Maksym Koval, Esq.
Ukrainian IP legislation, particularly concerning patents for inventions and utility models, has undergone significant changes over the recent years. These reforms are a result of Ukraine’s efforts to harmonize its legislation with that of the European Union (EU) and to stay in competition with other pertinent markets worldwide (China, India, Pakistan, The Philippines, South Korea, Singapore, etc.).
One of the key milestones in this evolution is Law No. 816-IX “On Amendments to Certain Legislative Acts of Ukraine on the Reform of Patent Legislation”, dated August 16, 2020 (the “Patent Law”). The Patent Law introduced several important updates to patent-related legislation, such as the introduction of post-grant opposition procedures and supplementary protection certificates (SPCs).
Immediately below we provide you with an overview of the current IP legislation in Ukraine, focusing on the transition from the old to the new Patent Law by comparing their provisions andhighlighting the implications.
Prior to the adoption of the Patent Law, Ukraine’s patent legislation was governed by various laws and supporting regulations that did not fully accommodate modern challenges or align with international standards. The patent system under the old legislation lacked certain critical mechanisms, such as administrative procedures for revoking patents (post-grant opposition) and the availability of supplementary protection certificates, which are vital for extending the protection of pharmaceutical and other patents beyond their standard term. The absence of these mechanisms often resulted in prolonged disputes and limited the ability to challenge patents effectively, leading to egregious damages caused to legitimate patent holders.
The passage of the Patent Law marked a turning point in Ukraine’s IP landscape, introducing several key innovations that greatly enhance the patent system. The main changes are as follows:
a.Non-Patentable Technologies
Under the Patent Law, the range of technologies eligible for protection as utility models has been somewhat narrowed. For example, protection is now limited to devices or processes, while substances are no longer considered patentable as utility models.
Furthermore, the Patent Law expands the list of objects excluded from patent protection, including the following:
•Surgical or therapeutic methods for treating humans or animals, and diagnostic methods applied to human or animal physiques;
•Processes related to human cloning or altering the genetic identity of humans through germline modification;
•The use of human embryos for industrial or commercial purposes; and
•The human body at various stages of its formation and development, as well as the discovery of elements of the human body, such as gene sequences.
This is designed to prevent the abuse of the utility model system and ensure that patents are granted only for genuinely innovative and industrially applicable inventions.
b.Combatting “Evergreening” Patents
The Patent Law specifically addresses the issue of “evergreening”, where minor modifications to existing pharmaceuticals are used to unjustifiably extend patent protection without substantiation. For example, known pharmaceutical, such as salts, esters and polymorphs, are deemed obvious and non-patentable, unless they demonstrate significant differences in effect via testing. This change is designed to encourage genuine innovation and competition rather than allow the perpetual extension of monopolies on existing products.
c.Electronic Documentation and Filing
The Patent Law provides for the option to submit and file documentation electronically, which streamlines administrative procedures and increases accessibility for patent applicants. Ukraine’s consistent moves towards digitalization are taking a lead in current global trends and facilitate more efficient state processing.
d.Opposition Procedures
An important advancement under the Patent Law is the introduction of a pre-grant opposition mechanism. Any interested party can now file an objection against a patent application within six months of its publication. If a party believes that its patent rights have been violated, the party may submit a claim to argue non-patentability, offensiveness to public morals, and non-compliance with effective patentability criteria. This mechanism enhances transparency and allows for the scrutiny of patent applications before rights are granted.
Additionally, post-grant opposition has been introduced, allowing patents to be challenged after they have been administratively granted. The Appeals Chamber can invalidate patents if they fail to meet the requirements of patentability. The timeframe for filing such claims varies depending on patent type: nine months for inventions and at any time during the term of a utility model patent. This new administrative route provides a quicker and less costly alternative to court proceedings for contesting patent validity.
e.Supplementary Protection Certificates
The introduction of supplementary protection certificates (“SPC”) is another significant novelty for Ukraine. Patent holders can now apply for an SPC to extend the term of IP rights for up to five years beyond the original patent term, particularly for pharmaceutical and agrochemical products that require regulatory approval before market entry. The Patent Law also provides for an additional six months of protection if pediatric studies have been conducted.
During the SPC period, third parties are permitted to undertake certain activities, such as manufacturing the product for export or preparing for market entry post-SPC expiration. This provision, similar to the EU’s Bolar exemption (discussed below), is designed to balance patent rights with public interest by facilitating the timely introduction of generic medicines.
There is an ongoing debate concerning certain provisions within the Law “On the Procedure for Considering Requests for Granting Supplementary Protection for Inventions”. Significantly, due to a legislatively unregulated situation, applicants who filed their applications prior to the new legislation came into effect are potentially not eligible for supplementary protection. Unless a “grandfather clause” is introduced to this law, this creates legal uncertainty and potential inequity for earlier applicants, as they are unable to benefit from the extended protection granted under the new rules.
f.Bolar Provision
The Patent Law introduced a “Bolar-like” provision in Ukraine, which allows third parties to use patented inventions without the patent holder’s consent for research purposes only, particularly to prepare regulatory submissions for generic pharmaceuticals. The aim is to expedite the availability of generic medicines on the Ukrainian market, thus increasing competition and reducing costs.
In conclusion, the reforms brought about by the new Patent Law represent a significant step forward in modernizing Ukraine’s patent legislation. By incorporating international practices, such as the introduction of opposition procedures, SPCs, and the Bolar provision, this Law enhances the balance between protecting inventors’ rights and promoting public access to innovation. These changes are expected to improve the overall effectiveness of the patent system in Ukraine, fostering a more innovation-friendly environment while aligning the country’s IP laws more closely with those of the EU.
