Patents in Biotechnology: What, How & Why?

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Patents in Biotechnology:

What, how & why?Dr Anton Hutter

Chartered & European Patent Attorney

January 2012


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Patents: What, how & why?

What are they & what do they protect?How to apply for & get a granted patent

Patentability requirements Inventorship & ownership issues How to get a granted patent

Why file a patent application? Uses of patents Investing in IP


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Patents: What?


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Patents

Protect technical inventionsA patent is an exclusive right allowing the owner to preventthird parties from doing certain things in respect of the claimedinvention:-

- making

- using- selling (offering to sell)

- importing- keeping

Patent lasts for 20 years from filing dateTerritorial nature of patentsPost-grant infringement and validity usually judged in nationalcourts


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Patents as a monopoly

The monopoly or scope of protection is defined by the claims: Products/articles/compositions Processes/methods/uses

Careful claim drafting required to maximise scope of protection


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What is patentable in bioscience?

Chemical and biological compoundsper se Biological materials (nucleotides, constructs, peptides,

proteins, antibodies etc.)

Primary, secondary & tertiary structures of macromolecules Processes formaking them Processes forusing them Substances useful in these processes, e.g. enzymes Cell lines, micro-organisms, transgenic organisms and plants


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What is patentable in bioscience?

Analytical/diagnostic methods Medical uses Drug delivery Dosage regimens Exclusions where contrary to morality : no

protection for processes for cloning human beings,

using human embryos for commercial purposes etc.


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Patents: How?


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Patentability

Requirements


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1) Novelty

In Europe, there is an absolute novelty requirementAt date of filing, invention must not have been made available to thepublic:

- in any way

- in any language

- at any time

- anywhere

- by anyone

Examples:-

- Academic paper

- Publication of an abstract on internet

- Public presentation or lecture

- Poster at a conference

- Open discussions at a conference- PhD Thesis

- Sale of a product- Non-confidential use of a product


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Confidentiality

Invention must be confidential before application filed Be careful what you disclose & what you keep secret Difficult in academia due to collaborations with other institutions

Take care when trying to attract funding, writing grantproposals & promoting your work

Use a confidentiality agreement if disclosing to 3rd parties Err on the side of caution and disclosenothing until a patent

application has been filed


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2) Inventive Step

Invention must not be obvious over the prior art and common generalknowledge

Prior art is everything that was in the public domain before the patentapplication was filed

Inventive step is arguable:-- Unexpected orsurprising result?

- Use ofnon-routine techniques?

- Not obvious to try?


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Other patentability requirements

3) Industrial Applicability

Invention must be capable of being applied in industry/agricultureMention at least one use in the patent applicationNeeded at filing date!


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4) Sufficiency

The patent specification must be sufficiently detailed so that a personskilled in the art can repeat the invention without undue burden

Include full details of all non-routine techniques usedNeeded at filing date!


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5) Support

Include example(s) to prove the claimed invention actually worksIn vitro & in vivo dataNeeded at filing date!


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Inventorship &

ownership issues


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Inventorship

Important to sort this out at the outsetThe inventor is the actual deviser of the inventionMay be a team, consider, e.g.

- Academics professors, lecturers, post-docs, post-grads, PhD

students, undergrads, students- Consultants- External contractors

- Employees

- Company directors

Multi-disciplinary teams becoming more common


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Ownership

The ownerdepends on the relationship between inventor(s) and otherparties involved

Usually owned by employer (employed to invent?)Contract?In academia, the university usually owns the IPIP may subsequently be assigned from university to spin-out


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How to get a granted

patent


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0 monthsFile UK application

(1.5k-4k)

+12 months

File international (PCT) application(3k-5k)

+15 months

International Search & Written Opinion(200)

+18 monthsInternational publication

+31 monthsFile European application

All designations(3.5k)

+30/31 monthsFile national applications

(1k-5k each)

For example:-

AustraliaBrazil

CanadaChina

IndiaJapan

Russia

USA

+60 months

GRANT OF EUROPEAN PATENTComplete formalities and register NATIONALLY

(500-5k per country)

For example:-

AustriaFrance

GermanyItaly

The NetherlandsUK

Patent

Filing

Procedure


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Patents: Why?


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Uses of Patents


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Patents are Commercial Tools

When building a patent portfolio, be clear about yourcommercial aims:

- Attracting funding/investment?

- Spin-out or equivalent?

- Create an income stream (licensing royalties)?

- As a bargaining chip in negotiations?

- Deterrent effect against competitors?

- Create barrier to others to enter market

- Seeking a collaboration?


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When to file?

A serious commercial opportunity is likely to require filing a patentapplication, even if ultimately obtaining patent protection may be

challenging

However, if the commercial opportunity is small, a patent application maynot be justified, even if the invention is eminently patentable

File patent

application

Do not file patent

application


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Investing in IP


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Due diligence

Much more than simply listing a company

s IP portfolio

An assessment of:-(i) the strength of a companys IP;

(ii) the strength of your competitors rights

Crucial to getting funding


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What are investors looking for?

1.

Check entitlement

2. Check the inventors are correctly named3. Assess patentability with respect to the prior art4. Assess validity with respect to sufficiency & support


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What are investors looking for?

5.

Check if company has strong patent portfolio offering goodprotection

6. Check the numbers of patent families offering different breadths ofprotection

7. Check geographical coverage of protection8. Check remaining term of patent protection9. Check the company has freedom-to-operate


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Freedom-to-operate

Look for any dominating patent rights You may require a licence to even work

in your area

Consider cross-licensing If you have to pay royalties, this may make your commercial venture

economically unviable

Without clearance for the market you wish to enter, there is always asignificant risk that you will be barred, or at least have to pay aroyalty stack to proceed with your business


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Summary A patent is an exclusive right allowing you to prevent a third party from

working your invention

BUT, you need freedom-to-operate to work the invention yourself File patent applications where commercial opportunities are good, even

if ultimately obtaining broad protection may be difficult

Novelty, inventive step, industrial application, sufficiency and support Important to get inventorship & ownership issues right at outset Due diligence will be carried out on your patent portfolio, so think ahead Be clear about your commercial aims


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Anton HutterBSc MSc PhD CPA EPA

Chartered & European Patent Attorney

Venner Shipley LLP

200 Aldersgate

London

EC1A 7HD

Tel: 020 7600 4212

Fax: 020 7600 4188

E: [email protected]

W: www.vennershipley.co.uk

Documents

Patents in Biotechnology: What, How & Why?