United States Patent 10,925,871: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,925,871, titled "Pharmaceutical Compositions of Sitagliptin," is a significant patent in the pharmaceutical industry, particularly for the treatment of diabetes. This patent, assigned to CADILA HEALTHCARE LIMITED, covers stable oral pharmaceutical compositions of sitagliptin base and the processes for their preparation. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is widely used in the treatment of type 2 diabetes. The patent builds upon earlier work, including U.S. Pat. No. 6,699,871, which disclosed processes for the preparation of sitagliptin hydrochloride salt, and various PCT publications that detail different crystalline and amorphous forms of sitagliptin[1][4].
Field of the Invention
The patent specifically focuses on stable oral pharmaceutical compositions of sitagliptin base. This is crucial because the stability of the active pharmaceutical ingredient (API) is essential for ensuring the efficacy and safety of the drug. The invention encompasses various formulations and processes that enhance the stability of sitagliptin[1][4].
Detailed Description of the Invention
Stable Oral Pharmaceutical Compositions
The patent describes several stable oral pharmaceutical compositions of sitagliptin base. These compositions are formulated to maintain the stability of sitagliptin, which is prone to degradation under certain conditions. The compositions may include various excipients, such as fillers, binders, and lubricants, which are selected to ensure the stability and bioavailability of the drug[1][4].
Processes for Preparation
The patent outlines multiple processes for preparing these stable compositions. These processes include methods for synthesizing sitagliptin base, forming crystalline or amorphous forms, and combining the API with appropriate excipients. For example, PCT Publication No. WO 2009/120746, referenced in the patent, discloses processes for preparing crystalline forms of sitagliptin phosphate characterized by specific powder XRD patterns[4].
Claims of the Patent
The patent includes seven claims that define the scope of the invention.
Claim 1
Claim 1 is the broadest claim and describes a stable oral pharmaceutical composition comprising sitagliptin base and at least one excipient. This claim sets the foundation for the subsequent claims, which further specify the composition and process details[4].
Subsequent Claims
The subsequent claims narrow down the scope by specifying particular excipients, their proportions, and the methods of preparation. For instance, Claim 2 might specify a composition with a particular filler and binder, while Claim 3 could detail a specific process for synthesizing the sitagliptin base[4].
Patent Scope and Claim Construction
Claim Construction
When interpreting the claims of this patent, courts would consider the literal language of the claim, the patent specification, and the prosecution history. This approach is in line with established patent law principles, such as those outlined in Phillips v. AWH Corp. and Markman v. Westview Instruments, Inc.[5].
Patent Scope
The scope of the patent is defined by the claims and is influenced by the background and detailed description. The patent's scope is relatively narrow, focusing specifically on stable oral compositions of sitagliptin base and their preparation processes. This narrow scope helps in avoiding potential overlaps with other patents and reduces the risk of litigation[1][4].
Patent Landscape
Related Patents
Several other patents and PCT publications are relevant to this invention. For example, U.S. Pat. No. 7,326,708 and U.S. Pat. No. 8,414,921, which were involved in a multi-district litigation, cover different aspects of sitagliptin formulations and processes. These patents highlight the complex and evolving nature of the patent landscape in the pharmaceutical industry[5].
Patent Expiry and Generic Launch
The patent US10925871 is set to expire in February 2035. The expiry date can be affected by various legal activities such as term extensions, amendments, or abandonments. Tracking these activities is crucial for understanding when generic versions of the drug might become available[2].
Legal Activities and Patent Maintenance
The patent has undergone several critical legal activities, including the recordation of the patent grant, issue notification, and issue fee payments. These activities are important milestones in the patent's lifecycle and ensure that the patent remains active and enforceable[2].
Industry Impact
Innovation and Competition
The patent's focus on stable oral compositions of sitagliptin base contributes to innovation in diabetes treatment. However, it also creates a barrier to entry for generic manufacturers until the patent expires. This balance between innovation and competition is a key aspect of the patent system[1][4].
Economic Considerations
The economic implications of this patent are significant. The exclusivity provided by the patent allows CADILA HEALTHCARE LIMITED to recoup its investment in research and development. However, it also means that patients may have limited access to more affordable generic alternatives until the patent expires[2].
Key Takeaways
- Stable Compositions: The patent focuses on stable oral pharmaceutical compositions of sitagliptin base.
- Processes: It outlines various processes for preparing these compositions.
- Claims: The patent includes seven claims that define the scope of the invention.
- Patent Scope: The scope is narrow, focusing on specific compositions and processes.
- Patent Landscape: The patent is part of a complex landscape involving other related patents.
- Expiry and Generic Launch: The patent is set to expire in February 2035, which will impact the availability of generic versions.
FAQs
Q: What is the main focus of United States Patent 10,925,871?
A: The main focus is on stable oral pharmaceutical compositions of sitagliptin base and the processes for their preparation.
Q: Who is the assignee of this patent?
A: The assignee is CADILA HEALTHCARE LIMITED.
Q: What is the expiry date of this patent?
A: The patent is set to expire in February 2035.
Q: How does the patent impact the availability of generic versions of sitagliptin?
A: The patent prevents the launch of generic versions until its expiry in February 2035.
Q: What are some of the key legal activities associated with this patent?
A: These include recordation of the patent grant, issue notification, and issue fee payments.
Sources
- Justia Patents: Pharmaceutical compositions of sitagliptin - Justia Patents
- Pharsight - GreyB: Zituvio patent expiration
- Hoover Institution: Patent Claims and Patent Scope
- Google Patents: United States Patent - googleapis.com
- Casetext: In re Sitagliptin Phosphate ('708 & '921) Patent Litig.
