NCHR Comments on USPTO-FDA Collaboration and Engagement

February 6, 2023

Kathi Vidal, JD
Director
U.S. Patent and Trademark Office
Alexandria, VA 22314

Robert Califf, MD
Commissioner
U.S. Food and Drug Administration
Silver Spring, MD 20993

Re: Docket No. PTO-P-2022-0037

Director Vidal and Commissioner Califf:

Please accept the following comments on behalf of the National Center for Health Research (NCHR) in response to the request by the Food and Drug Administration (FDA) and the Patent and Trademark Office (USPTO) for public input on USPTO-FDA collaboration and engagement. NCHR is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective and affordable for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

Access to generics and biosimilars is vital to lowering overall health expenditures for the country, so we strongly support your decision to prioritize a collaborative bi-agency approach to this issue. The current U.S. patent system for drugs provides substantial opportunities for companies to abuse the system by making very minor changes that result in new patents for popular older drugs. Additionally, existing drugs can be patented for new uses or new formulations. Although the patent’s primary lifespan is 20 years from filing, it can be extended with additional applications, which creates barriers to competition and allows companies to charge higher prices for many additional years. For example, as has recently been reported, AbbVie has 165 successful patents for Humira, which has allowed the company to raise the price approximately 60% since 2016.1

Access to generics and biosimilars tends to generate new competition that has the potential to bring savings to the overall market. Brand-name drugs account for only 10% of prescriptions dispensed in the U.S. and 74% of the spending.2 Generic drug approvals in 2018 resulted in an annual savings of over $17.8 billion and grew to $24.8 billion in 2019.3 Unfortunately, many brand name drugs remain without a generic or biosimilar equivalent due to abuse of patents by pharmaceutical companies.

Congress has expressed concern over the strategies companies use to suppress competition. A 2021 House Oversight and Reform Committee investigation identified more than 600 patents for the 12 drugs reviewed, and found the monopoly periods could be extended to a combined total of nearly 300 years.4 Research has also found that of roughly 100 bestselling drugs, nearly 70 percent obtained an additional patent to extend its monopoly period at least once; nearly 50 percent extended it more than once.5 We enthusiastically support efforts for the FDA and the USPTO to work together to address these issues that contribute to higher prices for patients.

We also agree with other experts that FDA-required processes or protocols should not be eligible for patents. Current law allows drug companies to patent protocols such as the Risk Evaluation and Mitigation Strategy (REMS), which is intended to lower the risk of certain drugs that are on the market. This enables companies to patent a mandatory REMS procedure and to use that patent to block competitors. Granting this type of patent does not advance innovation since REMS programs do not change the drug itself. For this reason, we urge the USPTO to cease issuing patents on distribution programs.

We look forward to working with both of you and your staff on these urgent issues. Access to generic drugs and biosimilars is critically important and abuse of the patent system remains a major barrier. We are hopeful that meaningful collaboration between the FDA and the USPTO will result in substantial improvements.

 

  1. Robbins, R. (2023). How a Drug Company Made $114 Billion by Gaming the U.S. Patent System. The New York Times. https://www.nytimes.com/2023/01/28/business/humira-abbvie-monopoly.html
  2. Association for Accessible Medications. (2017). Generic Drug Access & Savings in the U.S. https://accessiblemeds.org/sites/default/files/2017-07/2017-AAM-Access-Savings-Report-2017-web2.pdf
  3. Ryan Conrad PhD et al., “Estimating Cost Savings from New Generic Drug Approvals in 2018, 2019, and 2020”, US Food and Drug Administration, August 2022, accessed at https://www.fda.gov/media/161540/download
  4. House of Representatives Committee on Oversight and Reform (2021). Drug Pricing Report. https://oversight.house.gov/sites/democrats.oversight.house.gov/files/DRUG%20PRICING%20REPORT%20WITH%20APPENDIX%20v3.pdf
  5. Feldman, R. (2018). May Your Drug Price by Evergreen. Journal of Law and the Biosciences. 5(3), 590-647. https://doi.org/10.1093/jlb/lsy022