1.

This request for a preliminary ruling from the Higher Regional Court, Vienna (Oberlandesgericht, Wien) arises out of an appeal brought by Seattle Genetics Inc. (‘Seattle Genetics’) against a decision of the Austrian Patent Office (Österreichisches Patentamt). By its appeal, Seattle Genetics seeks the rectification of the date fixed in the decision for the expiry of a supplementary protection certificate (‘SPC’ or ‘certificate’) issued to it in respect of a medicinal product for human use developed on the basis of a patent of which it is the proprietor.

2.

The request for a preliminary ruling concerns the interpretation of Article 13(1) of Regulation (EC) No 469/2009 ( 2 ) and, more specifically, the concept of the ‘date of the first authorisation to place the product on the market in the [European Union]’ to which that provision refers and by reference to which the date of expiry of an SPC may be determined in accordance with that provision.

3.

The Court is asked, first, whether that concept is to be defined in accordance with the legislation of the Member States or in accordance with EU law and, secondly, in the latter case, whether the relevant date is the date of the decision granting the first authorisation to place the product on the market or the date on which the addressee was given notification of that decision.

4.

Recitals 4, 8 and 9 in the preamble to Regulation No 469/2009 are worded as follows:

…

5.

Article 3 of Regulation No 469/2009, entitled ‘Conditions for obtaining a certificate’, provides that ‘[a] certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:

6.

Pursuant to Article 7(1) of Regulation No 469/2009, ‘[t]he application for a certificate shall be lodged within six months of the date on which the authorisation referred to in Article 3(b) to place the product on the market as a medicinal product was granted’.

7.

Article 11(1)(d) and (e) of Regulation No 469/2009 provides that a notice of the fact that an SPC has been granted must be published by the competent authority and that the notice must at least contain the information listed in paragraph 1, including:

8.

Article 13 of the same regulation, entitled ‘Duration of the certificate’, provides in paragraph 1 thereof that ‘[t]he certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years’. ( 6 ) Article 13(2) adds that, ‘[n]otwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect’.

9.

It is apparent from the information placed on the file that Seattle Genetics, a company established in the United States, is the holder of a European basic patent ( 7 ) which was applied for on 31 July 2003 and granted on 20 July 2011.

10.

On 31 May 2011, Takeda Global Research and Development Centre (Europe) Ltd (‘Takeda Global’), a company established in the United Kingdom, applied, in accordance with the provisions of Regulation No 726/2004, for a conditional marketing authorisation for a new active substance bearing the international non-proprietary name ‘Brentuximab vedotin’ and the commercial name ‘Adcetris’, which had been developed using the abovementioned patent.

11.

The European Commission granted Takeda Global a marketing authorisation for the medicinal product Adcetris ( 8 ) by decision dated 25 October 2012, Article 4 of which states that ‘[t]he period of validity of the authorisation shall be one year from the date of notification of this Decision’. ( 9 ) The marketing authorisation thus granted was notified to Takeda Global on 30 October 2012 and published in the Official Journal of the European Union (‘the OJ’) for 30 November 2012, ( 10 ) pursuant to Article 13(2) of Regulation No 726/2004.

12.

On 2 November 2012, Seattle Genetics applied to the Austrian Patent Office for an SPC based on the basic patent. ( 11 ) The Patent Office granted the application and stated that the SPC would take effect upon the expiry of the basic patent and would expire on 25 October 2027, ( 12 ) thus taking the view that the ‘date of the first authorisation to place the product on the market in the [European Union]’, within the meaning of Article 13(1) of Regulation No 469/2009, should be the date of the decision granting the marketing authorisation, adopted by the Commission on 25 October 2012.

13.

In October 2013, Takeda Global assigned the marketing authorisation in question to Takeda Pharma A/S, a licencee of Seattle Genetics.

14.

On 22 April 2014, Seattle Genetics brought proceedings before the Higher Regional Court, Vienna, against the Austrian Patent Office’s decision, seeking rectification of the expiry date of the SPC so that it would not expire until 30 October 2027, that is, five days later than the date given in the decision. In support of its action, it argued that the ‘date of the first authorisation to place the product on the market’, within the meaning of Article 13(1) of Regulation No 469/2009, should in fact be taken to be date on which the decision authorising Adcetris was notified to the addressee, that is to say, 30 October 2012.

15.

On 22 August 2014, the Commission renewed the marketing authorisation in question by a decision Article 3 of which stated: ‘[t]he period of validity of the renewed authorisation shall be one year from 30 October 2014’. ( 13 )

16.

In those circumstances, and having regard to the apparently differing practices followed in other Member States when determining the duration of an SPC in accordance with Article 13(1) of Regulation No 469/2009, ( 14 ) the Higher Regional Court, Vienna, decided by Order of 2 October 2014, received at the Court on 15 October 2014, to stay the proceedings and refer the following questions to the Court for a preliminary ruling:

17.

