Introduction to Georgian Patent Law Amendments
Recent amendments to the Georgian patent law, effective as of June 2, 2023, have significantly impacted the patentability, enforceability, and scope of claims for biopharmaceutical patents. These changes aim to harmonize Georgian patent law with European legislation and the European Patent Convention (EPC)[1].
Validation Agreement with the European Patent Organization
Georgia has signed a validation agreement with the European Patent Organization (EPO), allowing European patent applications filed on or after January 15, 2024, to be validated in Georgia. This validation grants European patents the same legal effects as national patents in Georgia, providing a simple and cost-effective way for biopharmaceutical companies to secure patent protection in the country[4][5].
Harmonization with European Legislation
The amendments align Georgian patent law with the EPC and European legislation, introducing several key changes:
Supplementary Protection Certificates (SPCs)
The law now regulates SPCs, harmonizing their term with the EPC. This includes a six-month extension for pediatric pharmaceuticals, which is crucial for biopharmaceuticals that require extended market exclusivity[1].
Bolar Exemption
The Bolar exemption has been introduced, permitting the use of a patented invention for research and development purposes and for obtaining a marketing license for a pharmaceutical product. This exemption is vital for generic and biosimilar manufacturers to conduct necessary research without infringing on existing patents[1].
Patentability of Medical Use Claims
Explicit provisions regarding the patentability of first and second medical use claims have been included. This clarity helps biopharmaceutical companies in understanding what can be patented and how to draft their claims effectively[1].
Patentability Criteria and Exceptions
General Patentability Criteria
The amended law provides clearer definitions of patentability criteria, exceptions to patentability, and the scope of protection. This includes better-defined requirements for novelty, inventive step, and industrial applicability[1].
Biological Material and Microorganisms
The law now mentions the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, providing clarity on the deposition of biological material. This is particularly relevant for biopharmaceutical patents involving microorganisms and biological materials[1].
Utility Models
While utility models are addressed in the amendments, they exclude microorganism strains, plant and animal cell cultures, biotechnology, genetic engineering, and products obtained by chemical synthesis, including pharmaceuticals. This narrows down the subject matter that can be protected under utility models, focusing more on mechanical and other non-biological inventions[1].
Enforceability of Biopharmaceutical Patents
Compulsory Licenses
The concept of compulsory licenses has been introduced and clearly defined. This allows for the use of patented inventions under certain conditions, such as public health emergencies, without the consent of the patent holder[1].
Prohibition of Infringing Acts
The law extends the prohibition of infringing acts to third parties who were aware or should have been aware of taking part in infringing activities. This strengthens the enforcement of biopharmaceutical patents by holding more parties accountable for infringement[1].
Damages and Compensation
The range of measures against infringers has been extended, including damages and compensation. This provides stronger legal recourse for patent holders to protect their rights against infringement[1].
Scope of Claims
Clear, Concise, and Supported Claims
The amendments introduce a requirement for claims to be clear, concise, and supported by the description. This ensures that biopharmaceutical patent claims are well-defined and enforceable[1].
Double Patenting
Double patenting is now explicitly prohibited, preventing the same invention from being patented multiple times. This clarity helps in avoiding conflicts and ensures that each invention is uniquely protected[1].
Publication and Provisional Protection
Applications filed as of June 2, 2023, may now be published 18 months from the priority date or earlier at the request of the applicant. This provision enables effective provisional protection, allowing biopharmaceutical companies to safeguard their inventions during the application process[1].
Role of Patent Attorneys
Qualification and Registration
The amendments specify qualification requirements and registration rules for Georgian patent attorneys. After January 1, 2025, non-resident applicants must be represented by a Georgian patent attorney to avoid termination of their applications[1].
Exceptions and Limitations to Patent Rights
Private and Non-commercial Use
The law allows for private and non-commercial use of inventions for personal ends, provided such actions are not intended for commercial purposes. This exception is relevant for research and personal use scenarios that do not infringe on the commercial rights of the patent holder[3].
Acts for Obtaining Regulatory Approval
Exceptions are provided for acts related to obtaining regulatory approval from authorities, such as conducting studies and tests necessary for the registration of medicines. This is crucial for biopharmaceutical companies needing to comply with regulatory requirements without infringing on existing patents[3].
Exhaustion of Patent Rights
The law includes provisions for the exhaustion of patent rights, which means that once a patented product is placed on the market by the patent holder or with their consent, the patent rights are exhausted, and further distribution or use of the product does not infringe the patent[3].
Key Takeaways
- Validation Agreement: European patent applications filed on or after January 15, 2024, can be validated in Georgia, providing the same legal effects as national patents.
- Harmonization: Georgian patent law is now aligned with the EPC and European legislation, including SPCs, Bolar exemption, and clear patentability criteria.
- Enforceability: Stronger measures against infringement, including compulsory licenses and extended prohibition of infringing acts.
- Scope of Claims: Clear, concise, and supported claims are required, with explicit prohibition on double patenting.
- Publication and Provisional Protection: Applications can be published 18 months from the priority date or earlier, enabling effective provisional protection.
- Patent Attorneys: Non-resident applicants must be represented by a Georgian patent attorney after January 1, 2025.
FAQs
What is the validation agreement between Georgia and the EPO?
The validation agreement allows European patent applications filed on or after January 15, 2024, to be validated in Georgia, granting them the same legal effects as national patents.
How do the amendments affect biopharmaceutical patents?
The amendments introduce clearer patentability criteria, the Bolar exemption, and stronger enforcement measures, which are particularly beneficial for biopharmaceutical patents.
What is the Bolar exemption, and how does it impact biopharmaceutical research?
The Bolar exemption permits the use of a patented invention for research and development purposes and for obtaining a marketing license for a pharmaceutical product, facilitating generic and biosimilar research without infringing on existing patents.
How do the amendments impact the role of patent attorneys in Georgia?
Non-resident applicants must be represented by a Georgian patent attorney after January 1, 2025, to avoid termination of their applications.
What are the key exceptions to patent rights in Georgian law?
Exceptions include private and non-commercial use, acts for obtaining regulatory approval, and exhaustion of patent rights, among others.
Sources
- PETOŠEVIĆ - Georgia Amends Patent Law
- World Trade Organization - Patent law of Georgia
- WIPO - Questionnaire on exceptions and limitations to patent rights - Georgia
- EPO - Validation of European patents in Georgia
- Murgitroyd - Georgia On My (and the EPO's) Mind
