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Patents Labeling

Knobbe Martens

Federal Circuit Review | June 2024

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Reliably Determining Reasonable Royalty Rates from Lump Sum Licenses - In Ecofactor, Inc. V. Google LLC, Appeal No. 23-1101, The Federal Circuit held that license agreements containing a lump sum payment “based on” a royalty...more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Unveils Examiner Guidance on Searching Drug-related Applications

Last November, the U.S. Patent and Trademark Office issued Guidance to the Examiner Corps that was disclosed to the public at the March 19, 2024 Biotechnology, Chemical, and Pharmaceutical Partnership Meeting, on resources to...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – June 2024

This latest edition features articles on biotech client Siolta Therapeutics, the use of safety and efficacy findings to extend drug exclusivity periods, life sciences venture financings for clients in 2023, and updated USPTO...more

American Conference Institute (ACI)

[Event] 15th Summit on Biosimilars & Innovator Biologics - June 20th - 21st, New York, NY

Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...more

Kilpatrick

The Supreme Court Leaves Skinny Labels to Another Day

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The Supreme Court recently rendered two important decisions for the biopharma industry. In the first decision, the Supreme Court ruled on enablement of genus claims for therapeutic antibodies, unanimously affirming the...more

McDermott Will & Emery

Federal Circuit Divided on Whether Skinny Labeling Compliance Precludes Inducement or Supports Equitable Estoppel

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The US Court of Appeals for the Federal Circuit denied a generic drug manufacturer’s petition for en banc review of a panel opinion finding induced infringement liability despite the manufacturer’s adherence to skinny...more

MoFo Life Sciences

Skinny Labels Back In Focus After HHS Report On Addressing Drug Prices

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Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a...more

Cooley LLP

Alert - GSK v. Teva: Federal Circuit Opinion After Rehearing Confirms Induced Infringement Liability Despite Skinny Label

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In October 2020, as reported in a previous Cooley alert, the US Court of Appeals for the Federal Circuit reinstated a jury’s verdict that Teva infringed GSK’s patented method of using its Coreg drug product, even though...more

Schwabe, Williamson & Wyatt PC

‎Latest Federal Court Cases - August 2021 #2

Our Case of the Week this week is a re-write of our Case of the Week on October 5, 2020. The case involves a drug that could be used for multiple therapeutic purposes. A patent covered use of the product for a specific...more

Locke Lord LLP

Federal Circuit Places “Skinny Labels” Back in Danger

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On October 2, 2020, the Federal Circuit issued a precedential opinion vacating a district court’s judgment as a matter of law and reinstating a jury verdict finding of induced infringement of a patented use that had been...more

McDermott Will & Emery

The Future of Skinny Labeling in Patent Litigation Will be Reconsidered

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The US Court of Appeals for the Federal Circuit has now vacated its prior ruling finding induced infringement based on so-called skinny labeling on a pharmaceutical product. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA...more

Fish & Richardson

[Webinar] Life Sciences | 2020 Year in Review - January 27th, 1:30 pm - 2:30 pm ET

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2020 has been referred to as an unprecedented year for the world in so many ways—the pandemic, the California and Washington fires, the racial justice protests and calls to action—but that didn’t stop the Federal Circuit from...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - October 2020

GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., Appeal No. 2018-1976, -2023 (Fed. Cir. Oct. 2, 2020) - Our Case of the Week focuses on the question of induced infringement, and particularly induced infringement in...more

American Conference Institute (ACI)

[Virtual Event] FDA Boot Camp - September 23rd - 24th, 8:15 am - 12:45 pm EDT

For over 15 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Now the conference returns for its 37th iteration, in a fully...more

McDermott Will & Emery

Definiteness, Drug Labels and Diclofenac, Oh My

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The US Court of Appeals for the Federal Circuit affirmed a district court’s invalidity and infringement judgments for patents directed to a topical nonsteroidal anti-inflammatory drug, finding that a patent claim reciting a...more

American Conference Institute (ACI)

[Event] Global Legal and Regulatory Summit On Biosimilars - December 3rd-4th, Munich, Germany

Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more

McDermott Will & Emery

European SPC Manufacturing Waiver Goes into Force

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Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

BakerHostetler

FDA and Pharmacy Weekly Digest - June 2019 #4

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Food/Dietary Supplements - FDA Announces Guidance on Added Sugar Labeling – The FDA published a new guidance for labeling of added sugars. ...more

Locke Lord LLP

How to Get that Final Approval - FDA Issues New Draft Guidance

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On January 16, 2019, the United States Food and Drug Administration issued a new draft Guidance entitled “ANDA Submissions –Amendments and Requests for Final Approval to Tentatively Approved ANDAs”. This new FDA Guidance...more

Fish & Richardson

Establishing Drug Labels as Printed Publications

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This article is a summary of material presented in Post-Grant for Practitioners: BioPharma Patents at the PTAB, hosted by Dorothy Whelan and Tasha Francis. A major question facing the PTAB recently concerns the evidentiary...more

Hogan Lovells

Hogan Lovells ITC Section 337 Monthly Highlights

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The latest news round-up from our Hogan Lovells ITC Section 337 practice, including a new section featuring "tips from the bench" by former ITC Judge Theodore (Ted) R. Essex. ...more

Fenwick & West LLP

Patent Marking

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Labeling your product with information about patent(s) that cover that product is called “patent marking” and is one way to inform the public about your IP rights. While under U.S. law you aren’t required to mark your...more

McDermott Will & Emery

ANDA Update - October 2015

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Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

McDonnell Boehnen Hulbert & Berghoff LLP

Eli Lilly and Company v. Teva Parenteral Medicines, Inc. (S.D. Ind. 2015) - District Court Finds Lilly Patent Infringed Based on...

Last week, in Eli Lilly and Company v. Teva Parenteral Medicines, Inc., Judge Tanya Walton Pratt of the U.S. District Court for the Southern District of Indiana determined that Eli Lilly and Company had shown by a...more

K&L Gates LLP

The Name Game Continues: AbbVie Files Supplemental Citizen Petition Raising Additional Concerns Regarding Biosimilar Labeling

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AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more

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