News & Analysis as of

Appeals Biotechnology

Smart & Biggar

Twice is not nice – second notice of allegation may be abusive

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On December 23, 2023, the Federal Court of Appeal (FCA) held that it was an abuse of process for Apotex to raise invalidity in defending actions under the Patented Medicines (Notice of Compliance) Regulations (Regulations)...more

McDermott Will & Emery

2023 IP Outlook: Patent Decisions Affecting Pharma and Biotech Companies

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The past year brought many developments in the life sciences patent legal space. Three decisions in particular hold potential ramifications for drug makers and patent holders in 2023. This year, the Supreme Court of the...more

McDermott Will & Emery

Intellectual Property & Health | News To Know – June 2022

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RUSSIA RESPONDS TO WESTERN SANCTIONS WITH PATENT RETALIATION - On March 6, 2022, the Russian government retaliated against the West’s imposition of sanctions by issuing a decree permitting patented innovations to be used...more

Harris Beach PLLC

Federal Circuit Denial of En Banc Rehearing in Amgen v. Sanofi Prompts New Considerations in Genus Claims

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Based on the denial of rehearing and the Amgen v. Sanofi decision itself, inventors should: Claim as many separate species as possible. Attempt to fashion genus claims that have a limited number of members supported...more

Haug Partners LLP

Can Biopharma Functional Genus Patent Claims Be Resuscitated?

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An en banc rehearing petition to the Federal Circuit seeks to breathe life back into the widespread practice of patenting a genus of compounds by claiming their common functional characteristics. This claiming practice was...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Sanofi (Fed. Cir. 2021)

A little less than four years ago, the Federal Circuit rendered a decision in Amgen Inc. v. Sanofi that brought clarity to how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement...more

Holland & Knight LLP

Food and Beverage Law Update: December 2018

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Regulation - FDA-USDA Propose Joint Regulatory Framework for Cell-Grown Meat - On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement...more

Knobbe Martens

Ynano’s Artificial Glands

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On July 2, 2018, the Federal Circuit Court of Appeals affirmed the decision of the Patent Trial and Appeal Board holding that some of the claims relating to artificial glands and various methods of creating them were not...more

Hogan Lovells

FDA proposes streamlining combination product regulations

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On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more

Knobbe Martens

FDA Issues Refusal-to-File Letter to Alkermes for Depression Treatment

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On April 2, 2018, Irish biotech Alkermes revealed that it had received a Refusal-to-File letter from the FDA regarding its depression drug ALKS 5461. The announcement caused Alkermes shares to drop 22.4%, and adversely...more

Knobbe Martens

Inherent Anticipation for Biotechnology Inventions

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Anticipation by inherent disclosure requires that a single prior art reference necessarily includes the unstated limitation. The unpredictable nature of biological processes means that winning summary judgment of invalidity...more

Carlton Fields

Food for Thought: Ninth Circuit Rejects GMO and Pesticide Bans in Three Hawaii Counties Because State and Federal Laws Preempt the...

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Alika Atay et al v. County of Maui, et al, No. 15-16466 (9th Cir., Nov. 18, 2016) - Hawai’i Papaya Indus. Assn., et al v. County of Hawaii, No. 14-17538 (9th Circ., Nov. 18, 2016) - Robert Ito Farm, Inc., et al. v. County...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit’s Application of Mayo Revives Biotech Patent

In Rapid Litig. Mgmt. Ltd v. CellzDirect, Inc., the Federal Circuit reversed a ruling of patent invalidity under Section 101, reviving a biotech patent to a method of preserving hepatocytes, liver cells, for medical use. The...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Preview -- Cuozzo Speed Technologies, LLC v. Lee -- Question 2

On March 4, the Supreme Court announced that the Cuozzo Speed Technologies, LLC v. Lee appeal would be argued on April 25, 2016 (the last week of oral hearings for the October Term 2015). As we reported previously, the...more

Knobbe Martens

Federal Circuit Review | July 2015

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Nunc Pro Tunc Assignments Insufficient To Confer Retroactive Standing - In ALPS SOUTH, LLC v. OHIO WILLOW WOOD CO., Appeal Nos. 2013-1452, 2013-1488, 2014-1147, and 2014-1426, the Federal Circuit reversed the denial of a...more

McDonnell Boehnen Hulbert & Berghoff LLP

News from Abroad: Second Referral for the "Broccoli" Patent Case to the Enlarged Board of Appeal

Following the issuance of decision G2/07 in connection with the "Broccoli" patent, which discussed whether plant breeding methods were excluded from patentability as essentially biological processes for the production of...more

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