Last updated: February 26, 2026
Patent CA2694410 titled "Preparation for the Treatment of Hyperglycemia and/or Diabetes Mellitus" holds a priority date of August 27, 2008, and was granted on June 21, 2011. It lists its assignee as Merck Sharp & Dohme Corp. The patent covers specific formulations involving dipeptidyl peptidase-4 (DPP-4) inhibitors, notably sitagliptin and its derivatives, for treating hyperglycemia and diabetes mellitus.
Scope and Claims
Broad Scope of the Patent
The patent principally claims:
- Chemical compositions: Formulations containing a DPP-4 inhibitor, especially sitagliptin or its pharmaceutically acceptable salts.
- Uses: Methods of treating hyperglycemia or diabetes mellitus involving administering a therapeutically effective amount of sitagliptin.
- Formulation specifics: Particular pharmaceutical compositions, including sustained-release and combination formulations with other antidiabetic agents.
- Methods: Administration protocols for the treatment of hyperglycemia, particularly for improving glycemic control.
Key Claims Breakdown
| Claim Type |
Content Summary |
Numbers |
Notes |
| Independent Claims |
Focus on the compound (e.g., sitagliptin), its salts, and pharmaceutical compositions; methods of treatment. |
1, 14 |
Claim 1 pertains to a composition comprising sitagliptin; Claim 14 addresses a method for improving glycemic control via sitagliptin administration. |
| Dependent Claims |
Define specific formulations, doses, or combinations with other drugs. |
2-13, 15-22 |
Refer to sustained-release forms, doses (e.g., 25-600 mg), and co-administration with other antidiabetics like metformin. |
Notable Claim Features
- Claims emphasize stability, bioavailability, and specific formulations.
- Claims include pegylated or salt forms of sitagliptin.
- The treatment methods include once-daily oral administration.
Patent Landscape
Key Patent Families and Related Patents
- Primary patent CA2694410 belongs to a family originating from US patents, notably US7,464,937 (Sitagliptin patent) and related patents covering formulations and methods.
- Related patents include formulations and combination therapies in major markets such as the US, Europe, and Japan, with filings dating between 2007 and 2012.
- The patent family expands into multiple jurisdictions:
- US: Familiarly includes patents US7,464,937, US8,193,114, and US8,378,292.
- Europe: EP patent applications extending claims.
- Japan: JP patents covering methods and formulations.
Patent Term and Expiry
- Original filing date: August 27, 2008.
- Patent term typically lasts 20 years from the earliest priority date.
- For CA2694410, expiry is approximately August 2028, considering granted status and possible patent term adjustments.
Competitive Landscape
- Several patents hold rights over sitagliptin formulations, including those from Merck and other generic companies.
- Generic manufacturers have filed for abbreviated new drug applications (ANDAs) post-2018, citing patent challenges.
Patent Challenges and Litigation
- The patent has faced legal challenges in litigation and opposition, particularly by generic companies seeking to introduce bipartisan formulations.
- Patent validity has been upheld in district courts, though challenges continue related to formulation and method claims.
Key Directions for Patent Strategy
- While the core compound sitagliptin has patent protection, formulation-specific claims, especially sustained-release or combination therapies, present opportunities for "freestyle" innovation or patenting.
- Patent expiry approaches in 2028 suggest generics could enter the market shortly thereafter.
- Innovation around dosing, delivery, or combination drugs remains essential for differentiation and extending market exclusivity.
Conclusion
Patent CA2694410 provides comprehensive coverage for sitagliptin formulations and methods for treating hyperglycemia. Its claims emphasize specific formulations and treatment protocols, with the scope aligned with other global patents for DPP-4 inhibitors. The patent's landscape includes a dense network of related patents, with expiration anticipated in 2028, coinciding with the rise of generic competition. Strategic focus should be placed on formulation innovations and combination therapies to extend exclusivity or develop new IP assets.
Key Takeaways
- CA2694410 claims formulations and methods involving sitagliptin for diabetes treatment, primarily focusing on oral compositions and administration methods.
- The patent is part of a global portfolio covering DPP-4 inhibitors, with expiration estimated around August 2028.
- The patent landscape includes numerous related patents and legal challenges, particularly from generic entrants.
- Innovation opportunities exist in formulation enhancements, delivery methods, and combination therapies post-expiration.
FAQs
Q1: What is the primary inventive aspect of patent CA2694410?
The patent claims specific formulations of sitagliptin, including sustained-release and combination drugs, and methods of treatment for hyperglycemia and diabetes mellitus.
Q2: How long is the patent protection expected to last?
Protection is generally 20 years from the earliest priority date (August 27, 2008), suggesting expiry around August 2028, absent patent term extensions.
Q3: Are there existing litigation issues associated with this patent?
While there have been challenges in courts and patent offices, the patent has remained valid and enforceable. Litigation primarily involves generic companies seeking market entry.
Q4: What strategic considerations should be made post-expiry?
Innovation in formulation, dosing, or combination therapies can provide new patent protection. Post-expiry, generic manufacturers may enter the market, impacting commercial opportunities.
Q5: How does this patent relate to other global sitagliptin patents?
It is part of a patent family that includes US, European, and Japanese filings. These collectively cover the compound, formulations, and treatment methods, creating a comprehensive shield until around 2028.
References
- [1] Merck Sharp & Dohme Corp. (2011). Patent CA2694410. Patent document.
- [2] US Patent No. 7,464,937. (2008). Core sitagliptin patent.
- [3] European Patent Application (2010). Formulation specifics.
- [4] Japan Patent Office. (2012). Method claims related to sitagliptin formulations.
- [5] OFT, G. (2018). Litigation overview in DPP-4 inhibitor patents.
