Understanding the Scope and Claims of United States Patent 10,420,734
Introduction
United States Patent 10,420,734, filed by Duke University, is a significant patent in the field of pharmaceuticals, particularly focusing on methods for treating cancer using selective estrogen receptor modulators. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Patent Overview
The patent, titled "Method of treating cancer using selective estrogen receptor modulators," discloses methods for treating subjects suffering from estrogen receptor-positive cancer, especially in the brain, using specific compounds that modulate estrogen receptors[4].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific methods and compositions that are protected under the patent.
Independent Claims
Independent claims are crucial as they define the broadest scope of the invention. For US Patent 10,420,734, these claims typically include:
- Methods of treating estrogen receptor-positive cancer by administering a selective estrogen receptor modulator.
- Specific compounds and their use in therapeutic regimens.
Dependent Claims
Dependent claims further narrow down the scope by adding additional limitations to the independent claims. These might include:
- Specific dosages and administration routes of the selective estrogen receptor modulators.
- Combination therapies involving other cancer treatments.
Claim Language and Patent Scope
The language used in the claims is critical for determining the patent's scope. Research has shown that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Regulatory Review Period and Patent Term Extension
The patent's lifecycle is also influenced by regulatory processes. For instance, the FDA's determination of the regulatory review period for related drug products like ORSERDU (which involves similar regulatory pathways) can impact the patent term extension. The FDA has determined a regulatory review period of 2,965 days for ORSERDU, which includes both the testing and approval phases. This period can influence the maximum potential length of a patent extension, although the USPTO applies statutory limitations to calculate the actual extension period[1][5].
Due Diligence and Petitions
The process of obtaining a patent term extension involves demonstrating due diligence during the regulatory review period. Any interested person can petition the FDA to determine whether the applicant acted with due diligence. These petitions must comply with specific requirements, including being timely, containing sufficient facts, and being filed in the correct format[1][2].
Patent Landscape
The patent landscape for cancer treatments using selective estrogen receptor modulators is complex and evolving. This patent is part of a broader ecosystem that includes various other patents and ongoing research in the field.
Competing Patents
Other patents in this space may cover different aspects of cancer treatment, such as different compounds, administration methods, or combination therapies. For example, patents like US10420734B2 focus on specific methods of treating estrogen receptor-positive cancer, while others might cover broader or narrower aspects of cancer treatment[4].
Innovation and Litigation
The patent landscape in pharmaceuticals is often marked by innovation and litigation. Patents with broader claims can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation. However, narrower claims, as seen in US Patent 10,420,734, can help in maintaining clarity and validity, supporting a healthier innovation environment[3].
Illustrative Statistics and Expert Insights
The regulatory review period for pharmaceuticals is lengthy and complex. For instance, the regulatory review period for ORSERDU was 2,965 days, with 2,740 days in the testing phase and 225 days in the approval phase. This highlights the extensive time and resources involved in bringing a drug to market[1].
Key Takeaways
- Patent Scope: Defined by independent and dependent claims, with a focus on methods for treating estrogen receptor-positive cancer.
- Regulatory Review: The FDA's determination of the regulatory review period can significantly impact patent term extensions.
- Due Diligence: Petitions can be filed to determine whether the applicant acted with due diligence during the regulatory review period.
- Patent Landscape: Part of a complex ecosystem with competing patents and ongoing research in cancer treatments.
FAQs
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What is the main focus of United States Patent 10,420,734?
- The main focus is on methods for treating estrogen receptor-positive cancer using selective estrogen receptor modulators.
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How is the scope of the patent defined?
- The scope is defined by the independent and dependent claims outlined in the patent.
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What is the significance of the regulatory review period in patent term extension?
- The regulatory review period determines the maximum potential length of a patent extension, although statutory limitations apply.
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Can anyone petition the FDA regarding due diligence during the regulatory review period?
- Yes, any interested person can petition the FDA to determine whether the applicant acted with due diligence.
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How does the patent landscape impact innovation in cancer treatments?
- A balanced patent landscape with clear and valid claims can support innovation by reducing licensing and litigation costs.
Cited Sources
- Federal Register/Vol. 89, No. 179/Monday, September 16, 2024
- Federal Register, Volume 89 Issue 179 (Monday, September 16, 2024)
- Patent Claims and Patent Scope - Search eLibrary :: SSRN
- US10420734B2 - Method of treating cancer using selective estrogen receptor modulators - Google Patents
- Federal Register/Vol. 89, No. 179/Monday, September 16, 2024
