The Senate and the FDA are appealing to the U.S. Patent and Trademark Office (USPTO) to examine how it can limit the ability of pharmaceutical companies to leverage patent strategies to extend their drug monopolies.
In separate letters last week to the USPTO, FDA acting Commissioner Janet Woodcock, M.D., and Sens. Patrick Leahy, D-Vermont, and Thom Tillis, R-North Carolina, of the Senate Judiciary Intellectual Property Subcommittee provided (PDF) suggestions on how the organization can better screen patent applications.
The letters are in response to President Joe Biden’s executive order in July that called on federal agencies to establish policies to promote increased competition in the U.S. economy. One of the order's objectives was to lower prescription drug prices by increasing generic and biosimilar competition.
In the decadeslong drug pricing debate, which has intensified this month with Biden’s push and budget reconciliation talks in Congress, the patenting process has come under increased scrutiny.
In order to extend exclusivity of their drugs, companies secure a multitude of patents covering often insignificant adjustments of their treatments, blocking competition or dissuading competitors from undergoing lengthy and costly litigation to challenge them.
In her letter to the USPTO, Woodcock cited a study that showed that 78% of the new patents issued between 2005 and 2015 were for existing drug products as opposed to new drugs entering the market.
The most notorious example of erecting a “patent wall” to stave off competition is that of AbbVie protecting the exclusivity of its cash cow Humira by applying for more than 245 patents, 89% of which were submitted after the drug was initially approved. The extended monopoly will cost American payers and taxpayers $14.4 billion over Humira's final four years of exclusivity, said I-MAK, which evaluates the effects of patenting strategies by biopharmaceutical companies.
AbbVie is following the same tactic with another of its blockbusters, Imbruvica. The company has filed for 165 patents for the cancer treatment, extending the exclusivity of the cancer treatment for more than nine years.
Woodcock added that stakeholders have “questioned whether some of these patenting practices encourage innovation that is meaningful for patients.”
Woodcock also cited the practice of “product hopping,” which forces patients to switch to new formulations of a newly patented drug that has little or no therapeutic difference. The tactic is used before generic competition for the original drug enters the market. Studies show patients are less likely to switch from a new drug to a generic regardless of cost.
“We would be interested in learning USPTO’s perspective on these practices and whether it is considering means of limiting such practices,” Woodcock wrote.
Woodcock offered suggestions to help increase drug competition, including more engagement between the FDA and the USPTO to facilitate greater awareness and efficiency. She also asks whether increasing resources and time for examiners to evaluate cases would “help ensure the right balance of rewarding innovation and facilitating competition.”
In their letter to the USPTO’s acting Director Andrew Hirshfeld, Leahy and Tillis wrote that patent applicants often make conflicting statements on their products to other federal agencies. The senators asked the USPTO to consider requiring applicants to disclose those statements.