Written observations have been submitted to the Court by Seattle Genetics, the Greek, Italian, Latvian and Lithuanian Governments and by the Commission. No hearing has been held.

18.

As a preliminary point, I would observe that the aims of the system of special protection certificates introduced at Community level are to remedy the shortcomings of national patent schemes in protecting pharmaceutical research and to check the development of too great a disparity between those schemes, which would be likely to impede the free movement of medicinal products between Member States and thus impair the proper functioning of the internal market. ( 15 )

19.

By its first question, the referring court asks the Court, in substance, whether the ‘date of the first authorisation to place the product on the market in the [European Union]’, within the meaning of Article 13(1) of Regulation No 469/2009, is to be identified by means of the application of EU law or in accordance with the legislation of the Member States, in particular the legislation of the Member State in which the marketing authorisation under consideration was used as the basis for obtaining an SPC.

20.

In setting out the reasons for its request for a preliminary ruling, the Higher Regional Court, Vienna, points out that Article 13 does not indicate clearly whether the rule for the calculation of the period of exclusivity conferred by an SPC also refers to the procedural law of the Member State concerned ( 16 ) or whether the method for determining the period of exclusivity is governed entirely by that provision. It adds that, in German legal literature, different answers are given to the question of the relevant date and that it appears that the solution varies depending on the laws of the Member States. ( 17 )

21.

Like all the parties that have submitted observations to the Court, with the exception of the Italian Government, I take the view that the concept of the ‘date of the first authorisation to place the product on the market in the [European Union]’ referred to in Article 13(1) of Regulation No 469/2009 must be defined solely on the basis of EU law. That approach rests, first of all, on the general principles which govern the interpretation of EU law, secondly, on the legal nature and purpose of the regulation in question, thirdly, on the parameters of the concept at issue, which have been partially circumscribed in the Court’s case-law and, lastly on considerations of a practical nature.

22.

Indeed, according to settled case-law, for the purpose of determining the meaning and scope of the terms of a provision of EU law which makes no express reference to the law of the Member States, as is the case with Article 13(1), the provision must be given an autonomous and uniform interpretation that will apply throughout the Union. That interpretation must take into account the context of the provision and the purpose of the legislation in question. It follows that the method by which the date in question is determined under the legislation of a Member State is of no relevance to the interpretation of Article 13(1). ( 18 ) I would observe in this connection that, inasmuch as it concerns the duration of an SPC as provided for in Article 13 of Regulation No 469/2009, this request for a preliminary ruling raises questions which, in my view, are of a substantive, rather than a procedural nature. ( 19 ) Therefore, contrary to the Italian Government’s assertion, the issue raised does not, I think, concern the procedural autonomy of the Member States. ( 20 )

23.

Moreover, it would appear that, by opting for a legal instrument such as a regulation in order to introduce a ‘standard system’ for supplementary protection certificates at Community level, the legislature expressed its wish that the rules adopted in this area should be common rules, so as to remove any obstacles to the free movement of medicinal products and prevent distortion of competition within the internal market, ( 21 ) as well as its intention that all Member States should apply simultaneously the provisions on extending the protection afforded by patents. ( 22 ) This desire to achieve a ‘uniform solution’ and thus a single model for the SPC applicable in all Member States, in particular as regards the conditions for issue and the certificate’s duration, was expressed in the preamble to Regulation No 1768/92 and reiterated even more clearly in the preamble to Regulation No 469/2009, which codified the earlier regulation. ( 23 )

24.

As regards, more specifically, the concept of ‘the first authorisation to place the product on the market in the [European Union]’, referred to in Article 13(1) of Regulation No 469/2009, the Court has already held that that concept must be interpreted in the same way, irrespective of the content of the provision of the regulation in which it appears. ( 24 ) The Court has also pointed out that, by referring to the first marketing authorisation in the Community, the system introduced by Regulation No 1768/92 was intended to prevent the grant of certificates whose validity varied in duration from one Member State to another. ( 25 ) I would observe in this connection that a marketing authorisation issued by the Commission in accordance with Regulation No 726/2004 is valid at the same time ‘throughout the Community’. ( 26 )

25.

If it were accepted that the date on which a marketing authorisation took effect and consequently the date on which, by reference to that criterion, a SPC expired had to be determined in accordance with national law, then both the objectives and the general scheme, and indeed the effectiveness of Regulation No 469/2009 would be compromised, since the result would be that, for one and the same medicinal product, the duration of the SPCs could vary from one Member State to another. The Commission rightly points out that any disparity in the dates of expiry of SPCs could, in practice, give rise to an unwanted parallel trade between Member States in which SPCs had already expired and those in which they were still valid. In addition to the fact that differences in the protection afforded to one and the same medicinal product would entail fragmentation of the market, the very thing that the Community legislature wished to avoid, ( 27 ) I consider that the existence of different categories would also make for legal uncertainty prejudicial to the interests of the economic actors concerned.

