Lowering drug prices in the U.S. has long been discussed with numerous proposals put forward on steps that could be taken to reach that goal. In July 2021, President Biden issued an Executive Order on Promoting Competition in the American Economy that contained provisions seeking to lower drug prices and promote innovation through increased competition in the pharmaceutical marketplace.
On September 10, 2021, pursuant to the executive order, Janet Woodcock, acting commissioner of food and drugs at the U.S. Food & Drug Administration (FDA), wrote a letter to Andrew Hirshfeld, acting director of the U.S. Patent and Trademark Office (USPTO), outlining steps the FDA and USPTO can pursue together to “help 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.”
Commissioner Woodcock’s letter discusses some of the FDA’s concerns relating to uses of the patent system that have been criticized as impeding competition from generic, biosimilar, and interchangeable products. The concerns include the practice of filing continuation patent applications that can allow for numerous follow-on patents, resulting in “patent thickets” of multiple patents on various aspects of the same product; patent “evergreening” (extending patent protection through obtaining patents on changed aspects of approved drugs, such as their formulation or delivery system, or adding new methods of use close in time to when earlier patents on the drug are expiring); and “product-hopping” (changing a dosing regimen, patenting that change, then switching patients to the new product just before a generic or biosimilar drug can come on the market).
Because the FDA and USPTO are both integral to advancing innovation in the pharmaceutical industry, to address the FDA’s concerns, Commissioner Woodcock suggested that the FDA and USPTO could take steps to work together “with the goal of increasing competition and access to affordable drugs while respecting the need to preserve patent rights and incentives for innovation generally.” She suggested that the agencies could further engage on the following topics:
- Engagement between FDA and USPTO: FDA and USPTO can increase their engagement to facilitate efficiency in their work streams. FDA can provide training to USPTO patent examiners on FDA databases to help them locate prior art references. FDA also suggested other joint training topics, such as the agencies’ respective roles in determining eligibility for patent term extensions to ensure they are accurately and fairly granted.
- Possible Misuse of the Patent System: FDA would like to learn the USPTO’s perspectives on the FDA’s concerns that patent thickets, evergreening, and product-hopping are being used to keep drug prices high through extending monopolies, and whether the USPTO is considering ways to limit these practices.
- Adequate Time and Resources for PTO Examiners: FDA is interested in whether increasing the time available for patent examiners to review patent applications for complex technologies like pharmaceuticals or increasing other resources for patent examiners would help to strike the right balance between innovation and competition.
- The Patent Trial and Appeal Board (PTAB): FDA would like to receive data on post-grant review (PGR) and inter partes review (IPR) proceedings at the PTAB, particularly their impact on Orange Book-listed and biological drug patents. FDA is open to discussing how these proceedings may be optimized to ensure generic drugs reach the market in a timely manner.
- FDA and USPTO Information Exchange: FDA would like to discuss any other areas in which the USPTO thinks the agencies may be able to exchange information and experiences to help them reach a proper balance between innovation and patient access to medications.