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Life Sciences › Guidance Update

King & Spalding

It’s Not Just for Dietary Supplements Anymore: FTC Revises and Expands Guidance for Health Claims

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Signaling a renewed focus on consumer protection in the health claims space, the Federal Trade Commission (“FTC”) has revamped its 1998 guidance titled Dietary Supplements: An Advertising Guide for Industry and extended the...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

Goodwin on

As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

Hogan Lovells

CDRH plan for FY-2021 guidance prioritizes cybersecurity, CDS software, COVID-19 updates

Hogan Lovells on

On October 16, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced the list of priority guidance documents that CDRH intends to publish this fiscal year (FY-2021)....more

Seyfarth Shaw LLP

FDA Issues Guidance Documents Directed to Blood Donations as Part of COVID-19 Public Health Emergency Measures

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To address critical shortages of blood and plasma during the COVID-19 pandemic, the U.S. Food and Drug Administration (the “FDA”) released several guidance documents on April 2, 2020.  ...more

Knobbe Martens

Trends and Changes in View of the USPTO’s Updated Revised Guidance (Presentation)

Knobbe Martens on

Partner Mauricio Uribe hosted a webinar presenting, "Trends and Changes in View of the USPTO's Updated Revised Guidance." Topics Include: • Summary of the October 2019 Update to the Revised Guidance •...more

Foley & Lardner LLP

USPTO October 2019 Patent Eligibility Guidance Update Includes New Guidance And Examples For Life Sciences

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The USPTO has released additional patent eligibility guidance to supplement the guidance released in January. While much of the October 2019 Patent Eligibility Guidance Update relates to claims falling under the “abstract...more

Hogan Lovells

A broader definition of “unmet needs” has been proposed to support the development of anti-bacterial medicinal products

Hogan Lovells on

The concept paper - The EMA has published a “Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections.”...more

McAfee & Taft

Two-step analysis to assist in determining patent eligibility

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Napoleon Hill once famously said, “Whatever the mind of man can conceive and believe, it can achieve.” However, what the mind of man can conceive is not necessarily patentable. Courts have long held that laws of nature,...more

Foley & Lardner LLP

Canada Provides More Guidance On Patent Eligibility Of Diagnostic Method Claims

Foley & Lardner LLP on

While the patent eligibility of diagnostic method claims remains questionable in the United States, the Canadian Intellectual Property Office has issued updated guidance on the types of diagnostic method claims that can–and...more

Foley & Lardner LLP

USPTO Patent Eligibility Guidance In View Of CellzDirect And Sequenom

Foley & Lardner LLP on

On July 14, 2016, the USPTO issued a Memorandum to the Patent Examining Corps on patent eligibility in view of recent court decisions. The July 2016 Memorandum extracts more guidance for assessing patent eligibility from the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Subject Matter Eligibility Guidance -- Example on Diagnosing and Treating Julitis

McDonnell Boehnen Hulbert & Berghoff LLP on

Last week, the U.S. Patent and Trademark Office issued further guidance for determining subject matter eligibility under 35 U.S.C. § 101. In addition to a memorandum on subject matter eligibility determinations that was...more

BCLP

With a Focus on Life Sciences Claims, USPTO Issues 2016 Guidance on Patentable Subject Matter

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Earlier this month, the U.S. Patent & Trademark Office (“USPTO”) issued updated guidance to its examining corps concerning subject matter eligibility rejections and responses under 35 U.S.C. § 101. The 2016 Guidance,...more

K&L Gates LLP

U.S. Patent Office Issues New Examples of Patent Eligibility Analysis of Life Sciences Claims

K&L Gates LLP on

On May 4, 2016, the United States Patent Office published a subject matter eligibility update for determining patent eligibility under 35 U.S.C. § 101. The Update supplements the previous guidelines and includes additional...more

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