National Human Genome Research Institute National Institutes of Health The Future of the Research Exemption A Presentation to the Gene Patenting Roundtable Washington, DC 4 December 2002

University of Maryland School of Law Lawrence M. Sung Assistant Professor of Law

University of Maryland School of Law Discussion Past Definition & Origin of Research Exemption Present Status Present Risk Calculus & Recognized Defenses International Standards Future

University of Maryland School of Law Definition Common law Distinct De minimis 35 U.S.C. § 271(e)(1) Plant Variety Protection Act Fair Use (copyright & trademark)

University of Maryland School of Law Origin [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. Whittemore v. Cutter, 29 F. Cas (C.C.D. Mass. 1813).

University of Maryland School of Law Past [A]n experiment with a patented article for the sole purpose of gratifying a philosophical taste, or curiosity, or for mere amusement is not an infringement of the rights of the patentee. Roche Prods., Inc. v. Bolar Pharm. Co., 733 F.2d 858, 862 (Fed. Cir. 1984) (citing Peppenhausen v. Falke, 19 Fed. Cas. 1048, 1049 (C.C.S.D.N.Y. 1861)).

University of Maryland School of Law Present Narrow scope Limited to actions performed for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry. Madey v. Duke Univ., 307 F.3d 1351 (Fed. Cir. Oct. 3, 2002).

University of Maryland School of Law Madey v. Duke Univ. [U]ndertaken in the guise of scientific inquiry but has definite, cognizable, and not insubstantial commercial purposes. [I]f it has the slightest commercial implication. [I]n keeping with the legitimate business of the alleged infringer.... [T]he profit or non-profit status of the user is not determinative.

University of Maryland School of Law Madey v. Duke Univ. [M]ajor research universities... often sanction and fund research projects with arguably no commercial application whatsoever. However, these projects unmistakably further the institutions legitimate business objectives, including educating and enlightening students and faculty participating in these projects. These projects also serve, for example, to increase the status of the institution and lure lucrative research grants, students and faculty.

University of Maryland School of Law Present Experimentation Permissible Reproducibility Verification Impermissible Improvement Innovation

University of Maryland School of Law Present Landscape Risk calculus Recognized defenses 28 U.S.C. § 1498 March-in rights States 11 th Amendment immunity International Standards

University of Maryland School of Law EPO [R]ights conferred by a Community patent shall not extend to acts done for experimental purposes relating to the subject matter of the patented invention. Community Patent Convention Art. 27(b)

University of Maryland School of Law Germany The effects of the patent shall not extend to... acts done for experimental purposes which are related to the subject matter of the patented invention.... German Patent Act § 11, No. 2

University of Maryland School of Law United Kingdom An act which... would constitute an infringement of a patent for an invention shall not do so if – (a) it is done privately and for purposes which are not commercial; (b) it is done for experimental purposes relating to the subject-matter of the invention.... Patents Act 1977, Art. 60 § 5

University of Maryland School of Law Japan [T]he effects of the patent right shall not extend to the working of the patent right for the purposes of experiment or research. Japanese Patent Law § 69(1)

University of Maryland School of Law China None of the following shall be deemed an infringement of the patent right:... where any person uses the patent concerned solely for the purpose of scientific research and experiment. Chinese Patent Law ¶ 5, Art. 62

University of Maryland School of Law Future Judicial Appeal Proposed Legislation H.R Alternatives

University of Maryland School of Law H.R It shall not be an act of infringement for any individual or entity to use any patent for or patented use of genetic sequence information for purposes of research [where] the term 'research' means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

University of Maryland School of Law Exemption from Liability Affirmative defense Entity specific or Conduct specific Causation (ex post, ex ante) Primary Purpose standard Rebuttable presumption Patentee or Researcher burden of proof Covenant not to sue

University of Maryland School of Law Exemption from Remedies Preclusion of injunctive relief Public interest primacy Compulsory license (royalty bearing) Preclusion of money damages Compulsory license (royalty free) Other terms Nonexclusivity, field of use, sublicense/transfer

University of Maryland School of Law

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