United States Patent 10,292,990: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,292,990, titled "Abiraterone steroid formulation," is a significant patent in the pharmaceutical industry, particularly in the treatment of castration-resistant prostate cancer. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Abiraterone Acetate
Abiraterone acetate, the subject of this patent, is a prodrug of abiraterone, which is approved in the United States for the treatment of castration-resistant prostate cancer. This drug works by inhibiting the enzyme CYP17, which is crucial in the biosynthesis of androgens, thereby reducing the levels of testosterone and other androgens that can fuel the growth of prostate cancer cells[1].
Scope of the Patent
The patent covers specific formulations of abiraterone acetate, focusing on the composition and method of preparation. Here are some key aspects:
Composition
The patent describes formulations that include abiraterone acetate, along with other components such as sodium lauryl sulfate, methylprednisolone, and various excipients. These formulations are designed to enhance the bioavailability and stability of the drug[1].
Method of Preparation
The method involves milling or grinding the active ingredients and excipients to achieve a uniform particle size, which is crucial for consistent drug delivery. The patent also details the process of encapsulating the formulation in capsules or other dosage forms[1].
Claims of the Patent
The claims of the patent are critical in defining the scope of protection. Here are some key claims:
Independent Claims
- Claim 1 describes a pharmaceutical composition comprising abiraterone acetate, sodium lauryl sulfate, and a glucocorticoid, such as methylprednisolone[1].
Dependent Claims
- These claims further specify the proportions of the components, the particle size of the active ingredients, and the method of preparing the formulation[1].
Patent Landscape
Understanding the patent landscape is essential for navigating the intellectual property rights surrounding abiraterone acetate formulations.
Related Patents
- Other patents related to abiraterone acetate formulations may exist, but this patent stands out due to its specific focus on the composition and method of preparation. For instance, patents related to different dosage forms or delivery mechanisms might be part of the broader landscape[1].
Expiration and Generic Entry
- The patent's expiration date is crucial for generic manufacturers. As of the current date, the patent is still active, but its expiration will open the market for generic versions of the drug. According to patent databases, the expiration date for this patent would typically be around 20 years from the priority date, assuming no extensions or terminal disclaimers[5].
Legal and Regulatory Aspects
The validity and enforceability of the patent are subject to legal and regulatory scrutiny.
Obviousness and Double Patenting
- Issues such as obviousness-type double patenting can arise, especially if there are multiple patents claiming similar inventions. However, this patent's unique claims and specifications help distinguish it from other related patents[2].
FDA Approval
- The FDA approval process is a critical step for any pharmaceutical drug. The approval of abiraterone acetate formulations under this patent ensures that the drug meets safety and efficacy standards set by regulatory bodies[2].
Impact on the Pharmaceutical Industry
The patent has significant implications for the pharmaceutical industry.
Market Dominance
- The exclusive rights granted by this patent allow the patent holder to dominate the market for abiraterone acetate formulations until the patent expires. This can impact competition and pricing in the market[5].
Research and Development
- The patent can also influence research and development in the field. Other companies may need to develop alternative formulations or delivery methods to avoid infringing on the patented claims[1].
Conclusion
United States Patent 10,292,990 is a pivotal patent in the treatment of castration-resistant prostate cancer. Its scope and claims are carefully defined to protect specific formulations and methods of preparation of abiraterone acetate. Understanding the patent landscape, including related patents, expiration dates, and legal aspects, is crucial for both the patent holder and potential competitors.
Key Takeaways
- Specific Formulations: The patent covers specific formulations of abiraterone acetate, including the composition and method of preparation.
- Claims: The claims are detailed and include both independent and dependent claims that specify the proportions and preparation methods.
- Patent Landscape: The patent is part of a broader landscape that includes other related patents and regulatory approvals.
- Expiration and Generic Entry: The patent's expiration date is critical for generic manufacturers.
- Legal and Regulatory Aspects: The patent's validity and enforceability are subject to legal scrutiny, including issues of obviousness and double patenting.
FAQs
What is the primary use of abiraterone acetate?
Abiraterone acetate is primarily used for the treatment of castration-resistant prostate cancer.
What are the key components of the patented formulation?
The formulation includes abiraterone acetate, sodium lauryl sulfate, and a glucocorticoid such as methylprednisolone.
How is the formulation prepared?
The formulation involves milling or grinding the active ingredients and excipients to achieve a uniform particle size, followed by encapsulation in capsules or other dosage forms.
What is the significance of the patent's expiration date?
The expiration date marks the end of the exclusive rights granted to the patent holder, allowing generic manufacturers to enter the market.
How does the patent impact the pharmaceutical industry?
The patent allows the holder to dominate the market for abiraterone acetate formulations until expiration, influencing competition and pricing, and guiding research and development in the field.
Sources
- US10292990B2 - Abiraterone steroid formulation - Google Patents
- ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD. - CAFC
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- Pharmaceutical drugs covered by patent 10,292,990 - DrugPatentWatch
