Ukraine: 100% LIFE opposes patent on TB drug for children

Our campaign partner in Ukraine, 100% LIFE, has submitted the first patent opposition on bedaquiline in the Eastern Europe and Central Asia (EECA) region, to prevent a costly monopoly on the pediatric version of the TB drug.

Last month, our civil society intellectual property (IP) experts in Thailand and Brazil also opposed applications for bedaquiline.

Janssen Pharmaceutica N.V, one of Johnson & Johnson’s pharmaceutical companies, filed the application at the Ukrainian Patent and Trademark Office. If granted, Janssen would secure a 20 year monopoly, which 100% LIFE believes would be unmerited.

For years, parents have been dissolving pills that are too large for children to swallow – this is not an inventive step.

The application refers to composition and method of preparation. 100% LIFE are technical experts in assessing the right to intellectual property protection and patentability criteria. They have deemed that the technical solution is “obvious to any average expert in that sphere” and that the application lacks the ‘inventive step’ required in order for a product to be patentable.

The drug, which would enable children living with TB to endure shorter treatment times and less side-effects, is essentially a soluble version of the adult drug. Parents and care-givers could dissolve the tablets into water, or mix with yoghurt for example – something parents have already been doing with pills for decades.


“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 Ukrainian Patent and Trademark Office 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, which will stimulate reduction of prices, making the product accessible for the patients,” says Sergey Dmytriev, 100% LIFE’s Director of Policy and Advocacy.

The final decision of the Patent and Trademark Office on the opposed patent application is expected within two years. Applying for unmerited patents is a tactic frequently employed by pharmaceutical companies. It delays generic competition to a ‘market’ or country as an application in itself creates uncertainty around what Intellectual Property (IP) protections may or may not be instated in a country at a later date.