Pharmaceuticals — US PTAB Patent Cases
185 decisions indexed
Page 2 of 7 · 185 total
Alvotech USA Inc. et al. v.Regeneron Pharmaceuticals, Inc.
The PTAB granted institution for the PGR proceeding (PGR2025-00085) involving Alvotech and Regeneron regarding patent 12168036. The petitioner met the likelihood of prevailing standard.
Porta Sophia v.Ellis, Greg
Porta Sophia petitions the PTAB to invalidate U.S. Patent 11,235,110 covering a vaporizer device for psychedelic compounds, asserting that the device, formulations, and isotopomer claims are fully anticipated or obvious by extensive prior‑art references.
Tempus AI, Inc. v.Guardant Health Inc.
Guardant Health files an IPR petition seeking to invalidate multiple claims of Foundation Medicine’s ’830 cancer‑sequencing patent, asserting that the claims are obvious over prior‑art methods for targeted enrichment and NGS analysis.
ITM Isotope Technologies Munich SE v.The Johns Hopkins University et al.
ITM Isotope Technologies challenges Johns Hopkins’ U.S. Patent 12,115,233, arguing that its FAP‑α imaging claims are obvious, lack enablement, are indefinite, and double‑patented. The petition seeks institution of the PGR and cancellation of claims 1‑4.
Fresenius Kabi SwissBioSim GmbH et al. v.Regeneron Pharmaceuticals, Inc.
Regeneron defends the PTAB’s discretionary denial of Fresenius’s request to review the denial of institution for an IPR targeting its aflibercept biosimilar patent. The response argues that Fresenius ignored the controlling Fintiv factors, misapplied settled‑expectations, and raised meritless constitutional claims.
Fresenius Kabi SwissBioSim GmbH et al. v.Regeneron Pharmaceuticals, Inc.
Fresenius Kabi seeks Director Review of a PTAB decision that denied institution of an IPR against Regeneron’s biosimilar patent. The petition argues the Board’s “settled expectations” rule and discretionary denial are unlawful and harm drug‑price competition.
Fresenius Kabi SwissBioSim GmbH et al. v.Regeneron Pharmaceuticals, Inc.
Fresenius Kabi SwissBioSim petitions the PTAB to invalidate Regeneron’s anti‑VEGF eye‑drug patent, asserting that the Dix ’226 reference anticipates all challenged claims and that the patent owner has not shown any criticality for the claimed formulation parameters.
Fresenius Kabi SwissBiosim, GmbH et al. v.Regeneron Pharmaceuticals, Inc.
Fresenius Kabi SwissBiosim petitions the PTAB to invalidate claims 1‑11 of Regeneron’s aflibercept eye‑drug patent, arguing anticipation and obviousness based on earlier clinical studies and publications.
GE Healthcare Ltd. et al. v.The Johns Hopkins University et al.
GE Healthcare Ltd.'s Post-Grant Review petition against The Johns Hopkins University was instituted by the PTAB, focusing on obviousness and statutory defects. The Board acknowledged strong arguments regarding combining prior art (US-633/Meletta with Jansen) and potential lack of enablement for radiopharmaceutical claims.
Fresenius Kabi SwissBiosim, GmbH et al. v.Regeneron Pharmaceuticals, Inc.
The PTAB denied institution of the IPR in a dispute between Fresenius Kabi SwissBiosim and Regeneron Pharmaceuticals, finding that the petitioner failed to meet the required likelihood standard.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck has filed a post‑grant review petition challenging Halozyme’s U.S. Patent 12,077,791 covering modified PH20 hyaluronidase proteins. The petition asserts that the claims are overly broad and lack both written description and enablement under 35 U.S.C. §112(a). Merck seeks institution of the proceeding and cancellation of all claims.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck Sharp & Dohme LLC successfully petitioned the PTAB to challenge Halozyme's PH20 polypeptide claims under 35 U.S.C. § 112 for lack of written description and enablement. The Board instituted the petition, finding that the specification broadly defines a 'modified PH20 polypeptide' but lacked sufficient examples to support the vast scope of multiply-substituted variants claimed.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck has filed a post‑grant review petition challenging Halozyme’s enzyme‑based contraceptive patent, arguing that the claims lack sufficient written description and enablement. The reply emphasizes the vast, undefined genus of modified PH20 polypeptides and the impossibility of testing all variants.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck has filed a post‑grant review petition challenging Halozyme’s U.S. Patent 12,049,652 covering engineered PH20 hyaluronidase proteins. The petition asserts lack of written description, lack of enablement, and obviousness of key mutants. The Board has not yet ruled on the petition.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck Sharp & Dohme LLC successfully challenged Halozyme, Inc.'s patent claims on grounds of enablement and obviousness. The Board ruled that the claimed modified polypeptides must exhibit hyaluronidase activity, narrowing the scope of the genus. This decision sets a precedent for interpreting functional limitations in polypeptide patents.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck has filed a post‑grant review petition challenging Halozyme’s U.S. Patent 12,264,345, which claims thousands of modified PH20 hyaluronidase polypeptides. The petition alleges lack of written description, enablement, indefiniteness, and obviousness. The Board must decide whether to institute the proceeding.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck Sharp & Dohme LLC successfully petitioned the PTAB to invalidate Halozyme, Inc.'s claims covering a genus of modified PH20 polypeptides. The Board found that the broad scope of the claimed variants lacked adequate written description and enablement support in the original patent disclosure. This decision significantly challenges the breadth of the patented technology in hyaluronidase drug development.
