The Role of Courts for Sustainable Innovation

1. The Role of Courts for Sustainable Innovation - As Predominantly Reflected in Case Law on Patentable Subject Matter - Joseph Straus, Munich/Pretoria 2013 Tongji Global Intellectual Property Forum, Tongji IP Institute, Shanghai, December 4, 2013

2. Topics to Consider • The rationale of the patent system & IP rights in general • Science & technology – perpetual challenge for legislature • Courts as key interpreters of "law" and "technology" – pacemakers of technological innovation • Innovation – shared responsibility of legislature & courts • Some concluding thoughts – from a European perspective

3. The Rationale of the Patent System & IP Rights in General • "To promote the Progress of Science and Useful Arts, by securing for limited times to Authors and Inventors the exclusive rights to their respective Writings & Discoveries" U.S. Const. Art. I, § 8, cl. 8 • "[T]he Patent Clause reflects a balance between the need to encourage innovation and the avoidance of monopolies which stifle competition without any concomitant advance in the 'Progress of Science and Useful Arts'". U.S. Supreme Court, Bonito Boats, 489 U.S. at 146

4. The Rationale of the Patent System „The ground for granting a patent to the inventor is ultimately the public interest in scientific and technological progress. Therefore the unlimited protection of the patent is not justified in a case where the further development of technology is hindered. The patent right – in the national sector as well as in principle in foreign law is aimed at promoting technological progress and stimulating the spirit of invention in the industry in a profitable manner.“ German Federal Supreme Court [1998] R.P.C. 423 (435) – Confirmed by the German Federal Constitutional Court in 2000

5. The Genuine "Traditional" Function of a Patent “It is clearly settled at law that a man, to entitle himself to the benefit of a patent for monopoly, must disclose his secrets and specify his invention in such a way that others may be taught by it to do the thing for which the patent is granted, for the end and meaning of the specification is to teach the public after the term for which the patent is granted, what the art is, and it must put the public in possession of secret in as ample and beneficial a way as the patentee himself uses it…” [Judge Buller in King v. Arkwright (1785)]

6. The Rationale of the Patent System & IP Rights TRIPS Objectives • The protection and enforcement of IP rights should contribute to • the promotion of technological innovation and • the transfer and dissemination of technology • the mutual advantage of produces and users of technological knowledge, and • in a manner conducive to social and economic welfare, and to a balance of rights and obligations. Article 7 TRIPS

7. Science & Technology – Perpetual Challenge for Legislature The Problems of Legislatures & Courts • Any system of positive law which attempts to regulate matter relating to imperfectly understood mental or physical facts – problem loaded • They are not the development of evident and necessary truths, but are built up through the interpretations given by the courts to the terms in which the arbitrary will of the legislative body is expressed. • Terms not always carefully selected, nor accurately adapted to the subjects which they are intended to control • Court's interpretations are characterized by many apparent contradictions, by much uncertainty of language, and by frequent confusion of ideas which are, in themselves, essential dissimilar W.C. Robinson, The Law of Patents [1890]

8. Science & Technology – Perpetual Challenge for Legislature Terms Left to Courts for Interpretation & Application Inter alia "Technology", "Discovery", "Invention", "Laws of Nature", "Physical Phenomena", "Abstract Ideas", "Apparatus", "Process", "Machine", "Computer Program", "Microorganism", "Plants", "Animals", "Plant & Animal Varieties", "Essentially Biological & Non-Biological Processes", etc.

9. Technology – An Evolutionary Notion • Can an invention for breeding doves be patented? • According to § 1(1) of the Patent Act – Unchanged since 1877 – patents available for new inventions that permit industrial application • Originally – this was interpreted as a teaching of a technical character employing physical and chemical means aloneknown as predictable at the time the act was passed • However, this original view can no longer determine interpretation of the Patent Act, because science and technology have changed significantly in the meantime German Fed. Supreme Court - Red Dove Decision [1969] The Response of the Courts

10. Technology – An Evolutionary Notion The Response of the Courts • An historical interpretation of the term invention is even more unsatisfactory because inventionis a basic concept in a field of law having as its most important task encompassing the patentable results of the most recent states of science and of research. • Therefore, the intent of the Patent Act itself not only permits but even compels drawing upon the latest state of scientific knowledge to interpret the concept of invention, which was not construed more precisely by the legislator and which by its nature requires judicial determination German Fed. Supreme Court - Red Dove [1969]

11. Living v. Non-Living Technology an Evolutionary Notion & Ethics • Can a genetically modified microorganism be patented? • Not patentable: Laws of nature, physical phenomena and abstract ideas • Patentable: anything under the sun made by man • “Congress… recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.” • “The briefs present a gruesome parade of horribles. Scientists, among them Nobel Laureates are quoted suggesting that genetic research may pose a serious threat to the human race, or …” U.S. Supreme Court - Diamond v. Chakrabarty[1980]

