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 this Hatch-Waxman case, Bristol-Myers Squibb, owner of the drug entecavir (sold as Baraclude®, indicated for hepatitis B (HBV) infection), sued Teva Pharmaceuticals for patent infringement. Teva responded that the patent (the only patent at issue was US5206244, priority date 10/18/1990), which claims the chemical structure of entecavir, was obvious. The district court found in […]
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 Robert Bosch, LLC v. Snap-On, Inc., No. 2014-1040 (Fed. Cir. 10/14/2014). The Federal Circuit panel, (Prost, Taranto, and Hughes) outlines a two-step framework for determining if a claim invokes 35 U.S.C. § 112(f) (formerly (formerly 112 ¶ 6). The panel concludes the challenged claim invoked 35 U.S.C. § 112(f), i.e., the claim is […]
Contact the author: Andrew Berks AbbVie Deutschland GmbH v. Janssen Biotech, Inc., No. 2013-1338 (Fed. Cir. 7/1/2014) This is a significant decision that extends the Federal Circuit’s holdings on written description from Ariad Pharms., Inc. v. Eli Lilly Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc), and has important lessons for patent applicants seeking to […]
Contact the author: Andrew Berks Nautilus, Inc. v. Biosig Instr.. Inc., No. 13-369 (S. Ct. 6/2/2014) Opinion by Ginsburg. The definiteness requirement, 35 U.S.C. §112(b) (AIA, effective 9/12/2012; previously §112 second para.) requires that a patent “specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or […]
The panel concludes that looking to the earliest patent expiration for patents that are obvious variants “best fits and serves the purpose of the doctrine of double patenting.”
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 […]
Contact the author: Andrew Berks Inst. Pasteur v. Focarino, No. 2012-1485 (Fed. Cir. 12/30/2013) Three patents were at issue, US6610545, US6833252, and US7309605, all based on an application originally filed 5/6/1992 and expired on 5/6/2012. The patents disclose group I intron encoded (GIIE) endonucleases. GIIE endonucleases are valuable research tools that are highly specific in selecting […]