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IOP Genomics WorkshopIOP Genomics Workshop
Patents and Patenting Biotech InventionsPatents and Patenting Biotech Inventions
Annemieke Breukink, Ph.D.
September 8th, 2009
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Outline presentationOutline presentation
I. IP Rights and patent law
II. Patent procedure & costs
III. Patent strategy
IV. Patents and Biotechnology
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Patents
Trademarks
Designs
Copyright
Database right
Trading names Ahold
Intellectual property rights:Intellectual property rights:
Other rights:
no registration required
Industrial rights:
registration required
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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.
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“Why botherwith patents?”
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The patent system:The patent system:
Patent
Monopoly torecover investments
Disclosure oftechnical progress
R&D
Patent
PROTECTION
INFORMATION
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Example: technical information
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• First to file principle
company vs employee
patentapplicant vs inventor
• Inventor:
right to be mentioned
entitled to compensation (cao)
Who obtains patent right ? Who obtains patent right ?
(art. 12 Dutch Patent Act 1995)
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Legal requirementsLegal requirements
• Novel
• Involve an inventive step
• Industrially applicable
• Technical invention
• Clear and complete disclosure
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Patent infringement ?Patent infringement ?
• Commercial exploitation
• Research (scientific, fundamental)
• Prior use
YES:
NO:
• Contract research
• Clinical trials
MAYBE:
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Example:Example:
NL 1012379: Flat product and wrapper
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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)
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Patent procedure: Patent procedure:
establishment of patent right
0
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publication
Time (months)
priority year
examination
filing
search
20Y
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Example of a patent familyExample of a patent family
2,5 y
WO 01/10739
PCT procedure
USA
Japan
Europe (EP)
Netherlands
Germany
Great Britain
1,5 y
publ.
France
……
1 y
Netherlands
application
JP 2001/072151
NL 1018659
US 6569387
EP 1076014
EP Grant
20 y
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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
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Patent strategyPatent strategy
university and company viewsuniversity and company views
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• Cost of investment
• (R&D, clinical trials)
• New technology
• Highly competitive field
• Financial risks
Importance of patentsImportance of patents
in the biotech/pharmacy field: in the biotech/pharmacy field:
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Patent protection: Patent protection:
company point of view company point of view
• Protect product or process (invention)
patent = monopoly = market
investment protection
• Negotiation tool
stop or collaborate competitors
sell or buy technical know-how
• Venture capital
attract investors
image
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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 budget
technology transfer?
• Who benefits?
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• (Increase) collaboration with industry
• Generate new source of funding
• Potential breakthrough technology ?
• Patent does not exclude publication
Patent protection:Patent protection:
university considerationsuniversity considerations
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Science publication,
May 30th, 2003
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Patent application
filed April 8th, 2003
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Execution
Desk research
Research proposal
Publication
Search literature
in scientific
publications
Patent literature as
source of inspiration
Write research
proposal
Patent literature as
source of information
Obtain funds for
research
Plan costs for patent
application
Make records of
results / Invention
based on research
Registration of
invention(s)
Financing
Approach:CombiningPatents andResearchApproach:CombiningPatents andResearch
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• 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
Strategy: Plan for ExplorationStrategy: Plan for Exploration
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Patents and BiotechnologyPatents and Biotechnology
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Patent statistics:Patent statistics:
• Each year >140.000 European patent applications
• .. 5 % concerns biotechnology
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Patenting biotech inventions…Patenting biotech inventions…
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Patent requirementsPatent requirements
• Absolute novelty
• Inventive step
• Industrial application
Invention:
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What is an invention ?What is an invention ?
(what is a discovery….?)
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Compound X selectivelybinds to receptor Y.
Example:Example:
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“The selective occupation of a receptor cannot beconsidered in itself as a therapeutic application; thediscovery that a substance selectively binds a receptor,even if representing an important piece of scientificknowledge, still needs to find a practical application inthe form of a defined, real treatment of any pathologicalcondition in order to make a technical contribution to theart and to be considered as an invention eligible forpatent protection”
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Is each invention patentable ?
NO !
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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”
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Inventions contrary to “ordre public”Inventions contrary to “ordre public”
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Unpatentable (biotech) inventionsUnpatentable (biotech) inventions
regulated by:regulated by:
Dutch Patents Act 1995
European patent convention (EPC)
Directive on Biotechnological inventions 98/44/EC
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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
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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
• …….
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• A method to…
• Use of X for…
• A product
Patenting (biotech) inventionsPatenting (biotech) inventions
Allowable subject matter
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InformationInformation
http://www.octrooicentrum.nl/
http://www.epo.org/
http://www.wipo.int/
Patent registers:
http://register.octrooicentrum.nl
http://www.epoline.org/portal/public/registerplus
Patent search:
http://nl.espacenet.com/
http://patft.uspto.gov
http://www.google.com/patents