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.
in an obviousness analysis, an inherency argument has a heightened standard that must be the natural result flowing from the operation as disclosed in prior art references.
Contact the author: Andrew Berks Takeda Pharm. Co. Ltd. v. Zydus Pharms. USA, Inc., No. 2013-1406 (Fed. Cir. 2/20/2014) This Hatch-Waxman case pertains to particle size claims for the brand name drug Prevacid® SoluTab™. The product is an orally dissolving tablet (ODT) containing lansoprzaole. Only claim 1 of US6328994 is in dispute, which reads, in relevant […]
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.
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. 2010-1246 (Fed. Cir. 8/5/2010) (Linn, Moore, Friedman, opinion by Moore).This case highlights several important issues in an ANDA litigation. Background Adams owns the ‘252 patent for controlled release guaifenesin. Adams markets Mucinex® which is the preferred embodiment of the ‘252 patent. Slip op. at 3. Perrigo filed an ANDA seeking to market 600 mg […]
On Monday, May 10, 2010, the Federal Circuit issued two decisions dealing with 35 U.S.C. § 156 (patent term extension to compensate for regulatory delays). In Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc., No. 2009-1362 (Fed. Cir. 5/10/2010) (Judges Newman, Rader, Linn; opinion by Newman). Daiichi Pharmaceuticals owns U.S. 5,053,404, and obtained a patent term […]