Bristol-Myers Squibb Co./Ono Pharmaceutical Co. Ltd. v. Merck

14-cv-01131, District of Delaware

Bristol and Ono filed suit in September 2014 claiming Merck’s marketing of Keytruda (pembrolizumab) will infringe patent No. 8,728,474 covering use of antibodies that bind to PD-1 to treat cancer. BMS used the invention to develop Opdivo (nivolumab).

The suit was filed the same day FDA approved Keytruda. (Also see "Late-Stage Data Advantage Or Just Late To The Game: Bristol’s Opdivo Approval Sets Off PD-1 Competition" - Pink Sheet, 5 January, 2015.)

In June 2015, Ono filed suits alleging infringement of two other patents (Nos. 9,067,999 and 9,073,994). In June 2016, Merck filed petitions for inter partes review challenging the validity of these patents.

In April 2016, Merck filed declaratory judgement action against BMS and Ono seeking a ruling that two other patents (Nos. 8,779,105 and 9,084,776) are invalid and/or not infringed by the sale of Keytruda. BMS and Ono filed a counterclaim of infringement in June.

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