20 August 2020

Summertime reading: Servier decision

Key points

  • Today a decision of the EU Commission (AT.39612) in the Servier case, as published online 30.09.2016.
  • “On 24 November 2008, the Commission started its ex-officio investigation with unannounced inspections of the premises of Servier, Krka, {} and Teva in various Member States.”
  • “From the end of the 1990s and in the early 2000s, Servier progressively devised a strategy aimed at preventing or at least delaying generic entry after expiry of the perindopril compound patent. The strategy consisted of a variety of measures that were constantly adapted to take into account market developments.”
  • “All of these practices are described in the subsequent subsections in the following order: (1) filing a patent cluster  [...] The description of these practices is without prejudice to their legality under Union competition law.”
  • “In this context, contemporaneous evidence reveals that, of the 33 process patents (mostly patents for synthesis routes), 21 {patents} were described by Servier internally as "*blocking" patents or "*paper patent". Three of these 21 process patents were in addition characterised as involving "*zero inventive step". As shown in Table 4, these patents were, however, granted by the EPO.”
  • “Furthermore, minutes of one of Servier's internal meetings {}, show that Servier continued throughout the lifecycle of perindopril to develop and file patent applications which were themselves considered internally as "*blocking" patents.
    The minutes categorise as such 31 synthesis process patent applications. For those patent applications Servier proposes filing with the EPO as a purely editorial task – i.e. without conducting any patentability studies or any laboratory trials: "*Purpose of the meeting: […] to establish a list of ‘reasonable’ synthesis processes of perindopril or of its synthesis intermediates, which will be the subject of ‘blocking’ patent applications. […] The 31 corresponding patent applications, which will be subjected neither to patentability studies nor to laboratory tests, will have to be drafted and filed as soon as possible (as early as February 2003 for the first), the aim being to obtain the publication of a first ‘wave’ of these applications in June 2003".”
  • An appeal was filed with the General Court. In the decision of 12.12.2018, the Court reduced the fine imposed on Servier (and Biogaran) from EUR 330  million to EUR 228 million. Of note, this fine was imposed in view of certain agreements with generic companies  (as I understand it), not in view of the filing strategy mentioned above.
  • The General Court decision includes the statement that: “It should also be noted that, in the present case, in the contested decision, although the Commission referred, in recitals 113 to 123, to the applicants’ strategy of creating a ‘patent cluster’ and ‘paper patents’, it did not, however, rule on the validity of the disputed patents at the time the agreements were concluded.”
  • Still from the Commission decision: “During the inspections in 2008, a number of documents were identified for which Servier claimed inter alia that they were protected by Legal Professional Privilege (hereinafter "LPP"). Servier's claims for LPP were all subsequently resolved. On 10 June 2010, the Commission returned unopened two sealed envelopes to Servier, opened four sealed envelopes and added the latter content to the case file with Servier's consent.”
  • For all quotes: footnotes omitted; underlining added; insertions and edits marked with {} are made by me.

Commission Decision AT.39612 09.07.2014
https://ec.europa.eu/competition/elojade/isef/case_details.cfm?proc_code=1_39612
https://ec.europa.eu/competition/antitrust/cases/dec_docs/39612/39612_12422_3.pdf

Appeal press release
https://curia.europa.eu/jcms/upload/docs/application/pdf/2018-12/cp180194en.pdf
Appeal decision ECLI:EU:T:2018:922. French only. See in particular para. 243.

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