News & Analysis as of

Patent Infringement Pharmaceutical Patents

DLA Piper

The Federal Circuit Widens The ITC as a Venue for Life Sciences

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Federal Circuit reshapes foundational requirements for viability of a case in the ITC - Pharmaceutical and life sciences companies have historically been rare participants before the International Trade Commission (ITC) – in...more

McDonnell Boehnen Hulbert & Berghoff LLP

Treprostinil Saga Continues

United Therapeutics Corp. (UTC) and Liquidia Technologies Inc. have been battling for close to a decade over their respective inhaled formulations of treprostinil (UTC's Tyvaso®, Liquidia's Yutrepia™) for treatment of...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

Sheppard Mullin Richter & Hampton LLP

Biopharmaceutical Patent Litigation: Regeneron’s Defense Against Biosimilar Launches

This case involves an appeal from Regeneron Pharmaceuticals, Inc.’s (Regeneron) efforts to prevent defendants from marketing biosimilar versions of EYLEA®, a drug used to treat eye diseases, by asserting patent infringement....more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Statements Made During Prosecution of Parent Application Disavow Claim Scope in Subsequent Patents

The Federal Circuit affirmed a District of Delaware finding of non-infringement in an ANDA litigation due to the patentee’s clear and unmistakable disavowal of claim scope during prosecution. Specifically, the court held that...more

Smart & Biggar

Alexion awarded injunction against Amgen in SOLIRIS patent action; Court considers anticipation by incorporation by reference

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The Federal Court has granted Alexion a declaration of infringement and an injunction preventing Amgen from manufacturing, using, and selling its proposed biosimilar eculizumab product, BEKEMV, in Canada until the expiration...more

Goodwin

Biogen Files Suit Against Neurimmune Over Rights to Bispecific Antibody

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On May 13, 2025, Biogen Inc. and Biogen MA Inc. (“Biogen”) filed a Complaint for Declaratory Judgment and Permanent Injunctive Relief against Neurimmune Holding AG and Neurimmune SubOne AG (“Neurimmune”) in the U.S. District...more

Haug Partners LLP

Federal Circuit Clarifies Safe Harbor from Injunctive Relief in Jazz v. Avadel

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On May 6, 2025, the U.S. Court of Appeals for the Federal Circuit refined the boundaries of injunctive relief under the Hatch-Waxman Act in its precedential opinion in Jazz Pharms., Inc. v. Avadel CNS Pharms. The decision...more

Goodwin

HyClone Seeks to Quash Amgen’s Subpoena Issued in Amgen/Accord Denosumab BPCIA Litigation

Goodwin on

On May 14, 2025, HyClone Laboratories, LLC (“HyClone”) filed a Motion to Quash in the U.S. District Court for the District of Utah, seeking to quash Amgen Inc.’s (“Amgen”) subpoena to HyClone issued in Amgen’s denosumab BPCIA...more

McDermott Will & Emery

Hatch-Waxman or Not, Clinical Trials Aren’t Subject to Injunction

McDermott Will & Emery on

Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running...more

Alston & Bird

Patent Case Summaries | Week Ending May 9, 2025

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Ingenico Inc., et al. v. IOENGINE, LLC, No. 2023-1367 (Fed. Cir. (D. Del.) May 7, 2025). Opinion by Hughes, joined by Dyk and Prost. Ingenico filed a declaratory judgment action against IOENGINE relating to two patents owned...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: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) - May 2025

Venable LLP on

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: Pharmaceutical Patent Protections

This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development. In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the...more

Venable LLP

Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv™ / Xbryk™ (denosumab-dssb) / Stoboclo®...

Venable LLP on

Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...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

Rothwell, Figg, Ernst & Manbeck, P.C.

Jazz Pharma. v. Avadel CNS Pharma: Federal Circuit Applies a Fact-Specific Approach to the Patent Infringement Safe Harbor

In a precedential ruling, the U.S. Court of Appeals for the Federal Circuit in Jazz Pharma. v. Avadel CNS Pharma., 2025 WL 1298920, — F.4th — (Fed. Cir. May 6, 2025), addressed the scope of the 35 U.S.C. § 271(e)(1) “safe...more

Venable LLP

Spotlight On: Biosimilar Litigations - May 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) /...

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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

Venable LLP

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

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

Robins Kaplan LLP

New ANDA Cases

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Federal district court cases that are filed pursuant to the Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more

Robins Kaplan LLP

ANDA Litigation Settlements

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Reported settlements in federal district court cases - This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant...more

Robins Kaplan LLP

Boehringer Ingelheim Pharms. Inc. v. Apotex Inc.

Robins Kaplan LLP on

Tradjenta® (linagliptin) - Case Name: Boehringer Ingelheim Pharms. Inc. v. Apotex Inc., Civ. No. 23-685-CFC, 2025 WL 71979 (D. Del. Jan. 10, 2025) (Connolly, J.)  Drug Product and Patent(s)-in-Suit: Tradjenta® (linagliptin);...more

Robins Kaplan LLP

Taiho Pharma Co. v. MSN Labs Private Ltd.

Robins Kaplan LLP on

Lonsurf® (tipiracil) - Case Name: Taiho Pharma Co. v. MSN Labs Private Ltd., No. 19-2342-JLH (D. Del. Jan. 23, 2025) (Hall, J.)  Drug Product and Patent(s)-in-Suit: Lonsurf® (tipiracil); U.S. Patent No. 10,457,666 (“the ’666...more

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