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.
Tag Archives: ANDA
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.
Megestrol Nanoparticle Formulation Claims – Not Inherently Obvious (at least not yet)
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.
Zydus Not Infringing Lansoprazole ODT Particle Size Claim
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 …
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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.
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 …
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Adams Respiratory Therapeutics, Inc. v. Perrigo Co.
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 …
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Federal Circuit Issues Two § 156 Decisions
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 …
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