1. Page 1 IOP Genomics Workshop Patents and Patenting Biotech Inventions Annemieke Breukink, Ph.D. September 8th, 2009

2. Page 2 Outline presentation I. IP Rights and patent law II. Patent procedure & costs III. Patent strategy IV. Patents and Biotechnology

3. Page 3 Patents Trademarks Designs Copyright Database right Trading names Ahold Intellectual property rights: Other rights: no registration required Industrial rights: registration required

4. Page 4 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.

5. Page 5 “Why bother with patents?”

6. Page 6 The patent system: Patent Monopoly to recover investments Disclosure of technical progress R&D Patent PROTECTIONINFORMATION

7. Page 7 Example: technical information

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9. 9 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)

10. Page 10 Legal requirements Novel Involve an inventive step Industrially applicable Technical invention Clear and complete disclosure

11. Page 11 Patent infringement ? Commercial exploitation Research (scientific, fundamental) Prior use YES: NO: Contract research Clinical trials MAYBE:

12. Page 12 Example: NL 1012379: Flat product and wrapper

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14. Page 14 Patent system in the Netherlands Dutch Patent Act (ROW 1995) European Patent Convention (1973); EPC 2000 Patent Cooperation Treaty (PCT; 1970)

15. Page 15 Patent procedure: Patent procedure: establishment of patent right 01218 publication Time (months) priority year examination filing search 20Y

16. Page 16 Example 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

17. Page 17 Patent 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

18. Page 18 Patent strategy university and company views

19. Page 19 Cost of investment ( R&D, clinical trials) New technology Highly competitive field Financial risks Importance of patents in the biotech/pharmacy field: in the biotech/pharmacy field:

20. Page 20 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

21. Page 21 Patent protection: Patent protection: university point of view Why apply for a patent? publish or perish negotiation position Finance, who pays? university budget technology transfer? Who benefits?

22. Page 22 (Increase) collaboration with industry Generate new source of funding Potential breakthrough technology ? Patent does not exclude publication Patent protection: university considerations

23. Page 23 Science publication, May 30th, 2003

24. Page 24 Patent application filed April 8th, 2003

25. Page 25 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: Combining Patents and Research

26. Page 26 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 Exploration

27. Page 27 Patents and Biotechnology

28. Page 28 Patent statistics: Each year >140.000 European patent applications.. 5 % concerns biotechnology

29. Page 29 Patenting biotech inventions…

30. Page 30 Patent requirements Absolute novelty Inventive step Industrial application Invention:

31. Page 31 What is an invention ? (what is a discovery….?)

32. Page 32 Compound X selectively binds to receptor Y. Example:

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34. Page 34 “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”

35. Page 35 Is each invention patentable ? NO !

36. Page 36 Unpatentable subject matter: Discoveries Scientific theories, mathematical methods Computer programs Aesthetic creations Business methods Treatment of human / animal body Inventions contrary to “ordre public”

37. Page 37 Inventions contrary to “ordre public”

38. Page 38 Unpatentable (biotech) inventions regulated by: Dutch Patents Act 1995 European patent convention (EPC) Directive on Biotechnological inventions 98/44/EC

39. Page 39 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

40. Page 40 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 …….

41. Page 41 A method to… Use of X for… A product Patenting (biotech) inventions Allowable subject matter

42. Page 42 Information 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