IP Reform: What’s New in Ukrainian Patent Law?

The year 2020 is best remembered in Ukraine not only for the pandemic, quarantines and lockdowns, but for rapid ongoing reform in the field of intellectual property. The long-awaited reform of the IP field has progressed, but has not yet put all things right.

In general, the reform has affected the system of state protection of intellectual property. A reminder that on 1 June 2016, the Cabinet of Ministers of Ukraine approved the Concept of Reforming the State System of Legal Protection of Intellectual Property in Ukraine. The Concept provided for, inter alia, replacement of the three-level system of state administration of intellectual property with a two-level one. In 2019, the draft National Strategy for the Development of the Field of Intellectual Property was presented, which highlighted the need for institutional reform in the field of intellectual property.

Within the framework of implementation of the Concept, on 16 June 2020, the Verkhovna Rada of Ukraine adopted the Law of Ukraine No. 703-IX On Introducing Amendments to Certain Laws of Ukraine regarding the Establishment of the National Intellectual Property Authority (hereinafter — the Law). The Law came into force on 14 October 2020.

The two-level system of legal protection of intellectual property in Ukraine introduced by the Law provides for the establishment of: (1) the National Intellectual Property Authority of Ukraine (NIPA), the state organization, which exercises powers in the field of intellectual property and has the right to represent Ukraine in international and regional organizations; at the same time, the NIPA will perform certain public functions (authoritative powers) for the implementation of state policy (for example, the granting of titles of protection for intellectual property objects), and (2) the Ministry of Economy will ensure the formation and implementation of state policy in the field of intellectual property.

Thus, the two mentioned levels: the National Intellectual Property Authority and the Ministry of Economy should have provided the possibility of introducing a “one-stop shop” for state services in the field of intellectual property.

However, that did not go according to plan. On 13 October 2020, the Decree of the Cabinet of Ministers of Ukraine No. 1267-p On the National Intellectual Property Authority was approved, in accordance with which the exercise of the functions of the National Intellectual Property Authority was assigned to the State Enterprise Ukrainian Intellectual Property Institute (Ukrpatent). Such wording of the Decree raised questions from the very beginning about the adequacy of the NIPA’s “establishment” procedure. To date, the “transformation” of Ukrpatent into the National Intellectual Property Authority has not actually taken place. The Law stipulates that the Supervisory Board, the Attestation Commission, and the Appeals Chamber, which, in particular, shall discharge the functions of “post-grant opposition” should be formed in the structure of the NIPA. As of today, they are absent. A competition for the position of the NIPA’s head has not taken place yet, although there was more than enough time for that.

The “reform” also affected the relevant laws on intellectual property objects, which have undergone significant changes. Taking into account the topic, let’s dwell in more detail on the main changes in Ukrainian patent law. Therefore, the following amendments have been introduced by Law of Ukraine No. 816-IX of 21 July 2020 On Amendments to Certain Legislative Acts of Ukraine Regarding the Patent Law Reform.

The amended patent law introduced the possibility for foreigners (both natural persons and legal entities) to independently perform a number of actions aimed at obtaining a patent, such as filing applications, paying fees, receiving notifications, etc. Previously, the mentioned actions on behalf of a foreign person could be performed exclusively by a patent attorney. However, the Law nevertheless obliges foreign persons to appoint patent attorneys and inform the NIPA of them no later than two months from the date of performance of the above-mentioned independent actions. Otherwise, the application will be considered withdrawn.

The Law significantly expands the list of objects that may not receive legal protection either as inventions or as utility models.

It includes methods of treatment and diagnostics; human cloning processes; processes of changing the genetic identity of humans and animals; use of human embryos for industrial or commercial purposes; the human body at different stages of its formation and development, as well as the mere detection of one of its elements, in particular, a gene sequence or a part of a gene sequence; a product or process relating to a plant or an animal, the use of which is limited to a certain variety of plants or a certain breed of animals; a product or process relating to a natural biological material, which is not separated from its natural environment or which is not the product of a technical process.

