US appeals court takes Roche’s side in Hemlibra patent dispute with Takeda
21 Sep 2023
Drug ApprovalPatent InfringementAcquisitionBiosimilarPatent Expiration
A US appeals court upheld an earlier ruling, affirming that Roche's haemophilia treatment Hemlibra (emicizumab) does not infringe a patent owned by Takeda's Baxalta unit. Roche generated more than $2.5 billion from sales of the product in the US last year.
Hemlibra gained FDA approval in 2017 to prevent or reduce the frequency of bleeding episodes in patients with haemophilia A who have developed resistance to Factor VIII replacement therapy. The label for the once-weekly drug was expanded the following year to include patients with haemophilia A without Factor VIII inhibitors.
However, shortly after securing its first FDA approval, Shire – which merged with Baxalta in 2016 - filed a motion for preliminary injunction against Roche’s Genentech and Chugai Pharmaceutical subsidiaries as part of its claims that Hemlibra infringed one of its patents. In its suit, Baxalta argued that Hemlibra clots blood in the same way as its patented antibodies.
Last year, a Delaware federal court judge determined that the relevant parts of Baxalta’s patent are invalid because it did not enable a person of ordinary skill to recreate all of the antibodies it claimed without "unreasonable experimentation." A three-judge panel at the US Court of Appeals for the Federal Circuit has now agreed with the earlier ruling, citing a recent Supreme Court decision in a legal battle between Amgen and Sanofi focused on patents covering PCSK9-blocking antibodies.
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