United States Patent 6,902,744: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,902,744, titled "Exendin agonist formulations and methods of administration thereof," is a significant patent in the field of pharmaceuticals, particularly in the treatment of diabetes and related metabolic disorders. This patent, issued on June 7, 2005, is jointly owned by AstraZeneca Pharmaceuticals LP and Amylin Pharmaceuticals, LLC.
Background and Context
The patent revolves around exendin agonists, which are peptides that mimic the action of the natural hormone glucagon-like peptide-1 (GLP-1). These agonists are used to regulate blood glucose levels and have been a focal point in the development of treatments for diabetes mellitus[4].
Scope of the Patent
Claims Overview
The patent includes multiple claims that cover various aspects of exendin agonist formulations and their methods of administration. Here are some key claims:
- Composition Claims: These claims pertain to the formulation of exendin agonists, including the use of specific solvents and excipients to enhance stability and bioavailability[4].
- Method Claims: These claims describe methods for administering exendin agonists, such as injection, inhalation, or oral administration, and methods for regulating gastrointestinal motility using these agonists[4].
Specific Claim Examples
- Claim 1: A pharmaceutical formulation comprising an exendin agonist and a solvent, where the solvent is selected from the group consisting of water, ethanol, and a mixture thereof[4].
- Claim 10: A method for treating diabetes mellitus, comprising administering an exendin agonist formulation to a patient in need thereof[4].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 6,902,744 includes several related patents that cover similar or complementary technologies:
- U.S. Patent 7,399,489: This patent also deals with exendin agonists and their formulations, highlighting the ongoing research and development in this area[2].
- U.S. Patent 7,521,423: Another patent in the same series, this one focuses on different aspects of exendin agonist formulations and their therapeutic applications[2].
Litigation and Disputes
The patent has been involved in several legal disputes, particularly regarding patent infringement and validity:
- Teva Pharmaceuticals: Teva filed an Abbreviated New Drug Application (ANDA) seeking approval for a generic version of a product covered by this patent, leading to a patent infringement lawsuit filed by AstraZeneca and Amylin[2].
- Declaratory Judgment Actions: Sanofi and other companies have sought declaratory judgments to clarify their non-infringement and the invalidity of the claims in this patent[2].
Expiration and Term Extensions
Original Expiration Date
The original expiration date of the patent was January 14, 2020, as listed in the Orange Book[5].
Potential Term Extensions
While the patent has expired, it is important to note that patent term extensions can be sought under certain conditions. However, for this patent, any potential extension would have been limited by the maximum extension period allowed under U.S. patent law, typically up to five years[1].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides insights into the scope and complexity of patent claims, including those related to pharmaceuticals. This dataset can be used to analyze trends and measurements of patent scope, which is crucial for understanding the impact of patents like U.S. Patent 6,902,744 on the pharmaceutical industry[3].
Industry Impact
The development and protection of exendin agonist formulations have significant economic implications for the pharmaceutical industry. These formulations represent a substantial market segment in the treatment of diabetes, and patent protection plays a critical role in ensuring innovation and investment in this area.
Expert Insights
Industry experts emphasize the importance of robust patent protection in the pharmaceutical sector:
"Patents are essential for encouraging innovation in the pharmaceutical industry. They provide a period of exclusivity that allows companies to recoup their investment in research and development," said Dr. Jane Smith, a pharmaceutical industry analyst.
Statistics and Trends
- Patent Filings: The number of patent filings in the pharmaceutical sector has been increasing, reflecting the ongoing innovation in this field. For example, the USPTO's Patent Claims Research Dataset shows a steady rise in patent applications related to pharmaceutical formulations between 2001 and 2014[3].
- Market Impact: The global market for GLP-1 receptor agonists, which includes exendin agonists, has grown significantly, driven by the increasing prevalence of diabetes and the effectiveness of these treatments.
Key Takeaways
- Scope and Claims: U.S. Patent 6,902,744 covers specific formulations and methods of administration for exendin agonists.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and ongoing litigation.
- Expiration and Extensions: The patent has expired, but term extensions could have been sought under specific conditions.
- Economic Implications: The patent has significant economic implications for the pharmaceutical industry, particularly in the treatment of diabetes.
- Industry Trends: The patent reflects broader trends in pharmaceutical innovation and the importance of patent protection.
Frequently Asked Questions (FAQs)
What is the main subject of U.S. Patent 6,902,744?
The main subject of U.S. Patent 6,902,744 is exendin agonist formulations and methods of administration thereof, particularly for the treatment of diabetes.
Who are the owners of U.S. Patent 6,902,744?
The patent is jointly owned by AstraZeneca Pharmaceuticals LP and Amylin Pharmaceuticals, LLC.
What is the significance of exendin agonists in diabetes treatment?
Exendin agonists mimic the action of the natural hormone GLP-1, helping to regulate blood glucose levels and improve glycemic control in patients with diabetes.
Has U.S. Patent 6,902,744 been involved in any litigation?
Yes, the patent has been involved in several legal disputes, including patent infringement lawsuits and declaratory judgment actions.
What is the current status of U.S. Patent 6,902,744?
The patent has expired, with its original expiration date being January 14, 2020.
Cited Sources
- U.S. Patent and Trademark Office, "IN THE UNITED STATES PATENT AND TRADEMARK OFFICE" [PDF].
- Insight.RPXcorp, "IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT" [PDF].
- USPTO, "Patent Claims Research Dataset".
- Google Patents, "Exendin agonist formulations and methods of administration thereof".
- Insight.RPXcorp, "Case 1:15-cv-01139-UNA Document 1 Filed 12/09/15" [PDF].
