United States Patent 10,799,505: A Detailed Analysis of Scope and Claims
Overview of the Patent
United States Patent 10,799,505, titled "Crystalline Form of (S)-N-(5-((R)-2-(2,5-Difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxy pyrrolidine-1-carboxamide hydrogen sulfate," was granted to Array BioPharma, Inc. on October 13, 2020. This patent is part of a broader portfolio related to pharmaceutical compounds, particularly those used in cancer treatment.
Patent Scope and Claims
Understanding Patent Scope
The scope of a patent is crucial as it defines the legal boundaries of what is protected. A broader patent scope generally offers more protection against infringers because it is harder to design around[3].
First Independent Claim
The first independent claim of a patent is often considered the most indicative of its scope. For US Patent 10,799,505, the first claim describes a specific crystalline form of a compound, which is a key aspect of the invention. The longer and more detailed the first claim, the narrower the patent scope tends to be, as it specifies more conditions that must be met to infringe the patent[3].
Claim Structure
The patent includes 15 claims, which can be categorized into independent and dependent claims. Independent claims define the broadest scope of the invention, while dependent claims are narrower and serve as fallback positions in case the independent claims are invalidated. The structure of these claims is designed to ensure comprehensive protection of the invention while adhering to patent office requirements[3].
Specific Claims of US Patent 10,799,505
Independent Claims
- The patent includes several independent claims that describe different aspects of the crystalline form of the compound, including its chemical structure, crystalline form, and pharmaceutical compositions containing this compound.
- For example, Claim 1 describes a specific crystalline form of the compound, while subsequent independent claims may cover different formulations or methods of preparation[1].
Dependent Claims
- Dependent claims build upon the independent claims by adding additional limitations or specifications. These claims are narrower and provide additional protection by covering specific variations of the invention.
- For instance, a dependent claim might specify a particular method of synthesizing the crystalline form or a specific use of the compound in a pharmaceutical composition[1].
Patent Landscape
Related Patents and Exclusivities
US Patent 10,799,505 is part of a larger patent portfolio held by Array BioPharma, Inc. This portfolio includes multiple patents related to similar compounds and their uses in cancer treatment. The patent landscape is complex, with various patents expiring at different times, which can impact the overall exclusivity period of the drug.
Patent Expiration and Maintenance
The patent is subject to maintenance fees, which have been paid to extend its term. For example, a maintenance fee for the 4th year was paid on March 27, 2024[2].
The estimated expiration date for this patent is around 2036, based on the patent's issue date and the typical term of a U.S. patent[2].
Competitive Landscape
The pharmaceutical industry, particularly in the area of cancer treatment, is highly competitive. Patents like US 10,799,505 play a critical role in protecting intellectual property and preventing competitors from producing similar drugs. The scope and claims of this patent are designed to ensure that any potential competitors must significantly differentiate their products to avoid infringement[3].
Impact on Drug Development
Larotrectinib and Similar Compounds
The compound described in US Patent 10,799,505 is related to larotrectinib, a tyrosine kinase inhibitor used in the treatment of solid tumors with specific mutations. The patent's scope ensures that Array BioPharma, Inc. maintains exclusivity over this specific crystalline form, which is crucial for the drug's efficacy and stability[4].
Clinical and Therapeutic Implications
The protection afforded by this patent allows the company to invest in further research and development without the immediate threat of generic competition. This is particularly important in the field of cancer treatment, where small variations in drug formulation can have significant clinical implications.
Key Takeaways
- Patent Scope: The scope of US Patent 10,799,505 is defined by its first independent claim, which describes a specific crystalline form of a compound.
- Claims Structure: The patent includes both independent and dependent claims, with the former defining the broadest scope and the latter providing additional, narrower protection.
- Patent Landscape: The patent is part of a larger portfolio and is subject to maintenance fees, with an estimated expiration date in 2036.
- Competitive Impact: The patent protects Array BioPharma, Inc.'s intellectual property, preventing competitors from producing similar drugs without significant differentiation.
- Clinical Implications: The patent's protection is crucial for the development and exclusivity of specific drug formulations used in cancer treatment.
FAQs
What is the main subject of US Patent 10,799,505?
The main subject of US Patent 10,799,505 is a specific crystalline form of a compound used in pharmaceutical compositions, particularly for cancer treatment.
How is the scope of a patent measured?
The scope of a patent is often measured by the length and complexity of its first independent claim. Longer claims typically indicate a narrower scope[3].
What is the estimated expiration date of US Patent 10,799,505?
The estimated expiration date of US Patent 10,799,505 is around 2036, based on the patent's issue date and maintenance fees[2].
How does this patent impact the development of cancer treatments?
This patent ensures that Array BioPharma, Inc. maintains exclusivity over a specific crystalline form of a compound, allowing the company to invest in further research and development without immediate generic competition[4].
What is the relationship between this patent and larotrectinib?
The compound described in US Patent 10,799,505 is related to larotrectinib, a tyrosine kinase inhibitor used in cancer treatment. The patent protects a specific crystalline form of a similar compound, ensuring its exclusivity and stability[4].
Sources
- United States Patent and Trademark Office, "Crystalline Form of (S)-N-(5-((R)-2-(2,5-Difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxy pyrrolidine-1-carboxamide hydrogen sulfate," US Patent 10,799,505 B2, October 13, 2020.
- Pharsight, "Vitrakvi patent expiration," https://pharsight.greyb.com/drug/vitrakvi-patent-expiration.
- Boston University Law, "The Ways We've been Measuring Patent Scope are Wrong: How to Measure and Draw Causal Inferences with Patent Scope," https://www.bu.edu/law/files/2017/10/The-Ways-Weve-Been-Measuring-Patent-Scope-Are-Wrong-How-to-Measure-and-Draw-Causal-Inferences-with-Patent-Scope.pdf.
- DrugBank, "Larotrectinib: Uses, Interactions, Mechanism of Action," https://go.drugbank.com/drugs/DB14723.
