Peshkova /
29 October 2015Big Pharma

English High Court affirms validity of Ono’s cancer patent, despite Merck challenge

The English High Court has affirmed the validity of the Ono Pharmaceutical’s cancer immunotherapy drug after it was challenged by pharmaceutical company Merck.

At the centre of the dispute is Ono’s European patent called “Immunopotentiating compositions” issued by the European Patent Office in 2010.

The patent covers the anti-PD-1 antibody and is marketed under the trade name Opdivo (nivolumab). Biopharmaceutical company Bristol-Myers Squibb (BMS) is the exclusive licensee of the patent.

Merck markets its own anti-PD-1 antibody under the brand name Keytruda (pembrolizumab), which Ono and BMS had claimed was infringing its patent. Both drugs are used to treat lung cancer.

Merck had challenged the patent claiming that it was obvious, but had accepted that if the court ruled that it was valid then Merck’s product “falls within the ambit of the relevant claims” of Ono’s patent and is therefore infringing.

In a decision handed down on Thursday, October 22, Justice Colin Birss was not convinced by Merck’s challenge and deemed the patent to be valid. And because Merck admitted its product falls within the relevant claims, Birss also concluded that Merck had infringed Ono’s patent.

“The patent enables the skilled person to make and use anti-PD-1 antibodies as anti-cancer medicines. Moreover, and crucially, the evidence today shows that anti-PD-1 antibodies have been approved to treat a number of different cancers and are worth investigating in a very wide range of cancers. The evidence today also shows that anti-PD-1 monotherapy probably does not treat prostate cancer and most colorectal cancers, but this does not demonstrate a lack of technical contribution or undue burden.

“The law does not require perfection,” he added.

A spokesperson for BMS told LSIPR that it is pleased with the decision.

"This protection has, in turn, allowed us to develop a deep and broad portfolio of innovative medicines.  It is in this spirit that we will continue to defend our intellectual property rights against infringement," it added.

A spokesperson for Merck said: "The company will seek permission from the court to appeal against the decision. We are confident that we will be able to market Keytruda in any country in which it is approved."

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at