On July 21, 2020, the Parliament of Ukraine introduced several major amendments to Ukrainian patent law. Although the amendments still need to be approved by the President in order to become effective, this is considered a mere formality and is expected to be completed within the next several weeks.
The amendments are particularly relevant for the pharmaceutical industry, and even more so for local generic manufacturers, for which the amendments are very favorable. The amendments are as follows:
Significant limitation in the scope of patent protection
According to the amendments, methods of treatment claims are no longer patentable. Additionally, patent protection for new forms of known substances, such as salts, esters, ethers, complexes, combinations and other derivatives, polymorphs, metabolites, pure form, particle size, isomers, will be difficult to obtain unless the Applicant can demonstrate that the new form of the known substances differs significantly from the original substances with respect to efficacy. This change is very similar to the wording of Section 3(d) of the Indian Patent Act of 1970 (http://ipindia.nic.in/writereaddata/Portal/ev/sections/ps3.html), and is contradictory to Ukraine’s international obligations of harmonizing its law with the European Union’s (EU) legislation.
New rules regarding supplementary protection certificates (SPC)
The amendments also require that a valid Ukrainian marketing authorization (MA) exist when a Patent Owner applies for a SPC. Additionally, there are new timing requirements with respect to the filing for an SPC. Specifically, a Patent Owner can only obtain an SPC in Ukraine if a Ukrainian MA is filed within one year after the filing of the very first MA application for the product in another country. For example, if the very first MA is filed in the United States on May 1, 2018, and a second MA is filed in Russia on June 15, 2019, in order to obtain an SPC for any patent filed in the Ukraine covering the product, the MA in Ukraine would have to be filed before May 1, 2019. Additionally, a request for a SPC must be filed within 6 months after the initial Ukrainian MA is obtained or after a patent (that covers the product encompassed by the MA) is granted, whichever occurs first.
Another change relates to the limits on protection provided by a granted SPC. Specifically, a SPC in Ukraine will not cover the use of a patented product that is solely exported out of the country. Moreover, a SPC will not be deemed to be infringed if a patented drug is used within 6 months prior to the expiration of a SPC for purposes of creating a stockpile of product for sale after patent expiry.
New options with respect to oppositions
The amendments also introduce an opposition procedure into Ukrainian patent law. This is good news as the availability of an opposition procedure provides an alternative to the lengthy and costly litigation previously required to invalidate a patent. The amendments provide two opportunities for an opposition: a pre-grant opposition, which can be filed within 6 months after the patent application publishes, and a post-grant opposition that can filed within 9 months after publication of the grant of the patent. Both oppositions will be conducted by the Ukrainian Patent Office. The grounds for a pre-grant and post-grant opposition will be different. Specifically, the grounds available for a pre-grant opposition will include novelty, inventive step, lack of industrial applicability, lack of subject matter eligibility (i.e., the invention is directed to a method of treatment or plant variety), or that the invention is contrary to moral principles. In contrast, a post-grant opposition will be limited to just novelty, inventive step and lack of industrial applicability.
In summary, the new amendments to Ukrainian patent law will make life more challenging for larger pharmaceutical companies and will require greater expenditure of resources and time in order to obtain, maintain, and enforce patents against generic companies in the country.
Please continue to watch BRICS & Beyond for updates on patent law changes in Ukraine.
This post was written by Lisa Mueller and Taras Kyslyy of Arzinger.