Industry Sector

Pharmaceuticals — US PTAB Patent Cases

185 decisions indexed

Page 3 of 7 · 185 total

patent denied · May 16, 2025

Aquestive Therapeutics, Inc. v.Iono Pharma, LLC

· IPR2025-00874

The USPTO Director denied a request for review of the earlier decision denying institution of an IPR against Iono Pharma’s patent. The denial leaves the institution decision unchanged.

patent · May 16, 2025

Aquestive Therapeutics, Inc. v.Iono Pharma, LLC

· IPR2025-00874

Aquestive Therapeutics has filed an IPR petition seeking to invalidate claims 1‑3 of Iono Pharma’s ‘437 patent covering sublingual/ buccal epinephrine prodrugs. The challenger relies on obviousness over multiple prior‑art references, including Truelove patents, an academic paper, and the Almoazen paper.

patent · Apr 29, 2025

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

· PGR2025-00046

Merck has filed a Post‑Grant Review petition challenging Halozyme’s U.S. Patent No. 12,091,692 covering engineered human PH20 hyaluronidase variants. The petition alleges lack of written description, enablement, and obviousness of the claimed mutants.

patent instituted · Apr 29, 2025

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

· PGR2025-00046

Merck Sharp & Dohme LLC challenged Halozyme, Inc.'s patent on hyaluronidase polypeptides under grounds of enablement and obviousness. The PTAB granted institution, finding the claims cover a vast genus that requires undue experimentation to fully enable.

patent denied · Apr 22, 2025

Sun Pharmaceutical Industries, Inc. v.Nivagen Pharmaceuticals, Inc.

· IPR2025-00893

Nivagen successfully opposes Sun Pharmaceutical’s request for a Director review of the institution denial, arguing that Sun raised new issues and failed to meet the rehearing standard. The Board affirms the Acting Director’s discretionary denial under 35 U.S.C. § 314(a).

patent · Apr 22, 2025

Sun Pharmaceutical Industries, Inc. v.Nivagen Pharmaceuticals, Inc.

· IPR2025-00893

Sun Pharmaceutical has filed a request for Director Review after the PTAB denied institution of its IPR challenging Nivagen’s orphan‑drug patent. The petitioner argues the denial improperly treated claim‑construction issues as discretionary and was issued by the wrong official.

patent denied · Apr 22, 2025

Sun Pharmaceutical Industries, Inc. v.Nivagen Pharmaceuticals, Inc.

· IPR2025-00893

The USPTO denied Sun Pharmaceutical's request for Director Review of the institution denial in IPR2025-00893, leaving the original decision that the IPR would not be instituted unchanged.

patent · Apr 22, 2025

Sun Pharmaceutical Industries, Inc. v.Nivagen Pharmaceuticals, Inc.

· IPR2025-00893

Sun Pharmaceutical filed a Director Review request in IPR2025-00893 concerning patent 11878076 owned by Nivagen Pharmaceuticals. The Patent Owner may file a limited response within five business days, and no new evidence is allowed.

patent · Apr 22, 2025

Sun Pharmaceutical Industries, Inc. v.Nivagen Pharmaceuticals, Inc.

· IPR2025-00893

Sun Pharmaceutical Industries petitions the PTAB to invalidate claims 1‑20 of Nivagen’s ’076 patent covering lyophilized phenobarbital sodium formulations. The petition alleges obviousness over PIF, Parker, and West‑Ward references and anticipation/obviousness by the ’608 Publication, and challenges the patent’s priority date and written description support.

patent · Apr 15, 2025

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

· PGR2025-00042

Merck challenges Halozyme’s broad PH20 hyaluronidase patent, asserting lack of written description, enablement, and obviousness. The petition seeks to invalidate all 40 claims.

patent instituted · Apr 15, 2025

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

· PGR2025-00042

Merck Sharp & Dohme LLC successfully challenged Halozyme, Inc.'s '618 patent on grounds of enablement and obviousness regarding modified PH20 polypeptides. The PTAB adopted a functional claim construction requiring hyaluronidase activity for the claimed genus.

patent · Apr 8, 2025

BPI Labs, LLC et al. v.Eli Lilly & Co.

· IPR2025-01346

BPI Labs requests Director Review of the PTAB’s denial to institute an IPR against Eli Lilly’s tirzepatide patent (US 9,474,780). The petitioner argues the denial misapplies § 325(d), ignores material prosecution errors, and violates APA rulemaking requirements. Consistency with a related pending IPR is also urged.

patent denied · Apr 8, 2025

BPI Labs, LLC et al. v.Eli Lilly & Co.

· IPR2025-01346

Eli Lilly successfully defended its tirzepatide patent after the PTAB denied BPI Labs' request for Director Review of the institution denial, citing strong settled expectations and proper exercise of discretion.

patent · Apr 8, 2025

BPI Labs, LLC et al. v.Eli Lilly & Co.

