United States Patent 10,849,888: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,849,888, titled "Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer," is a significant patent in the field of oncology, particularly for the treatment of prostate cancer. This patent, assigned to Aragon Pharmaceuticals, Inc., outlines methods and compositions for treating a specific type of prostate cancer using anti-androgen therapies.
Background
Prostate cancer is a common malignancy among men, and its treatment often involves hormonal therapies, especially in cases where the cancer is castrate-resistant. The patent in question addresses a critical need in the treatment of non-metastatic castrate-resistant prostate cancer (nmCRPC), a stage where the cancer has not spread beyond the prostate but is no longer responsive to traditional hormone therapies.
Patent Overview
Applicant and Assignee
The patent was filed by Isan Chen, an inventor from San Diego, CA, and assigned to Aragon Pharmaceuticals, Inc., also based in San Diego, CA[4].
Patent Claims
The patent includes 15 claims that describe the methods and compositions for treating nmCRPC using anti-androgens. These claims are divided into various categories, including the specific anti-androgen compounds, their dosages, and the treatment regimens[4].
International Classification
The patent is classified under several international categories, including A61K 31/4439, A61K 31/4166, and A61K 31/00, which pertain to pharmaceutical preparations and therapeutic compositions[4].
Scope of the Patent
Independent Claims
The scope of the patent is defined by its independent claims, which are crucial for determining the patent's breadth and validity. Independent claims in this patent focus on the specific anti-androgen compounds and their use in treating nmCRPC. For instance, Claim 1 describes a method of treating nmCRPC by administering a specific anti-androgen compound[4].
Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can influence the patent's breadth and the likelihood of its grant. In this case, the patent has a moderate number of claims, which indicates a balanced approach between specificity and breadth[3].
Claims Analysis
Specific Compounds
The patent specifies several anti-androgen compounds, including those with methylbenzamide, oxo, and cyano groups. These compounds are designed to inhibit androgen receptors, which are critical for the growth and proliferation of prostate cancer cells[4].
Treatment Regimens
The claims also outline various treatment regimens, including dosages and administration schedules. This detailed approach ensures that the patent covers a range of therapeutic options, enhancing its utility and scope[4].
Patent Landscape
Related Patents
The patent is part of a larger family of patents related to the treatment of prostate cancer. It is a continuation of earlier applications, such as application No. 15/851,444, and is linked to other patents like 10,052,314 and 9,884,054[4].
Expiration and Generic Entry
The patent's expiration date and potential generic entry are critical for understanding its commercial impact. As of the current date, the patent remains active, but its expiration will open the door for generic versions of the anti-androgen compounds[5].
Public Sector Involvement
Government Funding
While this specific patent does not indicate direct government funding, the broader context of pharmaceutical patents often involves public sector funding. Research has shown that a significant portion of pharmaceutical patents, especially those related to priority-review drugs, have some level of public sector involvement[2].
Impact on Innovation
Patent Quality and Scope
The debate on patent quality and scope is relevant here. The patent's claims are specific and well-defined, which is in line with best practices for maintaining patent quality. This specificity helps in reducing licensing and litigation costs, thereby promoting innovation[3].
Clinical Significance
Treatment of nmCRPC
The methods described in the patent are clinically significant as they provide new therapeutic options for patients with nmCRPC. Anti-androgen therapies have shown promise in delaying the progression of prostate cancer, improving patient outcomes[4].
Regulatory Considerations
FDA Approval
The patent's relevance is also tied to FDA approval processes. Drugs developed under this patent would need to undergo rigorous clinical trials and regulatory approvals before they can be marketed. The patent's claims must align with FDA guidelines to ensure the drug's safety and efficacy[2].
Economic Implications
Market Impact
The patent's expiration will have significant economic implications, particularly in terms of market competition. Generic versions of the anti-androgen compounds could enter the market, potentially reducing costs and increasing accessibility for patients[5].
Key Takeaways
- Specific Anti-androgen Compounds: The patent focuses on specific anti-androgen compounds for treating nmCRPC.
- Treatment Regimens: Detailed treatment regimens are outlined, including dosages and administration schedules.
- Patent Scope: The patent's scope is defined by its independent claims, which are specific and well-defined.
- Public Sector Involvement: While this patent does not indicate direct government funding, public sector involvement is common in pharmaceutical patents.
- Clinical Significance: The patent provides new therapeutic options for patients with nmCRPC.
- Regulatory Considerations: The patent must align with FDA guidelines for drug approval.
FAQs
Q: What is the primary focus of United States Patent 10,849,888?
A: The primary focus is on methods and compositions for treating non-metastatic castrate-resistant prostate cancer using anti-androgen therapies.
Q: Who is the assignee of this patent?
A: The patent is assigned to Aragon Pharmaceuticals, Inc.
Q: What are the key claims of this patent?
A: The key claims describe specific anti-androgen compounds and their use in treating nmCRPC, along with detailed treatment regimens.
Q: How does this patent impact innovation in the pharmaceutical industry?
A: The patent's specific and well-defined claims help in reducing licensing and litigation costs, thereby promoting innovation.
Q: When is the patent set to expire?
A: The exact expiration date is not specified in the provided sources, but it can be determined by checking the patent's details on the USPTO website.
Sources
- US10849888B2 - Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer - Google Patents
- The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices - NBER
- Patent Claims and Patent Scope - Hoover Institution
- United States Patent - googleapis.com
- Pharmaceutical drugs covered by patent 10,849,888 - Drug Patent Watch
