national human genome research institute national institutes of health the future of the research...
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National Human Genome Research InstituteNational Institutes of Health
The Future of the Research Exemption
A Presentation to the Gene Patenting RoundtableWashington, DC
4 December 2002
University of Maryland School of Law
Lawrence M. SungAssistant 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
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Definition
Common law Distinct
De minimis 35 U.S.C. § 271(e)(1) Plant Variety Protection Act Fair Use (copyright & trademark)
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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. 1120 (C.C.D. Mass. 1813).
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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)).
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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).
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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.
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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
institution’s 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.
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Present
Experimentation Permissible
Reproducibility Verification
Impermissible Improvement Innovation
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Present Landscape
Risk calculus Recognized defenses
28 U.S.C. § 1498 March-in rights States’ 11th Amendment immunity
International Standards
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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)
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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
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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
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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)
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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
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Future
Judicial Appeal Proposed Legislation
H.R. 3967 Alternatives
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H.R. 3967
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.
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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
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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
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University of Maryland School of Law
Patent Law Updates
http://www.law.umaryland.edu/fac_lsung_decision.asp