Introduction
Patent protection is a crucial aspect for biopharmaceutical companies, ensuring exclusive rights to their inventions and preventing unauthorized use. In San Marino, the patent system is designed to protect innovative pharmaceutical products, but it comes with specific requirements and procedures.
Patentability Requirements
For a biopharmaceutical invention to be patentable in San Marino, it must meet several key criteria:
Novelty
The invention must be new and not obvious to a person skilled in the art. This means that the invention should not have been disclosed or made available to the public before the filing date of the patent application[3].
Inventive Step
The invention must involve an inventive activity, meaning it should not be obvious to a person skilled in the art, having regard to the state of the art at the time of the application[2].
Industrial Application
The invention must be susceptible of industrial application, which means it must be capable of being made or used in any kind of industry[2].
Filing and Documentation Requirements
To apply for a patent in San Marino, the following documents and information are necessary:
Specification
The patent application must include a detailed specification, which includes the description, abstract, claims, and any drawings related to the invention[2].
Proof of Payment
The application must be accompanied by proof of the payment of the prescribed official fees[2].
Designation of Inventor
The designation of the inventor must be provided, and this can be filed within two months from the filing date of the application[2].
Power of Attorney
If the applicant is represented by a professional representative, a Power of Attorney must be filed, which does not require notarization or legalization[2].
Priority Claims
If priority is claimed for a previous application, the applicant must provide all documents and information proving the existence of the priority. This includes filings made during a period of 12 months from the date of filing of the application at the San Marino Patents and Trade Marks State Office[3].
Examination and Grant Process
The patent application undergoes a formal examination to ensure it meets the patentability requirements. Here are some key points:
Prior Art Search
The applicant may request a prior art search to establish whether the subject-matter of the patent application complies with the patentability requirements. This can be requested at any time until the decision to grant the patent[2].
Objections and Appeals
If the San Marino Patent and Trademark Office raises objections, the applicant must respond within the specified time limit. Failure to respond can result in the rejection of the application. The applicant has the right to lodge an appeal against the partial or total rejection of the patent application[2].
Enforceability of Patents
Once a patent is granted, it confers exclusive rights to the patent holder. Here are some aspects related to the enforceability of patents in San Marino:
Scope of Claims
The scope of the exclusive rights conferred by the patent is defined by the scope of the claims, which must be interpreted in the light of the specification and drawings[3].
Term of Protection
Patents in San Marino are generally valid for 20 years from the filing date. However, annual fees must be paid to maintain the patent. For European patents validated in San Marino, the first annual fee due is the one concerning the year following the year in which the mention of the grant of the patent was published in the European Patent Bulletin[2].
Late Payment and Lapse
If annual fees are not paid on time, a fine can be paid to extend the payment period by six months. Failure to comply with these requirements can result in the lapse of the patent at the end of the ninth year from the filing date if the patentability requirements are not satisfied[2].
International and Regional Patents
San Marino also recognizes international and regional patents:
European Patents
Patent protection in San Marino can also be obtained through a European patent validated in San Marino. This involves entering the national phase within 31 months from the priority date and filing the necessary translations[2].
PCT Applications
For international patent applications under the Patent Cooperation Treaty (PCT), the time limit for entering the national phase in San Marino is 31 months from the priority date. The relevant translations must also be filed within this period[2].
Practical Implications for Biopharmaceutical Companies
Example: Nuplazid Patent Litigation
The case of Acadia Pharmaceuticals' drug Nuplazid (pimavanserin) illustrates the importance of robust patent protection. Acadia successfully defended its patents in court, ensuring protection for Nuplazid until 2037 and 2038 for its different formulations. This highlights the critical role of patent litigation in maintaining exclusivity and preventing generic competition[1].
Generic Competition
Biopharmaceutical companies must be aware that even after the primary patent expires, other patents or exclusivity clauses may still prevent generic competition. For instance, multiple patents and exclusivity clauses can extend the period of exclusivity, as seen with drugs like Humira and Otezla[5].
Key Takeaways
- Patentability Requirements: Inventions must be novel, involve an inventive step, and be susceptible of industrial application.
- Filing and Documentation: Detailed specifications, proof of payment, designation of inventor, and Power of Attorney are necessary.
- Priority Claims: Priority can be claimed for previous applications within 12 months.
- Examination and Grant: Formal examination includes prior art search and potential objections.
- Enforceability: Patents confer exclusive rights defined by the scope of claims and are valid for 20 years with annual fees.
- International and Regional Patents: European patents and PCT applications are recognized with specific filing requirements.
FAQs
Q: What are the key requirements for a biopharmaceutical invention to be patentable in San Marino?
A: The invention must be new, involve an inventive step, and be susceptible of industrial application.
Q: How long is a patent valid in San Marino?
A: Patents are generally valid for 20 years from the filing date, provided annual fees are paid.
Q: Can European patents be validated in San Marino?
A: Yes, European patents can be validated in San Marino, and this involves entering the national phase within 31 months from the priority date.
Q: What happens if annual fees are not paid on time?
A: A fine can be paid to extend the payment period by six months; otherwise, the patent may lapse.
Q: How does the San Marino patent system handle prior art searches?
A: Applicants may request a prior art search at any time until the decision to grant the patent to ensure the invention meets patentability requirements.
Sources
- Acadia victorious in court for Parkinson's drug Nuplazid patent litigation. Pharmaceutical Technology.
- PATENTS SAN MARINO. Kluwer Law International BV.
- REPUBLIC OF SAN MARINO - USBM. San Marino Patent and Trademark State Office.
- An Analysis of the Proposal for Reforming Brazilian Patent Law. Repository.law.uic.edu.
- The Biopharma Patent Cliff: 9 Drugs Losing Exclusivity by the End of 2023. Biospace.
