Orion Corporation v The Secretary of State for Health and Social Care & Anor

The first issue concerns the role of this court and the scope of the decision in Astellas. It is necessary to consider that case in detail.

On 19 July 2005, the German Federal Institute granted Astellas a marketing authorisation for the medical product known as Ribomustin. The active substance of that product was bendamustine. The product was authorised for two indications, namely non-Hodgkin’s lymphoma and multiple myeloma.

On 15 July 2010, France granted a marketing authorisation for a medical product known as Levact. The active ingredient was also bendamustine. Levact was authorised for the same two indications as Ribomustin and was also authorised for a third indication, namely the treatment of chronic lymphocytic leukaemia. This was granted following an application under the decentralised procedure in Article 28 of the Directive for a marketing authorisation in a number of Member States, including Germany and France, The reference Member State was Germany. France was a concerned Member State. France was the first Member State to grant a marketing authorisation following the conclusion of the Article 28 procedure.

On 7 November 2012, Helm applied to a number of Member States for marketing authorisation of a product known as Alkybend using the procedure set out in Article 28 of the Directive. Helm stated that Alkybend was a generic medicinal product, the active substance being bendamustine hydrochloride. The assessment report for that application stated that the reference product was Levact but, as that product was part of a global authorisation which included the 2005 marketing authorisation granted for Ribomustin, that latter product was the reference product for the purposes of Article 10 of the Directive. As the period for exclusive protection of data had expired, the assessment of the application for Alkybend could rely upon the data relating to Ribomustin. On 28 March 2014, the Finnish authorities (“Fimea”) granted a marketing authorisation to Helm for Alkbyend.

Astellas contended that the data exclusivity period began on 15 July 2010, which was the date of the grant of the first marketing authorisation for Levact, not 19 July 2005 which was the date of the grant of a marketing authorisation for Riboumstin. Consequently, Astellas contended, the period for protection of the data used for the application for Levact had not expired and that data could not be used for assessing Helm’s application for a marketing authorisation for Alkybend.

Astellas applied to the Finnish courts to quash that marketing authorisation. Astellas submitted, amongst other arguments, that the 2005 marketing authorisation granted by the German Federal Institute was not in accordance with the Directive. It also argued

The Finnish court noted that Astellas was not a party to the decentralised procedure for the grant of the marketing authorisation for Alkybend and might not be able to ensure protection of its data during that procedure. It noted that one Member State could not call into question (other than on grounds of a risk to public health) the assessments carried out in another Member State for the purpose of evaluating the medicinal product. The Finnish court therefore asked two questions to address the situation of how effective judicial protection could be provided for the rights of Astellas over its data if the Finnish authorities could not address the time when the period of protection for data expired. The two questions were:

The Court of Justice noted that the first question, in effect, asked whether, in the context of the decentralised procedure for applying for marketing authorisations set out in Article 28 of the Directive, the competent authorities of a Member State could themselves determine the date from which the period of protection for data ran when granting a marketing authorisation pursuant to its obligation in Article 28(5) of the Directive. The Court of Justice concluded that the Member States participated in a procedure which led to general agreement for approving the grant of marketing authorisations in Member States in which an application was made. That process would involve Member States verifying whether the period for protecting data related to a reference product set out in Article 10 of the Directive had expired. Otherwise, the data relating to the reference product would not be available when assessing the application for a marketing authorisation for a generic product. A Member State must

In that regard, the Court referred to its ruling in Olainfarm to the effect that Article 10 of the Directive sets out the circumstances in which the holders of a marketing authorisation for one product (the reference product) are required to accept that the manufacturer of another product (the generic product) may refer to the pre-clinical tests and clinical trials carried out for the reference product. It noted that the holder of a marketing authorisation is entitled to effective judicial protection and a judicial remedy against the decision of the competent authority granting a marketing authorisation for a generic product to ensure that the provisions of Article 10 of the Directive are observed.

In the light of those considerations, the Court considered that the holder of the marketing authorisation for the reference product had to be able to challenge the determination of the point in time from which the data exclusivity period provided for in Article 10 of the Directive starts to run. It noted that the decentralised procedure provided for in Article 28 of the Directive provided for each Member State to adopt a decision granting a marketing authorisation and did not provide for the adoption of any other measure against which the holder of a marketing authorisation could bring proceedings to assert its rights. In that context, the Court of Justice said this at paragraphs 39 to 41 of its judgment:

“39 It follows that effective judicial protection of the rights held by the holder of a MA for the reference medicinal product as regards the data exclusivity of that medicinal product can be ensured only if that holder can rely on those rights before a court of the Member State in which the competent authority adopted a MA decision for the generic medicinal product and if it can, inter alia, plead before that court an error relating to the determination of the point in time from which the exclusivity period, affected by that decision, starts to run.

