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Intellectual Property Litigation Appeals Pharmaceutical Industry

Knobbe Martens

Litigation Update | July 2025

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JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC. - Before Prost, Reyna, and Taranto. Appeal from the United States District Court for the District of New Jersey. The Federal Circuit found that claims reciting a...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

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

Hogan Lovells

Court of Appeal hands down reasons for awarding AZ an interim injunction in the UK against Glenmark’s generic dapagliflozin for...

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Just under two weeks ago, we reported the Court of Appeal had awarded AstraZeneca (AZ) a preliminary injunction in the UK against Glenmark’s generic dapagliflozin (dapa) product for type II diabetes, until the hearing...more

Hogan Lovells

UK Court of Appeal grants AstraZeneca an interim injunction against Glenmark’s generic dapagliflozin for type II diabetes

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In a reversal of fortune, yesterday (9 April) the UK Court of Appeal awarded AstraZeneca (AZ) an interim injunction keeping Glenmark’s dapagliflozin (dapa) off the UK market until the form of order hearing in the parallel...more

McDonnell Boehnen Hulbert & Berghoff LLP

Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (Fed. Cir. 2025)

Early last year, Aurobindo, one of the Defendants* in ANDA litigation against Merck, advanced the proposition that in cases where a patent had been reissued patent term extension ("PTE") under 35 U.S.C. § 156 should be...more

Venable LLP

Federal Circuit Affirms Preliminary Injunction Decisions for EYLEA® Biosimilars

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On March 5, 2025, the Federal Circuit affirmed the grant of a preliminary injunction against the launch of Celltrion’s proposed EYLEA® (aflibercept) biosimilar CT-P42 in CAFC Case Nos. 24-2058 and 24-2147 (appealing from...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

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

2024 Federal Circuit IP Appeals – Amarin Pharma, Inc. v. Hikma Pharm. USA Inc., 104 F.4th 1370 (Fed. Cir. 2024) (Moore, Lourie,...

Amarin sells the drug icosapent ethyl under the brand name Vascepa. Vascepa is approved by the FDA for two indications: (i) to treat severe hypertriglyceridemia, a condition characterized by blood triglyceride levels greater...more

McDonnell Boehnen Hulbert & Berghoff LLP

Aurobindo v. Merck Sharp and Dohme -- Oral Argument

The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue...more

A&O Shearman

UPC Court of Appeal confirms strict approach to correcting patent errors by interpretation

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Alexion Pharmaceuticals v Amgen (UPC_Coa-405/2024) and Alexion Pharmaceuticals v Samsung Bioepis NL BV (UPC_CoA-402/2024); December 20, 2024. The UPC Court of Appeal has confirmed a strict approach to correcting erroneous...more

WilmerHale

Federal Circuit Patent Watch: FDA Filing Can Create Personal Jurisdiction; “Compelling” Arguments that Reverse Doctrine of...

WilmerHale on

Precedential and Key Federal Circuit Opinions - STEUBEN FOODS, INC. v. SHIBUYA HOPPMANN CORPORATION [OPINION] (2023-1790, 1/24/2025) (Moore, Hughes, Cunningham) - Moore, Chief J. The Court reversed the district...more

Robins Kaplan LLP

Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC

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ProAir® HFA (albuterol sulfate) - Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, No. 2024-1936, 2024 WL 5176737 (Fed. Cir. Dec. 20, 2024) (Circuit Judges Prost, Taranto, and Hughes...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit Reverses Decision Finding Lack of Written Description for Patent Claiming a Pharmaceutical Composition Comprising...

The Federal Circuit recently reversed a District of Delaware decision that invalidated claims of Novartis’s Orange Book listed patent, U.S. Patent No. 8,101,659 (the “’659 patent”), for its blockbuster drug Entresto®, a...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

McDermott Will & Schulte

Complex or Not Written Description Is Evaluated Against Claims

The US Court of Appeals for the Federal Circuit reversed a district court’s ruling of invalidity for lack of written description, finding that the district court erred in its analysis of written description because patents...more

Alston & Bird

Patent Case Summaries | Week Ending January 10, 2025

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Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., et al., Nos. 2023-2218, -2220, -2221 (Fed. Cir. (D. Del.) Jan. 10, 2025). Opinion by Lourie, joined by Prost and Reyna. The FDA approved a New Drug Application from...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

McDermott Will & Schulte

Same Product in Different Packaging May Constitute Separate Market for Antitrust Purposes

Addressing an issue of first impression, the US Court of Appeals for the Second Circuit concluded that two medications that contain the same ingredients but are packaged in different forms constitute separate markets for...more

Smart & Biggar

BYOOVIZ is confusing with BEOVU: Federal Court finds violation of Novartis’ trademark rights

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In a decision dated January 24, 2024, Justice Pallotta allowed Novartis’ application, finding that Biogen and Samsung’s use of the trademark BYOOVIZ in association with an ophthalmologic drug violates Novartis’ rights in its...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

A&O Shearman

Half an hour for a bifurcation: UPC Central Division rejects preliminary objection after first oral hearing

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The decision concerns the time of filing and admissibility of a revocation action at the Central Division when a parallel infringement action is filed at a local division (Art. 33(4) UPCA). Art 33(4) UPCA states that...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

Smart & Biggar

Rx IP Update - March 2019

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Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more

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