United States Patent 7,598,276: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,598,276, titled "Pharmaceutical salts and polymorphs of a factor Xa inhibitor," is a significant patent in the pharmaceutical industry, particularly in the field of anticoagulant drugs. This patent, issued on October 6, 2009, is associated with the drug BEVYXXA® (betrixaban), a factor Xa inhibitor used to prevent venous thromboembolism. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent was filed by Millennium Pharmaceuticals, Inc., and it covers specific pharmaceutical salts and polymorphs of betrixaban, a compound with activity against mammalian factor Xa. Factor Xa is a critical enzyme in the coagulation cascade, and inhibiting it is a common approach to preventing blood clots[4].
Scope of the Patent
The scope of U.S. Patent 7,598,276 is defined by its claims, which are the legal boundaries of what the patent protects. Here are the key aspects:
Claims Overview
The patent includes five claims, each detailing different aspects of the invention:
- Claim 1: A salt represented by a specific formula, having a crystalline polymorph form.
- Claim 2: The salt of claim 1, with a powder X-ray diffraction pattern having at least four approximate characteristic peak locations.
- Claim 3: The salt of claim 1, with a powder X-ray diffraction pattern having at least eight characteristic peak locations.
- Claims 4 and 5: These claims further specify the crystalline form and X-ray diffraction patterns of the salt[1][4].
Approved Product
The approved product, BEVYXXA® (betrixaban), is in crystalline form and matches the descriptions in the claims. This alignment is crucial for the patent term extension application under 35 U.S.C. §156, as it must be demonstrated that the patent claims the approved product or a method of using or manufacturing it[1].
Patent Claims and Scope Metrics
The scope of a patent can be analyzed using various metrics, such as independent claim length and independent claim count. These metrics help in understanding the breadth and clarity of the patent claims.
Independent Claim Length
This metric measures the number of words used in the shortest independent claim. Shorter claims are generally considered narrower and more specific, which can indicate higher patent quality and reduced litigation risks[3].
Independent Claim Count
This metric counts the total number of independent claims. Fewer independent claims often suggest a more focused and narrower scope, which can be associated with a higher probability of grant and shorter examination processes[3].
In the case of U.S. Patent 7,598,276, the claims are relatively specific, focusing on the crystalline forms and X-ray diffraction patterns of the betrixaban salt. This specificity suggests a well-defined scope that is less likely to be overly broad or ambiguous.
Patent Term Extension
The patent term extension application under 35 U.S.C. §156 is a significant aspect of this patent. Here are the key points:
Eligibility
The patent is eligible for extension because:
- One or more claims of the patent cover the approved product, BEVYXXA®.
- The patent has not expired.
- The term of the patent has not been previously extended under 35 U.S.C. §156.
- The application is submitted by the owner of record, Millennium Pharmaceuticals, Inc.
- The approved product has been subject to regulatory review prior to commercial marketing or use[1].
Calculation of Extension
The extension period is calculated based on the regulatory review period, which in this case resulted in an extension of 1531 days. However, the maximum extension available is capped at 14 years from the date of NDA approval or five years from the original expiration date of the patent. The resulting expiration date of the patent, after the extension, is January 17, 2031[1].
Regulatory Review and Approval
The drug BEVYXXA® received permission for commercial marketing or use on June 23, 2017. This regulatory approval is a critical factor in the patent term extension application, as it validates that the product has undergone the necessary regulatory review prior to its commercial use[1][2].
Patent Landscape
The patent landscape surrounding U.S. Patent 7,598,276 includes several other patents related to betrixaban and factor Xa inhibitors. Here are some key points:
Related Patents
Other patents, such as U.S. Patent No. 6,835,739 and U.S. Patent No. 8,518,977, also cover aspects of betrixaban and its use. These patents were filed concurrently with the application for patent term extension for U.S. Patent 7,598,276, indicating a comprehensive approach to protecting the intellectual property related to this drug[2].
Industry Context
The development and protection of factor Xa inhibitors are part of a broader trend in the pharmaceutical industry to create effective anticoagulant drugs. Patents in this field are crucial for companies to secure market exclusivity and protect their investments in research and development.
Challenges and Critiques
Patent scope and claim clarity have been significant concerns in the pharmaceutical industry. Broad or unclear claims can lead to increased licensing and litigation costs, potentially hindering innovation. However, the specific and well-defined claims in U.S. Patent 7,598,276 mitigate these risks, suggesting a higher quality patent[3].
Conclusion
U.S. Patent 7,598,276 is a critical patent in the pharmaceutical industry, particularly for the drug BEVYXXA®. The patent's scope is well-defined by its specific claims related to the crystalline forms and X-ray diffraction patterns of betrixaban. The patent term extension under 35 U.S.C. §156 ensures that the patent remains in force until January 17, 2031, providing continued protection for the approved product.
Key Takeaways
- Specific Claims: The patent includes five specific claims focusing on the crystalline forms and X-ray diffraction patterns of betrixaban.
- Approved Product: The approved product, BEVYXXA®, matches the descriptions in the claims.
- Patent Term Extension: The patent is eligible for a term extension under 35 U.S.C. §156, with the extended expiration date being January 17, 2031.
- Regulatory Review: The drug received regulatory approval on June 23, 2017.
- Patent Landscape: The patent is part of a broader landscape of patents related to betrixaban and factor Xa inhibitors.
FAQs
What is the main subject of U.S. Patent 7,598,276?
The main subject of U.S. Patent 7,598,276 is pharmaceutical salts and polymorphs of a factor Xa inhibitor, specifically betrixaban.
What is the approved product associated with this patent?
The approved product is BEVYXXA® (betrixaban), a factor Xa inhibitor used to prevent venous thromboembolism.
Why is the patent term extension important?
The patent term extension under 35 U.S.C. §156 ensures that the patent remains in force until January 17, 2031, providing continued protection for the approved product.
What are the key metrics for measuring patent scope?
Key metrics include independent claim length and independent claim count, which help in understanding the breadth and clarity of the patent claims.
How does the regulatory approval impact the patent?
The regulatory approval of BEVYXXA® on June 23, 2017, is crucial for the patent term extension application, as it validates that the product has undergone necessary regulatory review prior to commercial use.
Sources
- Application for Extension of Patent Term Under 35 U.S.C. §156 - U.S. Patent No. 7,598,276[1].
- FDA-2018-E-0281-0002 - Regulations.gov[2].
- Patent Claims and Patent Scope - Hoover Institution[3].
- Pharmaceutical salts and polymorphs of a factor Xa inhibitor - Google Patents[4].
