By Suresh Pillai --
Teva
Loses Bid For Dismissal of Famciclovir Infringement Suit
Last week, the U.S. District Court for the District
of New Jersey denied Teva Pharmaceutical's bid to have
Novartis Pharmaceuticals'
patent infringement suit dismissed for lack of plaintiff standing. Novartis and two of its subsidiaries
filed the original lawsuit in 2005 after Teva had filed an Abbreviated New Drug
Application (ANDA) with the FDA in which it sought permission to market and manufacture
a generic version of Novartis' famciclovir-based herpes treatment. In its complaint, Novartis alleged that
Teva's proposed product would infringe U.S. Patent No. 5,246,937,
the patent covering famciclovir formulations and methods of treatment. Teva countered, alleging that the '937
patent was invalid for obviousness as well as unenforceable due to inequitable
conduct by the inventors before the U.S. Patent and Trademark Office
during prosecution.
In its most recent motion, Teva argued that
Novartis Corp. and Novartis Pharma AG both lacked standing to sue because
Novartis International Pharmaceutical Ltd. was the true patent holder of the '937
patent. Teva further
argued that, as Novartis International was a patent holding company and not a
manufacturer, Novartis International was unlikely to succeed in showing
irreparable harm. The District Court,
however, concluded that it did not have sufficient facts to conclude the
standing issue. As the Court found
that there was an issue of fact as to whether Novartis subsidiaries owned
exclusive licenses via an implied license agreement or were titleholders to the
'937 patent, the Court concluded that the issue should be determined by the
trier of fact in the case.
Allergan
Prevails in Alphagan® P Infringement Suit
The U.S. District Court for the District
of Delaware has ruled that proposed products by Apotex Inc.
and Exela PharmSci Pvt. Ltd. infringed the asserted claims of patents from
Allergan Inc.
covering glaucoma treatments. The
patents-in-suit, U.S. Patent Nos. 6,627,210,
6,673,337,
6,641,834,
6,562,873,
and 5,424,078,
all cover formulations for Alphagan® P,
Allergan's ophthalmic solution for the treatment of glaucoma. The defendants had asserted noninfringement of the
patents-in-suit, and that the patents-in-suit were invalid on grounds of obviousness,
nonenablement, indefiniteness, lack of an adequate written description, lack of
utility, incorrect inventorship, and operability (see "Court Report,"
April 23, 2007). Expert testimony from witnesses for Exela
also tried to emphasize differences between the products from both
companies.
However, the District Court found all of the patents to be
valid and infringed. Although Exela
provided valid expert testimony to the contrary with regard to infringement,
the Court concluded that the testimony offered was insufficient to rebut
Allergan's evidence of infringement. Exela's case was also harmed by expert testimony provided by their
co-defendant, as the Court stated that Allergan's case was bolstered by expert
testimony offered by Apotex.
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