Shares of Eagle Pharmaceuticals and Teva Pharmaceuticals are climbing following a favorable ruling in U.S. District Court that protects the patent for cancer drug Bendeka from generic competition through 2031.
Bendeka will not enter generics category until 2031.
Shares of Eagle Pharmaceuticals and Teva Pharmaceuticals are climbing following a favorable ruling in U.S. District Court that protects the patent for cancer drug Bendeka from generic competition through 2031.
A federal judge upheld Teva and Eagle’s 2017 patent claims that generic versions of the cancer treatment infringed on at least four separate patents for Bendeka (bendamustine hydrochloride injection, or bendamustine HCl), which was approved in 2015 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. In the ruling, the court upheld the asserted patent claims made by Eagle and Teva, which licensed the drug from the smaller pharma company. Additionally, the judge ruled that the Abbreviated New Drug Applications filed by generic drugmakers Slayback Pharma LLC, Apotex Inc. and Apotex Corp., Fresenius Kabi USA and Mylan infringe upon those patents and as such, their products are barred from launching until 2031.
In his ruling, U.S. District Court Judge Colm Connolly said the claims made by the generic drugmakers are invalid.
“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,” Connolly wrote in his opinion, according to a report from Bloomberg.
The patents in question cover the formulation of Bendeka, as well as the administration of the medication. The formulation patients are not set to expire until 2031 and the administration patents expire in 2033, Bloomberg reported, citing the U.S. Food and Drug Administration’s registry of information on approved drugs.
Eagle Pharma Chief Executive Officer Scott Tarriff said he was happy with the ruling that protects the “longevity” of Bendeka.
“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,” Tariff said in a statement. Bendeka has earned more than $2 billion since its launch.
Kelley Dougherty, a spokesperson for Teva, told Bloomberg the company is pleased with the court’s decision that upholds the validity of its patents. Dougherty added the company will continue to focus on providing Bendeka to the patients who need it.
