No. 15-1182 ================================================================ In The Supreme Court of the United States --------------------------------- --------------------------------- SEQUENOM, INC., Petitioner, v. ARIOSA DIAGNOSTICS, INC., et al., Respondents. --------------------------------- --------------------------------- On Petition For A Writ Of Certiorari To The United States Court Of Appeals For The Federal Circuit --------------------------------- --------------------------------- BRIEF OF PROFESSOR TIMO MINSSEN AND ROBERT M. SCHWARTZ WITH 10 EUROPEAN AND AUSTRALIAN LAW PROFESSORS AS AMICI CURIAE IN SUPPORT OF PETITIONER --------------------------------- --------------------------------- ANDREW J. DHUEY Counsel of Record 456 Boynton Avenue Berkeley, CA 94707 (510) 528-8200 [email protected] Counsel for Amici Curiae TIMO MINSSEN Professor of Biotechnology Law (fr. 1 May 2016) FACULTY OF LAW UNIVERSITY OF COPENHAGEN Studiestraede 6 DK-1455 Copenhagen K, Denmark ROBERT M. SCHWARTZ Researcher FACULTY OF LAW LUND UNIVERSITY Lilla Gråbrödersgatan 4 222 22 Lund, Sweden ================================================================ COCKLE LEGAL BRIEFS (800) 225-6964 WWW.COCKLELEGALBRIEFS.COM i TABLE OF CONTENTS Page TABLE OF AUTHORITIES ................................... ii INTEREST OF THE AMICI CURIAE ................... 1 SUMMARY OF ARGUMENT ................................ 2 ARGUMENT ........................................................... 3 I. The European legal framework for patent eligibility ...................................................... 8 II. Patentable Subject Matter and Technical Features ....................................................... 10 III. Exclusions and Exceptions under the EPC .... 11 IV. The patent eligibility of equivalent claims at the EPO .................................................... 16 V. Interim Conclusions regarding the situa- tion in Europe .............................................. 18 VI. Innovation Policy Considerations ............... 19 VII. The choice between patents, complemen- tary incentives and trade secrets ................ 21 CONCLUSION ....................................................... 26 APPENDIX List of Amici Curiae ............................................. App. 1 ii TABLE OF AUTHORITIES Page CASES Alice Corporation Pty. Ltd. v. CLS Bank Inter- national, ___ U.S. ___, 134 S.Ct. 2347, 189 L.Ed.2d 296 (2014) .......................................... passim Ariosa Diagnostics, Inc. v. Sequenom, Inc., 2013 WL 5701532 (N.D. Cal. October 16, 2013) (not reported in F. Supp. 2d) ........................... 3 Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1377 (Fed. Cir. 2015) ............................... passim Ariosa Diagnostics, Inc. v. Sequenom, Inc., 802 F.3d 1282 (Fed. Cir. 2015) ......................................... 7 Association for Molecular Pathology v. Myriad Genetics, Inc., ___ U.S. ___, 133 S.Ct. 2107, 186 L.Ed.2d 124 (2013) ..................... 6, 20, 21, 22, 24 Biogen Inc. v. Medeva Plc. [1997] R.P.C. 1 (H.L.)........................................................................ 11 Bundesgerichtshof [BGH] [Federal Court of Justice] March 27, 1969, X ZB 15/67 Rote Taube (Red Dove), [BGHZ] 52 (Ger.) ...................... 11 Case T-80/05 (Method of diagnosis/UNIVERSITY OF UTAH) of 19 November 2008 ........................... 16 Case T-146/07 of 13 December 2011 (Non- invasive prenatal diagnosis/ISIS INNOVA- TION LTD) .............................................................. 17 Case T-156/08 (BRCA2/UNIVERSITY OF UTAH) of 14 January 2011 .................................................. 16 Case T-666/05 (Mutation/UNIVERSITY OF UTAH) of 13 November 2008 .............................................. 16 iii TABLE OF AUTHORITIES – Continued Page Case T-1213/05 (Breast and ovarian cancer/ UNIVERSITY OF UTAH) of 27 September 2007 ......................................................................... 16 D’Arcy v Myriad Genetics, Inc. [2015] HCA 35 ............ 5 Decision G-1/07 of 15 February 2010 (Treat- ment by surgery-MEDI-PHYSICS) ..................... 2, 14 Decision of the Administrative Council of June 16, 1999. OJ EPO 1999, pp. 437 et seq. .................... 9 Diamond v. Diehr, 450 U.S. 175 (1981) ............. 3, 7, 12 Mayo Collaborative Services v. Prometheus Lab- oratories, Inc., 566 U.S. ___, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012) ................................... passim National Research and Development Corpora- tion v Commissioner of Patents (1959) 102 CLR 252 ..................................................................... 5 Opinion G-02/13 of 25 March 2015 (tomato II/ brocolli II) .......................................................... 