Pharmaceuticals — US PTAB Patent Cases
185 decisions indexed
Page 4 of 7 · 185 total
Amgen Inc. et al. v.Bristol-Myers Squibb Company
Amgen petitions the PTAB to overturn a Director’s denial of institution for an IPR challenging Bristol‑Myers Squibb’s Opdivo dosing patent, arguing the denial misapplied settled‑expectations criteria and ignored European claim abandonments.
Amgen Inc. et al. v.Bristol-Myers Squibb Company
Amgen’s request for Director Review of IPR denial is rebuffed by Bristol‑Myers Squibb, which argues the petitioner offers no credible basis and that European prosecution does not affect settled expectations for the U.S. patent.
Azurity Pharmaceuticals, Inc. et al. v.Heron Therapeutics, Inc.
Azurity has filed a PGR petition seeking cancellation of claims 1‑30 of Heron’s U.S. 12,115,254 patent covering injectable aprepitant emulsions. The petition alleges obviousness over four prior‑art references and asserts lack of written description and enablement due to overly broad claim ranges. Institution is requested and discretionary denial is contested.
Amgen Inc. et al. v.Bristol-Myers Squibb Company
Amgen petitions the PTAB to invalidate Bristol‑Myers Squibb’s ’529 patent covering anti‑PD‑1/anti‑CTLA‑4 regimens for MSI‑H colorectal cancer, citing anticipation and obviousness over multiple clinical‑trial disclosures. The petition argues no secondary considerations or discretionary grounds support the patent’s validity.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck has filed a post‑grant review petition challenging Halozyme’s PH20 enzyme patent, asserting the claims lack adequate written description and enablement. The reply emphasizes the breadth of the claimed genus and the impossibility of testing all variants.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck has filed a PGR petition challenging Halozyme’s U.S. Patent 12,060,590 covering thousands of engineered PH20 hyaluronidase variants, asserting lack of written description, enablement, and obviousness.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck Sharp & Dohme LLC successfully challenged Halozyme, Inc.'s '590 patent on grounds of enablement and obviousness. The PTAB found the claims were overly broad regarding polypeptide scope, requiring undue experimentation for a skilled artisan.
Sarepta Therapeutics, Inc. et al. v.Genzyme Corporation et al.
Sarepta Therapeutics has filed an IPR petition seeking cancellation of claims 1‑20 of Genzyme’s ‘377 patent on AAV detection methods, arguing the claims are obvious over four prior‑art references. The petition details three grounds of obviousness and asserts no secondary considerations outweigh the evidence.
Apotex Inc. et al. v.Alkermes Pharma Ireland Limited
Apotex petitions the PTAB to review US 7,919,499, covering a long‑acting naltrexone formulation, asserting that the claims are anticipated or obvious over Comer, Nuwayser, Rubio and Wright. The petition cites a prior IPR that was instituted and later terminated, and argues that discretionary denial is unwarranted.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck has filed a post‑grant review petition challenging Halozyme’s patent on modified PH20 hyaluronidase enzymes, arguing the claims lack adequate written description and enablement. The petition cites extensive expert analysis and prior‑art exhibits to show undue experimentation would be required to identify the claimed mutants.
Padagis US LLC et al. v.Neurelis, Inc.
The PTAB held that all 36 claims of Neurelis’s intranasal benzodiazepine patent are obvious over prior art references Gwozdz, Meezan ’962, and Cartt ’784, rendering the patent entirely unpatentable.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck has filed a PGR petition challenging Halozyme’s U.S. Patent 12,110,520 covering engineered PH20 hyaluronidase proteins. The petition asserts lack of written description, lack of enablement, and obviousness over prior art. The Board has not yet ruled.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck Sharp & Dohme LLC successfully challenged Halozyme, Inc.'s patent on enablement and obviousness grounds in a PTAB decision. The Board found that the patent documents supported a broad definition of modified PH20 polypeptides, while noting the petitioner had established a likelihood of prevailing on enablement but failed to prove obviousness.
Padagis US LLC et al. v.Neurelis, Inc.
Padagis US LLC successfully challenged claims 1-18 of Neurelis, Inc.'s patent under grounds of obviousness (103) and lack of written description (102). The Board found a reasonable likelihood that the invention is unpatentable, based on combining prior art references Gwozdz and Meezan.
