1. International Intellectual Property Prof. Manheim Spring, 2007 Biotechnology Patents Copyright © 2007

2. Spring, 2007Int'l IP2 Subject Matter  35 USC § 101 35 USC § 101  any “process, machine, manufacture, composition of matter”  TRIPs Art. 27 TRIPs Art. 27  patents shall be available for any inventions, whether products or processes, in all fields of technology  Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or moralityordre public  Members may also exclude from patentability: (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals  NAFTA Art. 1709 EU Biotechnology Directive European Patent Convention NAFTA Art. 1709EU Biotechnology DirectiveEuropean Patent Convention

3. Spring, 2007Int'l IP3 GMO Patents  Background  GMO - Organism whose genetic material is altered using recombinant DNA technologyrecombinant DNA technology  DNA from multiple organisms combined in lab  GMO technology is controversial discussion  EU moratorium on GMO foods (frankenfoods)GMO foods  Dispute resolved by WTO on 29/9/06 summaryfull  Contrast cross-breeding, mutagenesis  Biotechnological Process Patent Act of 1995  Added 35 USC § 103(b) relaxing obviousness rules35 USC § 103(b)

4. Spring, 2007Int'l IP4 Life Form Patents  Background  Diamond v. Chakrabarty (1980) Diamond v. Chakrabarty  Genetically modified life forms patentable in US  A live, human-made micro-organism is patentable subject matter under 35 USC § 101. Respondent's micro-organism constitutes a "manufacture" or "composition of matter"  U.S. Patent 4,259,444 (1981) U.S. Patent 4,259,444  Increased biotech FDI in US (biotech friendly)  Harvard Oncomouse  Transgenic (gene spliced in at embryonic stage)  Increasing mouse’s susceptibility to cancer  U.S. Patent 4,736,866 (1988) [never challenged] U.S. Patent 4,736,866

5. Spring, 2007Int'l IP5 Gene Splicing / Transfection

6. Spring, 2007Int'l IP6 Harvard v. Canada (CA SCt. 2002)  Canada Patent Act § 2  “invention” means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter”  Higher Life Forms  Not contemplated by Parliament under § 2  Dramatic expansion of traditional patent regime  Serious policy matter for Parliament (not courts)  See also recommendations of Canadian Biotechnology Advisory CommitteeCanadian Biotechnology Advisory Committee Bastarche, J

7. Spring, 2007Int'l IP7 Harvard v. Canada (CA SCt. 2002)  Higher Life Forms (eukaryotes)eukaryotes  Rejects interpretation by USSC in Chakrabarty  Cdn. SC is more textualist than intentionalist  More spiritual? (life consists of more than “ matter ” )  Infringement problem  Life forms self-reproduce, giving rise to liability for “innocent infringer”  Balance of interests under Canadian Law  Promotion of ingenuity vs. other social welfare  Lower Life Forms (prokaryotes)prokaryotes  Still patentable in Canada - why different?

8. Spring, 2007Int'l IP8 Harvard v. Canada (CA SCt. 2002)  Relation to Treaty Obligations  TRIPs Art. 27 TRIPs Art. 27  3. Members may also exclude from patentability:  (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non- biological and microbiological processes.  NAFTA Article 1709 NAFTA Article 1709  [same]  Do these require affirmative exception?  Or preserve status quo if already non-patentable?

9. Spring, 2007Int'l IP9 Harvard v. Canada (CA SCt. 2002)  What are the long-term implications of this case?  If R&D generally is global/transitory, does any nation’s patent doctrine really matter?  Current law in Canada  Harvard not overturned by legislation  But see Monsanto Canada Inc. v. Schmeiser, 1 S.C.R. 902 (2004)  Monsanto’s GM “Roundup-Resistant” seed was patentable

10. Spring, 2007Int'l IP10 European Patent Organization (EPOrg)  Created by European Patent Convention  Eur. Patent Office (EPO) – executive body Eur. Patent Office  HQ – Munich : Offices in NL, DE, AT, BE  EPO Departments  Receiving Section/Examining Division (  USPTO)  Also serves as ISA under PCT  Opposition Division  post-grant, adversarial administrative procedure to challenge a patent (allegedly) wrongly granted  Boards of Appeal / Enlarged Board of Appeal Boards of Appeal  No Court (yet) Compare US reexamination procedures

