Teva’s cancer drug Bendeka protected from generics until 2031, judge rules
pharmafile | April 30, 2020 | News story | Business Services | Bendeka, Teva, Teva and Eagle
A US federal judge has ruled that generic versions of the cancer treatment Bendeka infringe on four separate patents, and has delayed them from launching until 2031.
The patents are owned by Eagle Pharmaceuticals and Teva Pharmaceuticals. Bendeka was approved in 2015 by the FDA for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab containing regimen.
The patents cover both the formula and the administration method of the treatment.
US District Court Judge Colm Connolly ruled that the Abbreviated New Drug Applications filed by the generic drugmakers Slayback Pharma LLC, Apotex Inc, Apotex Corp, Fresenius Kabi USA and Mylan infringed upon Eagle and Teva’s patents. He barred their generic versions of Bendeka from launching until 2031.
Connolly wrote his opinion and stated that: “Although the evidence of commercial success does not support a finding of nonobviousness, I still find that defendants have not shown by clear and convincing evidence that the prior art they cited would have motivated a person of skill in the art to reach the claimed formulations.”
Speaking on the ruling, Eagle Pharma Chief Executive Officer Scott Tarriff said: “With this decision, Bendeka’s value is likely to be intact for many years, thus ensuring our continued ability to invest in our growing research program and product pipeline.”
Bendeka has earned the companies more than $2 billion since its launch.
Conor Kavanagh
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