By Suresh Pillai --
Sepracor Settles Xopenex Suit With Barr
Last week, Sepracor Inc. and Barr Pharmaceuticals, Inc. (a Teva Pharmaceuticals subsidiary) entered into a settlement agreement that effectively ends a dispute between the two companies over the patent family covering Xopenex®, an inhaled asthma treatment. Sepracor's initial complaint against Barr, filed in July of 2007 (see "Court Report," July 22, 2007), alleged infringement of five patents (U.S. Patent Nos. 5,362,755, 5,547,994, 5,760,090, 5,844,002, and 6,083,993) and was filed in response to Barr's ANDA filing seeking FDA approval for production of generic levabutrol hydrochloride inhalation solutions.
Under the terms of the settlement agreement, Sepracor will grant a nonexclusive license to Barr to manufacture and market generic versions of Xopenex beginning in February 2013. The agreement also provides, however, for earlier effective dates of the license if certain conditions are met. In exchange for the grant of the license, Barr is obligated to pay to Sepracor royalties on sales, based on profit margins, of these generic versions. The settlement agreement will become effective upon the filing of a consent final judgment and dismissal in the U.S. District Court for the District of Delaware.
Additional information regarding the settlement agreement can be found in Sepracor's press release.
Life Technologies Seeks to Invalidate Oxford Patent
Life Technologies, Inc. has filed an amended complaint in the U.S. District Court for the Middle District of Tennessee seeking to invalidate U.S. Patent No. 5,886,157, owned by Oxford Biomedical Research Inc. The '157 patent covers a method of purification for cytochrome P450 proteins. Life Technologies' complaint was filed in response to Oxford's breach of contract suit against Life Technologies, filed in the U.S. District Court for the Eastern District of Michigan in 2005, alleging that Life Technologies owed hundreds of millions of dollars in anticipated damages from Life Techologies' breach of a sublicensee agreement acquired from Oxford's previous sublicensee.
Oxford claims that the patent at issue is enforceable until its expiration in 2016, but the agreement stipulates that the license would expire in 2006 if no patent covering "licensed material" ever issued. Because the patent that issued only covered methods and not any licensed material, Life Technologies claimed that the agreement's royalty terms had expired. By filing the amended complaint in order to invalidate the patent, Life Technologies hopes to weaken Oxford's argument that any royalties are due.
Breckenridge Loses Suit to Invalidate Everett Patent
On March 12, the U.S. District Court for the Southern District of Florida dismissed Breckenridge Pharmaceutical Inc.'s suit to invalidate Everett Laboratories Inc.'s patents for a prescription multivitamin due to a lack of subject matter jurisdiction. Breckenridge launched its Nutravance product on January 7, 2009 and filed suit seeking to invalidate the Everett patents before the existence of any controversy. The District Court held that Breckenridge could not file suit without provocation from Everett. In this case, at the time the suit was filed, Everett was unaware that Breckenridge was marketing a product that might have been infringing on Everett's own product. Though Breckenridge claimed that past litigious activity by Everett in enforcing their patent rights created a controversy suitable for federal court jurisdiction, the Court disagreed. The Court concluded that subject matter jurisdiction could only be established where there was "an actual and substantial controversy" between the parties.
Although Breckenridge's immediate complaint has been dismissed, it will still be able to contest validity in the infringement suit, filed by Everett after Breckenridge had filed suit in Florida, in the U.S. District Court for the District of New Jersey. The patents at issue in the suit are U.S. Patent Nos. 6,660,293 and 6,893,904.
Comments