United States Patent 6,376,515: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,376,515, granted to Bing-Yan Zhu and Penglie Zhang, is a significant patent in the pharmaceutical industry, particularly in the field of anticoagulant drugs. This patent is associated with betrixaban, a factor Xa inhibitor marketed under the brand name BEVYXXA®. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Grant and Ownership
The patent was granted on April 23, 2002, and is owned by Millennium Pharmaceuticals, Inc., which is the assignee of the entire interest in the patent[1].
Scope of the Patent
Claims
The '515 Patent includes 72 claims, which are comprehensive and cover various aspects of betrixaban and its uses. Key claims include:
- Compound Claims: Claims 1, 14, 19, 20, and 21 specifically claim betrixaban, pharmaceutical compositions comprising betrixaban, and approved methods of using betrixaban[1].
- Method of Use Claims: These claims cover the methods of using betrixaban for therapeutic purposes, such as preventing and treating thromboembolic disorders.
- Manufacturing Claims: The patent also includes claims related to the methods of manufacturing betrixaban and its pharmaceutical compositions.
Formula and Structure
The patent describes a compound of formula VI, which includes specific structural elements such as C1-C6 alkyl groups that may be optionally substituted with hydroxyl, carboxylic acid, or carboxylic acid ester groups. The formula also specifies the positions and types of other functional groups[1].
Patent Term Extension
Regulatory Review Period
The patent is eligible for a term extension under 35 U.S.C. § 156 due to the lengthy regulatory review period for the approved product, BEVYXXA®. The regulatory review period was calculated from the effective date of the Investigational New Drug (IND) application (November 30, 2005) to the approval of the New Drug Application (NDA) (June 23, 2017), totaling 4,225 days[1].
Calculation of Extension
The term extension was calculated by subtracting the days before the patent issuance and any days where the applicant did not act with due diligence from the total regulatory review period. This resulted in an extension of 2,234 days[1].
Patent Landscape
Related Patents
Several other patents are related to the preparation and recovery of betrixaban, such as U.S. Patent 8,394,964 B2. This patent describes methods for preparing and recovering betrixaban free base or its salts, indicating a broader landscape of intellectual property surrounding this compound[2].
Patent Scope and Quality
The scope of the '515 Patent is significant, with 72 claims that cover a wide range of aspects related to betrixaban. This aligns with discussions on patent scope and quality, where broader patents can sometimes be seen as overly broad or lacking in clarity. However, the '515 Patent's claims are specific and well-defined, which is crucial for maintaining patent quality and avoiding unnecessary litigation[3].
Impact on Innovation
Licensing and Litigation
The breadth and clarity of the '515 Patent's claims can influence innovation in the pharmaceutical industry. Well-defined claims can reduce licensing and litigation costs, thereby encouraging further innovation. The patent's extension under 35 U.S.C. § 156 also reflects the significant investment in time and resources required for regulatory approval, which can be a barrier to entry for other innovators[3].
Industry Expert Insights
Industry experts often highlight the importance of clear and specific patent claims. For example, "Narrower claims at publication are associated with a higher probability of grant and a shorter examination process than broader claims," indicating that the '515 Patent's detailed claims may have facilitated its approval and subsequent extensions[3].
Regulatory Compliance
FDA Approval
The approval of BEVYXXA® by the FDA is a critical milestone that validates the patent's claims. The regulatory review process, which spanned over 4,200 days, underscores the rigorous standards that pharmaceutical products must meet before they are approved for market[1].
Economic and Market Impact
Market Domination
The exclusive rights granted by the '515 Patent allow Millennium Pharmaceuticals to dominate the market for betrixaban-based anticoagulant drugs. This exclusivity can impact market dynamics, pricing, and access to the drug, highlighting the significant economic implications of pharmaceutical patents[1].
Conclusion
United States Patent 6,376,515 is a pivotal patent in the pharmaceutical industry, particularly in the area of anticoagulant therapy. Its comprehensive claims, detailed structural descriptions, and regulatory extensions underscore its importance. The patent's impact on innovation, licensing, and market dynamics is substantial, reflecting the complex interplay between intellectual property, regulatory compliance, and market competition.
Key Takeaways
- Comprehensive Claims: The patent includes 72 claims covering betrixaban, its pharmaceutical compositions, and methods of use and manufacture.
- Regulatory Extensions: The patent was extended under 35 U.S.C. § 156 due to a lengthy regulatory review period.
- Impact on Innovation: Clear and specific claims can reduce licensing and litigation costs, encouraging innovation.
- Market Exclusivity: The patent grants exclusive rights, allowing the owner to dominate the market for betrixaban-based drugs.
- Regulatory Compliance: The patent's approval and extensions are tied to rigorous FDA regulatory standards.
FAQs
What is the main compound claimed in U.S. Patent 6,376,515?
The main compound claimed is betrixaban, a factor Xa inhibitor.
How many claims are included in the '515 Patent?
The patent includes 72 claims.
Why was the '515 Patent eligible for a term extension?
The patent was eligible due to the lengthy regulatory review period for the approved product, BEVYXXA®.
What is the significance of the regulatory review period in patent term extension?
The regulatory review period, totaling 4,225 days, justified the extension of the patent term by 2,234 days.
How does the scope of the '515 Patent impact innovation in the pharmaceutical industry?
The clear and specific claims reduce licensing and litigation costs, thereby encouraging further innovation in the industry.