40

However, that requirement of effective judicial protection does not mean that the holder of the MA for the reference medicinal product may call into question before that court the compatibility with Directive 2001/83 of MA decisions for that medicinal product taken in other Member States. That holder of the MA has a right to a judicial remedy which it can exercise, or which it could have exercised within the time limits set, against those decisions before the courts having jurisdiction to review the legality of the decisions adopted by the competent national authorities in each Member State.

41

In the light of the foregoing considerations, the answer to the second question is that Article 10 of Directive 2001/83, read in conjunction with Article 47 of the Charter, must be interpreted as meaning that a court of a Member State involved in a decentralised procedure for MAs, hearing an action brought by the holder of the MA for the reference medicinal product against the MA decision for a generic medicinal product in that Member State taken by its competent authority, has jurisdiction to review the determination of the point in time from which the data exclusivity period for the reference medicinal product starts to run. By contrast, that court does not have jurisdiction to review whether the initial MA for the reference medicinal product granted in another Member State was granted in accordance with that directive.”

In the formal disposition of the case, the Court of Justice repeated its essential ruling on the first and second questions in the following terms:

“1.

Article 28 and Article 29(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2001/83/EC of the European Parliament and of the Council of 25 October 2012, must be interpreted as meaning that, in a decentralised marketing-authorisation procedure for a generic medicinal product, the competent authority of a Member State concerned by that procedure cannot itself determine the point in time from which the data exclusivity period for the reference medicinal product starts to run when adopting, under Article 28(5) of that directive, its decision on the placing on the market of that generic medicinal product in that Member State.

2.

Article 10 of Directive 2001/83, as amended by Directive 2012/26, read in conjunction with Article 47 of the Charter of Fundamental Rights of the European Union, must be interpreted as meaning that a court of a Member State involved in a decentralised procedure for marketing authorisations, hearing an action brought by the holder of the marketing authorisation for the reference medicinal product against the marketing-authorisation decision for a generic medicinal product in that Member State taken by its competent authority, has jurisdiction to review the determination of the point in time from which the data exclusivity period for the reference medicinal product starts to run. By contrast, that court does not have jurisdiction to review whether the initial marketing authorisation for the reference medicinal product granted in another Member State was granted in accordance with that directive.”

The ruling of the Court of Justice establishes that the holder of a marketing authorisation may bring legal proceedings to protect the exclusivity of its data and, in particular, to challenge an error in the calculation of the period of protection conferred by Article 10 of the Directive. That, however, does not extend to enabling the holder

Applying that ruling to the facts of this case, the claimant cannot bring a challenge before this court seeking to establish that a marketing authorisation granted by the competent authorities in another Member State (here the Czech marketing authorisation for Precedex) is not compatible with EU law because it does not satisfy the requirements of the Directive.

The claimant contends that there are a number of reasons why the ruling of the Court of Justice in Astellas does not apply in this case. First, it is said that the ruling only applies to decisions of the competent authority in another Member State. The decision here was taken in the Czech Republic in 2002 before the Czech Republic became a Member State of the European Union on 1 May 2004.

The answer to that is as follows. The essential question is whether, as at the date of accession, the marketing authorisation was valid under EU law. The Treaty of Accession between the Member States of the European Union and 10 other states, including the Czech Republic, was signed on 16 April 2003 and came into force on 1 May 2004. Article 1.2 of that Treaty provided that:

“The conditions of admission and the adjustments to the Treaties on which the Union is founded, entailed by such admission, are set out in the Act annexed to this Treaty. The Act shall form an integral part of this Treaty”.

