News & Analysis as of

Patents Prior Art Pharmaceutical Industry

Goodwin

Eight on AI: Quick Considerations on Patenting Drug Discovery Therapeutics using Artificial Intelligence (AI) and Life...

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Many life science companies are using AI/ML to identify new disease targets and new therapeutics, predict the efficacy and toxicity of potential clinical therapeutic candidates, design clinical trials and dosing or treatment...more

Foley & Lardner LLP

Cancer Drugs: Strategies For Patenting Antibody-Drug Conjugate Inventions

Foley & Lardner LLP on

Antibody-drug conjugate (ADC) is a promising class of cancer treatments with accelerating U.S. Food and Drug Administration (FDA) approval and rapidly growing market size as discussed in previous articles in this series. This...more

Goodwin

Moderna Litigation Against BioNTech and Pfizer Stayed Pending IPR

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We previously reported on the litigation brought by ModernaTX, Inc. and Moderna US, Inc. (collectively, “Moderna”) against BioNTech SE, BioNTech Manufacturing GmbH, BioNTech US Inc. (collectively, “BioNTech”), and Pfizer Inc....more

McDonnell Boehnen Hulbert & Berghoff LLP

Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc. (Fed. Cir. 2024)

The Federal Circuit handed down an opinion last week that invalidated several asserted claims and found infringement under 35 U.S.C. § 271(e)(2) of the claims, while refusing to modify its judgment on infringement after...more

Knobbe Martens

Routine Optimization of Result-Effective Variable Can Bridge Gaps in Prior Art

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PFIZER INC. v. SANOFI PASTEUR INC. - Before Lourie, Bryson, and Stark.  Appeal from the Patent Trial and Appeal Board....more

McDonnell Boehnen Hulbert & Berghoff LLP

Medtronic, Inc. v. Teleflex Life Sciences Ltd. (Fed. Cir. 2024)

Last week the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings.  This post concerns the decision in Medtronic, Inc....more

Venable LLP

Merck Files Four IPRs Challenging The Johns Hopkins University Pembrolizumab Patents

Venable LLP on

On March 4, 2024, Merck Sharp & Dohme, LLC (“Merck”) filed four IPRs challenging The Johns Hopkins University (“JHU”) patents covering methods of treatment using pembrolizumab, which Merck sells under the trade name...more

Goodwin

PTAB Issues Final Written Decisions Finding Claims of Aflibercept-related Patents Invalid

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On January 9, 2024, the PTAB issued final written decisions in IPR2022-01225 and IPR2022-01226, filed by Mylan on two Regeneron patents directed to dosing of aflibercept — U.S. Patent Nos. 10,130,681 and 10,888,601. The PTAB...more

Akin Gump Strauss Hauer & Feld LLP

Patentee’s Own Clinical Trial Renders Unpatentable Patent Claims Directed to Antibody Treatment

In a final written decision of an inter partes review proceeding, the Patent Trial and Appeal Board found all 12 claims of a challenged patent unpatentable as either anticipated or obvious. Each ground of unpatentability...more

Jones Day

PTAB Rejects Double-Dose of Prior Art

Jones Day on

In Sandoz Inc. v. Acerta Pharma B.V. (IPR2023-00478), a Patent Trial and Appeal Board (“PTAB”) panel denied IPR institution where the asserted prior art was cumulative of that considered during prosecution. This denial...more

MoFo Life Sciences

Obviousness In Drug Combinations – Unexpected Results Vs. Unexpected Mechanisms Of Action

MoFo Life Sciences on

Ascertaining the differences between prior art and claims at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole. The Supreme Court emphasized “the need...more

Knobbe Martens

Federal Circuit Review - June 2023

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Objective Evidence in Determining Obviousness - In Medtronic, Inc. v. Teleflex Innovations, Appeal No. 21-2357, the Federal Circuit held that a close prima facie case of obviousness can be overcome by strong evidence of...more

A&O Shearman

When is the composition of a product on the market prior art?

A&O Shearman on

G1/23 – EPO Enlarged Board of Appeals of the EPO “available” (referral from T 0438/19) - Under which circumstances can the public prior use of a product constitute prior art for novelty or inventive step[s], specifically...more

Haug Partners LLP

In re Couvaras: Limitations of Unexpected Results for Non-Obviousness of Claimed Mechanisms of Action

Haug Partners LLP on

On June 14, 2023, the Federal Circuit affirmed the decision of the Patent Trial and Appeal Board upholding an Examiner’s rejection of all pending claims in U.S. Patent Application 15/131,442 (’442 application). The Federal...more

Knobbe Martens

Analogous Art Must Be Compared to the Challenged Patent

Knobbe Martens on

In Sanofi-Aventis Deutschland GmbH v. Mylan Pharm. Inc., Case No. 2021-1981, the Federal Circuit reversed an obviousness determination by the PTAB. At issue was Sanofi’s reissued U.S. Patent No. RE47,614 (the ’614 patent),...more

AEON Law

Patent Poetry: Federal Circuit: Particle Patent Claims Anticipated

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The Federal Circuit has held that the claims of a “SNALP” patent were inherently anticipated by prior art. In Arbutus Biopharma Corp. v. ModernaTX, Inc., Arbutus appealed a decision in an inter partes proceeding by the Patent...more

Foley & Lardner LLP

Federal Circuit Considers Patentability of Overlapping Ranges

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In UCB Inc. v. Actavis Laboratories UT Inc., the Federal Circuit affirmed the district court’s judgement of invalidity on obviousness grounds but reversed the finding of anticipation. In reaching its decision on anticipation,...more

BakerHostetler

Incorporated References Can Be Used in an Anticipation Rejection

BakerHostetler on

A claim is said to be anticipated when a single prior art reference discloses, either expressly or inherently, each and every limitation of the claim. But what happens when a prior art reference discloses some aspects of the...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

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more

A&O Shearman

PTAB Decision Invalidating Claims Finding Lack of Written Description and Later Priority Date Upheld by Federal Circuit

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Procedural History - Regents of the University of Minnesota v. Gilead Sciences, Inc., Case No. 2021-2168 (Fed. Cir. Mar. 6, 2023) is an appeal by the Regents of the University of Minnesota (“Minnesota”) from a final...more

Robins Kaplan LLP

Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd.,

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Case Name:  Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd., No. CV 20-5426 (SRC), 2022 WL 17352334 (D.N.J. Dec. 1, 2022) (Chesler, J.)  Drug Products and Patent(s)-in-Suit: Duobrii® (halobetasol...more

Robins Kaplan LLP

Takeda Pharm. Co. Ltd. v. Norwich Pharms., Inc.

Robins Kaplan LLP on

Case Name: Takeda Pharm. Co. Ltd. v. Norwich Pharms., Inc., No. 20-8966 (SRC), 2022 WL 17959811 (D.N.J. Dec. 27, 2022) (Chesler, J.) Drug Product and Patent(s)-in-Suit: Vyvanse® (1-lysine-d-amphetamine dimesylate); U.S....more

Goodwin

Year in Review: Top Legal Developments of 2022

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As we ring in the new year, we look back at the top legal developments of 2022 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at...more

McDonnell Boehnen Hulbert & Berghoff LLP

Tris Pharma, Inc. v. Actavis Laboratories FL, Inc. (Fed. Cir. 2022)

Almost four years ago, in a relatively rare occurrence based on there being an insufficient factual record to permit proper appellate review, the Federal Circuit vacated a District Court decision rendering invalid the claims...more

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