Duty of disclosure and duty of reasonable inquiry promote robust and reliable patents, drive competition and economic growth, and bring life-saving drugs to the American people

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Duty of disclosure and duty of reasonable inquiry promote robust and reliable patents, drive competition and economic growth, and bring life-saving drugs to the American people

3 min read

The United States is a global leader in new drug development. The important contributions and life-saving treatments developed by the pharmaceutical industry have fully or nearly eradicated deadly diseases like smallpox, polio, measles, diphtheria, hepatitis B, and meningitis, as well as created highly effective treatments for various cancers and chronic diseases. Much of this was made possible because of our strong patent protection.

For patents to play this critical role, they must be robust and reliable. Robust and reliable patents incentivize and protect breakthrough innovation, but they also ensure our system as a whole does not unnecessarily delay getting generic and more affordable versions of those drugs into the hands of Americans who need them.

President Biden recognized this need in the July 9, 2021, Executive Order on Promoting Competition in the American Economy (EO). The EO required the Food and Drug Administration (FDA) to identify any concerns about the patent system being used to unjustifiably delay generic drug and biosimilar competition beyond that reasonably contemplated by applicable law. On September 10, 2021, we received a letter from Acting FDA Commissioner Woodcock in which the FDA suggested further engagement between the FDA and USPTO “to facilitate greater awareness of our complementary work and introduce efficiency in our respective workstreams.”

I recently sent a response to the FDA's letter to FDA Commissioner Dr. Robert Califf. In it, I described many of the initiatives we're working on to strengthen our patent system for all technologies, in addition to the work the USPTO is doing with the FDA directly.

One of those initiatives relates to ensuring that the USPTO has the key information our examiners need when deciding whether to grant patent rights. The USPTO and the American people rely on inventors, applicants, and parties abiding by their “duty of disclosure” and “duty of reasonable inquiry,” including their ongoing duty to provide consistent statements about drugs to the USPTO and the FDA. This duty applies during examination of patent applications, including continuation applications, and after issuance during any post-grant examination or proceeding to review the issued patent. Adherence to these duties helps our patent examiners and administrative patent judges within the Patent Trial and Appeal Board effectively and efficiently determine whether an invention—for instance, a drug product—is patentable by providing them with key relevant information. Failure to abide by these duties is not only a disservice to the American public, it is sanctionable.

To reinforce the importance of these duties, today we announced information in a federal register notice (FRN) on the “duty of reasonable inquiry” and “duty of disclosure” owed to the USPTO and American public.

The FRN also addresses a letter from Senators Leahy and Tillis expressing their belief that improving patent quality will increase competition and drive economic growth. The letter requested that we take steps to ensure that drugmakers disclose relevant statements they have made to other agencies, such as the FDA, when seeking patent protection for their pharmaceutical products at the USPTO. The letter expressed concern that, “[f]or example, inconsistent statements submitted to the Food and Drug Administration (FDA) to secure approval of a product—asserting that the product is the same as a prior product that is already on the market—can then be directly contradicted by statements made to the PTO to secure a patent on the product.”

In addition to today's FRN, we are considering additional measures to ensure issued patents are robust and reliable. Visit our USPTO-FDA Collaboration Initiatives page for more information on our efforts in the pharmaceutical space. As always, we welcome your feedback at drugpricing@uspto.gov and invite you to join us at an upcoming public event. You can also sign up for email updates to get the latest on news from the USPTO and other upcoming events and connect with me through the Engage with the Director webpage.

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