By Suresh Pillai --
Lupin Pharmaceuticals Inc. has filed counterclaims in its suit with Ortho-McNeil-Janssen Pharmaceuticals
Inc., alleging that Ortho's patent
covering its Tri-Cyclen® Lo contraceptive, U.S. Patent No. 6,214,815,
is invalid. In its complaint,
filed on January 15, 2010 in the U.S. District Court for the District
of New Jersey, Ortho alleged that Lupin's proposed generic oral contraceptive
infringed the '815 patent (see
"Court Report,"
February 8, 2010). Ortho
filed suit following receipt of a letter from Lupin stating its intention to
market and manufacture generic Tri-Cyclen® following FDA approval of Lupin's ANDA seeking regulatory approval. The letter also included a Paragraph IV certification
claiming that the '815 patent was invalid. Although both Lupin's Paragraph IV certification and
counterclaims allege invalidity of the '815 patent, Lupin has thus far failed
to state grounds for invalidity. In addition to its counterclaims alleging invalidity, Lupin has also
claimed that its ANDA would not infringe the '815 patent.
NexMed and Beta Technologies Patent Dispute on Hold Pending
Ownership Determination
The patent infringement suit between NexMed
Holdings Inc. and Beta
Technologies Inc. has been stayed following a determination by the U.S. District Court for the
District of Utah that plaintiff NexMed may not own one of the
patents-in-suit. NexMed originally
sued Beta in 2006 over Beta's alleged infringement of U.S. Patent Nos. 5,133,352 and 6,083,250,
both of which cover methods for treating herpes simplex related lesions (see "Court Report," December 17, 2006). At the time the suit began, NexMed contended that the '352
patent, originally held by Peter Lathrop and Steven Johnston, had been transferred
to Target Capital Inc. and then to NexMed. However, in the current case, Mr. Johnston has provided
testimony suggesting that the original transfer to Target was never
consummated, testimony that has thrown NexMed's claim of ownership into
doubt. The District Court has directed both
parties to submit supplemental briefs on the issue of ownership of the '352
patent.
Teva Pharmaceuticals USA Inc. has appealed
the ruling of the U.S. District Court for the District of New Jersey that
Pfizer Inc.'s patent covering the bladder control drug Detrol®, U.S. Patent No.
5,382,600,
is valid and enforceable. The
original infringement suit was initiated by Pfizer in 2003 on the heels of Teva's
submission of an ANDA with the FDA seeking regulatory approval to market a
generic version of Detrol®. While acknowledging that its proposed generic would infringe the '600 patent, Teva alleged that the '600 patent was invalid due to inequitable conduct on the
part of Pfizer during patent prosecution. Specifically, Teva alleged that Pfizer ignored errors in an inventor
statement filed during prosecution of the application that ultimately issued as the '600 patent. Teva had also alleged that the '600 patent was obvious in
light of two prior art references that covered similar diphenylpropylamine
compounds. However, the District Court
disagreed with Teva's arguments and held that the '600 patent was not invalid for obviousness or unenforceable due to inequitable conduct.
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