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FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.
As part of the Biden administration’s ongoing campaign to reduce outlays for prescription drugs, FDA is collaborating with the US Patent & Trademark Office (USPTO) to limit patent extensions for minor changes to a medicine. The initiative aims to promote competition in the biopharmaceutical market by challenging strategies designed to block timely approval of less costly generics and biosimilars to innovator products.
The joint effort was outlined by FDA Commissioner Robert Califf and USPTO Director Kathi Vidal in a statement issued July 6, 2022 on the need to prevent the patenting of “incremental, obvious changes to existing drugs.” The aim is to prevent delays in generic drug competition “based on trivial changes” to a drug product (1). While the “issuance of robust and reliable patents to incentivize pharmaceutical innovators is critical, our patent systems must not be used to unjustifiably delay generic drugs and biosimilar competition beyond that reasonably contemplated by law,” President Biden noted in an Executive Order last year.The two agencies aim to “leverage our collective expertise” in advancing innovation, competition, and the approval of safe and effective drugs.
To ensure that patent examiners have the time and resources needed for thorough review of pharma patent applications, FDA will assist the USPTO by providing patent examiners with training on pharmaceutical and biologics state-of-the-art development to help determine whether similar innovations already exist. FDA will ensure USPTO access to sources maintained by the agency for this purpose, and the two agencies will collaborate on developing policies aimed at protecting and promoting US innovation, a process that will solicit public input in upcoming events and listening sessions.
FDA’s role in addressing patent practices likely to delay competition were described earlier in a September 2021 letter from then-Acting FDA Commissioner Janet Woodcock to her PTO counterpart, urging greater collaboration and engagement between the two agencies to prevent “possible misuse of the patent system” (2). Woodcock outlined how FDA’s Orange Book aims to ensure transparency in patent listings, as does additional similar information on certain licensed biological products. She further described concerns about companies creating “patent thickets” by obtaining multiple patents on different aspects of the same products, as well as patent “evergreening” and “product-hopping” practices designed to forestall competition without advancing innovation.
Woodcock suggested that FDA assist USPTO by offering patent examiners training on its public information and databases that can help identify what is “prior art” to a claimed invention. Joint efforts could cover product eligibility for patent term extensions and information to help USPTO “accurately and fairly” grant patent term extensions where they are appropriate.
The FDA-USPTO collaboration comes as Congress appears to be moving forward with drug pricing legislation, which Democrats hope to include in key budget reconciliation legislation before Congress. The Senate leadership released the text of a bill that updates previous price reform efforts and claims to have support from all 50 Senate Democrats (3). The main proposal requires the Department of Health and Human Services (HHS) to negotiate lower prices paid by Medicare for certain prescription drugs, with the exception of insulin, where separate legislation has been proposed to address the need for significant cost controls. Additional provisions in the Senate bill would cap out-of-pocket spending on drugs by Medicare patients at $2000 a year, and ensure free vaccines to patients. The measure also revises manufacturer rebates on Medical Part B and D and repeals the controversial Part D rebate rule proposed by the Trump administration.
Biotech and pharma innovators have strongly attacked the legislation as a threat to innovation and global competitiveness of US-based firms, predicting big drops in developing new cancer drugs and therapies for rare diseases. At the same time, marketers of generic drugs and biosimilars claim that the revised Medicare negotiating process would undermine the development of lower-cost therapies.
FDA officials acknowledge that the agency plays only an indirect role in drug pricing debates, largely by instituting added efficiencies to drug development and ensuring a transparent and responsive product review process. At the same time, Woodcock noted earlier thatthe agency is “committed to identifying abuses of the system that can impede competition” and to recognizing how pharmaceutical patents impact access to approved medicines.
Jill Wechsler is Washington editor for BioPharm International.
Vol. 35, No. 8
When referring to this article, please cite it as J. Wechsler, “FDA Joins Effort to Curb Drug Patent Abuses,” BioPharm International 35 (8) 2022.