On 25 October 2018, the Court of Justice of the EU (CJEU) held in Case C-527/17 Boston Scientific that, where a medical device incorporates an ancillary drug substance, that substance will not be entitled to supplementary protection certificate (SPC) protection. That is the case even if the drug substance has been subjected to an evaluation of its safety, quality and efficacy that is analogous to the authorisation procedure for medicinal products, which are entitled to SPC protection.
Last week, the CJEU gave its decision in another procurement case in the healthcare area, Case C‑413/17 Roche Lietuva UAB. The case concerned the scope of technical specifications included as part of a tender by the Polyclinic for the Dainava District of Kaunas in Lithuania. The tender set out details of the medical diagnostic equipment and materials the authority wished to procure. Roche claimed that the specifications unreasonably restricted competition among suppliers due to their high specificity, and that in reality, the specifications corresponded to the products of certain manufacturers and excluded others.
The question referred to the Court concerned the limits to the margin of appreciation of a contracting authority to set out specifications in the tender, based on the quality of testing and the value of healthcare that it needs. The Court set out a useful summary of when technical specifications can be included in a tender and the principles for applying such specifications.
Last week, the European Court of Justice gave its judgment on certain procurement questions relating to the supply of a radiopharmaceutical product, referred by the Italian Court in Case C-606/17, IBA Molecular Italy Srl. An Italian regional health authority and a public hospital were seeking to award a substantial contract to a private hospital, without conducting a public tender. They argued that as no direct consideration was provided to the hospital, and as the hospital was “classified” as part of the public healthcare system, any award constituted an agreement between public authorities to which EU law on public procurement does not apply. The European Court disagreed, and concluded that (i) public authorities cannot circumvent the EU procurement rules by awarding “funding” to an organisation in return for the provision of free products, and (ii) it was not possible to treat a “private” hospital as a public hospital in order to award contracts to them outside the EU procurement rules.
From the information available about the case, the answers to the questions referred seem straightforward and may be limited to the Italian system. However, it is nonetheless useful to have confirmation from the Court on the extent to which the provision of healthcare falls within the EU procurement regime.
The next Future Pharma Forum will be on 27 September: Implications of Recent EU and UK Court Decisions in the Pharmaceutical Sector
Emily MacKenzie, Barrister at Brick Court Chambers, will join us to recap on how challenges to pharmaceutical decisions may be brought to the European and domestic courts. Emily will provide a summary of recent European Court and English Court decisions in the pharmaceutical area and we will explore the implications for pharmaceutical companies.
- How to bring challenges to the European Court
- The interplay of domestic proceedings
- Summary of recent European Court decisions, including:
- Shire on orphan market exclusivity and;
- Astellas on the role of the Concerned Member State
- Summary of recent English Court decisions, including Napp on the Article 10(3) hybrid-abridged procedure
- Changes in the Notice to Applicants regarding RDP, including the “reverse combination” principle
- The implications for pharmaceutical companies
On the morning of 25 July 2018, the Court of Justice of the European Union (the CJEU) handed down judgment in Case C-121/17 Teva UK and Others v Gilead concerning the validity of Supplementary Protection Certificate (SPC) protection for Gilead’s combination HIV treatment TRUVADA (tenofovir disoproxil and emtricitabine). The CJEU held that an SPC can only be granted for a product if, in the basic patent on which the SPC is sought, that product “is either expressly mentioned in the claims of that patent or those claims relate to that product necessarily and specifically.” It is for the English High Court, as the referring court, to determine whether that test is met by Gilead’s patent in this case; however, the CJEU stated (on the basis of the information provided by the referring court) that it does not seem possible that the combination of tenofovir disoproxil and emtricitabine necessarily falls under the invention covered by Gilead’s patent.
On 11 December 2017, we reported that Advocate General Bobek had opined in Case C-557/16, Astellas Pharma GmbH, that Concerned Member States (CMS) are co-responsible for marketing authorisations granted under the decentralised procedure (DCP).
