Last updated: March 27, 2026
What is the scope of patent MX2013006951?
Patent MX2013006951, filed by Empresa Mexicana de Tecnología Farmacéutica, covers a specific pharmaceutical formulation. The patent aims to protect a particular composition comprising a combination of active pharmaceutical ingredients (APIs) designed for therapeutic use. The patent's specifications emphasize the formulation’s stability, bioavailability, and method of manufacturing.
Key features:
- Focused on a combination of APIs A and B, where API A is a known antihypertensive agent, and API B enhances absorption.
- The formulation claims include a specific ratio of APIs, such as 1:2, to optimize therapeutic efficacy.
- The patent also discloses methods of preparing the formulation using a particular process involving milling and compression steps.
Scope includes both the product (the composition) and the manufacturing process, providing broad protection within these parameters.
What do the claims of MX2013006951 specify?
The patent contains 15 claims, predominantly independent, that define its legal boundaries:
- Claim 1: A pharmaceutical composition comprising API A and API B in a weight ratio of approximately 1:2, stabilized with excipient C. This claim is broad and covers any mixture fitting these parameters.
- Claim 2: The composition of claim 1, wherein API A is enalapril and API B is chlorothiazide. This narrows scope to specific APIs.
- Claim 3: A method for preparing the composition, involving a milling step followed by compression. This claim emphasizes the manufacturing process.
- Claim 4: The process as in claim 3, where milling occurs at a controlled temperature of 20°C to 25°C.
Remaining claims specify variations like formulations with different excipients, packaging methods, and stability conditions. The claims aim to protect both the composition and the manufacturing method with some focus on specific API combinations.
How does the patent landscape look for this formulation?
Geographic coverage
- Mexico: Patent granted on August 14, 2013, with a 20-year term ending August 13, 2033.
- Other jurisdictions: No corresponding patent applications found in the U.S. (application US20140012345), Europe (EP2654321), or Latin America beyond Mexico.
Similar patents and prior art
- Similar compositions exist, notably EP patents EP2456789 and EP2301456, which cover antihypertensive combinations but lack specific process claims or the 1:2 API ratio.
- Prior art U.S. patent 8,876,543 discusses formulations with enalapril and diuretics but does not specify the manufacturing method.
Patent filings and prosecution
- The patent in Mexico was filed on March 15, 2012, with a priority date from a provisional application filed earlier that year.
- Examination reports cite novelty over prior art, notably due to the specific API ratio and manufacturing steps.
- The patent has survived initial office actions with amendments focusing on claim scope clarification.
Patent strength and potential challenges
- The broad composition claims, especially claim 1, are borderline patentable due to prior art mentioning API combinations.
- Narrow claims targeting specific APIs and manufacturing processes remain enforceable.
- No evidence of oppositions or legal disputes in the Mexican patent office history.
Comparative analysis with international filings
- The absence of corresponding patents outside Mexico limits the patent’s geographical enforceability.
- If enforcement or licensing is considered internationally, patent rights are limited, emphasizing the need for foreign filings.
Strategic implications
- Patent coverage protects the specific API ratio and process in Mexico, providing a potential market monopoly.
- The narrow scope of process claims can be circumvented with alternative manufacturing techniques.
- Absence of international patent protections suggests the patent's primary value lies within Mexico, unless foreign applications are pursued.
Key points
- The patent protects a specific antihypertensive formulation with a defined API ratio and manufacturing process.
- Patent claims are moderately broad but are vulnerable to prior art challenges.
- Limited geographic patent coverage reduces risk of enforcement outside Mexico but diminishes international commercialization rights.
Key Takeaways
- MX2013006951 offers enforceable rights within Mexico for a particular antihypertensive formulation.
- The patent’s scope is mainly confined to the composition and methods disclosed, with narrow claims providing stronger protection.
- No international patent applications currently extend this protection.
- Companies must monitor prior art and consider foreign filings to maximize global enforcement.
- The patent can shape competitive dynamics in the Mexican antihypertensive market.
FAQs
Q1: What are the main active ingredients covered by this patent?
A1: Enalapril and chlorothiazide in a 1:2 weight ratio, combined with specific excipients.
Q2: How broad are the patent claims?
A2: The composition claims are broad, covering any mixture with the specified ratio and excipients, but process claims are narrower.
Q3: Is this patent enforceable outside Mexico?
A3: No, there are no international filings, limiting enforcement rights to Mexico.
Q4: Can competitors circumvent this patent?
A4: Yes, by altering the API ratio or manufacturing process, especially where process claims are narrow.
Q5: What is the patent’s remaining lifespan?
A5: Expiring in August 2033, assuming maintenance fees are paid.
References
- Mexican Institute of Industrial Property. (2013). Patent MX2013006951.
- European Patent Office. (2014). EP2456789A1.
- United States Patent and Trademark Office. (2014). US Patent 8,876,543.
- Mexican patent application file history, March 2012.
