Big Molecule Watch
June 17, 2022

U.S. Senators Request PTO Action – Big Molecule Watch

On June 8, 2022, a bipartisan group of U.S. Senators sent a letter to Kathi Vidal, Director of the U.S. Patent & Trademark Office, requesting that the PTO take action on patent thickets.  According to the Senators, “large numbers of patents cover a single product or minor variations on a single product, commonly known as patent thickets” that “negatively impacts millions of Americans.”  The Senators quoted a recent statement by President Biden that patent thickets “have been misused to inhibit or delay—for years and even decades—competition from generic drugs and biosimilars, denying Americans access to lower cost drugs.”  According to the Senators, “[i]n the drug industry, with the most minor, even cosmetic, tweaks to delivery mechanisms, dosages, and formulations, companies are able to obtain dozens or hundreds of patents for a single drug,” and “[t]his practice impedes generic drugs’ production, hurts competition, and can even extend exclusivity beyond the  congressionally mandated patent term.”

The Senators expressed specific concern about the prevalence of “continuation and other highly similar patents.”  According to the Senators, the “Patent Act envisions a single patent per invention, not a large portfolio based on one creation,” whereas “continuations now account for almost a quarter of all patent filings.”

The Senators presented a list of questions to the Patent Office and requested that the Patent Office issue a notice of proposed rulemaking or a public request for comments regarding those questions by September 1, 2022.

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