Understanding the Scope and Claims of United States Patent 7,407,955
Introduction
The United States Patent 7,407,955, hereafter referred to as the '955 patent, is a critical component of the patent landscape surrounding the pharmaceutical compound linagliptin, used in the treatment of type 2 diabetes. This analysis will delve into the scope, claims, and the broader patent landscape associated with this patent.
Patent Overview
The '955 patent, titled "8-[3-amino-piperidin-1-yl]-xanthines," was issued to Boehringer Ingelheim Pharmaceuticals, Inc. and pertains to a class of substituted xanthines. These compounds are significant in the context of diabetes treatment due to their role as dipeptidyl peptidase-4 (DPP-4) inhibitors[5].
Claim Construction
Claim construction is a crucial aspect of patent law, as it defines the scope of what is protected by the patent. Here are some key points regarding the claim construction of the '955 patent:
Claim Language
The patent includes multiple claims that define the chemical structure and properties of the substituted xanthines. Claims 1 to 16 specify various aspects of the compounds, including the general formula and the definitions of the substituents R1 to R3[5].
Context and Specification
The meaning of claim terms is often derived from the context in which they are used within the patent specification. The specification serves as the single best guide to the meaning of disputed terms, as it may include definitions or clarifications provided by the patentee[1].
Scope of Protection
The scope of the '955 patent is defined by its claims and the specification.
Chemical Structure
The patent protects specific chemical structures of substituted xanthines, which are essential for their function as DPP-4 inhibitors. This specificity ensures that the patent does not overly broaden the scope of protection, which could lead to disputes over patent quality and validity[3].
Method of Use
While the '955 patent itself does not claim methods of use, it is part of a broader portfolio that includes method-of-use patents. For example, other related patents like the '927 and '695 patents claim methods of treating type 2 diabetes using linagliptin, often in combination with other drugs like metformin or insulin[2][4].
Patent Expiration and Litigation
Expiration Date
The '955 patent is set to expire on May 2, 2025, marking the end of its exclusive protection period[2].
Litigation
The '955 patent has been involved in litigation related to generic drug approvals. For instance, Boehringer Ingelheim initiated litigation against generic drug manufacturers like Zydus and Dr. Reddy's Laboratories Limited for infringement of this and other related patents[2][4].
Broader Patent Landscape
The '955 patent is part of a complex patent landscape surrounding linagliptin and its use in treating type 2 diabetes.
Related Patents
Other patents such as the '648, '927, '695, '156, and '859 patents are also crucial in this landscape. These patents cover various aspects, including different methods of use and combinations with other drugs. The '648 patent, for example, pertains to the use of linagliptin in combination with insulin, while the '695 patent covers a broader range of treatment methods[2][4].
Patent Quality and Scope
The debate over patent quality often centers on the breadth and clarity of patent claims. Metrics such as independent claim length and count can be used to measure patent scope. In the case of the '955 patent, the specificity of the chemical structures and the clear definitions within the specification help to maintain a balanced scope that does not overly broaden the protection[3].
Regulatory Environment
The FDA plays a significant role in the approval process of generic drugs, which often involves navigating the patent landscape.
ANDA Filings
Generic drug manufacturers must file Abbreviated New Drug Applications (ANDAs) and address any relevant patents listed in the FDA's Orange Book. For the '955 patent, generic manufacturers have submitted paragraph IV certifications, arguing that the patent is invalid, unenforceable, or will not be infringed by their products[2][4].
Key Takeaways
- Specificity in Claims: The '955 patent's claims are specific to the chemical structures of substituted xanthines, ensuring a clear scope of protection.
- Broader Patent Portfolio: The patent is part of a larger portfolio that includes method-of-use patents, such as the '927 and '695 patents.
- Litigation and Expiration: The patent has been involved in litigation and is set to expire on May 2, 2025.
- Regulatory Compliance: Generic drug manufacturers must navigate the patent landscape, including addressing the '955 patent in their ANDA filings.
FAQs
Q: What is the main subject of the '955 patent?
A: The '955 patent pertains to substituted xanthines, specifically those used as DPP-4 inhibitors in the treatment of type 2 diabetes.
Q: When is the '955 patent set to expire?
A: The '955 patent is set to expire on May 2, 2025.
Q: What other patents are related to the '955 patent in the context of linagliptin?
A: Other related patents include the '648, '927, '695, '156, and '859 patents, which cover various methods of use and combinations with other drugs.
Q: How do generic drug manufacturers address the '955 patent in their ANDA filings?
A: Generic manufacturers submit paragraph IV certifications, arguing that the patent is invalid, unenforceable, or will not be infringed by their products.
Q: What role does the FDA play in the approval process of generic drugs related to the '955 patent?
A: The FDA requires generic manufacturers to address any relevant patents listed in the Orange Book, including the '955 patent, as part of their ANDA filings.
Sources
- Boehringer Ingelheim Pharms., Inc. v. Hec Pharm Co. - Casetext
- Linagliptin Tablets - FDA
- Patent Claims and Patent Scope - Hoover Institution
- Linagliptin Tablets - FDA
- US-7407955-B2 - Unified Patents Portal
