News & Analysis as of

Obviousness Patents Pharmaceutical Industry

A&O Shearman

Federal Circuit clarifies presumption of obviousness for overlapping ranges

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After the Federal Circuit vacated and remanded the district court’s non-obviousness determination, the district court again found that Teva failed to show, by clear and convincing evidence, that the claims of Janssen’s patent...more

Alston & Bird

Patent Case Summaries | Week Ending July 11, 2025

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Egenera, Inc. v. Cisco Systems, Inc., No. 2023-1428 (Fed. Cir. (D. Mass.) July 7, 2025). Opinion by Stark, joined by Prost and Taranto. Egenera owns a patent related to improved systems and methods for deploying and...more

McDermott Will & Schulte

Prosecution history primacy: “Consisting essentially of” means what applicant said it meant

In a decision that underscores the primacy of prosecution history to determine claim scope, the US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s interpretation of the transitional phrase...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Eye Therapies, LLC v. Slayback Pharma, LLC

Eye Therapies, LLC v. Slayback Pharma, LLC, Appeal No. 2023-2173 (Fed. Cir. June 30, 2025) In its only precedential patent opinion last week, the Federal Circuit reviewed construction of the transitional claim phrase...more

Venable LLP

Pembrolizumab Patent IPR Final Written Decision Issued and Director Review Requested

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On June 9, 2025, the Patent Trial and Appeal Board (“Board”) issued a Final Written Decision (“FWD”) in Merck’s IPR2024-00240 against The Johns Hopkins University’s (“JHU”) U.S. Patent No. 11,591,393 (“the ’393 patent”),...more

Venable LLP

Sarepta Files Two IPRs Against Genzyme’s Patents Gene Therapy Elevidys® Allegedly Infringes

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On June 26, 2025, Sarepta Therapeutics filed IPR2025-01194, challenging as obvious claims 3-6 of Genzyme’s U.S. Patent No. 9,051,542 (“the ’542 patent), and IPR2025-01195 challenging claims 1-4, 6-7 and 11 of U.S. Patent No....more

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

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

Jones Day

Federal Circuit: Plans for Future Activity Created a Substantial Risk of Future Infringement

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Restem filed a petition for inter partes review of U.S. Patent No. 9,803,176, directed to stem cells obtained from umbilical cord tissue and isolated through a two-step process to create a specific cell marker expression...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

Venable LLP on

Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

Venable LLP on

Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...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

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

Foley & Lardner LLP

Leveraging USPTO Delays To Maximize Patent Term

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Before the USPTO was subject to a hiring freeze, it assumed it would onboard 400 new examiners between fiscal year 2025 and fiscal year 2026, and still predicted an increase in the backlog of unexamined patent applications....more

MoFo Life Sciences

Navigating Obviousness: Federal Circuit Addresses Patentability of Pharmaceutical Dosing Methods

MoFo Life Sciences on

On March 6, 2025, the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) issued a precedential decision in ImmunoGen, Inc. v. Stewart, in which the court clarified its standards for determining...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

Venable LLP on

Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

Polsinelli

New PTAB Guidance on Enabling Requirement Under § 102 of the AIA and Construction of Chemical Compound

Polsinelli on

Synopsis: In a recently issued final written decision, the Patent Trial and Appeal Board (the “Board”) found all challenged claims of U.S. Patent No.11,572,334 (“the ’334 patent”) unpatentable.1 The Board’s decision centered...more

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

Robins Kaplan LLP

Janssen Pharms., Inc. v. Teva Pharms. USA, Inc.

Robins Kaplan LLP on

Invega Sustenna® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., Civ. Nos. 18-734, 19-16484, 2024 WL 5135666 (D.N.J. Dec. 17, 2024) (Cecchi, J.)  Drug Product and Patent(s)-in-Suit:...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

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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

McDermott Will & Schulte

Skilled Artisan’s View Is Decisive in Assessing Asserted Claim Drafting Error

The Court of Appeal (CoA) of the Unified Patent Court (UPC) clarified the legal standard for correcting obvious type inaccuracies in patent claims, explaining that the view of a skilled person at the filing date is decisive...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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2024

Mirror Worlds Technologies, LLC v. Meta Platforms, Inc., Appeal Nos. 2022-1600, -1709 (Fed. Cir. Dec. 4, 2024) In this appeal from the United States District Court for the Southern District of New York, the Federal...more

Womble Bond Dickinson

Unexpected Results in Hatch Waxman Litigation: A Review of Legal Decisions from 2023

Womble Bond Dickinson on

Patent owners generally look to secondary indicia to bolster their nonobvious defenses when prior art and/or knowledge of a person of ordinary skill in the art (“POSA”) seem to make the obviousness decision a close call. This...more

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