By Suresh Pillai --
Settlement Announced in Focalin® Infringement Suit
Celgene,
Novartis Pharmaceuticals,
and Teva Pharmaceuticals
have filed three separate stipulations in the U.S. District Court for the
District of New Jersey that will, if approved by the Court, put an end to all
claims among the parties. The long
running dispute stemmed from Teva's plan to market a generic version of Focalin®
XR,
an attention deficit hyperactivity disorder drug. At issue was whether Teva infringed the plaintiff's
patents covering Focalin®, U.S. Patent Nos. 5,908,850;
6,355,656;
6,528,530;
5,837,284;
and 6,635,284. Between 2004 and 2007, Celgene (as the
patent owner) and Novartis (as the exclusive licensee) filed four lawsuits
against Teva alleging infringement (see "Court Report," January 2,
2007). Each cause of action stemmed from Abbreviated New Drug Applications filed by Teva with the FDA in which Teva
sought regulatory approval to market and manufacture generic versions of
Focalin®. Each of the plaintiffs'
complaints alleged that because each generic was a bioequivalent of the
patented drug, containing the same active ingredients, routes of
administration, dosage form, proposed labeling, and indication and usage as the
patented drug, Teva was liable for infringement. Terms of the settlement have not been disclosed.
Generic Drug Makers Seek to Remove AstraZeneca LP
as Party in Crestor® Suit
A group of generic drug makers, all defendants in a
patent infringement suit over the cholesterol drug Crestor®,
have argued that one of the named plaintiffs, AstraZeneca,
lacks the requisite standing to bring suit. In their motion to dismiss filed with the U.S. District
Court for the District of Delaware, defendents Teva Pharmaceuticals, Apotex,
Mylan Pharmaceuticals, Sun Pharmaceuticals Industries,
Par Pharmaceuticals,
Aurobindo Pharma,
and Cobalt Pharmaceuticals stated that because AstraZeneca, one of the four named plaintiffs in the case, merely shares a license to
market Crestor®, AstraZeneca lacks standing to pursue infringement
claims. The original litigation
commenced in December 2007 when AstraZeneca filed suit against some of the
defendants who had filed Abbreviated New Drug Applications seeking permission
to market and manufacture generic versions of Crestor® (see "Court Report,"
December 16, 2007). In its suits, AstraZeneca alleges
that the defendants' products would infringe U.S. Patent No. RE37,314.
Settlement Announced in TroVax® Suit
Bavarian Nordic and
Oxford BioMedica have entered into cross-licensing agreements as part of a settlement that ends
all litigation between the two companies over BioMedica's alleged infringement
of Bavarian's patents covering a method of delivering recombinant
vaccines. The original litigation
commenced in 2008, when Bavarian filed suit in the U.S. District Court for the
Southern District of California, alleging that BioMedica's development of its TroVax® vaccine infringed U.S. Patent Nos. 6,761,893;
6,913,752;
7,335,364;
and 7,459,270.
The settlement follows BioMedica's failed bid for
an interlocutory appeal to the Court of Appeals for the Federal Circuit to
address issues of subject matter jurisdiction (see "Biotech/Pharma Docket,"
July 7, 2009). The settlement also clears the way for
BioMedica to exploit TroVax®, as the settlement grants BioMedica licenses for
the four patents-in-suit, all of which are related to the MVA-BN virus, a key
factor in the smallpox vaccine and an effective delivery vector for vaccines
against other diseases. In
exchange, Bavarian will have a license to related poxvirus patents owned by
BioMedica partner Sanofi-Aventis.
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