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17 February 2022Big Pharma

Roche and AstraZeneca units settle blood drug suit

Roche’s Chugai and AstraZeneca’s Alexion Pharmaceuticals have brought their patent infringement dispute over a treatment for rare, fatal blood diseases to an end.

Japan-based Chugai had accused Alexion of two patents through Ultomiris (ravulizumab), a drug used to treat rare life-threatening blood diseases.

Chugai said that it had developed a technology that “extends the half-life of an antibody in blood plasma, thereby improving the duration of time in which the antibody binds and neutralises target antigen”.

According to the company, its inventions allow patients taking C5 inhibitors (to treat life-threatening blood disorders) to reduce the quantity and frequency of their treatments.

These inventions were protected by patent applications pending at the time of the complaint and US patent number 9,890,377. The patent describes methods of removing an antigen from blood plasma using modified antibodies that are capable of recycling, so that they repeat the antigen-binding process multiple times rather than a single time.

At the time of the complaint, filed in late 2018, Alexion was already marketing Soliris (eculizumab), a C5 inhibitor prescribed for patients with rare blood conditions.

But, in June 2018, Alexion submitted a b iologics  licence a pplication to the US Food and Drug Administration seeking approval for Ultomiris, an improved C5 inhibiting biologic product with a pH-dependent recycling effect.

Chugai alleged that Alexion had sought a licence of its antibody recycling technology, but when Chugai refused the licence, Alexion knowingly incorporated the technology into its Ultomiris product anyway.

Ultomiris is now approved in the US as a treatment for paroxysmal nocturnal hemoglobinuria.

On Monday, February 14, the parties filed under seal, requesting a stay pending settlement. US District Judge Maryellen Noreika granted the proposed order the following day.

February 14 was due to be the first day of an anticipated five day jury trial, a trial that has been postponed a number of times since its original timing of May last year.

The terms of the settlement are not publicly available.

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