12. Living v. Non-Living Technology an Evolutionary Notion & Ethics • “It is argued that this Court should weigh these patented hazards in considering whether respondent’s invention is patentable subject matter under 101. We disagree…” • “The choice we are urged to make is a matter of high policy for resolution within the legislative process after the kind of investigations,…, that legislative bodies can provide and courts cannot.” U.S. Supreme Court - Diamond v. Chakrabarty [1980]

13. Discovery v. Invention Courts as Pacemakers of Innovation “It is trite law that you cannot patent a discovery, but if on the basis of that discovery you can tell people how it can be usefully employed, then a patentable invention may result. This in my view would be the case, even though once you have made the discovery, the way in which it can be usefully employed is obvious enough.” Whitford J - Genentech Inc's Patent [1987] Expressly approved by HOL - Kirin-Amgen Inc. v. Hoechst Marion Roussel [2005]

14. Manner of Manufacture under Section 18(1)(a) Australian Patent Act Courts as Pacemakers of Innovation “There is no doubt that naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent. However, the disputed claims do not cover naturally occurring DNA and RNA as they exist inside such cells. The disputed claims extend only to naturally occurring DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated.” Federal Court of Australia - Cancer Voices Australia v. Myriad Genetics [2013]

15. Practical Considerations v. Theoretical Reflections Courts as Pacemakers of Innovation "In accordance with the purpose of the Patent Act to promote technical progress and stimulate the inventive spirit for industry in a beneficial manner practical considerations also deserve stronger recognition than theoretical reflections in the interpretation and application of the Patent Act." German Fed. Supreme Court - Rabies Virus [1987]

16. Experimental Use Exemption Courts as Pacemakers of Innovation • Experiment under Sec. 11 No. 2 Patent Act “… any planned act for the acquisition of knowledge, independent of the purpose for which the acquired knowledge is intended to serve eventually.” • The subject matter of the invention must be the object of the test activity for the purpose of gaining knowledge • Covers acts performed to determine the effects of a substance or new previously unknown applications – further medical uses • Test may, eventually, serve commercial interests German Fed. Supreme Court – Clinical Trials I [1997]

17. Experimental Use Exemption Courts as Pacemakers of Innovation • Clinical trials with substances of same indication allowed as long as not solely aimed at clarifying commercial facts, such as market needs, price acceptance and marketing possibilities but not at further clarifying properties, effects, possible uses and production possibilities of the subject matter of an invention • Even if introduced and carried out with the commercial goal of obtaining marketing authorization with the data obtained German Fed. Supreme Court – Clinical Trials II [1998]

18. Limits of the Experimental Use Exemption- Europe's Approach - Courts as Pacemakers of Innovation • Yardstick: activity aimed at gaining new knowledge – enriching the state of the art • Not covered: use of the invention as research tool (PCR, ESTs), i.e. for the patented purpose

19. Limits of the Experimental Use Exemption- US Approach - Courts as Pacemakers of Innovation? • "[I]t could never have been the intention of the legislature to punish a man, who constructed such a machine merely for philosophical experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its described effects." Justice Story - Whittemore v. Cuttler [1813] • Only if the act is "solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry" – no infringement CAFC, Embrex v. Service Engineering [2000]; Madey v. Duke [2002]

20. Selection Inventions Courts as Pacemakers of Innovation • With the disclosure of a chemical structural formula, the individual compounds covered by this formula are, in principle, not yet disclosed. • Deciding factor – whether the concrete compound disclosed • Required information that easily enables the person skilled in the art to specifically implement the invention relating to this chemical compound, i.e. to obtain the specific compound • Otherwise – in case of pre-published chemical structural formula with some medical indications nobody could invest in clinical trials to identify the specific and useful compound! German Fed. Supreme Court – Olanzapine [2008]

21. Legal & Economic Consequences – US & Europe Courts as Pacemakers of Innovation • Numerous patents granted on genomic & cDNA encoding proteins, hormones or representing diagnostic markers, GM plants, etc. • Repeatedly challenged in courts – never viewed as – in principle - unpatentable • Provided the foundation for a new branch of industry – biotechnology • New companies emerged, e.g. Amgen, Biogen, Cetus, Chiron, Genentech and many more • New drugs and diagnostics developed & entered the market: recombinant h-insulin, erythropoietin, GCFS (Neupogen), hGH, HCV, HIV, BRAC diagnostics – many based on patents claiming genomic DNA: not a multi billion business only and clear US lead, but cures and diagnostics for patients world-wide!

