News date: 24 April 2015
On April 21, 2015 the Higher Commercial Court of Ukraine affirmed a court decision upheld by the Commercial Court of Kyiv City as of December 25, 2014 and ruling of Kyiv Commercial Court of Appeal as of February 27, 2015 under the claim lodged by Megainpharm GmbH (Austria) against the Ministry of Health of Ukraine, CJSC Pharmaceutical Company DARNYTSIA and the State Enterprise State Expert Center of the Ministry of Health of Ukraine on invalidation of the state registration of a medical product which is under protection of patent rights of Megainpharm GmbH registered to the invention called “ophthalmic antiseptic”. The product represented the unapproved copy of the original medication named “Okomistin” produced by Megainpharm GmbH (Registration certificate No. UA/7537/01/01, the Order of the Ministry of Health of Ukraine No. 159 as of March 05, 2014). The medication is a universal antiseptic effective against all possible microorganisms causing infectious and inflammatory diseases of an eye and nasal pharynx and registered in several European countries. In Ukraine “Okomistin” is produced by PJSC FARMAK.
In addition, the generic product was brought to registration as full analogue of “Okomistin” and is similar to it in all quality and effect characteristics. In the process of settlement of the dispute the court appointed an expert examination which established equivalence of this generic to the original product – “Okomistin” (product of Megainpharm GmbH) and, correspondingly, confirmed application of essential attributes of formula of invention called “ophthalmic antiseptic”.
Following performance of thorough analysis of all details related to the dispute, as well as review of all the evidence in the case, the Commercial Court of Kyiv City sustained the stated claims of Megainpharm GmbH, namely, the state registration of the generic product was held invalid as a result of which Megainpharm GmbH (as the owner of invention called “ophthalmic antiseptic”) shall have the exclusive right for production of medical product under the name “Okomistin” currently produced by FARMAK.