United States Patent 7,078,381: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,078,381, titled "Method of regulating glucose metabolism, and reagents related thereto," is a significant patent in the field of diabetes treatment. This patent, issued to various assignees including pharmaceutical companies, outlines methods and compositions for modifying glucose metabolism and treating Type II diabetes.
Background
Type II diabetes is a chronic condition characterized by insulin resistance and impaired insulin secretion. The treatment often involves medications that enhance insulin sensitivity or increase insulin production. The patent in question addresses this need by providing innovative methods and reagents.
Scope of the Patent
The patent covers a broad range of methods and compositions aimed at regulating glucose metabolism. Here are the key aspects:
Methods for Regulating Glucose Metabolism
The patent describes methods for treating Type II diabetes by inhibiting the enzyme Dipeptidyl Peptidase 4 (DPP-4). DPP-4 inhibitors are known to increase the levels of incretin hormones, which in turn enhance insulin release and decrease glucagon levels, thereby improving glucose metabolism[1].
Compositions and Reagents
The patent includes detailed descriptions of various chemical compounds and their derivatives that can be used as DPP-4 inhibitors. These compounds are categorized into several chemical groups, including alkenyl, alkyl, alkynyl, aryl, and heterocyclic groups. The patent also specifies the synthesis and purification methods for these compounds[1].
Claims of the Patent
The patent contains multiple claims that define the scope of the invention. Here are some key claims:
Independent Claims
- Claim 1: A method for treating Type II diabetes in an animal, comprising administering a DPP-4 inhibitor.
- Claim 10: A pharmaceutical composition comprising a DPP-4 inhibitor and a pharmaceutically acceptable carrier.
Dependent Claims
- Claim 2: The method of claim 1, wherein the DPP-4 inhibitor is selected from a group of specified chemical compounds.
- Claim 11: The pharmaceutical composition of claim 10, wherein the DPP-4 inhibitor is in a specific dosage form[1].
Patent Landscape
The patent landscape surrounding US 7,078,381 is complex and involves several related patents and legal disputes.
Related Patents
The patent is part of a larger family of patents related to DPP-4 inhibitors. Other patents in this family include US 6,890,898, US 7,407,955, and US 7,459,428, which also deal with methods and compositions for treating diabetes using similar mechanisms[2][5].
Litigation and Legal Status
The patent has been involved in several legal disputes. For instance, Merck Sharp & Dohme Corp. has sought declaratory judgments of non-infringement and invalidity against various patent holders, including those related to this patent. These disputes highlight the competitive nature of the pharmaceutical industry and the importance of patent protection[5].
Expiration and Licensing
The patent expired on February 2, 2019, which has significant implications for generic drug manufacturers. Prior to its expiration, the patent was subject to paragraph IV certifications under the FD&C Act, indicating that generic manufacturers believed the patent to be invalid, unenforceable, or not infringed by their products[2].
Impact on the Pharmaceutical Industry
The expiration of US 7,078,381 has opened up the market for generic versions of DPP-4 inhibitors. This has increased competition and potentially lowered the cost of these medications for patients.
Generic Approvals
Following the expiration of the patent, several generic drug manufacturers have received tentative approvals from the FDA to market their versions of DPP-4 inhibitors. This includes approvals for Linagliptin Tablets, which are used to treat Type II diabetes[2].
Conclusion and Future Implications
US 7,078,381 has played a crucial role in the development and commercialization of DPP-4 inhibitors for the treatment of Type II diabetes. As the patent landscape continues to evolve, it is essential for pharmaceutical companies to navigate these complexities to ensure innovation and access to life-saving medications.
Key Takeaways
- Innovative Methods: The patent introduces novel methods for regulating glucose metabolism using DPP-4 inhibitors.
- Comprehensive Claims: The patent includes detailed claims covering various chemical compounds and their uses.
- Legal Disputes: The patent has been involved in significant legal disputes regarding its validity and infringement.
- Expiration and Generic Impact: The expiration of the patent has led to increased competition and the availability of generic versions of DPP-4 inhibitors.
- Future Implications: The patent landscape will continue to influence the development and accessibility of diabetes treatments.
Frequently Asked Questions (FAQs)
What is the primary focus of US 7,078,381?
The primary focus of US 7,078,381 is on methods and compositions for regulating glucose metabolism, specifically through the inhibition of the DPP-4 enzyme to treat Type II diabetes.
What are the key chemical groups mentioned in the patent?
The patent mentions several chemical groups, including alkenyl, alkyl, alkynyl, aryl, and heterocyclic groups, which are used to describe the DPP-4 inhibitors.
What is the legal status of US 7,078,381?
US 7,078,381 has expired as of February 2, 2019.
How has the expiration of the patent affected the pharmaceutical industry?
The expiration has led to the approval and marketing of generic versions of DPP-4 inhibitors, increasing competition and potentially reducing costs for patients.
What are some related patents in this family?
Related patents include US 6,890,898, US 7,407,955, and US 7,459,428, all of which deal with similar mechanisms for treating diabetes.
Cited Sources:
- US7078381B2 - Method of regulating glucose metabolism, and reagents related thereto - Google Patents
- ANDA 208472 ANDA TENTATIVE APPROVAL - accessdata.fda.gov
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- Case 1:15-cv-00757-UNA Document 1 Filed 08/28/15 - RPX Insight
