SPC manufacturing waiver

The manufacturing waiver is the exception to the supplementary protection certificate that authorises manufacturers of generics and biosimilars established in the Union to manufacture the protected product during the term of the certificate, either to export it to third countries where protection has expired or never existed, or to build up stocks for launch in the Union as soon as the certificate expires. It was introduced by a 2019 regulation amending the Regulation concerning the supplementary protection certificate for medicinal products. The manufacturing waiver aims to restore the competitiveness of European manufacturers against their competitors established outside the Union.

The two parts of the manufacturing waiver

First, manufacturing for export: the manufacturer may produce, and perform the acts strictly necessary for manufacturing and export, throughout the term of the certificate, provided the products are exported to third countries. Next, manufacturing for stockpiling: during the last six months of the certificate, the manufacturer may produce and store the product in the Union, in order to place it on the market from the first day after expiry. Finally, the indispensable related acts, such as importing the active ingredient or packaging, are covered, excluding any placing on the Union market before expiry.

Conditions and safeguards

The manufacturer must notify its intention to the national office that granted the certificate, in France theINPI, and to the certificate holder, at least three months before manufacturing starts, indicating the export countries and the certificate references. Products intended for export must bear a specific logo indicating that they are reserved for export outside the Union. The manufacturer must inform its partners in the manufacturing and distribution chain of the limits of the waiver. The certificate holder may check compliance with these conditions and act in case of diversion. The texts can be consulted on EUR-Lex.

Key points

In practice, the manufacturing waiver concerns only the supplementary protection certificate: it does not apply to the basic patent still in force, nor to other patents covering the product. A manufacturer relying on it must check the whole patent landscape. Disputes concern the regularity of the notification, the actual destination of the products and the diversion of stocks. The firm handles these issues, as presented on the page pharmaceutical patents and regulation and on the entry biosimilar.