Industry Sector

Biotechnology — US PTAB Patent Cases

129 decisions indexed

Page 1 of 5 · 129 total

patent · Mar 23, 2026

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

· IPR2026-00313

Merck Sharp & Dohme LLC has filed an IPR petition challenging Halozyme’s U.S. Patent 11,041,149 covering engineered PH20 hyaluronidase proteins. The petition alleges lack of written description, enablement, and anticipates all claims under prior art US‑275.

patent · Feb 26, 2026

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

· IPR2026-00270

Sarepta filed an IPR petition seeking to invalidate Genzyme’s ’313 AAV detection patent. The petition asserts that all 27 claims are obvious in view of earlier publications on LC‑MS and RP‑HPLC analysis of viral proteins. No secondary considerations are believed to overcome the obviousness argument.

patent · Nov 2, 2025

Xencor, Inc. v.Merus N.V.

· IPR2025-00604

Xencor, Inc. has filed an IPR petition seeking to invalidate Merus N.V.'s U.S. Patent No. 9,358,286 covering bispecific antibodies. The petition alleges anticipation and obviousness over prior art references Lazar, Arathoon, and Cabrera, and argues against discretionary denial.

patent · Oct 12, 2025

Halozyme, Inc. v.Alteogen Inc.

· IPR2026-00176

Halozyme has filed an IPR petition seeking cancellation of all 15 claims of Alteogen’s 2025 ‘638 patent covering a temperature‑shift method for producing recombinant hyaluronidase PH20. The petition relies on obviousness over prior art Wei and Zmuda, with a second ground adding Wei 2013.

patent · Sep 15, 2025

Bio-Rad Laboratories, Inc. v.California Institute of Technology

· IPR2025-01546

Bio‑Rad petitions IPR to invalidate Caltech’s ’797 patent on multiplex PCR signal encoding, asserting the claims are obvious over Jouvenot and other prior art.

patent mixed - some claims cancelled, some upheld · Aug 15, 2025

Tempus AI, Inc. v.Guardant Health Inc.

· IPR2025-01435

The PTAB held that most of Guardant Health’s ’822 patent claims are obvious over prior‑art sequencing methods, cancelling claims 1‑11, 13, and 17‑20, while claim 12 remains patentable.

patent all challenged claims upheld · Aug 15, 2025

Tempus AI, Inc. v.Guardant Health Inc.

· IPR2025-01435

The PTAB affirmed Guardant Health’s patent on cfDNA tagging methods, finding none of the 29 challenged claims unpatentable after rejecting Tempus AI’s obviousness arguments.

patent · Aug 15, 2025

Tempus AI, Inc. v.Guardant Health Inc.

· IPR2025-01435

Guardant Health petitions the PTAB to invalidate Foundation Medicine’s 9,340,830 cancer‑diagnostic patent, asserting that all challenged claims are obvious over prior‑art methods for targeted enrichment and next‑generation sequencing.

patent all challenged claims upheld · Aug 15, 2025

Tempus AI, Inc. v.Guardant Health Inc.

· IPR2025-01434

The PTAB affirmed Guardant Health's U.S. Patent 11,149,306 covering cell‑free DNA tagging and counting, finding none of the 29 challenged claims unpatentable after Tempus AI's IPR challenge.

patent · Aug 15, 2025

Tempus AI, Inc. v.Guardant Health Inc.

· IPR2025-01434

Tempus AI has petitioned the PTAB to invalidate Guardant Health’s 10,689,699 patent covering molecular‑tagging methods for DNA sequencing, arguing the claims are obvious over Kinde, Miner, and Fan. The petition seeks institution of the IPR and cancellation of claims 1‑27.

patent · Aug 15, 2025

Tempus AI, Inc. v.Guardant Health Inc.

· IPR2025-01434

Tempus AI petitions the PTAB to invalidate Guardant Health’s 10,689,699 patent covering duplex consensus sequencing, arguing obviousness over Kinde and Miner and citing a new claim‑construction that broadens the scope to cellular DNA.

patent terminated or settled · Aug 15, 2025

Tempus AI, Inc. v.Guardant Health Inc.

· IPR2025-01435

Guardant Health settled its digital sequencing patent dispute with Foundation Medicine for $25 million plus royalties, granting a non‑exclusive license and dismissing all related litigation.

patent instituted · Aug 15, 2025

Tempus AI, Inc. v.Guardant Health Inc.

· IPR2025-01435

The PTAB instituted an inter partes review of Guardant Health’s cfDNA sequencing patent after Foundation Medicine (Petitioner) showed a reasonable likelihood of success on an obviousness ground over several prior‑art references.

patent · Aug 15, 2025

Tempus AI, Inc. v.Guardant Health Inc.

· IPR2025-01434

TwinStrand Biosciences petitions the PTAB to invalidate Guardant Health’s 29‑claim ‘306 patent on the basis that the claims are obvious over prior art such as Narayan and Schmitt, and that Guardant misled the examiner. The petition seeks cancellation of all claims.

patent · Aug 15, 2025

Tempus AI, Inc. v.Guardant Health Inc.

· IPR2025-01435

TwinStrand Biosciences petitions the PTAB to invalidate Guardant Health’s 11,149,306 patent covering cfDNA sequencing methods, asserting that the claims are obvious over prior art such as Narayan and Schmitt. The petition also alleges examiner misdirection by Guardant. The case is pending institution.

patent · Aug 15, 2025

Tempus AI, Inc. v.Guardant Health Inc.

