Australian blood products giant CSL has been accused of “willful” and “deliberate” breach of patents for drugs to help haemophilia sufferers that are owned by a US rival.
US company Bioverativ launched a suit against CSL subsidiary CSL Behring in the District Court of Delaware on Friday alleging CSL has actively breached three of its patents.
CSL is caught up in another patent stoush in the US. Photo: James Davies
Bioverativ is seeking an injunction against CSL selling its products, and damages equivalent to three times the amount of any money the court finds Bioverativ has lost from CSL’s alleged breach of the patents.
The legal dispute centres on CSL’s new drug Idelvion, which Bioverativ says is similar to its drug Alprolix.
Both drugs work to prevent or reduce the frequency of bleeding episodes in haemophiliacs.
According to Bioverativ, its Alprolix drug was registered with the US Food and Drug Administration two years before CSL obtained FDA approval for Idelvion in March 2016. Bioverativ is the haemophilia spin-off of US drug giant Biogen.
Bioverativ argues in its legal complaint that Alprolix was a major advance in medical technology as it allowed haemophilia sufferers to use their medication less frequently.
“Alprolix is the first FDA-approved recombinant, clotting-factor therapy with prolonged circulation in the body,” Bioverativ says in its claim.
“It is indicated for use in adults and children for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with haemophilia B.”
CSL said it was “highly confident of its intellectual property position for Idelvion”, adding it had spent decades researching the product and it was a major advance for patients.
Idelvion is one of CSL’s best-performing products due to its rapid uptake by doctors and patients.
According to a recent note from Morgan Stanley, the drug delivered $US37 million ($48.7 million) in revenue to CSL during the first half of 2017.
The investment bank estimates Idelvion will produce revenues of $US156 million in 2018 and $US67 million in the second half of 2017.
CSL said it could not comment on specific details of the case because it was a litigation matter.
“CSL Behring is committed to making Idelvion available to patients and believes that patients and physicians have the right, and should have the ability, to choose among a variety of treatment options for haemophilia B, including Idelvion,” the company said in a statement.
CSL’s shares dipped slightly on the news, falling 85¢, or 0.63 per cent, to close at $133.32.