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.
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.
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 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.
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.
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 […]
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. […]