News & Analysis as of

Patent Infringement CAFC Pharmaceutical Patents

Robins Kaplan LLP

Azurity Pharms., Inc. v. Alkem Labs. Ltd.

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: The ’948 patent claims non-sterile drinkable liquid formulations of vancomycin, an antibiotic used to treat Clostridium difficile infection. These formulations are particularly...more

Knobbe Martens

A Patent Does Not Guarantee the Patent Owner Will Be First to Market

Knobbe Martens on

INCYTE CORPORATION V. SUN PHARMACEUTICAL INDUSTRIES, LTD. - Before Moore, Prost and Hughes. Appeal from the United States District Court for the District of New Jersey. A district court erred in issuing a preliminary...more

Knobbe Martens

No Takebacks: The High Bar for Departing From Patent Lexicography

Knobbe Martens on

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

WilmerHale

Federal Circuit Patent Watch: An Enabling Anticipatory Prior Art Reference Need Only Enable a Single Embodiment of the Claim

WilmerHale on

Precedential and Key Federal Circuit Opinions - ALNYLAM PHARMACEUTICALS, INC. v. MODERNA, INC. [OPINION] (2023-2357, 06/04/2025) (Taranto, Chen, Hughes) - Taranto, J. The Court affirmed the district court’s claim...more

Venable LLP

Regeneron and Biocon Settle Litigation over EYLEA® Biosimilar Yesafili™

Venable LLP on

On April 15, 2025, Biocon announced it reached a settlement agreement with Regeneron, dismissing CAFC Appeal No. 24-2002 and Case No. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the...more

Knobbe Martens

Hard to Stomach: Things You Say to Prosecute a Patent Can and Will Be Used Against You

Knobbe Martens on

AZURITY PHARMACEUTICALS, INC. v. ALKEM LABORATORIES LTD. Before Murphy, Moore, and Chen. Appeal from the United States District Court for the District of Delaware. Arguments and amendments made during prosecution of a parent...more

MoFo Life Sciences

In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

MoFo Life Sciences on

While a Miranda warning isn’t given prior to starting substantive examination, perhaps it should be. In Azurity Pharmaceuticals, Inc. v. Alkem Laboratories, Ltd., a precedential decision issued on April 8, 2025, the Federal...more

Haug Partners LLP

Federal Circuit Affirms Presumption of Separateness in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. et al., C.A....

Haug Partners LLP on

In a formulation claim, if elements are listed separately, does this necessarily entail that those elements are “separate and distinct components”?  This was the question before the district court in Regeneron...more

Baker Donelson

A Baker's Dozen of Patent Law Developments for 2024

Baker Donelson on

The world of intellectual property law is always changing, and it can be difficult to keep up. Here are 13 developments in patent law so far in 2024 to help you stay in the know....more

Irwin IP LLP

CAFC Holds Priority Favors True Trailblazers, Not Maze-Like Paths Through a Forest of Prior Applications: Regents of the...

Irwin IP LLP on

The Court of Appeals for the Federal Circuit (“CAFC”) recently upheld a decision of the Patent Trial and Appeal Board (“PTAB”) that found some claims of U.S. Patent 8,815,830 (“the ’830 patent”) unpatentable as anticipated....more

Proskauer - The Patent Playbook

A Reminder of Doctrine of Equivalents in Biotechnology: Jennewein Biotechnologie GmbH v. International Trade Commission

Doctrine of equivalents (DOE) can be applied as a mechanism to hold a party liable for patent infringement even if the product or process does not literally infringe a patent claim, if the difference is “insubstantial”....more

Hogan Lovells

Federal Circuit affirms GSK labeling carve-out ruling in favor of innovator

Hogan Lovells on

Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more

Hogan Lovells

Labeling carve-out does not shield generic drug makers from induced infringement claims, CAFC rules

Hogan Lovells on

The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug sponsor did not preclude a finding of...more

Foley & Lardner LLP

CAFC Finds Publication Did Not Inherently Disclose Aveed Composition

Foley & Lardner LLP on

In Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc., the Federal Circuit affirmed the district court’s finding that two patents listed in the Orange Book for Aveed® had not been shown to be obvious. Although prior art...more

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

Recent Trends on the U.S. Doctrine of Equivalents

U.S. courts have long recognized that a product or process which does not literally infringe a patent can nevertheless infringe under the "doctrine of equivalents" if it is equivalent to the claimed invention. The percentage...more

Foley & Lardner LLP

CAFC Finds ANDA Infringement Despite Differences Between FDA Labeling And Claim Language

Foley & Lardner LLP on

In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court’s grant of summary judgment of noninfringement in favor of Breckenridge, and...more

Troutman Pepper Locke

AIA On-Sale Bar Applies to Publicized Sales, Even When Knowledge of Sale Did Not Disclose the Underlying Invention

Troutman Pepper Locke on

The Court of Appeals for the Federal Circuit (CAFC) recently construed the on-sale bar provision of 35 U.S.C. 102(a) in a way that will make it easier for petitioners to challenge third party patents. While in an inter-partes...more

Foley & Lardner LLP

CAFC Affirms Finacea Gel Infringement Under Doctrine of Equivalents

Foley & Lardner LLP on

In Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA, the Federal Circuit affirmed the district court decision that found infringement under the doctrine of equivalents. This case shows that the doctrine of equivalents...more

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