United States Patent 7,981,877 B2: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,981,877 B2, titled "Stabilized steroid composition and method for its preparation," is a significant patent in the field of pharmaceuticals, particularly concerning the stabilization of steroid compounds. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
The patent, filed by Pravin M. Patel, addresses the stabilization of 17-substituted hydrocortisone compounds, specifically hydrocortisone 17-butyrate. The background highlights the instability of these compounds, which can lead to isomerization and degradation, affecting their efficacy and shelf life[4].
Scope of the Patent
The scope of this patent is narrowly focused on methods and compositions for stabilizing hydrocortisone compounds. It involves the use of omega-6 acids or their esters as stabilizers. The invention is particularly relevant in the pharmaceutical industry, where the stability of active ingredients is crucial for the effectiveness and safety of medications.
Claims of the Patent
The patent includes several key claims:
- Claim 11: A stabilized composition comprising hydrocortisone 17-butyrate and a stabilizer that includes an omega-6 acid or its ester, where the molar concentration of the omega-6 acid component is greater than that of the hydrocortisone butyrate[4].
- Claim 12: The composition where the stabilizer comprises safflower oil[4].
- Claim 13: The composition where the weight percentage of safflower oil is at least ten times greater than the weight percentage of hydrocortisone butyrate[4].
These claims define the core of the invention, emphasizing the role of omega-6 acids and their esters in stabilizing the steroid compounds.
Method of Preparation
The patent describes a method for preparing these stabilized compositions. This involves mixing the hydrocortisone 17-butyrate with an appropriate amount of an omega-6 acid or its ester, ensuring the stabilizer is present in sufficient concentration to prevent isomerization and degradation[4].
Patent Landscape
Related Patents and Applications
The patent is part of a series of related applications and patents filed by the inventor. These include:
- US10/762,652: A continuation-in-part application filed on January 22, 2004, which claims priority from a provisional patent application filed on January 23, 2003[4].
- US13/155,493: Another continuation-in-part application filed on June 8, 2011, which also claims priority from the same provisional patent application[4].
Citations and Prior Art
The patent cites several prior art documents, including patents related to steroid formulations and stabilizers. For example:
- US4344940A: A patent by E. R. Squibb & Sons, Inc., related to steroid formulations containing dipotassium EDTA[4].
- JPS6124518A: A Japanese patent by Kao Corp, related to remedies for hemorrhoids[5].
Patent Expiration and Status
The patent is currently active and is set to expire in 2025, based on the filing date and the standard patent term[4].
Impact on Patent Quality and Scope
The debate over patent quality and scope is relevant here. The patent's claims are specific and narrowly defined, which aligns with the trend observed in patent examination processes where narrower claims are associated with a higher probability of grant and a shorter examination process[3].
Industry Relevance
This patent is significant in the pharmaceutical industry, particularly for companies like Bausch Health Americas Inc., which own drugs like Locoid that may benefit from stabilized steroid compositions[2].
Conclusion
United States Patent 7,981,877 B2 provides a critical solution for stabilizing hydrocortisone compounds, enhancing their shelf life and efficacy. The patent's scope and claims are well-defined, focusing on the use of omega-6 acids and their esters as stabilizers. The broader patent landscape shows a series of related applications and citations that underscore the importance of this invention in the pharmaceutical field.
Key Takeaways
- The patent addresses the stabilization of 17-substituted hydrocortisone compounds using omega-6 acids or their esters.
- Key claims include the use of safflower oil as a stabilizer and specific concentration ratios.
- The method of preparation involves mixing the steroid compound with the stabilizer.
- The patent is part of a series of related applications and citations.
- The patent's narrow claims align with best practices in patent quality and scope.
Frequently Asked Questions (FAQs)
What is the main purpose of United States Patent 7,981,877 B2?
The main purpose is to provide a method and composition for stabilizing 17-substituted hydrocortisone compounds, specifically hydrocortisone 17-butyrate, using omega-6 acids or their esters.
What is the role of omega-6 acids in this patent?
Omega-6 acids, such as those found in safflower oil, act as stabilizers to prevent isomerization and degradation of the hydrocortisone compounds.
When is the patent set to expire?
The patent is set to expire in 2025, based on the filing date and standard patent term.
How does this patent relate to other pharmaceutical patents?
This patent is relevant to other pharmaceutical patents, especially those involving steroid formulations, and is part of a broader landscape of related applications and citations.
What are the implications of this patent for the pharmaceutical industry?
The patent enhances the stability and shelf life of hydrocortisone compounds, which is crucial for the effectiveness and safety of medications in the pharmaceutical industry.
Sources:
- United States Patent and Trademark Office. Stabilized steroid composition and method for its preparation. US Patent 7,981,877 B2, July 19, 2011.
- Pharsight. Locoid patent expiration. Retrieved from https://pharsight.greyb.com/drug/locoid-patent-expiration
- Hoover Institution. Patent Claims and Patent Scope. Retrieved from https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf
- Google Patents. Stabilized steroid composition and method for its preparation. US Patent 7,981,877 B2. Retrieved from https://patents.google.com/patent/US7981877B2/en
- PubChem. Remedy for hermorrhoids - Patent JP-S6124518-A. Retrieved from https://pubchem.ncbi.nlm.nih.gov/patent/JP-S6124518-A
