Call it a bad day for Teva and a good one for CSL Vifor. A Delaware district court ruled that a proposed Teva generic of CSL Vifor’s chronic kidney (CKD) drug Velphoro infringes an existing patent.
The CSL Vifor patent in question expires in July 2030, although the drug is protected by other patents that expire between 2029 and 2035. Specifically, the patent is held by Vifor Fresenius Medical Care Renal Pharma (VFMCRP), a joint company between CSL Vifor and Fresenius Medical Care that focuses on chronic kidney disease.
“We are vigorously defending our intellectual property and protecting our market position,” Florian Jehle, VFMCRP’s CEO, said in a company statement. “With this decision, we can continue to deliver this innovative drug to improve the lives of patients with chronic kidney disease on dialysis.”
Vifor Fresenius Medical Care Renal Pharma previously reached settlements with Lupin Pharmaceuticals and Annora Pharma, two companies that filed FDA applications to market their own generic versions of Velphoro. The companies will be allowed to launch the generics in the U.S. on an “agreed upon date,” but details of those settlements remain confidential.
Velphoro garnered 179.2 million Swiss Franc for Vifor in 2021. The drug is approved in 32 countries.
Meanwhile, Vifor now flies under the CSL banner after the company agreed to sell itself late last year for $11.7 billion. With the deal, CSL purchased marketed franchises in kidney disease and iron deficiency, plus a pipeline of 37 medicines in development.