law-legal-litigationBristol-Myers Squibb (BMS) and Merck & Co. have settled a year-long patent fight regarding Keytruda (pembrolizumab), a drug that is quickly becoming available for a number of cancer indications including non-small cell lung cancer (NSCLC), according to an analyst with research and consulting firm GlobalData.

The dispute arose after BMS claimed that Merck had infringed BMS and Ono’s patent related to the use of programme cell death 1 (PD-1) antibodies to treat cancer in the US, Europe, Australia, and Japan.

As part of the settlement, which was confirmed on 20 January, Merck agreed to pay BMS and Ono an initial sum of $625 million, and royalties of 6.5% of Keytruda’s global sales from 2017 to 2023, and 2.5% from 2024 through 2026.

Fenix Leung, DPhil, Pharmaceutical Consultant for GlobalData, explains: “BMS and Ono’s Opdivo has been in close competition with Keytruda to become the first available PD-1 drug in various cancer indications. Opdivo had a clear win against Keytruda in 2015 and the first half of 2016. However, it has seen major setbacks recently as it flopped in a first-line trial for NSCLC, and BMS has just given up the accelerated approval pathway for the Opdivo and Yervoy combination in NSCLC.”

“By contrast, Keytruda has been speedily expanding into the first-line setting in NSCLC. Nevertheless, BMS can now sit back and enjoy the stream of royalty revenue coming from Keytruda while Merck pays the bills for the drug’s aggressive clinical development programme.”

GlobalData expects more patent litigations to take place, as more PD-1-targeting drugs are expected to launch in the next couple of years.

So far, Roche’s Tecentriq (atezolizumab) has not received any complaints, probably because it is hitting another target in the pathway, the programme death ligand 1 (PD-L1). However, as more “me-too” PD-1/PD-L1 drugs appear on the market, big companies will increasingly engage their competitors in costly legal battles.