page 1 iop genomics workshop patents and patenting biotech inventions annemieke breukink, ph.d....

IOP Genomics WorkshopIOP Genomics WorkshopPatents and Patenting Biotech InventionsPatents and Patenting Biotech Inventions

Annemieke Breukink, Ph.D.

September 8th, 2009

Outline presentationOutline presentation

I. IP Rights and patent law

II. Patent procedure & costs

III. Patent strategy

IV. Patents and Biotechnology

Patents

Trademarks

Designs

Copyright

Database right

Trading names Ahold

Intellectual property rights:Intellectual property rights:

Other rights:no registration required

Industrial rights:registration required

What is a patent ?What is a patent ?

An exclusive right, granted by the state, to exclude others from making, selling, etc. your invention during a specific period in the jurisdiction of the state.

“Why bother with patents?”

The patent The patent system:system: Patent

Monopoly to

recover investments

Disclosure of

technical progress

R&D

Patent

PROTECTION INFORMATION

Example: technical information

• First to file principlecompany vs employee patentapplicant vs inventor

• Inventor: right to be mentionedentitled to compensation (cao)

Who obtains patent right ?Who obtains patent right ? (art. 12 Dutch Patent Act 1995)

Legal requirementsLegal requirements

• Novel• Involve an inventive step• Industrially applicable• Technical invention • Clear and complete disclosure

Patent infringement ?Patent infringement ?

• Commercial exploitation

• Research (scientific, fundamental) • Prior use

YES:

NO:

• Contract research• Clinical trialsMAYBE:

Example:Example: NL 1012379: Flat product and wrapper

Patent system in the NetherlandsPatent system in the Netherlands

• Dutch Patent Act (ROW 1995)

• European Patent Convention (1973); EPC 2000

• Patent Cooperation Treaty (PCT; 1970)

Patent procedure:Patent procedure:establishment of patent right

0 12 18

publication

Time (months)priority year

examinationfiling search

20Y

Example of a patent familyExample of a patent family

2,5 y

WO 01/10739PCT procedure

USA

Japan

Europe (EP)NetherlandsGermanyGreat Britain

1,5 ypubl.

France……

1 yNetherlandsapplication

JP 2001/072151

NL 1018659

US 6569387

EP 1076014

EP Grant

20 y

Patent procedure: total costsPatent procedure: total costs

• National € 5.000, result: Dutch patent

• European (EPO)€ 30.000, result: bundle of national patents

• International “PCT” (WIPO)€ 150.000, result: bundle of patent applications

Patent strategyPatent strategyuniversity and company viewsuniversity and company views

• Cost of investment

• (R&D, clinical trials)

• New technology

• Highly competitive field

• Financial risks

Importance of patents Importance of patents in the biotech/pharmacy field:in the biotech/pharmacy field:

Patent protection:Patent protection: company point of viewcompany point of view

• Protect product or process (invention)patent = monopoly = market investment protection

• Negotiation toolstop or collaborate competitors sell or buy technical know-how

• Venture capital attract investorsimage

Patent protection:Patent protection:university point of viewuniversity point of view

• Why apply for a patent?publish or perish

negotiation position

• Finance, who pays?university budgettechnology transfer?

• Who benefits?

• (Increase) collaboration with industry

• Generate new source of funding

• Potential breakthrough technology ?

• Patent does not exclude publication

Patent protection:Patent protection:university considerationsuniversity considerations

Science publication,May 30th, 2003

Patent applicationfiled April 8th, 2003

Execution

Desk research

Research proposal

Publication

Search literature in scientific publications

Patent literature as source of inspiration

Write research proposal

Patent literature assource of information

Obtain funds forresearch

Plan costs for patentapplication

Make records of results / Invention based on research

Registration of invention(s)

Financing

Approach:Approach: Combining Combining Patents and Patents and ResearchResearch

• Examine the field of your invention - Use patent literature

- Know the key companies

• Apply for a patent: obtain a priority date• Or sell your patent idea.

- Inventor is inventor

• Attract key companies attention- Sell / License / Project within 30 month period

• Proceed with your research

StrategyStrategy: Plan for Exploration: Plan for Exploration

Patents and BiotechnologyPatents and Biotechnology

Patent statistics:Patent statistics:

• Each year >140.000 European patent applications

• .. 5 % concerns biotechnology

Patenting biotech inventions…Patenting biotech inventions…

PPatentatent requirements requirements

• Absolute novelty

• Inventive step

• Industrial application

Invention:

What is an invention ?What is an invention ?

(what is a discovery….?)

Compound X selectively binds to receptor Y.

Example:Example:

“The selective occupation of a receptor cannot be considered in itself as a therapeutic application; the discovery that a substance selectively binds a receptor, even if representing an important piece of scientific knowledge, still needs to find a practical application in the form of a defined, real treatment of any pathological condition in order to make a technical contribution to the art and to be considered as an invention eligible for patent protection”

Is each invention patentable ?

NO !

Unpatentable subject matter:Unpatentable subject matter:

• Discoveries• Scientific theories, mathematical methods• Computer programs• Aesthetic creations• Business methods• Treatment of human / animal body• Inventions contrary to “ordre public”

Inventions contrary to “ordre public”Inventions contrary to “ordre public”

Unpatentable (biotech) inventionsUnpatentable (biotech) inventionsregulated by:regulated by:

Dutch Patents Act 1995

European patent convention (EPC)

Directive on Biotechnological inventions 98/44/EC

Unpatentable (biotech) inventions:Unpatentable (biotech) inventions:

• Plant or animal variety

• (parts of) human body which are not “isolated”

• DNA/protein sequence without description of function

• Method for cloning humans

• Method for altering genetic identity humans

• Method for altering genetic identity animals : suffering?

• Industrial or commercial use of embryo’s

Patentable (biotech) inventions:Patentable (biotech) inventions:

• Methods (e.g. DNA-array, cDNA library screening)

• Isolated (parts of) human body (proteins, enzymes)

• Isolated (partial) DNA sequence with function

• Genetically modified organism

• …….

• A method to…

• Use of X for…

• A product

Patenting (biotech) inventionsPatenting (biotech) inventions

Allowable subject matter

InformationInformation

http://www.octrooicentrum.nl/http://www.epo.org/http://www.wipo.int/

Patent registers:http://register.octrooicentrum.nlhttp://www.epoline.org/portal/public/registerplus

Patent search:http://nl.espacenet.com/http://patft.uspto.govhttp://www.google.com/patents

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