Nikolay Miruta
Patent Counsel for IPR GROUP
In the ever-evolving field of patent protection, the IPR Group has amassed extensive experience in protecting patents for pharmaceutical inventions. Recently, we have observed a significant rise in inquiries concerning claims formulated around the object of “use.” This trend underscores the growing need for specialized strategies to address arising challenges. Drawing from our wealth of expertise, we are eager to share practical insights and solutions for overcoming these challenges.
The field of patent protection in Ukraine has seen significant changes in recent years, particularly in how the concept of “use” is approached. To better understand the current situation, it’s helpful to look at how the legal framework has developed over time.
Prior to the amendments to the Law of Ukraine “On Protection of Rights to Inventions and Utility Models” on August 16, 2020, the following could be objects of patent protection: a product, process (method), as well as a new use of a well-known product or process. This provision enabled protection for:
However, with the amendments to the Law effective from August 16, 2020, the object “use” was explicitly removed from the list of patentable subjects. While Ukraine’s exclusion of “use” mirrors European patent law, the EU still allows some flexibility under the EPC (European Patent Convention) for second medical use claims when appropriately drafted. For instance, claims such as “Compound X for use in treating disease Y” can still be patented under European law. Ukraine, however, does not recognize such claims, making the rules stricter.
It is worth noting that for applications filed before August 16, 2020, the amendments did not apply retroactively, meaning that patents for “use” could still be granted if the application filing date preceded the amendment’s effective date. However, for applications filed after this date, the object “use” is no longer recognized.
Why “Use” Is Not Patentable
1. Lack of Technical Specificity
The term “use” does not describe a tangible object or technical process. It merely indicates the purpose or application of something, which is insufficient for patent protection.
Example:
▪ Claim: “Use of compound X for improving plant growth.”
→ such a claim is not patentable because it lacks technical detail and fails to specify a product or method.
2. Lack of Reproducibility
To be patentable, an invention must be reproducible. “Use” alone does not provide enough information to enable replication.
Example:
▪ Claim: “Use of enzyme Y for cleaning surfaces.”
→ This is too broad and does not detail how the enzyme is applied, under what conditions, or its technical characteristics.
3. Non-compliance with Patent Claims Requirements
Patent claims must define the invention in a clear, specific, and technical manner. A “use” claim does not meet these criteria because it does not describe the invention’s structure or method of operation.
Challenges for Pharmaceutical Companies
Loss of Exclusivity
Many pharmaceutical companies relied on “use” claims to secure market exclusivity for drugs with new indications. With the removal of this option, companies may struggle to protect their investments in repurposed drugs.
Increased R&D Costs
Without the ability to patent second medical uses, companies face greater risks in pursuing costly research to discover new indications for known drugs.
Competitor Challenges
Generic manufacturers are less restricted, as they can produce and market drugs for new indications without infringing on “use”-based patents. This significantly affects the revenue streams of originator companies.
How to Adapt “Use” to a Patentable Object
Pharmaceutical companies must adapt their patent strategies to align with the Ukrainian legal framework. The following approaches can help mitigate the impact of the removal of “use” as a patentable object:
Instead of patenting a new use, companies can strengthen product claims by emphasizing:
▪ Specific formulations tailored to the new indication.
▪ Novel combinations of active ingredients.
▪ Delivery mechanisms designed for the targeted disease.
Example:
▪ “Use of compound X for treating disease Y.”
→ Reformulated as:
“A pharmaceutical composition comprising compound X in a sustained-release formulation for the treatment of disease Y.”
Companies can protect new treatment methods involving known substances by focusing on unique processes or administration protocols.
Example:
▪ “Use of compound X for treating disease Y.”
→ Reformulated as:
“A method of treating disease Y comprising administering compound X at a dosage of 50 mg/day in combination with compound Z.”
Best Practices for Drafting Patent Claims
Specify the Object:
When drafting patent claims, it is essential to identify and define the object of the invention in compliance with Ukrainian patent law. The key step is to evaluate whether the proposed object falls into one of the legally recognized categories, such as a product or a method. Claims that do not align with these objects, including those solely based on “use,” are not allowed for patent registration.
Provide Technical Details:
Include clear parameters, conditions, and characteristics that define the invention.
Focus on Reproducibility:
Ensure that the invention can be replicated based on the description.
Highlight Technical Results:
Define the specific technical effect achieved by the invention.
Conclusion:
In Ukraine, the concept of “use” is not recognized as a standalone patentable object under the Law of Ukraine. To comply with the legal framework, such claims must be carefully reformulated as either a product or method, with precise technical details and a clear definition of the invention’s structure or process. This approach ensures that the invention aligns with the legal requirements, enabling reproducibility and clarity. Properly structuring patent claims not only increases the chances of successful registration but also strengthens the protection of intellectual property rights.
At IPR Group, we are dedicated to assisting numerous pharmaceutical companies in navigating the complexities of patent protection. Among our valued clients are leaders in the pharmaceutical industry who rely on our expertise to provide personalized solutions that effectively address complex patent issues. Our unwavering goal is to provide comprehensive protection for inventions. Should you have any questions related to patents (including PCT entries) or other IP objects, please feel free to contact us.
