OPDIVO (Nivolumab, Ono and Bristol) and KEYTRUDA (Pembrolizumab, MSD) are anticancer drugs containing anti-PD-1 antibody as an active ingredient.  In 2019, OPDIVO and KEYTRUDA ranked fourth and first among all prescription drugs in Japan in terms of sales.

Recently, an invalidation trial was filed against Ono’s anti-PD-1 antibody patent.  The outline is as follows.

Outline of the Invalidation Trial
Drugs covered by the patent
OPDIVO (Nivolumab), KEYTRUDA (Pembrolizumab)

Trial number (Date)
2020-800088 (October 1, 2020)

Patent number
JP 4409430

Patent owner
Ono Pharmaceutical Co., Ltd.
Tasuku Honjo

Not yet published

Title of invention (Machine translation)
Immunostimulatory composition

Claim 1 (Machine translation)
A melanoma therapeutic agent containing a PD-1 antibody as an active ingredient and having an action of suppressing the growth or metastasis of melanoma in vivo.

Other invalidation trials against the following Ono’s patents were also filed.

JP 5159730: anti-PD-1 antibody patent
JP 5885764: anti-PD-L1 antibody patent
JP 6035372: anti-PD-1 antibody patent
JP 6258428: anti-PD-L1 antibody patent

In Japan, a few invalidation trials or oppositions against prescription drug patents are filed almost every month.  It is recommended that pharmaceutical companies monitor these invalidation trials and oppositions.

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