11. Spring, 2007Int'l IP11 European Patent Office (EPO)  Boards of Appeal  Disciplinary BoA  Legal BoA  Technical BoA  Ad Hoc BoA (Board for a Particular Appeal)  Enlarged Board of Appeal (EPC Art. 112)  to ensure uniform application of the law  Compare US Cts of Appeal en banc hearing  important point of law  Only where necessary to decide case sub judice Appellate Procedure Jurisdiction described in Kolbenschmidt (EBA) Kolbenschmidt See also EPC Art. 21Art. 21

12. Spring, 2007Int'l IP12 Oncomouse - EPO  Procedural History  EPO Application no. 85304490.7  Filed 1985 (priority date 1984)  Refused 1989  Appeal to Technical BoA 1990 [T 19/90]  Referred back to Examining Division 1990  Granted 1992 (summary) [EP 0169672]summary  Oppositions  Filed 1993  Partially allowed 2003  Appeal to Technical BoA 2003

13. Spring, 2007Int'l IP13 Oncomouse - EPO  EPC Art. 53 EPC Art. 53  European patents shall not be granted in respect of: a)inventions the publication or exploitation of which would be contrary to "ordre public" or morality… b)plant or animal varieties or essentially biological processes for the production of plants or animals...  Rule 23d [adopted in response to T 19/90] Rule 23d  Under Article 53(a), Eur. patents shall not be granted in respect of biotechnological inventions [for]:Article 53(a) d)processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

14. Spring, 2007Int'l IP14 Oncomouse - EPO  Board’s methology  Does Rule 23d(d) bar this patent? [biotech only]  Does Art. 53(a) bar this patent?  Does Art. 53(b) bar this patent?  Does caselaw bar this patent?  Focus of EPC 53(a) ordre public & morality  Invention itself? Transgenic animals  Patenting the invention? Oncomouse patent  Publication or exploitation of the patent?  Diffusion of knowledge or practicing the invention

15. Spring, 2007Int'l IP15 Oncomouse - EPO  Rule 23d(d) - genetic engineering of animals  cause animal suffering?  Very purpose of the oncomouse  substantial medical benefit to man or animal?  Compare animal testing in general  Correspondence (relationship) – balancing test  Yes with mice; No with rodents in general  T 19/90 test – caselaw  Degree of animal suffering – rejected as factor  Non-animal alternatives – evidence favors patent  Environmental dangers – failure of evidence

16. Spring, 2007Int'l IP16 Oncomouse - EPO  Art. 53(a) “ordre public”  Public security  Physical integrity of individuals  Environmental protection  Threat to evolution  Art. 53(a) morality  Cultural norms inherent in European society and civilization (not country specific)  Illicit trade in animals - patent may reduce trade  Moral reprehension public peace social order

17. Spring, 2007Int'l IP17 Oncomouse - EPO  Art. 53(b) “plant or animal varieties”  Subject-matter exclusion  Applies only to plant or animal varieties that are identified in the specification  Based on taxonomic rank  Official languages (English, French, German) differ  Claims  Mammal (class Mammalia)  Rodent (order Rodentia)  Mouse (genus Mus) All higher than species, race and variety (the various 53(b) terms) Not claimed in EPO app.

18. Spring, 2007Int'l IP18 Oncomouse - EPO  Art. 53(b) “essentially biological process”  Natural phenomenon  Genetic manipulation is, in part, artificial  Plant and Animal patents generally  Art 53(b) based on European Patent Dir. Art. 4European Patent Dir.  North/South divide on patentability  Biodiversity & biopiracy issues  Reflected in TRIPs Art. 27(3)(b)

19. Spring, 2007Int'l IP19 Other Biotech Patent Resources  USPTO sequence Listings USPTO sequence Listings  More on Biotechnology Patents from WIPO More on Biotechnology Patents from WIPO  More on Biotechnology Patents from BIO More on Biotechnology Patents from BIO  Genetics and Patenting Genetics and Patenting  DNA Patenting DNA Patenting  Biotechnology Law @ LLS (other resources) Biotechnology Law @ LLS (other resources)  US Patent 7,179,594 (SNP detection) US Patent 7,179,594 (SNP detection)