By James DeGiulio --
Impax Settles Amrix Patent Suit with Cephalon
Impax and Cephalon have reached an agreement to settle the suit over Impax's generic version of Cephalon's muscle relaxant drug Amrix.
Impax filed an Abbreviated New Drug Application (ANDA) for its generic version of Amrix in September 2008, and Cephalon brought suit against Impax on January 7, 2009 for infringement of U.S. Patent No. 7,387,793 (see "Court Report," January 11, 2009). Cephalon has launched a total of six cases relating to Amrix, which were consolidated in the U.S. District Court for the District of Delaware in December 2009. Recently, Judge Sue L. Robinson concluded a seven-day bench trial where Barr and Mylan challenged the validity of Cephalon's Amrix patents, and the outcome has yet to be resolved.
Cephalon and Impax entered into the settlement on October 7, asking Judge Robinson to dismiss the infringement action. The settlement grants Impax a non-exclusive, royalty-bearing license to the '793 patent and right to sell a generic version of Amrix a year before the patent's expiration in 2025. Judge Robinson's order can be found here.
Takeda Settles Actos Patent Dispute with Wockhardt
Takeda has reached an agreement with Wockhardt in the patent infringement suit over the diabetes drug Actos.
Takeda has filed a number of infringement suits in the Southern District of New York since 2003, accusing several generics drug makers of infringing its Actos patents. Takeda filed suit against Wockhardt on July 28, alleging infringement of U.S. Patent Nos. 5,965,584; 6,329,404; 6,166,043; 6,172,090; 6,211,205; 6,271,243; and 6,305,640 (see "Court Report," August 1, 2010). Wockhardt replied by asserting that the patent claims were invalid, unenforceable, or would not be infringed by its drug.
On October 7, Judge Denise L. Cote dismissed the case, but the terms of the agreement were not disclosed. Judge Cote's order can be found here.
Endo Settles Patent Dispute with Watson over Opana ER
Endo Pharmaceuticals has reached an agreement with Watson Pharmaceuticals over Watson's proposed generic version of the painkiller Opana ER, joining other generics Teva, Barr, and Impax in reaching settlements over the drug.
In March, Endo brought suit against Impax in the U.S. District Court for the District of New Jersey, arguing that Impax's ANDA infringed Endo's U.S. Patent Nos. 5,662,933 and 5,958,456 (see "Court Report," March 14, 2010). In January, Watson sent Endo notice that its ANDA included a Paragraph IV certification asserting that these patents were invalid, unenforceable, or not infringed. Endo has settled with Teva, Barr, and Impax over proposed generic versions of the painkiller.
Under the terms of the settlement, Endo has granted Watson a royalty-free license to the '933 and '456 patents, and Watson can launch its generic version of Opana ER on Sept. 15, 2012. Settlement documents have not yet been filed, and other details of the settlement were not disclosed.
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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