Patents hurt Pharma Innovation
Fedman et al 21 [Robin Feldman, David Hyman, W. Nicholson Price II, Mark Ratain; 10 Aug 2021; University of California Hastings College of the Law, San Francisco, CA, USA Robin C. Feldman Georgetown University Law Center, Washington, DC, USA David A. Hyman University of Michigan Law School, Ann Arbor, MI, USA W. Nicholson Price II The University of Chicago, Chicago, IL, USA Mark J. Ratain; Negative innovation: when patents are bad for patients; https://www.nature.com/articles/s41587-021-00999-0]
Negative innovation causes real harms. Ibrutinib is a case study of the risks that resulted from the ability of Pharmacyclics to game the patenting and drug approval processes. The costs and health consequences are borne by payers (including large self-insured corporations) and cancer patients, who are subjected to a patent-protected dosing method far in excess of what is required to obtain the desired therapeutic effects—a point that the FDA noted in its initial 2013 review—which may also result in unnecessary cardiovascular toxicities9. If we want to prevent repetition, we need to mandate greater coordination between the FDA and USPTO, create robust incentives (including severe penalties) discouraging drug companies from engaging in such conduct, and fix the regulations that allowed and potentially encouraged this outcome.
Of course, all of our proposals involve difficult and complicated issues of implementation. However, if we want to prevent future negative innovation and the associated harms to patients, we need to make some changes. Promoting the progress of Science and useful Arts—the Constitutional purpose of the patent system—demands nothing less.