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INOMax® (nitric oxide) - Case Name: Mallinckrodt Pharms. Ireland Ltd. v. Airgas Therapeutics LLC, Civ. No. 22-1648-RGA, 2025 WL 472557 (D. Del. Feb. 12, 2025) (Andrews, J.) Drug Product and Patent(s)-in-Suit: INOMax® (nitric...more
Recently, the Patent Trial and Appeal Board (“the Board”) was persuaded to consider the merits of three out of seven concurrent petitions for an inter partes review of a single patent due to the patent’s complicated claiming...more
Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
AliveCor, Inc. v. Apple, Inc., No. 23-1512 (Fed. Cir. 2025) – On March 7, 2025, the Federal Circuit affirmed the Patent Trial and Appeal Board’s inter partes review (“IPR”) decisions invalidating all claims of three AliveCor...more
Since serving as a Federal Circuit clerk, Michael Hawes has monitored that court's precedential opinions and prepares a deeply outlined index by subject matter (invalidity, infringement, claim construction, etc.) of relevant...more
Experts play a crucial role in patent cases. Experts opine on claim construction, infringement, invalidity and the proper amount of damages. And the exclusion of an expert witness can significantly impact the outcome of a...more
On March 4, 2025, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (“PTAB”) decision in Restem, LLC v. Jadi Cell, LLC, No. 23-2054, 2025 WL 679195, at *1 (Fed. Cir. Mar. 4, 2025), finding that the patent...more
On March 5, 2025, the Federal Circuit affirmed the grant of a preliminary injunction against the launch of Celltrion’s proposed EYLEA® (aflibercept) biosimilar CT-P42 in CAFC Case Nos. 24-2058 and 24-2147 (appealing from...more
Synopsis: In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera,...more
Completing a recent jurisprudential "hat trick,"* the Federal Circuit affirmed a District Court grant of a preliminary injunction against a biosimilar applicant for Regeneron's EYLEA biologic drug in Regeneron...more
On February 12, 2025, the United States District Court for the District of Delaware denied defendant Parse Biosciences’s (“Parse”) motions for summary judgment that: (i) Parse had never actually conducted any direct or...more
The door may now be open for additional challenges to patents covering mRNA vaccine technologies, paving the way for increased competition in the mRNA vaccine space. On Wednesday, March 5, 2025, the United States Patent...more
On February 10, 2025, the United States Court of Appeals for the Federal Circuit issued a decision in Kroy IP Holdings, LLC v. Groupon, Inc., reversing and remanding a district court ruling that had dismissed Kroy’s patent...more
On 25 February, the Court of Justice of the European Union (CJEU) issued its much-anticipated decision in BSH Hausgeräte v. Electrolux (C-339/22) on cross-border competence in patent litigation. At the heart of the dispute is...more
The US Court Appeals for the Federal Circuit found that despite a Patent Trial & Appeal Board determination that certain challenged patent claims were unpatentable based on a preponderance of the evidence standard, the patent...more
In this edition of The Precedent, we outline the validity of a pharmaceutical patent concerning the patent’s written description. Following an appeal from the United States District Court for the District of Delaware, the...more
On January 29, 2025, the CAFC issued opinions affirming the preliminary injunctions issued against biosimilars of Regeneron’s EYLEA® (aflibercept): Samsung Bioepis’s Opuviz™ (aflibercept-yszy) (CAFC Case Nos. 24-1965,...more
Alexion Pharmaceuticals v Amgen (UPC_Coa-405/2024) and Alexion Pharmaceuticals v Samsung Bioepis NL BV (UPC_CoA-402/2024); December 20, 2024. The UPC Court of Appeal has confirmed a strict approach to correcting erroneous...more
Nearly two years in, the Unified Patent Court (UPC) continues to reshape the patent litigation landscape in Europe by providing swift, cross-border resolutions and an innovative approach to patent enforcement and revocation....more
Steuben Foods, Inc. v. Shibuya Hoppmann Corp., et al., No. 2023-1790 (Fed. Cir. (D. Del.) Jan. 24, 2024). Opinion by Moore, joined by Hughes and Cunningham. Steuben sued Shibuya for infringement of three patents relating to...more
Three subjects stood out in patent litigation in Texas in December 2024: (1) knowledge of related patents, general patent portfolio, or other asserted patents do not establish the knowledge requirement for pre-suit indirect...more
The Federal Circuit recently reversed a District of Delaware decision that invalidated claims of Novartis’s Orange Book listed patent, U.S. Patent No. 8,101,659 (the “’659 patent”), for its blockbuster drug Entresto®, a...more
On January 10, 2025, the US Court of Appeals for the Federal Circuit issued a precedential opinion in Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., reversing a lower court decision that claims of a Novartis patent...more
Before Lourie, Prost, and Reyna. Appeal from the U.S. District Court for the District of Delaware. Summary: A patent was not invalid for lack of written description for failing to describe the specific infringing embodiment...more
Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., et al., Nos. 2023-2218, -2220, -2221 (Fed. Cir. (D. Del.) Jan. 10, 2025). Opinion by Lourie, joined by Prost and Reyna. The FDA approved a New Drug Application from...more