Sarepta Therapeutics, Inc. et al. v.Genzyme Corporation et al.
Sarepta has filed an IPR petition seeking to invalidate claims 3‑6 of Genzyme’s ’542 AAV formulation patent, alleging obviousness over multiple prior‑art references. The petition details how Wu, Konz, Croyle, and Potter collectively disclose all claim limitations.
Sarepta Therapeutics, Inc. et al. v.Genzyme Corporation et al.
The USPTO Board denied the institution of IPR proceedings (IPR2025-01194) involving Sarepta Therapeutics and Genzyme Corporation, meaning no trial will proceed on the challenged patent.
Conjupro Biotherapeutics, Inc. et al. v.Ascletis Pharma China Co. Ltd.
Conjupro Biotherapeutics has filed a PGR petition seeking to invalidate Ascletis’s U.S. 12,234,236 patent covering small‑molecule GLP‑1R agonists. The petition argues obviousness over multiple prior‑art references and challenges the examiner’s narrow allowance. The Board must decide whether to institute the review.
MSN Pharmaceuticals, Inc. et al. v.Breckenridge Pharmaceutical, Inc.
MSN Pharmaceuticals and its affiliate filed a supplemental certificate of service to confirm that the IPR petition and related documents were delivered to Breckenridge Pharmaceutical. The filing complies with USPTO service rules.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck has filed a post‑grant review petition challenging Halozyme’s U.S. Patent 12,195,773 covering soluble human PH20 hyaluronidase variants. The petition alleges lack of written description, lack of enablement, and obviousness over prior art. The case is pending before the PTAB.
MSN Pharmaceuticals, Inc. et al. v.Breckenridge Pharmaceutical, Inc.
MSN Pharmaceuticals and its Indian affiliate petition PTAB to invalidate 18 claims of Breckenridge’s 2021 dabigatran composition patent, arguing obviousness over Brauns combined with Leane or Sugimoto.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck Sharp & Dohme LLC successfully petitioned to institute IPR against Halozyme, Inc.'s patent (12195773) based on grounds of enablement and obviousness. The Board found it likely that the claims defining a vast genus of modified polypeptides are unpatentable due to insufficient disclosure regarding solubility and activity prediction.
Empower Clinic Services, LLC. (d/b/a Empower Pharmacy) v.Eli Lilly & Co.
Eli Lilly successfully defended its tirzepatide patent against Empower Clinic Services’ request for Director Review. The PTAB affirmed the discretionary denial of institution, citing Lilly’s strong settled expectations and lack of material examination error.
Empower Clinic Services, LLC. (d/b/a Empower Pharmacy) v.Eli Lilly & Co.
Empower Pharmacy filed a Director Review request challenging the Board’s discretionary denial of institution for Lilly’s tirzepatide patent (US 9,474,780). The petition argues that Lilly’s reliance on settled‑expectations and Orange Book listings is misplaced and that the examiner’s error was manifest. The request seeks to have the trial instituted to correct the alleged error and curb high drug prices.
Empower Clinic Services, LLC. (d/b/a Empower Pharmacy) v.Eli Lilly & Co.
The PTAB denied Empower Clinic Services' request for Director Review of the decision denying institution of IPR2025‑01024, which challenges Eli Lilly's patent 9,474,780. The institution remains denied, ending the challenge.
Empower Clinic Services, LLC. (d/b/a Empower Pharmacy) v.Eli Lilly & Co.
Empower Clinic Services filed an IPR petition seeking to invalidate 16 claims of Eli Lilly’s peptide patent (US 9,474,780) on the ground of obviousness over three pre‑2015 WO publications. The petition argues that a skilled artisan would have combined these teachings to arrive at the claimed GIP/GLP‑1 dual‑agonist peptides.
Aquestive Therapeutics, Inc. v.Iono Pharma, LLC
Aquestive Therapeutics seeks Director Review of the PTAB’s denial of institution for its IPR against Iono Pharma’s epinephrine prodrug patent. Iono Pharma argues the request fails statutory standards and should be denied.
Aquestive Therapeutics, Inc. v.Iono Pharma, LLC
Aquestive Therapeutics petitions the PTAB Director to overturn a discretionary denial of institution for an IPR on its epinephrine prodrug patent, arguing factual errors and improper reliance on settled‑expectation criteria.
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