Watch out, pharma—the federal government has its eye on add-on drug patents that can lead to higher prices. In a new effort, the FDA and the U.S. Patent and Trademark Office (PTO) are teaming up to take a close look at patenting procedures.
Wednesday, the PTO said it plans to crack down on patenting of “incremental, obvious changes to existing drugs that do not qualify" for new protections. The initiative follows President Joe Biden's 2021 executive order asking the agencies to leverage their collective experience in promoting “innovation, competition, and the approval and regulation of safe and effective drugs.”
The latest effort is the result of officials at the PTO and the FDA exchanging letters outlining their concerns about pharma patents. The joint work is set to expand their resources for patent regulation.
Last September, then-acting FDA Commissioner Janet Woodcock, M.D., wrote a letter (PDF) to PTO official Andrew Hirshfeld expressing her concern over how “certain uses of the patent system” delay the introduction of generics and biosimilars. In her letter, Woodcock cited a study that found that 78% of new drug patents awarded between 2005 and 2015 were not for new drugs, but existing ones.
She asked that the PTO engage more with the FDA, address the possible misuse of the patent system, provide adequate time and resources for patent examiners and more.
In the PTO’s response, dated yesterday, Director Kathi Vidal emphasized Biden’s concern that too often, patent and other laws have been “misused to inhibit and delay—for years and even decades—competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.”
Vidal noted that while U.S. laws were created to work for the benefit for the people, “we must make sure our system as a whole does not unnecessarily delay getting generic, biosimilar, and more affordable versions of those drugs into the hands of Americans who need them.” She pledged collaboration with the FDA.
As pharma watchers know, patent protections for individual drugs can often drag on for decades. In 2020, the Initiative for Medicines, Access & Knowledge reported that AbbVie filed for 165 patents on cancer drug Imbruvica, 88 of which were granted. The add-on patents earned the company another nine years of protections, bringing the commercial exclusivity period to 29 years.
The strategy exploited “weakness in the procedures of the PTO and courts to extend exclusivity,” then-Bernstein analyst Ronny Gal wrote in a note to clients at the time. Gal also predicted that the move would “gradually lead to efforts to reform.”
Over the years, AbbVie has routinely faced criticism for placing a "patent thicket" around its top drug, Humira, as well.
As part of their effort, the PTO and FDA invite the public to participate through upcoming outreach events and listening sessions. They're in the process of developing policies aimed at “protecting and promoting” innovation as well as advancing competition that could lead to lower drug prices, Vidal said.