On April 16, 2020 Larysa Tomachynska, Head of Patent Department of Pakharenko and Partners, took part as a speaker in an expert discussion on “Production and use of medicines for public health protection in emergency situation from the IP rights protection perspective” which was held online.

In her presentation, a company’s expert highlighted the following issues: the subject matter and scope of patent protection for the invention (utility model); production of medicines after the expiry of patent protection for the active substance; compulsory licensing of a patented invention (utility model) for a medicine. During the debate, the innovations proposed by the bill No. 2259 were discussed, since the amendments to Part 3 of Article 6 of the Law of Ukraine “On Protection of Rights to Inventions and Utility Models” provide for exceptions from the patent protection for new forms, dosages and use of a known drug, regardless of their compliance with the criteria of patentability, namely novelty, inventive step and industrial applicability.

The main summarizing idea of the expert’s presentation was not to allow such exemptions from patent protection in the national legislation, since they fail to meet the current international standards of patent protection of inventions, and their adoption by the Verkhovna Rada of Ukraine will have as a consequence the national scientists’ being unable to protect the results of their scientific research and developments in the field of organic synthesis of new materials, as well as new modifications of already known materials by patents, and domestic manufacturers of pharmaceutical products will not be able to obtain patent protection for drugs they created based on known active substances.

As regards “evergreen patents”, the professional community in its majority considers that such term is not appropriate and generally limits the research activities of pharmaceutical manufacturers. It is important to emphasize that being able to obtain patent protection for the previous forms of a medicine known from prior art encourages pharmaceutical companies to innovate in the discovery of new medicines (or indications for their use) with increased safety and/or effeciency as compared with existing ones. This offers greater choice for patients on the one hand and ensures healthy competition in the pharmaceutical market on the other hand.

The expert emphasized that as a result of the enhancement of the previous forms of medicines known from the state of the art, improved drugs are created on the basis of known active substances, which are the result of another scientific development, in which considerable material and intellectual resources have been invested, and the improved drug is the subject matter of a new invention. An expert explained that such subject matter can be represented by new modifications of a known substance, new formulations based on the known active substance, new combinations with other active substances, the new use of the known active substance, or a new dosage of the active substance involving another administration mechanism and effect of drugs. All of these objects are patentable in European countries, as they are novel and provide a different technical result.

The discussion was organized by the Intellectual Property Relations Development Department of the State Enterprise “Ukrainian Intellectual Property Institute” (Ukrpatent) within the 10th episode of “Live journal. Knowledge for the Future.”

Closing the discussion, the moderator, Head of the Department of Training Programs and Educational Support, Olga Kulinich, thanked the participants for a meaningful discussion, proposed to continue exploring and addressing these issues at further expert meetings, and invited to join the following events within “Live journal. Knowledge for the Future” in online format.