12, 13 Opinion G-2/08 of 11 December 1989 (Friction reducing additive/MOBIL OIL III) ......................... 12 Opinion G-3/08 of 12 May 2010 (computer- implemented inventions, CIIs) .......................... 12, 13 Opinion G-1/04 of 16 December 2005 (Diagnos- tic methods) ................................................. 14, 15, 16 Ruckelshaus v. Monsanto Co., 467 U.S. 986 (1984) ....................................................................... 23 iv TABLE OF AUTHORITIES – Continued Page CONSTITUTIONAL PROVISIONS U.S. Const. Art. VI, cl. 2 ............................................... 2 TREATIES Agreement on a Unified Patent Court of 19 February 2013 OJ 2013 (C 175/) 1 ........................... 9 Agreement on Trade-Related Aspects of Intellec- tual Property Rights. Annex 1C of the Marrakesh Agreement establishing the World Trade Or- ganization, signed in Marrakesh, Morocco on 15 April 1994, 1869 U.N.T.S. 299 ....................... 4, 23 Convention on the Grant of European Patents, Munich 5 October 1973, 1065 U.N.T.S. 199, as revised by the Act Revising Article 63 EPC of 17 December 1991 and the Act revising the EPC of 29 November 2000 .............................. passim Paris Convention for the Protection of Indus- trial Property of 20 March 1883, as revised and amended. 21 U.S.T. 1583 ................................. 23 Patent Cooperation Treaty, Washington 19 June 1970, in force 24 January 1978, as amended. 28 U.S.T. 7645 ........................................................... 4 STATUTES 35 U.S.C. §§101 et seq. .......................................... 2, 7, 8 v TABLE OF AUTHORITIES – Continued Page Council Regulation (EU) 1260/2012 of 17 December 2012 implementing enhanced co- operation in the area of the creation of uni- tary patent protection with regard to the applicable translation requirement OJ 2012 (L 361) 89 ................................................................... 9 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, OJ 1998 (L 213) ......................................................... 9, 18 Regulation (EU) 536/2014 of the European Par- liament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/ EC, OJ 2014 (L 158) 1 ............................................. 23 Regulation (EU) 1257/2012 of the European Parliament and of the Council of 17 Decem- ber 2012 implementing enhanced coopera- tion in the area of the creation of unitary patent protection OJ 2012 (L 361) 1 ........................ 9 Uniform Trade Secrets Act. 14 U.L.A. 433 (1985) ....................................................................... 23 RULES Guidelines for Examination in the European Patent Office November 2015 ................................. 13 Implementing Regulations to the EPC of 5 October 1973 as amended to 15 October 2014 ......... 9 vi TABLE OF AUTHORITIES – Continued Page Preliminary set of provisions for the Rules of Procedure of the Unified Patent Court, 18th draft of 1 July 2015 Adopted by the Prepara- tory Committee on 19 October 2015 (not yet in force) ...................................................................... 9 OTHER AUTHORITIES Margo A. Bagley, “A Global Controversy: The Role of Morality” in Vol. 2 Biotechnology Pat- ent Law Intellectual Property and Informa- tion Wealth: Issues and Practices in the Digital Age, Peter K. Yu Ed. (Westport, Praeger Press 2007) ................................................................ 4 Dan L. Burk, Patents as Data Aggregators in Personalized Medicine, 21 B.U. J. Sci. & Tech. 233 (2015) .......................................... 20, 22, 25 John M. Conley, Robert Cook-Deegan, Gabriel Lazaro-Munoz, Myriad after Myriad: The Pro- prietary Data Dilemma, 15 N.C.J.L. & Tech. 597 (2014) (“Myriad after Myriad”.) ............. 20, 21, 22 Enquiries Into Intellectual Property’s Economic Impact (OECD 2015) ............................................... 22 European Commission’s Trade Secrets web page. http://ec.europa.eu/growth/industry/intellectual- property/trade-secrets/index_en.htm ..................... 23 European Medicines Agency policy on publica- tion of clinical data for medicinal products for human use EMA/240810/2013 (2 October 2014) ........................................................................ 23 vii TABLE OF AUTHORITIES – Continued Page European Patent EP 994 963 ..................................... 17 Isabelle Huys, Geertrui Van Overwalle and Gert Matthijs, Gene and genetic diagnostic method patent claims: a comparison under current European and U.S. patent law, 19 Eur. J. Hum. Genet. 1104 (2011) ........................ 5, 14 Lisa Larrimore Ouellette, Patentable Subject Matter and Non-Patent