Ukraine. Intellectual property in pharmaceuticals

Medicinal products may be produced by companies, institutions, organizations and natural persons. An author (co-author) of a medicinal product is a natural person (persons), by whose creative work this medicinal product has been created. He/she (they) is (are) entitled for a fee for use of the medicinal product created by him (them). The fee may be paid in any form which is not prohibited by legislation in effect. Property and no-property rights with regard to creation and production of medicinal products are regulated according to legislation.

For the state registration of a medicinal product involving intellectual property protected by a patent an applicant should file a copy of the patent or license allowing manufacturing and sale of the registered medicinal product. The applicants file a document stating that the third parties’ rights protected by a patent are not violated in connection with registration of a medicinal product.

A person may be denied in registration if such a registration leads to violation of intellectual property rights within manufacturing, usage, sale of medicinal products. In case if any disputes arise, a court decision shall be decisive.

Patenting of medicinal products in Ukraine is regulated according to the Law of Ukraine «On Protection of Rights to Inventions and Useful Models» dd 15.12.1993 # 3687-XII. A chemical substance and a method of its preparation are patented to guarantee the control over its use. A person that intends to patent a medicinal product should file a registration form which consists of an application, a specification of the invention, a formula of invention, an essay, an illustration. The registration form is filed in accordance with the Order of the Ministry of Education and Science of Ukraine dd 22.01.2001 # 22. The registration form is confidential, an applicant is provided with the temporary legal protection with regard to the formula of the invention by the Ukrpatent that takes a relevant decision. The state registration of the patent takes place based on the decision after payment of duties and other compulsory payments.

The patent is issued in a month after its state registration. The data on issuance of the patent is published in an official bulletin. The period of validity of a patent is 20 years from the filing date. The validity of a patent may be extended for a period equal to the period between the date of filling of an application for the invention and the date of the state registration of medicinal product, but not more than 5 years, according to the Instruction approved by the Ministry of Education and Science of Ukraine dd 13.05.2002 # 298. The issue of patent extension shall be considered by the State Department of Intellectual Property on the request of the interested person.

Packaging and external shape of medicinal products may be objects of industrial design’s rights, protection of which is held in accordance with the Law «On Protection of Rights to Industrial Designs» dd. 15.12.1993 # 3688-XII. The ownership title to an industrial design is certified by a patent. The period of validity of a patent is 10 years from the date of filing to the State Enterprise «Ukrainian Institute of Industrial Property» (hereinafter – Ukrpatent) and may be extended on the owner’s request, but not more than for 5 years.

A medicinal product enters the civil circulation under the trade mark which is protected under the Law «On Protection of Rights to Trademarks for Goods and Services" dd 15.12.1993 # 3689-XII. The trademark’s protection can be granted only to original, specially invented names of drugs. The protection is established by the way of the registration of property rights to the trademark under the application, submitted to the Ukrpatent in accordance with the provisions of the Law. Based on the examination’s results the trademark’s registration is held, and a certificate of ownership is issued. The certificate is valid for 10 years, its validity can be extended every time for another 10 years at the request of the holder, the number of extensions is not limited. Upon termination of the certificate only the holder is entitled to register this mark again during the next 3 years.

While considering application the Ukrpatent shall be governed by the list of International non-proprietary names (INN) of World Healthcare Organization regarding medicinal products which may not be registered as trademarks. The mentioned is caused by the fact that INNs are directly connected with structural formulas of active substances of medicinal products and correspond to respective simplified substitutions of their chemical names. The so called «common» names of medicinal products which have been used since USSR times and are well known among some generations are not subject to a separate legal protection. In such cases a trademark may include the name of manufacturer as well as information on its formulation or indication.

The information which is contained in the application for state registration and its attachments is subject to state protection from disclosure and unfair commercial use. If a medicinal product is registered in Ukraine, it is prohibited for five years from the date of registration (regardless of the validity of any patent that is related to the drug) to use registration information for applying for state registration of another product, except when the right to refer or use such information obtained in due course.

For disclosure, improper use of the registration information guilty persons are brought to disciplinary, administrative, civil and/or criminal liability in accordance with the laws of Ukraine.
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