United States Patent 11,077,106: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,077,106, issued on August 3, 2021, is a significant patent in the field of cancer treatment, particularly focusing on the use of erdafitinib. This patent is assigned to Janssen Pharmaceutica NV and involves a method for treating urothelial cancer. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Erdafitinib is a fibroblast growth factor receptor (FGFR) inhibitor, which has shown promise in treating various cancers, including urothelial cancer. The development and patenting of such targeted therapies are crucial for pharmaceutical companies to secure exclusive rights and protect their investments.
Scope of the Patent
The patent 11,077,106 describes a method for the treatment of urothelial cancer harboring at least one FGFR genomic alteration. This scope is narrowly defined to ensure that the patent covers a specific and innovative application of erdafitinib, rather than a broad and potentially invalid claim.
Claims
The patent includes several claims that define the boundaries of the invention:
- Method Claims: These claims outline the specific steps and conditions under which erdafitinib is administered to treat urothelial cancer. For example, claims may specify the dosage, administration route, and patient population[2].
- Composition Claims: These might include claims related to the pharmaceutical compositions containing erdafitinib, including any specific formulations or combinations with other drugs.
- Use Claims: These claims define the therapeutic use of erdafitinib, specifically its application in treating urothelial cancer with FGFR genomic alterations.
Patent Claims Analysis
The claims in this patent are crafted to balance breadth and specificity. Here are some key considerations:
Written Description Requirement
The patent claims must comply with the written description requirement under 35 U.S.C. ยง 112(a), which mandates that the specification must describe the invention in "such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same"[3].
Enablement Requirement
The enablement requirement ensures that the patent specification provides sufficient information to enable a person skilled in the art to make and use the invention without undue experimentation. This is particularly challenging for genus claims, where the Federal Circuit has adopted a more rigid approach, requiring patentees to make and test all species within a genus to ensure enablement[3].
Patent Landscape
The patent landscape surrounding erdafitinib and FGFR inhibitors is complex and highly competitive.
Related Patents
Other patents related to erdafitinib and quinoxaline derivatives, such as those assigned to Astex Therapeutics Ltd (e.g., Patents 8,895,601 and 9,464,071), cover similar compounds and their use in treating diseases like cancer. These patents highlight the ongoing research and development in this field[4].
Exclusivity and Market Protection
The patent 11,077,106 provides Janssen Pharmaceutica NV with exclusive rights to use erdafitinib for the specified treatment, protecting their market position. Additionally, FDA exclusivity periods can run concurrently with patent protection, further securing the drug's market exclusivity[4].
Challenges in Pharmaceutical Patents
Pharmaceutical patents, especially those involving biologics and targeted therapies, face unique challenges:
Genus Claims
The Federal Circuit's current stance on genus claims has made it difficult for pharmaceutical and biotechnology companies to obtain broad and meaningful patent protection. Innovators must navigate the fine line between claiming too broadly and risking invalidation, or claiming too narrowly and allowing competitors to design around the claims[3].
Market Impact
The market for therapeutic antibodies and targeted therapies is vast and growing, with estimates suggesting the market for therapeutic antibodies could reach $300 billion by 2025. Robust and predictable patent protection is crucial for innovators to recoup their significant investments in research and development[3].
Patent Expiration and Maintenance
The patent 11,077,106 is set to expire on February 2, 2038. Maintenance fees are crucial to keep the patent in force; failure to pay these fees can result in the patent expiring prematurely, as outlined in 35 U.S.C. 41 and 37 CFR 1.362(g)[1].
Conclusion
United States Patent 11,077,106 represents a significant advancement in the treatment of urothelial cancer using erdafitinib. The patent's scope and claims are carefully crafted to ensure compliance with patent laws while providing meaningful protection for the inventors.
Key Takeaways
- Specific Method Claims: The patent includes specific method claims for treating urothelial cancer with erdafitinib.
- Compliance with Patent Laws: The claims must comply with the written description and enablement requirements.
- Competitive Landscape: The patent landscape is highly competitive, with multiple related patents covering similar compounds.
- Market Protection: The patent provides exclusive rights and market protection for Janssen Pharmaceutica NV.
- Challenges in Pharmaceutical Patents: Innovators face challenges in balancing the breadth and specificity of claims to avoid invalidation.
Frequently Asked Questions (FAQs)
Q: What is the primary focus of United States Patent 11,077,106?
A: The primary focus is a method for the treatment of urothelial cancer harboring at least one FGFR genomic alteration using erdafitinib.
Q: Who is the assignee of this patent?
A: The assignee is Janssen Pharmaceutica NV.
Q: What are the key challenges in drafting patent claims for pharmaceuticals?
A: The key challenges include balancing the breadth and specificity of claims to comply with written description and enablement requirements while avoiding invalidation.
Q: How long does the patent protection for 11,077,106 last?
A: The patent is set to expire on February 2, 2038.
Q: What happens if maintenance fees for the patent are not paid?
A: Failure to pay maintenance fees can result in the patent expiring prematurely, as outlined in 35 U.S.C. 41 and 37 CFR 1.362(g)[1].
Cited Sources
- USPTO Notices: Patent and Trademark Office Notices - USPTO.
- Patents Gazette: Untitled - Patents Gazette.
- DigitalCommons@NYLS: Eviscerating Patent Scope - DigitalCommons@NYLS.
- Drugs.com: Generic Balversa Availability - Drugs.com.
