Supplementary Protection Certificate - Scope of The Law

Scope of The Law

ECJ cases C-195/09 and C-427/09 effectively ruled that SPCs for medicaments (human or veterinary) are only available for those “products” that: (a) are protected by a patent; (b) have been subject to an administrative authorisation procedure; and (c) have not been placed on the market anywhere in the EEA as a medicinal product prior to being subject to safety and efficacy testing and a regulatory review.

Until recently, decisions C-195/09 and C-427/09 could have been interpreted as ruling out the possibility of SPC protection for all "products" previously included in medicinal products that were marketed prior to the date(s) of the Marketing Authorisation(s) (MA(s)) specified in the SPC application. This is because the ECJ's rulings in C-195/09 and C-427/09 were based in part upon a desire to ensure that national patent offices are not required to assess whether an earlier MA was compliant with the standards for testing of safety and efficacy that were introduced in the 1970s (meaning that all prior MAs, whether or not compliant with those standards, should be treated equally under the SPC legislation).

However, the decision in Neurim Pharmaceuticals (C-130/11) has cast doubt upon this interpretation. In C-130/11, the ECJ held that an SPC can be granted regardless of the prior marketing of earlier (veterinary) medicinal products containing the "product" in question. Thus, cases C-195/09 and C-427/09 (which, in common with C-130/11, related to SPC applications based upon newly patented uses for old "products") could perhaps now be viewed as being of relevance only to those "products" that were marketed before being subject to a regulatory review. However, this might necessitate patent offices making a determination of whether prior MAs are compliant with current standards (i.e. whether the "product" had been subject to safety and efficacy testing prior to being granted an MA). As this is precisely the kind of determination that the ECJ had previously been keen for patent offices to avoid, further references to the ECJ may be necessary to clarify precisely which "products" fall within the scope of the SPC legislation and which do not.

With respect to (a) above, the question of how to determine whether a "product" is protected by a patent is the subject of ongoing controversy. Cases such as C-322/10 and C-422/10 have indicated that the "product" needs to be "specified in the wording of the claims". However, the precise meaning of this test is yet to be clarified.

Further, although the SPC legislation mentions only Directives 2001/83/EC and 2001/82/EC as the "administrative authorisation procedure" for human or veterinary medicaments, SPCs are known to have been granted when MAs have not been obtained via those procedures (but instead via procedures that involve a similar level of safety and efficacy testing).