Patents in Biotechnology: What, how & why?

Dr Anton Hutter Chartered & European Patent Attorney

January 2012

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

Patents: What?

Patents

• Protect technical inventions

• A patent is an exclusive right allowing the owner to prevent third parties from doing certain things in respect of the claimed invention:- - making

- using- selling (offering to sell)- importing- keeping

• Patent lasts for 20 years from filing date

• Territorial nature of patents

• Post-grant infringement and validity usually judged in national courts

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

What is patentable in bioscience?

• Chemical and biological compounds per se

• Biological materials (nucleotides, constructs, peptides, proteins, antibodies etc.)

• Primary, secondary & tertiary structures of macromolecules

• Processes for making them

• Processes for using them

• Substances useful in these processes, e.g. enzymes

• Cell lines, micro-organisms, transgenic organisms and plants

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.

Patents: How?

Patentability

Requirements

1) Novelty• In Europe, there is an absolute novelty requirement

• At date of filing, invention must not have been “made available to the public”:

- 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

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 grant proposals & promoting your work

• Use a confidentiality agreement if disclosing to 3rd parties

• Err on the side of caution and disclose nothing until a patent application has been filed

2) Inventive Step

• Invention must not be obvious over the ‘prior art’ and common general knowledge

• ‘Prior art’ is everything that was in the public domain before the patent application was filed

• Inventive step is arguable:-

- Unexpected or surprising result?

- Use of non-routine techniques?

- Not obvious to try?

Other patentability requirements

3) Industrial Applicability

• Invention must be capable of being applied in industry/agriculture

• Mention at least one use in the patent application

• Needed at filing date!

Other patentability requirements

4) Sufficiency

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

• Include full details of all non-routine techniques used

• Needed at filing date!

Other patentability requirements

5) Support

• Include example(s) to prove the claimed invention actually works

• In vitro & in vivo data

• Needed at filing date!

Inventorship & ownership issues

Inventorship

• Important to sort this out at the outset

• The inventor is the “actual deviser” of the invention

• May 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

Ownership• The owner depends on the relationship between inventor(s) and other

parties involved

• Usually owned by employer (‘employed to invent?’)

• Contract?

• In academia, the university usually owns the IP

• IP may subsequently be assigned from university to spin-out

How to get a granted patent

0 monthsFile UK application

(£1.5k-£4k)

+12 months File international (PCT) application

(£3k-£5k)

+15 months International Search & Written Opinion

(£200)

+18 months International publication

+31 months File European application

All designations(£3.5k)

+30/31 monthsFile national applications

(£1k-£5k each)

For example:-Australia

BrazilCanada

ChinaIndia

JapanRussiaUSA

+60 months GRANT OF EUROPEAN PATENT

Complete formalities and register NATIONALLY(£500-£5k per country)

For example:-AustriaFrance

Germany Italy

The NetherlandsUK

PatentFiling

Procedure

Is invention new?

Better than secrecy?

Would a patent be valuable?

Is it inventive?

Reasonable product life?

Are the costs justifiable?

File patent application

Yes or maybe

Yes or maybe

Yes or maybe

Yes or maybe

Yes or maybe

Yes

Do not file a patent

application

No

No

No

No

No

No

When to patent

Patents: Why?

Uses of Patents

Patents are Commercial Tools

• When building a patent portfolio, be clear about your commercial 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?

When to file?

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

• However, if the commercial opportunity is small, a patent application may not be justified, even if the invention is eminently patentable

File patentapplication

Do not file patentapplication

Investing in IP

Due diligence

• Much more than simply listing a company’s IP portfolio

• An assessment of:-(i) the strength of a company’s IP;(ii) the strength of your competitor’s rights

• Crucial to getting funding

What are investors looking for?

1. Check entitlement

2. Check the inventors are correctly named

3. Assess patentability with respect to the prior art

4. Assess validity with respect to sufficiency & support

What are investors looking for?

5. Check if company has strong patent portfolio offering good protection

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

7. Check geographical coverage of protection

8. Check remaining term of patent protection

9. Check the company has freedom-to-operate

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 a significant risk that you will be barred, or at least have to pay a royalty stack to proceed with your business

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

Anton Hutter BSc MSc PhD CPA EPA Chartered & European Patent AttorneyVenner Shipley LLP200 AldersgateLondonEC1A 7HD

Tel: 020 7600 4212Fax: 020 7600 4188

E: ahutter@vennershipley.co.uk W: www.vennershipley.co.uk

Thank you for your attention!