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Intellectual Property Litigation Patents Patent Litigation

Venable LLP

Amgen Files Three New Prolia® / Xgeva® BPCIA Litigations Against Hikma, Shanghai Henlius Biotech, and Biocon’s Proposed...

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On June 25, 2025, Amgen filed its sixth and seventh BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-12152 (D.N.J.) against Hikma and Gedeon Richter’s RGB-14 and Case No....more

Knobbe Martens

Did They Want to Infringe? – Federal Circuit Denies Declaratory Judgment When Party at No Risk of Lawsuit

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[MITEK SYSTEMS, INC., v. UNITED SERVICES AUTOMOBILE ASSOCIATION [OPINION]] - Before Taranto, Schall, and Chen. Appeal from the United States District Court for the Eastern District of Texas. The plaintiff could not seek...more

McDonnell Boehnen Hulbert & Berghoff LLP

Government Files Statement in Support of Preliminary Injunction Motion in Radian Memory Systems v. Samsung Electronics

Almost two decades ago, the Supreme Court handed down what has turned out to be one of its most significant patent decisions of this century:  eBay v. MercExchange.  The eBay case has had the effect of precluding prevailing...more

Knobbe Martens

Reissue Applications Are Bound by the Scope of the Claims as Written, Not as Intended

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IN RE KOSTIC - Before Stoll, Clevenger, and Cunningham. Appeal from the Patent Trial and Appeal Board. When considering whether a reissue claim broadens the scope of the original patent, the PTAB determines the actual scope...more

Knobbe Martens

No Takebacks: The High Bar for Departing From Patent Lexicography

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ALNYLAM PHARMACEUTICALS, INC. v. MODERNA, INC. - Before Taranto, Chen, and Hughes. Appeal from the United States District Court for the District of Delaware. Once the high threshold for lexicography is met, there must be a...more

Knobbe Martens

Keeping PACE With CRISPR

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AGILENT TECHNOLOGIES, INC. v. SYNTHEGO CORP. - Before Prost, Linn, and Reyna. Appeal from the Patent Trial and Appeal Board. Obviousness does not require all claimed limitations to be expressly disclosed in a primary prior...more

Fenwick & West LLP

Reassessing Irreparable Harm: Are Injunctions Making a Comeback?

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In an unusual move, the U.S. Department of Justice and U.S. Patent and Trademark Office submitted a “Statement of Interest” this week in a pending patent case in the Eastern District of Texas—sharing “views” on whether...more

McDermott Will & Emery

When it comes to objective criteria of nonobviousness, nexus is looser for license evidence

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The US Court of Appeals for the Federal Circuit partially reversed a decision by the Patent Trial & Appeal Board, effectively relaxing the nexus requirements for patent licenses pertaining to their usage as objective indicia...more

McDermott Will & Emery

Looks like estoppel, sounds like estoppel … but it’s just director discretion

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The acting director of the US Patent & Trademark Office (PTO) granted a patent owner’s request for discretionary denial and denied institution of an inter partes review (IPR) proceeding, finding that the petitioner engaged in...more

Fish & Richardson

USPTO: No Bright-Line Rule on When Expectations Become Settled

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On June 18, 2025, U.S. Patent and Trademark Office Acting Director Stewart issued a discretionary denial decision in Dabico Airport Solutions Inc. v. AXA Power ApS, granting the patent owner’s request for discretionary denial...more

White & Case LLP

Federal Circuit Reinforces Standard for Prior Art Enablement in CRISPR Dispute

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On June 11, 2025, the U.S. Court of Appeals for the Federal Circuit decided Agilent Technologies, Inc. v. Synthego Corp. (No. 23-2186), addressing enablement of prior art references for disputed CRISPR-Cas9 gene-editing...more

Jones Day

USPTO Acting Director Denies IPR Institution Based on "Settled Expectations"

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Under a new U.S. Patent and Trademark Office ("USPTO") policy issued in March 2025, pre-institution inter partes review ("IPR") proceedings are now bifurcated, consisting of a first phase in which the director considers...more

Vorys, Sater, Seymour and Pease LLP

New Settled Expectations Policy at the PTAB Augurs Major Practice Changes

In a startling development, Acting Director of the USPTO Coke Morgan Stewart has denied institution of an inter partes review (IPR) on the basis of “settled expectations,” on the sole ground that the subject patent had been...more

Vinson & Elkins LLP

File Early or Risk Denial: iRhythm IPR Institution Denial Underscores the Importance of Filing IPR Petitions Sooner Rather Than...

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On June 6, 2025, the Acting Director of the United States Patent and Trademark Office (“USPTO”), Coke Morgan Stewart, issued a decision denying institution of five inter partes review (“IPR”) petitions filed by iRhythm, Inc....more

Alston & Bird

Intellectual Property Litigation Newsletter | June 2025

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Welcome to the Intellectual Property Litigation Newsletter, our review of decisions and trends in the intellectual property arena. In this edition, we learn that unilateral assertion is not industry standard, the IPR...more

Venable LLP

Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) - June 2025

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Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

McDonnell Boehnen Hulbert & Berghoff LLP

Agilent Technologies, Inc. v. Synthego Corp. (Fed. Cir. 2025)

An argument could be made that one of the most significant Supreme Court decisions in U.S. patent law in the last thirty years was Dickinson v. Zurko.  In that case the Court held that the Federal Circuit was bound by the...more

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

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Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

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Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

Proskauer - The Patent Playbook

Discretionary Denials in Action: iRhythm Technologies Inc. v. Welch Allyn Inc.

The U.S. Patent and Trademark Office (“USPTO”) Acting Director’s recent decision to deny institution of inter partes review (“IPR”) in iRhythm Technologies Inc. v. Welch Allyn Inc. offers valuable lessons for both patent...more

Venable LLP

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb)...

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Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Biosimilar Litigations - June 2025

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Mitek Systems Inc. v. United Services Automobile Association

Mitek Systems Inc. v. United Services Automobile Association, Appeal No. 2023-1687 (Fed. Cir. June 12, 2025) In our Case of the Week, the Federal Circuit examined the limits of declaratory judgment jurisdiction for a...more

Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

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Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin...

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Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

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