1. © J. Straus 2006 1 Patenting of Genes and Life Forms, and the impact of Patenting on Upstream Science Joseph Straus, Munich WIPO Open Forum on the Draft SPLT Geneva, March 3, 2006

2. © J. Straus 2006 2 Overview What are Genes – A Reminder Existing Legal Framework Facts and Experience of Relevance Status quo measured by 1997 HUGO’s yardstick

3. © J. Straus 2006 3 Reminder I: DNA - Sequence - Gene DNA Sequence – any sequence of DNA building blocks Gene – fundamental physical and functional unit of heredity, in its broadest sense, which consists of an ordered sequence of nucleotides located in a particular position on a particular chromosome, and which encodes specific functional products, such as protein or RNA molecule.

4. © J. Straus 2006 4 Reminder II: Double Nature of Gene Sequences Physical carrier of information Information as such – multifunctional –The (actual)-biological function  e.g. coding for (a) protein(s) (alternative splicing!) –The (actual) – non-biological function – hybridising  e.g. DNA probe, diagnostic marker, etc.

5. © J. Straus 2006 5 Reminder III: Human Genome Human Genome Programme (HUGO) – 1995-2000 –4 years – 1st Billion base pairs –4 months – 2nd Billion base pairs –Eventually – 10 % base pairs per month Celera (Craig Venter) – ca. 2 years – 3 Billion bp Result: instead of 100.000 some 30-35 (48?) thousands of genes 40% alternatively spliced

6. © J. Straus 2006 6 Mandatory TRIPS Protection Standards Patents must be available for inventions in all fields of technology – no discrimination allowed (Art. 27 (1)) Exclusions allowed – if necessary to prevent commercial exploitation which would violate ordre public or morality – thus applicable only if the respective exploitation not allowed (Art. 27 (2)) Subject matter eligible for protection shall include products and processes [, in all fields of technology,] which can be made and used in any field of activity, except mere discoveries; … (Art. 12) DSPLT

7. © J. Straus 2006 7 Available Manœuvring Space - Allowed Limitations of the Exclusive Right Conferred - Research Exemption covering: research for further improvements and further developments, clinical trials of all kinds with patented substances (see, e.g. USA, Japan), irrespective eventual commercial aim, use as research tools (in academe?) (Art. 30) Compulsory and dependency compulsory licenses, also for plant breeders vs. Patentees (Art. 31 TRIPS, EU Biotech Directive)

8. © J. Straus 2006 8 EU Directive 98/44/EC Regime Gene Sequences = Chemical Substances? If isolated from the human body or technically produced (e.g. through synthesis) – sequences or partial sequences of a gene – patentable inventions – even if structurally identical to that of a natural element [Art. 5 (2)]. However the industrial application of a sequence or a partial sequence of a gene must be [specifically] disclosed in the application [Art. 5 (3)]. A mere DNA sequence without indication of a function – not a patentable invention [Recital 23] – thus „function“ integral part of the notion „invention“.

9. © J. Straus 2006 9 EU Directive 98/44/EC Regime Gene Sequences = Chemical Substances? Use of a sequence or partial sequence of a gene to produce a protein or part of a protein „industrially applicable“ only if the protein or part of the protein and its functions specifically disclosed [Recital 24]. Special rules on dependency in case or overlapping patented sequences [Recital 25]. Product protection for products containing or consisting of genetic information extends to all material – EXCEPT TO THE HUMAN BODY – „in which the product is incorporated and in which the genetic information is contained and PERFORMS ITS FUNCTION“ [Art. 9].

10. © J. Straus 2006 10 No Patents for ESTs in the US “643’ application does not meet the utility requirement of § 101 because Fisher does not identify the function for the underlying protein-encoding genes. Absent such identification, we hold that the claimed ESTs have not been researched and understood to the point of providing an immediate, well-defined, real world benefit to the public meriting the grant of a patent.” [In. re Dane K. Fisher Fed. Cir. Sept. 7, 2005]

11. © J. Straus 2006 11 Facts Source NRC 2005

12. © J. Straus 2006 12 Facts

13. © J. Straus 2006 13 Facts Source: NRC 2005

14. © J. Straus 2006 14 Facts Source: NRC 2005

15. © J. Straus 2006 15 Facts

16. © J. Straus 2006 16 Facts Access to Genetic Discoveries 85 % of US university-based genetic discoveries directly released into the public domain – not covered by proprietary rights [Henry et al. (2002)] [Movery et al. (2001)]

17. © J. Straus 2006 17 Facts Impact on Industrial Development Amgen Biogen Genentech Millenium and numerous other biotech companies – all originally based on DNA and other biotech patents

18. © J. Straus 2006 18 Facts No empirical evidence for serious negative impacts on upstream science: No-specific Breakdowns Royalty stacking Patent trolls [Walsh/Arora/Cohen (2005)] [Straus/Holzapfel/Lindenmeir (2004)] NRCs concerns not shared – statutory research exemption in Europe; Supreme Court Merck v. Integra in USA – Shielding upstream research

19. © J. Straus 2006 19

20. © J. Straus 2006 20 © J. Straus 2006

21. 21

22. © J. Straus 2006 22 Status Quo Measured by 1997 HUGO’s Yardstick HUGO’s expectations overall fulfilled No negative impact of patenting on upstream science empirically proven No substantial change of the system needed Provided the existing patentability requirements are strictly applied

23. © J. Straus 2006 23