Businessman crossing fingers behind his back.

Get Your Story Straight: Patent Office Cracks Down on Inconsistent Statements Made Before the FDA

By Matthew Chun

In an effort to “promote robust and reliable patents” and increase access to life-saving drugs, the United States Patent and Trademark Office (USPTO) recently issued a Federal Register Notice clarifying the responsibilities of individuals involved in the patent application process.

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. While the goals of the Federal Register Notice are certainly noble, its disruptive practical effects leave much to be desired.

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Student fellows 2022-2023 cohort.

Petrie-Flom Welcomes 2022-2023 Student Fellows

(Clockwise from top left: Matt Chun, Sarah Gabriele, Katie Gu, Sanjay Reddy, Aparajita Lath)

We are excited to welcome a new group of Student Fellows to the Petrie-Flom Center family. These five students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join us from across Harvard.

They each will undertake a year-long research project with mentorship from Center faculty and affiliates, and also will blog here at Bill of Health regularly. Keep an eye out for their bylines!

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