Introduction to Biopharmaceutical Patents in Portugal
Biopharmaceutical patents in Portugal are governed by a combination of national and European Union regulations. Understanding the specific rules and recent developments is crucial for navigating the complex landscape of patent litigation and protection.
Patentability of Biopharmaceutical Inventions
In Portugal, biopharmaceutical inventions are subject to the same patentability criteria as other inventions, with additional specific guidelines.
- General Patentability Criteria: Biotechnological inventions, including those in the biopharmaceutical field, are patentable if they are novel, involve an inventive step, and are capable of industrial application[4].
- European Directive 98/44/EC: This directive provides supplementary means of interpretation for biotechnological inventions. It emphasizes that inventions concerning plants or animals are patentable as long as the application is not technically confined to a single plant or animal[4].
The Role of the National Industrial Property Institute (INPI)
- Governing Body: The INPI is responsible for the grant procedure in Portugal, conducting both formal and substantive examinations of patents[3].
Obtaining a Patent
- Filing Procedure: Applicants with residence or principal place of business in Portugal must file European patent applications with INPI, unless claiming the priority of an earlier Portuguese application. Applications can be filed in various languages, but a translation into Portuguese must be provided within one month if the application is not in Portuguese[5].
- Examination Process: The INPI conducts thorough examinations to ensure that the patent meets the criteria of novelty, inventive step, and industrial applicability[3].
Supplementary Protection Certificates (SPCs)
- Extension of Patent Term: For pharmaceutical and phytopharmaceutical patents, the 20-year patent term can be extended by up to five years through an SPC. An additional six months can be granted for medicinal products for pediatric use[3].
- Recent Judicial Decisions: The Intellectual Property Court in Portugal has decided that a product protected by an SPC is protected if the active principle is claimed in the basic patent or if the functional definition formulae of the claims implicitly contain and necessarily identify the active principle[1].
Enforceability of Biopharmaceutical Patents
- Litigation Trends: The number of patent litigation cases in Portugal, particularly in the pharmaceutical sector, has decreased since the amendment of Law 62/2011 in 2018. This amendment changed the mandatory arbitration system to a voluntary one, leading to more cases being filed in the Intellectual Property Court[1][2].
- Intellectual Property Court: Disputes involving pharmaceutical patents are now subject to the jurisdiction of the Intellectual Property Court, rather than mandatory arbitration. This change has led to a decrease in patent litigation cases but has also prompted a significant number of settlement agreements between patent holders and generic companies[2].
Scope of Claims
- Active Principles and Excipients: A landmark decision by the Court of Appeal of Lisbon granted an SPC based on the therapeutic efficacy of an excipient combined with an active principle. This decision expanded the scope of what can be considered a protected product under EU Regulation 469/2009[1].
- Functional Definition Formulae: The court has also clarified that a product is protected if the functional definition formulae of the claims, interpreted in light of the description of the basic patent, implicitly contain and necessarily identify the active principle[1].
Information Technology and Trade Secrets Litigation
While not directly related to biopharmaceuticals, there is an increasing trend in litigation regarding patents in the fields of telecommunications and information technology in Portugal. This includes computer-implemented inventions and copyright issues, which can sometimes intersect with biopharmaceutical patents in terms of data protection and intellectual property strategies[1].
Patent Linkage and Regulatory Approvals
- No Patent Linkage: Portuguese law does not establish a patent linkage system, where the approval of market authorizations (MAs) for generics would depend on the status of patents protecting the originators’ medicines. Instead, the law aims to encourage stakeholders to ascertain potential patent infringements before the launch of generic medicines[2].
Administrative and Judicial Actions
- Preventive Actions: The law limits the right of action for patent holders by establishing a short statute of limitations (30 days) for filing preliminary and permanent injunctions following the publication of a generic MA application[2].
- Constitutional and Administrative Laws: Patent holders can complain about breaches of constitutional and administrative laws protecting fundamental rights, such as patent rights, but this does not affect the grant or effectiveness of MAs for generic medicines[2].
Key Takeaways
- Patentability: Biopharmaceutical inventions are patentable under EU and national regulations if they meet the criteria of novelty, inventive step, and industrial applicability.
- SPCs: These can extend the patent term for pharmaceutical and phytopharmaceutical products by up to five years, with an additional six months for pediatric use.
- Litigation Trends: The shift from mandatory to voluntary arbitration has reduced patent litigation cases but increased settlement agreements.
- Scope of Claims: The scope includes active principles and, under certain conditions, excipients with therapeutic efficacy.
- Regulatory Approvals: There is no patent linkage system in Portugal, and the law encourages early assessment of potential patent infringements.
Frequently Asked Questions (FAQs)
Q: What is the duration of a patent in Portugal?
A: A patent is granted for 20 years from the date of filing, provided all annual fees are paid. It can be extended by up to five years through an SPC for pharmaceutical and phytopharmaceutical products[3].
Q: How does the Intellectual Property Court handle disputes involving pharmaceutical patents?
A: Disputes are now subject to the jurisdiction of the Intellectual Property Court, rather than mandatory arbitration, leading to a decrease in patent litigation cases but an increase in settlement agreements[1][2].
Q: Can excipients be included in the definition of a protected product?
A: Yes, an excipient can be included if it produces a pharmacologic, immunologic, or metabolic effect covered by the therapeutic indications in the Marketing Authorisation[1].
Q: Is there a patent linkage system in Portugal?
A: No, Portuguese law does not establish a patent linkage system where the approval of MAs for generics depends on the status of patents protecting originators’ medicines[2].
Q: How long do patent holders have to file an action following the publication of a generic MA application?
A: Patent holders have 30 days to file preliminary and permanent injunctions following the publication of a generic MA application[2].