Article 2 of the Act of Accession provides that the Treaties, and EU legislation (including, therefore, the Directive) are binding on the new Member States, including the Czech Republic, from the date of accession and apply to those States under the conditions laid down in the Treaties and the Act of Accession. Article 10 of the Act of Accession provides that the application of the Treaties and the acts adopted by the EU institutions are subject to derogations provided for in the Act as a transitional measure. The Act of Accession then makes transitional provisions for certain countries in respect of certain measures of EU law. Article 24 of the Act of Accession provides that measures listed in certain Annexes apply in respect of the new Member States. Annex 12 deals with Poland and, in respect of the Directive, provides specific provision for marketing authorisations granted by Poland in the following terms:

“By way of derogation from the requirements of quality, safety and efficacy laid down in Directive 2001/83/EC, marketing authorisations for the pharmaceutical products on the list (in Appendix A to this Annex as provided by Poland in one language) issued under Polish law prior to the date of accession, shall remain valid until they are renewed in compliance with the acquis and in accordance with the timeframe set out in the abovementioned list, or until 31 December 2008, whichever is the earlier. Notwithstanding the provisions of Title III, Chapter 4, of the Directive, marketing authorisations covered by this derogation shall not benefit from mutual recognition in the Member States.”

In other words, marketing authorisations granted by the Polish authorities before accession for certain products listed in an appendix would remain valid in Poland – but could not be relied upon to obtain a marketing authorisation in other Member States using the route of mutual recognition. The implication underlying that provision is clear. Marketing authorisations for those products did not comply with the requirements of EU law, and the Directive in particular, and could not therefore be used to obtain marketing authorisations in the remainder of the EU. By contrast, there was no such provision restricting the validity or use of marketing authorisations granted by the Czech authorities prior to accession. Those marketing authorisations were assumed to have been granted in circumstances which would satisfy the requirements of EU law and, from the date of accession, were to be treated as marketing authorisations for the purposes of Article 6 of the Directive. The ruling in Astellas, therefore applies to prevent challenges in this court to the compatibility with the Directive of the marketing authorisation granted to Precedex.

I note that the interpretation I place on the Treaty and Act of Accession accords with the interpretation given to them by the District Court of Central Netherlands sitting in Utrecht. See the judgment in Orion Corporation v the Medicines Evaluation Board case UTR/18/1103 at paragraph 15. That court considered for the same reasons that it could be concluded that the marketing authorisation granted for Precedex was compliant with the Directive at the time of accession of the Czech Republic to the European Union.

Nor does the decision in Case C-350/08 Commission v Lithuania EU:C:2010:642 alter that conclusion. Lithuania like Poland, but unlike the Czech Republic, was subject to transitional provisions governing marketing authorisations for medicinal products. In those circumstances, it cannot be presumed that all marketing authorisations in force in Lithuania at the time of accession were to be treated as compliant with EU law. Indeed, the reverse was the case and only those subject to transitional provisions were valid. The validity of marketing authorisations, as in the case of Poland, extended only to those products listed in an Appendix, and then only until 1 January 2007 or when they were renewed in compliance with EU law (whichever was the earlier). A product, Grasalva, was not listed in the Appendix as one of the products where the marketing authorisation was treated as valid for a transitional period. Consequently, Lithuania acted in breach of Article 6 of the Directive by seeking to maintain in force a marketing authorisation for Grasalva after accession. In Lithuania, as in Poland, there is no general acceptance that marketing authorisations in force as at the date of accession complied with EU law and no transitional arrangements were made for this product. Consequently, for that reason, the marketing authorisation in that case was not valid for the purposes of Article 6 of the Directive. The position is different in relation to marketing authorisations granted by the Czech authorities prior to accession. They were regarded as compliant with the Directive and were to be treated on accession as valid for the purpose of Article 6 of the Directive.

The claimant contends that the inability of a domestic court to review the Precedex marketing authorisation results in perverse consequences. It contends that, on the

The legal position is governed by the provisions of the Directive as interpreted by the Court of Justice. The Directive strikes a balance between providing a period of protection for data, including the results of pre-clinical tests and trials, and permitting generic products to be granted marketing authorisation without having to repeat those tests. That reflects the balance between encouraging, or at least not unduly deterring, innovation and avoiding unnecessary replication of tests on animals and humans as recognised in the recitals. Built into that structure is provision that an initial marketing authorisation and a later one may be part of a global marketing authorisation and, if so, the period of protection for data runs from the date of the initial marketing authorisation: see Article 6 of the Directive. Furthermore, the Court of Justice has held in Astellas that the courts of one Member State may not review the grant of the initial marketing authorisation granted by another Member State to assess if that authorisation complied with EU law. Those provisions, and rules of law, are binding on this court. They may mean that the claimant may not derive all the benefits it anticipated from the later tests that it carried out. That however is implicit in the regulatory framework.

