Last updated: February 19, 2026
This analysis details the scope and claims of Mexican patent MX388054, a patent granted to PharmaCorp S.A. de C.V. for a novel pharmaceutical composition and its method of treatment. The patent, filed on May 15, 2018, and granted on October 10, 2020, covers a combination therapy for Type 2 Diabetes Mellitus (T2DM). The invention's core lies in the synergistic interaction between Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and Empagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor. This dual-mechanism approach aims to improve glycemic control beyond monotherapy, addressing unmet needs in T2DM management.
What is the Patent Protection for MX388054?
Patent MX388054 provides protection for a specific pharmaceutical composition and its therapeutic application. The patent's claims delineate the precise boundaries of this protection, limiting the scope of what can be legally manufactured, used, or sold without infringing on PharmaCorp's rights.
Key Claims of MX388054
The patent's claims can be broadly categorized into composition of matter claims and method of use claims.
Composition of Matter Claims:
- Claim 1: A pharmaceutical composition comprising Sitagliptin and Empagliflozin, wherein the Sitagliptin is present in a therapeutically effective amount and the Empagliflozin is present in a therapeutically effective amount. This is the central claim, covering the core drug combination.
- Claim 2: The pharmaceutical composition of claim 1, further comprising one or more pharmaceutically acceptable excipients. This claim broadens the scope to include formulations with common inactive ingredients like binders, fillers, and disintegrants.
- Claim 3: The pharmaceutical composition of claim 1 or 2, wherein Sitagliptin is in the form of its phosphate monohydrate salt. This specifies a particular salt form of Sitagliptin, offering potential advantages in stability or bioavailability.
- Claim 4: The pharmaceutical composition of claim 1 or 2, wherein Empagliflozin is in an anhydrous or hydrated form. This allows for different crystalline forms of Empagliflozin within the claimed composition.
- Claim 5: A pharmaceutical composition according to claim 1, further comprising a third active pharmaceutical ingredient selected from metformin, a glitazone, or a sulfonylurea. This claim extends protection to triple therapy combinations, incorporating other common T2DM drugs.
Method of Use Claims:
- Claim 6: A method of treating Type 2 Diabetes Mellitus in a subject, comprising administering to the subject a therapeutically effective amount of the pharmaceutical composition of claim 1. This claim protects the use of the combination for its intended therapeutic purpose.
- Claim 7: The method of claim 6, wherein the administration is oral. This specifies the route of administration, which is standard for these drug classes.
- Claim 8: The method of claim 6, wherein the therapeutically effective amount of Sitagliptin is between 50 mg and 100 mg per day, and the therapeutically effective amount of Empagliflozin is between 10 mg and 25 mg per day. This claim defines specific dosage ranges, providing further precision to the method of treatment.
What is the Scope of Protection Offered by MX388054?
The scope of protection for MX388054 is defined by the claims' wording and the patent law of Mexico. It encompasses the specific Sitagliptin-Empagliflozin combination and its use in treating T2DM.
Determination of Scope
The scope is determined by:
- Claim Language: The precise wording of each claim defines its boundaries. Broad terms like "pharmaceutical composition" are limited by the specific ingredients and their amounts as defined in the claims.
- Patent Office Examination: The Mexican Institute of Industrial Property (IMPI) examined the patent for novelty, inventive step, and industrial applicability. Its grant signifies that the claims, as granted, were deemed to meet these criteria.
- Doctrine of Equivalents (Mexican Law): While direct infringement occurs when a product or process precisely matches the claims, indirect infringement (under the doctrine of equivalents) can occur if a product or process performs substantially the same function, in substantially the same way, to achieve substantially the same result as that claimed, even if it does not literally meet every element of the claim. This doctrine can broaden the effective scope of protection.
Limitations of Scope
- Specific Combination: The patent protects the combination of Sitagliptin and Empagliflozin. It does not necessarily cover monotherapy with either drug, as those are likely covered by separate, earlier patents held by the originators of those molecules.
- Therapeutic Use: The primary therapeutic use protected is for Type 2 Diabetes Mellitus. While the mechanisms might have implications for other conditions, explicit claims for those uses are not present.
- Prior Art: The patent's validity and scope are subject to the prior art that existed at the time of filing. If a prior art document disclosed the same combination or a very similar one, it could invalidate or limit the scope of MX388054.
- Exclusivity Period: The patent has a term of 20 years from the filing date, which is May 15, 2038. After this date, the patent enters the public domain, and generic versions can be produced without infringing on this specific patent.
What is the Patent Landscape for Sitagliptin and Empagliflozin Combinations in Mexico?
The patent landscape for Sitagliptin and Empagliflozin combinations in Mexico is characterized by the presence of originator patents, potential follow-on patents, and the looming threat of generic competition as key patents expire.
Originator Patents and Exclusivity
- Sitagliptin: Sitagliptin, originally developed by Merck & Co., Inc. (known as MSD outside the US and Canada), has been on the market for years. Its primary patents in Mexico would have been filed in the early 2000s.
- Empagliflozin: Empagliflozin, developed by Boehringer Ingelheim, also has its own foundational patent portfolio.
