Industry Sector

Pharmaceuticals — US PTAB Patent Cases

247 decisions indexed

Page 5 of 9 · 247 total

patent · Feb 21, 2025

Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.

· PGR2025-00024

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.

patent · Feb 21, 2025

Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.

· PGR2025-00024

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.

patent instituted · Feb 21, 2025

Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.

· PGR2025-00024

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.

patent · Feb 12, 2025

Sarepta Therapeutics, Inc. et al. v.Genzyme Corporation et al.

· IPR2026-00168

Sarepta has filed an IPR petition seeking cancellation of all 21 claims of Genzyme’s ’880 AAV detection patent, asserting obviousness over six prior‑art references. The petition details how each claim is taught by combinations of those references and argues that secondary considerations are irrelevant.

patent · Feb 12, 2025

Sarepta Therapeutics, Inc. et al. v.Genzyme Corporation et al.

· IPR2026-00167

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.

patent · Jan 30, 2025

Apotex Inc. et al. v.Alkermes Pharma Ireland Limited

· IPR2025-00514

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.

patent · Jan 17, 2025

Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.

· PGR2025-00017

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.

patent · Jan 17, 2025

Padagis US LLC et al. v.Neurelis, Inc.

· IPR2025-00466

The PTAB held that all 36 claims of Neurelis' nasal benzodiazepine formulation patent are obvious over Gwozdz, Meezan ’962 and Cartt ’784, rendering the patent entirely unpatentable.

patent all challenged claims unpatentable · Jan 17, 2025

Padagis US LLC et al. v.Neurelis, Inc.

· IPR2025-00465

The PTAB held that all 36 claims of Neurelis’s intranasal benzodiazepine patent are obvious over a combination of prior‑art references, rendering the patent entirely unpatentable.

patent all challenged claims unpatentable · Jan 17, 2025

Padagis US LLC et al. v.Neurelis, Inc.

· IPR2025-00464

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.

patent · Jan 17, 2025

Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.

· PGR2025-00017

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.

patent · Jan 17, 2025

Padagis US LLC et al. v.Neurelis, Inc.

· IPR2025-00464

Padagis US LLC seeks IPR cancellation of Neurelis' 8,895,546 patent covering intranasal benzodiazepine solutions, arguing obviousness over Gwozdz and Meezan and invoking collateral estoppel from a prior IPR.

patent · Jan 17, 2025

Padagis US LLC et al. v.Neurelis, Inc.

· IPR2025-00465

Padagis seeks to invalidate Neurelis' 11,241,414 patent covering intranasal benzodiazepine solutions, arguing obviousness over Gwozdz and Meezan and invoking collateral estoppel from a prior IPR.

patent · Jan 17, 2025

CSPC Pharmaceutical Group Limited et al. v.Ipsen Biopharm Ltd. et al.

· IPR2025-00505

CSPC Pharmaceutical Group has filed an IPR petition challenging all 15 claims of Ipsen’s U.S. Patent 11,344,552 covering a liposomal irinotecan regimen for metastatic pancreatic cancer, asserting obviousness over a suite of prior‑art references.

patent · Jan 17, 2025

Padagis US LLC et al. v.Neurelis, Inc.

· IPR2025-00466

Padagis seeks inter partes review of Neurelis’s 11,793,786 patent covering intranasal benzodiazepine solutions, arguing that all 27 claims are obvious over prior art and that the patent owner is estopped from contesting issues already decided in a prior IPR.

patent instituted · Jan 17, 2025

Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.

· PGR2025-00017

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.

patent instituted · Jan 17, 2025

CSPC Pharmaceutical Group Limited et al. v.Ipsen Biopharm Ltd. et al.

· IPR2025-00505

The PTAB institution decision in this oncology IPR upheld the patent claims against numerous prior art references related to FOLFIRINOX and nanoliposomal irinotecan. The Board adopted a specific claim construction defining 'treatment' as requiring more than a de minimis therapeutic benefit for the patient.

patent instituted · Jan 17, 2025

Padagis US LLC et al. v.Neurelis, Inc.