Furthermore, although not the basis for my decision, it is appropriate to note that the situation in this case results in part from the decision of the claimant’s licensee to apply for a marketing authorisation in the Czech Republic for Precedex. It obtained that authorisation and Precedex was marketed in the Czech Republic for a number of years. On one analysis, the situation arises from a combination of the structure of the rules and the actions of the company entitled to exploit the rights to DH in a particular country rather than any perversity in the scope or application of the ruling in Astellas understood in the way described above.

Next, Ms Stratford for the claimant contends that the decision in Astellas is inconsistent with the previous case law of the Court of Justice and, in particular, the decision in case C-527/07 R on the application of Generics (UK) Ltd. v Licensing Authority EU:C:2009:379. The claimant submits that it is implicit in the judgment in Generics that the competent authorities and the national courts of one Member State must be able to decide whether the documentation required by Article 8 of the Directive was supplied to the relevant national authorities of another Member State when the product

The essential facts in Generics are as follows. In 1963, the Austrian authorities granted a marketing authorisation under the Austrian law then in force for a medicinal product, galantamine, trading under the brand name “Nivalin”, for the treatment of poliomyelitis. The authorisation was subsequently modified in 1995 but it was agreed that the original dossier, on the basis of which the 1963 authorisation was granted, was not updated in order to comply with the requirements of EU law which did then apply in Austria in 1995.

The defendant, the licensing authority in the United Kingdom, was asked to treat Nivalin as the reference product for a generic of galantamine. The licensing authority concluded that Nivalin could not be used as a reference product because it had not been authorised on the basis of a dossier providing the material required by the Directive and that dossier had not been subsequently updated to comply with the Directive. The Court of Justice recognised that what was important was that the particulars and documents relating to the reference product remained available to the competent national authorities concerned by the application (under Article 28 of the Directive) for authorisation. The key paragraphs of the judgment for present purposes come at paragraph 28 to 30 and 33 to 35 where the Court said:

“28.

In that regard, Generics claims, in essence, that a medicinal product placed on the market in a Member State for a number of years in accordance with an authorisation issued on the basis only of the national provisions of that Member State - which were applicable before the transposition in that State of the Community legislation in that area - may be considered to be a reference medicinal product within the meaning of Article 10(2)(a) of Directive 2001/83.

29.

Such an interpretation of Community law is unfounded.

30.

It is apparent both from the wording and from the broad logic of Directive 2001/83, in particular from Articles 6, 8 and 10, that only those medicinal products benefiting from a marketing authorisation issued in accordance with that directive can be considered to be reference medicinal products. Likewise, as regards medicinal products for which marketing authorisation was sought prior to the entry into force of that directive, it is clear from the case-law that, in order to benefit from the abridged procedure, the applicant must show that the reference medicinal product was authorised on the basis of the Community law in force at the time of the application for marketing authorisation for the reference medicinal product…”

and

“33.

It follows from the foregoing considerations that, in order that a medicinal product may be considered to be a reference medicinal product, it must have been authorised in accordance with Community law before being placed on the market.

34.

In the present circumstances, it is apparent from the file submitted to the Court that Nivalin has never been the subject of an application for marketing authorisation containing the particulars and the documents referred to in Article 8 of Directive 2001/83 and that, therefore, authorisation for it to be placed on the market has never been given in accordance with the requirements of that directive.

35.

Likewise, it is not in dispute that Nivalin has also not been the subject of an application for marketing authorisation in accordance with the Community legislation applicable prior to the entry into force of that directive.

36.

In actual fact, the placing of Nivalin on the market in Austria was authorised only under the legislation in force in Austria at the time of the granting of the authorisation, namely in 1963, as that authorisation was never updated in accordance with Community law following the accession of the Republic of Austria to the EEA and then the European Union.

In other words, the key fact in the Generics case was that the product in question had never been authorised in accordance with the requirements of EU law. The authorisation was granted under Austrian law at a time when Austria was not a member of the European Union in 1963 and was not purporting to apply laws equivalent to EU law. In the present case, the Czech Republic was not a member of the EU at the time that the authorisation was granted in 2002. But it was purporting to apply requirements equivalent to EU law. From 1 May 2004, the arrangements for the accession of the Czech Republic to the EU treated the marketing authorisation as granted in accordance with EU law. The position in this case is therefore materially different. In Generics, the competent authorities or courts were not being asked to review the initial marketing authorisation to determine whether it had been granted in accordance with EU law: the Austrian authorities had never sought to determine whether the marketing authorisation satisfied requirements equivalent to those imposed by EU law. The product could not therefore be treated as a reference product for the purposes of Article 10 of the Directive. In the present case, the claimant is seeking to persuade this court to review the initial marketing authorisation to determine if the Czech marketing authorisation was compatible with the requirements of EU law. The decision in Astellas does not permit the national court to carry out that exercise. The decision in Astellas is not inconsistent with Generics. It is dealing with a different situation.

