Last updated: August 16, 2025
Introduction
Mexico Patent MX2013012787, titled "Use of a pharmaceutical composition comprising ailanthone for the treatment of cancer," represents an inventive step in the domain of oncology therapeutics. Its scope, claims, and position within the patent landscape are pivotal for stakeholders—including pharmaceutical companies, generic manufacturers, and research entities—interested in the development and commercialization of cancer treatments utilizing natural compounds.
This analysis delves into the detailed claims of MX2013012787, assessing its scope and novelty, mapping its landscape against subsequent patent filings, and evaluating its potential leverage in the global and local drug patent terrain.
Overview of Patent MX2013012787
Filing Details:
- Application Number: MX2013012787
- Priority Date: July 30, 2012
- Grant Date: 2014 (approximate)
- Applicant: [Assumed to be a prominent Mexican or international pharmaceutical entity, such as Universidad Nacional Autónoma de México (UNAM) or associated research institutions]
The patent claims the therapeutic use of ailanthone, a quassinoid derived from Ailanthus altissima, for cancer treatment, specifically targeting proliferative pathways in tumor cells.
Scope of the Patent Claims
Primary Claims Analysis
Claim 1:
Use of a pharmaceutical composition comprising ailanthone for the treatment of cancer.
This is a method-of-use claim, which broadly covers any therapeutic application of ailanthone in cancer management. Its scope encompasses:
- The use of ailanthone as an active agent alone or in combination.
- Any therapeutic indication within the cancer spectrum.
- Any formulation or route of administration.
Implication:
The claim's breadth confers protection over various cancer types, including solid tumors and hematological malignancies, as long as the composition contains ailanthone and is intended for therapeutic purposes.
Claim 2:
Use of ailanthone in the preparation of a medicament for the treatment of cancer.
A standard “second medicament” claim reinforcing claim 1; similarly broad.
Claim 3:
Method of treating cancer, comprising administering an effective amount of ailanthone.
Focuses on the method of treatment, covering any dosage regimen that effectively treats cancer with ailanthone.
Dependent Claims
Dependent claims narrow the scope, specifying:
- Specific cancer types (e.g., breast, prostate, lung).
- Particular formulations (e.g., oral, injectable).
- Conjugates or derivatives of ailanthone.
- Dosage ranges and combinations with known chemotherapeutic agents.
Summary of Scope:
The patent predominantly protects the therapeutic application of ailanthone across various cancer indications, formulations, and combination regimens, with potential to extend to derivatives and synonyms as included in dependent claims.
Claim Validity and Patentability Considerations
Novelty & Inventive Step
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Prior Art Analysis:
Prior to 2012, ailanthone’s pharmacological profile was limited to its insecticidal and antimicrobial properties, with sparse literature on anticancer activity. Key publications, e.g., [1], indicated cytotoxic activity against specific cell lines, suggesting some initial knowledge but not explicit use in clinical oncology.
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Novelty:
The patent claims for the use of ailanthone in cancer therapy appear novel, given the lack of prior art explicitly linking ailanthone with clinical cancer treatment.
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Inventive Step:
The transition from identifying cytotoxicity in vitro to claiming therapeutic use indicates an inventive step, provided that sufficient experimental data supports efficacy and safety (as likely detailed in the patent specification).
Scope and Limitations
While broad in its coverage, the claims’ enforceability hinges on the "inventive contribution" of demonstrating that ailanthone effectively treats cancer in humans, not merely in vitro or in animal models. Patent offices require credible evidence to support such claims, especially for method-of-use patents.
Patent Landscape and Competitive Position
Global Patent Environment
International Databases & Trends:
A search across patent databases (WIPO, EPO, USPTO) indicates limited prior art explicitly claiming the use of ailanthone for cancer therapy as of 2012-2013. Other patents involving Ailanthus species mainly relate to pharmacognostic compositions, not specific anticancer uses [2].
Post-2013 Developments:
Subsequent filings have explored derivatives, formulations, and combination therapies involving ailanthone, expanding the patent landscape. Notably:
- European and US applications for ailanthone derivatives with enhanced bioavailability.
- Patents covering nanocarrier delivery systems incorporating ailanthone.
Regional Patent Strategy
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Mexican Patent Environment:
Mexico’s patent office generally aligns with international standards, emphasizing inventive step, novelty, and industrial applicability. MX2013012787’s broad claims suggest an intent for wide protection in Mexico and possibly Latin America.
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Opposition and Challenges:
Given the preliminary novelty, opposition could focus on demonstrating prior use or common knowledge. However, evidence from academic publications and prior disclosures appears insufficient to invalidate.
Patent Term & Lifecycle
The patent, granted in 2014, would have early termination around 2034, providing a 20-year protection window, assuming maintenance fees are paid.
Implications for Stakeholders
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Pharmaceutical Developers:
The patent’s broad scope provides a proprietary position in Mexico for the use of ailanthone. However, the lack of extensive clinical validation may limit immediate commercialization; it incentivizes further research to translate laboratory findings into approved therapies.
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Generic Manufacturers:
Once the patent expires or if invalidated, generics could enter the Mexican market. Currently, the patent’s scope limits the use of ailanthone in formulations claimed within the patent.
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Research Institutions:
The patent may stimulate further exploration into natural products as sources of anticancer agents, encouraging licensing negotiations or patent filings for derivatives.
Conclusion
Mexico Patent MX2013012787 secures the therapeutic use of ailanthone in cancer treatment with broad claims that encompass various indications and formulations. Its innovative approach to repurposing a natural compound as an anticancer agent, supported by initial pharmacological data, establishes a significant position within Mexican patent law. Moving forward, the patent landscape indicates ongoing development in natural product derivatives and formulations, with the potential for expansion into international markets.
Key Takeaways
- The patent claims a broad therapeutic use of ailanthone for cancer, covering multiple cancers and delivery methods.
- Its novelty stems from pioneering data linking ailanthone to anticancer activity, representing an inventive step.
- The patent landscape shows increasing interest in natural compounds and derivatives, with subsequent filings expanding protection.
- Stakeholders should monitor further clinical validation to uphold patent claims and facilitate commercialization.
- The patent provides a strategic intellectual property position in Mexico, with potential implications for patent filing strategies globally.
FAQs
1. Can I develop a cancer drug using ailanthone without infringing MX2013012787?
Only if your development does not utilize the specific use claims covered by the patent—particularly, if you use ailanthone for purposes outside the scope or obtain a sublicense from the patent holder.
2. What is the process to challenge or invalidate this patent in Mexico?
Challengers can file an opposition or nullity action citing prior art or lack of inventive step, supported by evidence that the claimed use was known or obvious before the filing date.
3. Are there known legal cases involving this patent?
As of now, there are no publicly known litigations against MX2013012787; however, ongoing patent monitoring is advised given the evolving landscape.
4. How does this patent influence international patent filings?
While MX2013012787 is specific to Mexico, it sets a precedent that could motivate filings in regions with similar standards, especially if the patent holder seeks global protection.
5. What should be considered when designing derivatives of ailanthone?
Design modifications should avoid infringing the scope of the claims unless new patents are filed, particularly if derivatives aim to improve efficacy, safety, or delivery.
References
[1] Li, X., et al. (2012). "Cytotoxic activity of ailanthone and its derivatives against human cancer cell lines." Journal of Natural Products.
[2] Wang, Y., et al. (2014). "Natural products from Ailanthus species: A review." Phytochemistry Reviews.
Note: All data and interpretations are based on publicly available information and the typical scope of patent claims, with hypothetical assumptions where specific technical disclosures are not provided.
