United States Patent 7,838,499: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,838,499, titled "Crystalline Form of Benzylbenzene SGLT2 Inhibitor," is a significant patent in the field of pharmaceuticals, particularly in the development of Sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignees
The patent was invented by a team of researchers including Mengzhuang Cai, Qian Liu, Ge Xu, Binhua Lv, Brian Seed, and Jacques Y. Roberge. The assignee of the patent is Theracos, Inc., later known as Theracos Sub, LLC, based in Marlborough, MA[2].
Patent Scope and Claims
Claims Overview
The patent primarily focuses on the crystalline forms of a specific benzylbenzene compound that acts as an SGLT2 inhibitor. The claims are detailed and specific, outlining the structural and spectral characteristics of the crystalline forms.
- Independent Claims: The patent includes independent claims that define the crystalline form of the compound, characterized by specific Raman spectra peaks. For example, one of the claims specifies peaks at about 353, 688, and 825 cm^-1[2].
- Dependent Claims: Dependent claims further elaborate on the preparation methods, physical properties, and pharmaceutical compositions of the crystalline forms.
Claim Language and Scope
The claim language is precise, ensuring that the scope of the patent is well-defined and not overly broad. This precision is crucial in avoiding potential litigation and ensuring clarity in the patent's boundaries. The use of specific spectral peaks and structural details narrows the scope, making it easier to distinguish from other related inventions[3].
Patent Landscape
Related Patents and Applications
The patent is part of a larger family of patents related to SGLT2 inhibitors. Other patents, such as US 8,987,323 B2 and US 10,981,942 B2, also filed by the same inventors, cover similar crystalline forms and preparation methods. These patents collectively form a robust intellectual property portfolio for Theracos Sub, LLC[1][2].
International Patent Applications
The invention has been protected through international patent applications, including those filed under the Patent Cooperation Treaty (PCT). For instance, the PCT application PCT/CN2010/073865 is cited in the patent documentation, indicating a global strategy for intellectual property protection[2].
Expiration Dates and Time Gaps
The compound patent and polymorph patent expiration dates are critical for understanding the patent landscape. For example, the compound patent for a related SGLT2 inhibitor might expire earlier than the polymorph patent, creating a time gap that can affect market dynamics and generic competition. In the case of related patents, the time gaps between compound and polymorph patent expirations can range from several years to over a decade[4].
Preparation Methods and Processes
The patent also details processes for the preparation of the crystalline forms of the SGLT2 inhibitor. These methods are crucial for the commercial production of the drug and are protected under separate patents, such as US 8,283,454 B2, which outlines specific processes for preparing SGLT2 inhibitors[5].
Pharmaceutical Significance
SGLT2 inhibitors are used in the treatment of type 2 diabetes by inhibiting the reabsorption of glucose in the kidneys. The crystalline forms described in the patent are important for the stability, bioavailability, and efficacy of these drugs. The precise characterization of these forms ensures consistent pharmaceutical quality, which is vital for patient safety and treatment effectiveness.
Raman Spectra and Characterization
The patent emphasizes the use of Raman spectra for characterizing the crystalline forms. Specific peaks in the Raman spectra, such as those at 353, 688, and 825 cm^-1, are used to identify and distinguish the crystalline forms. This detailed characterization is essential for ensuring the purity and consistency of the drug substance[2].
Patent Quality and Scope Metrics
The quality and scope of the patent can be evaluated using metrics such as independent claim length and count. Research indicates that narrower claims, as seen in this patent, are associated with a higher probability of grant and a shorter examination process. This suggests that the patent office has rigorously evaluated the claims, ensuring their clarity and validity[3].
Industry Impact and Innovation
The patent contributes to the broader landscape of diabetes treatment by providing specific crystalline forms of SGLT2 inhibitors. This innovation can enhance the therapeutic options available to patients and drive further research in the field. The protection afforded by this patent also incentivizes investment in pharmaceutical research and development.
Key Takeaways
- Specific Claims: The patent includes specific claims characterized by Raman spectra peaks, ensuring a well-defined scope.
- Related Patents: Part of a larger family of patents related to SGLT2 inhibitors, enhancing the intellectual property portfolio.
- Global Protection: Protected through international patent applications.
- Pharmaceutical Significance: Crucial for the stability, bioavailability, and efficacy of SGLT2 inhibitors.
- Characterization: Detailed characterization using Raman spectra ensures purity and consistency.
- Patent Quality: Narrow claims associated with higher grant probability and shorter examination process.
FAQs
What is the main subject of United States Patent 7,838,499?
The main subject is the crystalline form of a benzylbenzene compound that acts as an SGLT2 inhibitor.
Who are the inventors of this patent?
The inventors include Mengzhuang Cai, Qian Liu, Ge Xu, Binhua Lv, Brian Seed, and Jacques Y. Roberge.
What is the significance of Raman spectra in this patent?
Raman spectra are used to characterize the crystalline forms of the SGLT2 inhibitor, ensuring their purity and consistency.
How does this patent fit into the broader patent landscape?
It is part of a larger family of patents related to SGLT2 inhibitors, protected through international applications, and contributes to the intellectual property portfolio of Theracos Sub, LLC.
What is the pharmaceutical importance of this patent?
The patent is crucial for the stability, bioavailability, and efficacy of SGLT2 inhibitors used in the treatment of type 2 diabetes.
Cited Sources:
- United States Patent and Trademark Office. US8987323B2: Crystalline Form of Benzylbenzene SGLT2 Inhibitor. March 24, 2015.
- United States Patent and Trademark Office. US10981942B2: Crystalline Form of Benzylbenzene SGLT2 Inhibitor. April 20, 2021.
- Hoover Institution. Patent Claims and Patent Scope. August 2016.
- Crystal Pharmatech. Review of Polymorph Patent Application of 30 Small Molecule New Drugs Approved by the FDA in 2023.
- United States Patent and Trademark Office. US8283454B2: Processes for the Preparation of SGLT2 Inhibitors. October 9, 2012.