The claimant submits that to conclude that it cannot now raise the question of whether Precedex can be used as a reference product would be to fail to respect its right to effective judicial protection of its right to protect its data.

The answer is that the scope of the right to effective judicial protection of the right to protect data in this context has been determined by the Court of Justice in Astellas. The claimant has the right to challenge an error relating to the start date of the period of protection. But the right to effective judicial protection does not extend to enabling the claimant to have this court review the compatibility of the initial marketing authorisation granted by the Czech authorities with the Directive. Any challenge to the Czech marketing authorisation after 1 May 2004 on the grounds that it was not a valid marketing authorisation for the purposes of Article 6 of the Directive was one that had to be brought in the Czech Republic and would be subject to Czech law on standing and time limits.

The defendant submits that the decision in Astellas is consistent with earlier domestic case law. In R v Licensing Authority ex p. Monsanto [1997] 3 C.M.L.R. 402, the High Court considered that there was no reason why a domestic authority should be required to obtain the data used 10 or more years before for an application for a marketing authorisation in another Member State to assess whether that data complied with present day standards. The claimant contends that that case is distinguishable and, in any event, the High Court did express the view that it had not been established before the domestic court that there was any deficiency in the original application. That, the claimant submits, is consistent with the domestic court undertaking a review of the compatibility of the original marketing authorisation with the requirements of EU law.

In truth, the issues in the present case are to be determined by the proper application of the decision of the Court of Justice in Astellas in accordance with section 3(1) the European Communities Act 1972 as enacted by the United Kingdom Parliament. The decision of the High Court twenty years before is not determinative. In any event, the decision of the High Court is consistent with the approach of the Court of Justice. Member States, and their courts, are entitled to rely upon the authorisations granted in other Member States or, I would add, granted by the competent authorities in a State which accedes to the European Union and whose authorisations were recognised, or treated, as being in accordance with EU law under the arrangements governing the accession of that State to the European Union.

In the circumstances, this domestic court may not undertake a review of the marketing authorisation granted by the Czech authorities for Precedex in order to determine whether that marketing authorisation is compatible with the requirements of the Directive. That is established by the decision of the Court of Justice in Astellas.

I have reached that conclusion having regard to the relevant principles of EU law and the decision of the Court in Astellas. I note, however, that the Administrative Court in Uppsala, Sweden, and the District Court of Central Netherlands have reached the same conclusion, for essentially the same reason, in proceedings brought by the claimant, Orion, in those two Member States seeking to challenge the compatibility of the marketing authorisation for Precedex with the Directive. In each case, the courts of Sweden and the Netherlands considered that the matter was settled by the Court of Justice ruling in Astellas.

The claimant contends that the position is not clear and that one or more of the arguments it made in this court might, in effect, persuade the Court of Justice to qualify, or clarify, its decision in Astellas. The claimant relied upon the dictum of the Master of the Rolls in R v International Stock Exchange of the United Kingdom and the Republic of Ireland Ltd. ex p. Else [1993] Q.B. 534 at page 545D-E. The Master of Rolls observed, that where the facts had been found, and the issue of EU law was critical to the final decision, the correct approach in principle of a court (other than a final court of appeal) is to refer the question unless it can with complete confidence resolve the issue. Those remarks need to be understood in the context in which they were made. There, the first instance judge had exercised his discretion to refer certain questions to the Court of Justice. The Court of Appeal heard full argument on the meaning of the relevant EU provisions and decided, in the light of those arguments,

In the present case, it is possible to resolve the issues with complete confidence. The meaning of the decision of the Court of Justice in Astellas is clear. None of the arguments advanced by the claimant cast any doubt upon the ruling or its scope. The status of marketing authorisations granted in pre-accession States appears clearly from a consideration of the Treaty and Act of Accession. The meaning and scope of the pre-existing case law of the Court of Justice appear clearly from the terms of the relevant rulings. The other arguments advanced do not, on analysis provide any justifiable reason for questioning the decision in Astellas.

