On 11 July 2018 the Healthcare Committee of the Parliament of Ukraine approved Draft Law of Ukraine No. 7538 "On Amending Certain Laws of Ukraine on Enhancing Legal Protection for Inventions and Utility Models" ("Draft Law"). The Draft Law was registered in parliament on 1 February 2018. The approval of the Draft Law by the Healthcare Committee is a preliminary step required for the consideration of the Draft Law by the parliament. It does not guarantee that the Draft Law will be passed into law, but if adopted, it will significantly weaken patent protection for pharmaceuticals.
Changes stipulated in the Draft Law include the following:
- Exclusion of novel forms of pharmaceuticals (salts, ethers etc.), new dosage forms, new characteristics or new use of a known pharmaceutical from patent protection.
- Introduction of a supplementary certificate of patent protection for the extension of the validity term of intellectual property rights to an invention. The rights to supplementary protection will be limited to the product and its use.
- Permitting the use of the invention (utility model) in studies conducted for the purpose of preparation and submission of information for the registration of a pharmaceutical.
Authors of the Draft Law claim that its aim is to incentivize inventions in Ukraine and introduce provisions of the EU legislation on protecting rights for utilities and inventions into Ukrainian legislation. However, some changes mentioned above, on the contrary, do not comply with EU legislation and international treaties.
The Draft Law will become effective only if it is adopted by the Parliament of Ukraine, signed by the President of Ukraine and published in the official gazette.