Two Prestigious Wins for our Life Sciences Team at the LMG Life Sciences Awards EMEA 2022

Congratulations to our Life Sciences and Healthcare team who have won two prestigious “Impact Case of the Year Awards” at the 2022 LMG Life Sciences Europe Awards, which were announced on 12th May. This is for the firm’s outstanding work in the two high profile and complex cases:

  • CE - 450163 Doctolib successful before Conseil d'État
  • Pharmaceutical Works Polpharma SA v European Medicines Agency (EMA).

The team was nominated for 11 categories across our European offices - we were the only firm to win two Impact Case of the Year awards.

Willy Mikalef, Counsel who advised Doctolib (alongside Ariane Mole), said: “The Conseil d’État’s decision has been a huge victory for our Data Protection team which brought important developments to the Schrems II debate and was highly commented on by the press internationally. Unlike in the Facebook case that led to the CJEU decision on "Schrems II", what was at stake here was not the transfer of data to the US, but the fact that the processor in the EU is a subsidiary of a US company. The ruling is based on "Schrems II" even though the data is held in France and Germany by a company established in Luxembourg, so the ruling has far reaching consequences for many businesses. In this case we were able to successfully demonstrate that the contract between Doctolib and hosting service provider has sufficient safeguards in place in the event of access requests by US surveillance authorities."

Sarah Faircliffe, Legal Director, who advised Polpharma alongside Marc Martens and Nicolas Carbonnelle, said: “Polpharma’s success in a judicial review action in the European General Court involved challenging the regulatory data protection (RDP) of Biogen’s "blockbuster" product Tecfidera. In essence, Polpharma argued that the European Commission decision establishing RDP for Tecfidera did not apply the law correctly; the General Court issued a judgment in the client’s favour in May 2021.

RDP is an important incentive as it protects data filed in support of marketing authorisation applications for innovative medicines, and its expiry in effect opens the door to generic medicines being able to apply for a marketing authorisation. This important judgment provided the General Court’s first clarification on the applicability of the “global marketing authorisation” concept (part of the RDP framework) in the field of “fixed dose combination” products. It also established that decisions on RDP are acts of general application that can be challenged by means of a plea of illegality, confirming that generic companies may challenge decisions on the RDP of potential “reference products” at the time at which they wish to submit a generic application, even if that RDP decision was taken some time ago. This latter point is particularly important and could have broad consequences for regulatory litigation in the future, as a number of regulatory incentives can have implications for third parties several years after a decision on applicability of the incentive is initially taken.”

To view the full list of awards and winners click here

About the LMG Life Sciences Awards EMEA 2022

The awards look to recognise leading law firms and lawyers specialised in the life sciences industry throughout the Europe, Middle East, and Africa region. The awards ceremony celebrates outstanding legal work over the previous calendar year and aims to honour firms and attorneys on the forefront of legal work in life sciences. In addition to several firm and individual award categories, many special awards are announced each year to highlight Hall of Fame honors, in-house teams and Impact Cases and Deals of the Year.

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