Chinta, Perdomo, Berks and Fratangelo LLP

Entecavir Obvious?

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...

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Megestrol Nanoparticle Formulation Claims – Not Inherently Obvious (at least not yet)

Contact the author: Andrew Berks Case citation: Par Pharmaceutical Inc. v. TWi Pharmaceuticals, Inc., No. 2014-1391 (Fed. Cir. 12/3/2014) (O'Malley, Wallach, Hughes, opinion by O'Malley) In this dispute, Par is in the role of innovator drug company—they make a product called...

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Means-plus-function claims – indefinite because of insufficient structure in the specification

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)....

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Abbvie v. Janssen: Another nail in the coffin of functional claiming

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...

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Nautilus v. Biosig – The Supreme Court Clarifies the Clarity Requirement

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...

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Gilead v. Natco – Gilead’s patent invalid for obviousness-type double patenting

Contact the author: Andrew Berks Gilead Sciences, Inc. v. Natco Pharma Ltd., No. 2013-1418 (Fed. Cir. 4/22/2014) Gilead owns U.S. Patents 5,763,483 and 5,952,375, directed to antiviral compounds and their methods of use. The two patents have the same inventorship and...

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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...

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PTAB Obviousness Finding Reversed in Institut Pasteur GIIE Endonuclease Patents

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...

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Wyeth’s expansive claim construction results in finding of non-enablement

Contact the author: Andrew Berks Patents on rapamycin for restenosis held invalid for lack of enablement. Wyeth v. Abbott Laboratories, 720 F.3d 1380 (Fed. Cir. 2013). Wyeth sued defendants for patent infringement. Defendants counterclaimed that the patents were invalid as not enabled...

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Sloppy Claim Drafting Invalidates Teva Copaxone Claims

Teva Pharms. USA, Inc. v. Sandoz, Inc.,, No. 2012-1567 (Fed. Cir. 7/26/2013) (no reporter cite) (Rader, Moore, and Benson (sitting by designation from the District of Utah). Opinion by Moore. Teva sued Mylan and Sandoz for patent infringement of nine...

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