NIPMO Eases IPR Act Controls for Certain Clinical Trials
Clinical Trials in phases 1 to 3 are regarded as “research” and as such fall under the Intellectual Property Rights from Publicly Financed R&D Act (the IPR Act) where they are not conducted at full cost. There have been challenges negotiating contracts with philanthropic funders who are focussed on diseases such as TB, cannot pay Full Cost, but want certain IP rights. It is important for both the university and the country to be able to participate in these trials as there are broad benefits.
NIPMO has granted upfront approval for IP transactions (that include royalty-free non-exclusive licenses, offshore exclusive licenses, or local and offshore assignments) for specific infectious diseases which include HIV/Aids, TB, malaria and neglected diseases where a philanthropic organisation or its intermediary is funding the trial, at below full cost. There needs to be an objective to making the drugs being tested available at a preferential rate or reduced cost in developing countries.
Serendipitous IP arising during the course of the trial would still be owned by the university in these below full cost projects and is governed by the usual provisions of the IPR Act.
The full list of neglected diseases are listed in the NIPMO Notice on Clinical Trials which can be downloaded from the IPR Act page.
RCIPS needs to report six-monthly to NIPMO on such clinical trial agreements that have been entered into. This special dispensation is available on a trial basis till 30 August 2016.