Introduction to Patent Law in Panama
In Panama, the regulation and registration of patents are governed by Law No. 35 of May 10, 1996, which outlines the provisions regarding industrial property. This law is crucial for understanding the patentability, enforceability, and scope of claims for biopharmaceutical patents.
Patentability of Biopharmaceutical Inventions
Criteria for Patentability
To be patentable in Panama, an invention must meet three primary criteria:
- It must be a new invention.
- It must result from an inventive activity.
- It must be subject to an industrial application[5].
Biological Medicines and Biosimilars
Biological medicines, including biosimilars, can be patentable if they meet the above criteria. However, it is important to note that biosimilar medicines are not considered the same as generic medicines. Biosimilars must demonstrate superior effectiveness, quality, and safety compared to the reference product from which they are derived[2].
Enforceability of Biopharmaceutical Patents
Pharmaceutical Patents
Pharmaceutical patents are highly enforceable in Panama, representing approximately 80% of the total patents registered annually in the Panamanian Patent Office. This indicates a strong emphasis on protecting pharmaceutical innovations[5].
Regulatory Framework
The U.S.-Panama Trade Promotion Agreement further strengthens the enforcement of intellectual property rights, including patents. It mandates strong, deterrent criminal penalties against copyright piracy and trademark counterfeiting, and it authorizes the seizure, forfeiture, and destruction of counterfeit and pirated goods[1].
Scope of Claims for Biopharmaceutical Patents
Patent Claims
The scope of a patent is determined by its claims. For biopharmaceutical patents, it is often beneficial to have claims that are slightly wider or preferably much wider than the specific product to prevent competitors from easily designing around the patent. This approach ensures that all compounds covered by the genus are protected, provided the specification enables a skilled artisan to successfully use all the compounds in the genus[3].
Genus Claims
In the pharmaceutical industry, genus claims are common, especially when dealing with large families of compounds. These claims must comply with the enablement requirement, meaning the specification must show an efficient and successful use of all the compounds in the genus. This is typically demonstrated through representative examples in the specification[3].
Regulatory Data Protection
Test Data Protection
The U.S.-Panama Trade Promotion Agreement ensures robust test data protection. For pharmaceuticals, the test data submitted for product approval is protected against unfair commercial use for a period of 5 years from the date of product approval. For agricultural chemicals, this protection extends to 10 years. If Panama relies on U.S. FDA approval, the data protection period begins on the date of product approval in the United States[1].
Patent Term and Extensions
Patent Term
Patents in Panama are granted for 20 years from the deposit date. Utility models, which may also apply to certain biopharmaceutical innovations, are granted for a 10-year period[5].
Patent Term Extensions
While Panama's current laws do not explicitly provide for patent term extensions to offset regulatory delays, such provisions are common in other trade agreements and could be considered in future amendments to the law[4].
Approval and Marketing Authorization
No Patent Linkage
Unlike some other countries, Panama does not have a patent linkage system, which means that the health regulatory authority can approve generic products without the consent of the patent holder during the patent term[2][4].
Regulatory Framework for Biosimilars
Currently, there is no specific regulatory framework for the marketing authorization of biosimilar medicines in Panama. Biosimilar medicines are neither defined nor regulated by Panamanian law, which can create challenges for their approval and marketing[2].
Licensing and Registration Requirements
Filing Requirements
To file a patent or utility model application in Panama, one must submit a power of attorney, a certificate of existence of the company, priority documents, drawings, description, summary, and claims of the invention. The State of the Art Report must be filed within 14 months from the date of the prior foreign application[5].
Registration Process
The registration proceedings for patents can take from 20 to 36 months, while design registrations generally take between 18 to 24 months. Patents and design registrations require annuity payments to maintain protection[5].
Conclusion
In Panama, biopharmaceutical patents are subject to stringent criteria for patentability, enforceability, and scope of claims. Here are the key takeaways:
- Patentability: Biopharmaceutical inventions must be new, result from inventive activity, and be subject to industrial application.
- Enforceability: Pharmaceutical patents are highly enforceable, with strong penalties against piracy and counterfeiting.
- Scope of Claims: Claims should be broad enough to prevent design-around strategies, with a focus on enabling all compounds in the genus.
- Regulatory Data Protection: Test data is protected for 5 years for pharmaceuticals and 10 years for agricultural chemicals.
- Patent Term: Patents are granted for 20 years, with no current provisions for term extensions.
- Approval and Marketing: No patent linkage system exists, and biosimilars lack a specific regulatory framework.
Key Takeaways
- Strong Enforcement: Panama has strong enforcement mechanisms against intellectual property violations.
- Broad Claims: Biopharmaceutical patents benefit from broad claims to protect against competitors.
- Data Protection: Robust protection for test data submitted for product approval.
- No Patent Linkage: Generic products can be approved without patent holder consent.
- Regulatory Gaps: Biosimilars lack a specific regulatory framework.
FAQs
1. Are biosimilar medicines considered the same as generic medicines in Panama?
No, biosimilar medicines are not considered the same as generic medicines. They must demonstrate superior effectiveness, quality, and safety compared to the reference product[2].
2. Can biological medicines be patented in Panama?
Yes, biological medicines can be patented if they meet the criteria of being new, resulting from inventive activity, and being subject to industrial application[2].
3. Is there a specific regulatory framework for biosimilar medicines in Panama?
No, there is no specific regulatory framework for the marketing authorization of biosimilar medicines in Panama[2].
4. How long does the registration process for patents take in Panama?
The registration proceedings for patents can take from 20 to 36 months[5].
5. What is the duration of protection for pharmaceutical patents in Panama?
Pharmaceutical patents are granted for 20 years from the deposit date[5].
Sources
- USTR - Intellectual Property Rights in the U.S.-Panama Trade Promotion Agreement
- The Pharma Legal Handbook: Panama
- Pearl Cohen - Patent claims' scope – is bigger always better? Trends in the pharmaceuticals industry
- CEPAL - The Problems of Intellectual Property in Latin America and the Caribbean
- Pardini & Asociados - Panama Facts: Patents and Industrial Designs
