Understanding the Scope and Claims of United States Patent 9,861,713
Introduction
United States Patent 9,861,713, like many patents, involves a complex interplay of technological innovation, legal frameworks, and strategic patenting strategies. This analysis will delve into the key aspects of this patent, including its scope, claims, and the broader patent landscape it operates within.
Patent Overview
The patent in question, U.S. Patent No. 9,861,713, is associated with the human drug product known by the tradename PYLARIFY® (piflufolastat F18 injection), which was approved by the Food and Drug Administration (FDA)[2].
Scope of the Patent
The scope of a patent is defined by its claims, which outline the specific inventions or innovations that are protected. For U.S. Patent No. 9,861,713, the scope includes methods of manufacturing or using the drug product piflufolastat F18 injection.
Claim Structure
Patent claims can be broadly categorized into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. The structure and language of these claims are crucial in determining the patent's scope and validity[3].
Claims Analysis
To understand the claims of U.S. Patent No. 9,861,713, one must analyze the specific language and limitations included in each claim.
Independent Claims
Independent claims typically define the broadest scope of the invention. For example, if the patent includes claims related to the composition of piflufolastat F18, these would be independent claims that set the foundation for the patent's protection.
Dependent Claims
Dependent claims narrow down the scope by adding additional limitations to the independent claims. These could include specific methods of use, dosages, or formulations that further define the invention.
Practical Applications and Patent Eligibility
The recent USPTO guidance update on AI patents, though not directly related to pharmaceuticals, highlights the importance of practical applications in patent eligibility. This principle can be applied broadly: demonstrating how the claimed invention provides concrete benefits or solves specific problems is crucial. For U.S. Patent No. 9,861,713, the practical application would be the use of piflufolastat F18 injection in medical treatments, which provides tangible benefits such as improved diagnostic outcomes[1].
Patent Term Extension
The application for patent term extension (PTE) under 35 U.S.C. 156 is relevant here. This provision allows for the extension of a patent term if the product has been subject to a regulatory review period, such as FDA approval. The patent in question has been subject to such an application, indicating that the regulatory review process has impacted the patent's term[2].
Patent Landscape
The patent landscape for pharmaceuticals, particularly those involving FDA-approved drugs, is complex and highly regulated.
Regulatory Environment
The FDA approval process is a critical component of the patent landscape for pharmaceuticals. Patents like U.S. Patent No. 9,861,713 must navigate this regulatory environment to ensure that the product is both safe and effective before it can be marketed[2].
Competitor Patents
Understanding the patent landscape involves identifying similar patents held by competitors. This can be done through comprehensive patent searches using tools like the USPTO's Patent Public Search, Global Dossier, and other international patent databases[4].
Search and Analysis Tools
Several tools are available for searching and analyzing patents:
USPTO Resources
The USPTO provides various resources, including the Patent Public Search tool, Global Dossier, and the Public Search Facility. These tools help in identifying prior art, related applications, and the overall patent family[4].
International Databases
Databases from other international intellectual property offices, such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), are also essential for a comprehensive search[4].
Key Takeaways
- Scope and Claims: The patent's scope is defined by its claims, which must be carefully analyzed to understand the protected invention.
- Practical Applications: Demonstrating practical applications and tangible benefits is crucial for patent eligibility and validity.
- Regulatory Environment: FDA approval and regulatory review periods are critical for pharmaceutical patents.
- Patent Landscape: Understanding competitor patents and the broader patent landscape is essential for strategic patenting and innovation.
FAQs
Q: What is the significance of FDA approval in the context of U.S. Patent No. 9,861,713?
A: FDA approval is crucial as it affects the patent term extension under 35 U.S.C. 156 and ensures the product's safety and efficacy.
Q: How do dependent claims differ from independent claims in a patent?
A: Dependent claims narrow down the scope of the invention by adding additional limitations to the independent claims.
Q: What tools are available for searching and analyzing patents?
A: Tools include the USPTO's Patent Public Search, Global Dossier, Public Search Facility, and international databases like EPO, JPO, and WIPO.
Q: Why is demonstrating practical applications important for patent eligibility?
A: Demonstrating practical applications shows that the claimed invention provides concrete benefits, transforming abstract ideas into patent-eligible subject matter.
Q: How does the regulatory review period impact the patent term?
A: The regulatory review period can lead to a patent term extension under 35 U.S.C. 156, as seen in the application for U.S. Patent No. 9,861,713.
Sources
- Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz
- Application for Patent Term Extension - Regulations.gov
- Patent Claims and Patent Scope - SSRN
- Search for Patents - USPTO
