[Ip-health] Notes from Today's Federal Circuit Arguments in Integra v. Merck

[Jeffrey Light]

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On remand from the Supreme Court, the Federal Circuit today heard oral argu=
ments in Integra Lifesciences v. Merck (Fed. Cir. Docket 2002-1052).  Surpr=
isingly, the panel focused most of its attention on a footnote in the Supre=
me Court's opinion regarding an issue never raised by either party.

  In its recent decision, the Supreme Court had broadly interpreted 271(e)(=
1) as providing exemption from liability for patent infringement to compani=
es conducting research for submission to the FDA (usually generics preparin=
g to submit an ANDA).  Prior to the Supreme Court decision, the Federal Cir=
cuit had reasoned that a narrow reading of 271(e)(1) was required so that a=
ll "research tools" patents do not lose their value.  The Supreme Court, in=
 footnote 7, declined to "express a view about whether, or to what extent, =
271(e)(1) exempts from infringement the use of 'research tools' in the deve=
lopment of information for the regulatory process" because neither party ra=
ised this argument.

  Judge Rader suggested that the case now be remanded to the District Court=
 for a jury to decide whether the patented invention was a research tool.  =
Merck opposed, noting that the research tool argument was never raised by I=
ntegra.  Rader, showing his frustration with the high court, responded that=
 Integra couldn't have made the argument earlier because nobody would have =
imagined that a "research tools" exemption existed until the Supreme Court'=
s statement in footnote 7.

  Integra also opposed remand, arguing that the Supreme Court's interpretat=
ion of section 271(e)(1) did not require the jury verdict in its favor to b=
e overturned.  Under Rule 50, a jury verdict cannot be overturned unless th=
e jury was required to come to the opposite conclusion.  Integra argued tha=
t nothing in the the Supreme Court's new test under 271(e)(1) requires a fi=
nding of noninfringement.

  I found it amusing that Merck's lawyers took an expansive view of how muc=
h data they are required to submit to the FDA, and a narrow view on the sco=
pe of patent protection.

  Jeff




Jeffrey L. Light
Executive Director,
Patients not Patents
1712 Eye St., NW Suite 915
Washington, DC 20006
202.277.6213

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