News & Analysis as of

Life Sciences Pharmaceutical Industry Patent Trial and Appeal Board

Foley & Lardner LLP

Cancer Drugs: Antibody-Drug Conjugate Litigation

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Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - June 2024

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Venable’s BiologicsHQ Monthly Injection – June 2024...more

MoFo Life Sciences

Federal Court Invalidates Dosing Patent Based On Clinical Trials Disclosure

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As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more

Goodwin

The Appeals Review Panel’s In Re Xencor Decision: The USPTO Provides Its Position on Written Description and Means-Plus-Function...

Goodwin on

On May 17, 2024, an Appeals Review Panel (ARP) of the United States Patent and Trademark Office (“USPTO”) released its decision in Ex parte Chamberlain (referred to in Federal Circuit proceedings as In re Xencor;...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

Cardiovalve Ltd. v. Edwards Lifesciences Corp. (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Last week, the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings.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 Cardiovalve Ltd....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Last week the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings.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

Goodwin

Year in Review: Top Legal Developments of 2023

Goodwin on

​​​​​​​As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and...more

Wolf, Greenfield & Sacks, P.C.

A Look Ahead: Key Intellectual Property Legal Topics in 2024

What should in-house counsel be on the lookout for in 2024? As we begin a new year, our attorneys look ahead at intellectual property topics they expect will be trending in 2024. They cover areas including life sciences,...more

Ballard Spahr LLP

Life Sciences Landscape: 2023 Mid-Year Industry Update

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The Inflation Reduction Act (IRA), signed into law in August 2022, impacted a wide range of tax laws and touched many aspects of government. Significantly, part of the IRA provides Medicare with the ability to negotiate the...more

Knobbe Martens

Federal Circuit Vacates PTAB’s Decisions in Axonics, Inc. v. Medtronic, Inc.

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Sacral neuromodulation stimulates nerves above the tailbone to treat fetal incontinence and related bowel and bladder control issues. After California-based Axonics Inc. (“Axonics”) entered the sacral neuromodulation market...more

Irwin IP LLP

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

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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

A&O Shearman

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

A&O Shearman on

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

Morgan Lewis

Blockbuster Biologics Review | Issue 18

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation...more

Robins Kaplan LLP

Sanofi-Aventis U.S. LLC v. Apotex Corp. Jevtana® (Cabazitaxel)

Robins Kaplan LLP on

Case Name: Sanofi-Aventis U.S. LLC v. Apotex Corp., C.A. No. 20-cv-804-RGA, 2022 WL 2643532 (D. Del. July 8, 2022) (Hall, J.)  Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patents Nos. 8,927,592 (“the ’592...more

Fish & Richardson

What to Know About the USPTO’s Duty of Candor Guidance Regarding FDA Submissions

Fish & Richardson on

​​​​​​​By now you have seen multiple reports discussing the PTO’s Notice of July 29, 2022, relating to the duties of candor and good faith. Federal Register, Vol. 87, No. 145, July 29, 2022....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

American Conference Institute (ACI)

[Event] 13th Summit on Biosimilars & Innovator Biologics - June 28th - 29th, Boston, MA

This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather in Boston for ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics....more

Knobbe Martens

Is Evidence of Generic Industry Skepticism Enough to Preclude a Finding of a Motivation to Combine?

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AURIS HEALTH, INC., v. INTUITIVE SURGICAL OPERATIONS, INC., Before Dyk, Prost, and Reyna. Appeal from the Patent Trial and Appeal Board (PTAB). Summary: Evidence of generic industry skepticism cannot, by itself, form...more

Jones Day

Board Requires Settlement Agreement to Dismiss Pre-Institution Proceeding

Jones Day on

Biofrontera AG (“Petitioner”) filed an unopposed motion to dismiss the petition during the preliminary phase of the proceedings.  Here, DUSA Pharmaceuticals, Inc. (“Patent Owner”) had not yet filed a Preliminary Response, and...more

Knobbe Martens

Limitations in Claim Language Frame Reasonable Expectation of Success Analysis

Knobbe Martens on

TEVA PHARMACEUTICALS USA, INC., v. CORCEPT THERAPEUTICS, INC. Before Moore, Newman, and Reyna. Appeal from the Patent Trial and Appeal Board. Summary: Limitations, such as specific drug doses, in claim language can...more

Morgan Lewis

Blockbuster Biologics Review Issue 14

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

Wilson Sonsini Goodrich & Rosati

Illumina Azidomethyl Blocker Patent Claims Invalidated in Patent Infringement Suit Against BGI Genomics

On November 30, 2021, a jury in the patent infringement suits between Illumina, Inc. and BGI Genomics Co. in the U.S. District Court for the Northern District of California returned a verdict invalidating certain patent...more

Knobbe Martens

Ranges for Interdependent and Interactive Components Can Be Tricky to Derive

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MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION - Before Lourie, O’Malley and Stoll.  Appeal from the Patent Trial and Appeal Board. Summary: A presumption of obviousness based on overlapping ranges requires showing...more

Proskauer - Life Sciences

When (Patent) Success Isn’t Obvious

In Univ. of Strathclyde v. Clear-Vu Lighting LLC, the Federal Circuit grappled with the issue of whether claims directed to methods and systems for inactivating bacteria using blue light were obvious in view of a prior art...more

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