Actavis Group PTC EHF and Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG.
Date: 2015-03-12
33. It should be recalled in that regard, first, that it is possible, in principle, on the basis of a patent which protects several different ‘products’, to obtain several SPCs in relation to each of those different products, provided, inter alia, that each of those products is ‘protected’ as such by that ‘basic patent’ within the meaning of Article 3(a) of Regulation No 469/2009, in conjunction with Article 1(b) and (c) of that regulation (see, to that effect, judgments in Actavis Group PTC and Actavis UK , C‑443/12, EU:C:2013:833, paragraph 29, and Georgetown University , C‑484/12, EU:C:2013:828, paragraph 30).
34. Second, it should be noted that, according to recitals 4, 5 and 9 in the preamble to Directive No 469/2009, the SPC is designed to re-establish a sufficient period of effective protection of a basic patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of his patent, which is intended to compensate, at least in part, for the delay to the commercial exploitation of his invention by reason of the time which has elapsed between the date on which the application for that patent was filed and the date on which the first marketing authorisation in the European Union was granted (see, to that effect, judgment in Actavis Group PTC and Actavis UK , C‑443/12, EU:C:2013:833, paragraph 31 and the case-law cited).
35. However, the Court has also held that the objective pursued by Regulation No 469/2009 is not to compensate the holder fully for the delay to the marketing of his invention or to compensate for such delay in connection with the marketing of that invention in all its possible commercial forms, including in the form of combinations based on the same active ingredient (see, to that effect, judgment in Actavis Group PTC and Actavis UK , EU:C:2013:833, paragraph 40).
36. In the light of the need, referred to, inter alia, in recital 10 in the preamble to Regulation No 469/2009, to take into account all the interests at stake, including those of public health, if it were accepted that all subsequent marketing of an active ingredient in conjunction with an unlimited number of other active ingredients which do not constitute the subject-matter of the invention covered by the basic patent would confer entitlement to multiple SPCs, that would be contrary to the requirement to balance the interests of the pharmaceutical industry and those of public health as regards the encouragement of research within the European Union by the use of SPCs (see, to that effect, judgment in Actavis Group PTC and Actavis UK , EU:C:2013:833, paragraph 41).
37. Accordingly, in view of the interests referred to in recitals 4, 5, 9 and 10 in the preamble to Directive 469/2009, it cannot be accepted that the holder of a basic patent in force may obtain a new SPC, potentially for a longer period of protection, each time he places on the market in a Member State a medicinal product containing, on the one hand, an active ingredient, protected as such by the holder’s basic patent and constituting the subject-matter of the invention covered by that patent, and, on the other, another substance which does not constitute the subject-matter of the invention covered by the basic patent (see, to that effect, judgment in Actavis Group PTC and Actavis UK , EU:C:2013:833, paragraph 30).