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Patents Pharmaceutical Patents Patent Infringement

Sheppard Mullin Richter & Hampton LLP

Lexicography: Clear And Unequivocal

This Federal Circuit opinion analyzes lexicography in the context of claim construction. Alnylam Pharmaceuticals owns U.S. Patent Nos. 11,246,933 (parent) and 11,382,979 (child). These patents relate to biodegradable...more

A&O Shearman

Overlapping Range Presumption Not Applied Given Specified Doses Administered At Specified Times

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On July 8, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the validity of a Janssen patent, finding that Teva did not meet its burden to prove obviousness. In so doing, the Federal Circuit provided...more

McDermott Will & Emery

Motivation, expectation of success negate obviousness presumption in overlapping range case

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The US Court of Appeals for the Federal Circuit affirmed (on its second review) a district court’s ruling upholding the validity of patent claims related to a long-acting injectable dosing regimen, finding that the...more

Carlton Fields

Court Finds MSN Does Not Infringe Novartis’s Patent and Clears the Way for Generic Entresto

Carlton Fields on

In In re Entresto (Sacubitril/Valsartan) Patent Litigation, Judge Richard G. Andrews of the U.S. District Court for the District of Delaware granted MSN Pharmaceuticals Inc. a victory on noninfringement of U.S. Patent No....more

Jones Day

Discretionary Denial of IPR Institution Due to Advanced Hatch-Waxman Litigation

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In a recent decision, the Patent Trial and Appeals Board (“PTAB”) exercised its discretion under 35 U.S.C. § 314(a) to deny institution of an inter partes review (“IPR”) after applying the Fintiv factors, despite Petitioner’s...more

Venable LLP

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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.

Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal Nos. 2025-1228, -1252 (Fed. Cir. July 8, 2025) Our Case of the Week focuses on obviousness. More particularly, the decision included a lengthy...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

Amgen Files Three New Prolia® / Xgeva® BPCIA Litigations Against Hikma, Shanghai Henlius Biotech, and Biocon’s Proposed...

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On June 25, 2025, Amgen filed its sixth and seventh BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-12152 (D.N.J.) against Hikma and Gedeon Richter’s RGB-14 and Case No....more

Venable LLP

Sarepta Files Two IPRs Against Genzyme’s Patents Gene Therapy Elevidys® Allegedly Infringes

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On June 26, 2025, Sarepta Therapeutics filed IPR2025-01194, challenging as obvious claims 3-6 of Genzyme’s U.S. Patent No. 9,051,542 (“the ’542 patent), and IPR2025-01195 challenging claims 1-4, 6-7 and 11 of U.S. Patent No....more

Knobbe Martens

No Takebacks: The High Bar for Departing From Patent Lexicography

Knobbe Martens on

ALNYLAM PHARMACEUTICALS, INC. v. MODERNA, INC. - Before Taranto, Chen, and Hughes. Appeal from the United States District Court for the District of Delaware. Once the high threshold for lexicography is met, there must be a...more

Jones Day

USPTO 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

Venable LLP

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

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

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

Venable LLP on

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

Venable LLP

Spotlight On: Biosimilar Litigations - June 2025

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Venable LLP

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

Venable LLP on

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

Venable LLP

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

Venable LLP on

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

Fenwick & West LLP

Key Takeaways: Strategies from the First Two Years of the UPC

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The Unified Patent Court (UPC) represents a transformative development in European patent litigation. Fenwick’s Ryan Johnson teamed up with Bird & Bird’s Boris Kreye and Chris de Mauny to explore important considerations and...more

Venable LLP

Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) / Ruxience® (rituximab-pvvr) / Riabni™ (rituximab-arrx) - June 2025

Venable LLP on

Rituximab 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

Lathrop GPM

Claim Construction Matters: Federal Circuit Decision Highlights the Significance of Lexicography in Patent Drafting

Lathrop GPM on

A precedential ruling by the U.S. Court of Appeals for the Federal Circuit on June 4 affirmed that Moderna’s mRNA-based COVID-19 vaccine SPIKEVAX® does not infringe two patents owned by Alnylam Pharmaceuticals, upholding a...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.

Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., Appeal No. 2023-2357 (Fed. Cir. June 4, 2025) In this week’s Case of the Week, the Federal Circuit affirmed a final judgment that Moderna’s mRNA-based COVID-19 vaccine did...more

Jones Day

April 2025 Institution Rate Slips Below 45 Percent

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The PTAB has published its monthly statistics wrap up for April 2025. As expected, those statistics show a significant decline in the institution rate compared to the first six months of the fiscal year. In those first six...more

Fish & Richardson

Federal Circuit Reverses Injunction That Barred Clinical Trials in Jazz v. Avadel

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The Federal Circuit recently considered the scope of a permanent injunction that prohibited a drug manufacturer from conducting certain clinical and regulatory activities in Jazz Pharmaceuticals, Inc. v. Avadel CNS...more

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