Will clinical trial data disclosure reduce incentives to develop new uses of drugs?
Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the University of New Hampshire School of Law, and past Visiting Scholar Timo Minnsen, Associate Professor at the University of Copenhagen School of Law, have published an article in Nature Biotechnology on how changes in the regulation of clinical trial data could affect drug development.
From the article:
[...] New and non-obvious uses discovered during clinical trials would still be patentable. Frequently, though, such uses are discovered after the original drug's approval, or they are noted but not adequately appreciated before disclosure would be required—too late to be patented. Furthermore, disclosure crosses international borders: European disclosures will block US patents, and vice versa.
Without patents and with little or no data exclusivity available for originator companies, companies will have little incentive to invest in validating new uses and bringing them into widespread use. Similar challenges may arise even for completely new drugs, such as innovative biologics, where the broad increase to the 'prior art' and 'common general knowledge' created by clinical trial disclosure may render many related new drugs unpatentably obvious. [...]fda health law policy human subjects research innovation intellectual property international pharmaceuticals regulation