Case C-557/16, Astellas Pharma – measuring the data exclusivity period on a marketing authorisation

Pharmaceutical drugs need a marketing authorisation before they can be sold in the EU. In 2005, a company obtained one for a particular drug. In 2010, it re-marketed the same drug to treat a slightly different illness and got a fresh marketing authorisation. What then should be done for a rival company who is asking for a marketing authorisation for its cheap generic alternative? Should this be granted because the legal protection associated with the initial authorisation has now elapsed?

Bendamustine is an essential medicine used to treat some cancers and lymphomas.

The intellectual property rights on bendamustine were acquired by the German branch of the Japanese pharmaceutical company, Astellas Pharma. This company then licensed another pharmaceutical company, Mundipharma, to make and market a bendamustine drug under the name of ‘Ribomustin’. Ribomustin was to be used in the treatment of non-Hodgkin’s lymphoma and multiple myeloma, and the drug received its regulatory approval from the German authorities in 2005.

A few years later, the Japanese company created another bendamustine product, ‘Levact’. Although made from the same active ingredient found in Ribomustin, Levact was now to be used to treat chronic lymphatic leukaemia. Regulatory approval in the form of a marketing authorisation was granted by the French authorities in 2010.

A couple of years later, another bendamustine product appeared on the market. This time though, it was not made by Astellas. Rather, its maker was the pharmaceutical company, Helm. A marketing authorisation for Helm’s product, ‘Alkybend’, was granted by the Danish authorities in 2012. The marketing authorisation covered sales in Denmark, Norway, and Finland.

In 2014, Helm really wanted to sell Alkybend in Finland so it applied to the Finnish Medicines Agency for the relevant marketing authorisation. However, the application for a marketing authorisation annoyed Astellas. It put in an objection to the Finnish Medicines Agency pointing out that no authorisation could be given without the Agency infringing the legal protection on the existing French-authorised product, Levact.

Undeterred, the Finnish Agency granted Helm a marketing authorisation. The Agency reasoned that while it was true that Levact had been protected from 2010 for a period of six years, the Danish authorities which had licensed Helm’s Alkybend had also issued a report in 2014. That report said that Levact ought to be considered part of the general Ribomustin authorisation. The Agency reasoned that since the general authorisation had been granted by the German authorities back in 2005, legal protection had expired, and so Alkybend could be authorised for sale in Finland as a generic drug.

Astellas appealed the Finnish Agency’s decision into Finland’s Supreme Court.

At the Finnish Supreme Court
The relevant piece of EU legislation was the EU’s ‘marketing authorisations for medicinal products’ Directive 2001/83/EC.

Under Article 10 of the Directive, a person wanting a marketing authorisation for a generic drug can apply for one without first needing to conduct clinical trials. All the applicant must do is show that their drug is a generic of a ‘reference medicinal product’ which has already been authorised under the Directive. There is however a ‘cost’ for applicants. To compensate for being spared the need to do clinical trials, the producer of the reference medicinal product gets an extra period of legal protection. This extra protection is ostensibly to allow it to benefit exclusively from the data generated from its pre-clinical tests and clinical trials. This delay period is known as the ‘data exclusivity period’.

With Article 10 in mind, here was the first problem – what was the reference medicinal product? According to Astellas, it was Levact. Since the data exclusivity period on Levact was six years of protection from the moment when the product was first put on the market in France in 2010, Astellas took the view that no authorisation for a generic could be given by the Finnish Agency.

However, the Finnish Agency disagreed. It believed the reference medicinal product to be not Levact but Ribomustin. The German authority had initially approved this back in 2005. The scope of that initial authorisation not only covered Ribomustin in a variety of concentrations but also, and importantly, it covered all of various its pharmaceutical forms, including Ribomustin’s hydrochloride form – the form which was at the heart of Helm’s generic product Alkybend.

There was a further difficulty with this case, which arose from a fact and the law. That is to say, when Helm’s Alkybend product had received authorisation from the Danish authorities, Astellas had not been involved. That fact might have a legal significance in light of what the CJEU had said in its Olainfarm judgment (ECLI:EU:C:2014:2316, paras 34, 38 and 40). Namely, the CJEU had indicated that the ‘creative’ pharmaceutical company could ask an authority to make changes to an application for a marketing authorisation on a generic to ensure, for example, that the protection on the reference medicinal product would not be infringed. Since Astellas had not been involved in the Danish authorisation, Astellas’ lack of involvement seemed to rub up against what the CJEU had said.

