Supplementary Protection Certificates: The Court Of Justice Agrees With Potter Clarkson That SPCs With Negative Terms Are Acceptable

Author:Mr John Miles, Mike Snodin, Ross Cummings and Michael Pears
Profession:Potter Clarkson

The Court of Justice of the European Union (CJEU) ruled yesterday in an important case (C-125/10, Merck Sharp & Dohme Corp. v Deutsches Patent- und Markenamt), relating to Supplementary Protection Certificates (SPCs). The decision of the CJEU is binding upon all national patent offices and courts, and dictates how the term of an SPC is calculated, especially in view of a 6-month extension of term that may be available.

In essence, the CJEU has approved "Model A" of an article published on 7 July 2007 by Mike Snodin and John Miles of this firm, which introduced the revolutionary concept of zero and negative term SPCs.

That is, the CJEU has decided that SPCs can be granted even if they initially have a zero or negative term, i.e. if less than 5 years and 1 day has elapsed between patent filing and Marketing Authorisation (MA) issuance. This is because, provided that at least 4 years, 6 months and 1 day has elapsed from between patent filing and MA issuance, a zero or negative term SPC can serve as the basis for an extended SPC with a positive term.

The particular factual background to this case is discussed in our IP Update no. 153 (relating to the opinion of the Advocate-General that has effectively been confirmed by the Court). However, the essential points of the case, as well as possible actions that you may wish to take, are outlined below.

Legal Principles

SPCs provide additional protection, beyond patent expiry, for products (medicinal or plant protection) that require a marketing authorisation.

The "normal" (unextended) duration of an SPC after the patent expiry is X - 5 years, where X is the period between the patent filing date and the (subsequent) issuance of the marketing authorisation. Although the normal duration is capped at a maximum of 5 years after the patent expiry, this duration can be extended by 6 months if the product has been the subject of clinical trials in the paediatric population in accordance with an investigation plan that has been agreed with the European Medicines Agency.

The question addressed by the CJEU is whether the potential availability of a 6-month extension of term gives rise to the possibility of obtaining...

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