Nature of the Case and Issue(s) Presented: Ozobax is indicated for treatment of spasticity resulting from multiple sclerosis, and particularly flexor spasms and concomitant pain, clonus, and muscular rigidity. While the use...more
Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...more
On May 15, 2023, the Supreme Court of the United States denied Teva Pharmaceuticals USA, Inc.’s (“Teva”) petition for certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline, LLC, ending a nearly nine-year court...more
Hosted by C5, the 16th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns 23-24 May, at the DoubleTree by Hilton Amsterdam Central Station, Amsterdam with curated programing for you to gain the knowledge and...more
Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more
Case Name: Salix Pharms., Ltd. v. Norwich Pharms., Inc., C.A. No. 20-cv-430-RGA, 2022 WL 3225381 (D. Del. Aug. 10, 2022) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Xifaxan® (rifaximin); U.S. Patents Nos. 7,612,199...more
Case Name: Amarin Pharm., Inc. v. Hikma Pharms. USA Inc., No. 20-1630-RGA-JLH, 2022 WL 605734 (D. Del. Jan. 4. 2022) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Vascepa® (icosapent ethyl); U.S. Patents Nos. 8,642,077...more
Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 25 F.4th 949 (Fed. Cir. 2022) (Circuit Judges Moore, Newman, Dyk, Prost, O’Malley, Reyna, Taranto, Chen, Hughes, and Stoll presiding; Moore, Newman, O’Malley, Taranto,...more
Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more
The US Court of Appeals for the Federal Circuit denied a generic drug manufacturer’s petition for en banc review of a panel opinion finding induced infringement liability despite the manufacturer’s adherence to skinny...more
In one of the first district court opinions applying the Federal Circuit’s recent GSK decision on induced infringement in the context of label carve-outs, Judge Richard Andrews in the District of Delaware held that plaintiff...more
Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more
On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding...more
In October 2020, as reported in a previous Cooley alert, the US Court of Appeals for the Federal Circuit reinstated a jury’s verdict that Teva infringed GSK’s patented method of using its Coreg drug product, even though...more
Most judicial outcomes, particularly on appeal, are broadly based on varying combinations of process and outcome. The law is replete with process-based decisions (standing, jurisdiction, waiver, to name a few) and of course...more
GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. [OPINION] – PRECEDENTIAL - Before Moore, Newman, Prost (dissent). Panel rehearing of an appeal from the U.S. District Court for the District of Delaware - Summary:...more
On October 2, 2020, the Federal Circuit issued a precedential opinion vacating a district court’s judgment as a matter of law and reinstating a jury verdict finding of induced infringement of a patented use that had been...more
Statutory Basis For Label Carve-Outs - Section viii of the Hatch-Waxman Act permits an Abbreviated New Drug Application (ANDA) applicant to obtain FDA approval to market a generic version of a drug for a non-patented use...more
Section viii of the Hatch-Waxman Act, 21 U.S.C. § 355(j)(2)(A)(viii), allows a generic applicant to “carve out” indications and other use information from its labeling that are protected by patents listed in FDA’s Orange Book...more
Addressing the issue of whether a generic pharmaceutical company can be found to induce infringement even when all patented uses have been “carved out” of the label (resulting in a so-called “skinny label”), the US Court of...more
On October 2, 2020, the Federal Circuit issued a decision in GlaxoSmithKline LLC v. Teva Pharm. USA, Inc.1 that addressed whether a generic drug manufacturer induced infringement of a method of use patent when its product...more
The Federal Circuit recently held in a 2-1 decision that there was substantial evidence supporting a jury finding that Teva was liable for induced infringement for an indication carved out of its skinny label for its generic...more
What Quantum of Culpable Conduct Is Required for an ANDA Applicant to Induce Infringement? The back-and-forth, (almost) cat-and-mouse-like competition between branded innovator and generic drug makers sanctioned under the...more
In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reinstated a jury's verdict that Teva infringed GSK's patented method of using its Coreg® drug product, even though Teva's product was initially...more