Overview of Patent Registration in Ukraine
When it comes to patenting biopharmaceutical inventions in Ukraine, understanding the local patent laws and procedures is crucial. Here are the key insights you need to know:
Validity Term and Extensions
- The validity term of a patent in Ukraine is 20 years from the filing date. For pharmaceutical patents and patents for agrochemicals, an extension of up to 5 years is possible through the issuance of a Supplementary Protection Certificate (SPC)[1].
Novelty Grace Period
- Ukraine allows a 6-month novelty grace period from the disclosure of the invention before filing an application or claiming a priority date[1].
Patent Registration Procedure
- The patent registration process in Ukraine involves a formal examination lasting 2-3 months, followed by a substantive examination if requested within 3 years from the filing date. If the invention meets patentability requirements, a grant decision is issued, and after payment of fees, the patent is granted. The entire process typically takes 3 to 5 years[1].
Requirements for Filing a Patent Application
- To file a patent application, you need to provide detailed information including the applicant's and inventor's names, addresses, and citizenships; a specification with claims, abstract, and drawings; a Power of Attorney; and, if applicable, a certified copy of the priority document[1].
Representation and Deadlines
- Foreign applicants must be represented by a registered Ukrainian patent attorney. The term for entering the Ukrainian national phase of a PCT application is 31 months from the priority date, and for conventional applications, it is 12 months from the priority date[1].
Patentability of Biopharmaceutical Inventions
Methods of Treatment
- Recent amendments to Ukrainian patent law have significantly limited the scope of patent protection. Methods of treatment are no longer patentable, which can impact biopharmaceutical inventions that involve therapeutic methods[3].
Bolar Exemption
- The Bolar exemption, introduced in Article 31(5) of the Patents Act, allows generic companies to conduct bioequivalence studies during the life of a patent. However, the Supreme Court of Ukraine has interpreted this exemption narrowly, covering only bioequivalence studies and not the application for or granting of marketing authorisation. This interpretation delays generic market entry and is contrary to practices in leading jurisdictions like the EU and US[2].
Enforceability of Biopharmaceutical Patents
Patent Linkage
- Patent linkage provisions in Ukraine, as outlined in Article 9 of the Law of Ukraine ‘On Medicinal Products’, require generic applicants to certify that their products do not infringe on existing patent rights. This often leads to litigation by originators, delaying the marketing authorisation of generic medicines even after the patent has expired[2].
Compulsory Licensing
- The compulsory licensing mechanism in Ukraine is cumbersome and often ineffective, especially in times of crisis. The process involves the Cabinet of Ministers allowing the use of a patented invention without the patent owner's consent, but this can be delayed by court proceedings. Revisions to make this mechanism more effective and speedy are necessary, especially during the ongoing war[2].
Scope of Claims
Scope of Patent Protection
- The scope of patent protection in Ukraine is defined by the claims in the patent application. However, recent changes have limited the scope, particularly by excluding methods of treatment from patentability[3].
Interpretation by Courts
- The interpretation of patent laws by Ukrainian courts, such as the narrow interpretation of the Bolar exemption, can significantly impact the scope of claims. This often results in delays and barriers to generic competition, extending the monopoly of originators beyond the patent expiration[2].
Practical Considerations
IP Strategy
- It is crucial to have a comprehensive IP strategy that includes patent protection in Ukraine before introducing products or services into the market. This strategy should consider global IP protection to avoid losing rights in other countries[4].
Legal Representation
- Given the complexities and specific requirements of Ukrainian patent law, it is advisable to be represented by a registered Ukrainian patent attorney to ensure compliance and effective representation[1].
Key Takeaways
- Validity Term: 20 years with possible extensions for pharmaceutical and agrochemical patents.
- Novelty Grace Period: 6 months from disclosure.
- Registration Process: Formal and substantive examinations with a total duration of 3 to 5 years.
- Bolar Exemption: Narrowly interpreted, covering only bioequivalence studies.
- Compulsory Licensing: Currently cumbersome and in need of revision.
- Scope of Claims: Limited by recent amendments, excluding methods of treatment.
- IP Strategy: Essential for global protection and compliance with local laws.
FAQs
Q: How long is the validity term of a patent in Ukraine?
A: The validity term of a patent in Ukraine is 20 years from the filing date, with possible extensions for pharmaceutical and agrochemical patents.
Q: What is the novelty grace period in Ukraine?
A: Ukraine allows a 6-month novelty grace period from the disclosure of the invention before filing an application or claiming a priority date.
Q: Can methods of treatment be patented in Ukraine?
A: No, methods of treatment are no longer patentable under recent amendments to Ukrainian patent law.
Q: How does the Bolar exemption work in Ukraine?
A: The Bolar exemption in Ukraine is narrowly interpreted to cover only bioequivalence studies, not the application for or granting of marketing authorisation.
Q: What are the challenges with compulsory licensing in Ukraine?
A: The compulsory licensing mechanism in Ukraine is cumbersome and often delayed by court proceedings, making it ineffective, especially in times of crisis.
Sources
- Mikhailyuk, Sorokolat & Partners - PATENT in Ukraine
- Medicines Law and Policy - The new IP strategy of war-torn Ukraine should prioritise public health and national security
- Brics and Beyond - Changes in Ukrainian Patent Law Strongly Favor Generic Manufacturers
- U.S. Department of Commerce - Ukraine - Protecting Intellectual Property
