Nijmegen, the Netherlands, 13 September 2017 - Yesterday, 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.
Synthon, with headquarters in Nijmegen, the Netherlands, is an international pharmaceutical company and a leader in the field of generic medicines. The company started its biopharmaceutical franchise in 2007 and is building a promising portfolio of next generation medicines. Synthon is developing rapidly into a specialty pharmaceutical company, focusing on the therapeutic areas of oncology and auto-immune diseases. Synthon products are currently approved by regulatory agencies in over 90 countries worldwide and marketed through strategic partnerships and – in dedicated areas – through direct sales. Synthon employs about 1,900 staff worldwide, and in 2016 it recorded a turnover of EUR 258 million.
* Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.