Incyte Corporation v Szellemi Tulajdon Nemzeti Hivatala.
Date: 2017-12-20
30


However, the fact that a national court has, formally speaking, worded a request for a preliminary ruling with reference to certain provisions of EU law does not preclude the Court from providing to the national court all the elements of interpretation which may be of assistance in adjudicating on the case pending before it, whether or not that court has referred to them in its questions (judgment of 10 September 2014, Kušionová, C‑34/13, EU:C:2014:2189, paragraph 71).
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In that regard, it should be noted that, in accordance with settled case-law, the interpretation which the Court, in the exercise of the jurisdiction conferred upon it by Article 267 TFEU, gives to a rule of EU law clarifies and, where necessary, defines the meaning and scope of that rule as it must be, or ought to have been, understood and applied from the date of its entry into force. It follows that the rule as thus interpreted may, and must, be applied by the courts even to legal relationships arising and established before the delivery of the judgment ruling on the request for interpretation, provided that in other respects the conditions under which an action relating to the application of that rule may be brought before the courts having jurisdiction are satisfied (judgment of 14 April 2015, Manea, C‑76/14, EU:C:2015:216, paragraph 53 and the case-law cited).
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In that regard, it should be noted that, according to settled case-law, finality of an administrative decision, which is acquired upon expiry of the reasonable time limits for legal remedies or by exhaustion of those remedies, contributes to legal certainty, and it follows that EU law does not require that an administrative body be, in principle, under an obligation to reopen an administrative decision which has become final (see, inter alia, judgments of 13 January 2004, Kühne & Heitz, C‑453/00, EU:C:2004:17, paragraph 24; of 12 February 2008, Kempter, C‑2/06, EU:C:2008:78, paragraph 37; and of 4 October 2012, Byankov, C‑249/11, EU:C:2012:608, paragraph 76).
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Nonetheless, the Court has held that an administrative body has, under the principle of cooperation, an obligation to review a decision, where an application for such review is made to it, in order to take account of the interpretation of the relevant provision of EU law given in the meantime by the Court where, (i) under national law, it has the power to reopen that decision, (ii) the administrative decision in question has become final as a result of a judgment of a national court ruling at final instance, (iii) that judgment is, in the light of a decision given by the Court subsequent to it, based on a misinterpretation of EU law which was adopted without a question being referred to the Court for a preliminary ruling under the third paragraph of Article 267 TFEU and (iv) the person concerned complained to the administrative body immediately after becoming aware of that decision of the Court (see, to that effect, judgment of 13 January 2004, Kühne & Heitz, C‑453/00, EU:C:2004:17, paragraph 28).
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It can thus be seen from that case-law that particular circumstances may be capable, by virtue of the principle of sincere cooperation arising from Article 4(3) TEU, of requiring a national administrative body to review an administrative decision that has become final to take account of the interpretation of a relevant provision of EU law which the Court has given subsequently. A balance between the requirement for legal certainty and the requirement for legality under EU law is thereby struck (judgment of 4 October 2012, Byankov, C‑249/11, EU:C:2012:608, paragraph 77 and the case-law cited).
55


As regards the objectives pursued by Regulation No 469/2009, it should be noted, first, that the fundamental objective of Regulation No 469/2009, as mentioned, inter alia, in recitals 3 to 5 and 8 and 9 of that regulation, is 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, inter alia, judgment of 6 October 2015, Seattle Genetics, C‑471/14, EU:C:2015:659, paragraph 32 and the case-law cited).
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Furthermore, as is apparent from recitals 7 and 8 thereof, Regulation No 469/2009 establishes a uniform solution at European Union level by creating an SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State. It thus aims to prevent the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the European Union and thus directly affect the establishment and the functioning of the internal market (see, inter alia, judgment of 6 October 2015, Seattle Genetics, C‑471/14, EU:C:2015:659, paragraph 26 and the case-law cited).