· IPR2025-01346

BPI Labs has filed an IPR petition seeking to invalidate 15 claims of Eli Lilly’s 9,474,780 patent covering GLP‑1/GIP co‑agonist peptides. The petition relies on obviousness over three prior‑art references (Alsina‑Fernandez, DiMarchi, Lau). No secondary considerations are alleged.

patent · Apr 2, 2025

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

· PGR2025-00030

Merck has filed a post‑grant review petition challenging Halozyme’s PH20 enzyme patent, asserting lack of written description and enablement. The reply argues the claims cover an unmanageable genus of mutants and cites case law to support unpatentability.

patent · Apr 2, 2025

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

· PGR2025-00030

Merck has filed a Post‑Grant Review petition challenging Halozyme’s U.S. Patent No. 12,054,758 covering engineered PH20 hyaluronidase proteins, arguing lack of written description, enablement, and obviousness.

patent instituted · Apr 2, 2025

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

· PGR2025-00030

Merck Sharp & Dohme LLC successfully petitioned for institution in a PGR proceeding against Halozyme, Inc., challenging the '758 patent on grounds of enablement and obviousness. The Board adopted a broad claim construction for 'modified PH20 polypeptide,' which significantly broadened the scope of the challenged claims.

patent terminated or settled · Mar 31, 2025

Valneva Austria GMBH v.Takeda Vaccines, Inc.

· IPR2025-00776

Valneva Austria and Takeda Vaccines jointly moved to terminate an IPR covering 67 vaccine‑related claims. The Board granted the motion, dismissing the petition without a merits decision.

patent · Mar 31, 2025

Valneva Austria GMBH v.Takeda Vaccines, Inc.

· IPR2025-00776

Valneva has filed an IPR petition challenging all 67 claims of Takeda’s Zika vaccine patent, asserting anticipation and obviousness over multiple prior‑art references. The petitioner argues the examiner erred and that no discretionary bars apply, seeking cancellation of the entire patent.

patent instituted · Mar 31, 2025

Valneva Austria GMBH v.Takeda Vaccines, Inc.

· IPR2025-00776

Valneva Austria GMBH successfully convinced the PTAB to institute IPR proceedings against Takeda Vaccines regarding a vaccine patent. The Board found a reasonable likelihood that several claims are unpatentable over combinations of prior art, specifically citing evidence related to fetal protection and antibody transfer.

patent · Mar 28, 2025

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

· PGR2025-00039

Merck’s petition reply contends that Halozyme’s hyaluronidase enzyme patent fails the written‑description and enablement requirements of 35 U.S.C. §112(a). The company argues the disclosed genus is too broad and impossible to enable without undue experimentation.

patent · Mar 28, 2025

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

· PGR2025-00039

Merck has filed a Post‑Grant Review petition challenging Halozyme’s U.S. Patent 12,104,185 covering modified PH20 hyaluronidase proteins. The petition argues the claims are overly broad, lack written description and enablement, and are obvious in view of prior art. The case is pending institution.

patent instituted · Mar 28, 2025

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

· PGR2025-00039

Merck Sharp & Dohme successfully challenged Halozyme's patent claims in a PGR proceeding, focusing on enablement and obviousness. The Board adopted a functional claim construction requiring 'modified PH20 polypeptide' to exhibit hyaluronidase activity.

patent terminated or settled · Mar 4, 2025

Intas Pharmaceuticals, Ltd. et al. v.Atossa Therapeutics, Inc.

· PGR2025-00043

Intas Pharmaceuticals and Atossa Therapeutics have settled their dispute over U.S. Patent 12,071,391 and jointly moved to terminate the post‑grant review. The Board is asked to end the proceeding under 35 U.S.C. §327.

patent · Mar 4, 2025

Intas Pharmaceuticals, Ltd. et al. v.Atossa Therapeutics, Inc.

· PGR2025-00043

Intas Pharmaceuticals and Atossa Therapeutics filed a joint request to keep their settlement agreement confidential under 35 U.S.C. § 327 and to terminate the ongoing post‑grant review of Patent 12,071,391.

patent denied · Mar 4, 2025

Intas Pharmaceuticals, Ltd. et al. v.Atossa Therapeutics, Inc.

· IPR2025-00799

The Director denied Intas Pharmaceuticals' request for review of the institution decision in IPR2025-00799, leaving Atossa Therapeutics' Patent 11,261,151 in place.

patent · Mar 4, 2025

Intas Pharmaceuticals, Ltd. et al. v.Atossa Therapeutics, Inc.

· IPR2025-00799

Intas Pharmaceuticals challenges Atossa Therapeutics’ endoxifen patent in IPR 2025‑00799. The petitioner argues the Board correctly instituted the case and that the Patent Owner’s new arguments are unsupported. The response seeks denial of the Owner’s request for Director Review.

patent · Mar 4, 2025

Intas Pharmaceuticals, Ltd. et al. v.Atossa Therapeutics, Inc.

· PGR2025-00043

Intas Pharmaceuticals petitions the PTAB to invalidate all 44 claims of Atossa’s 391 patent covering 90% (Z)-endoxifen compositions, asserting anticipation, obviousness, and lack of written description.

patent instituted · Mar 4, 2025

Intas Pharmaceuticals, Ltd. et al. v.Atossa Therapeutics, Inc.

· IPR2025-00799

Intas Pharmaceuticals successfully secured the institution of IPR against Atossa Therapeutics over a drug polymorph patent (11,261,151), challenging claims based on anticipation and obviousness using prior art Liu.

patent instituted · Mar 3, 2025

CSPC Megalith Biopharmaceutical Co., Ltd. et al. v.Shanghai Miracogen Inc. et al.

· IPR2025-00685

CSPC Megalith Biopharmaceutical Co., Ltd. successfully argued obviousness over Wei, Liu, and Leanna in an IPR proceeding against Shanghai Miracogen Inc. The Board found a reasonable likelihood of success on multiple claims, leading to the institution of the case for trial.

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