Cipla settles blood cancer drug litigation with Bristol Myers in US

As it takes away the legal overhang, Cipla can launch the drug once its ANDA is approved

Mumbai-based Cipla on Friday said that the settlement of its patent litigation with a Bristol Myers Squibb (BMS) subsidiary on Revilimid or a drug for blood cancer. 

Calgene, a wholly-owned subsidiary of BMS, has agreed to provide Cipla with a license to Calgene's patents required to manufacture and sell certain limited volumes of generic lenalidomide (a drug sold under the name Revilimid that treats myeloma, a cancer that forms in the blood plasma cell), in the US. 

Kedar Upadhye, Global Chief  financial officer of Cipla, told Business Standard that this was a major boost to their US business as it builds certainty on the launch date. Terming it as a "right step & a good  settlement" Upadhye said. "This takes away the litigation overhang and reduces ongoing legal spend on para-IV case."

Cipla would need to obtain an abbreviated new drug application (ANDA) before it can start marketing the drug in the US. Cipla's US business had seen a boost in the second quarter after it launched generic Albuterol, an inhaler drug in the market. US revenues had grown by 4.4 per cent sequentially. 

As part of the settlement, the parties would  file consent judgments with the US district court for New Jersey. 

"In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Cipla with a license to Celgene’s patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the United States beginning on a confidential date that is some time after the March 2022," Cipla said here. 

For each consecutive twelve-month period (or part thereof) following the volume-limited entry date until January 31, 2026, the volume of generic lenalidomide sold by Cipla cannot exceed certain agreed-upon percentages, the company added. 

The specific volume-limited license date and percentages agreed-upon with Cipla are confidential.

In addition, Celgene has agreed to provide Cipla with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the US beginning no earlier than January 31, 2026.