Understanding the Scope and Claims of United States Patent 8,796,318
Introduction
United States Patent 8,796,318, titled "Modulators of Sphingosine Phosphate Receptors," is a significant patent in the field of pharmaceuticals and biotechnology. This patent, assigned to The Scripps Research Institute, involves the development of compounds that act as modulators of sphingosine phosphate receptors, particularly the S1P1 receptor subtype. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape it operates within.
Background on Sphingosine Phosphate Receptors
Sphingosine phosphate receptors are a class of G protein-coupled receptors that play crucial roles in various physiological processes, including immune responses, vascular integrity, and cell migration. The S1P1 receptor subtype is particularly important in these processes, making it a target for therapeutic interventions[4].
Patent Overview
Inventors and Assignees
The patent was invented by Edward Roberts, Hugh Rosen, Steven Brown, and Miguel A. Llano, among others, and is assigned to The Scripps Research Institute. This indicates that the research and development were likely funded by or conducted in collaboration with academic or research institutions[4].
Patent Claims
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
- Compound Claims: The patent claims cover specific chemical compounds that act as modulators of the S1P1 receptor. These compounds are described in detail, including their structural formulas and methods of preparation[4].
- Method Claims: In addition to the compounds themselves, the patent claims methods of using these compounds to treat various conditions. These methods include administering the compounds to patients to achieve therapeutic effects related to the modulation of S1P1 receptors[4].
Scope of Protection
The scope of protection for this patent is defined by the breadth and specificity of its claims. Here are a few key points:
- Specificity: The claims are specific to certain chemical structures and their use in modulating the S1P1 receptor. This specificity helps in distinguishing the invention from prior art and ensures that the patent does not overly broaden the scope of protection[4].
- Breadth: While the claims are specific, they also cover a range of compounds and methods, providing a broad enough scope to protect the inventors' contributions without being overly restrictive. This balance is crucial in pharmaceutical and biotechnology patents, where the ability to claim a genus of compounds can be vital for meaningful patent protection[3].
Patent Landscape and Challenges
Genus Claims and Patent Scope
In the pharmaceutical and biotechnology industries, genus claims are critical for capturing the full scope of an invention. However, recent jurisprudence, particularly from the Federal Circuit, has made it challenging to obtain and maintain broad genus claims. The requirement for a written description and enablement under 35 U.S.C. § 112(a) has become more stringent, making it difficult for innovators to claim the full scope of their inventions without violating these requirements[3].
Impact on Pharmaceutical and Biotechnology Industries
The rigid application of § 112(a) has significant implications for the pharmaceutical and biotechnology sectors. Innovators face a dilemma where claiming too broadly risks invalidation due to lack of enablement or written description, while claiming too narrowly allows competitors to design around the patent claims easily. This situation is particularly problematic in industries where billions of dollars are invested in developing new drugs and therapies[3].
Data and Statistics
- Patent Numbers: The patent in question is part of a larger dataset of pharmaceutical and biotechnology patents. For instance, between 1985 and 2022, 883 new molecular entities (NMEs) were approved, with 4,748 associated patents, of which 4,497 were unique[1].
- Government Funding: Some of these patents, including those related to sphingosine phosphate receptors, may have been developed with government funding. However, only a small percentage of these patents have government-interest statements, indicating the complexity in tracking and enforcing march-in rights under the Bayh-Dole Act[1].
Practical Applications and Future Directions
The compounds and methods described in this patent have potential therapeutic applications, particularly in treating conditions related to immune responses and vascular health. The development and commercialization of these compounds depend on robust and predictable patent protection, which is currently under scrutiny due to the evolving legal landscape.
Key Takeaways
- Specific Claims: The patent claims specific compounds and methods, ensuring a balanced scope of protection.
- Challenges in Genus Claims: The pharmaceutical and biotechnology industries face challenges in obtaining broad genus claims due to stringent legal requirements.
- Impact on Innovation: The current legal environment affects the ability of innovators to protect their inventions adequately, potentially hindering the development of new therapies.
- Government Funding: The role of government funding in patent development and the potential for march-in rights under the Bayh-Dole Act add another layer of complexity to the patent landscape.
FAQs
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What is the main focus of United States Patent 8,796,318?
- The patent focuses on modulators of sphingosine phosphate receptors, particularly the S1P1 receptor subtype.
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Who are the inventors and assignees of this patent?
- The inventors include Edward Roberts, Hugh Rosen, Steven Brown, and Miguel A. Llano, among others, and the patent is assigned to The Scripps Research Institute.
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What are the challenges in obtaining broad genus claims in pharmaceutical patents?
- The challenges include meeting the stringent requirements for written description and enablement under 35 U.S.C. § 112(a), which can make it difficult to claim the full scope of an invention without risking invalidation.
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How does government funding impact the patent landscape?
- Government funding can lead to government-interest statements in patents, which may allow for march-in rights under the Bayh-Dole Act, although this has never been exercised in practice.
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What is the potential therapeutic application of the compounds described in this patent?
- The compounds have potential therapeutic applications in treating conditions related to immune responses and vascular health.
Sources
- The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices - National Bureau of Economic Research.
- US8796318B2 - Modulators of sphingosine phosphate receptors - Google Patents.
- Eviscerating Patent Scope - DigitalCommons@NYLS.
- US 8,796,318 B2 - Modulators of sphingosine phosphate receptors - Google Patents.
