Teva UK Ltd and Others v Gilead Sciences Inc.
Date: 2018-07-25
31


According to the Court’s settled case-law, since no harmonised European Union patent rules are applicable in the main proceedings, the extent of the protection conferred by a basic patent can be determined only in the light of the non-European Union rules governing patents (see, to that effect, judgment of 12 December 2013, Eli Lilly and Company, C‑493/12, EU:C:2013:835, paragraph 31 and the case-law cited).
32


The Court has stated that the rules for determining what is ‘protected by a basic patent in force’ within the meaning of Article 3(a) of Regulation No 469/2009 are those relating to the extent of the invention covered by such a patent, just as is provided, in the case before the Court, in Article 69 of the EPC and the Protocol on the interpretation of that provision, to which section 125 of the UK Patents Act 1977 gives effect in the United Kingdom (see, to that effect, judgment of 12 December 2013, Eli Lilly and Company, C‑493/12, EU:C:2013:835, paragraph 32).
33


First, for the purpose of applying Article 3(a) of Regulation No 469/2009, recourse may not be had to the rules governing infringement proceedings, such as, in the main proceedings, those laid down in section 60 of the UK Patents Act 1977 (see, to that effect, judgment of 12 December 2013, Eli Lilly and Company, C‑493/12, EU:C:2013:835, paragraph 33).
34


Secondly, the Court has repeatedly emphasised the key role played by the claims for the purpose of determining whether a product is protected by a basic patent within the meaning of that provision (see, to that effect, judgment of 12 December 2013, Eli Lilly and Company, C‑493/12, EU:C:2013:835, paragraph 34 and the case-law cited).
35


So far as, specifically, the European patent is concerned, pursuant to Article 69 of the EPC, the extent of the protection conferred by such a patent is determined by the claims. The information in Article 1 of the Protocol on the Interpretation of Article 69 of the EPC states that those claims must ensure both a fair protection for the patent proprietor and a reasonable degree of legal certainty for third parties. Thus, they are not to serve only as a guideline, nor can they be interpreted as meaning that the extent of the protection conferred by a patent is that defined by the narrow, literal meaning of the wording used in the claims.
36


In this respect, the Court has held that Article 3(a) of Regulation No 469/2009 does not, in principle, preclude an active ingredient which is given a functional definition in the claims of a basic patent issued by the EPO being regarded as protected by the patent, on condition that it is possible, on the basis of those claims as interpreted inter alia in the light of the description of the invention, as required under Article 69 of the EPC and Protocol on the Interpretation of that provision, to conclude that the claims relate implicitly but necessarily and specifically to the active ingredient in question (see judgment of 12 December 2013, Eli Lilly and Company, C‑493/12, EU:C:2013:835, paragraph 39).
39


That requirement is in line with the objective of the SPC, which is to re-establish a sufficient period of effective protection of the basic patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of that 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 the patent was filed and the date on which the first MA in the European Union was granted. As indicated in recital 4 of Regulation No 469/2009, the purpose of that additional period of exclusivity is to encourage research and, to that end, it is designed to ensure that the investments put into such research are covered (see, to that effect, judgment of 12 December 2013, Eli Lilly and Company, C‑493/12, EU:C:2013:835, paragraphs 41 and 42 and the case-law cited).
40


However, it is not the purpose of the SPC to extend the protection conferred by that patent beyond the invention which the patent covers. It would be contrary to the objective of Regulation No 469/2009, reiterated in the preceding paragraph, to grant an SPC for a product which does not fall under the invention covered by the basic patent, inasmuch as such an SPC would not relate to the results of the research claimed under that patent.
41


In the light of the need, referred to inter alia in recital 10 of the preamble to Regulation No 469/2009, to take into account all the interests at stake, including those of public health, to accept that an SPC could grant to the holder of the basic patent protection which goes beyond the protection guaranteed by that patent in connection with the invention it covers 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, by analogy, judgment of 12 March 2015, Actavis Group PTC and Actavis UK, C‑577/13, EU:C:2015:165, paragraph 36 and the case-law cited).
42


It must be added that, in view of the interests referred to in recitals 4, 5, 9 and 10 of Directive 469/2009, it cannot be accepted that the holder of a basic patent in force may obtain an SPC 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 of 12 March 2015, Actavis Group PTC and Actavis UK, C‑577/13, EU:C:2015:165, paragraph 37 and the case-law cited).
45


The same is true regarding Article 5 of that regulation, under which the SPC confers the same rights as conferred by the basic patent and is subject to the same obligations. Accordingly, if, during the period in which the patent was valid, the patent holder could oppose, on the basis of his patent, all use or certain uses of his product in the form of a medicinal product consisting of such a product or containing it, the SPC granted in relation to that product would confer on the holder the same rights for all uses of the product, as a medicinal product, which were authorised before the expiry of the certificate (judgments of 24 November 2011, Medeva, C‑322/10, EU:C:2011:773, paragraph 39, and of 24 November 2011, Georgetown University and Others, C‑422/10, EU:C:2011:776, paragraph 32).
46


It follows from the above that the subject matter of the protection conferred by an SPC must be restricted to the technical specifications of the invention covered by the basic patent, such as claimed in that patent.
52


Having regard to all the foregoing considerations, a product is ‘protected by a basic patent in force’ within the meaning of Article 3(a) of Regulation No 469/2009 in so far as, if that product is not expressly mentioned in the claims of the basic patent, one of those claims relates to it necessarily and specifically. For that purpose, that product must, from the point of view of a person skilled in the art and in the light of the description and drawings of the basic patent, necessarily fall under the invention covered by that patent. The person skilled in the art must be able identify that product specifically in the light of all the information disclosed by that patent, on the basis of the prior art at the filing date or priority date of the patent concerned.