This is the short briefing note that KEI is sending to TPP negotiators, on the issue of regulatory test data, which is currently a monopoly without space for exceptions, in the TPP text:
Exceptions to rights in regulatory test data
Under all agreements the USA is signing, a country can grant a compulsory license or other non-voluntary authorizations to use a patent. But it is not clear how this works with rights in regulatory test data, which are patent like barriers for affordable generic products. Since test data protections are growing in terms, and apply to products even when there is no patent, or a complusory license has been issued on a patent, it is necessary to have some way to grant exceptions. We suggest that the following language we added to the TPP text, to address this issue. It basically says you can create the same exceptions for test data that you can create for patents.
Notwithstanding other provisions in Article QQ.E.16, a Party may provide for limitations and exceptions to the rights to rely upon regulatory test data, applying mutatis mutandis the standards for exceptions in Article 30 or 31 of the TRIPS.