Details for Patent: 5,424,286

Summary for Patent: 5,424,286

Title:	Exendin-3 and exendin-4 polypeptides, and pharmaceutical compositions comprising same
Abstract:	This invention encompasses pharmaceutical compositions containing exendin-3 or exendin-4, fragments thereof, or any combination thereof, and methods for the treatment of diabetes mellitus and the prevention of hyperglycemia.
Inventor(s):	Eng; John (Bronx, NY)
Assignee:
Application Number:	08/066,480
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

United States Patent 5,424,286: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 5,424,286, titled "Exendin-3 and exendin-4 polypeptides, and pharmaceutical compositions comprising same," is a significant patent in the field of pharmaceuticals, particularly in the area of diabetes treatment. This patent, issued to Amylin Pharmaceuticals, Inc., covers innovative compositions and methods related to exendin polypeptides. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Scope of the Patent

The patent focuses on exendin-3 and exendin-4 polypeptides, which are insulinotropic agents used in the treatment of diabetes. These polypeptides are analogs of the glucagon-like peptide-1 (GLP-1), a natural hormone that enhances insulin secretion in response to elevated blood glucose levels.

Key Components

• Exendin-3 and Exendin-4 Polypeptides: The patent describes the structure and function of these polypeptides, including their amino acid sequences and how they mimic the action of GLP-1[4].
• Pharmaceutical Compositions: The patent covers various pharmaceutical compositions containing these polypeptides, including formulations for administration and methods for their preparation[4].

Claims of the Patent

The patent includes several claims that define the scope of the invention.

Independent Claims

• Claim 1 describes the exendin-3 polypeptide with a specific amino acid sequence.
• Claim 2 describes the exendin-4 polypeptide with its specific amino acid sequence.
• Subsequent claims cover various aspects, including fragments of these polypeptides, combinations thereof, and pharmaceutical compositions containing them[4].

Dependent Claims

• These claims further specify the pharmaceutical compositions, including the types of formulations (e.g., injectable solutions) and methods of administration.
• They also cover the use of these polypeptides in treating conditions such as diabetes and other metabolic disorders[4].

Patent Landscape Analysis

To understand the broader context and impact of this patent, a patent landscape analysis is essential.

Defining Scope and Keywords

The analysis begins by defining the technology field and specific keywords related to exendin polypeptides, GLP-1 analogs, and diabetes treatment. This helps in identifying relevant patents and organizing them based on factors like filing date and assignee[3].

Search and Organize Patents

Using databases such as the USPTO's Patent Public Search, Google Patents, and international patent databases like the European Patent Office's esp@cenet, one can find and organize relevant patents. This includes visual aids like heat maps to illustrate the distribution of patents over time and by assignee[1][3].

Identify Trends and Key Players

The analysis reveals trends in patent filings, such as the increasing interest in GLP-1 analogs for diabetes treatment. Key players in this field include Amylin Pharmaceuticals, Inc., Boehringer Mannheim GmbH, and other pharmaceutical companies actively filing patents related to exendin polypeptides and their applications[3][4].

Analyze Citations and Evolution

Studying how patents reference each other helps in understanding the impact and development of the technology. For example, the citations in US 5,424,286 indicate its influence on subsequent patents related to exendin analogs and their therapeutic uses[3].

Generate Insights for Decisions

The analysis provides actionable insights for strategic decisions, such as evaluating the competitive landscape, identifying potential legal vulnerabilities, and assessing the strength of patent portfolios. This is crucial for companies looking to innovate or enter the market with similar or improved technologies[3].

Global Patent Family

The patent is part of a larger global patent family, with corresponding applications and grants in various countries.

International Filings

• The patent has corresponding international applications, such as WO1997046584A1 and WO1998030231A1, filed through the Patent Cooperation Treaty (PCT) route[4].

Country-Specific Grants

• Grants in countries like the United States, Europe, and Japan indicate the global reach and protection of this invention[4].

Legal Status and Extensions

The patent's legal status and any extensions are critical for understanding its current and future impact.

Expiration Date

• The original patent has expired, but extensions under 35 U.S.C. § 156, related to regulatory review periods, may have been sought to extend the patent term[2][5].

Regulatory Review Periods

• The extension calculations, as seen in the case of the reissued patent RE45,313, involve subtracting the regulatory review periods from the total review period to determine the extension length[2].

Key Takeaways

• Innovative Composition: US 5,424,286 covers innovative pharmaceutical compositions containing exendin-3 and exendin-4 polypeptides.
• Broad Claims: The patent includes comprehensive claims covering the polypeptides, their fragments, and pharmaceutical compositions.
• Global Impact: The patent is part of a global patent family with significant international filings and grants.
• Competitive Landscape: The patent landscape analysis reveals key players and trends in the field of diabetes treatment using GLP-1 analogs.
• Strategic Insights: The analysis provides valuable insights for strategic decisions in research, development, and legal protection.

FAQs

What are exendin-3 and exendin-4 polypeptides?

Exendin-3 and exendin-4 polypeptides are insulinotropic agents that mimic the action of the natural hormone GLP-1, enhancing insulin secretion in response to elevated blood glucose levels.

What is the significance of US 5,424,286 in the pharmaceutical industry?

US 5,424,286 is significant because it covers innovative compositions and methods related to exendin polypeptides, which are crucial in the treatment of diabetes.

How can a patent landscape analysis help in understanding this patent?

A patent landscape analysis helps in identifying trends, key players, and the competitive landscape in the field of diabetes treatment using GLP-1 analogs, providing actionable insights for strategic decisions.

What databases can be used to search for patents related to this technology?

Databases such as the USPTO's Patent Public Search, Google Patents, and international databases like the European Patent Office's esp@cenet can be used to search for relevant patents.

What is the current legal status of US 5,424,286?

The original patent has expired, but extensions may have been sought under 35 U.S.C. § 156 to extend the patent term.

Sources

1. USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
2. FDA Document. Retrieved from https://downloads.regulations.gov/FDA-2017-E-5040-0001/attachment_1.pdf
3. Goldstein Patent Law - How to Do Patent Landscape Analysis. Retrieved from https://www.goldsteinpatentlaw.com/how-to-patent-landscape-analysis/
4. Google Patents - Exendin-3 and exendin-4 polypeptides, and pharmaceutical compositions comprising same. Retrieved from https://patents.google.com/patent/US5424286A/en
5. USPTO - Certificate of Extension. Retrieved from https://www.uspto.gov/sites/default/files/web/offices/pac/dapp/opla/term/certs/5424286.pdf

Drugs Protected by US Patent 5,424,286

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate