BIO 2015 Dispatches: Data transparency initiatives could deter industry investment, attorney says
by Sue Sutter
Clinical trial data transparency initiatives could make it difficult for drug developers to secure patents for new products and, in turn, investment for their compounds, an industry attorney said on 15 June.
During a panel discussion at the Biotechnology Industry Organization's annual convention in Philadelphia, Covington and Burling partner Richard Kingham said global transparency initiatives that require publication of trial results while a compound is still early in development could close off a drug developer's ability to patent an innovation.
"The moment the information is disclosed it becomes part of the prior art, and therefore you can't get a patent," Kingham said.
While Kingham asserted that transparency initiatives could undercut intellectual property, deterring investment and drug development in the process, European Medicines Agency Senior Medical Officer Hans-Georg Eichler had a decidedly more optimistic view of the investor impact of public and private data transparency initiatives sweeping across the globe. Greater data-sharing will increase efficiency in drug development and reduce the high rate of failure in the clinical stages, which is something that investors should welcome, Eichler said.
EMA led, and industry followed
The panel discussion at BIO brought together representatives from industry and the European Union regulator to discuss recent developments in global initiatives to increase clinical data transparency.
EMA has taken a driving role in these initiatives, and its interest in the subject has led industry to develop its own voluntary measures...
