1. Patents in Biotechnology:
What, how & why?
Dr Anton Hutter
Chartered & European Patent Attorney
January 2012

2. 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

3. Patents: What?

4. 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

5. 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

6. 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

7. 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.

8. Patents: How?

9. Patentability
Requirements

10. 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

11. 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

12. 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?

13. 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!

14. 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!

15. Other patentability requirements
5) Support
• Include example(s) to prove the claimed invention actually works
• In vitro & in vivo data
• Needed at filing date!

16. Inventorship &
ownership issues

17. 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

18. 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

19. How to get a granted
patent

20. 0 months
File UK application
(£1.5k-£4k)
Patent
+12 months
Filing File international (PCT) application
(£3k-£5k)
Procedure +15 months
International Search & Written Opinion
(£200)
+18 months
International publication
+31 months
File European application
+30/31 months
All designations
File national applications
(£3.5k)
(£1k-£5k each)
+60 months For example:-
GRANT OF EUROPEAN PATENT Australia
Complete formalities and register NATIONALLY Brazil
(£500-£5k per country) Canada
China
For example:- India
Austria Japan
France Russia
Germany USA
Italy
The Netherlands
UK

21. No
Is invention new?
Yes or maybe
No
Is it inventive? When to patent
Yes or maybe
No
Would a patent be valuable?
Yes or maybe
No Do not file a
Better than secrecy?
patent
Yes or maybe application
No
Reasonable product life?
Yes or maybe
No
Are the costs justifiable?
Yes
File patent application

22. Patents: Why?

23. Uses of Patents

24. 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?

25. When to file?
• A serious commercial opportunity is likely to require filing a patent
application, even if ultimately obtaining patent protection may be
challenging
File patent
application
Do not file patent
application
• However, if the commercial opportunity is small, a patent application may
not be justified, even if the invention is eminently patentable

26. Investing in IP

27. 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

28. 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

29. 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

30. 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

31. 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

32. Thank you for your attention!
Anton Hutter BSc 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: ahutter@vennershipley.co.uk
W: www.vennershipley.co.uk