The case Pharmaceutical Works Polpharma v. European Medicines Agency is important both for producers of generic pharmaceuticals and for holders of marketing authorisations for reference medicinal products. It demonstrates how a marketing authorisation for a reference medicinal product can be attacked indirectly long after the deadline for a direct challenge has expired. It equally shows how the General Court does not shy away from reviewing the interpretation of scientific data by the European Medicines Agency (EMA), in particular whether the relevant scientific information has been taken into account.
Facts
Pharmaceutical Works Polpharma (hereafter PWP) was seeking marketing authorisation for a generic medicinal product derived from Biogen’s Tecfidera. Tecfidera is a medicinal product containing dimethyl fumarate (DMF) and intended for the treatment of multiple sclerosis. It received an initial marketing authorisation by way of Commission implementing decision C(2014) 601 final of 30 January 2014. An initial marketing authorisation confers eight years of data protection and ten years of marketing protection upon the medicinal product.
Data protection is an important part of the protection conferred by such an initial marketing authorisation. When a data protection period ends, a marketing authorisation for a generic version can be obtained by reference to the data accompanying the application for marketing authorisation of the reference medicinal product without the need to submit own data. Data protection periods thus constitute an important impediment for the development of generics but at the same time protect the investments made by the holder of marketing authorisation for the reference medicinal product.
PWP’s application for a marketing authorisation was rejected by EMA. According to the EMA, PWP could not rely in its application on the data accompanying the application for marketing authorisation of Tecfidera since these data were still protected. Therefore, in absence of other data capable of sufficiently supporting PWP’s application, the EMA could not validate its application. PWP brought an action before the General Court against the decision of the EMA.
In order to understand PWP’s arguments supporting its action, it is important to consider briefly the authorisation procedure for Tecfidera. A discussion ensued about whether Tecfidera was not already covered by the global marketing authorisation for the medicinal product Fumaderm granted in 1994, as Fumaderm also contained DMF as an active substance. If this was the case, Tecfidera would have been covered by the market authorisation for Fumaderm granted in 1994, and for which protection had expired.
The issue was that Fumaderm contained another substance apart from DMF, namely MEF, and that a marketing authorisation had only been granted for the combined use of DMF and MEF. Biogen argued that the use of DMF as a mono-substance, without MEF, justified a separate initial marketing authorisation.
On 30 January 2014, Tecfidera was granted an initial marketing authorisation by way of Commission implementing decision C(2014) 601 final. Recital three of that decision stated expressly that Tecfidera did not belong to the same global marketing authorisation as Fumaderm and could thus benefit from data protection and marketing authorisation protection.
Ground of appeal
PWP’s appeal against the EMA decision rejecting its application relied exclusively on disputing the content of recital three of the marketing authorisation for Tecfidera. The main argument was that the inclusion of MEF in Fumaderm had not been necessary for its therapeutic effect and that there was thus no relevant difference between Tecfidera and Fumaderm. In light of this, it was wrong for the Commission to hold that Tecfidera was not covered by the marketing authorisation for Fumaderm and, consequently, recital three did not constitute a valid legal ground for the EMA to reject PWP’s application.
Decision of the General Court
Article 277 TFEU allows parties to challenge incidentally the validity of an act of general application which forms the legal basis of a decision addressed to them. The main question was whether the marketing authorisation granted for Tecfidera was an act of general application constituting the legal basis of or having a direct legal connection with the EMA decision rejecting PWP’s application for a marketing authorisation of Tecfidera’s generic version. This was answered by the General Court in the affirmative.
First, the General Court decided that an implementing decision granting marketing authorisation to a specific company constituted an act of general application. By stating that Tecfidera was not covered by the global marketing authorisation for Fumaderm, the implementing decision conferred a regulatory protection period for the data relating to Tecfidera. This protection period was applicable to objectively determined situations, i.e. the use of MEF, and capable of producing legal effects with respect to categories of persons envisaged in a general and abstract manner, in particular to any operator capable of manufacturing a generic medicinal product derived from Tecfidera.
Second, the General Court held that a direct connection existed between Tecfidera’s marketing authorisation and the EMA’s decision rejecting PWP’s application. Although PWP was in substance disputing the scientific assessment of the EMA Committee for Medicinal Products for Human Use (CMPH), the General Court accepted that PWP was formally challenging the legality of the implementing decision and not the underlying CMPH opinion. Moreover, since the Commission relied explicitly on the CMPH opinion to conclude that Tecfidera was not covered by the marketing authorisation for Fumaderm, that opinion was an integral part of the statement of reasons for the implementing decision. Therefore, PWP was entitled to challenge the scientific assessments in the CMPH opinion.
After having cleared this procedural hurdle, the General Court found that neither the CMPH nor the Commission assessed the role played by MEF within Fumaderm. This led to the conclusion that the Commission decision granting market authorisation for Tecfidera should be declared inapplicable to the extent that the Commission found that Tecfidera did not belong to the same marketing authorisation as Fumaderm. Consequently, the decision of the EMA rejecting PWP’s application did not have a valid legal basis and had to be annulled.
Conclusion
The General Court’s decision is not a one-off. It should be seen as part of a global trend to diminish protection for reference medicinal products, which is now also finding its way into the courts. Another striking example is last year’s invalidation of, again, Biogen’s patent for Tecfidera by a US District Court. Producers of reference medicines should thus be alarmed.
At the same time, it is good news for producers of generic pharmaceuticals. The General Court has now made it clear that Article 277 TFEU can be used as an effective legal avenue to challenge marketing authorisations conferring protection upon reference medicinal products.
Please contact Pierre de Bandt or Raluca Gherghinaru for further information about this case and/or for general legal advice relating to EU litigation.