26.

Therefore, I propose that the answer to the first question should be that the concept of the ‘date of the first authorisation to place the product on the market in the [European Union]’ referred to in Article 13(1) of Regulation No 469/2009 must be given a uniform and autonomous interpretation in conformity with EU law and that it cannot, therefore, depend on the rules applicable in the Member States, in particular in the Member State in which the market authorisation has taken effect.

27.

By its second question, the referring court asks the Court, in substance, to rule on the question whether, in the event that Article 13(1) of Regulation No 469/2009 is to be interpreted on the basis of EU law, the ‘date of the first authorisation to place the product on the market in the [European Union]’ that must be taken into account in order to determine the duration of an SPC, to which that provision refers, is to be construed as being the date on which the marketing authorisation was granted or the date on which notification of the decision containing that authorisation was given to the addressee.

28.

Referring to certain judgments of the Court of Justice, ( 28 ) the Higher Regional Court, Vienna, submits that it can be inferred from those rulings that it is not the date on which notification of the marketing authorisation is given that is decisive but the date on which the authorisation itself is granted, and that that solution reinforces the case for uniform interpretation. While the Greek, Latvian and Lithuanian Governments share the referring court’s view, Seattle Genetics, the Commission and, expressing its alternative opinion, the Italian Government ( 29 ) submit, on the contrary, that it is the date on which notification of the marketing authorisation decision is given that is decisive.

29.

It is the latter view that I find convincing. It is corroborated by a number of criteria drawn from the primary law of the European Union, which defines the starting point of the legal effects of decisions adopted by the Commission. ( 30 ) Even though the EU legislature can, in my view, derogate from such provisions in individual decisions implementing a legislative act, ( 31 ) it nevertheless seems to me that Article 13(1) of Regulation No 469/2009 contains no suggestion of any such derogation, when viewed in the light of the usual interpretative criteria. ( 32 ) It is those criteria that I shall address first of all.

30.

In so far as concerns the wording of the provision which the Court is asked to interpret, a reading of that provision affords no easy answers, in my view. Indeed, the expression ‘the date of the first authorisation to place the product on the market in the [European Union]’, of which there are several slight variations of no significance in the various language versions of Regulation No 469/2009, ( 33 ) is not in itself sufficiently clear as to whether or not that date in fact corresponds to the date of the Commission decision granting marketing authorisation, as the Greek, Latvian and Lithuanian Governments maintain. ( 34 )

31.

Admittedly, that solution does appear to have the advantage of simplicity, inasmuch as that date is printed on the cover page of the authorisation decision. However, as the Commission points out, that is only a minimal advantage because, under the centralised marketing authorisation procedure, the date on which notification of the marketing decision is given to the addressee is just as easy to find, since, as in the present case, ( 35 ) the date of notification is always published in the OJ also. ( 36 ) The question which of those dates is the relevant date therefore remains open.

32.

As regards the general structure surrounding Article 13(1) of Regulation No 469/2009, it may be observed that other provisions of that regulation also refer to the ‘date of the first authorisation to place the product on the market’ or the ‘date of the authorisation to place the product on the market’, ( 37 ) without really being any more explicit than that in defining those dates. On the other hand, certain other provisions of the regulation are slightly more precise, inasmuch as they state that the relevant date is the date on which the marketing authorisation or first marketing authorisation was ‘granted’ or ‘obtained’. ( 38 )

33.

In this connection, the Latvian and Lithuanian Governments refer to certain judgments of the Court of Justice according to which, in their view, the date of the ‘grant’ or the ‘obtaining’ of the first authorisation to place the product on the market must be construed, for the purposes of Regulation No 469/2009, as being the date on which the decision granting that authorisation was adopted. However, I do not think that those judgments offer anything of decisive value for the purpose of answering the question posed in the present case. Admittedly, in its judgment in Merck Sharp & Dohme, the Court referred to the date on which the first authorisation to place the product on the market was ‘granted’ or ‘obtained’ in its interpretation of Article 13 of Regulation No 1768/92 ( 39 ) and, in its judgment in Kirin Amgen, it pointed out, when interpreting other provisions of the same regulation, that ‘the obtaining of a marketing authorisation occurs at the time when it is granted’. ( 40 ) However, the fact remains that, in the absence of any clearer guidance from the case-law, the concept of ‘obtaining’ marketing authorisation may relate equally well in my view, if not better, to the date on which the marketing authorisation granted came to the notice of the addressee of that decision and thus became capable of producing actual effects.

34.

