“Second, where a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent (see Biogen, paragraph 28)"and then explains that this statement
"may create the impression that each basic patent can only give rise to one certificate, regardless of how many different products this patent covers. However, this impression of the statement is misguided as it ignores Medeva’s (Biogen’s) reference to Art. 3(c) of Reg. 469/2009. Art. 3(c) does not limit the number of certificates per basic patent to one in general terms but limits this number to one for a specific product. Art. 3 as a whole does not, and cannot, address a situation concerning an assortment of products covered by a basic patent, but defines the granting requirements for a single product. It is noteworthy that Art. 3(a) to (d) uses the definite article “the” product and not “a” product. If a certificate for a product covered by a basic patent would rule out a certificate for another product, then the indefinite article would have been used in Art. 3(c). Therefore para. 28 of Biogen and similarly para. 41 of Medeva must be read and supplemented in conformity with Art. 3 (c) as follows:The SPC Blog thanks Herwig for his close analysis of the ipsissima verba of the ECJ and hopes to hear from any readers who have information concerning court decisions denying a certificate for a product covered by a basic patent where that basic patent previously gave rise to an earlier certificate covering another product based on Biogen para. 28.
“Under Article 3(c) of the Regulation, however, only one certificate may be granted for a product for each basic patent.”The statement in Medeva para. 41 does not create new law: it just repeats Biogen para. 28 which has been in place since 1997. To my knowledge there are no court decisions denying a certificate for a product covered by a basic patent where that basic patent already gave rise to an earlier certificate covering another product based on Biogen para. 28. However, if other SPC readers have different information, will they please come forward.
Daiichi (Case C-6/11) may be of relevance for the interpretation of Biogen para. 28/Medeva para. 41. It deals with a situation where the claims of a basic patent are limited to a single active ingredient A and the subject of the marketing authorization is directed to A+B. According to the decision, no SPC is possible for the combination A+B, because this combination is not identified (specified) in the claims of the basic patent, as required by Art. 3(a). However, Daiichi raised no objection pursuant to Art. 3(c), although previously a SPC had issued for A supported by the same basic patent, a fact before the British court and the ECJ. The ECJ’s ruling would at least imply that a SPC would have been possible for A+B, had the patent claims identified (specified) this combination. This further supports the opinion expressed here that, contrary to one impression created by Biogen para. 28/Medeva para. 41, a single basic patent would be capable of supporting more than one SPC (one for the product A and another one for the product A+B)".