In the past few weeks, we have received many inquiries regarding the scope of the injunction Shire is seeking in its lawsuit against Genentech/Roche. Certain information has become public during this period that enables NHF and HFA to provide some limited guidance as to the scope of the injunction that Shire has requested from the Court. The Court HAS NOT entered any injunction to date. According to a statement it issued, Shire does not expect any court decision on its motion for a preliminary injunction until the “summer of 2018”. The statement of Shire can be accessed here.
Genentech/Roche recently issued an open letter to the hemophilia community regarding the dispute between Shire and Genentech/Roche. The open letter of Genentech/Roche can be accessed here. According to that open letter issued by Genentech/Roche:
“If granted as proposed, Shire’s preliminary injunction would prevent certain patients in the U.S. from receiving HEMLIBRA. Specifically, Shire has proposed that the court prohibit Genentech from selling HEMLIBRA to the following patients:
- Hemophilia A patients with inhibitors (defined as those with an inhibitor titer of greater than 5 Bethesda units who cannot be treated effectively with Factor VIII replacement therapy), unless (i) they have already started HEMLIBRA before the injunction is granted by the court, or (ii) they have previous experience with on-demand or prophylactic bypassing agents and their needs are not currently being met, as defined by Shire using criteria that include experiencing certain life- or limb-threatening bleeds or venous access issues.
- Hemophilia A patients who have an inhibitor titer less than or equal to 5 Bethesda units, or who can be effectively treated with Factor VIII replacement therapy, regardless of whether they have already started HEMLIBRA.
- Hemophilia A patients without an inhibitor, regardless of whether they have already started HEMLIBRA.”
NHF and HFA reiterates that as of this date, NO INJUNCTION ORDER OF ANY KIND HAS BEEN ENTERED BY THE COURT.
NHF and HFA will NOT engage in the dialogue around patent ownership and will not be ‘choosing a side’ relative to this suit. NHF and HFA will remain focused on patient access to care and if and when we feel that is being jeopardized, we will take any and all action necessary to ensure patient access to their prescribed therapies is not interrupted or denied. We are hopeful that both sides will conduct themselves in a way that will not jeopardize the health of the patients in the bleeding disorders community.
Please note that NHF and HFA do not recommend, endorse or make any representation about the efficacy, appropriateness or suitability of any specific products, treatments, or opinions. Please consult your physician before use of any treatments.