On July 9, 2021, President Biden signed Executive Order (EO) 14036 on “Promoting Competition in the American Economy“ (Competition EO). In the Competition EO, President Biden stated that “too often, patent and other laws 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.”
To advance the Biden Administration’s goals of lowering the price of prescription drugs for American families and increasing competition in the pharmaceutical marketplace, section 5(p)(vi) of the EO states that the Secretary of Health and Human Services shall:
[H]elp ensure that the patent system, while incentivizing innovation, does not also unjustifiably delay generic drug and biosimilar competition beyond that reasonably contemplated by applicable law, not later than 45 days after the date of this order, through the Commissioner of Food and Drugs, write a letter to the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office enumerating and describing any relevant concerns of the FDA.
In response to the Competition EO, the U.S. Food and Drug Administration (FDA) sent a letter to the U.S. Patent and Trademark Office (USPTO) in September 2021, offering to collaborate with the USPTO on ways the two agencies can work together to lower drug prices for Americans. In its reply, the USPTO outlined specific initiatives to ensure that our system does not unnecessarily delay getting generic and more affordable versions of drugs into the hands of Americans who need them.
Initiatives the USPTO has outlined
These initiatives, which involve several functions of the USPTO, broadly include:
- Enhancing collaboration with other agencies, such as the FDA, on key technology areas, including pharmaceuticals and biologics
- Improving procedures for obtaining a patent to ensure that the USPTO issues robust and reliable patents
- Improving the process for challenging issued patents before the Patent Trial and Appeal Board (America Invents Act proceedings)
- Improving public participation in the patent system
- Considering new proposals for incentivizing and protecting innovation while minimizing unnecessary delays in getting more affordable drugs to market
How to provide input
The USPTO welcomes public input on these and other initiatives the agencies should consider. We will soon post more information regarding upcoming public listening sessions on USPTO-FDA collaboration initiatives to this page. In the meantime, please submit general inquiries to USPTO-FDAcollaboration@uspto.gov.