Pharmaceuticals — US PTAB Patent Cases
247 decisions indexed
Page 3 of 9 · 247 total
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck Sharp & Dohme LLC successfully petitioned the PTAB to invalidate Halozyme, Inc.'s claims covering a genus of modified PH20 polypeptides. The Board found that the broad scope of the claimed variants lacked adequate written description and enablement support in the original patent disclosure. This decision significantly challenges the breadth of the patented technology in hyaluronidase drug development.
Sarepta Therapeutics, Inc. et al. v.Genzyme Corporation et al.
Sarepta has filed an IPR petition seeking to invalidate claims 3‑6 of Genzyme’s ’542 AAV formulation patent, alleging obviousness over multiple prior‑art references. The petition details how Wu, Konz, Croyle, and Potter collectively disclose all claim limitations.
Sarepta Therapeutics, Inc. et al. v.Genzyme Corporation et al.
Sarepta has filed an IPR petition challenging Genzyme’s 7,704,721 AAV vector patent, asserting that the claims are obvious over prior‑art purification methods. The petition cites Auricchio, Konz, Potter and related references to support its grounds.
Sarepta Therapeutics, Inc. et al. v.Genzyme Corporation et al.
The USPTO Director denied institution for several Inter Partes Review petitions, including one concerning Sarepta Therapeutics and Genzyme Corporation's patent 7704721.
Sarepta Therapeutics, Inc. et al. v.Genzyme Corporation et al.
The USPTO Board denied the institution of IPR proceedings (IPR2025-01194) involving Sarepta Therapeutics and Genzyme Corporation, meaning no trial will proceed on the challenged patent.
Conjupro Biotherapeutics, Inc. et al. v.Ascletis Pharma China Co. Ltd.
Conjupro Biotherapeutics has filed a PGR petition seeking to invalidate Ascletis’s U.S. 12,234,236 patent covering small‑molecule GLP‑1R agonists. The petition argues obviousness over multiple prior‑art references and challenges the examiner’s narrow allowance. The Board must decide whether to institute the review.
MSN Pharmaceuticals, Inc. et al. v.Breckenridge Pharmaceutical, Inc.
MSN Pharmaceuticals and its affiliate filed a supplemental certificate of service to confirm that the IPR petition and related documents were delivered to Breckenridge Pharmaceutical. The filing complies with USPTO service rules.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck has filed a post‑grant review petition challenging Halozyme’s U.S. Patent 12,195,773 covering soluble human PH20 hyaluronidase variants. The petition alleges lack of written description, lack of enablement, and obviousness over prior art. The case is pending before the PTAB.
MSN Pharmaceuticals, Inc. et al. v.Breckenridge Pharmaceutical, Inc.
MSN Pharmaceuticals and its Indian affiliate petition PTAB to invalidate 18 claims of Breckenridge’s 2021 dabigatran composition patent, arguing obviousness over Brauns combined with Leane or Sugimoto.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
Merck Sharp & Dohme LLC successfully petitioned to institute IPR against Halozyme, Inc.'s patent (12195773) based on grounds of enablement and obviousness. The Board found it likely that the claims defining a vast genus of modified polypeptides are unpatentable due to insufficient disclosure regarding solubility and activity prediction.
Empower Clinic Services, LLC. (d/b/a Empower Pharmacy) v.Eli Lilly & Co.
Eli Lilly successfully defended its tirzepatide patent against Empower Clinic Services’ request for Director Review. The PTAB affirmed the discretionary denial of institution, citing Lilly’s strong settled expectations and lack of material examination error.
Empower Clinic Services, LLC. (d/b/a Empower Pharmacy) v.Eli Lilly & Co.
Empower Pharmacy filed a Director Review request challenging the Board’s discretionary denial of institution for Lilly’s tirzepatide patent (US 9,474,780). The petition argues that Lilly’s reliance on settled‑expectations and Orange Book listings is misplaced and that the examiner’s error was manifest. The request seeks to have the trial instituted to correct the alleged error and curb high drug prices.
Empower Clinic Services, LLC. (d/b/a Empower Pharmacy) v.Eli Lilly & Co.
The PTAB denied Empower Clinic Services' request for Director Review of the decision denying institution of IPR2025‑01024, which challenges Eli Lilly's patent 9,474,780. The institution remains denied, ending the challenge.
Empower Clinic Services, LLC. (d/b/a Empower Pharmacy) v.Eli Lilly & Co.
Empower Clinic Services filed an IPR petition seeking to invalidate 16 claims of Eli Lilly’s peptide patent (US 9,474,780) on the ground of obviousness over three pre‑2015 WO publications. The petition argues that a skilled artisan would have combined these teachings to arrive at the claimed GIP/GLP‑1 dual‑agonist peptides.
Aquestive Therapeutics, Inc. v.Iono Pharma, LLC
Aquestive Therapeutics seeks Director Review of the PTAB’s denial of institution for its IPR against Iono Pharma’s epinephrine prodrug patent. Iono Pharma argues the request fails statutory standards and should be denied.
Aquestive Therapeutics, Inc. v.Iono Pharma, LLC
Aquestive Therapeutics petitions the PTAB Director to overturn a discretionary denial of institution for an IPR on its epinephrine prodrug patent, arguing factual errors and improper reliance on settled‑expectation criteria.
Aquestive Therapeutics, Inc. v.Iono Pharma, LLC
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.
Aquestive Therapeutics, Inc. v.Iono Pharma, LLC
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.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
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.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
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.
Sun Pharmaceutical Industries, Inc. v.Nivagen Pharmaceuticals, Inc.
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).
Sun Pharmaceutical Industries, Inc. v.Nivagen Pharmaceuticals, Inc.
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.
Sun Pharmaceutical Industries, Inc. v.Nivagen Pharmaceuticals, Inc.
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.
Sun Pharmaceutical Industries, Inc. v.Nivagen Pharmaceuticals, Inc.
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.
Sun Pharmaceutical Industries, Inc. v.Nivagen Pharmaceuticals, Inc.
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.
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. The petition seeks to invalidate all 40 claims.
Merck Sharp & Dohme LLC v.Halozyme, Inc. et al.
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.
BPI Labs, LLC et al. v.Eli Lilly & Co.
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.
BPI Labs, LLC et al. v.Eli Lilly & Co.
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.
BPI Labs, LLC et al. v.Eli Lilly & Co.
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.
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