Collins, Colleagues Urge Patent Office to Address Anti-Competitive Drug Patent Thickets

Press Release

U.S. Senator Susan Collins (R-ME) joined a bipartisan group of her colleagues in sending a letter requesting that the U.S. Patent and Trademark Office (PTO) address an issue that substantially contributes to soaring drug prices.

The Senators asked PTO Director Kathi Vidal to crack down on the practice of granting multiple patents for minor variations on a single invention, which they said drug companies have sometimes used to stave off generic competition for decades.

"The patent system is an engine of our economy. But when misused, it can stifle innovation and harm ordinary Americans and small businesses… Patent thickets harm competition through sheer numbers. In 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," wrote the Senators. "This practice impedes generic drugs' production, hurts competition, and can even extend exclusivity beyond the congressionally mandated patent term."

We ask that you consider changes to your regulations and practices to address these problems where they start, during examination. While we still need consistent avenues to address poor-quality patents after issuance, this is an opportunity to take prompt action at the preissuance stage," continued the Senators.

The Senators concluded by requesting that the Patent Office look into specific ideas for curbing the pharmaceutical abusive practice and "take regulatory steps to improve patent quality and eliminate large collections of patents on a single invention."

In addition to Senator Collins, the letter was co-signed by Senators Patrick Leahy (D-VT), John Cornyn (R-TX), Richard Blumenthal (D-CT), Amy Klobuchar (D-MN), and Mike Braun (R-IN).

In 2015, Senator Collins and then-Senator Claire McCaskill (D-MO) launched the Senate's first bipartisan investigation into the causes, impacts, and potential solutions to egregious price spikes for certain off-patent drugs. Over the course of 10 hearings, the Committee examined patient hardships in affording prescription drugs, investigated the complex system that leads to high drug prices, and identified ways to bring costs down for older Americans. The Committee released a report on its investigation in 2016. Following their investigation, Senators Collins and McCaskill authored a bill to improve generic competition and lower the cost of prescription drugs that was signed into law as part of the FDA Reauthorization Act. In October 2018, Senator Collins' legislation to prohibit the use of pharmacy "gag clauses" was signed into law.

In 2019, Senator Collins introduced the Biologic Patent Transparency Act to help block the harmful patent strategies that prevent lower-cost biosimilars from coming to market. Senator Collins also recently introduced bipartisan legislation to strengthen the FDA approval process pipeline and increase transparency for critical medicines, which would lower costs and increase availability of key medications. The Interchangeable Biologics Clarity Act would more efficiently usher drugs to the market by making key improvements to the Food and Drug Administration's review process for interchangeable biosimilars

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