By James DeGiulio --
Roche Succeeds in Blocking Release of Cobalt's Generic Boniva
Hoffman-La Roche successfully secured a preliminary injunction against Cobalt Pharmaceuticals in the patent suit over the bone-loss drug Boniva, thus preventing Cobalt from launching a generic version of the drug.
Apotex and Cobalt filed Abbreviated New Drug Applications (ANDAs) for generic ibandronate, the active ingredient in Boniva. In September 2007, Roche sued Apotex and Cobalt in the U.S. District Court for the District of New Jersey for infringement of U.S. Patent Nos. 6,143,326, 6,294,196, 7,192,938, 4,927,814, and 7,410,957 (see "Court Report," September 30, 2007). Eventually, a total of six lawsuits were consolidated into two pretrial proceedings, and the claims relating to the '326, '196, and '938 patents were settled. In August, the District Court granted summary judgment to Roche, finding that Apotex's ANDA literally infringes the '814 patent. The defendants maintain that the '814 patent is unenforceable due to inequitable conduct.
On November 10, Judge Stanley R. Chesler enjoined Cobalt from making or selling a generic version of Boniva until the Court rules on the validity of the two remaining patents (the '814 and '957 patents). Judge Chesler found that Roche had shown that it was likely to succeed on the merits because the patent was likely to remain valid and enforceable. The judge also found that Roche was likely to suffer irreparable harm without an injunction since the damage it would sustain to its existing business without an injunction was far more severe than Cobalt's loss of its market opportunity for the generic. In balancing the hardships, Judge Chesler found that the public interest favored patent enforcement over the availability of low-cost generic drugs. The District Court ordered Roche to pay a bond of $10 million, far less than the $557 million bond requested by Cobalt. Judge Chesler's Opinion can be found here.
Allergan Fails to Secure New Trial in Zymar Case
After a bench trial earlier this year resulted in Allergan's patent covering the pinkeye drop Zymar being found obvious, Allergan moved for a new trial. On November 3, Allergan's motion was denied.
In 2007, Allergan, the co-owner of U.S. Patent No. 6,333,045, filed suit in the U.S. District Court for the District of Delaware against Apotex after Apotex filed an ANDA covering a generic version of Allergan's 0.3% gatifloxacin opthalmic solution (see "Court Report," December 9, 2007). A bench trial was held in January 2010, and the District Court found that Apotex had shown claim 7 to be obvious in view of a 1989 reference and two patents. Allergan subsequently moved for a new trial.
On November 3, Judge Sue L. Robinson denied the motion filed by plaintiffs Allergan, Senju, and Kyorin requesting a new trial or an amendment of the Court's invalidity judgment. At issue was the principle of the inverse relationship between solubility and precipitation, with Allergan arguing that defendants had not sufficiently established this principle. Judge Robinson refused to grant a new trial regarding the validity of claim 7 based solely on defendants' failure of proof with respect to a basic principle of science. Since the issue did not generate much attention during discovery, Judge Robinson ordered that the record of the litigation be opened so the parties can present additional testimony regarding the validity of the claim at issue. The District Court's Memorandum Order can be found here.
Novo Nordisk's PrandiMet Suit with Actavis Dismissed
Novo Nordisk and Actavis have moved to dismiss a patent infringement suit over Actavis' plan to bring a generic version of the diabetes drug PrandiMet to market.
In October 2009, Novo Nordisk brought suit in the U.S. District Court for the Southern District of New York against Actavis, alleging infringement of U.S. Patent No. 6,677,358 following Actavis' ANDA filing (see "Court Report," November 8, 2009). After Novo Nordisk brought the lawsuit, Actavis amended the ANDA and withdrew its Paragraph IV certification.
On November 4, Judge Paul G. Gardephe signed off on a Stipulation and Order of Dismissal of the action and all claims and counterclaims. According to the Order, Actavis' ANDA contains no Paragraph IV certification relating to the '358 patent, and thus, subject matter jurisdiction no longer exists. Actavis will provide Novo Nordisk with copies of all future submissions to the FDA relating to the '358 patent, including any amendments to its ANDA certification. Judge Gardephe's Stipulation and Order of Dismissal can be found here.
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