On June 23, 2025, the Supreme Court invited the Solicitor General to submit a brief expressing the views of the United States—dramatically increasing the likelihood that the Court will eventually grant review—in Hikma...more
On March 28, 2025, the United States Court of Appeals for the Federal Circuit issued an opinion affirming the United States District Court for the District of New Jersey decision that Mylan Laboratories Ltd. (“Mylan”) induced...more
Invega Trinza® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 2023-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) (Circuit Judges Dyk, Prost, and District Judge Goldberg presiding;...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
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: 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
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
Background - On August 5, 2021, the Federal Circuit issued an opinion in GlaxoSmithKline v. Teva Pharmaceuticals, Case No. 18-1976, in favor of GSK, finding that Teva was liable for inducing infringement of GSK's patent....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
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
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
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 an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more
Robinson, J. Plaintiff’s motion to reopen judgment and amend the complaint is granted. Plaintiff’s request for a preliminary injunction was denied and the denial was affirmed on appeal. On September 10, 2015, Takeda...more
Case Name: Takeda Pharms. U.S.A., Inc. v. West-ward Pharm. Corp., Civ. No. 14-1268-SLR, 2016 U.S. Dist. LEXIS 65317 (D. Del. May 18, 2016) (Robinson, J.) - Drug Product and Patent(s)-in-Suit: Colcrys® (colchicine); U.S....more
In a complaint filed June 14, 2016, Janssen Biotech Inc. seeks a preliminary injunction that would bar Celltrion and Hospira from selling the biosimilar version of Remicade® (infliximab) that received FDA approval April 2016,...more
New developments arose on Tuesday in the dispute between Janssen and Celltrion over Celltrion’s biosimilar of Janssen’s Remicade® (infliximab). On May 31, the district court overseeing the BPCIA litigation (D. Mass., C.A....more
Addressing the pleading standard for induced infringement, the U.S. District Court for the District of New Jersey dismissed Otsuka Pharmaceutical’s claims finding that a formulaic recitation of the legal standard without...more
Last week, in Eli Lilly and Company v. Teva Parenteral Medicines, Inc., Judge Tanya Walton Pratt of the U.S. District Court for the Southern District of Indiana determined that Eli Lilly and Company had shown by a...more
Nature of the Case and Issue(s) Presented: UTC claimed that Sandoz induced infringement of the ’007 patent by instructing physicians to dilute its product for use intravenously. The asserted claim required a particular...more