· IPR2025-00466

Padagis US LLC successfully challenged Neurelis, Inc.'s patent claims covering nasal drug delivery formulations. The Board found a reasonable likelihood of prevailing on multiple grounds, leading to the institution of the IPR.

patent instituted · Jan 17, 2025

Padagis US LLC et al. v.Neurelis, Inc.

· IPR2025-00465

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.

patent instituted · Jan 17, 2025

Padagis US LLC et al. v.Neurelis, Inc.

· IPR2025-00464

Padagis US LLC successfully petitioned to challenge Neurelis, Inc.'s nasal drug formulations patent (8895546) under 35 U.S.C. § 103. The PTAB institution decision allows Padagis to proceed with the unpatentability arguments against all 22 claims.

patent instituted · Jan 16, 2025

Charles River Laboratories, Inc. v.Seikagaku Corporation

· IPR2025-00440

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.

patent · Jan 15, 2025

Celltrion, Inc. v.Regeneron Pharmaceuticals, Inc.

· IPR2025-00456

Celltrion seeks IPR institution to invalidate all 50 claims of Regeneron’s US 11,084,865, arguing anticipation by US432 and lack of written description for glycosylation and stability limits.

patent instituted · Jan 15, 2025

Charles River Laboratories, Inc. v.Seikagaku Corporation

· PGR2025-00023

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.

patent · Jan 5, 2025

AZURITY PHARMACEUTICALS, INC. v.Helsinn Healthcare S.A.

· IPR2025-00945

Azurity has filed an IPR petition seeking cancellation of all 25 claims of Helsinn’s antiemetic patent (US 8,623,826) on the ground that the claims are obvious over multiple prior‑art references and that the asserted synergy is not unexpected.

patent · Jan 5, 2025

AZURITY PHARMACEUTICALS, INC. v.Helsinn Healthcare S.A.

· IPR2025-00948

Azurity has filed an IPR petition seeking cancellation of all 23 claims of Helsinn’s U.S. Patent 9,943,515 covering netupitant‑based anti‑emetic regimens, arguing the claims are obvious over prior‑art combinations and lack secondary considerations.

patent · Jan 5, 2025

AZURITY PHARMACEUTICALS, INC. v.Helsinn Healthcare S.A.

· IPR2025-00947

Azurity petitions to invalidate 39 claims of Helsinn’s anti‑emetic patent, arguing the claimed netupitant/palonosetron regimen is obvious over prior art and lacks any unexpected synergy.

patent · Jan 5, 2025

AZURITY PHARMACEUTICALS, INC. v.Helsinn Healthcare S.A.

· IPR2025-00946

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.

patent · Jan 5, 2025

AZURITY PHARMACEUTICALS, INC. v.Helsinn Healthcare S.A.

· IPR2025-00949

Azurity has filed an IPR petition seeking cancellation of all 23 claims of Helsinn’s anti‑emetic patent (US 10,828,297) on the ground that the claims are obvious over standard chemotherapy anti‑emetic regimens. The petition argues the examiner’s reliance on alleged unexpected synergy is unsupported.

patent instituted · Jan 5, 2025

AZURITY PHARMACEUTICALS, INC. v.Helsinn Healthcare S.A.

· IPR2025-00949

AZURITY PHARMACEUTICALS successfully convinced the PTAB that multiple claims of Helsinn Healthcare's anti-emetic patent were unpatentable. The Board granted institution based on obviousness (103) over several prior art references, paving the way for a full trial.

patent instituted · Jan 5, 2025

AZURITY PHARMACEUTICALS, INC. v.Helsinn Healthcare S.A.

· IPR2025-00948

AZURITY PHARMACEUTICALS successfully petitioned to institute IPR against Helsinn Healthcare's '515 patent covering anti-emetic agents. The Board found a reasonable likelihood of prevailing based on obviousness (103) and prior art, allowing the challenge to proceed.

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