Petitioner Apotex asserted that claims directed to fosaprepitant were obvious, but the PTAB finds that there was no valid lead compound, so the patent is not obvious.
Tag Archives: paragraph IV certifications
Apotex Bid to Steal Mylan Exclusivity on Benicar
In this Hatch-Waxman action, Apotex is attempting to trigger a forfeiture event, that if successful, will cause Mylan to forfeit its 180-day exclusivity for a generic copy of Benicar®, olmesartan medoximil, that Mylan is otherwise eligible to receive.
ATELVIA® Patents Obvious at District Court
The court therefore found clear and convincing evidence that a person of ordinary skill at the time of the invention (in 2005) would have been motivated to use EDTA in the claimed amounts with a reasonable expectation of success.
Prosecution Laches as Defense to Infringement — Cancer Res. Tech. Ltd. v. Barr Labs., Inc.
Prosecution laches is an equitable defense to a charge of patent infringement, that “may render a patent unenforceable when it has issued only after an unreasonable and unexplained delay in prosecution” that constitutes an egregious misuse of the statutory patent system.
Obviousness in prodrugs — Daiichi Sankyo Co. v. Mylan
Proof of obviousness based on structural similarity requires clear and convincing evidence that a medicinal chemist of ordinary skill would have been motivated to select and then to modify a prior art compound (e.g., a lead compound) to arrive at a claimed compound with a reasonable expectation that the new compound would have similar or improved properties compared with the old.
Donepezil: Teva has standing in declaratory judgement action that it doesn’t infringe listed patents
Teva Pharms. USA Inc. v. Eisai Co., Ltd., No. 2009-1593 (Fed. Cir. 10/6/2010). Ranbaxy was first-filer (pre-MMA) for donepezil of an ANDA with a “paragraph IV” certification, and Teva was a subsequent filer with a paragraph IV certification. Teva obtained tentative approval for its ANDA, but was prevented from marketing by Ranbaxy’s first-filing. Teva sued …
Obviousness upheld: Purdue Pharma Products L.P. v. Par Pharmaceutical, Inc.
No. 2009-1553 (Fed. Cir. 6/3/2010) (non precedential). Par filed an ANDA for once daily tramadol, with PIV cert’s against two patents. Purdue sued, and Par counterclaimed that the patents were invalid under 35 U.S.C. § 112 for lack of enablement and written description, invalid under § 103 for obviousness, and unenforceable due to inequitable conduct. …
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