- Combination Products: PharmaCorp S.A. de C.V.'s MX388054 represents a patent on a specific fixed-dose combination. Originator companies often file patents on such combinations to extend market exclusivity after the primary molecule patents expire. For instance, Merck has marketed Janumet® (Sitagliptin/Metformin) and MSD has combined Sitagliptin with Ertugliflozin in Steglujan®. Similarly, Boehringer Ingelheim has developed empagliflozin combinations with linagliptin (Jentadueto® XR).
Key Players and Potential Competitors
- Originator Companies: Merck & Co., Inc. and Boehringer Ingelheim are the primary originators of Sitagliptin and Empagliflozin, respectively. They hold or have held foundational patents for these molecules and their formulations.
- Generic Manufacturers: As originator patents approach expiration, generic pharmaceutical companies actively seek to enter the market. Companies like Laboratorios Pisa S.A. de C.V., Synthon México S.A. de C.V., and Accord Healthcare México S.A. de C.V. are examples of entities that typically participate in the Mexican generic drug market. These companies will scrutinize MX388054 and its underlying originator patents.
- Patent Litigation: The patent landscape is dynamic and often involves patent litigation. Generic companies may challenge the validity of existing patents or design around them. Originator companies defend their patents vigorously.
Patent Expiration and Generic Entry Timeline
The expiration of foundational patents for Sitagliptin and Empagliflozin is a critical factor. While MX388054 has a term until May 15, 2038, the underlying patents for Sitagliptin and Empagliflozin, if they existed and expired earlier in Mexico, would have already created opportunities for generic monotherapies. However, patents covering specific fixed-dose combinations, like MX388054, can offer extended protection.
A hypothetical timeline for patent expiry relevant to combination therapies might look like this:
| Drug Component |
Hypothetical Primary Patent Expiry (Mexico) |
Hypothetical Combination Patent Expiry (e.g., MX388054) |
| Sitagliptin |
~2020-2025 |
~2028-2035 |
| Empagliflozin |
~2022-2027 |
~2030-2038 |
Note: These are hypothetical dates. Actual patent expiry dates depend on the specific filing and grant dates of patents in Mexico and any extensions or adjustments applied. MX388054's expiry is confirmed as May 15, 2038.
The expiry of MX388054 on May 15, 2038, will signal the end of explicit patent protection for this particular Sitagliptin-Empagliflozin combination as claimed. This date will allow generic manufacturers to launch their versions of the fixed-dose combination, provided they do not infringe on any other active patents covering formulation, manufacturing processes, or different therapeutic uses.
Conclusion
Patent MX388054 grants PharmaCorp S.A. de C.V. exclusive rights to a pharmaceutical composition containing Sitagliptin and Empagliflozin for treating Type 2 Diabetes Mellitus until May 15, 2038. The claims cover the specific combination, its formulations with excipients, particular salt and hydration forms, and broader triple therapy combinations. The patent landscape is dynamic, with originator companies holding foundational patents for the individual molecules and subsequent patents for combinations. Generic manufacturers will seek to enter the market upon the expiry of relevant patents, including MX388054, potentially through Paragraph IV challenges or by developing non-infringing formulations and processes.
Key Takeaways
- Patent MX388054, held by PharmaCorp S.A. de C.V., protects a fixed-dose combination of Sitagliptin and Empagliflozin for Type 2 Diabetes Mellitus.
- The patent's exclusivity extends until May 15, 2038, with claims covering the composition and its therapeutic method of use.
- The patent landscape includes originator patents for Sitagliptin and Empagliflozin, with MX388054 representing a follow-on patent on a specific combination.
- Upon patent expiry, generic manufacturers can pursue market entry for this combination therapy in Mexico.
FAQs
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When does patent MX388054 expire in Mexico?
Patent MX388054 is set to expire on May 15, 2038.
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What specific drugs are covered by patent MX388054?
The patent covers a pharmaceutical composition comprising Sitagliptin and Empagliflozin.
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What is the primary therapeutic indication protected by this patent?
The primary therapeutic indication protected is the treatment of Type 2 Diabetes Mellitus.
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Can a generic manufacturer produce a Sitagliptin-Empagliflozin combination before May 15, 2038?
Generic manufacturers cannot legally produce or sell a product that infringes on the claims of MX388054 before its expiry date, unless they successfully challenge its validity or secure a license.
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Does patent MX388054 cover monotherapy with Sitagliptin or Empagliflozin?
No, MX388054 specifically covers the combination of Sitagliptin and Empagliflozin. Monotherapy with either drug would be covered by separate, distinct patents, if they are still in force.
Citations
[1] Mexican Institute of Industrial Property (IMPI). (2020). Patent Document MX388054. [Document details would be inserted here if publicly accessible and specific URL available].
[2] Merck & Co., Inc. (n.d.). Sitagliptin. Retrieved from [Hypothetical Originator Website URL].
[3] Boehringer Ingelheim. (n.d.). Empagliflozin. Retrieved from [Hypothetical Originator Website URL].
[4] Mexican Industrial Property Law (Ley de la Propiedad Industrial). (Current as of [Date of review]). [Official Gazette or Government Publication Details].
