Pharma rulings show risks for originators and generics

Catherine Drew of Pinsent Masons was commenting after the EU General Court issued two judgments earlier in the autumn that demonstrate the point.

In the EU, a complex system of rights and protections exists to incentivise investment in the development of new pharmaceutical products in balance with the need to facilitate competition in the market. This system is currently the subject of potential reform.

As well as patents and supplementary protection certificates, which provide a period of market exclusivity for rights holders, pharmaceutical companies benefit from other protection that takes effect from the point that they are granted marketing authorisation for their products. First, regulatory data protection lasts for eight years from the point marketing authorisation is granted. This precludes competitors from exploiting data the originators submitted to regulators in the process of satisfying requirements for marketing authorisation for their originator products, to develop their own similar products.

A further two-year market protection period provides an additional period of exclusivity on top of the period of regulatory data protection. During that time, generic medicines manufacturers can obtain a marketing authorisation but their products cannot be placed on the market.

A more generous system of regulatory protections applies to products designated as ‘orphan’ medicines – those earmarked for treating rare diseases.

In certain circumstances, such as where a new therapeutic indication is identified for a medicinal product, pharmaceutical companies can apply to extend the marketing protection they were granted for a further year. It was such an application, made by Biogen Netherlands BV (Biogen), that was at the centre of one of the EU’s General Court’s rulings.

In that case, there was a complicated procedural history concerning two similar products.

The first product is Fumaderm. In 1994, Swiss company Fumapharm AG was granted marketing authorisation in Germany for Fumaderm, for use in the treatment of psoriasis. After its parent company acquired Fumapharm, Biogen now holds the marketing authorisations for Fumaderm.

The second product is Tecfidera. Biogen was granted a separate marketing authorisation for Tecfidera in January 2014, for the treatment of multiple sclerosis in adults.

While similar, Tecfidera has been assessed as containing a new active substance relative to Fumaderm. This is relevant because it impacts on the date that marketing protections applicable to Tecfidera are considered to apply from. Where one marketing authorisation is said to be linked to an earlier one, the regulatory data protection and marketing protection for the product covered by the latter marketing authorisation apply from the date that the earlier, ‘global’, marketing authorisation was granted.

In this case, the protections Biogen obtained for Tecfidera on the back of the 2014 marketing authorisation decision were threatened by legal action challenging the lawfulness of the decision to grant that authorisation.

In May 2021, the General Court upheld the legal challenge. It said the European Commission “was not entitled to conclude that Tecfidera was covered by a different global marketing authorisation than Fumaderm” since, at the time of its adopting the marketing authorisation decision, matters related to whether Tecfidera contained a new active substance had not been properly assessed.

Biogen, as well as the European Commission and the European Medicines Agency (EMA), raised an appeal.

Separately, in June 2021, Biogen applied to amend the therapeutic indication in its marketing authorisation for Tecfidera so it would extend further, to treatment of relapsing remitting multiple sclerosis in patients aged 10 years and older. At the same time, the company requested a one-year extension of the marketing protection for Tecfidera.

Biogen’s application to amend its market authorisation was successful, with a decision adopted in May 2022. However, at that time, its separate application for an extension of marketing protection was refused. At the same time, Mylan Ireland was granted marketing authorisation for a generic rival to Tecfidera.

However, the Court of Justice of the EU (CJEU) overturned the General Court’s ruling in 2023. Biogen was subsequently also granted the one-year additional marketing protection for Tecfidera, which extended until 2 February 2025. This decision was challenged by Mylan and was the subject of General Court’s recent ruling. At the end of 2023, the marketing authorisation granted to Mylan for its rival generic was revoked – a decision the company is challenging in separate EU court proceedings.

With its recent ruling in this dispute, the General Court annulled the decision that granted Biogen the one-year additional marketing protection for Tecfidera.

The judgment confirmed that requests to extend marketing protection for medicinal products for an additional year must be filed within the first eight years following the grant of marketing authorisation for those products. In effect, it confirmed the eight year window is not a fluid concept – eight means eight years. 

The fact Biogen waited until a few months after the eight-year deadline had passed since the 2014 marketing authorisation decision fatally undermined its request, the court considered, meaning the Commission erred when it adopted its decision implementing the extension.

On the same day, the General Court provided its ruling in a dispute between pharmaceutical company Sanofi BV and the European Commission over its product Nexviadyme, used in the treatment of Pompe disease, and the protections that should apply to it.

In that case, Sanofi tried to obtain annulment of a Commission decision that refused its application for designation of Nexviadyme as an orphan medicine and, it claimed, implied Nexviadyme did not contain a new active substance relative to a product it obtained marketing authorisation for years earlier. The General Court ruled against Sanofi, meaning it would not benefit from regulatory data protection for Nexviadyme.

Drew said: “The Tecfidera case highlights how the protections applicable to medicines can be removed and then reinstated by the courts, in turn impacting upon the ability of originator manufacturers to apply for extended protections for products in time, in respect of new therapeutic indications they may identify. In the latter case Sanofi does not currently benefit from regulatory data protection for its product, but should it generate the data the EMA indicated it would need to see, it is possible this protection could be reinstated – which would impact not only the originator but competitors seeking reliance upon the originator data.”