Understanding the Scope and Claims of United States Patent 8,217,156
Introduction
United States Patent 8,217,156, assigned to Lexicon Pharmaceuticals, Inc., is a significant patent in the pharmaceutical industry, particularly in the realm of diabetes and related metabolic disorders. This patent protects a specific class of compounds and their methods of use, which are crucial for the treatment of various diseases.
Patent Overview
Patent Number and Title:
- Patent Number: US 8,217,156 B2
- Title: Solid forms of (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol and methods of their use[5].
Inventors and Assignee
- Inventors: Susan Margaret De Paul, Anett Perlberg, and Matthew Mangzhu Zhao
- Assignee: Lexicon Pharmaceuticals, Inc.[5].
Issue Date and Expiration
- Issue Date: July 10, 2012
- Expiration Date: October 7, 2030[2][5].
Claims and Scope
The patent primarily covers the solid forms of a specific compound, (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol, including anhydrous forms. Here are the key aspects of the claims:
Solid Forms
The patent describes various solid forms of the compound, including anhydrous forms, which are critical for the stability and efficacy of the drug. These solid forms are essential for pharmaceutical formulations[5].
Methods of Use
The patent includes methods of using these compounds for the treatment of various diseases and disorders. Specifically, it covers the use of these compounds in treating conditions such as diabetes and obesity. The methods outlined involve the administration of these compounds in pharmaceutical compositions to achieve therapeutic effects[5].
Patent Protection and Exclusivities
The patent is part of a broader strategy by Lexicon Pharmaceuticals to protect its intellectual property related to the drug Inpefa, which contains the active ingredient sotagliflozin.
- Patent Protection: The patent is one of several that protect Inpefa, ensuring that no generic or bioequivalent version can be marketed until the patent expires. Other related patents include US 7,781,577 and US 8,476,413, which also cover related compounds and methods[2][5].
- Exclusivities: In addition to patent protection, Inpefa has been granted several exclusivities by the FDA, which further delay the generic launch. These exclusivities are crucial in maintaining market exclusivity beyond the patent expiration dates[2].
Impact on the Pharmaceutical Industry
The patent landscape for pharmaceuticals, especially for small molecule drugs like those covered by US 8,217,156, is complex and highly regulated.
Polymorph Patents
The use of polymorph patents, which cover different crystalline forms of a compound, is a common strategy to extend the lifecycle of a drug. For example, the polymorph patent for another drug, Skyclarys, extends its protection by about 40 months beyond the compound patent expiration[4].
Generic Launch
The expiration of US 8,217,156 in 2030, combined with other patents and exclusivities, sets the stage for the potential generic launch of Inpefa. However, the exact generic launch date is estimated to be October 7, 2030, considering all the protective measures in place[2][5].
Challenges in Patent Scope and Claims
The pharmaceutical industry faces significant challenges in drafting and maintaining patent claims, particularly with the current rigid stance of the Federal Circuit on genus claims.
- Genus Claims: The Federal Circuit’s strict application of Section 112(a) of the U.S. patent laws makes it challenging to obtain broad patent protection for drugs and biologics. Innovators must balance between claiming too broadly, which can lead to invalidation, and claiming too narrowly, which can allow competitors to design around the claims[3].
Conclusion
United States Patent 8,217,156 is a critical component of Lexicon Pharmaceuticals’ intellectual property portfolio, protecting key aspects of the drug Inpefa. The patent’s scope and claims are designed to ensure robust protection for the compound and its methods of use, contributing to the drug’s market exclusivity until its expiration in 2030.
Key Takeaways
- Patent Coverage: US 8,217,156 covers solid forms of a specific compound and methods of its use for treating diseases like diabetes.
- Expiration Date: The patent expires on October 7, 2030.
- Exclusivities: Additional FDA-granted exclusivities delay the generic launch beyond the patent expiration.
- Industry Impact: The patent is part of a broader strategy to extend the lifecycle of Inpefa and protect its market position.
- Challenges: The pharmaceutical industry faces challenges in drafting patent claims due to the Federal Circuit’s strict stance on genus claims.
FAQs
Q: What is the main compound protected by US 8,217,156?
A: The main compound protected is (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol.
Q: What is the expiration date of US 8,217,156?
A: The patent expires on October 7, 2030.
Q: What are the methods of use covered by the patent?
A: The patent covers methods of using the compound for treating diseases such as diabetes and obesity.
Q: How does the patent fit into the broader protection strategy for Inpefa?
A: The patent is one of several that protect Inpefa, along with other patents and FDA-granted exclusivities, to maintain market exclusivity.
Q: What challenges does the pharmaceutical industry face in drafting patent claims?
A: The industry faces challenges due to the Federal Circuit’s strict application of Section 112(a), making it difficult to balance between broad and narrow claims.
Sources
- United States Patent and Trademark Office - US00920.0025B2.
- Pharsight - GreyB - Inpefa patent expiration.
- DigitalCommons@NYLS - Eviscerating Patent Scope.
- Crystal Pharmatech - Review of Polymorph Patent Application of 30 Small Molecule New Drugs Approved by the FDA in 2023.
- Drugs.com - Generic Inpefa Availability.
