Pharmaceuticals — US PTAB Patent Cases
247 decisions indexed
Page 2 of 9 · 247 total
United Therapeutics Corporation v.Actelion Pharmaceuticals Ltd. et al.
The PTAB denied institution for IPR2025-01139, preventing United Therapeutics Corporation from challenging Actelion's patent 8268847.
AdvanCell Pty Ltd. v.Sciencons AS et al.
AdvanCell has petitioned the PTAB to invalidate Sciencons’ 603 patent covering a radioisotope generator for targeted alpha‑therapy, arguing anticipation, obviousness, and lack of enablement. The petition seeks cancellation of all 20 claims.
AdvanCell Pty Ltd. v.Sciencons AS et al.
AdvanCell Pty Ltd.'s PGR against Sciencons AS et al. was instituted by the PTAB, finding sufficient evidence that several claims are unpatentable. The Board adopted Petitioner's interpretation of a key time-based limitation in Claim 20 during the institution phase.
Neurocrine Biosciences, Inc. v.Spruce Biosciences, Inc.
The PTAB held that Neurocrine Biosciences’ challenge to Spruce Biosciences’ ’201 patent succeeded; all 19 claims were found unpatentable for lack of written description under §112(a).
Neurocrine Biosciences, Inc. v.Spruce Biosciences, Inc.
The PTAB held that Neurocrine Biosciences' challenge succeeded; claims 1‑25 of Spruce Biosciences' ’908 patent were found unpatentable for lack of written description under 35 U.S.C. §112(a). The Board applied Ariad standards and rejected the genus claim.
Neurocrine Biosciences, Inc. v.Spruce Biosciences, Inc.
Neurocrine Biosciences has filed a PTAB post‑grant review petition seeking to invalidate Spruce Biosciences’ 11,007,201 patent covering CRF1 receptor antagonists for congenital adrenal hyperplasia. The petition alleges anticipation, obviousness, and lack of written description. Discretionary denial is contested.
Neurocrine Biosciences, Inc. v.Spruce Biosciences, Inc.
Neurocrine Biosciences has petitioned the PTAB to invalidate Spruce Biosciences' U.S. Patent 10,849,908 covering CRF1 receptor antagonists for congenital adrenal hyperplasia, arguing lack of written description, enablement, and that prior art anticipates or renders obvious the claims.
Neurocrine Biosciences, Inc. v.Spruce Biosciences, Inc.
Neurocrine Biosciences petitions the PTAB to invalidate Spruce Biosciences’ 12,115,166 patent covering a broad genus of CRF1 receptor antagonists for CAH, arguing lack of written description and enablement.
Neurocrine Biosciences, Inc. v.Spruce Biosciences, Inc.
The PTAB denied institution of a PGR for Neurocrine against Spruce because the patent owner had disclaimed all challenged claims.
Bonerge Lifescience (Hunan) Co., Ltd. v.Nanjing Nutrabuilding Bio-Tech Co., Ltd.
Bonerge Lifescience petitions the PTAB to invalidate five method claims of a diabetes‑treatment patent, asserting obviousness over Turner, Shaw, Zhang and Feng references.
Dr. Falk Pharma GmbH v.Ellodi Pharmaceuticals
Dr. Falk Pharma challenges Ellodi's U.S. Patent 12,290,598 covering orally disintegrating tablets, asserting lack of written description, enablement, indefiniteness, anticipation, and obviousness over numerous prior‑art references. The petition seeks cancellation of all 34 claims.
Dr. Falk Pharma GmbH v.Ellodi Pharmaceuticals
The PTAB granted institution for the PGR proceeding involving Dr. Falk Pharma and Ellodi Pharmaceuticals, allowing the challenge to move forward.
Alvotech USA Inc. et al. v.Regeneron Pharmaceuticals, Inc.
Alvotech petitions the PTAB to invalidate Regeneron’s ’036 patent covering high‑dose aflibercept eye‑treatment formulations, alleging obviousness and lack of written description. The petition relies on multiple Regeneron disclosures and external prior art. The Board has yet to rule.
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.
Azurity Pharmaceuticals, Inc. v.EXELIXIS, INC.
Azurity has filed an IPR petition seeking cancellation of all 22 claims of Exelixis’s U.S. 12,128,039 patent, arguing obviousness over Brown combined with Kubo and Robinson references.
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.
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