United States Patent 11,504,365: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,504,365, titled "Use of tivozanib to treat subjects with refractory cancer," is a significant patent in the field of oncology, particularly focusing on the treatment of refractory cancer using the drug tivozanib. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background on Tivozanib
Tivozanib, marketed under the brand name Fotivda, is a tyrosine kinase inhibitor that targets vascular endothelial growth factor receptors (VEGFRs). It is primarily used in the treatment of advanced renal cell carcinoma and other types of cancer[1][2].
Scope of the Patent
The patent 11,504,365 covers methods for treating cancer, specifically refractory cancer, using tivozanib. Here are the key aspects of the patent's scope:
- Treatment Methods: The patent describes various methods of administering tivozanib to patients with refractory cancer. This includes second-line and third-line therapies, indicating its use after other treatments have failed[1].
- Targeted Therapy: The patent emphasizes tivozanib's mechanism of action as a tyrosine kinase inhibitor, specifically targeting VEGFRs to inhibit angiogenesis, which is crucial for tumor growth[1].
Claims of the Patent
The claims of the patent are detailed and specific, ensuring broad protection for the use of tivozanib in cancer treatment:
- Administration Claims: The patent includes claims related to the administration of tivozanib, such as dosage regimens, treatment schedules, and combinations with other therapies[1].
- Patient Population: The claims specify the patient population, including those with refractory cancer who have not responded to previous treatments[1].
- Therapeutic Effects: Claims also cover the therapeutic effects of tivozanib, including survival benefits and reduction in tumor size[1].
Patent Landscape
Understanding the patent landscape is crucial for assessing the patent's strength and potential challenges.
Related Patents
- Patent 6,821,987: This patent, which has expired, relates to quinoline and quinazoline derivatives with antitumor activity. While it does not directly impact the current patent, it shows the broader context of research in tyrosine kinase inhibitors[4].
- Other Related Patents: Patents like 7,166,722, which also relate to tivozanib or similar compounds, are part of the broader patent landscape. These patents may have overlapping claims or expiration dates that could affect the market availability of generic versions[2].
Exclusivity and Patent Expiration
- Patent Expiration: The patent 11,504,365 is set to expire on November 5, 2039. This provides a significant period of exclusivity for the patent holder[2].
- Exclusivity: In addition to patent protection, the FDA has granted exclusivity until March 10, 2026, as a new chemical entity. This ensures that the patent holder has exclusive marketing rights during this period[2].
Impact on Cancer Treatment
The patent's impact on cancer treatment is substantial:
- Refractory Cancer: Tivozanib offers a treatment option for patients with refractory cancer, who have limited therapeutic alternatives. The patent's claims ensure that this treatment remains protected and available under the brand name Fotivda[1].
- Clinical Significance: The therapeutic effects of tivozanib, as described in the patent, include improved survival rates and reduced tumor growth. This makes it a valuable addition to the arsenal of cancer treatments[1].
Industry and Market Implications
The patent has significant implications for the pharmaceutical industry and the market:
- Generic Competition: The expiration of related patents and the exclusivity period ending in 2026 will pave the way for generic competition. However, the patent 11,504,365 will remain in force until 2039, protecting the brand name Fotivda during this period[2].
- Research and Development: The patent's focus on tyrosine kinase inhibitors encourages further research in this area, potentially leading to new and improved cancer therapies[1].
Legal and Regulatory Considerations
The patent is subject to various legal and regulatory considerations:
- Patent Litigation: The patent's validity and scope could be challenged through litigation. However, the detailed claims and the specific focus on tivozanib's use in refractory cancer provide strong protection[3].
- Regulatory Approvals: The FDA's approval and exclusivity grants are critical components of the patent's landscape. Any changes in regulatory policies could impact the patent's effectiveness[2].
Key Takeaways
- Tivozanib's Role: Tivozanib is a crucial treatment option for refractory cancer, protected by patent 11,504,365.
- Patent Scope: The patent covers specific methods of administering tivozanib and targets VEGFRs.
- Exclusivity and Expiration: The patent expires in 2039, with FDA exclusivity until 2026.
- Industry Impact: The patent affects the market availability of generic versions and encourages further research in tyrosine kinase inhibitors.
FAQs
What is the primary use of tivozanib as described in patent 11,504,365?
Tivozanib is used to treat subjects with refractory cancer, specifically targeting vascular endothelial growth factor receptors (VEGFRs) to inhibit tumor growth.
When does the patent 11,504,365 expire?
The patent 11,504,365 is set to expire on November 5, 2039.
What is the FDA exclusivity period for tivozanib?
The FDA has granted exclusivity until March 10, 2026, as a new chemical entity.
How does the patent impact the availability of generic versions of tivozanib?
The patent and FDA exclusivity ensure that generic versions of tivozanib will not be available until after the exclusivity period ends in 2026, and the patent expires in 2039.
What are the therapeutic effects of tivozanib as described in the patent?
The therapeutic effects include improved survival rates and reduction in tumor size, making it a valuable treatment option for patients with refractory cancer.
Sources
- US11504365B2 - Use of tivozanib to treat subjects with refractory cancer - Google Patents
- Generic Fotivda Availability - Drugs.com
- Mastering Patent Claim Construction - Digital Commons @ Touro Law
- US6821987B2 - Quinoline derivatives and quinazoline derivatives having azolyl group - Google Patents
