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New Guidance Patents Pharmaceutical Industry

Jones Day

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

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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

Fish & Richardson

What to Know About the USPTO’s Duty of Candor Guidance Regarding FDA Submissions

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​​​​​​​By now you have seen multiple reports discussing the PTO’s Notice of July 29, 2022, relating to the duties of candor and good faith. Federal Register, Vol. 87, No. 145, July 29, 2022....more

Polsinelli

FDA Publishes Industry Guidance Document for Amendments to Abbreviated New Drug Applications

Polsinelli on

In early July 2018, the United States Food and Drug Administration (FDA) issued a final guidance document titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA – Guidance for Industry." A...more

Harris Beach Murtha PLLC

Patent Office Issues New Guidance for Antibody Written Description Requirements

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

Goodwin

USPTO Releases New Guidance on Patentability of Antibody Claims

Goodwin on

Last month, Robert Bahr, Deputy Commissioner for Patent Examination Policy at the USPTO issued a memorandum to the Patent Examining Corps addressing written description of antibody claims. Many patents covering biological...more

Smart & Biggar

Rx IP Update - December 2017

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PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Releases Memorandum on Subject Matter Eligibility

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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