BIA submission to the IPO call for views on the SPC manufacturing waiver

The BIA has responded to the UK Intellectual Property Office's call for views on the European Commission's Proposal for an Supplementary Protection Certificate (SPC) manufacturing waiver.

In our submission, we said:

• SPCs are a valuable and proven incentive for promoting investment and innovation in the life sciences. The introduction of a manufacturing waiver undermines this incentive and weakens the EU environment as a destination for biopharmaceutical investment and the provision of innovative medicines for patients
• The BIA welcomes the fact that the proposed waiver does not extend to stockpiling nor granted SPCs, which would not be consistent with the general principles of legal certainty and life science businesses’ legitimate expectations
• However, the scope of the Proposal is poorly defined in some areas, including the definition of export markets and "the maker"
• Furthermore, the safeguards in the Proposal do not confer sufficient protection to SPC holders
• The BIA urges the UK government to support the general principles of legal certainty and life science businesses’ legitimate expectations by calling for the Proposal to be amended to remove pending SPC applications from its scope; and the notification period to be extended to 90 days and to be made to the SPC holder as well as the relevant authority