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Patent Litigation Patent Trial and Appeal Board Pharmaceutical Industry

Goodwin

UK Court of Appeal Upholds Moderna mRNA Patent Against Pfizer/BioNTech

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On August 1, 2025, a UK Court of Appeal upheld the validity of Moderna’s European Patent No. 3,590,949 (“EP’949”) in a dispute with Pfizer and BioNTech. The decision affirmed a July 2024 UK High Court ruling finding that...more

Robins Kaplan LLP

New ANDA Cases Second Quarter 2025

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This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

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Pegfilgrastim 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

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

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Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

Venable LLP

Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) - August 2025

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Etanercept 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

Venable LLP

Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin...

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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

Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

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Adalimumab 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

Robins Kaplan LLP

United Therapeutics Corp. v. Liquidia Techs., Inc.

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Nature of the Case and Issue(s) Presented: UTC’s ’782 patent claims a method for treating pulmonary hypertension (“PH”). PH manifests in different varieties, including pulmonary arterial hypertension (“PAH”) and pulmonary...more

Venable LLP

Fresenius Kabi Files Two EYLEA® IPRs Prior to aBLA Filing Announcement

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On July 14, 2025, Fresenius Kabi filed IPR2025-01268 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”) and IPR2025-01269 against U.S. Patent No. 10,828,345 (“the ’345 patent”), both relating to EYLEA®...more

A&O Shearman

UPC Court of Appeal clarifies approach to claim construction

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Insulet v EOFlow UPC_CoA_768/2024 (Ord_69078/2024) The Unified Patent Court (UPC) Court of Appeal has issued a significant decision that provides important guidance on the interpretation of patent claims in UPC...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

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Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

Venable LLP

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb)...

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Trastuzumab 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

McDermott Will & Schulte

Prosecution history primacy: “Consisting essentially of” means what applicant said it meant

In a decision that underscores the primacy of prosecution history to determine claim scope, the US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s interpretation of the transitional phrase...more

Knobbe Martens

An Eye Toward Prosecution History

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EYE THERAPIES, LLC v. SLAYBACK PHARMA LLC - Before Taranto, Stoll and Scarsi (sitting by designation). The patent’s prosecution history required a restrictive interpretation of the term “consisting essentially of.”...more

Jones Day

Acting Director Denies IPR Institution Based on “Settled Expectations”

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Under a new U.S. Patent and Trademark Office (“USPTO”) policy issued in March 2025, pre-institution inter partes review (“IPR”) proceedings are now bifurcated, consisting of a first phase in which the director considers...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Eye Therapies, LLC v. Slayback Pharma, LLC

Eye Therapies, LLC v. Slayback Pharma, LLC, Appeal No. 2023-2173 (Fed. Cir. June 30, 2025) In its only precedential patent opinion last week, the Federal Circuit reviewed construction of the transitional claim phrase...more

Venable LLP

Pembrolizumab Patent IPR Final Written Decision Issued and Director Review Requested

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On June 9, 2025, the Patent Trial and Appeal Board (“Board”) issued a Final Written Decision (“FWD”) in Merck’s IPR2024-00240 against The Johns Hopkins University’s (“JHU”) U.S. Patent No. 11,591,393 (“the ’393 patent”),...more

Knobbe Martens

Speculative Plans Are Insufficient to Establish Standing in PTAB Appeals

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INCYTE CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES, INC. - Before Moore, Hughes, and Cunningham. Appeal from the Patent Trial and Appeal Board. Speculative plans for potentially infringing activity are insufficient to...more

McDonnell Boehnen Hulbert & Berghoff LLP

MSN Laboratories Private Ltd. v. Bausch Health Ireland Ltd. (Fed. Cir. 2025)

As has been noted recently (Agilent Technologies, Inc. v. Synthego Corp.), fact-based decisions from the U.S. Patent and Trademark Office (typically from the Patent Trial and Appeal Board) are reviewed under the substantial...more

Jones Day

USPTO Acting Director Denies IPR Institution Based on "Settled Expectations"

Jones Day on

Under a new U.S. Patent and Trademark Office ("USPTO") policy issued in March 2025, pre-institution inter partes review ("IPR") proceedings are now bifurcated, consisting of a first phase in which the director considers...more

Goodwin

Recent PTAB Developments for Regeneron’s Aflibercept Formulation Patent

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Earlier this month, a Patent Trial and Appeal Board (“PTAB”) panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review (“IPR”)...more

WilmerHale

Federal Circuit Patent Watch: An Enabling Anticipatory Prior Art Reference Need Only Enable a Single Embodiment of the Claim

WilmerHale on

Precedential and Key Federal Circuit Opinions - ALNYLAM PHARMACEUTICALS, INC. v. MODERNA, INC. [OPINION] (2023-2357, 06/04/2025) (Taranto, Chen, Hughes) - Taranto, J. The Court affirmed the district court’s claim...more

Jones Day

Federal Circuit: Plans for Future Activity Created a Substantial Risk of Future Infringement

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Restem filed a petition for inter partes review of U.S. Patent No. 9,803,176, directed to stem cells obtained from umbilical cord tissue and isolated through a two-step process to create a specific cell marker expression...more

Fish & Richardson

The PREVAIL Act Is Back. Will It Prevail This Time?

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On May 1, 2025, Senators Chris Coons (D-DE), Thom Tillis (R-NC), Dick Durbin (D-IL), and Mazie Hirono (D-HI) reintroduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. The...more

Venable LLP

Court Finds bluebird bio’s Gene Therapy Zynteglo® (betibeglogene autotemcel) Does Not Infringe San Rocco Therapeutics’ Patents

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On May 16, 2025, the Court in Case No. 1:21-cv-01478 (D. Del.) granted bluebird bio’s motion for summary judgment, finding that its gene therapy Zynteglo® (betibeglogene autotemcel) does not infringe San Rocco Therapeutics‘...more

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