European patent office decides in Synthon’s favor in glatiramer patent case.
In opposition proceedings filed by inter alia Synthon, the Technical Board of Appeal (TBA) of the European Patent Office revoked the last of Teva’s three glatiramer so-called HBr patents which claimed an allegedly improved process for the synthesis of glatiramer acetate.
This decision clears the way for Synthon’s generic glatiramer acetate, thereby giving European patients with relapsing remitting multiple sclerosis access to a clinically validated, affordable, efficacious and safe alternative to Teva’s Copaxone®*.
Asserting one or more of these HBr patents, Teva filed applications for ex parte preliminary injunctions or other measures in 19 European countries against Synthon and / or Synthon’s partners which led to an even larger number of legal proceedings.
This TBA decision confirms that these actions lacked legal basis and thus were unjustified.
In many countries, Synthon and its partners have been able to prevent these preliminary injunctions from being issued or had these lifted in appeal.
Synthon is the only company to have performed a large-scale, multicenter Phase III study for glatiramer acetate 20mg/mL and to obtain marketing authorizations for the product in most European countries. Synthon’s partners introduced generic glatiramer in a number of these countries as of the end of 2016.
The TBA decision means that any preliminary injunctions still in place are now no longer effective or will be lifted within a short timeframe.
(Source: B3C Newswire)
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