News & Analysis as of

Prior Art Pharmaceutical Industry Intellectual Property Litigation

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®...

Venable LLP on

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: 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

Venable LLP on

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

DLA Piper

The Federal Circuit Upholds Drug Dosing Regimen as Valid and Nonobvious

DLA Piper on

In Janssen Pharmaceuticals, Inc. v. Mylan Laboratories., the United States Court of Appeals for the Federal Circuit affirmed a district court ruling that a pharmaceutical dosing claim limitation was nonobvious despite prior...more

Venable LLP

Federal Circuit Affirms PTAB’s Unpatentability Findings in Gene Therapy Hemgenix® IPRs

Venable LLP on

On May 22, 2025, the CAFC affirmed the PTAB’s (Board) Final Written Decisions in Pfizer’s IPR2021-00925 and IPR2021-00926 finding all challenged claims of uniQure’s U.S. Patent No. 9,982,248 (“the ’248 patent”) unpatentable...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: 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

Knobbe Martens

An Obvious Solution to an Unknown Problem?

Knobbe Martens on

IMMUNOGEN, INC. v. STEWART - Before Lourie, Dyk, and Prost. Appeal from the United States District Court for the Eastern District of Virginia. A solution to a problem can be obvious even when the problem itself was unknown in...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Highlights the Importance of Separating Claim Construction and Infringement Analysis When Dealing with...

Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc., No. 23-2218 (Fed. Cir. 2025) — On January 10, 2025, the Federal Circuit reversed the district court’s opinion that claims of a Novartis patent are invalid for lack...more

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more

BakerHostetler

Promoting the Progress of Science: Avoiding Inherent Obviousness

BakerHostetler on

You’ve thought long and hard about how your company’s clinical stage invention is novel over anything that’s ever been done before. Your analysis is finished, right? Not even close. The novelty barrier to patentability can be...more

Polsinelli

Federal Circuit Addresses Obviousness of Polymorphs in Grunenthal GmbH v. Alkem Labs. Ltd., No. 2017-1153 (Fed. Cir. Mar. 28,...

Polsinelli on

For the first time, on March 28, 2019, the Federal Circuit addressed obviousness of polymorph claims based on a known approach to polymorph screening, finding no reasonable expectation of success....more

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