In July 2021, President Joe Biden issued an Executive Order that took aim at increasing competition in the pharmaceutical industry. The President directed the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (PTO) to propose ways the two agencies could collaborate towards this end. The agencies responded with a joint proposal to change how patents protecting drugs are examined, prompting responses from a wide range of industry participants. This article reviews the proposed initiatives and the industry response, and outlines what to expect next.

Current Practice and Agency Roles

Pharmaceutical innovator companies that research, develop, and bring new drugs to market work with both the FDA and the PTO. Innovators must seek FDA approval before they can market a drug, and they typically go to the PTO to seek patent protection for the drug as well. When the FDA is asked to approve a proposed drug, it focuses on the safety and efficacy of the product. The details of the regulatory process will differ somewhat depending on whether the product is a so-called "small molecule" drug that is chemically manufactured, or a "biologic" that is made using a biological system, but the fundamental purpose of FDA review is the same. The PTO's review of patent applications has a different purpose: its basic goal is to determine whether patent applicants have made novel inventions meeting the statutory requirements for patent protection. To make that call, patent examiners with technical backgrounds review each application against what was already known in the field, or "prior art." And applicants in this process have a duty to provide examiners with material information to aid their examination. These processes happen on separate tracks: a drug patent can issue before the drug it covers is FDA-approved. Given the time it takes to complete them, patents covering a drug—which, like all patents, typically expire 20 years after an application is first filed—may have lost years of statutory patent protection before the drug can even be marketed.