Will Clinical Trial Data Sharing Hurt Innovation?
Posted on: Thursday, July 30, 2015

A recent report by two patent law professors, one from the US and one Denmark, raised concerns that reporting of detailed clinical trial information, as required under the current laws, could adversely affect the patentability of new uses of drugs. Analysis of full clinical trials data may reveal novel indications not previously known or obvious, making it difficult to patent a further, significant use of the drug at a later date. Due to lack of patentability, the new application may not be developed. It is widely accepted that sharing of detailed data from clinical trials would increase transparency, reduce redundancy, and improve the overall efficiency of clinical research. Over the last few years, FDA and EMA made rules for mandatory reporting of clinical trial data, not just results but full clinical study reports containing individual patient data (IPD). As of 1 July 2015, EMA will provide all clinical trial data including clinical study reports and IPD upon request. Most scientific journals require all clinical data to be made available before the results of a given trial can be published. The US and European pharmaceutical industry trade groups, PhRMA and EFPIA, respectively, announced the “Clinical Trial Data Sharing” initiative in July 2013 that seems to have created a system whereby companies disclose detailed information about clinical trials sponsored by them to researchers and public upon request. However, the authors of the Nature Biotechnology article argue that much of the new uses of a given drug are only known after the initial approval after further analysis of clinical trial results. A company developing a given drug has the specific skills and technical experience to make these new uses available to patients faster than others and hence would need an incentive to do the same such as being able to patent the new uses. The authors suggest that without a reasonable protection to developers of new uses of drug such as regulatory exclusivity and patent protection, the transparency laws may hurt innovation in the long run.

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research