News & Analysis as of

Pharmaceutical Patents Intellectual Property Litigation Obviousness

Venable LLP

Jury Finds Botox® Patent Claims Nonobvious and Awards Damages from Daxxify® Sales

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On July 18, 2025, after a five-day trial, the jury in Allergan v. Revance Case No. 1:21-cv-01411 (D. Del.) entered a verdict finding claim 8 of Allergan’s U.S. Patent No. 7,354,740 (“the ’740 patent”), claim 6 of U.S. Patent...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

DLA Piper

The Federal Circuit Upholds Drug Dosing Regimen as Valid and Nonobvious

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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

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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

Smart & Biggar

Alexion awarded injunction against Amgen in SOLIRIS patent action; Court considers anticipation by incorporation by reference

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The Federal Court has granted Alexion a declaration of infringement and an injunction preventing Amgen from manufacturing, using, and selling its proposed biosimilar eculizumab product, BEKEMV, in Canada until the expiration...more

McDermott Will & Schulte

Transatlantic Terminology: Skilled Artisan Could Equate UK, US Word Meanings

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board unpatentability determination, finding that a skilled artisan would have found the term “sterile” in a UK publication to mean the same as...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sage Products, LLC v. Stewart (Fed. Cir. 2025)

When a prevailing challenger withdraws from an appeal in post-grant proceedings, the Director can intervene under 35 U.S.C. § 143, which is what happened in an appeal in Sage Products, LLC v. Stewart after Challenger Becton...more

Jones Day

Expert Testimony Supporting POPR Can Be An Effective Strategy

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It is relatively uncommon for parties to submit expert declarations in the preliminary-response phase of an IPR proceeding, but recently the Patent Owner in Imperative Care, Inc. v. Inari Medical, Inc. effectively used that...more

Knobbe Martens

An Obvious Solution to an Unknown Problem?

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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

McDermott Will & Schulte

Inventor’s Motivation to Combine Does Not Control Obviousness

The US Court of Appeals for the Federal Circuit affirmed a district court decision rejecting claims of a patent application directed to a dosing regimen for a cancer treatment, finding the claims to be obvious where the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)

Completing a recent jurisprudential "hat trick,"* the Federal Circuit affirmed a District Court grant of a preliminary injunction against a biosimilar applicant for Regeneron's EYLEA biologic drug in Regeneron...more

McDonnell Boehnen Hulbert & Berghoff LLP

Immunogen, Inc. v. Stewart (Fed. Cir. 2025)

After creating something of a frisson due to the apprehension that the Federal Circuit might be convinced to re-evaluate whether it was a necessary element for establishing obviousness for the skilled artisan to have had a...more

Polsinelli

Federal Circuit Affirms District Court’s Obviousness Judgment on ImmunoGen Patent Application

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1. Background: ImmunoGen’s Patent Application & Dispute - In 2014, ImmunoGen, Inc. (Immunogen) filed U.S. Patent Application No. 14/509,809 (the ’809 application)....more

Kilpatrick

COVID-19 Vaccine Patent War: Moderna's Claims Invalidated by PTAB

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The door may now be open for additional challenges to patents covering mRNA vaccine technologies, paving the way for increased competition in the mRNA vaccine space. On Wednesday, March 5, 2025, the United States Patent...more

Vorys, Sater, Seymour and Pease LLP

The Precedent: Federal Circuit Provides Further Clarity on Issues Surrounding Patent Validity in Novartis Pharmaceuticals Corp. v....

In this edition of The Precedent, we outline the validity of a pharmaceutical patent concerning the patent’s written description. Following an appeal from the United States District Court for the District of Delaware, the...more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Challenges Reasonable Expectation of Success Prong of Obviousness Law Precedent in Immunogen v. Vidal

The U.S. Patent and Trademark Office has a history of attempting to challenge judicial decisions that the Office, usually for its own policy reasons, takes issue with.[1]  Recently, the Office decided to challenge the...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) Our Case of the Week is a 31-page decision that touches on a variety of issues, including...more

Venable LLP

Celltrion Files IPR on Regeneron’s EYLEA® Patent

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On January 15, 2025, Celltrion filed IPR2025-00456 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”), challenging claims 1-17, 19-42, 44-50 as anticipated and claims 1-50 as obvious....more

Cooley LLP

Precedential Federal Circuit Decision Overturns Lack of Written Description Based on Later-Discovered Technology

Cooley LLP on

On January 10, 2025, the US Court of Appeals for the Federal Circuit issued a precedential opinion in Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., reversing a lower court decision that claims of a Novartis patent...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - January 2025 #2

In re Entresto (Sacubitril/Valsartan), Appeal Nos. 2023-2218, -2220, -2221 (Fed. Cir. Jan. 10, 2025) In our Case of the Week, the Federal Circuit revived Novartis’s US Patent No. 8,101,659 by reversing the district...more

Smart & Biggar

[Webinar] Cross-border IP strategies for IP owners and litigators - September 18th, 2:00 pm PDT

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Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

Smart & Biggar

[Webinar] Cross-border IP strategies for IP owners and litigators - September 12th, 12:00 pm GMT

Smart & Biggar on

Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

Sheppard Mullin Richter & Hampton LLP

2023 Federal Circuit Case Summaries - Intellectual Property: Year End Report

We are pleased to share Sheppard Mullin’s inaugural “Year in Review” report that collects and reports on most key patent law-related Federal Circuit decisions for 2023. This is a follow up to the quarterly report we...more

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

Mind Your Ps and Qs, and Your PTAs Too

Last week, the Federal Circuit held that obviousness-type double patenting trumps patent term adjustment, opening the door for invalidity attacks that to date had been questionable. In re Cellect was an appeal from a...more

American Conference Institute (ACI)

[Event] 20th Advanced Summit on Life Sciences Patents - June 2nd - 3rd, New York, NY

ACI’s Advanced Summit on Life Sciences Patents is back in person on June 2–3 in New York City. Our reimagined 2022 conference will provide practical insights on how to implement bullet-proof patent prosecution tactics,...more

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