USITC begins probe into CSL Behring

The US International Trade Commission (ITC) has instituted a probe into CSL Behring, a biopharmaceutical company.

Announced on Tuesday, August 8, the ITC’s probe will investigate certain recombinant factor IX products for the treatment of haemophilia B.

Haemophilia B is a bleeding disorder characterised by deficiency of the coagulation factor IX.

The treatment combines recombinant factor IX (rFIX) with albumin, a protein found in blood plasma that helps factor IX stay active in the bloodstream longer.

The investigation is based on a complaint filed by Bioverativ, a biotech company, in July this year.

Bioverativ alleged violations of section 337 of the Tariff Act of 1930 in the importation into the US and sale of CSL’s product, which allegedly infringes Bioverativ’s patents.

The company is seeking a limited exclusion order and cease-and-desist orders from the ITC.

Bioverativ currently manufactures Alprolix, a recombinant factor IX product, in the US.

According to the complaint, Alprolix and other non-infringing suppliers (Pfizer, Shire and Aptevo) have the ability to replace CSL’s products if the ITC issues exclusion and cease-and-desist orders.

Idelvion, CSL’s product, was approved in the US in March last year.

The product is alleged to have infringed three of Bioverativ’s patents: US numbers 9,670,475; 9,623,091; and 9,629,903.

Approximately 4,400 people in the US live with haemophilia B, according to the World Federation of Hemophilia’s 2015 Survey.

Did you enjoy reading this story?  Sign up to our free newsletters and get stories like this sent straight to your inbox.