United States Patent 6,794,410: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,794,410, titled "Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis," is a significant patent in the pharmaceutical industry, particularly for the treatment of multiple sclerosis (MS). This patent, held by Sanofi-Aventis, revolves around the compound teriflunomide, which is marketed under the brand name Aubagio.
Background and Invention
The patent describes the use of teriflunomide, a compound of Formula I, for treating multiple sclerosis. Teriflunomide is an active metabolite of leflunomide, another compound known for its efficacy in treating MS and other autoimmune diseases[1][4].
Scope of the Patent
The scope of the patent includes methods of treating multiple sclerosis by administering teriflunomide or its pharmaceutically acceptable salts in therapeutically effective amounts. The patent also covers the use of teriflunomide in combination with other compounds known to be effective for treating MS[1][4].
Compound and Formulations
The patent specifically focuses on the compound (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide. It includes various formulations of this compound, such as tablets, and discusses the stability and efficacy of these formulations[5].
Claims
The patent claims are critical in defining the boundaries of the patent owner’s rights. Here are some key claims:
- Method of Treatment: The patent claims methods for treating multiple sclerosis by administering teriflunomide or its pharmaceutically acceptable salts.
- Combination Therapy: Claims include the use of teriflunomide in combination with other compounds effective for treating MS.
- Pharmaceutically Acceptable Salts: The patent covers both acid and basic addition salts of the base compound, ensuring a broad range of possible formulations[1][4].
Patent Landscape
Patent Expiration Dates
The patent is set to expire on September 12, 2026. This expiration date is crucial as it marks the end of the exclusive rights granted to the patent holder, allowing for the potential entry of generic versions of the drug[2][5].
Related Patents
Other related patents include:
- Patent 8,802,735: Issued for tablet formulations with improved stability.
- Patent 9,186,346: Expiring on February 4, 2034, which further extends the patent protection for teriflunomide[2][5].
Legal and Regulatory Aspects
The patent is subject to various legal and regulatory considerations:
- FDA Approval: The drug, Aubagio, has been approved by the FDA for the treatment of relapsing forms of multiple sclerosis.
- Patent Litigation: There have been legal challenges and certifications under section 505(j)(2)(A)(vii)(IV) of the FD&C Act regarding the validity and enforceability of the patents[2].
Impact on Pharmaceutical Industry
The patent landscape for teriflunomide highlights several challenges and considerations in the pharmaceutical industry:
- Genus Claims: The broader scope of genus claims can be problematic, as they must comply with the enablement requirement, which can be challenging, especially in the pharmaceutical and biotechnology industries[3].
- Competitive Landscape: The expiration of key patents can significantly impact the competitive landscape, allowing generic manufacturers to enter the market and potentially reducing the market share of the original patent holder[5].
Challenges in Patent Protection
The current jurisprudence on patent claims, particularly genus claims, poses significant challenges:
- Enablement Requirement: The requirement to identify every covered species within a genus claim can be impractical and may invalidate such claims if not fully satisfied[3].
- Written Description Requirement: The need for a written description that enables any person skilled in the art to make and use the invention adds another layer of complexity[3].
Conclusion
United States Patent 6,794,410 is a pivotal patent in the treatment of multiple sclerosis, focusing on the use of teriflunomide. The scope of the patent, including its claims and formulations, is comprehensive, but it is also subject to the complexities of patent law and regulatory requirements. As the patent approaches its expiration date, it is crucial for stakeholders to understand the implications for the pharmaceutical industry and the potential for generic competition.
Key Takeaways
- Teriflunomide: The patent revolves around the use of teriflunomide for treating multiple sclerosis.
- Patent Expiration: The patent is set to expire on September 12, 2026.
- Related Patents: Other patents extend the protection for teriflunomide formulations.
- Legal and Regulatory Considerations: The patent is subject to FDA approval and patent litigation.
- Impact on Industry: The patent landscape affects the competitive dynamics in the pharmaceutical industry.
Frequently Asked Questions (FAQs)
What is the primary compound covered by United States Patent 6,794,410?
The primary compound is (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide, commonly known as teriflunomide.
What is the therapeutic use of teriflunomide?
Teriflunomide is used for the treatment of multiple sclerosis, specifically relapsing forms of the disease.
When is the patent set to expire?
The patent is set to expire on September 12, 2026.
Are there other related patents for teriflunomide?
Yes, there are other related patents, including Patent 8,802,735 and Patent 9,186,346, which extend the protection for various formulations of teriflunomide.
What are the implications of the patent expiration for the pharmaceutical industry?
The expiration of the patent will allow generic manufacturers to enter the market, potentially reducing the market share of the original patent holder and increasing competition.
Cited Sources:
- US6794410B2 - Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis.
- Teriflunomide (teriflunomide) Approval Letter - accessdata.fda.gov.
- Eviscerating Patent Scope - DigitalCommons@NYLS.
- US6794410B2 - Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis - Google Patents.
- Generic Aubagio Availability - Drugs.com.
