Pharmaceuticals — US PTAB Patent Cases
185 decisions indexed
Page 5 of 7 · 185 total
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck files a PGR petition challenging Halozyme’s protein‑based contraceptive patent, arguing the claims lack written description and enablement. The reply emphasizes that the specification does not support the broad genus of modified PH20 polypeptides claimed.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
The USPTO Director denied Merck’s request for a review of the PTAB’s institution decisions in four Halozyme patent cases, leaving the institution findings intact.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck Sharp & Dohme LLC successfully challenged Halozyme, Inc.'s patent on modified PH20 polypeptides in a PGR proceeding. The Board found likelihood of prevailing based on arguments regarding the genus's scope and potential lack of enablement/obviousness.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Halozyme seeks Director Review to overturn the PTAB’s institution of a post‑grant review against its hyaluronidase patent, arguing filing‑date errors, improper claim construction, and Fintiv factors favoring denial.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck has filed a petition to invalidate Halozyme’s ’298 patent covering modified PH20 polypeptides, arguing the claims lack written description and enablement. The reply attacks Halozyme’s reliance on functional language and disclaimed dependent claims.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck challenges Halozyme’s request for Director review after the PTAB instituted a post‑grant review of U.S. Patent 12,018,298 covering modified PH20 polypeptides. Merck argues the eligibility and claim‑construction issues are meritless and that the Fintiv factors favor institution.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck challenges Halozyme’s broad PH20 hyaluronidase patent, asserting lack of written description, enablement, and obviousness of the claimed protein variants.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck Sharp & Dohme LLC successfully petitioned the PTAB against Halozyme, Inc.'s '298 patent covering modified PH20 polypeptides. The Board granted institution despite challenges based on Written Description and Enablement, allowing the dispute to proceed to trial.
Samsung Bioepis Co., Ltd. v.Regeneron Pharmaceuticals, Inc.
Samsung Bioepis sought to invalidate numerous claims of Regeneron Pharmaceuticals' ophthalmic formulations using grounds of obviousness (103). The PTAB denied institution based on a holistic Fintiv analysis, citing significant overlap with ongoing district court and MDL proceedings.
Azurity Pharmaceuticals, Inc. v.EXELIXIS, INC.
Azurity Pharmaceuticals has filed an IPR petition seeking cancellation of claims 1‑3 of Exelixis’s U.S. Pat. 11,298,349 covering oral cabozantinib (L)-malate formulations. The petition alleges anticipation by the earlier Wilson patent and obviousness over Brown, Kubo and Remington, while arguing that discretionary denial factors do not apply.
Azurity Pharmaceuticals, Inc. v.EXELIXIS, INC.
Azurity Pharmaceuticals failed to convince the PTAB that EXELIXIS's drug formulation patent was unpatentable, resulting in a denial of institution for IPR2025-00210. The Board rejected anticipation arguments based on prior art family relationships and dismissed obviousness claims regarding impurity control.
Helena Laboratories Corporation v.Sebia
Helena Laboratories Corporation's IPR challenge against Sebia regarding hemoglobin analysis claims was denied by the PTAB. The Board found that the petitioner failed to demonstrate material error in the Examiner's rejection, particularly concerning prior art references like Shihabi and Huang.
Cipla Limited v.Gilead Sciences, Inc.
Cipla has filed an IPR petition challenging Gilead’s 2023 ‘802 patent covering a bictegravir/TAF/FTC single‑tablet HIV regimen, asserting obviousness over multiple prior‑art references.
Cipla Limited v.Gilead Sciences, Inc.
The PTAB denied Cipla Limited's IPR petition against Gilead Sciences regarding patent 11,744,802, citing the advanced stage of parallel district court litigation and lack of compelling merits.
Dr. Falk Pharma GmbH v.Ellodi Pharmaceuticals LP
Dr. Falk Pharma GmbH successfully challenged a pharmaceutical patent (11260061) in an IPR, showing a reasonable likelihood of prevailing on grounds of obviousness (§ 103). The Board's decision hinged on extensive claim construction, particularly defining 'adsorbed onto a pharmaceutically acceptable carrier.'
