By Suresh Pillai --
Settlement Announced in University of Iowa Dispute with
Amgen
The University of Iowa Research Foundation
(UIRF) has announced a settlement in its
dispute with Amgen Inc. over alleged patent infringement of
two UIRF patents covering a cytomegalovirus promoter used in the design and
manufacture of a number of marketed vaccines and therapeutics. The two patents-in-suit, U.S. Patent Nos.
5,168,062
and 5,385,839, are collectively known as the Stinski patents after inventor Dr. Mark Stinski, an IU
Carver College of Medicine professor of microbiology. UIRF originally filed suit in September 2008 (see "Court Report,"
September 14, 2008) in
the U.S. District Court for the Southern District of Iowa, claiming
that Amgen, through its manufacture and marketing of the drugs Enbrel® and Vectibex®, infringed the Stinski patents.
Although UIRF filed dismissal papers with the court in
March, the terms of the settlement have not been made public. At least one news source, the Iowa
Press-Citizen, has reported that the
settlement was for an aggregate amount of $19 million, but this amount has been neither confirmed nor denied by representatives for either party. UIRF's only statement has been an
e-mail to the Biotech Transfer Week newsletter stating that UIRF
would have no comment on the settlement due to a confidentiality agreement in
place between the parties.
In June, UIRF filed a similar lawsuit against Abbott Labs, alleging that Abbott's manufacture of the
blockbuster drug Humira® also infringed the
Stinski patents (see "Court Report," June 28, 2009). UIRF's litigation with Abbott is still pending.
Judge Grants Schering's Motion for Summary Judgment in
Merial Suit
The U.S. District Court for the District of
Columbia has granted Schering-Plough Corp.
subsidiary Intervet Inc.'s motion for summary judgment of noninfringement in its suit
against Merial, Inc. Merial originally filed suit against Invervet in 2005,
claiming that Intervet infringed U.S. Patent
No. 6,368,601,
for which Merial was granted an exclusive license. The '601 patent covers porcine viruses related to post-weaning multisystemic wasting
syndrome. Intervet filed its
declaratory judgment action soon after the inventors filed the '601 patent
application. The U.S. District
Court for the Northern District of Georgia, where Merial filed its infringement
suit, dismissed the suit soon after Intervet filed the action.
In its ruling, the District Court rejected claims by Merial that
the term "strain" as used in the claims encompassed more than the
viruses at issue. The Court found
that such an interpretation was overbroad and would not help in the proper
classification of PCV-2 porcine viruses. The Court also did not find the Intervet viruses to be encompassed
under the doctrine of equivalents, holding that Merial was barred from claiming
equivalents due to prosecution history estoppel.
The previously announced call option agreement among Merck, sanofi-aventis, and Schering-Plough,
however, may put an end to further litigation between the parties, since
sanofi-aventis, as part of that deal, now holds an option to combine Intervet
with Merial at some future date.
Court Rules That Ultram® Patents Are Invalid
The U.S. District Court for the District of Delaware has
ruled that the patents-in-suit in the litigation between Par
Pharmaceutical Inc. and Purdue Pharma
Products L.P. are invalid. Purdue originally filed suit against
Par in May 2007 (see "Court Report," May 13, 2007)
following Par's filing of an Abbreviated New Drug Application with the FDA, alleging
patent infringement. The
patents-in-suit, U.S. Patent Nos. 7,074,430
and 6,254,887,
cover an extended release version of tramadol.
In its ruling, the District Court dismissed Par's arguments that
the patents were unenforceable due to inequitable conduct. However, on the issue of obviousness, the Court found in
favor of Par, ruling that the patents were invalid under both pre- and post-KSR
analyses. The Court reasoned that
the selection of tramadol as an active ingredient for a controlled released
drug would have been obvious at the time the invention was made.
Numerous pharmaceutical manufacturers are affected by the
outcome of this suit. Through its
affiliate Napp Pharmaceutical Group Ltd., Purdue holds both patents in suit. Through an agreement with Labopharm,
Inc., Purdue also markets slow-release tramadol
under the trade name Ryzolt®. Biovail Corp. also markets its own slow-release tramadol, Ultram®, in
Canada. Its partner, PriCara (a division of
Ortho-McNeil-Janssen Pharmaceuticals Inc.) markets Ryzolt® in the United
States.
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