A Pharmaceutical Patent is one of the most strategic and commercially important instruments of intellectual property law. In Georgia, as a developing pharmaceutical market, protecting new molecules, drug formulations, and manufacturing methods is crucial for both local manufacturers and international companies. A pharmaceutical patent grants the owner the exclusive right to manufacture, sell, or import the patented medication for a defined period (usually 20 years). This protects the innovator from premature generic competition and ensures the recoupment of Research and Development (R&D) investments. However, pharmaceutical patenting requires deep chemical and legal knowledge to ensure the application is strong and can withstand potential disputes.
Specialists on Legal.ge offer comprehensive patent services in the pharmaceutical sector:
- Patentability search: Preliminary search in global databases to determine the novelty and inventive step of a molecule or formulation.
- Application drafting and filing: Correct legal formulation of complex chemical structures and pharmacological data for submission to Sakpatenti.
- Supplementary Protection Certificate (SPC): Extending the patent term (by a maximum of 5 years) to compensate for the lengthy process of obtaining market authorization.
- Disputes with generics: Monitoring patent infringement and legal response if a competitor tries to register a copy of the patented drug before the patent expires.
- Licensing: Drafting licensing agreements with local manufacturers for technology transfer.
In practice, disputes often arise around so-called "secondary patents," where a company tries to patent a new dosage, salt form, or indication for use of an already known drug (Evergreening). Such patents frequently become targets for generic manufacturers trying to invalidate them. On the other hand, for innovator companies, protecting "data exclusivity" is critical, prohibiting the registration of generics based on the originator's clinical trials for a certain period. A qualified patent attorney helps you develop an optimal strategy to protect your portfolio.
In Georgia, pharmaceutical patents are regulated by the "Patent Law" and the Law "On Medicines and Pharmaceutical Activities." Georgia is a member of the WTO/TRIPS agreement, obliging the country to protect pharmaceutical innovations. The Supplementary Protection Certificate (SPC) institution, created specifically for pharmacy, is of particular importance. Simplified registration rules for drugs recognized in the EU also apply, influencing patent strategy.
Working with a specialist begins with an audit of your molecule or technology. If you are a local manufacturer, the lawyer will help you create a "Freedom to Operate" (FTO) analysis to ensure your generic production does not infringe on another's patent. If you are an innovator, the lawyer ensures the broadest possible formulation of the patent to block competitors.
Legal.ge gives you access to top patent attorneys with specific experience in pharmacy. A pharmaceutical patent is your business's most valuable asset. Protect it with the help of professionals to ensure return on investment and market leadership.
Updated: ...