Sanofi unit takes CSL to court over haemophilia therapy
Biotech company Bioverativ has accused CSL Behring of infringing three patents covering its haemophilia B treatment Alprolix (coagulation factor IX (Recombinant), Fc fusion protein).
In its suit, filed yesterday, March 4, at the US District Court for the District of Delaware, the Sanofi subsidiary accused CSL of infringing US patent numbers 10,548,954; 10,561,714; and 10,568,943, all of which cover “Factor IX polypeptides and methods of use thereof”.
CSL’s drug Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein), which also treats haemophilia B, is at the centre of the dispute.
In 2014, the Food and Drug Administration (FDA) approved Alprolix for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with haemophilia B.
Two years later, CSL obtained FDA approval for Idelvion and soon after began sales of the product in the US.
Hemophilia B is a rare, genetic disorder—in its global survey 2015, the World Federation of Hemophilia estimated that nearly 30,000 people worldwide, including approximately 4,400 people in the US, have haemophilia B.
Factor IX, a naturally occurring clotting factor, is missing (functionally deficient) or defective in people with haemophilia B.
Bioverativ’s drug fuses Factor IX with the Fc protein fragment, which “results in a protein that extends the half-life of Factor IX by using a naturally occurring mechanism called the FcRn recycling pathway to delay the breakdown of the protein”.
“The recombinant Factor IX molecule in Idelvion is fused to albumin, which uses the same Fc recycling pathway as Alprolix for half-life extension. The administration of Idelvion to patients in accordance with the Idelvion label infringes the asserted patents,” alleged the suit.
CSL is also allegedly inducing infringement the patents by instructing users, such as physicians and/or health care providers, to perform the infringement themselves.
Now, Bioverativ has asked the court for a finding of infringement, triple damages, and a finding that the case is exceptional.
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