In so far as concerns the objectives which the provision at issue seeks to attain, it is common ground that the SPC for medicinal products introduced by Regulation No 1768/92 and codified by Regulation No 469/2009 increases the duration of the period of exclusivity enjoyed by inventors under basic patents, ( 41 ) by extending the effects of the basic patent beyond its statutory expiry date. ( 42 ) That mechanism is designed to attenuate the erosive effect of the long period of time that can elapse between the lodging of a patent application, which often occurs soon after clinical tests are completed, and obtaining authorisation to place the medicinal product in question on the market. ( 43 ) That long period, which reduces by a corresponding period the duration of the exclusive right guaranteed by a patent, can make it difficult to recover the sometimes costly investments required for pharmaceutical research, which none the less contributes to continuing improvement in public health. ( 44 )

35.

Accordingly, the Court has repeatedly held that the SPC is ‘designed to re-establish an adequate period of effective protection of the basic patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of the basic 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 marketing authorisation in the European Union was granted’. ( 45 )

36.

The Court has also pointed out that the SPC is thus intended to ‘make up for the fact that the period of effective protection under the patent is insufficient to cover the investment put into [pharmaceutical] research’. ( 46 ) This concern to enable the holders of patents for medicinal products to recover, to a large extent, the funds invested in research, which is regarded as being ‘vital, both for the pharmaceuticals industry itself and for society as a whole’, has clearly informed the action of the EU legislature in this field. ( 47 )

37.

Moreover, emphasis has frequently been placed, both in legislative texts ( 48 ) and in the case-law, ( 49 ) on the intention to ensure, by means of the SPC provided for under EU law, that the protection afforded by a patent is effective, in particular in terms of its duration.

38.

The right to exploit a new medicinal product by marketing it, and thus the possibility of beginning to recover the investments associated with its invention, only become effective once the beneficiary of that right becomes aware of the fact that he is authorised to put the medicinal product on the market. Consequently, the ‘date of the first authorisation to place the product on the market in the [European Union]’, within the meaning of Article 13(1) of Regulation No 469/2009, must in my view correspond to the date on which notification of the decision is given to the addressee thereof and thus takes effect.

39.

If, contrary to that view, the Court should regard the date of the decision granting marketing authorisation as the relevant date, such an interpretation would reduce the period of validity of SPCs in a manner inconsistent with the fundamental objectives of that regulation. As the Commission argues, it would be unacceptable for the period of supplementary protection granted by the legislature, with the precise aim of prolonging the opportunities for marketing medicinal products, to be shortened by procedural steps carried out between the decision granting marketing authorisation and the notification of that decision, the duration of which is not within the control of the SPC applicant.

40.

The interpretation of Article 13(1) of Regulation No 469/2009 that I propose, to the effect that the date of notification of the decision granting marketing authorisation is the relevant date, is supported by considerations of a more general nature than those which relate to the instrument itself which I have just set out.

41.

It is important first of all to remember that the marketing authorisation for the medicinal product for human use at issue in the main proceedings was granted by decision of the Commission adopted under the centralised procedure laid down in Regulation No 726/2004, as opposed to a national marketing authorisation granted by the competent authorities of a Member State on the basis of Directive 2001/83.

42.

A decision of that nature falls within the category of legal acts adopted by the EU institutions referred to in the fourth paragraph of Article 288 TFEU. ( 50 ) Therefore, as Seattle Genetics maintains, account must be taken of the third paragraph of Article 297(2) TFEU, from which it is clear that notification of a decision which specifies the person to whom it is addressed must be given to that person in order to take effect and takes effect only upon such notification. That provision enshrines a general legal principle according to which notification must be given of all acts of an individual nature, in particular acts of an administrative nature, to the addressee and the rights and obligations arising under them cannot be relied on against the addressee until he has been duly made aware of the act in question. ( 51 )

43.

Similarly, according to its written observations, the Commission takes the view that, since derogation from that principle would have the consequence of shortening the period of validity of an SPC and would therefore be prejudicial to the holder of that SPC, the better option is to take as the relevant date the date on which notification was given of the decision granting marketing authorisation.

44.

This suggested approach is consistent with the practice adopted by the Commission not only in the present case ( 52 ) but systematically with regard to SPCs granted for medicinal products in respect of which an EU marketing authorisation has been granted, which has been mentioned in various public position statements. ( 53 ) Similarly, the European Medicines Agency takes the date of notification of marketing authorisations as the relevant date for calculating the period of protection provided for by provisions of EU law relating to the marketing of medicinal products. ( 54 )

45.

Consequently, I recommend that the answer to the second question should be that the ‘date of the first authorisation to place the product on the market in the [European Union]’, within the meaning of Article 13(1) of Regulation No 469/2009, is not the date on which the decision granting marketing authorisation is adopted, but the date on which notification of that decision is given to the addressee thereof.

46.

In light of the foregoing considerations, I propose that the Court of Justice answer the questions referred to it for a preliminary ruling by the Higher Regional Court, Vienna, as follows: