Detailed Analysis of the Scope and Claims of United States Patent 10,080,733
Introduction
United States Patent 10,080,733, titled "Prodrugs of fumarates and their use in treating various diseases," is a significant patent in the pharmaceutical industry, particularly in the treatment of autoimmune and inflammatory diseases. This patent, assigned to Alkermes Pharma Ireland Limited, covers a range of compounds and their applications, which are crucial for understanding the patent landscape and its implications.
Patent Overview
Issuance and Expiration
The patent was issued on September 25, 2018, and is set to expire on September 20, 2033[5].
Inventors and Assignees
The inventors listed on the patent include Tarek A. Zeidan, Scott Duncan, Christopher P. Hencken, Thomas Andrew Wynn, and Carlos N. Sanrame. The assignee is Alkermes Pharma Ireland Limited[5].
Scope of the Patent
Compounds and Formulations
The patent covers prodrugs of fumarates, which are compounds designed to release fumaric acid esters (FAEs) in the body. These prodrugs are formulated to improve the bioavailability and stability of FAEs, making them more effective for treating various diseases. The compounds are described by specific chemical formulas and structures, ensuring a clear definition of what is protected under the patent[1][5].
Therapeutic Uses
The primary therapeutic use of these prodrugs is in the treatment of autoimmune and inflammatory diseases, such as multiple sclerosis and psoriasis. The patent also explores the potential use of these compounds in treating other conditions, highlighting the broad therapeutic scope of the invention[1].
Claims of the Patent
Independent and Dependent Claims
The patent includes a series of independent and dependent claims that define the scope of the invention. Independent claims outline the core aspects of the prodrugs, such as their chemical structure and pharmaceutical compositions. Dependent claims further specify various aspects, including methods of preparation, dosages, and specific therapeutic applications[5].
Claim Language and Scope
The claim language is precise and detailed, ensuring that the scope of the patent is well-defined. This precision is crucial for distinguishing the invention from prior art and for determining the breadth of protection. The claims are structured to cover a range of scenarios, from the synthesis of the compounds to their administration in patients[1].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 10,080,733 includes several related patents, such as U.S. Patent 8,669,281 and U.S. Patent 9,090,558. These patents, also assigned to Alkermes Pharma Ireland Limited, cover similar compounds and methods, indicating a comprehensive strategy to protect the intellectual property related to fumarate prodrugs[2][5].
Patent Term Extension
The patent term extension for U.S. Patent 10,080,733 is an important aspect of its landscape. The patent is eligible for extension under 35 U.S.C. § 156 due to the regulatory review period for the drug product VUMERITY® (diroximel fumarate). However, the extension is limited to 39 days due to the 14-year limit imposed by 35 U.S.C. § 156(c)(3)[2].
Impact on the Pharmaceutical Industry
Market Dominance
The patent provides Alkermes Pharma Ireland Limited with significant market protection for their fumarate prodrugs. This protection is crucial for maintaining market dominance, especially since there is currently no generic version of VUMERITY® available in the United States[5].
Innovation and Research
The patent encourages innovation by protecting the intellectual property of the inventors, allowing them to recoup their investment in research and development. This protection also incentivizes further research into the therapeutic applications of fumarate prodrugs[3].
Challenges and Criticisms
Patent Scope and Quality
There are ongoing debates about patent scope and quality, particularly regarding the breadth and clarity of patent claims. The metrics used to measure patent scope, such as independent claim length and count, can indicate the complexity and validity of the patent. However, broader claims can sometimes lead to increased licensing and litigation costs, potentially hindering innovation[3].
Regulatory Considerations
FDA Approval and Regulatory Review
The regulatory review period for VUMERITY® played a critical role in determining the patent term extension. The FDA's approval process and the subsequent regulatory review period are essential factors in the patent's lifecycle, influencing both its term and its market impact[2].
Key Takeaways
- Patent Scope: The patent covers prodrugs of fumarates with specific chemical structures and therapeutic applications.
- Claims: The claims are detailed and precise, defining the core aspects of the invention.
- Related Patents: The patent is part of a broader portfolio of related patents protecting fumarate prodrugs.
- Patent Term Extension: The patent is eligible for a limited extension due to regulatory review periods.
- Market Impact: The patent provides significant market protection, maintaining Alkermes Pharma Ireland Limited's market dominance.
- Innovation: The patent protects intellectual property, encouraging further research and innovation.
FAQs
What is the primary therapeutic use of the prodrugs covered by U.S. Patent 10,080,733?
The primary therapeutic use is in the treatment of autoimmune and inflammatory diseases, such as multiple sclerosis and psoriasis.
Who is the assignee of U.S. Patent 10,080,733?
The assignee is Alkermes Pharma Ireland Limited.
What is the expiration date of U.S. Patent 10,080,733?
The patent is set to expire on September 20, 2033.
Is there a generic version of VUMERITY® available in the United States?
No, there is currently no therapeutically equivalent version of VUMERITY® available in the United States.
How does the patent term extension affect U.S. Patent 10,080,733?
The patent term extension is limited to 39 days due to the 14-year limit imposed by 35 U.S.C. § 156(c)(3).
Sources
- US10080733B2 - Prodrugs of fumarates and their use in treating various diseases - Google Patents
- NOTICE OF FINAL DETERMINATION AND REQUIREMENT FOR ELECTION - U.S. Patent and Trademark Office
- Patent Claims and Patent Scope - Hoover Institution
- Our Patent Portfolio - Biogen Investor Relations
- Generic Vumerity Availability - Drugs.com
