United States Patent 8,119,648: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,119,648, hereafter referred to as the '648 patent, is a significant intellectual property asset in the pharmaceutical sector, particularly in the treatment of type 2 diabetes. This patent is part of a broader portfolio held by Boehringer Ingelheim Pharmaceuticals, Inc. Here, we will delve into the scope, claims, and the patent landscape surrounding this patent.
Patent Overview
The '648 patent, issued on August 12, 2011, is one of several patents related to methods for treating type 2 diabetes. It is part of a family of patents that include the '955, '927, '695, and '859 patents, among others[1][2].
Claim Construction
The claim construction of the '648 patent is crucial for understanding its scope. The patent involves methods for treating type 2 diabetes, and the claims are closely related to those in other patents such as the '859 and '927 patents. The Court has construed the claim term "A method of treating type 2 diabetes" in a way that applies uniformly across these patents. This construction is essential for determining the patent's validity and infringement[1].
Patent Claims
The '648 patent includes multiple claims, but the key claims revolve around methods for treating type 2 diabetes. These claims typically involve specific therapeutic regimens and the use of particular compounds. For instance, Claim 1 of the '859 patent, which is closely related, states:
- "A method of treating type 2 diabetes comprising administering a pharmaceutical composition containing a specific compound"[1].
Patent Expiration
The '648 patent is set to expire on August 12, 2023. This expiration date is significant as it marks the end of the exclusive rights held by the patent holder, allowing generic versions of the drug to enter the market[2].
Patent Landscape
The '648 patent is part of a complex patent landscape involving multiple patents and claims related to the treatment of type 2 diabetes. This landscape includes other patents such as the '955, '927, '695, and '859 patents, each with its own set of claims and expiration dates. The Orange Book, published by the FDA, lists these patents along with their expiration dates, providing a comprehensive view of the patent landscape[2].
Related Patents
- U.S. Patent 7,407,955 ('955 patent): Expires on May 2, 2025.
- U.S. Patent 8,673,927 ('927 patent): Expires on May 4, 2027.
- U.S. Patent 8,846,695 ('695 patent): Expires on May 4, 2027.
- U.S. Patent 9,173,859 ('859 patent): Expires on May 4, 2027[2].
Patent Analytics and Claim Coverage
To manage and analyze the extensive patent portfolio, companies often use patent analytics tools. These tools help in tracking patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities. For example, Schwegman’s ClaimScape® software generates interactive claim charts that can be reviewed by technical experts to determine the applicability of scope concepts to target products or methods[3].
Litigation and Infringement
The '648 patent has been involved in several litigation cases, particularly concerning Abbreviated New Drug Applications (ANDAs) submitted by generic drug manufacturers. These cases are filed under the Food and Drug Laws and Patent Laws of the United States, Titles 21 and 35 of the United States Code, respectively. The litigation aims to protect the patent holder's rights against alleged infringement by generic manufacturers[5].
Government Interest and March-In Rights
While the '648 patent does not specifically involve government funding, the broader context of pharmaceutical patents includes considerations of government interest and march-in rights under the Bayh-Dole Act. This act allows the government to issue additional licenses if the patent holder is not taking effective steps to achieve practical application of the invention or to alleviate health or safety needs. Although march-in rights have never been exercised, they have been used as a threat to spur companies into voluntary price reductions[4].
Impact on the Pharmaceutical Industry
The '648 patent and its related patents play a significant role in the pharmaceutical industry, particularly in the development and marketing of drugs for type 2 diabetes. The expiration of these patents can lead to increased competition from generic manufacturers, potentially reducing drug prices and expanding access to treatment.
Conclusion
The United States Patent 8,119,648 is a critical component of the intellectual property landscape for type 2 diabetes treatments. Understanding its claims, expiration date, and the broader patent landscape is essential for both the patent holder and potential generic manufacturers. The use of patent analytics and the potential for litigation highlight the complexity and importance of managing pharmaceutical patents.
Key Takeaways
- Patent Scope: The '648 patent involves methods for treating type 2 diabetes.
- Claim Construction: The claims are closely related to those in other patents like the '859 and '927 patents.
- Expiration Date: The patent expires on August 12, 2023.
- Patent Landscape: Part of a complex landscape including multiple related patents.
- Litigation: Involved in cases related to ANDA submissions by generic manufacturers.
- Government Interest: Not directly involved but part of a broader context considering march-in rights.
FAQs
What is the main subject of the '648 patent?
The '648 patent primarily deals with methods for treating type 2 diabetes.
When does the '648 patent expire?
The '648 patent is set to expire on August 12, 2023.
How is the claim construction of the '648 patent determined?
The claim construction is determined through joint claim construction submitted by the parties involved and is uniformly applied across related patents like the '859 and '927 patents.
What tools are used to manage and analyze the patent portfolio?
Tools like Schwegman’s ClaimScape® software are used to track patents by claims and scope concepts, identifying gaps and future design opportunities.
Has the '648 patent been involved in any litigation?
Yes, the '648 patent has been involved in litigation cases related to ANDA submissions by generic drug manufacturers.
What are march-in rights, and how do they relate to pharmaceutical patents?
March-in rights, under the Bayh-Dole Act, allow the government to issue additional licenses if the patent holder is not taking effective steps to achieve practical application of the invention or to alleviate health or safety needs. Although not directly applied to the '648 patent, it is a relevant consideration in the broader pharmaceutical patent landscape.
Sources
- Boehringer Ingelheim Pharms., Inc. v. Hec Pharm Co. - Casetext
- US FOOD & DRUG - accessdata.fda.gov
- Patent Analytics | Intellectual Property Law - SLWIP
- The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices - NBER
- Case 3:15-cv-05982-PGS-TJB - RPX Insight
