News & Analysis as of

Obviousness Patent Invalidity Pharmaceutical Patents

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

Jones Day on

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

DLA Piper

Federal Circuit Refines Obviousness Framework for Drug and Biologic Dosing Regimens

DLA Piper on

The United States Court of Appeals for the Federal Circuit recently affirmed a district court ruling that a pharmaceutical dosing claim limitation was unpatentable due to obviousness-type double patenting. The court found...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

Kilpatrick

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

Kilpatrick on

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

WilmerHale

Federal Circuit Patent Watch: Federal Circuit Orders Remanded Case Reassigned to New Judge, Finding That Trial Judge’s Statements...

WilmerHale on

Precedential and Key Federal Circuit Opinions - HD SILICON SOLUTIONS LLC v. MICROCHIP TECHNOLOGY INC. [OPINION] (2023-1397, 2/6/2025) (Lourie, Stoll, Cunningham) - Lourie, J. The Board affirmed the Final Written...more

McDonnell Boehnen Hulbert & Berghoff LLP

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

Note: This post addresses two Federal Circuit decisions issued on January 29, 2025.  Both appeals involved Plaintiff-Appellee Regeneron Pharmaceuticals, Inc., with the first appeal involving Defendant-Appellant Formycon AG...more

Robins Kaplan LLP

Melinta Therapeutics, LLC v. Nexus Pharms., Inc.

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Minocin® (minocycline) - Case Name: Melinta Therapeutics, LLC v. Nexus Pharms., Inc., Civ. No. 21-2636, 2024 WL 4799896 (N.D. Ill. Nov. 15, 2024) (Kness, J.)  Drug Product and Patent(s)-in-Suit: Minocin® (minocycline);...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

White & Case LLP

Federal Circuit Limits the Application of Obviousness-Type Double Patenting for Patents in the Same Family

White & Case LLP on

On August 13, 2024, a three-judge panel of the Court of Appeals for the Federal Circuit issued a decision, authored by Judge Lourie, in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061, which limits the...more

Smart & Biggar

Federal Court finds patent for concentrated methotrexate solutions obvious

Smart & Biggar on

On March 26, 2024, the Federal Court dismissed Medexus and Medac’s action for patent infringement of Canadian Patent No 2,659,662 (the 662 Patent), finding the asserted claims invalid for obviousness: Medexus Pharmaceuticals...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - April 2024 #2

Janssen Pharms., Inc. et al. v. Teva Pharm. USA, Inc. et al., Appeal Nos. 2022-1258, -1307 (Fed. Cir. April 1, 2024) In this week’s Case of the Week, the Federal Circuit vacated-in-part a district court’s bench trial...more

Smart & Biggar

Canadian Patent Law 2023: A Year in Review

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In our annual review of developments in Canadian patent law, we considered over 60 patent decisions reported last year. This article highlights statutory changes and a selection of interesting points addressed in the reported...more

Smart & Biggar

Federal Court declines to grant injunction for infringement of HUMIRA formulation patent

Smart & Biggar on

On December 4, 2023, the Federal Court issued its public judgment and reasons in two patent infringement actions pursuant to s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations (“Regulations”) and two patent...more

Sheppard Mullin Richter & Hampton LLP

UCB, Inc. v. Actavis Laboratories UT, Inc. No. 2021-1924, (Fed. Cir. Apr. 12, 2023)

This case addresses the legal framework for determining whether prior art anticipates a claimed range. The appropriate legal framework applies a different test depending on whether the prior art discloses a point within the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Genentech, Inc. v. Sandoz Inc. (Fed. Cir. 2022)

The Federal Circuit recently affirmed a district court judgment of invalidity for obviousness and for noninfringement for a series of patents challenged in ANDA litigation, in Genentech Inc. v. Sandoz Inc.  In doing so, a...more

Smart & Biggar

Federal Court of Appeal upholds obviousness finding re: Janssen’s abiraterone acetate and prednisone combination therapy patent

Smart & Biggar on

As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (the 422 patent) invalid on the basis of obviousness and dismissed its actions against Apotex, Dr. Reddy’s Laboratories, and...more

Smart & Biggar

Federal Court of Appeal upholds invalidity of fampridine patent

Smart & Biggar on

The Federal Court of Appeal (FCA) dismissed an appeal by Biogen and a cross-appeal by Taro from a decision of the Federal Court... dismissing two actions by Biogen under the Patented Medicines (Notice of Compliance)...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Master Symposium - September 21st - 22nd, Chicago, IL

ACI’s 8th Annual Paragraph IV Disputes Master Symposium returns in person to Chicago on September 21-22! Join leading pharmaceutical patent litigators for brand name and generic drug companies to receive up-to-the-minute...more

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

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

McDermott Will & Emery

Long-Felt Need Not Felt Long Enough to Overcome Obviousness

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit upheld a finding that patents covering Narcan, a naloxone-based intranasal opioid overdose treatment, were obvious despite evidence of long-felt need. Adapt Pharma Operations...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court - February 2022 #2

Adapt Pharma Operations Limited v. Teva Pharmaceuticals USA, Inc., Appeal No. 2020-2106 (Fed. Cir. Feb. 10, 2022) - In our Case of the Week, the Court of Appeals for the Federal Circuit, in both the majority opinion and...more

Smart & Biggar

Federal Court of Appeal upholds validity of glatiramer acetate patent

Smart & Biggar on

The Federal Court of Appeal (FCA) dismissed an appeal by Pharmascience from a decision of the Federal Court... which found Canadian Patent No. 2,760,802 (802 Patent) valid and infringed by Pharmascience’s proposed glatiramer...more

Goodwin

PTAB Institutes Two IPRs on Tocilizumab Patents

Goodwin on

Last week, the PTAB instituted inter partes review of two Chugai patents directed to methods of treating rheumatoid arthritis with a combination of tocilizumab and methotrexate. Fresenius filed petitions for inter partes...more

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