Key Points

1. 1) 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.
2. 2) The general approach of limiting the number of patents in biosimilars lawsuits proposed in the Affordable Prescriptions for Patients Act (APPA)—the key reform proposal on the subject—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.
3. 3) 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. Reforms, such as stronger limits that would further reduce the number of patents that biosimilar makers would have to deal with, would make the bill more effective in view of the examined biosimilars patent litigation landscape.