Introduction
The Mexican patent system, particularly for biopharmaceuticals, is governed by a complex set of laws and regulations that aim to balance the rights of patent holders with the need to make generic drugs available to the public. Here are the key insights into patentability, enforceability, and the scope of claims for biopharmaceutical patents in Mexico.
Patentability of Biopharmaceutical Inventions
Non-Patentable Inventions
The Mexican Federal Law for the Protection of Industrial Property (LFPPI) outlines several categories of inventions that are not patentable. These include methods for surgical or therapeutic treatment of the human or animal body, methods of diagnostics applied to them, and the human body in its various states of constitution and development, including the full or partial sequence of a gene[4].
Double Patenting
The Mexican Institute of Industrial Property (IMPI) ensures that there is no double patenting of the same invention, protecting the public domain and preventing redundant patents[4].
Bolar Provision
The Bolar provision allows third parties to use, manufacture, offer to sell, or import a product with a patent in effect, exclusively for generating experimental tests, information, and production necessary to obtain sanitary registrations of drugs for human health. This provision is crucial for the development of generic drugs[4].
Enforceability of Biopharmaceutical Patents
Patent Linkage System
The patent linkage system in Mexico is designed to prevent the issuance of marketing authorizations for generic versions of patented pharmaceutical drugs. This system requires communication between IMPI and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). Applicants for marketing authorizations must file a statement under oath declaring that the product does not infringe any patents or that they are the patent assignee or authorized licensee[5].
Infringement and Nullity Proceedings
Infringement and nullity proceedings are carried out independently but in parallel. If a defendant counterclaims the invalidation of a patent during an infringement case, the processes are separate, but the final decision is given in a single resolution. If the patent is invalidated, the infringement proceeding is declared without merits[2].
Preliminary Injunctions
Pharmaceutical companies, especially those producing generic drugs, must be prepared to demonstrate non-violation of patents (free-to-operate – FTO) and may need to lift preliminary injunctions by providing a counter-guarantee and demonstrating the impact of the measures[2].
Scope of Claims for Biopharmaceutical Patents
Eligible Patents for Linkage System
Only certain types of patents are eligible for inclusion in the Linkage Gazette. These include patents that are "susceptible of being used in" pharmaceutical products. Formulation patents, active principle patents, combinations of active principles, and second medical use patents are all eligible, following clarifications from the Supreme Court[3][5].
Requirements for Inclusion in the Linkage Gazette
To be included in the Linkage Gazette, the patent owner must submit a request to IMPI, proving that the patent is related to an allopathic medicament, showing the correspondence between the International Non-proprietary Name (INN) and the active principle, and providing specific bibliographic information about the patent[5].
Appeal Process
If IMPI denies the inclusion of a patent in the Linkage Gazette, the patent owner can file an appeal before the Federal District Court, and subsequently before the Federal Circuit Court if necessary[5].
Tools and Resources for Patent Owners and Generic Drug Manufacturers
New Tools by the Mexican Patent Office
The Mexican Patent Office, in collaboration with COFEPRIS, has introduced tools such as a database for searching patents associated with allopathic drugs, a list of patents expiring in the next 10 years, and responses to COFEPRIS regarding patents related to medicaments. These tools aim to incentivize the generic drug industry and provide transparency[1].
Expert Evidence in Litigation
Expert evidence, typically in the form of written reports, is crucial in infringement and invalidation proceedings. These reports guide IMPI officials in issuing technical opinions that form the basis of the final resolution[2].
Challenges and Uncertainties
Limitations of the Linkage System
The linkage system is only applicable to allopathic drugs and does not cover medical devices or veterinary medicines, despite the rationale being equally applicable to these products. This creates significant uncertainty for manufacturers of these products[5].
Litigation and Judicial Interpretations
The criterion for demonstrating real and direct damage for filing the administrative declaration of invalidation of a patent has generated various litigations, mainly promoted by the generic pharmaceutical drugs industry. A decisive resolution from the Supreme Court is expected to clarify these issues[2].
Strategic Considerations for Biopharmaceutical Companies
Modifying Products to Avoid Infringement
Companies may need to modify their products to avoid infringement or restrict their therapeutic indications ("carve out") to comply with existing patents. Negotiating licenses with patent owners or changing the product launch strategy are also viable options[2].
Importance of Documentation
Companies must be well-prepared to demonstrate non-violation of patents and have documentation to preliminarily reject the plaintiff’s claim. This includes having a strong FTO analysis and being ready to lift preliminary injunctions[2].
Key Takeaways
- Patentability: Biopharmaceutical inventions must comply with LFPPI, avoiding non-patentable categories and double patenting.
- Enforceability: The patent linkage system and infringement/nullity proceedings are critical for protecting patent rights.
- Scope of Claims: Only specific types of patents are eligible for the Linkage Gazette, and inclusion requires detailed submissions.
- Tools and Resources: New tools by the Mexican Patent Office and expert evidence in litigation are essential for both patent owners and generic drug manufacturers.
- Challenges and Uncertainties: The linkage system has limitations, and ongoing litigation may impact the landscape.
- Strategic Considerations: Companies must be prepared to modify products, negotiate licenses, or change launch strategies to navigate the complex patent environment.
FAQs
Q: What is the purpose of the Mexican patent linkage system?
The Mexican patent linkage system aims to prevent the issuance of marketing authorizations for generic versions of patented pharmaceutical drugs by linking patent rights to the sanitary registration process[5].
Q: Can generic drug manufacturers conduct tests before the expiration of a patent?
Yes, the Bolar provision allows generic drug manufacturers to use, manufacture, offer to sell, or import a product with a patent in effect, exclusively for generating experimental tests necessary to obtain sanitary registrations[4].
Q: How do infringement and nullity proceedings work in Mexico?
Infringement and nullity proceedings are carried out independently but in parallel. If a patent is invalidated during an infringement case, the infringement proceeding is declared without merits[2].
Q: What types of patents are eligible for inclusion in the Linkage Gazette?
Eligible patents include those that are "susceptible of being used in" pharmaceutical products, such as active principle patents, formulation patents, and second medical use patents[3][5].
Q: Can a patent not listed in the Linkage Gazette still be enforced?
Yes, a patent not listed in the Linkage Gazette is equally enforceable through a normal infringement procedure, but it will not be considered in COFEPRIS consultations[5].
Sources
- NEW TOOLS IN THE MEXICAN PATENT OFFICE AVAILABLE FOR ... - PPM.
- Life Sciences & Pharma IP Litigation 2024 - Mexico - Chambers.
- The Mexican patent linkage system: present and future - ClarkeModet.
- Mexico's New Industrial Property Law: In a Nutshell - Holland & Knight.
- A Review of the Mexican Linkage System - AIPLA.
