid patent-evergreening, or overhanging of a patent term.

Key Obligations and Flexibilities

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The obligations in the TPPA do not prevent the government from taking measures to protect public health and in particular, to promote access to medicines for all by using the flexibilities in accordance with The Declaration on the TRIPS Agreement and Public Health, also known as the Doha Declaration. In situations of national emergency or extreme urgency, the government can issue a compulsory license to enable the local manufacture of a patented product or make use ‘Rights of Governments’ to import a patented product from a different source at a lower price. Malaysia has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.

Other Safeguards/Flexibilities

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• In the case of Malaysia, i. Patent term adjustment due to unnecessary delays Malaysia has 4.5 years to meet the obligation after the TPPA comes into

effect. ii. Patent linkage Malaysia has 4.5 years to meet this obligation after the TPPA comes into

effect. iii. Test data Protection for Biologics Malaysia has 5 years to meet this obligation after the TPPA comes into effect.

Transition period

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Within this transition period; Malaysia needs to i. amend the Patent Act ii. issue directives under the Control of Drugs and Cosmetics

Regulations 1984 iii. continue to provide capacity building and ensure enough

personnel to process efficiently all applications for marketing approval for pharmaceuticals and biologics

iv. enhance efficiency of QUEST system to process application

Transition Period

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