Abraxis Bioscience LLC v Comptroller General of Patents.
Date: 2019-03-21
16


In that regard, it is a matter of settled case-law that the Court may, of its own motion, on a proposal from the Advocate General, or at the request of the parties, order the reopening of the oral procedure under Article 83 of its Rules of Procedure if it considers that it lacks sufficient information or that the case must be decided on the basis of an argument which has not been debated between the parties. By contrast, neither the Statute of the Court of Justice of the European Union nor the Rules of Procedure make provision for the parties to submit observations in response to the Advocate General’s Opinion (judgment of 23 January 2018, F. Hoffmann-La Roche and Others, C‑179/16, EU:C:2018:25, paragraph 39 and the case-law cited).
25


According to the Court’s settled case-law, in the absence of any definition of the concept of ‘active ingredient’ in Regulation No 469/2009, the meaning and scope of those terms must be determined by considering the general context in which they are used and their usual meaning in everyday language. In this case, it is generally accepted in pharmacology that the term ‘active ingredient’ does not include substances forming part of a medicinal product which do not have an effect of their own on the human or animal body (order of 14 November 2013, Glaxosmithkline Biologicals and Glaxosmithkline Biologicals, Niederlassung der Smithkline Beecham Pharma, C‑210/13, EU:C:2013:762, paragraphs 27 and 28 and the case-law cited).
26


In that regard, paragraph 11 of the Explanatory Memorandum of 11 April 1990 to the Proposal for a Council Regulation (EEC) concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final), which led to Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (OJ 1992 L 182, p. 1), itself repealed and replaced by Regulation No 469/2009, indicates that the term ‘product’ is understood to mean an active substance in the strict sense and that minor changes to the medicinal product such as a new dose, the use of a different salt or ester or even of a different pharmaceutical form will not lead to the issue of a new SPC.
34


As the Advocate General noted, in essence, in point 30 of his Opinion, in the light of the definition of the scope of ‘product’, as is clear from the Court’s settled case-law, a literal interpretation of Article 3(d) of Regulation No 469/2009 presupposes that the first MA for the product as a medicinal product within the meaning of that provision means the first MA for a medicinal product incorporating the active ingredient or the combination of active ingredients at issue.
35


According to such an interpretation, only the authorisation in respect of the first medicinal product placed on the market, consisting of the product concerned, may be regarded as the first MA within the meaning of Article 3(d) of Regulation No 469/2009, as defined in Article 1(b) of that regulation (see, to that effect, judgment of 24 November 2011, Medeva, C‑322/10, EU:C:2011:773, paragraph 40).
36


It should be added that, with regard to the objective of Regulation No 469/2009, it is clear from the wording of recitals 3 to 5 and 9 thereof, as the Advocate General observed in point 50 of his Opinion, that the SPC regime has the purpose of compensating for the lack of protection conferred by a patent with respect to covering the investment put into research concerning new medicinal products and, therefore, of encouraging that research. However, it follows from recital 10 of that regulation that the legislature intended to achieve that objective so as to take into account all the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector.
37


That finding, which supports a narrow interpretation of Article 3(d) of Regulation No 469/2009, is confirmed by the Explanatory Memorandum of 11 April 1990 to the Proposal for a Regulation, referred to in paragraph 26 of the present judgment, the effect of which is, as the Advocate General observed in points 52 to 55, 66 and 69 of his Opinion, that the legislature intended, in establishing the SPC regime, to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product.
38


Such an objective would be jeopardised if, in order to fulfil the condition set out in Article 3(d) of Regulation No 469/2009, it were possible to take into account, in respect of a new formulation of an old active ingredient, solely the first MA to be covered by the scope of the basic patent protecting that new formulation and to disregard an MA which had been granted previously in respect of the same active ingredient in another formulation.