News & Analysis as of

United States Patent and Trademark Office › New Guidance › Pharmaceutical Patents

The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.... more +
The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.    less -
Jones Day

Blurring the Line Between the Dry and Wet Lab: Joint Inventorship in AI-Assisted Life Science Inventions

Jones Day on

In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more

Goodwin

USPTO Publishes Enablement Guidelines in view of Amgen v. Sanofi

Goodwin on

On January 10, 2024, the USPTO published guidelines for assessing enablement in view of Amgen v. Sanofi and other recent court cases (“the Guidelines”). The Guidelines state that they are not intended to “announce any major...more

Venable LLP

New USPTO Guidelines: After the Supreme Court's Amgen Decision, In re Wands Factors Remain Applicable Enablement Framework

Venable LLP on

On January 10, 2024, the United States Patent and Trademark Office (USPTO) issued "Guidelines for Assessing Enablement in Utility Applications and Patents in View of the U.S. Supreme Court Decision in Amgen Inc. et al. v....more

Womble Bond Dickinson

Enablement Post-Amgen and New USPTO Guidelines

Womble Bond Dickinson on

On January 10, 2024, the United States Patent and Trademark Office (USPTO) published Guidelines, applicable to any technology, for ascertaining compliance with the enablement requirement in view of the U.S. Supreme Court...more

Goodwin

The USPTO’s Increasing Focus on FDA Submissions and the Duty of Disclosure

Goodwin on

​​​​​​​The United States Patent and Trademark Office (USPTO) imposes a Duty of Disclosure, Candor and Good Faith (Duty of Disclosure) on all individuals associated with the filing and prosecution of a patent application...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

American Conference Institute (ACI)

[Virtual Event] 18th Advanced Summit on Life Sciences Patents - August 5th - 6th, 9:00 am EDT

American Conference Institute (ACI) on

Perfect Your Patent Prosecution Strategies and Master the Patent Application Process in the U.S and Around the World. ACI’s 18th Global Summit on Life Sciences Patents virtual conference this August will provide practical...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Upholds Invalidity of Cleveland Clinic’s Claims Directed to Methods for Detecting an Elevated MPO Concentration

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

In Cleveland Clinic Foundation, Cleveland Heartlab, Inc. v. True Health Diagnostics LLC, (Cleveland Clinic II)[1], a unanimous panel of the Federal Circuit provided yet another guidepost illustrating what is not...more

Sunstein LLP

July 2018 IP Update: New Guidance for Patenting Method-of-Treatment Inventions

Sunstein LLP on

The U.S. Patent and Trademark Office (USPTO) issued a memorandum on June 7 (the “Memorandum”), providing much-needed guidance to patent examiners as to whether method of treatment claims are to be considered patent-eligible...more

Harris Beach Murtha PLLC

Patent Office Issues New Guidance for Antibody Written Description Requirements

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Since 1999, the United States Patent and Trademark Office (“Patent Office”) has permitted the claiming of antibodies by disclosing the targeted antigen. In 2002, the Federal Circuit adopted Patent Office guidelines and...more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Releases Memorandum on Subject Matter Eligibility

McDonnell Boehnen Hulbert & Berghoff LLP on

On May 4th the U.S. Patent and Trademark Office issued its latest Guidance on how Examiners are to apply recent U.S. Supreme Court and Federal Circuit precedent related to subject matter eligibility (see "USPTO Issues Update...more

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