National Human Genome Research Institute National Institutes of Health The Future of the Research Exemption A Presentation to the Gene Patenting Roundtable.

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

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. 1120 (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

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.

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’ 11th 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. 3967 Alternatives

University of Maryland School of Law

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.

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

University of Maryland School of Law

Patent Law Updates

http://www.law.umaryland.edu/fac_lsung_decision.asp