By James DeGiulio --
Sepracor Settles with Wockhardt in Lunesta Patent Suit
Sepracor has reached a consent agreement with Wockhardt, thus settling its infringement suit over the sleep drug Lunesta.
In March 2009, Sepracor brought suit in the U.S. District Court for the District of New Jersey against several generic companies who intended to make generic versions of the sleep drug Lunesta (see "Court Report," March 29, 2009). Sepracor alleged that the generic makers' ANDAs infringed four patents covering the drug: U.S. Patent Nos. 6,319,926; 6,444,673; 6,864,257; and 7,381,724. In June 2010, the District Court denied Wockhardt's inequitable conduct claim, rejecting the argument that Sepracor had misled the U.S. Patent and Trademark Office by presenting inaccurate mouse and rat studies. The USPTO had previously determined that these particular studies were not material to patentability.
On August 19, Judge Dennis M. Cavanaugh signed off on an agreement that enjoins Wockhardt from manufacturing generic Lunesta until one of the patents expires in November 2013 or May 2014. The stipulation leaves open the possibility of an earlier date if a licensing agreement can be reached. The stipulation order can be found here.
Ranbaxy Settles Patent Dispute with Roche over Valcyte
Ranbaxy Laboratories has settled its patent dispute with Roche over the anti-viral drug Valcyte.
In March 2005, Ranbaxy notified Roche that it had submitted an ANDA seeking FDA approval to manufacture and distribute a generic version of Valcyte. Roche filed suit in April 2006 in the U.S. District Court for the District of New Jersey, alleging that Ranbaxy infringed Roche's U.S. Patent No. 6,083,953. Ranbaxy asserted that its proposed drug does not infringe the '953 patent because it contains amorphous, rather than crystalline, valganciclovir hydrochloride. Roche argued that the amorphous state of the drug is unstable and that it is not usable in pill form, but the District Court rejected this argument and found that there was no infringement by Ranbaxy. Roche appealed the decision.
On August 25, the settlement between Roche and Ranbaxy was disclosed in a filing to the Federal Circuit, and the resolution will apply to the patent infringement lawsuit in the District Court. The terms of the settlement have not been made public.
Sanofi Denied Preliminary Injunction against FDA Regarding Approval of Sandoz's Generic Lovenox
In the latest development in Sanofi-Aventis' campaign to defend its anti-coagulant drug Lovenox, Sanofi was denied a preliminary injunction which would have forced the FDA to withdraw its approval of Sandoz's generic version of Lovenox. The District Court concluded that Sanofi was unlikely to demonstrate that the FDA exceeded its authority when it approved Sanofi's ANDA.
Leading up to the instant case, Sanofi-Aventis was engaged in a long-running litigation seeking protect its Lovenox patents, U.S. Patent Nos. 5,389,618 and RE38,743 (see "Biotech/Pharma Docket," July 21, 2009. Following the conclusion of the infringement litigation, Sanofi brought this additional suit in the U.S. District Court for the District of Columbia on July 26 against the FDA, claiming that the FDA exceeded its authority when it approved Sandoz's ANDA, and failed to ensure that Sandoz's generic had the same active ingredient as Sanofi's brand drug. Sanofi alleges that the approval of Sandoz's ANDA was arbitrary, capricious and unlawful under the Administrative Procedure Act and improper under the Federal Food, Drug and Cosmetic Act.
On August 25, Judge Emmet G. Sullivan issued a memorandum opinion and order that denied Sanofi's motion for a temporary restraining order and preliminary injunction, finding Sanofi unlikely to succeed on the merits. Sanofi argued that the FDA improperly asked Sandoz for additional information on manufacturing processes, because the FDCA prohibits the FDA from requesting such supplemental documents. Judge Sullivan rejected this argument, and instead ruled that the statute does not specify which kinds of studies may be used to fulfill the FDA's assessment requirements. The judge also found that the FDA provided legitimate reasons as to why it was treating this drug differently than it had other drugs cited by the plaintiff. Finally, Judge Sullivan noted that an ANDA applicant need not use the same manufacturing process as the brand company in order to include the same ingredient. The judge also rejected Sanofi's argument that an injunction was necessary because sales of the generic version of Lovenox were causing irreparable financial harm. Judge Sullivan's memorandum opinion can be found here.
Novartis Drops One of Three Patents from ReFacto/Xyntha Suit against Wyeth
Novartis has agreed to drop one of three patents asserted against Wyeth in an infringement suit over the hemophilia drugs ReFacto and Xyntha.
Novartis initially brought suit against Wyeth in the Eastern District of Texas in February 2008, asserting that Wyeth was infringing U.S. Patent Nos. 6,060,447 and 6,228,620 (see "Court Report," February 24, 2008). In October 2008, Novartis amended its complaint, additionally accusing Wyeth of willful and deliberate infringement of both patents and requesting treble damages for the continued infringement. Novartis later amended its complaint to add U.S. Patent No. 7,138,505 to the suit.
On August 24, Judge T. John Ward approved the dismissal of both parties' claims and counterclaims over the '505 patent. Novartis and Wyeth agreed to cover their own legal costs with respect to this patent. The stipulated dismissal order can be found here.
James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a graduate of Northwestern University School of Law. Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be contacted at degiulio@mbhb.com.
Comments