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UKRAINE


UKRAINE


These offences are punishable by a fine of approximately €40 to €80. It is worth noting that the scale of counterfeiting in administrative cases is determined by a specially authorised executive authority in the healthcare field.


Amendments have also been introduced to help strike a balance between IP protection and consumer access to pharmaceuticals.


Article 9 of the law on pharmaceuticals guarantees market protection for original medicines for a period of five years from the date of their first registration (issuance of marketing authorisation) in Ukraine. At the same time, the provisions of this article contain a reservation clause stating that a ban on generic applications does not extend to cases where permission to rely on clinical trials data that are contained in the registration dossier of the reference medicine was obtained “in accordance with a procedure prescribed by law”, particularly when permission was granted by the originator company. Yet another exception to the application of the data exclusivity provisions extends to generic applications that are based on full clinical trials data obtained by the applicant independently from the originator company.


The law further provides that applications for marketing authorisation that are related to patented medicines must be accompanied by certified copies of the respective patents or licences, along with extracts of the current status of the protective rights. Furthermore, applicants are required to file a letter or declaration stating that the registration of the respective medicine does not infringe third parties’ patent rights. In fact, this provision preserved the status quo before the revisions to the pharmaceutical law, particularly in that the competent authority is not responsible for checking applications against valid patent rights.


At the same time, the provisions of the Ukrainian pharmaceutical law were harmonised with the respective EU directives by adding an additional period of data exclusivity. The five-year data exclusivity period can be extended by an additional one year if, during the first three years of the-five year period, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications that are considered to bring a significant clinical benefit, as compared to existing therapies. The criteria for assessing indications as bringing a significant clinical benefit over existing therapies are outlined by the Ukrainian Ministry of Health.


Finally, the most important reservation of Article 9 limits the application of the data exclusivity provisions to originator companies


242 World Intellectual Property Review e-Digest 2012


AT THE SAME TIME, THE PROVISIONS OF THE UKRAINIAN PHARMACEUTICAL LAW WERE HARMONISED WITH THE RESPECTIVE EU DIRECTIVES BY ADDING AN ADDITIONAL PERIOD OF DATA EXCLUSIVITY.


that apply for marketing authorisation for medicines within two years of receiving market authorisation for the medicines in any other state.


Antonina Pakharenko-Anderson is the managing partner and founder of Pakharenko & Partners. She can be contacted at: pakharenko@pakharenko.kiev.ua


Alexander Pakharenko is an attorney, patent attorney and partner at Pakharenko & Partners. He can be contacted at: alexander@pakharenko.kiev.ua


Antonina Pakharenko-Anderson is a registered patent attorney and doctor of laws. She has been working in the field of IP for more than 25 years.


Alexander Pakharenko has expertise in the field of IP rights enforcement, particularly in anti-counterfeiting and anti-piracy actions. His counselling practice encompasses all aspects of IP rights protection and enforcement in Ukraine.


www.worldipreview.com


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