United States Patent 7,297,761: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,297,761, hereafter referred to as the '761 patent, is a significant intellectual property asset in the pharmaceutical sector. This patent covers specific aspects of drug composition and methodology, which are crucial for understanding its scope, claims, and the broader patent landscape.
Background and Issuance
The '761 patent was issued on November 13, 2007, by the United States Patent and Trademark Office (USPTO). It is part of a larger family of patents related to pharmaceutical compositions and methods of administration[5].
Scope of the Patent
Subject Matter
The '761 patent pertains to the composition and formulation of certain pharmaceutical compounds. Specifically, it covers methods and compositions related to glucagon-like peptide-1 (GLP-1) agonists, which are used in the treatment of diabetes and other metabolic disorders. The patent describes specific formulations, dosing regimens, and methods of administration that enhance the efficacy and stability of these compounds[5].
Claims
The patent includes multiple claims that define the scope of the invention. These claims can be broadly categorized into:
- Composition Claims: These claims describe the specific formulations of the GLP-1 agonists, including the active ingredients, excipients, and other components.
- Method Claims: These claims outline the methods of preparing the formulations, methods of administration, and dosing regimens.
- Use Claims: These claims specify the therapeutic uses of the compositions, such as the treatment of diabetes and related conditions[5].
Patent Claims Analysis
Claim Structure
The claims in the '761 patent are structured to provide broad protection while also being specific enough to distinguish the invention from prior art. For example, Claim 1 might describe a pharmaceutical composition comprising a GLP-1 agonist, a solvent, and a stabilizer, while subsequent claims might narrow down the specific types of solvents or stabilizers used.
Dependency and Scope
Some claims are dependent on earlier claims, meaning they build upon the descriptions provided in those earlier claims. This structure helps in defining a clear hierarchy of invention scope, from broad to narrow. For instance, a dependent claim might specify a particular concentration of the GLP-1 agonist that is covered under the broader composition claim[5].
Patent Landscape
Related Patents
The '761 patent is part of a larger patent family that includes other related patents such as U.S. Patents 7,348,404 and 7,407,932. These patents collectively cover various aspects of GLP-1 agonists, including different formulations, methods of administration, and therapeutic uses. Understanding the relationships between these patents is crucial for navigating the intellectual property landscape in this field[1].
Litigation and Enforcement
Patents like the '761 patent are often involved in litigation, particularly when generic or biosimilar versions of the drugs are developed. For example, patent infringement cases may arise when a generic manufacturer seeks to enter the market before the expiration of the patent. The litigation landscape around such patents can be complex, involving multiple parties and legal challenges to the validity and enforceability of the patent claims[2].
Expiration and Extension
Original Expiration Date
The original expiration date of the '761 patent would typically be 20 years from the date of filing, unless extended. However, patent term extensions can be granted under certain conditions, such as delays in regulatory approval processes. For instance, under 35 U.S.C. § 156, a patent term extension can be granted to compensate for time spent in regulatory review, but this extension is subject to various limitations, including a maximum extension of five years[1].
Impact on the Pharmaceutical Industry
Market Protection
The '761 patent provides significant market protection for the innovator company, preventing generic or biosimilar competitors from entering the market until the patent expires. This protection allows the innovator to recoup investment in research and development and maintain market exclusivity.
Innovation and Competition
While the patent protects the innovator, it also encourages further innovation by providing a financial incentive for research and development. However, it can also limit competition, potentially affecting the availability and affordability of the drug for patients.
Key Takeaways
- Scope and Claims: The '761 patent covers specific compositions and methods related to GLP-1 agonists, with claims structured to provide broad and specific protection.
- Patent Landscape: The patent is part of a larger family of related patents and is subject to litigation and enforcement challenges.
- Expiration and Extension: The patent's expiration date can be extended under certain conditions, but is subject to limitations.
- Industry Impact: The patent provides market protection, encourages innovation, but can also limit competition.
FAQs
What is the primary subject matter of U.S. Patent 7,297,761?
The primary subject matter of U.S. Patent 7,297,761 is the composition and formulation of glucagon-like peptide-1 (GLP-1) agonists used in the treatment of diabetes and other metabolic disorders.
How are the claims in the '761 patent structured?
The claims are structured to provide broad protection while also being specific enough to distinguish the invention from prior art, with some claims being dependent on earlier claims.
Can the term of the '761 patent be extended?
Yes, the term of the '761 patent can be extended under certain conditions, such as delays in regulatory approval processes, but this extension is subject to various limitations, including a maximum extension of five years.
What is the impact of the '761 patent on the pharmaceutical industry?
The patent provides significant market protection for the innovator company, encourages further innovation, but can also limit competition and affect the availability and affordability of the drug for patients.
How does the '761 patent relate to other patents in the same field?
The '761 patent is part of a larger patent family that includes other related patents, collectively covering various aspects of GLP-1 agonists, including different formulations, methods of administration, and therapeutic uses.
Sources
- USPTO Document: "IN THE UNITED STATES PATENT AND TRADEMARK OFFICE" - [PDF][1]
- Case 1:15-cv-01139-UNA Document 1: "Patent Infringement Case" - [PDF][2]
- USPTO Patent Claims Research Dataset: "Patent Claims Research Dataset" - [USPTO][3]
- USPTO Search: "Search for patents - USPTO" - [USPTO][4]
- DrugPatentWatch: "Drugs covered by patent 7,297,761" - [DrugPatentWatch][5]
