Position paper 21 September 2016

Export Manufacturing Exemption during SPC/PTR Extended Patent Term: Global Position

Position paper

Proposals have been made recently to introduce a manufacturing exemption during the term of protection granted by incentive mechanisms, such as the Supplementary Protection Certificate (SPC) and Patent Term Restoration (PTR). These mechanisms are critically important to preserve incentives to develop new medicines and distribute them to patients by compensating for erosion of the patent term due lengthy testing requirements before an MA can be obtained.

Such proposals would provide an exception to existing norms of intellectual property protection by allowing generic and biosimilar producers to manufacture pharmaceutical products during the SPC/PTR term for export to countries where no patent or other relevant intellectual property rights protecting concerned products are available, or where these rights have expired.