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Patent Litigation Pharmaceutical Patents

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

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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: 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

Robins Kaplan LLP

ANDA Litigation Settlements Second Quarter 2025

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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 to the Hatch-Waxman Act. Novartis Pharms. Corp. v....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: Biosimilar Litigations - August 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: 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: Rituxan® (rituximab) / Truxima® (rituximab-abbs) / Ruxience® (rituximab-pvvr) / Riabni™ (rituximab-arrx) - August...

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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: 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: 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

Robins Kaplan LLP

Astellas Pharma Inc. v. Zydus, Inc. I

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Nature of the Case and Issue(s) Presented: Myrbetriq is a drug used to treat overactive bladder. It utilizes a hydrogel-based sustained-release oral tablet formulation to control the rate at which the active ingredient,...more

Robins Kaplan LLP

Norwich Pharms., Inc. v. Kennedy Jr.

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Nature of the Case and Issue(s) Presented: Salix holds NDAs for 200mg and 550mg Xifaxan. The 550mg strength product was approved to treat irritable bowel syndrome with diarrhea (“IBS-D indication”) and hepatic encephalopathy...more

A&O Shearman

Federal Circuit clarifies presumption of obviousness for overlapping ranges

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After the Federal Circuit vacated and remanded the district court’s non-obviousness determination, the district court again found that Teva failed to show, by clear and convincing evidence, that the claims of Janssen’s patent...more

A&O Shearman

Court of Appeal upholds invalidity of AstraZeneca's compound patent and clarifies the standard of plausibility

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On July 16 2025, the Court of Appeal dismissed AstraZeneca’s appeal and upheld the first instance decision, finding that AstraZeneca’s compound patent for dapagliflozin, an SGLT2 inhibitor used to treat diabetes, was invalid...more

Knobbe Martens

Federal Circuit Review | July 2025

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In Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal No. 25-1228, The Federal Circuit found that claims reciting a dosing regimen with unequal loading doses were not obvious and that a presumption of...more

Robins Kaplan LLP

Ingenus Pharms., LLC v. Nexus Pharms., Inc.

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Nature of the Case and Issue(s) Presented: Cyclophosphamide is an antineoplastic agent used to treat various cancers, including lymphomas, myeloma, leukemia, and breast carcinoma. The ’952 patent, issued to Plaintiffs in May...more

Hudnell Law Group

Federal Circuit Rejects Formalistic Shield to Prosecution History Estoppel

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On July 18, 2025, the U.S. Court of Appeals for the Federal Circuit reversed a $106 million jury verdict in Colibri Heart Valve LLC v. Medtronic CoreValve, LLC, No. 2023-2153, finding that Colibri’s infringement claim under...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

Goodwin

Final Judgment of Non-Infringement Entered in Alnylam v. Pfizer Vaccine Patent Dispute

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​​​​​​​On July 30, 2025, the U.S. District Court for the District of Delaware entered a Final Judgment in the dispute between Alnylam Pharmaceuticals, Inc. (“Alnylam”) and Pfizer, Inc. (“Pfizer”)—concluding that Pfizer’s...more

Womble Bond Dickinson

Reminder: “Consisting essentially of” Is U.S. Patent Claim Language Needing Interpretation

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On June 30, 2025, the Federal Circuit issued a precedential opinion in Eye Therapies v. Slayback Pharma in which the court interpreted the transition phrase “consisting essentially of” to be a closed term excluding other...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

Venable LLP

Jury Finds Botox® Patent Claims Nonobvious and Awards Damages from Daxxify® Sales

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On July 18, 2025, after a five-day trial, the jury in Allergan v. Revance Case No. 1:21-cv-01411 (D. Del.) entered a verdict finding claim 8 of Allergan’s U.S. Patent No. 7,354,740 (“the ’740 patent”), claim 6 of U.S. Patent...more

Robins Kaplan LLP

Astellas Pharma Inc. v. Zydus, Inc. II

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Nature of the Case and Issue(s) Presented: Astellas sued Lupin and Zydus based on the generics manufacturers’ ANDA filing and their efforts to make and sell generic mirabegron. In the leadup to the 2023 bench trial, the...more

Robins Kaplan LLP

Azurity Pharms., Inc. v. Alkem Labs. Ltd.

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Nature of the Case and Issue(s) Presented: The ’948 patent claims non-sterile drinkable liquid formulations of vancomycin, an antibiotic used to treat Clostridium difficile infection. These formulations are particularly...more

Goodwin

Fresenius Files Two IPRs Against Regeneron Aflibercept Patents

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On July 14, 2025 Fresenius filed two IPR petitions challenging Regeneron’s patents related to aflibercept. Regeneron has not asserted that Fresenius infringes either of these patents in district court litigation; however,...more

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