By
James DeGiulio --
Medicis
Pharmaceutical Corp. has reached consent and licensing agreements with Ranbaxy
Laboratories Inc., thus settling patent infringement claims against Ranbaxy
over Medicis' oral acne drug Solodyn. Medicis brought suit in May 2009 after
receiving a Paragraph IV letter from Ranbaxy Inc. asserting that
Medicis' U.S. Patent No. 5,908,838 covering Solodyn was invalid. In its complaint, Medicis
sought a permanent injunction, litigation costs, and an order barring
Ranbaxy from receiving approval of its ANDA until after the expiration of the '838
patent. Medicis argued further
that Ranbaxy Inc. aided, abetted, or induced the alleged infringement of its
parent corporation Ranbaxy Laboratories Inc.
In
the May 5th order, Ranbaxy acknowledged that Medicis' '838 patent is
valid and enforceable and admitted that products described in its ANDA are
covered by the patent. Judge
Farnan in the U.S. District Court for the District of Delaware entered the
judgment enjoining Ranbaxy from continuing to market generic minocycline
hydrochloride without a license. Details of the settlement agreement were not available.
Orchid
and Forest Labs Settle Namenda Infringement Dispute
Orchid
Chemicals & Pharmaceuticals Ltd. has reached a settlement with Forest Laboratories Inc.
in the patent infringement suit over the Alzheimer's drug Namenda. Forest brought suit against Orchid and
a number of defendants in January of 2008, following the filing of several
ANDAs seeking FDA approval to market generic Namenda. The case was later transferred from Delaware to New Jersey, after the
Delaware court ruled that it lacked personal jurisdiction over Orchid.
Judge
Cooper of the U.S. District Court for the District of New Jersey approved a
stipulation dismissing the case without prejudice and enjoining Orchid from
marketing generic Namenda. In the stipulation, Orchid admitted that the ANDA it
filed for generic Namenda infringed Forest's U.S. Patent No. 5,061,703. Additional terms of the settlement were not disclosed.
Sandoz
Inc. has reached a settlement with Takeda Pharmaceutical Co. Ltd. in the infringement suit
over Sandoz' effort to sell generic versions of diabetes treatments Actos and
Actoplus Met. In Takeda's initial
lawsuit against Sandoz, filed in May 2007, Takeda claimed that Sandoz's ANDA infringed
seven of its patents describing pioglitazone for the treatment of diabetes,
including U.S. Patent Nos. 5,965,584, 6,166,043,
6,172,090, 6,211,205, 6,217,243, 6,303,640, and 6,329,404.
Takeda
had two infringement suits pending against Sandoz. On April 27, Judge Cote of
the U.S. District Court for the Southern District of New York approved the
parties' stipulations and voluntarily dismissed both suits without prejudice. Each party agreed to bear its own fees and costs. Though Takeda still has
infringement cases pending against Teva Pharmaceutical Industries Ltd. and
Aurobindo Pharma Ltd., it expects that the entry of generic versions of Actos
and Actoplus Met will be August 17, 2012, and December 14, 2012, respectively.
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].
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