22. Statistics on Patents Granted in the US Nature Biotechnology, October 2013

23. US "Gene" Patents Granted Nature Biotechnology, October 2013

24. Top Ten Categories of Biologic Drugs in Terms of US Sales Courts as Pacemakers of Innovation Source: Nature Biotechnology , October 2007

25. Top 18 Companies that Comprised the Majority of Salesof Biologic Drugs Courts as Pacemakers of Innovation Source: Nature Biotechnology, October 2007

26. Development of Venture-Capital Investments Courts as Pacemakers of Innovation

27. Value of Venture-Backed IPOs Courts as Pacemakers of Innovation

28. FDA New Molecular Entities and Biologics Approvals 1997-2011 Courts as Pacemakers of Innovation Source: Nature Biotechnology, 2012

29. Patent DE 197 56 864 C1 of April 29, 1999 - Dr. O. Brüstle Courts as Pacemakers of Innovation? Neural precursors, method of production and use for therapy of neural defects Claims: • Isolated, purified precursor cells with neuronal or glial characteristics from embryonic stem cells1)2) containing at most about 15% of primitive embryonic and non-neural cells, obtainable through the following steps: a) culturing of ES-cells to embryoid bodies b) .... 5. Cells according to one of the Claims 1-4, whereby the embryonic stem cells from oocytes are obtained after a nuclear transplantation

30. No Patents for Human Embryonic Stem Cells in Europe Courts as Pacemakers of Innovation? • Applied the broadest possible definition of an embryo • No protection available for all inventions using stem cells derived from destroyed human embryos • No matter how legal the stem cells were generated • No matter that the invention claimed does not use human embryos and is not dependent on their repeated use • No matter that the generation of human pluripotent stem cells and stem cell lines is not even described • No matter that products derived from human embryonic stem cells may be commercialized in a number of EU Member States – Art. 27(2) TRIPS compliance? • Everybody can (even) commercially use/exploit the respective invention free of charge! Strange ethics! CJEU (Grand Chamber) - Brüstle v. Greenpeace [18 October 2011]

31. No Exhaustion of Rights in Patented Seeds Courts as Pacemakers of Innovation Held: • Patent exhaustion does not permit a farmer to reproduce patented seeds through planting and harvesting without the patent holder's permission • Exhaustion doctrine restricts the patentee's rights only as to the "particular article" sold – it leaves untouched the patentee's ability to prevent a buyer from making new copies of the patented item. • By planting and harvesting Monsanto's patented seeds, Bowman made additional copies of Monsanto's patented invention • His conduct thus falls outside the protections of patent exhaustion US Supreme Court – Bowman v. Monsanto Co. et al. [2013]

32. Genomic DNA Not Patentable Courts as Pacemakers of Innovation? We hold that: • A naturallyoccurringDNA segment is a product of nature andnot patent eligiblemerelybecauseithasbeenisolated • But thatcDNAispatent eligiblebecauseitis not naturallyoccurring • Patentableprocessesformanipulatingandisolating genes, aswellasnewapplicationsof genes • Not decided: patentabilityof DNA in whichtheorderofthenaturallyoccurringnucleotideshasbeenaltered US Supreme Court – Association for Molecular Pathology et al. v. Myriad Genetics Inc. [2013]

33. Myriad's Consequences Courts as Pacemakers of Innovation? • No patents on genomic DNA – granted and still in force patents can be challenged and not defended • The reach goes [could go] far beyond human genomics and genomics in general • Potentially puts into question patents on isolated biological material in general • May seriously affect [high]risk investments in this entire area • It may be used in Europe against the rules set forth in the EU Biotech Directive – allowing such patents

34. Concerns Raised Courts as Pacemakers of Innovation? • Non-statutory unpatentable subject matter – an area where the newly activist Supreme Court needs to act with caution • Recent decisions* over laws and products of nature have upset long-standing understanding of what is and what is not patentable – creating great uncertainty within research programs that have a long gestation • Business – it is often said – hates uncertainty and may hold back research funding in genomics until the patentability uncertainties are resolved Prof. W. Lesser (2013) * Mayo Cell. Serv. v. Prometheus Labs [2012] Association for Molecular Pathology et al. v. Myriad Genetics Inc.

35. Innovation – Shared Responsibility of Legislature & Courts • Legislature – to provide a statutory framework flexible enough to enable courts to cope with challenges of science and technology according to the mission and rationale of the patent system • Courts - to interpret and apply positive law in compliance with the mission and rationale of the patent system, i.e. to promote technological innovation • Legislature – to provide for statutory relieve if case law does not or cannot comply with the mission of the patent system, e.g. by adopting specific rules on "experimental use", patents on natural products, or patentability of human pluripotent embryonic stem cells.

36. Some Concluding Thoughts – From a European Perspective • Over centuries the patent system – if applied in line with its genuine mission has proven as a reliable promoter of technological innovation • The patent system has not been conceived for any particular technological world but as a permanent incentive for technological innovation in general • Law makers and courts should respect the genuine mission of the patent system and act accordingly! • They are responsible for promoting technological innovation also to the benefit of future generations!

37. Thank you for your attention! 谢谢大家听我的发言！