Furthermore, the CJEU in Olainfarm had gone on to stress the importance of people having access to a tribunal for an effective remedy if their EU rights had been violated – it was a right was enshrined in Article 47 of the EU Charter. That raised another legal problem. Astellas had not objected or intervened in the application which Helm had made to the Danish authorities. It had objected only to the Finnish Agency in the Finnish application. But could the Finnish Agency do anything? Article 28 of the Directive contained a strictly delineated obligation of mutual recognition, and the only exception was where there was a risk to public health (Synthon ECLI:EU:C:2008:565, paras 29, 31 and 32). Thus, it was not clear whether the Finnish Agency would have any legal competence to calculate the data exclusivity period on the reference medicinal product. Related to the possible lack of Finnish Agency competence, was the possibility that the judges in the Finnish courts would also be under the same limitations of mutual recognition. Even if the Finnish courts were not under those limitations, and conceivably had some autonomous competence, then it was not clear if that would extend so far as to allow them to test Astellas’ other claim that the reference medicinal product had to be that of the French product Levact because of its belief that the initial German authorisation for bendamustine products was not compatible with the EU Directive.

Niilo Jääskinen and the other judges in the Finnish Supreme Court decided to make a preliminary reference to the CJEU.

Questions Referred
The Curia website has yet to publish the official English translation of the questions asked by the Finnish Supreme Court but the Finnish questions in the Finnish referring order are: […]

Update – 23 January 2017
According to today’s Official Journal, the questions asked in the Finnish Astellas reference are:

1. Are Articles 28(5) and 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 to be as interpreted as meaning that the competent authorities of the concerned Member State in the decentralised procedure for marketing authorisations for generic medicinal products in accordance with Article 28(3) of that directive are not themselves competent when issuing a national marketing authorisation to determine the time from which the data exclusivity period for the reference medicinal product begins to run?

2. If the answer to the first question is that, when issuing a national marketing authorisation, the competent authorities of a Member State are not competent to determine the time from which the period of data exclusivity of the reference medicinal product starts to run:

– is the court of that Member State when dealing with an appeal by the holder of the marketing authorisation for the reference medicinal product required to determine the time from which the period of data exclusivity starts to run, or is it subject to the same limit as the national authorities of that Member State?

– in those circumstances, how is the national court to give effect to the right of the holder of the marketing authorisation of the reference medicinal product under Article 47 of the Charter of Fundamental Rights of the European Union and Article 10 of Directive 2001/83 to effective legal protection with regard to data exclusivity?

– does the claim for effective legal protection require the national court to examine whether the original marketing authorisation granted in another Member State was issued in accordance with the rules laid down by Directive 2001/83?


There may be some interest in this preliminary reference from other health service providers across the EU. The Finnish court’s referring order explained that Astellas had been objecting in other Member States to similar authorisation requests for drugs containing generic bendamustine. Astellas had lost those legal battles in Germany, Norway, and the UK. However, the Finnish court flagged up that litigation in Germany was still ongoing. To this, the Finnish Supreme Court added that there were another five pieces of litigation concerning Levact which were currently in the Finnish courts.

Readers of EU Law Radar interested in the English and Welsh bendamustine litigation are referred to the judgment of Mr Justice Morgan ([2015] EWHC 3676 (Ch)), which was handed down this time last year, and is available on the Bailii website.

This Finnish case may also be of passing interest to EU competition lawyers. This is because there is an Italian competition law case pending before the CJEU about a pharmaceutical company that legally protected one drug, and then a few years later developed an almost identical one but for a slightly different therapeutic use; see further, Case C-179/16, Hoffmann-La Roche – is off-label medicine use, off-limits to EU cartel law?

Some readers may also be interested to know that Astellas is also behind another preliminary reference which has winged its way to Luxembourg from the Dutch courts. The legal issue concerns when a party can access impounded evidence to prove its case. The preliminary reference has now been docketed by the CJEU; see further,
Case C-644/16, Synthon – resisting its impounded documents being inspected by a rival.

Update – 18 January 2017
There are two further SPC preliminary references from the High Court of England and Wales. Summaries of them are temporarily posted as updates to Case C-567/16, Merck Sharp – SPC Lazarus law.


Update – 16 February 2017
There is a new preliminary reference about an SPC from the German courts; see further, Case C-681/16, Pfizer Ireland – Specific Mechanism suppresses drug circulation.