The SPC Waiver: Will a manufacturing exemption be approved next week?

The proposed SPC manufacturing waiver (the SPC Waiver) will be subject to the European Parliament’s first plenary reading next week. If approved, the European Council can, subject to political priorities turn the SPC waiver into EU law before the end of the summer. The waiver implies significant changes to intellectual property protection for pharmaceutical products – here is Setterwalls’ recap of the latest proposal to amend the SPC Regulation (Regulation (EC) No 469/2009).

What is the SPC Waiver? If the current proposal is adopted, it will introduce several exemptions from Supplementary Protection Certificate (SPC) protection. Today, the SPC confers the same exclusive rights as conferred by the basic product patent and shall be subject to the same limitations and the same obligations. Under the SPC Waiver, competitors to SPC holders will be allowed to perform certain manufacturing, exporting and storing of SPC protected products during the SPC term. The exemptions have been subject to intensive debate since they will affect business areas of vast commercial value and likely lead to a re-balancing of the European pharmaceutical market.

Under the current SPC Waiver proposal, the exemptions from the SPC holder’s exclusive rights can be summarized as follows:

(a) Making a product for the purpose of export to non-EU countries;
(b) Making a product, within six months before SPC expiry, for the purpose of storing it in order to place it on the market of Member States after SPC expiry; 
(c) Any acts related to and strictly necessary for making according to (a) – (b), for export (a) or for storing (b). Acts concerning making and storing in accordance with (b) must be carried out within six months before SPC expiry.

However, utilizing these exemptions (a) – (c) would also require the product manufacturer to comply with a set of safeguard measures, which have been set up to facilitate compliance monitoring. Under the current proposal, the safeguard measures would, for instance, include informing the SPC holder and notifying the competent national patent office where the making and storing will take place, as well as ensuring that the product manufacturer’s contractors are fully informed and aware of the exemptions applied and the consequences of non-compliance. 

If adopted, the SPC Waiver proposal will lead to completely new challenges and opportunities for stakeholders on the European pharmaceutical market, who should follow the situation in the European Parliament next week closely. 

Setterwalls has extensive experience in providing advice on supplementary protection certificates for pharmaceuticals and we are following developments in this area. You are welcome to contact us.

Read about what happened here.