Checkpoint inhibitor patent challenges are settled by AZ and BMS

AZ and BMS End Patent Disputes Over Checkpoint Inhibitors

AstraZeneca has announced the resolution of three lawsuits filed against it by Bristol-Myers Squibb (BMS) and Ono Pharma, alleging patent infringement related to AstraZeneca’s checkpoint inhibitor drugs, Imjudo and Imfinzi.

To settle these patent disputes concerning its PD-L1 inhibitor, Imfinzi (durvalumab), and the recently launched CTLA4 inhibitor, Imjudo (tremelimumab), AstraZeneca has allocated a provision of $510 million.

The legal dispute started when BMS filed a claim in a Delaware court in 2022, asserting that Imfinzi infringed on patents covering its PD-1 inhibitor, Opdivo (nivolumab). Ono Pharma and the Dana-Farber Cancer Institute later joined the complaint.

Ono Pharma, a partner of BMS, also filed a similar complaint in Japan last year, followed by a BMS lawsuit in January, alleging that Imjudo violated two US patents associated with the use of CTLA4 drugs in combination with PD-1/PD-L1 inhibitors and chemotherapy.

Such patent infringement allegations are common in the pharmaceutical industry when drugs with similar mechanisms are introduced. In a previous case, BMS and Ono won a dispute with MSD over its PD-1 inhibitor, Keytruda (pembrolizumab), in 2017. MSD settled the litigation by making a $625 million payment and obtaining a non-exclusive license to patents, as well as agreeing to pay royalties on Keytruda sales until 2026.

The settlement comes as a relief for AstraZeneca, which reported significant growth in Imjudo and Imfinzi during the second quarter, with combined sales of the two drugs reaching $1.1 billion, a 58% increase. Although Imjudo’s contribution currently remains relatively modest, it is expected to rise as it enters additional markets and secures regulatory approvals for new indications, such as bladder and urothelial cancers.

In March 2022, BMS initiated a lawsuit against AstraZeneca, alleging infringement on eight Opdivo patents. The following month, BMS added another claim to the lawsuit. Subsequently, in January 2023, a third lawsuit was filed by BMS, targeting Yervoy and Imjudo. The District of Delaware scheduled the trial for April 2024.

In comparison, Yervoy, BMS’s CTLA4 inhibitor, achieved global sales of approximately $1 billion in the first half of 2023, while Opdivo generated $4.3 billion during the same period.

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