Overview of Patentability in Russia
In Russia, for a biopharmaceutical invention to be patentable, it must meet the standard criteria of novelty, involve an inventive step, and have industrial applicability. This is consistent with international patent laws, but the Russian approach has some unique aspects[1][2][4].
Specific Requirements for Antibody Patents
When it comes to antibody patents, the Russian Patent and Trademark Office (Rospatent) has specific requirements:
- Claims must specify the antibody’s name, biological function defining an intended use, and the amino acid sequence (partial or complete).
- The application should include the preparation method and data supporting the claimed biological function of the antibody.
- Post-filing data can be accepted to support the biological function of the antibody[1][2].
Sufficiency of Disclosure
As of October 2014, patent applications must meet the requirement of sufficiency of disclosure. For antibodies, this includes providing the sequence, biological function, and the preparation method. Experimental data supporting the claimed biological function is also crucial[1].
Inventive Step Assessment
The assessment of the inventive step in Russia differs from the European Patent Office (EPO). Russia focuses more on the technical effect brought about by the defining features of the invention, rather than the problem-solution approach used by the EPO. This requires a different line of argumentation when filing patents in Russia[2].
Patentable Subject Matter
In Russia, various pharmaceutical subject matters are patentable, including:
- Compounds
- Compositions
- Preparations
- Microorganism strains
- Cell cultures
- Methods for producing substances, compositions, or preparations
- The use of these products for a specific purpose
However, there are explicit restrictions on patenting methods for cloning humans, modifying genetically human cells, and using human embryos for industrial and commercial purposes[3][4].
Scope of Claims
Antibody Claims
- Claims should recite the protein’s name, biological function, and amino acid sequence.
- Including several antibody claims characterized by partial or complete amino acid sequences provides greater protection against potential nullity attacks.
- Use claims are generally more valuable from the enforceability standpoint than method-of-treatment claims[1][2].
Composition and Product Claims
- Claims directed to antibodies and corresponding compositions are eligible for patent term extension (PTE).
- Experimental data and demonstrating the technical effect of compounds are essential for obtaining broad claims[1][2].
Enforceability of Claims
Method-of-Treatment Claims
While method-of-treatment claims are allowed in Russia, unlike in many international jurisdictions, they are difficult to enforce due to the lack of recognition of indirect infringement in Russian patent law[1].
Use Claims
Use claims are more valuable and enforceable compared to method-of-treatment claims. This is because use claims can be more directly linked to the specific application of the biopharmaceutical product[1][2].
Patent Term Extension (PTE)
In Russia, patent term extensions are available for pharmaceutical inventions, including biopharmaceuticals. The maximum extension period is five years. To qualify, the patent must disclose the active agent of the marketed product, and the extension request must be filed within six months from either the first marketing authorization issue date or the patent grant date, whichever expires later[2].
Eurasian Patents
Biopharmaceutical patents can also be protected through Eurasian patents, which are valid in Russia. The examination practice for Eurasian patents is similar to that of Russian patents, with a focus on the technical effect and sufficiency of disclosure[1][3].
Compulsory Licenses
Russia has provisions for compulsory licenses, particularly in cases of national defense, security, and the protection of citizens’ life and health. This was demonstrated in the case of Lenalidomide, where a compulsory license was granted for a vitally important medicine. However, such instances are rare and typically require a government order[3][5].
Current Trends and Challenges
Evergreening
There is a growing concern about evergreening in the pharmaceutical sector, where patents are extended through minor modifications. The Federal Antimonopoly Service of Russia has been actively working to prevent such practices by proposing restrictions on patent grants for selective inventions, new dosage forms of known substances, and second or further medical uses[4].
Legal Uncertainty
Despite some legal mechanisms allowing for the bypass of patent rights in cases of national defense or public health, there is no indication of a general suspension or expropriation of patent rights in the pharmaceutical sector. The intellectual property system in Russia continues to function as usual, including for foreign right holders[5].
Key Takeaways
- Patentability Criteria: Biopharmaceutical inventions must be novel, involve an inventive step, and have industrial applicability.
- Specific Requirements for Antibodies: Claims must include the antibody’s name, biological function, and amino acid sequence, along with the preparation method and supporting data.
- Inventive Step: Russia focuses on the technical effect of the invention.
- Scope of Claims: Use claims are more valuable than method-of-treatment claims; multiple antibody claims with partial or complete sequences are recommended.
- Enforceability: Method-of-treatment claims are difficult to enforce; use claims are more enforceable.
- Patent Term Extension: Available for pharmaceutical inventions, with a maximum extension of five years.
- Compulsory Licenses: Can be granted in exceptional cases related to national defense, security, or public health.
FAQs
Q: What are the key requirements for patenting antibodies in Russia?
A: The key requirements include specifying the antibody’s name, biological function, and amino acid sequence, along with the preparation method and supporting data[1].
Q: How does Russia assess the inventive step for biopharmaceutical patents?
A: Russia focuses on the technical effect brought about by the defining features of the invention, differing from the problem-solution approach used by the EPO[2].
Q: Are method-of-treatment claims enforceable in Russia?
A: Method-of-treatment claims are difficult to enforce due to the lack of recognition of indirect infringement in Russian patent law[1].
Q: Can biopharmaceutical patents be extended in Russia?
A: Yes, patent term extensions are available for pharmaceutical inventions, with a maximum extension of five years, provided the patent discloses the active agent of the marketed product[2].
Q: What is the current stance on compulsory licenses for biopharmaceuticals in Russia?
A: Compulsory licenses can be granted in exceptional cases related to national defense, security, or public health, but such instances are rare and require a government order[3][5].
Sources
- AIPLA - Patents for Antibodies in Russia: Make your Protection Stronger
- Papula-Nevinpat - Patenting pharmaceuticals in Russia – what to know
- Azalesov - Current trends in the patent protection of pharmaceuticals in Russia
- AIPLA - Pharmaceutical Patents In Russia
- Dejalex - FREEZING OF FOREIGN PHARMA PATENTS IN RUSSIA? LEGAL UNCERTAINTY OR FAKE NEWS
