Understanding the Scope and Claims of United States Patent 8,911,786
Introduction
United States Patent 8,911,786, titled "Nanoparticle comprising rapamycin and albumin as anticancer agent," is a significant patent in the field of oncology and pharmaceuticals. This patent, held by Aadi Bioscience, Inc., involves the use of nanoparticles to deliver rapamycin, a well-known anticancer agent, bound to albumin. Here, we delve into the details of the patent's scope, claims, and the broader patent landscape.
Background and Context
The patent was approved by the FDA for the marketing of FYARRO, a sirolimus protein-bound injectable suspension indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor[1].
Patent Scope and Claims
Invention Overview
The patent describes methods for treating, stabilizing, preventing, and/or delaying cancer using nanoparticles that comprise rapamycin (also known as sirolimus) and albumin. These nanoparticles are designed to enhance the delivery and efficacy of rapamycin as an anticancer agent[4].
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- Composition: The nanoparticles comprising rapamycin and albumin.
- Methods: The methods for treating various cancers, including breast cancer, prostate cancer, lung cancer, and others, using these nanoparticles.
- Dosage Forms: The specific formulations and dosage forms of the nanoparticles[4].
Dependent Claims
Dependent claims further specify the details of the composition, methods of treatment, and the characteristics of the nanoparticles. These claims include:
- Specific Diseases: Treatment of specific types of cancers such as renal cell carcinoma, brain neoplasms, and multiple myelomas.
- Therapeutic Procedures: Combination therapies involving the nanoparticles along with other treatments like chemotherapy and hormone therapy[4].
Patent Term Restoration
The patent term for U.S. Patent 8,911,786 has been subject to restoration under the Drug Price Competition and Patent Term Restoration Act of 1984. This act allows for the extension of a patent term if the product was subject to regulatory review by the FDA before it was marketed. The FDA verified the regulatory review period for FYARRO, which included a testing phase starting on January 26, 2007, and an approval phase ending on November 22, 2021. Based on this, the USPTO is considering an extension of up to 1,357 days for the patent term[1].
Patent Landscape
Competitive Environment
The patent landscape for anticancer agents is highly competitive, with numerous patents covering various aspects of cancer treatment. The use of nanoparticles for drug delivery is a growing area, with several companies and research institutions exploring similar technologies[4].
Patent Scope Metrics
Research on patent scope suggests that the breadth and clarity of patent claims are crucial. Metrics such as independent claim length and independent claim count can indicate the scope and quality of a patent. Narrower claims, as seen in the examination process of this patent, are often associated with a higher probability of grant and shorter examination processes[3].
Regulatory Aspects
The approval and regulatory review process for FYARRO involved extensive verification by the FDA. The dates of the investigational new drug application, new drug application submission, and approval were critical in determining the patent term restoration. Any inaccuracies in these dates could lead to petitions for redetermination by interested parties[1].
Industry Impact
The approval of FYARRO and the associated patent have significant implications for the treatment of rare and aggressive cancers. The use of nanoparticles to deliver rapamycin enhances the therapeutic efficacy and reduces the side effects associated with traditional delivery methods. This innovation can drive further research and development in targeted cancer therapies[4].
Expert Insights
Industry experts highlight the importance of precise and narrow patent claims to avoid litigation and ensure clarity in the patent scope. For instance, "narrower claims at publication are associated with a higher probability of grant and a shorter examination process than broader claims," which underscores the strategic importance of claim drafting in patent applications[3].
Statistics and Examples
- Regulatory Review Period: The regulatory review period for FYARRO spanned over 14 years, from the initial investigational new drug application in 2007 to the final approval in 2021[1].
- Disease Coverage: The patent covers treatment methods for over 20 different types of cancers, including breast, prostate, lung, and renal cell carcinomas[4].
Key Takeaways
- Patent Scope: The patent covers the composition, methods, and dosage forms of nanoparticles comprising rapamycin and albumin for cancer treatment.
- Regulatory Approval: The FDA approved FYARRO, and the patent term is subject to restoration under the Drug Price Competition and Patent Term Restoration Act.
- Competitive Landscape: The patent operates in a highly competitive environment with ongoing research in nanoparticle drug delivery.
- Regulatory Aspects: The patent term restoration is based on the verified regulatory review period.
- Industry Impact: The innovation enhances cancer treatment efficacy and drives further research in targeted therapies.
Frequently Asked Questions (FAQs)
Q: What is the primary invention described in U.S. Patent 8,911,786?
A: The primary invention involves nanoparticles comprising rapamycin and albumin for treating various cancers.
Q: What is the significance of the FDA approval for FYARRO?
A: The FDA approval of FYARRO marks the first permitted commercial marketing or use of this specific nanoparticle formulation, which is crucial for the patent term restoration.
Q: How is the patent term restoration calculated for this patent?
A: The patent term restoration is calculated based on the regulatory review period, which includes the testing and approval phases verified by the FDA.
Q: What metrics are used to measure the scope of a patent?
A: Metrics such as independent claim length and independent claim count are used to measure the scope and quality of a patent.
Q: What is the competitive landscape like for this patent?
A: The patent operates in a highly competitive environment with numerous other patents and ongoing research in nanoparticle drug delivery technologies.
Cited Sources:
- Federal Register/Vol. 89, No. 43/Monday, March 4, 2024/Notices
- DrugPatentWatch - Patent 8,911,786
- SSRN - Patent Claims and Patent Scope
- Google Patents - US8911786B2