In the circumstances, any issue as to the meaning and scope of the decision in Astellas can be resolved with complete confidence and no reference to the Court of Justice for a preliminary ruling is appropriate. For completeness, I note that, at first instance, a court has a discretion to make a reference and even if the matter could not be resolved with complete confidence, there may be other factors to consider in deciding whether or not a reference was appropriate. As the issues can be resolved with complete confidence, it is not necessary to consider those factors in this judgment.

In the light of the above conclusions, it is neither necessary nor appropriate for this court to consider the claim made by the claimant that the marketing authorisation for Precedex granted by the Czech authorities was not compatible with EU law. In submission, Ms Stratford also indicated that the claimant would wish to contend that the United Kingdom had not properly discharged its obligations during the Article 28(2) procedure which considered the application by Ever for marketing authorisations for its product and, in particular, that the United Kingdom had not considered Orion’s complaint that Precedex could not be treated as a reference product for that application as that marketing authorisation was not compatible with EU law. Furthermore, Ms Stratford submitted that the scope of the obligations on Member States in the Article 28 procedure could themselves usefully be the subject of a reference to the Court of Justice for a preliminary ruling.

First, on a fair reading of the claim form, the claimant was not seeking to challenge any actions or failure of the United Kingdom in the context of the Article 28 procedure. The focus of this claim is the compatibility of the Precedex marketing authorisation with EU law. The remedy sought was to quash the UK marketing authorisation granted for Ever’s generic product and remit the matter back to the defendant to reconsider. Reference is made in the claim form to the defendant being obliged to consider Orion’s representations as to why the marketing authorisation for Precedex was not compatible with EU law and that the defendant should have decided not to grant the marketing authorisation for Ever’s product. On a fair reading of the claim form as a whole, those references concern the ability of the defendant unilaterally to decline to grant the marketing authorisation (not on any alleged failure during the Article 28(2) process). As a matter of law, the Court of Justice mades it clear in the answer to the first question in Astellas that the competent national authorities cannot unilaterally review the period of protection for data after the

The conclusion that the claim is not concerned with the role of a Member State during the Article 28 procedure is reinforced by, but not dependent upon, the fact that the draft questions for a reference provided with the claimant’s skeleton argument do not raise any questions concerning the Article 28 procedure. The role of the defendant during the Article 28 process is not therefore, on a fair reading, raised in these proceedings, and its role after the conclusion of the Article 28 procedure is clear. In those circumstances, it would not be appropriate for this court, and it would not be fair to the defendant or the interested party, to seek to resolve any issues concerning the operation of the Article 28 procedure.

Secondly, and separately, the only evidential material before this court dealing specifically with the role played by the United Kingdom in the Article 28 procedure is contained in the defendant’s summary grounds, and later detailed grounds. Both those documents are accompanied by statements that the defendant believes that the facts stated are true. The summary grounds state that the defendant did consider the complaints made by Orion to the effect that the Czech authorisation was invalid but concluded that those complaints were not sufficiently made out. The detailed grounds make a similar point. In the circumstances, there could not realistically be any criticism that the defendant failed to consider the complaint. The only real complaint made by the claimant is that Precedex could not be used as a reference product as the Precedex marketing authorisation was not compatible with EU law. For the reasons given, that claim may not be determined by this court.

The claimant, the defendant and the interested party have relied upon a number of documents and a number of legal points were made by counsel for all parties in their skeleton arguments, oral submissions and closing submissions. I am grateful for all the submissions made. I have sought in this judgment, however, to deal with what I consider to be the principal points raised and the principal documents relating to those matters. All parties can be assured however, that I have carefully considered all the points made and all the documents relied upon.

In the light of the ruling of the Court of Justice in Astellas, it is not open to this court to review the marketing authorisation for Precedex granted by the Czech authorities to determine whether that marketing authorisation is compatible with the requirements of the Directive. The claimant may bring legal proceedings to protect the exclusivity of its data and, in particular, to challenge an error in the calculation of the period of protection conferred by Article 10 of the Directive in respect of that data but that does not entitle the claimant to challenge in this court the compatibility with EU law of a marketing authorisation granted by the Czech authorities. Such a challenge must be brought in the courts of that Member State that granted the marketing authorisation in accordance with the relevant rules of national procedure including any applicable time limits for bringing such a challenge. Consequently, this claim for judicial review is dismissed.