By James DeGiulio --
Cephalon and Mylan Pharmaceuticals Agree to Drop Two Patents from Nuvigil Patent Suit
Cephalon Inc. and Mylan Pharmaceuticals Inc. have agreed to drop two of the three patents originally involved in their infringement suit over the narcolepsy drug Nuvigil.
After Mylan filed an ANDA for generic Nuvigil, Cephalon brought suit against Mylan in the U.S. District Court for the District of Delaware for infringing U.S. Patent Nos. RE37,516 and 7,132,570. Mylan responded to Cephalon's infringement allegations with counterclaims of noninfringement, invalidity, and unenforceability. Mylan also sought a declaratory judgment of noninfringement with respect to U.S. Patent No. 7,297,346, which Cephalon has asserted against Teva in a related suit.
On July 28, Judge Gregory M. Sleet issued an order allowing the parties to drop claims and counterclaims over the '516 patent. Mylan also agreed to dismiss the declaratory judgment action regarding the '346 patent, which Cephalon had not asserted in the suit.
Judge Sleet's order can be found here.
Sandoz Ends Attempt to Market Generic Mirapex
Following a preliminary injunction ruling, Sandoz Inc. has abandoned its attempt to market a generic version of Mirapex before the expiration of Boehringer's patent, instead deciding to wait until the patent expires in October to move forward.
In May, the Federal Circuit declined to review its decision in a dispute between Boehringer and Mylan Pharmaceuticals Inc. that U.S. Patent No. 4,886,812, covering Mirapex, was not invalid for double patenting. Immediately following this ruling, Sandoz sued Boehringer in the U.S. District Court for the Middle District of Florida for declaratory judgment that the '812 patent was invalid. Sandoz argued that the patent was invalid on grounds which the Federal Circuit had not earlier addressed. Boehringer responded to Sandoz's declaratory judgment action by filing counterclaims of infringement and moving for a preliminary injunction.
On July 28, Sandoz filed a stipulation that it would not try to market generic Mirapex before the expiration of the '812 patent on October 8, 2010. The stipulation followed an order by Judge Timothy J. Corrigan which granted Boehringer's motion for a preliminary injunction. The case will be stayed until the '812 patent expires, and will be dismissed as moot thereafter.
The stipulation and order can be found here.
Alcon Denied Permanent Injunction against Teva In Vigamox Litigation
On August 5, Alcon Inc.'s request for a permanent injunction against Teva was denied, thus allowing Teva to perform work on a generic version of Vigamox before the patent covering the anti-bacterial eye drop expires.
Alcon sued Teva in April 2006, following Teva's ANDA filing, alleging infringement of its U.S. Patent No. 6,716,830. Alcon claimed that Teva's ANDA infringed two other patents as well, but the companies later agreed that those patents were unenforceable. In 2008, Judge Robinson of the U.S. District Court for the District of Delaware ruled that the generic product in Teva's ANDA infringes the claims of the '830 patent, rejecting Teva's arguments that the claim is invalid. Judge Robinson issued a declaration that the FDA may not approve Teva's ANDA until March 2020, giving Alcon a pediatric exclusivity period of six months after the patent expires in September 2019.
Alcon asked Judge Robinson to broaden her order, arguing that the marketing restriction alone was insufficient because it allowed Teva to infringe the patent by beginning work on the generic before the patent expired. Judge Robinson rejected this argument, holding that Alcon had failed to prove that it suffered irreparable harm.
Judge Robinson's order and opinion can be found here.
Glenmark Pharmaceuticals and Sepracor Settle Lunesta Patent Litigation
Glenmark Pharmaceuticals Ltd. has reached a settlement with Sepracor Inc., thus ending its involvement in the multi-defendant infringement suit brought by Sepracor 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. Sepracor alleged that the generic maker's ANDAs infringed four patents covering the drug: U.S. Patent Nos. 6,319,926; 6,444,673; 6,864,257; and 7,381,724.
The recent settlement, which still must be approved by the Court, dismisses Sepracor's and Glenmark's claims in the ongoing litigation. Under the agreement, Sepracor will grant Glenmark a license to market generic eszopiclone either on Nov. 30, 2013 or on May 30, 2014, depending on whether Sepracor obtains pediatric exclusivity for Lunesta. Additional terms of the settlement were not disclosed.
The settlement statement 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 [email protected].
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