Introduction to Moroccan Patent Law
Morocco has established a robust framework for patent protection, particularly through Law No. 17-97 on the Protection of Industrial Property, which has been amended and supplemented by subsequent laws. This framework is crucial for biopharmaceutical companies looking to protect their innovations in the Moroccan market.
Patentability of Biopharmaceutical Inventions
Types of Patents
In Morocco, the primary type of patent that can be registered is the Patent for Invention. This patent protects new inventions that demonstrate innovative progress and have industrial applicability. Biopharmaceutical inventions, such as new chemical entities, pharmaceutical products, or substances, fall under this category as long as they meet the criteria of novelty, creative progress, and industrial applicability[3].
Specific Considerations
- New Chemical Entities: These are generally patentable in Morocco, similar to other countries in the MENA region. Innovations in pharmaceutical products or substances are protected as long as they are novel and have industrial applicability[2].
- Second Medical Use and Swiss-Type Claims: While not explicitly mentioned in Moroccan law, the trend in the MENA region suggests that second medical use or Swiss-type claims might be allowed in some cases, although this is not as clear-cut as in other jurisdictions[2].
Enforceability of Biopharmaceutical Patents
Validation of European Patents
Morocco has a validation agreement with the European Patent Organisation, allowing European patent applicants to validate their patents in Morocco. This process is governed by national law and provides a cost-effective way to obtain patent protection. The validated patent has the same effects as a national patent, but any amendments or revocations made during EPO proceedings must be published and recorded by the Moroccan industrial property authority (OMPIC)[1].
Compliance with National Law
To enjoy protection, the proprietor must file the claims in Arabic or French within three months of the patent's publication by the EPO and pay the prescribed fees. Failure to comply with these requirements can result in the patent being deemed null and void ab initio[1].
Renewal Fees
Renewal fees for validated patents are payable to OMPIC, ensuring the continued protection of the patent over its 20-year term[1].
Scope of Claims
Definition of Patentable Inventions
The scope of claims is defined by the novelty, creative progress, and industrial applicability of the invention. Claims must be clear and concise, defining the exclusive rights of the applicant. In Morocco, the claims are the most critical part of the patent application, as they delineate the scope of protection[3].
Translation Requirements
For a patent to be validated in Morocco, the claims must be translated into Arabic or French. If the translation confers narrower protection than the original text, the translation will be considered the authentic text, except in revocation proceedings[1].
Provisional Protection
Published European applications can provide provisional protection in Morocco, but this protection can lapse retroactively if the validation request or the patent itself is revoked or lapses[1].
Additional Protections
Supplementary Protection Certificates
Morocco offers supplementary protection certificates (SPCs) to extend the patent term for pharmaceutical products. This extension is granted to compensate for delays in obtaining marketing approval, ensuring that the effective patent term is not significantly reduced by regulatory delays[2].
Practical Considerations
Filing and Withdrawal of Validation Requests
Validation requests can be submitted to the EPO for any European patent application filed on or after 1 March 2015. These requests can be withdrawn at any time, and if the prescribed fee is not paid or the application is refused, the request will be deemed withdrawn[1].
Publication and Record-Keeping
OMPIC publishes and records any mentions of amendments to validated patents made during EPO proceedings. This ensures transparency and maintains the integrity of the patent register[1].
Industry Expert Insights
"Patent laws and regulations in the MENA region, including Morocco, are increasingly offering better protection for innovator pharmaceutical companies. Through patenting or data exclusivity, these companies can safely and securely penetrate the rapidly growing market," notes an industry expert[2].
Statistics and Trends
- The number of MENA countries with PCT membership is increasing, facilitating international patent applications and providing growth opportunities for businesses[2].
- Morocco's patent office has seen an increase in patent applications, reflecting the country's efforts to encourage innovation and create a conducive business environment[3].
Key Takeaways
- Patentability: Biopharmaceutical inventions, including new chemical entities and pharmaceutical products, are patentable in Morocco if they meet the criteria of novelty, creative progress, and industrial applicability.
- Enforceability: Patents can be validated through the EPO, and compliance with national law, including translation and fee payment, is crucial for maintaining protection.
- Scope of Claims: Claims must be clear and concise, defining the exclusive rights of the applicant, and translations must be filed within specified timelines.
- Additional Protections: Supplementary protection certificates can extend the patent term to compensate for regulatory delays.
FAQs
1. What types of patents can be registered in Morocco?
In Morocco, only the Patent for Invention can be registered, which protects new inventions with innovative progress and industrial applicability[3].
2. Can European patents be validated in Morocco?
Yes, European patents can be validated in Morocco through an agreement between the European Patent Organisation and the Moroccan government, providing a cost-effective way to obtain patent protection[1].
3. What are the translation requirements for patent validation in Morocco?
Claims must be translated into Arabic or French within three months of the patent's publication by the EPO, and the translation will be considered the authentic text unless in revocation proceedings[1].
4. How can biopharmaceutical companies extend their patent term in Morocco?
Biopharmaceutical companies can obtain supplementary protection certificates to extend their patent term, compensating for delays in obtaining marketing approval[2].
5. What happens if the validation request for a European patent lapses in Morocco?
If the validation request lapses, the provisional protection conferred by the published European application will be lost ab initio[1].
Sources
- European Patent Office, "OJ EPO 2016, A5 – Validation of European patents in Morocco (MA)".
- Saba IP, "MENA: Evaluating Risks and Opportunities for Pharmaceutical Patenting".
- Viet An Law, "Register Patent Application in Morocco".
- WIPO, "STUDY ON PATENTS AND THE PUBLIC DOMAIN".
- Al Tamimi & Company, "Protecting Medical & Pharmaceutical Inventions in the GCC Countries".