A discovery, scientific theory, mathematical method; scheme, rules and method of holding games, competitions, auctions, physical exercises, intellectual or organizational, in particular, economic, activities (planning, financing, supplying, accounting, lending, forecasting, rationing, etc.); computer software; information presentation form; appearance of products aimed at meeting purely aesthetic needs also no longer meet the concept of the “invention (utility model)”.

As regards such criterion for granting legal protection as novelty, it is now not affected by the disclosure of information about the patent (utility model) earlier than 6 months before the date of filing of the application or, if priority is claimed, before the date of priority. Previously, the grace period was twice as long.

An important innovation is introduction of Pre-grant and Post-grant opposition procedures. A petition for Pre-grant opposition may be filed within 6 months from the date of publication of information about application for invention. In addition, after the publication of information about the application for invention, any person may submit to the examining authority a request for carrying out an information search on the basis of the claims, taking into account the description of the invention and appropriate drawings, as well observations regarding the compliance of the claimed invention with the requirements for granting legal protection.

The Post-grant opposition term for a patent for invention is 9 months from the date of publication of information on the state registration of the invention. At the same time, a petition for invalidation of rights to a utility model may be filed with the Appeals Chamber within the entire period of validity of the property rights to the utility model and after the expiration thereof.

The applicant’s rights to amend the claims during the qualifying (substantive) examination and to divide the application into two or more before the date of receipt of the NIPA’s decision are also new.

It should be noted that the widest response was drawn by the amendments associated with inventions, the objects of which are active pharmaceutical ingredients of a medicinal product.

At last, legislators took a position on the need to fight against “evergreen” patents and introduced in the patent law a rule that would afford an opportunity to the person concerned to prove the “obviousness” of the invention filed for registration. That is, incompliance thereof with the “inventive step” requirement. At present, the patent law stipulates those new forms of a medicinal product known from prior art, including salts, esters, ethers, compositions, combinations and other derivatives, polymorphs, metabolites, pure forms, particle sizes, isomers, if they do not differ significantly in efficiency, may be considered evidently following from the state of the art. It should be noted that the mentioned “substances” are not automatically excluded from legal protection. However, close attention will be paid to them, since they may be considered evidently following from the state of the art.

One of the most discussed amendments to the patent legislation of Ukraine is a Ukrainian version of “Bolar exemption”. In fact, the Ukrainian Bolar exemption is reduced to permitting the following actions, which are not recognized as an infringement of rights arising from the patent: (1) importation into the customs territory of Ukraine, in accordance with the procedure established by law, of goods manufactured with the use of the invention (utility model) for research and/or (2) use of the invention (utility model) in research conducted for the purpose of preparing and submitting information for the registration of a medicinal product. In particular, the question as to whether the registration of a generic drug (obtaining marketing authorization) will be considered as an infringement of the rights of the patent owner remains debatable and has not been confirmed by current judicial practice. The provisions of the draft law, which directly indicated the possibility of the mentioned registration during the last years of the term of the patent, were not included in the final version of the amended patent law.

In addition, the introduction of supplementary protection certificates (SPC) for pharmaceutical, animal and plant protection products is completely new to Ukrainian law. By introducing the mentioned norm, Ukraine has implemented the relevant provisions of the European Directive and tried to fulfill its obligations under the Association Agreement signed with the EU.

The SPCs can in no way be equated with so-called “extended” patents, the term of which was extended under the rules of the previously effective version of the patent law. They shall remain in force until the expiry of the relevant extension term. As regards the SPC, this is, as already mentioned, an absolute innovation for Ukraine. At present, Ukraine has received the legal basis for introduction of the procedure for obtaining the SPC. However, there is still a long process ahead in the development of the practice of applying details, resolving points at issue and avoiding the pitfalls of the mentioned procedure.

In summary, it should be emphasized that the changes introduced to Ukrainian patent legislation were long overdue and ultimately quite expected. However, such changes can in no way be considered conclusive and finalizing the reform of patent law. In fact, this is only the first important step in the process of improving the patent legislation of Ukraine and harmonization thereof with European legislation. We have a lot of work ahead of us, and any stoppage at this stage can cancel out all the achievements.