Charles River Laboratories, Inc. v.Seikagaku Corporation
Charles River Laboratories successfully petitioned to institute IPR against Seikagaku Corporation's patent (11236318) based on grounds of lack of written description and obviousness. The Board found sufficient evidence at this preliminary stage, allowing the challenge to proceed into full litigation.
Charles River Laboratories, Inc. v.Seikagaku Corporation
Charles River Laboratories successfully petitioned to invalidate Seikagaku Corporation's patent claims related to endotoxin detection. The Board found grounds for invalidity under 35 U.S.C. § 102 and § 112, specifically citing anticipation by a prior publication.
AZURITY PHARMACEUTICALS, INC. v.Helsinn Healthcare S.A.
Azurity has filed an IPR petition seeking cancellation of 23 claims of Helsinn’s anti‑emetic patent covering netupitant, palonosetron and dexamethasone regimens. The challenger alleges obviousness over multiple prior‑art references and disputes the asserted unexpected synergy. No decision has been issued yet.
AZURITY PHARMACEUTICALS, INC. v.Helsinn Healthcare S.A.
AZURITY PHARMACEUTICALS successfully petitioned to institute IPR proceedings against Helsinn Healthcare S.A.'s anti-emetic patent (8623826). The Board found a reasonable likelihood of prevailing on independent claim 19, allowing the challenge based on obviousness over prior art like MASCC and Hoffmann.
AZURITY PHARMACEUTICALS, INC. v.Helsinn Healthcare S.A.
AZURITY PHARMACEUTICALS, INC. successfully secured institution of its IPR against Helsinn Healthcare S.A.'s patent (9186357) for anti-emetic agents. The Board found a reasonable likelihood that several claims would be unpatentable over prior art, specifically regarding the combination of triple-drug CINV treatment and superior NK antagonists.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck has filed a post‑grant review petition challenging Halozyme’s enzyme patent, arguing the claims lack adequate written description and enablement. The reply emphasizes functional language and the impossibility of testing the claimed 1,059+ PH20 variants.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck defends its PH20 enzyme patent in a PTAB Director Review proceeding, arguing that the claims satisfy §112 written description and enablement and that Halozyme's claim‑construction objections are unfounded. The petitioner also contends that Fintiv factors do not justify discretionary denial.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Halozyme seeks Director Review to overturn the PTAB’s institution of a post‑grant review of its ’035 enzyme patent. The petition contends the Board mis‑interpreted claim language and mis‑applied eligibility standards, and argues that Fintiv factors demand denial of institution.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Halozyme has sought a Director Review of the PGR, and Merck has 5 business days to file a brief response without new evidence.
Biofrontera Incorporated et al. v.Sun Pharmaceutical Industries, Inc.
The USPTO denied Biofrontera's request for rehearing of the decision that refused to institute its IPR against Sun Pharmaceutical's patent 11,446,512. The Board affirmed the discretionary denial, leaving the patent unchallenged.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck has filed a Post‑Grant Review petition challenging Halozyme’s U.S. Patent 12,123,035 covering PH20 hyaluronidase mutants. The petition asserts lack of written description, lack of enablement, and obviousness of the claims. The Board has yet to decide whether to institute the trial.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
The PTAB instituted the PGR petition challenging Halozyme's patent covering modified PH20 polypeptides. The Board found that the claims were not sufficiently supported by the specification regarding enablement and obviousness, despite Petitioner's arguments about the genus size.
Ajinomoto Co., Inc. v.AbTis Co., Ltd.
Ajinomoto has filed an IPR petition challenging AbTis’s U.S. Patent 11,896,675 covering site‑specific antibody‑drug conjugates. The petitioner alleges lack of written description, improper priority, and that all 13 claims are anticipated or obvious over several pre‑grant publications and conference disclosures. The petition seeks cancellation of every claim.
ITM Isotope Technologies Munich SE v.The Johns Hopkins University et al.
ITM Isotope Technologies Munich SE challenged The Johns Hopkins University's claims regarding FAP-α targeting moieties based on obviousness and patentability issues (103/112). The Board instituted the PGR, finding that the claims face significant challenges related to enablement and indefiniteness.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Halozyme has filed a Director Review request asking the PTAB to overturn its institution of a post‑grant review of the ’600 hyaluronidase protein patent, arguing procedural errors and an improper claim construction.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck Sharp & Dohme LLC filed a response defending the institution of a post‑grant review of Halozyme’s enzyme patent. The brief rebuts Halozyme’s eligibility, claim‑construction, and Fintiv arguments, emphasizing that the Board’s earlier findings remain sound.
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