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Error 101: IP Associations Propose Legislation for Patentable Subject Matter

USA - December 6 2018 Three prominent IP groups propose amending § 101 to clarify what is patentable subject matter. The American Bar Association (ABA) IP Section, and the…

Adriana L. Burgy

Error 101: Director Iancu Wants to Clarify Patentable Subject Matter

USA - October 25 2018 On September 24, 2018, USPTO Director Andrei Iancu told the Intellectual Property Owners Association (IPO) that examiners, applicants, patent owners…

Adriana L. Burgy

FDA Draft Guidance on Content and Format for Instructions for Use

USA - July 12 2019 On July 1, 2019, FDA issued draft guidance on the content and format of Instructions for Use (IFU) documents that accompany prescription drugs…

Justin J. Hasford

Forum-Selection Clause in a Franchise Agreement Establishes Jurisdiction Over “Closely Related” Companies That Did Not Sign the Agreement

USA - January 27 2021 A Colorado court concluded that a forum-selection clause in a franchise agreement established jurisdiction over companies that did not sign the…

D. Brian Kacedon, Anthony D. Del Monaco, John C. Paul, Cecilia Sanabria

FDA Draft Guidance on Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications

USA - October 8 2018 On September 28, 2018, FDA issued draft guidance on contents of a complete submission for threshold analyses and human factors (HF) submissions to…