The SPC Manufacturing & Stockpiling Waiver
In the EU, Supplementary Protection Certificates (SPCs) extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse between when the patent application is filed and when marketing authorization is granted.
Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 introduces an exception to the protection conferred by an SPC for products, or medicinal products containing those products, manufactured for export purposes and/or stockpiling purposes. Under the Regulation, generic and biosimilar makers will be able to obtain a waiver to manufacture SPC-protected products for export to non-EU countries where intellectual property protections for those products have expired or never existed. The proposal will also allow for the stockpiling of generic and biosimilars during the final six months of SPC protection to enable day-one market entry for those products. The Regulation will enter into force across all Member States on 01 July 2019.
The main provisions of the SPC manufacturing waiver regulation can be summarized as follows:
· The waiver will have the effect of creating an exception to the protection conferred by an SPC so as to allow the making of a product, or a medicinal product containing that product, for the purpose of export to third countries outside the EU as well as permitting stockpiling for day-1 entry to the EU market immediately after SPC expiry.
· The waiver will allow the manufacture for export of generics and biosimilars throughout the entire SPC lifetime whereas the manufacturing and stockpiling for day-1 marketing in the EU will be permitted only during the last six months before SPC expiry.
· The Regulation requires a generics or biosimilar producer intending to benefit from the manufacturing waiver to notify not only the national patent office that granted the SPC in question, using a standardized form, but must also directly inform the SPC holder and all those involved in the commercialisation of the product, no later than three months before the intended start of manufacture (or the first related act). The competent national patent office will be required to publish the notified information together with the date of notification as soon as possible.
· The information to be notified to the competent national patent office includes the name and address of the manufacturer; an indication whether the intended manufacture is for the purpose of export, storing, or both export and storing; the EU member state where the manufacture is to take place (and, if applicable, the member state where the first related act prior to manufacture is to take place); the number of the SPC in question; and, in the case of export to third countries, the reference number of the marketing authorization in each third country of export. Any subsequent changes to this information must also be notified. The standard form provided for notifications is available in PDF or Word to download.
Notifications may be sent to the Intellectual Property Office of Ireland which is the competent authority for Ireland, by email to: email@example.com
or alternatively by post to:
Intellectual Property Office of Ireland
· The Regulation requires that the new “EU export” logo (shown below) must be affixed by the maker to the outer packaging and, where feasible, the immediate packaging of products made for the purpose of export to third countries outside the EU.