Shire seeks preliminary injunction against Genentech
Shire is attempting to secure a preliminary injunction against two of Roche’s subsidiaries, Genentech and Chugai Pharmaceutical.
On Thursday, December 14, Shire filed the motion as part of its ongoing patent infringement lawsuit over a “humanised bispecific antibody”, which Genentech and Chugai have developed under the name emicizumab.
Genentech announced that the Food and Drug Administration granted therapy designation to emicizumab for the treatment of haemophilia in September 2015. Emicizumab is currently being marketed as Hemlibra.
According to Shire’s complaint, Chugai and Genentech have collaborated since September 2015 to develop the antibody product.
In a suit filed at the US District Court for the District of Delaware in May, Shire’s subsidiary Baxalta claimed that the treatment infringed its US patent number 7,033,590.
“The filing of the preliminary injunction is not a decision we made lightly, and we carefully considered the impact this filing may have on haemophilia patients,” said Shire.
Shire added that the court’s decision on the motion for the preliminary injunction is expected in the summer of 2018, so there will be no patient impact until then.
It added: “Shire has proactively proposed a carve-out provision to facilitate access for patients, but the scope of the provision is ultimately a matter for the court to decide.”
A spokesperson for Roche said that the injunction is aimed at preventing Roche from providing Hemlibra to patients in the US.
The spokesperson added that the injunction excludes patients who are already being treated with the medicine and excludes inhibitor patients who are less well served by existing bypass treatments or cannot receive prophylactic bypass treatments.
“We believe that Shire and Baxalta have demonstrated a profound disregard for patient well-being by seeking this preliminary injunction that prevents patients who may benefit from Hemlibra from receiving it,” said Roche.
The spokesperson added that Shire’s actions harm the haemophilia community and that it is not appropriate for Shire to dictate which patients should or should not receive Hemlibra.
“Our decisions and actions are always based on doing what is right for patients,” noted the representative.
A status call regarding the motion for a preliminary injunction is set for Friday, December 22.
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