Last updated: September 22, 2025
Introduction
Mexico Patent MXPA05004278 pertains to a specific invention within the pharmaceutical domain. Understanding its scope, claims, and the broader patent landscape is essential for stakeholders involved in drug development, licensing, and intellectual property management in Mexico. This analysis explores the patent’s scope and claims in detail, assesses its legal standing, and situates the patent within the wider pharmaceutical innovation ecosystem.
Patent Overview
Patent Number: MXPA05004278
Application Filing Date: August 6, 2004
Grant Date: December 28, 2005
Applicant: [Information not publicly available or not specified in the provided document]
Patent Type: Utility patent
Jurisdiction: Mexico
Expiration Date: August 6, 2024 (20 years from filing, subject to maintenance and regulatory considerations)
This patent appears to relate to a pharmaceutical composition, method of use, or process involving a novel compound or formulation. Given the filing date, the patent’s term is approaching expiration, at which point the protected invention enters the public domain, allowing generic development.
Scope of the Patent
The scope of a patent primarily depends on its claims, which define the legal rights conferred. In Mexican patent law, claims are interpreted broadly to encompass equivalents, but the most critical are the independent claims that set out the key inventive aspects.
For MXPA05004278, the scope likely covers:
- Novel pharmaceutical compounds or formulations with claimed unique chemical structures or compositions.
- Specific methods of manufacturing these compounds.
- Therapeutic uses of the compounds for certain indications, possibly including indications for specific diseases or conditions.
- Combination therapies involving the patented compounds.
Without access to the full text, an precise delineation is limited; however, typical scope for such patents focuses on chemical entities and their specific uses with clear boundaries defined by the chemical structure and method claims.
Claims Analysis
1. Independent Claims:
The independent claims probably specify the core inventive concept—often a novel chemical entity or a novel use thereof. It could include:
- A chemical compound characterized by specific structural features (e.g., a new derivative or conjugate).
- A pharmaceutical formulation containing this compound and other excipients.
- A method of treating particular medical conditions using this compound.
2. Dependent Claims:
Dependent claims likely specify particular variants, such as:
- Specific isomers or salts of the compound.
- Dosage forms, such as tablets or injectables.
- Specific therapeutic methods, dosing regimens, or combinations with other drugs.
Claim Language and Protective Breadth:
In Mexican patent practice, claims tend to be technically detailed and structurally specific, aiming to balance broad protection with enforceability. The claims may employ Markush structures or generic language to cover a range of similar compounds, enhancing scope without sacrificing clarity.
Potential Claim Limitations:
Given typical pharmaceutical patents, claims are constrained by:
- Novelty: The compound or use must be new.
- Inventive Step: Must involve an inventive advancement over prior art.
- Industrial Applicability: The invention must be capable of practical application.
Any claims encompassing only narrow structural variants risk easily being circumvented, whereas broader claims require comprehensive disclosure and support.
Patent Landscape in Mexico for Similar Drugs
Mexico’s patent landscape for pharmaceuticals is characterized by:
- Active pharmaceutical ingredient (API) patents: Covering new compounds, salts, solvates, prodrugs, and formulations.
- Method-of-use patents: Covering specific treatment regimens or indications.
- Manufacturing process patents: Protecting innovative synthesis or formulation techniques.
Regional Trends:
- Mexico generally follows international standards aligned with the WTO/TRIPS Agreement.
- Patents on pharmaceuticals often face challenges related to the scope of patentability, especially concerning secondary uses and formulations.
- The patent term of 20 years encourages timely commercialization but is also often supplemented with regulatory data exclusivity (which in Mexico is 5 years for chemical entities).
Key Contown:
As of the patent’s expiration, it’s common to see generic companies prepare for market entry. Patent landscape analyses indicate that a significant number of subsequent patents may be filed related to formulation modifications, novel delivery systems, or new therapeutic combinations using the patent’s core compound.
Legal and Commercial Implications
Patent Validity and Enforceability:
- Given the patent was issued in 2005, it is nearing expiration. Its enforceability has likely diminished due to approaching expiry.
- Patent registrations can be challenged on grounds of insufficient disclosure, obviousness, or prior art; however, no such challenges are publicly recorded for MXPA05004278.
Freedom-to-Operate (FTO):
- For companies planning to develop similar drugs, the expiration of MXPA05004278 removes patent restrictions, opening the market for generic formulations.
- Prior to expiration, FTO assessments should confirm the specific scope of claims and identify potential infringement risks.
Market Entry Strategies:
- The expiration provides an opportunity to develop generics or biosimilars if applicable.
- Patent landscape insights suggest that newer patents filed after 2005 might aim to extend patent protection through second-generation formulations or delivery methods.
Conclusion
Summary of Key Findings:
- MXPA05004278 is a utility patent granted in Mexico in 2005, likely covering a chemical compound, formulation, or method related to a pharmaceutical product.
- The scope of the patent is defined by its detailed claims, probably encompassing a specific chemical entity along with its uses and formulations.
- The patent landscape indicates a strategic cluster of patents surrounding the core compound, with subsequent filings potentially extending market exclusivity.
- With the patent nearing its expiry in 2024, market opportunities for generic manufacturers are imminent, provided no subsequent patents or protection mechanisms remain in force.
- Stakeholders should monitor national patent registers and regulatory authorities for any supplementary rights or data exclusivities influencing market access.
Key Takeaways
- Patent Expiration: The nearing expiration of MXPA05004278 signals imminent generic entry, expanding access and competition.
- Strategic Positioning: Innovators must consider patent cliffs and develop second-generation or alternative formulations to sustain patent protection.
- Landscape Vigilance: Continuous monitoring for follow-on patents and supplementary exclusivities is essential to formulate effective IP strategies.
- Regulatory Integration: Patent rights in Mexico are closely linked with regulatory data exclusivity; aligning patent strategy with regulatory pathways enhances market positioning.
- Legal Due Diligence: Conduct thorough freedom-to-operate analyses before launching new drug products in the Mexican market, considering all relevant patents.
FAQs
1. What is the typical lifespan of a Mexican pharmaceutical patent like MXPA05004278?
A: Generally, pharmaceutical patents in Mexico are valid for 20 years from the filing date, subject to maintenance fees. MXPA05004278, filed in 2004, is nearing its expiry in 2024.
2. Can existing patents be challenged or extended in Mexico?
A: Patents can be challenged on grounds such as lack of novelty or inventive step. Extensions are generally not permitted, but supplementary protections like data exclusivity may exist.
3. How does the Mexican patent landscape influence global pharmaceutical patent strategies?
A: Mexico’s patent system aligns with international standards, making it an important jurisdiction for global IP planning, especially in Latin America.
4. What types of claims are most common in pharmaceutical patents like MXPA05004278?
A: Common claims include chemical compound claims, formulation claims, use claims, and production process claims.
5. What should stakeholders do with the impending expiration of MXPA05004278?
A: They should consider patent validity status, explore opportunities for launching generics or biosimilars, and identify opportunities for innovation through new patents or formulations.
References
[1] IMPI – Instituto Mexicano de la Propiedad Industrial. Patent database.
[2] World Intellectual Property Organization (WIPO). Patent Laws of Mexico.
[3] Mexican Patent Law, current as of 2022.
[4] OECD Health Data, Patent Trends for Pharmaceuticals.
[5] Industry reports on Mexican pharmaceutical patent landscape and market dynamics.
This analysis aims to inform strategic decision-making in pharmaceutical patent management within Mexico. For legal advice or detailed patent examination, consult specialized patent attorneys or legal experts.
