In July 2021, President Biden issued an Executive Order directed at promoting competition in the American economy. A portion of that order directed changes to address drug pricing, and some provisions directed the Food and Drug Administration (“FDA”) and the United States Patent and Trademark Office (“USPTO”) to communicate regarding drug pricing. The USPTO is the government entity that grants patent applications, including those on pharmaceuticals and medical devices, while the FDA reviews and approves drug, biologic, and medical device applications for use and sale in the United States. The FDA additionally grants exclusivities which prevents the agency from reviewing any applications of competitor products for a period defined by statute.
The landscape of pharmaceutical patents and drug approvals has led to some negative effects including anti-competitive promotion of patented drugs and unbalanced research and development. This problem can occur when manufacturers report statements to the FDA during the drug approval process that conflict with those made to the USPTO during the process of obtaining a patent (“patent prosecution”). Because most of the information going to the FDA is confidential, it is usually not available to the USPTO during patent prosecution, and most patent examiners are untrained on using the FDA’s information to determine patentability.
The Executive Order was issued to address these issues between patents and other laws being misused to delay or prohibit competition between generic drugs and branded pharmaceuticals. In addition to the Executive Order, Senators Leahy and Tillis have asked the USPTO to take action. As the system currently stands, the solution to these conflicting statements has been to invalidate patents using the inequitable conduct doctrine, but the confidential nature of the FDA information makes the doctrine difficult to apply. The inequitable conduct finding renders all claims on a patent unpatentable or invalid under a USPTO statute.
In response to the order and the ongoing problems, the FDA and the USPTO began communications. They have held various seminars, including cross-training on patents and drug approval pathways in March and July 2023. In addition, the USPTO held a virtual panel on the duty of disclosure and reasonable inquiry in relation to patent prosecution as well as a joint virtual and in-person collaborative listening session with the FDA in 2023 for the public to weigh in.
One of the more recent developments was in June 2024, when the USPTO published results from a drug patent and exclusivity study. The study was designed to investigate the current timeline from the initiation of a New Drug Application (“NDA”) to the entrance in the market of a generic drug. The study found that in some cases, the generic launch was not impacted by patent and exclusivity calculations but by other factors, although the time period from filing an NDA to a generic launch is influenced by the relations between patents and FDA regulations.