United States Patent 11,185,519: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,185,519, titled "Methods of treatment of cholestatic diseases," is a significant patent in the field of pharmaceuticals, particularly in the treatment of cholestatic diseases such as Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventor and Assignee
The patent was invented by Rémy Hanf and assigned to Genfit, a biopharmaceutical company focused on the development of innovative treatments for liver diseases and other metabolic disorders[2].
Patent Scope
The patent pertains to the use of a specific compound, 1-[4-methylthiophenyl]-3-[3,5-dimethyl-4-carboxydimethyl-methyloxyphenyl]prop-2-en-1-one, also known as Elafibranor or GFT505, for the treatment of cholestatic diseases. Cholestatic diseases are characterized by a reduction or stoppage of bile flow, leading to the accumulation of bile in the liver, which can cause significant liver damage and other complications[5].
Claims
The patent includes several claims that define the scope of the invention. Here are some key claims:
- Claim 1: The use of Elafibranor for the treatment of cholestatic diseases, specifically PBC and/or PSC.
- Claim 2: The method of treating cholestatic diseases by administering Elafibranor to a patient in need thereof.
- Claim 3: The use of Elafibranor in combination with other therapeutic agents, such as ursodeoxycholic acid (UDCA), for the treatment of cholestatic diseases[5].
Patent Expiration Dates
The patent is set to expire on March 30, 2037. This expiration date is crucial as it determines the period during which the patent holder, Genfit, has exclusive rights to the invention[2].
Related Patents and Exclusivities
Several related patents and exclusivities are associated with this invention:
- Related Patents: Other patents such as 11,331,292, 11,850,223, and 11,857,523 also relate to the use of Elafibranor for various therapeutic applications, all expiring on March 30, 2037[2].
- Exclusivities: The FDA has granted exclusivity for the treatment of Primary Biliary Cholangitis (PBC) in adults who have had an inadequate response to UDCA or are unable to tolerate UDCA, which will expire on June 10, 2031[2].
Global Patent Landscape
To understand the global implications, it is essential to look at the broader patent landscape:
- International Patent Offices: Patents related to Elafibranor may be searched through databases provided by international intellectual property offices such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO)[1].
- Global Dossier: This service allows users to access the file histories of related applications from participating IP Offices, providing a comprehensive view of the patent family and related applications[1].
Patent Search and Analysis Tools
Several tools are available for conducting thorough patent searches and analyses:
- Patent Public Search: This tool provides enhanced access to prior art and is useful for identifying existing patents and published patent applications[1].
- Patent Claims Research Dataset: This dataset from the USPTO contains detailed information on claims from US patents and can be used to analyze the scope and trends of patent claims[3].
Impact on Patent Litigation
The patent landscape and the claims within can significantly impact patent litigation. For instance:
- Patent Infringement Litigation: The increase in patent infringement lawsuits, particularly those involving pharmaceutical patents, can be influenced by factors such as changes in patent laws and the anticipation of such changes. The Leahy-Smith America Invents Act (AIA) of 2011 is an example of how legislative changes can affect patent litigation[4].
Economic and Regulatory Implications
The economic and regulatory implications of this patent are substantial:
- Market Exclusivity: The exclusive marketing rights granted by the FDA and the patent expiration dates determine the period during which Genfit can enjoy market exclusivity, impacting the company's revenue and competitive position[2].
- Regulatory Compliance: Compliance with regulatory requirements and the maintenance of patent validity are crucial for the continued protection of the invention and its commercial success[4].
Conclusion
United States Patent 11,185,519 is a critical patent in the treatment of cholestatic diseases, offering a specific therapeutic approach using Elafibranor. Understanding the scope, claims, and the broader patent landscape is essential for both the patent holder and other stakeholders in the pharmaceutical industry. The patent's expiration dates, related patents, and exclusivities all play a significant role in determining its commercial and regulatory impact.
Key Takeaways
- Patent Scope: The patent pertains to the use of Elafibranor for treating cholestatic diseases.
- Claims: Key claims include the use of Elafibranor alone or in combination with other therapeutic agents.
- Patent Expiration: The patent expires on March 30, 2037.
- Related Patents and Exclusivities: Several related patents and FDA-granted exclusivities are associated with this invention.
- Global Patent Landscape: International patent offices and services like Global Dossier provide access to related applications.
- Impact on Patent Litigation: Changes in patent laws and litigation trends can affect the patent's validity and enforcement.
FAQs
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What is the main subject of United States Patent 11,185,519?
- The main subject is the use of Elafibranor (GFT505) for the treatment of cholestatic diseases, specifically PBC and PSC.
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Who is the inventor and assignee of this patent?
- The inventor is Rémy Hanf, and the assignee is Genfit.
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What are the key claims of this patent?
- The key claims include the use of Elafibranor for treating cholestatic diseases, both alone and in combination with other therapeutic agents.
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When does the patent expire?
- The patent is set to expire on March 30, 2037.
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What other exclusivities are associated with this patent?
- FDA-granted exclusivity for the treatment of PBC in adults who have had an inadequate response to UDCA or are unable to tolerate UDCA, expiring on June 10, 2031.
Cited Sources
- USPTO - Search for patents[1]
- Drugs.com - Generic Iqirvo Availability[2]
- USPTO - Patent Claims Research Dataset[3]
- GAO - Assessing Factors That Affect Patent Infringement Litigation[4]
- Google Patents - US11185519B2[5]
