WASHINGTON (Feb. 17, 2021)—As pressure mounts on Congress and the Biden administration to address COVID-19 and domestic healthcare policy more generally, there has been increasing attention to lowering drug prices by imposing limits on patents that prevent generic competition.

In a new policy study, Charles Duan, a senior fellow of technology and innovation policy at the R Street Institute, investigates one particular area of reform, namely streamlining patent litigation to enable greater entry of an especially important class of competitive drugs called biosimilars. His research finds that biosimilars patent litigation is growing in complexity as more biosimilars come to market, meaning that reforms in this area will be important and potentially effective.

With respect to the key reform proposal on this subject, the Affordable Prescriptions for Patients Act (APPA), Duan finds that the bill’s general approach of limiting the number of patents in biosimilars lawsuits would likely cut down on the most costly and time-consuming cases while still enabling innovators to protect their interests, contrary to the fears of some of the bill’s critics.

Nevertheless, the study finds that the particular limits provided in the APPA are too generous to pharmaceutical patent holders to make a useful dent in litigation complexity or biosimilar entry. Duan proposes stronger limits that would further reduce the number of patents that biosimilar makers would have to deal with, and additional reforms to make the bill more effective in view of the biosimilars patent litigation landscape examined.

According to Duan: “This study confirms that biologics patent litigation is becoming increasingly complex and voluminous, so imposing limits could cut down on the most cost-prohibitive litigation. At the same time, nearly all biologics litigation would be unaffected by the particular numerical limitations that the APPA provides…More stringent litigation limits may increase the effectiveness of the legislation while still avoiding widescale industry disruption.”

Read the full study, “Biologics Patent Litigation: Reforms for Lowering Drug Prices,” here.