The first patent opposition on bedaquiline in the EECA region has been submitted by the 100% Life

On 16 of June the 100% Life submitted to the Ukrainian Patent and Trademark Office (UA PTO) an opposition against granting a patent on a pediatric version of an anti-TB medicine – bedaquiline. It has become the first opposition against bedaquiline patent in the EECA region.

The subject matter of the application submitted to the UA PTO by Janssen Pharmaceutica NV is a substance in a form of composition and method of preparation of the composition. In case a patent based on the said application is granted  Janssen Pharmaceutica NV will become the only manufacturer liable for importation of the pediatric bedaquiline to Ukraine. The argument against granting of the patent is it’s incompatibility with inventive step criteria, which means that the technical solution described in the application for patent is obvious for the average expert in that sphere.

“We firmly believe that the opposed patent application is a typical example of an “evergreening” patent and doesn’t bring anything new to contemporary pharmaceutical science. Therefore, we have submitted our arguments to the UA PTO in order to prevent monopolization of the medicine in Ukraine.  It is in the best interest of Ukrainian patients that there will be the high number of manufacturers at the medicines market, which will stimulate reduction of prices and making the product accessible for the patients,” says Sergey Dmytriev, 100% Life’s Director of Policy and Advocacy.

The final decision of the UA PTO on the opposed patent application is expected within two years. At stake is the price of the medicine and it’s affordability for the state and individual consumers