United States Patent 8,324,232 B2: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,324,232 B2, issued on December 4, 2012, is a significant patent in the pharmaceutical sector, particularly for the compound aprocitentan, a potent endothelin receptor antagonist. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
The Invention and Its Use
Compound and Structural Formula
The patent pertains to the compound of structural formula (I) and its salts, which are useful as endothelin receptor antagonists. This compound, known as aprocitentan, is specifically designed to target endothelin receptors, which are implicated in various cardiovascular and pulmonary diseases, including hypertension and pulmonary arterial hypertension[4].
Pharmaceutical Composition
The patent claims include a pharmaceutical composition comprising the approved product, aprocitentan. This composition can be formulated in various ways, including film coatings that contain inactive ingredients such as hydroxypropyl cellulose, iron oxide black, and iron oxide red[1].
Patent Claims
Types of Claims
The patent includes multiple types of claims:
- Claims to the Approved Product: Claims 1 and 2 specifically read on the approved product, aprocitentan[1].
- Claims to Pharmaceutical Composition: Claim 3 reads on a pharmaceutical composition containing aprocitentan as the active principle[1].
- Claims to Methods of Use: The patent also claims methods of using the approved product, which include therapeutic applications for conditions such as hypertension[1][4].
- Claims to Methods of Manufacturing: Additionally, the patent covers methods of manufacturing the approved product, ensuring that the production process is protected[1].
Patent Scope
Metrics for Measuring Patent Scope
The scope of a patent can be measured using various metrics, including independent claim length (ICL) and independent claim count (ICC). These metrics help in understanding the breadth and clarity of the patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Specific Scope of U.S. Patent 8,324,232 B2
The scope of this patent is defined by its claims, which are specific to the compound aprocitentan and its uses. The patent does not have overly broad claims, which is a common critique in patent quality debates. Instead, it focuses on the specific structural formula and its therapeutic applications, ensuring clarity and validity[3].
Patent Landscape
Current Status and Expiration
The patent is currently active and is set to expire on September 21, 2029. No disclaimers, re-examination certificates, certificates of corrections, or re-issues have been submitted or issued for this patent[1].
Maintenance Fees
The maintenance fees for this patent have been diligently paid, with the first maintenance fee paid on May 25, 2016, and the second on May 26, 2020. This ensures the patent remains in force until its expiration date[1].
Regulatory Approval
The patent claims the approved product and methods related to it, which have undergone rigorous regulatory review. The applicant has demonstrated continuous and diligent activities to obtain FDA approval, as evidenced by the chronology of major communications between the FDA and the applicant[1].
Eligibility for Extension
Criteria for Extension
The patent is eligible for extension under 35 U.S.C. § 156 and 37 C.F.R. § 1.720 because it satisfies all the necessary requirements:
- It claims a human drug product.
- The term of the patent has not expired before the submission of the application.
- The term of the patent has never been extended under 35 U.S.C. § 156[1].
Impact on Innovation and Litigation
Innovation Incentives
The clarity and specificity of the claims in this patent help in maintaining incentives for innovation. Unlike overly broad or unclear patents, which can lead to increased licensing and litigation costs, this patent's clear scope ensures that it does not impede innovation in the pharmaceutical sector[3].
Litigation and Patent Quality
The patent's clear and narrow claims reduce the likelihood of complex and lengthy litigation. This aligns with studies that suggest narrower claims at publication are associated with a shorter examination process and higher grant probability, indicating better patent quality[3].
Industry Expert Insights
"Patent scope is one of the important aspects in the debates over ‘patent quality.’ The purported decrease in patent quality over the past decade or two has supposedly led to granting patents of increased breadth (or ‘overly broad’ patents), decreased clarity, and questionable validity."
- Alan C. Marco, U.S. Patent and Trademark Office[3]
Statistics and Examples
- Patent Maintenance Payments: The payment of maintenance fees for this patent highlights the importance of keeping patents in force. For instance, the second maintenance fee paid on May 26, 2020, ensures the patent remains active until its expiration[1].
- Forward Citations: While specific forward citations for this patent are not provided, the general trend is that patents with narrower claims tend to have more forward citations, indicating their influence on subsequent innovations[3].
Key Takeaways
- Specific Claims: The patent includes specific claims to the compound aprocitentan, its pharmaceutical composition, and methods of use and manufacturing.
- Patent Scope: The scope is measured by metrics such as independent claim length and count, ensuring clarity and validity.
- Current Status: The patent is active and set to expire on September 21, 2029, with all necessary maintenance fees paid.
- Regulatory Approval: The patent has undergone rigorous regulatory review and is approved for therapeutic use.
- Impact on Innovation: The clear and specific claims of this patent support innovation by avoiding the pitfalls of overly broad or unclear patents.
FAQs
What is the compound claimed in U.S. Patent 8,324,232 B2?
The compound claimed is aprocitentan, a potent endothelin receptor antagonist.
What are the key claims of the patent?
The patent claims include the compound aprocitentan, its pharmaceutical composition, and methods of using and manufacturing the approved product.
When is the patent set to expire?
The patent is set to expire on September 21, 2029.
Has the patent been extended under 35 U.S.C. § 156?
No, the term of the patent has never been extended under 35 U.S.C. § 156.
What metrics are used to measure the scope of this patent?
The scope is measured using metrics such as independent claim length (ICL) and independent claim count (ICC).
Sources
- U.S. Patent No. 8324232 B2 Issued - Regulations.gov
- Martin Bolli Inventions, Patents and Patent Applications - Justia
- Patent Claims and Patent Scope - Hoover Institution
- US8324232B2 - 4-pyrimidinesulfamide derivative - Google Patents
- Tryvio patent expiration - Pharsight
