IP protection for pharmaceutical companies due to the ratification of the Association Agreement Ukraine - EU


Probably, the pharmaceutical industry is one of the most closely related to intellectual property. There are few factors about product creation and sales on the market and their attitude to intellectual property. Investment and research are required to create pharmaceutical product. At this stage it is important to protect the product with a patent. Next step registration of commercial name, which as well should be protected.

In connection with the ratification of the Association Agreement with the EU, Ukrainian legislation should be harmonized. It actually means that IP protection in Ukraine will undergo significant changes.

Trademarks
Opened TM database
Article 193 of Agreement establishes that ‘The EU Party and Ukraine shall provide a publicly available electronic database of trademark applications and trademark registrations’. In turn, this will enable enterprises to monitor possible violations of their rights before the registration of the TM. Today official fee for TM search in one class (for example, class 5 for pharmaceutical and veterinary drugs) will cost 720 HRN.
At present, a lot of disputes regarding infringing rights while registration of TM in Ukraine are resolved in the court, not on the pretrial stage. Opened database should prevent majority of court proceedings.
Terms of TM non-use cancellation
According to Ukrainian law, if the TM is not used for 3 years from the date of registration or by any other date after the registration, it could be cancelled for non-use reasons. Agreement between EU and Ukraine indicates extended term. Trademark shall be liable to revocation if, within a continuous period of five years, it has not been put to genuine use in the relevant territory in connection with the goods or services in respect of which it is registered.

Industrial designs
Although the Agreement directly is not targeted to fight against patent trolls, according to Art. 213, Ukraine is obliged to enter individual character as additional criterion for granting legal protection for industrial design.
At the moment, the industrial design must be just new. In contrast to such a criteria as a novelty, the design shall be considered to have individual character if the overall impression it produces on an informed user differs from the overall impression produced on such a user by any other design which has been made available to the public.
Protection for unregistered designs is provided as well, i.e. unregistered designs made available to the public shall confer the same exclusive rights, but only if the contested use results from copying the protected design.
The duration of protection shall amount to at least five years for registered designs. The right holder may have the term of protection renewed for one or more periods of five years each, up to a total term of 25 years from the date of filing.
The duration of protection for unregistered designs - at least three years as from the date on which the design was made available to the public.

Validity of the patent
According to Ukrainian law the term of patent protection is 20 years from the date of filing of the application. For utility model such term is 10 years. However, due to the fact that before you bring a medicinal to market, you must go through a long administrative procedures, legislation provides the possibility of extending the term for the patent.
Thus, according to Law of Ukraine ‘On Protection of Rights to Inventions and Utility Models’ the validity of a patent for an invention, the object of which has been subject to an administrative authorization procedure, may be extended at the request of the owner for a period which is equal to the period between the filing date and the date of receipt of the resolution, but not more than 5 years. In other words, if the application for the patent was filed Feb. 1, 2007, and permission is obtained only after 7 years - February 1, 2014, the term of the patent can be extended today for only 5 years.
Agreement (Art. 220) provides a slightly different period which is the same as the administrative procedure, reducing by a period of five years.

Protection of data submitted to obtain an authorization to put a medicinal product on the market
The agreement also provides protection of the data in order to obtain permission to launch the medication on the market. When Party of Agreement requires research on the safety and efficacy of a medicinal product prior to granting approval for the marketing of such product, the other party for not less than 5 years from the date of the first permission would not allow another applicant withdraw such or similar medication, on the basis of the marketing approval granted to the applicant which had provided the test data or studies, unless the applicant which had provided the test data or studies has given consent.

This is not a complete list of innovations in IP protection, which are provided by Agreement. In general, it must be said that the Association Agreement with the EU provides tremendous opportunities, as well as Ukraine holds equally serious obligations.

Mariya Ortynska
Trademark and Patent Attorney of Ukraine

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