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AN E-BULLETIN
LEGAL INFORMATION INSTITUTE -- CORNELL LAW SCHOOL
lii\@lii.law.cornell.edu
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The following decisions have just arrived via the LII's
direct Project HERMES feed from the Supreme Court.
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MERCK KGAA V. INTEGRA LIFESCIENCES I, LTD. (03-1237)
Web-accessible at:
http://supct.law.cornell.edu/supct/html/03-1237.ZS.html
Argued April 20, 2005 -- Decided June 13, 2005
Opinion author: Scalia
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It is not "an act of [patent]
infringement to ... use ... or import into the United
States a patented invention ... solely for uses reasonably
related to the development and submission of information under
a Federal law which regulates the ... use ... of
drugs." 35
U.S.C. sect. 271(e)(1). The Federal Food, Drug, and
Cosmetic Act of 1938 (FDCA) is such a law. Under the FDCA, a
drug maker must submit research data to the Food and Drug
Administration (FDA) in an investigational new drug application
(IND) when seeking authorization to conduct human clinical
trials, and in a new drug application (NDA) when seeking
authorization to market a new drug. Respondents filed a
patent-infringement suit, claiming, inter alia, that
petitioner had willfully infringed their patents by supplying
respondents' RGD peptides to other defendants for use in
preclinical research. Petitioner answered, among other things,
that sect.271(e)(1) exempted its actions from infringement.
The jury found otherwise and awarded damages. In post-trial
motions, the District Court affirmed the jury's award and
denied petitioner's motion for judgment as a matter of
law. The Federal Circuit affirmed that denial, finding that
sect.271(e)(1)'s safe harbor did not apply. It reversed
the District Court's refusal to modify the damages award
and remanded for further proceedings.
Held: The use of patented
compounds in preclinical studies is protected under
sect.271(e)(1) at least as long as there is a reasonable basis
to believe that the compound tested could be the subject of an
FDA submission and the experiments will produce the types of
information relevant to an IND or NDA.The statutory text
makes clear that sect.271(e)(1) provides a wide berth for the
use of patented drugs in activities related to the federal
regulatory process, including uses reasonably related to the
development and submission of any information under the FDCA.
Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661,
665-669. This necessarily includes preclinical studies,
both those pertaining to a drug's safety in humans and
those related to, e.g., a drug's efficacy and
mechanism of action. Additionally, sect.271(e)(1) exempts
from infringement the use of patented compounds in preclinical
research, even when the patented compounds do not themselves
become the subject of an FDA submission. The "reasonable
relation" requirement cannot be read effectively to limit
sect.271(e)(1)'s stated protection of activities leading
to FDA approval for all drugs to those activities leading to
FDA approval for generic drugs. Similarly, the use of a
patented compound in experiments not themselves included in a
"submission of information" to the FDA does not,
standing alone, render the use infringing. Because the Federal
Circuit applied the wrong standard in rejecting
petitioner's challenge to the jury's finding that
petitioner failed to show that its activities were covered by
sect.271(e)(1), the trial evidence has yet to be reviewed
under the standard set forth in the jury instruction, and
developed in more detail here.Pp. 8-15.
331 F.3d 860, vacated and remanded.
Scalia, J., delivered
the opinion for a unanimous Court.
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