News & Analysis as of

Biotechnology Prescription Drugs Patents

Polsinelli

Federal Circuit Clarifies Rules for Skinny Labeling for Generics and Biosimilar Companies

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Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more

Jones Day

Federal Agencies Seeking Patent Seizure Authority Through Draft NIST Guidance

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The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more

Foley & Lardner LLP

IP Toolbox Is Crucial In AI-Powered Drug Discovery

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Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering. As the cost of developing new drugs...more

Smart & Biggar

Top 10 patent and regulatory things you need to know when bringing a biopharma product to Canada

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Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...more

Morgan Lewis

Blockbuster Biologics Review | Issue 17

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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

Proskauer - Life Sciences

Preparing for Europe’s Unified Patent Court

After years of contemplation and delays, Europe’s Unified Patent Court will be operational in about one year. U.S.-based Life Sciences patent applicants should start preparing now to ensure that their applications withstand...more

Proskauer - Life Sciences

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

Jones Day

Patent Linkage and Article 76 Proceedings in China: A Litigator's Perspective

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China has recently unveiled its own version of a patent linkage system that has been highly watched by stakeholders and industry observers.  This new system will also create a new form of pharmaceutical patent litigation in...more

Proskauer - Life Sciences

GSK v. Teva: Federal Circuit Issues New Opinion Analyzing Induced Infringement

On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding...more

McDonnell Boehnen Hulbert & Berghoff LLP

Top Drugs Losing Patent Exclusivity in 2021

Earlier this month, Eric Sagonowsky reviewed the top ten drugs in the U.S. (in terms of sales) losing patent exclusivity in an article published by Fierce Pharma....more

A&O Shearman

China: Patent Law Amendment brings sea change to pharmaceutical patent regime

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Article 76 of the Amendment establishes the longanticipated patent linkage scheme in China. It aims to allow early resolution of patent disputes between innovators and generic companies during the drug review and approval...more

Kramer Levin Naftalis & Frankel LLP

BPCIA Scope Widens: 2020 Spending Bill Moves Chemically Synthesized Polypeptides to Biologic Status

Buried in a 2020 spending bill passed in December 2019 is a provision that amends the definition of “Biological Product” in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and thereby expands the products...more

American Conference Institute (ACI)

[Event] Pharmaceutical Patent Term Extensions – The Only Specialized Forum on SPCs and Patent Protection in Europe and Around the...

This year’s C5’s Pharma Patent Term Extensions Forum arrives at a critical time for the pharmaceutical industry. Overarching developments from the Teva U.K. decision (C-121/17) to the SPC Manufacturing Waiver and the most...more

American Conference Institute (ACI)

[Event] Biosimilars Summit – Legal, Regulatory, and Commercial Strategies – June 24th-25th, New York City, NY

2019 marks the 9th anniversary of the Biologics Price Competition and Innovation Act (BPCIA). ACI has been with you from the introduction of the first House and Senate bills through to the actual signing of the law. As we...more

Hogan Lovells

Patent law in Europe: What pharmaceutical companies need to know

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Increasing competition within Europe’s pharmaceutical space makes knowing the market and understanding available patent protections more critical than ever for both well established and new market players. Andreas von Falck...more

Cooley LLP

Blog: Pharmaceutical and Biotechnology Industry Representatives File Lawsuit Over Nevada’s Prescription Drug Transparency Bill

Cooley LLP on

On September 1, 2017, Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization (collectively “Plaintiffs”) filed a complaint (the “Lawsuit”) in the United States District Court for the...more

Fish & Richardson

Legislative Developments in Post-Grant Proceedings

Fish & Richardson on

Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - February 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis AG et al. v. Ezra Ventures LLC. 1:15-cv-00150; filed February 11, 2015 in the District Court of Delaware. •...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report -- Part II - July 2014 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Acorda Therapeutics Inc. v. Actavis Laboratories FL Inc. 1:14-cv-00882; filed July 7, 2014 in the District Court of...more

BakerHostetler

BakerHostetler Patent Watch: Novozymes A/S v. DuPont Nutrition Biosciences APS

BakerHostetler on

On July 22, 2013, in Novozymes A/S v. DuPont Nutrition Biosciences APS, the U.S. Court of Appeals for the Federal Circuit (Rader, Schall,* Bryson) affirmed the district court's judgment as a matter of law that U.S. Patent No....more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report -- June 30, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Alpex Pharma S A et al. v. Zydus Pharmaceuticals USA Inc. et al. 1:13-cv-01143; filed June 26, 2013 in the District...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report -- June 17, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Fresenius Kabi USA, LLC v. Watson Laboratories Inc. et al. 1:13-cv-01015; filed June 6, 2013 in the District Court of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report -- June 02, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Takeda Pharmaceutical Co. et al. v. Impax Laboratories, Inc. 3:13-cv-02416; filed May 29, 2013 in the Northern District...more

McDonnell Boehnen Hulbert & Berghoff LLP

News from Abroad: UK Court of Appeal Upholds Invalidity of Enantiomer Patent

Originally published in WP Thompson & Co. on April 1, 2013. The "Obvious to Try" Test Is Overused in Assessing Obviousness - The UK Court of Appeal Decision in Novartis AG vs Generics (UK) Ltd (trading as United...more

Morrison & Foerster LLP

Sharing an Umbrella

Big Pharma and academia cement big deals in the quest for bigger prizes - With the patents of many highly profitable blockbuster drugs expiring over the course of a few years, the search is on for new drugs to fill...more

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