News & Analysis as of

Patent Litigation Intellectual Property Litigation Patent Infringement

Goodwin

Amgen and Accord BioPharma Settle Denosumab BPCIA Case

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​​​​​​​On July 16, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen, Inc. (“Amgen”) and Accord BioPharma, Inc. (“Accord”)...more

McDermott Will & Emery

Appeal is too late to raise percolating claim construction dispute

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding of noninfringement, concluding that the patent owner had improperly raised a claim construction issue for the first time on appeal – an...more

Venable LLP

Spotlight On: Biosimilar Litigations - July 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

Proskauer Rose LLP

Three Point Shot - June 2025

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Hubble-Bubble in the Chewing Gum Industry: Big League Chew and Licensee Stretch Arguments in Ongoing Trade Dress Suit - The business relationship between Big League Chew Properties LLC (“Big League Chew”), the owner of...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: IP Litigation and Trials

Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the tenth episode of When Your Life Sciences Are on the...more

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

Knobbe Martens on

[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

Ballard Spahr LLP

Government Signals Potential Shift Toward Preliminary Injunctions in Patent Infringement Cases

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In a recent patent case, the U.S. government urged a Texas federal court to give greater weight to the difficulty of calculating damages as a basis for finding irreparable harm. If embraced by courts, the move could give...more

Knobbe Martens

A Question for Everyone: Juries Must Determine Infringement on a Patent-By-Patent Basis

Knobbe Martens on

OPTIS CELLULAR TECHNOLOGY, LLC v. APPLE INC. - Before Prost, Reyna, and Stark. Appeal from the United States District Court for the Eastern District of Texas. Patent plaintiffs have a right to a unanimous verdict on each...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

Akin Gump Strauss Hauer & Feld LLP

District Court Declines to Order Production of Test Results Referenced in Complaint and Initial Disclosures

The Northern District of Ohio denied a motion to compel the plaintiff to produce test results referenced in its initial disclosures and complaint. The court found that because the “test results are not facts but rather are...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Patent Licensing & Standing: A.L.M. Holding Co. v. Zydex Indus. Private Ltd. (D. Del. Nov. 25, 2024)

In the United States, a plaintiff must have standing to bring suit in U.S. courts. For patent cases, this means that for a plaintiff to have constitutional standing, the plaintiff must show that it has “an exclusionary right...more

Jones Day

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

Jones Day on

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

Vinson & Elkins LLP

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

Vinson & Elkins LLP on

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

Venable LLP

Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv™ / Xbryk™ (denosumab-dssb) / Stoboclo®...

Venable LLP on

Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more

Venable LLP

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

Venable LLP on

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

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

Venable LLP on

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

Venable LLP on

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

Parker Poe Adams & Bernstein LLP

Honeywell Strikes Back Against 'Patent Troll' With North Carolina Lawsuit Under Abusive Patent Assertions Act

Honeywell International Inc. has taken a proactive stance against what it describes as "unwarranted and unfounded" patent litigation by filing a declaratory judgment action in the Western District of North Carolina against...more

Venable LLP

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

Venable LLP on

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

Venable LLP

Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) / Ruxience® (rituximab-pvvr) / Riabni™ (rituximab-arrx) - June 2025

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Rituximab 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

Patterson Belknap Webb & Tyler LLP

Judge Román Dismisses Infringement Claims Based “Upon Information and Belief” in Surgical Instruments Case

Judge Nelson S. Román (S.D.N.Y.) recently dismissed a patent-infringement complaint for failure to state a claim, emphasizing the requirement that plaintiffs plead factual allegations rather than legal conclusions....more

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