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck’s petition challenges Halozyme’s claims to modified PH20 polypeptides, arguing lack of written description and enablement. The reply reinforces these arguments with case law and scientific exhibits.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck requests Director Review to deny institution of a PTAB post‑grant review of Halozyme’s ‘262 patent covering modified PH20 polypeptides, arguing the Board misapplied eligibility rules and imported a functional limitation into the claim construction.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck defends the institution of a PGR covering modified PH20 enzymes, rejecting Halozyme’s eligibility, claim‑construction, and Fintiv arguments. The response urges the Director to uphold the Board’s earlier institution decision.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck has filed a PGR petition challenging Halozyme’s 13 claims covering PH20 hyaluronidase variants, asserting lack of written description, enablement, and obviousness. The petition seeks to have the claims declared unpatentable.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck Sharp & Dohme LLC successfully challenged Halozyme, Inc.'s claims regarding modified PH20 polypeptides in a PTAB decision. The Board instituted trial based on enablement and written description grounds, finding that the broad genus of claimed molecules required undue experimentation to identify active variants.
HIKMA PHARMACEUTICALS USA INC. v.Axsome Malta Ltd. et al.
Hikma Pharmaceuticals and the patent owners filed a joint motion asking the PTAB to treat their settlement agreement as confidential business information, keeping it separate from the patent file. The request relies on 35 U.S.C. § 317(b) and related regulations.
HIKMA PHARMACEUTICALS USA INC. v.Axsome Malta Ltd. et al.
Hikma Pharmaceuticals filed an IPR against Axsome Malta’s 11,560,354 patent. The parties settled the dispute early and jointly moved to terminate the proceeding. The Board granted the motion and ordered the settlement agreement to be kept confidential.
HIKMA PHARMACEUTICALS USA INC. v.Axsome Malta Ltd. et al.
Hikma Pharmaceuticals filed a joint motion with Axsome Malta to terminate IPR2024‑01418 after reaching a confidential settlement, resulting in dismissal of the petition before institution.
HIKMA PHARMACEUTICALS USA INC. v.Axsome Malta Ltd. et al.
Hikma Pharmaceuticals has filed an IPR petition challenging Axsome’s U.S. Patent 11,560,354 covering solriamfetol compositions. The petition alleges obviousness of claims 1‑8 based on three prior‑art references and argues against discretionary denial of institution.
Biofrontera Incorporated et al. v.Sun Pharmaceutical Industries, Inc.
The PTAB has sent a Director Review request to Biofrontera in IPR2024-01312, limiting the petitioner’s response to 15 pages and prohibiting new evidence. The petitioner must respond within five business days.
Nexus Pharmaceuticals LLC v.Exela Pharma Sciences, LLC
Nexus Pharmaceuticals has filed a PGR petition challenging all 30 claims of Exela Pharma Sciences' L‑cysteine parenteral nutrition patent, asserting lack of enablement, insufficient written description, and, alternatively, obviousness over the Sandoz label.
Nexus Pharmaceuticals LLC v.Exela Pharma Sciences, LLC
Nexus Pharmaceuticals' PGR challenge against Exela Pharma Sciences was denied institution because the arguments regarding enablement, written description, and obviousness were largely identical to those previously presented during prosecution. The Board found that the Patent Owner successfully demonstrated how process controls overcome prior rejections, leading to a denial of the petition under § 325(d).
DR. FALK PHARMA GMBH v.Ellodi Pharmaceuticals LP
Dr. Falk Pharma GmbH initiated an IPR challenge against Ellodi Pharmaceuticals LP concerning a patent covering oral/topical drug delivery systems. The petition asserts that the challenged claims are obvious under 35 U.S.C. § 103, citing prior art references including Dohil and Grother.
Salvacion USA, Inc. et al. v.Trutek Corp.
The Petitioner successfully demonstrated that the challenged claims (1-3 and 8) were anticipated by multiple prior art references, including Chen. The Board found that the prior art disclosed all claim elements, leading to a final decision of unpatentability.
Encube Ethicals Pvt. Ltd. v.Dermavant Sciences GmbH et al.
Encube Ethicals Pvt. Ltd. initiated a Petition challenging the validity of Dermavant Sciences GmbH's patent (US 11590088) in the context of psoriasis treatment. The petitioner asserts that the claimed methods are anticipated or obvious based on prior art references like Sonti and Bissonnette.
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