United States Patent 7,713,938: A Detailed Analysis
Overview of the Patent
The United States Patent 7,713,938, titled "Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene," is a patent that covers a specific crystalline form of a compound and methods for its preparation. Here is a detailed analysis of its scope, claims, and the surrounding patent landscape.
Invention Description
The patent describes a crystalline form of a complex organic compound, specifically 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene. This compound is part of a broader class of molecules that have potential pharmaceutical applications, particularly in the field of diabetes treatment[4][5].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Claim 1: This claim specifies the crystalline form of the compound, including its structural characteristics and physical properties.
- Subsequent Claims: These claims cover various aspects such as methods for preparing the crystalline form, pharmaceutical compositions containing the compound, and uses of the compound in medical treatments[4][5].
Scope of Protection
The scope of protection for this patent is limited to the specific crystalline form of the compound and the methods described for its preparation. This means that any other crystalline forms or preparation methods not covered by the claims are not protected by this patent.
Patent Landscape
Related Patents and Litigation
The patent 7,713,938 is part of a larger patent portfolio related to the drug empagliflozin, which is used in the treatment of type 2 diabetes. Other related patents include U.S. Patent Nos. 8,551,957 and 9,949,998, which also pertain to empagliflozin and its formulations[2].
- Litigation: There have been several legal cases involving these patents, particularly in the context of Abbreviated New Drug Applications (ANDAs) filed by generic drug manufacturers. For example, Boehringer Ingelheim Pharmaceuticals, Inc. has been involved in litigation against various generic manufacturers to protect the patents related to empagliflozin, including U.S. Patent 7,713,938[2].
Regulatory Environment
Patents like 7,713,938 are often subject to regulatory review periods before the commercial marketing or use of the product. This regulatory review can impact the patent term, potentially leading to patent term extensions under 35 U.S.C. § 156, as seen in other pharmaceutical patents[1].
Impact on Generic Competition
The presence of this patent and related patents in the portfolio can significantly delay the entry of generic versions of empagliflozin into the market. Generic manufacturers must either wait for the expiration of these patents or negotiate settlement agreements that allow them to enter the market earlier, often with certain restrictions[2].
PTAB and District Court Proceedings
Patents in the pharmaceutical sector, including 7,713,938, are frequently challenged through inter partes reviews (IPRs) and post-grant reviews (PGRs) at the Patent Trial and Appeal Board (PTAB). Additionally, they may be litigated in U.S. district courts to determine their validity, enforceability, and infringement[3].
Exclusivity and Market Dominance
The exclusivity provided by this patent, along with other related patents, allows the patent holder to maintain market dominance for the drug empagliflozin. This exclusivity is crucial for pharmaceutical companies to recoup their significant investment in research and development.
Key Takeaways
- Specific Crystalline Form: The patent protects a specific crystalline form of a compound used in diabetes treatment.
- Method of Preparation: The patent also covers methods for preparing this crystalline form.
- Regulatory and Litigation Context: The patent is part of a broader regulatory and litigation landscape involving generic competition and patent term extensions.
- Market Impact: The patent plays a significant role in maintaining market exclusivity for the drug empagliflozin.
FAQs
Q: What is the main subject of U.S. Patent 7,713,938?
A: The main subject is a specific crystalline form of the compound 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene.
Q: What are the potential applications of the compound protected by this patent?
A: The compound is used in the treatment of type 2 diabetes, specifically as part of the drug empagliflozin.
Q: How does this patent impact generic competition?
A: This patent, along with related patents, delays the entry of generic versions of empagliflozin into the market, allowing the patent holder to maintain market exclusivity.
Q: What legal challenges might this patent face?
A: The patent could face challenges through inter partes reviews (IPRs) at the PTAB and litigation in U.S. district courts to determine its validity and enforceability.
Q: Can the term of this patent be extended?
A: Yes, the patent term can be extended under certain conditions, such as regulatory review periods, as specified under 35 U.S.C. § 156.
Sources Cited
- IMIN THE UNITED STATES PATENT AND ... - Regulations.gov
- ANDA Litigation Settlements Fall 2020 | Hatch-Waxman
- The BioLoquitur Bulletin - Seyfarth Shaw LLP
- US7713938B2 - Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)
- US-7713938-B2 - Crystalline Form of 1-chloro-4-(β-d-glucopyranos ...
