By James DeGiulio
Celgene
Corp. and Barr Laboratories Inc. have resolved their patent dispute over the
multiple myeloma cancer drug Thalomid, with Celgene agreeing to drop its patent
infringement claims and Barr dropping its invalidity and antitrust claims.
Celgene
initiated the dispute in January 2007, after Barr filed an ANDA for generic
thalidomide in September 2006 (see "Court Report," February 28, 2007). Celgene claimed that Barr's product infringed
seven of its patents, and then added another asserted patent in a second
lawsuit against Barr in August 2007 (see "Court Report," September 3, 2007). Barr responded in October 2007 by filing
its own suit, alleging that Celgene failed to disclose material information to
the U.S. Patent and Trademark Office and that Celgene interfered with its attempts to get the raw material
needed for studies required to file its ANDA. Celgene filed a third lawsuit before the District Court consolidated
these actions in July 2008. Finally, in December 2008, Celgene filed an amended
complaint alleging infringement of the three patents currently at issue: U.S. Patent Nos. 5,629,327;
6,235,756; and 7,435,745
GlaxoSmithKline
PLC unit Glaxo Group Ltd. has settled with Teva Pharmaceuticals USA Inc. in its patent infringement suit over the HIV drug Combivir.
GSK
sued Teva in November 2007, alleging that Teva's proposed generic product would
infringe U.S. Patent No. 5,859,021 patent over Combivir (see "Court Report," November 11, 2007). Teva's ANDA for its generic drug
was tentatively approved in 2009, after which Teva said it planned to release
the generic product May 17, about two years before the expiration of the '021
patent. Teva had already
stipulated that its generic version would infringe the '021 patent, so the only
issue remaining for trial was the validity of the patent.
Sandoz's
counterclaims against Merck relating to two patents were dismissed in an
infringement suit over Emend, a drug used to suppress nausea resulting from
chemotherapy drugs and surgery.
The dispute began January 15, 2009 when Sandoz notified Merck in a letter that it had
filed an ANDA seeking approval for a generic version of Emend. Merck filed a complaint in February 2009 alleging
infringement of four patents: U.S. Patent Nos. 5,719,147; 6,048,859; 6,096,742; and 6,235,735 (see "Court Report," March 8, 2009). In its answer, Sandoz included counterclaims for declaratory judgment of
noninfringement, invalidity and/or unenforceability of the four patents listed,
and additional patents, U.S. Patent Nos. 5,538,982 and 7,214,692. The counterclaims state that if
Sandoz were to prevail, it would still be faced with the threat of litigation
over the additional patents, which cover the same products.
James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a third-year law student at the Northwestern University School of Law. Dr. DeGiulio was a member of MBHB's 2009 class of summer associates, and he can be contacted at [email protected].
Comments