AUTH/3125/11/18 - Takeda v Merck Sharp & Dohme

Inter-company dialogue

  • Received
    23 November 2018
  • Case number
    AUTH/3125/11/18
  • Applicable Code year
    2016
  • Completed
    09 January 2019
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    To be published in the May 2019 Review

Case Summary

Takeda UK Ltd complained about the failure of Merck Sharp & Dohme Ltd to comply with an undertaking provided during inter-company dialogue between the two parties.   Takeda marketed Vipidia (alogliptin) and Merck Sharp & Dohme marketed Januvia (sitagliptin).  Both medicines were used in adults with type 2 diabetes mellitus.

Takeda explained that it became aware of a Januvia promotional item displayed on a Merck Sharp & Dohme promotional stand in October 2018 at a diabetes conference which contained a mention of alogliptin and incorrectly associated the product with the inverted black triangle symbol, contrary to the undertaking provided by Merck Sharp & Dohme that no materials incorrectly associating alogliptin with the black triangle would be in use after the end of August 2018.  Takeda was disappointed that Merck Sharp & Dohme failed to honour its undertaking and alleged that in doing so it had not maintained high standards

The detailed response from Merck Sharp & Dohme is given below.

The Panel noted that although undertakings given by companies during the course of inter-company dialogue were not covered by the Code and were thus not subject to the requirements of the Code, it was important that companies complied with such undertakings. Failing to implement an inter-company undertaking might indicate that previous inter-company dialogue had ultimately been unsuccessful. 

The Panel noted that whilst Merck Sharp & Dohme had endeavoured to withdraw all the relevant material, the company had been let down by one of its representatives who confirmed that he/she had destroyed all of the relevant material in his/her possession but had not done so. The employee still possessed and had used a Januvia leavepiece in October in which five inhibitors of dipeptidyl peptidase 4 (DPP-4 inhibitors) were compared in a table and alogliptin was incorrectly associated with a black triangle when the black triangle had been removed from the product on 18 June 2018.  The material was not up-to-date and the Panel considered therefore that high standards had not been maintained and a breach of the Code was ruled.