· IPR2025-01434

Tempus AI has filed an IPR petition seeking to invalidate Guardant Health’s U.S. Patent 10,287,631 covering duplex consensus sequencing, arguing that all 23 claims are obvious over Kinde, Craig, and Travers publications.

patent terminated or settled · Aug 15, 2025

Tempus AI, Inc. v.Guardant Health Inc.

· IPR2025-01434

Guardant Health settled its digital sequencing patent dispute with Foundation Medicine for $25 million, granting a non‑exclusive license and ending all related litigation.

patent all challenged claims unpatentable · Jul 25, 2025

Guardant Health, Inc. v.Cold Spring Harbor Laboratory

· IPR2025-01355

Guardant Health’s IPR against the ’013 single‑cell sequencing patent resulted in the Board finding all 28 claims unpatentable as obvious over prior publications by Linnarsson and McCloskey. The petition’s obviousness arguments were accepted and the patent owner’s defenses were rejected.

patent all challenged claims unpatentable · Jul 25, 2025

Guardant Health, Inc. v.Cold Spring Harbor Laboratory

· IPR2025-01353

Guardant Health’s IPR resulted in all 28 claims of the 10,697,013 B1 patent being held unpatentable for obviousness over prior‑art tagging methods. The Board affirmed the petitioner’s combination of Linnarsson and McCloskey references.

patent · Jul 25, 2025

Guardant Health, Inc. v.Cold Spring Harbor Laboratory

· IPR2025-01353

Guardant Health petitions the PTAB to invalidate Cold Spring Harbor Laboratory’s ’510 DNA‑sequencing patent, asserting that all challenged claims are obvious over the Lo application and other prior‑art references. The petition lists six grounds covering 30 claims and seeks cancellation of the entire patent.

patent · Jul 25, 2025

Guardant Health, Inc. v.Cold Spring Harbor Laboratory

· IPR2025-01355

Guardant Health petitions the PTAB to invalidate 18 claims of Cold Spring Harbor’s ’589 patent covering DNA‑tagging methods for copy‑number analysis, asserting the claims are obvious over Lo and other prior art. The petition seeks cancellation of the entire patent.

patent denied · Jul 25, 2025

Guardant Health, Inc. v.Cold Spring Harbor Laboratory

· IPR2025-01355

The PTAB denied Guardant Health's IPR challenge against Cold Spring Harbor Laboratory's patent, finding the petitioner failed to show a reasonable likelihood of prevailing on any challenged claims.

patent · Apr 15, 2025

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

· PGR2025-00042

Merck has filed a Post‑Grant Review petition challenging Halozyme’s U.S. Patent 12,037,618 covering engineered PH20 hyaluronidase proteins. The petition argues the claims lack written description, are not enabled, and are obvious over prior patents and publications.

patent · Feb 24, 2025

Gator Bio Inc. et al. v.Sartorius Bioanalytical Instruments, Inc.

· IPR2025-00633

Gator Bio challenges Sartorius’s ’588 patent covering tip‑tray devices for optical sensing assemblies, asserting that the claims are obvious in view of Miles, Yang, WO854 and Rainin. The petition seeks institution of an IPR on all 19 claims.

patent terminated or settled · Feb 19, 2025

RegenX Science Inc. v.Nextgen Biologics, Inc.

· IPR2025-00620

A bankruptcy court approved a settlement between ISE Professional Testing & Consulting Services and Synogen Management Group, releasing all claims and assigning a non‑mammalian biotech patent portfolio. The agreement satisfies statutory settlement factors and includes cash payments and patent assignments.

patent · Feb 19, 2025

RegenX Science Inc. v.Nextgen Biologics, Inc.

· IPR2025-00620

RegenX Science filed a bankruptcy motion to approve a settlement with Synogen and Nextgen Biologics that transfers ownership of a non‑mammalian tissue‑engineering patent portfolio. The settlement includes patent assignments, cash consideration, and mutual releases, aiming to end all related disputes.

patent terminated or settled · Feb 19, 2025

RegenX Science Inc. v.NeXtGen Biologics, Inc.

· IPR2025-00621

RegenX Science and NeXtGen Biologics reached a settlement in a Chapter 11 case, assigning a non‑mammalian patent portfolio and providing cash consideration. The agreement releases all claims and dismisses related litigation, aiming to preserve estate value and satisfy creditors.

patent terminated or settled · Feb 19, 2025

RegenX Science Inc. v.NeXtGen Biologics, Inc.

· IPR2025-00621

Bankruptcy court approved a settlement between ISE and Synogen parties, including patent assignments and cash payments, leading to dismissal of related disputes.

patent · Feb 19, 2025

RegenX Science Inc. v.Nextgen Biologics, Inc.

· IPR2025-00620

RegenX Science has filed an IPR petition seeking cancellation of 32 claims of Nextgen Biologics’ tissue‑engineered graft patent, arguing that the claims are obvious over a suite of prior‑art ECM references.

patent · Feb 19, 2025

RegenX Science Inc. v.NeXtGen Biologics, Inc.

· IPR2025-00621

RegenX Science has filed an IPR petition seeking cancellation of 30 claims of NeXtGen’s 2023 patent covering axolotl‑derived extracellular matrix scaffolds, arguing the claims are obvious over multiple prior‑art references.

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