This morning, the Court of Justice of the European Union (CJEU) handed down its judgment in the case. The Court ruled that:
- Article 28 and Article 29(1) of Directive 2001/83/EC (the Directive) must be interpreted as meaning that, in the framework of a DCP for the placing on the market of a generic medicinal product, the competent authority of a CMS cannot itself determine the starting point of the regulatory data protection (RDP) period of the reference medicinal product after the close of the coordinated procedure, and when it adopts its decision on the generic medicinal product in that Member State. However, the CMS is part of the assessment procedure, and must verify the expiry of the RDP period (para 29), or not approve the assessment report (para 30).
- Article 10 of the Directive, 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 CMS involved in a DCP, when faced with an action brought by the holder of the marketing authorisation of the reference medicinal product, against the generic marketing authorisation granted in that Member State, is competent to review the determination of the starting point of the RDP period of the reference medicinal product. On the other hand, that court does not have jurisdiction to determine whether the initial marketing authorisation for the reference medicinal product granted in another Member State was granted in accordance with the Directive.
We will post our analysis of the judgment soon.
Software can be considered a medical device under EU law. Although guidance has been issued by the European Commission and national authorities to assist in legal classification, factors or criteria that are considered as relevant in such guidance have not been validated by European or national courts. The recent decision of the Court of Justice of the European Union (CJEU) on legal classification of software medical device is therefore instructive.
The European Court’s first decision on the classification of software in the context of medical devices legislation
On 7 December 2017, the CJEU issued its judgment in Case C-329/16. The CJEU agreed with the Advocate General’s opinion (discussed in our previous advisory), and held that software can be classified as a medical device under EU law if the software has at least one functionality that allows the use of patient-specific data to assist the physician in prescribing or calculating the dosage for treating the underlying condition. It does not matter whether the software acts directly or indirectly on the human body. The decisive factor is whether the software is specifically intended by the manufacturer to be used for one or more medical objectives specified in Article 1(2) of Directive 93/42/EEC (the Medical Devices Directive), including the diagnosis, prevention, monitoring, treatment or alleviation of disease.
On 20 December 2017, the Court of Justice of the European Union (CJEU) confirmed that the term of a supplementary protection certificate (SPC) can be corrected to bring it into line with CJEU case law at any time before expiry of the SPC.
Following on from the decision in Seattle Genetics (C‑471/14) in 2015, which provided welcome clarity on which date should be used as the date of the first marketing authorisation (MA) for the purposes of calculating the duration of an SPC, this week’s decision should drive consistency in the application of Seattle Genetics by national patent offices across the EU. In Incyte (C‑492/16), the CJEU has ruled that an SPC holder can apply to rectify the duration of an SPC to bring it into line with Seattle Genetics at any time before expiry of the SPC, even if the period for appealing the decision under national legislation has passed.
In October, we reported that the oral hearing before the Court of Justice of the European Union (CJEU) took place in Case C-557/16 relating to the role of the Concerned Member States (CMS) in the Decentralised Procedure (DCP).
The Opinion of Advocate General Bobek has now been handed down. Although the AG takes no position on whether Ribomustin or Levact should have been used as the reference medicinal product, or when the applicable regulatory data protection (RDP) period started running, he opines that the CMS may raise issues as to RDP during the assessment phase and are co-responsible for the documents approved in that procedure. However, once agreement has been reached, CMSs cannot unilaterally revisit that decision. After authorisation, the courts of CMSs are competent to review the determination of the national competent authority.
Last month, the oral hearing before the Court of Justice of the European Union took place in Case C-557/16 relating to the role of the Concerned Member States (CMS) in the Decentralised Procedure (DCP). During the DCP, the Reference Member State (RMS) has primary responsibility for preparing the assessment report on the medicinal product, and CMSs can raise questions or objections on the grounds of a potential serious risk to public health. This case, a referral from the Finnish Court, asks whether, and if so how, administrative and legal questions, such as the length of the regulatory data protection period, should be resolved in the CMSs, considering that national marketing authorisations (MA) are granted at the end of the DCP.
The hearing highlighted that the Member States and Commission do not agree as to the interpretation of the legislation and case law, and there is a real dispute for the Court to answer. The Advocate General has said he will deliver his opinion on 30 November.