United States Patent 9,593,099: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,593,099, titled "Compounds and Compositions as Protein Kinase Inhibitors," was granted to Array BioPharma, Inc. on March 14, 2017. This patent is significant in the field of pharmaceuticals, particularly in the development of protein kinase inhibitors. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention
The patent describes compounds and compositions that act as protein kinase inhibitors. Protein kinases are enzymes that play crucial roles in various cellular processes, including cell signaling pathways. Inhibitors of these enzymes are often used in the treatment of diseases such as cancer, where abnormal kinase activity can lead to uncontrolled cell growth.
Scope of the Patent
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
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Compound Claims: The patent claims specific chemical compounds of Formula I, which are synthesized through the removal of protecting groups from precursor compounds. These compounds are designed to inhibit protein kinases, particularly those involved in cancer pathways[2].
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Composition Claims: The patent also claims compositions containing these compounds, often in combination with other therapeutic agents or excipients. These compositions are formulated for various administration routes, such as oral or parenteral routes[2].
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Method Claims: Additionally, the patent includes method claims for using these compounds and compositions in the treatment of diseases, such as cancer, where protein kinase inhibition is beneficial[2].
Dependent Claims
Dependent claims further narrow down the scope by specifying particular aspects of the compounds, compositions, or methods. For example, some claims specify the type of protein kinase targeted or the specific disease being treated.
Patent Landscape
Prior Art and Related Patents
The patent landscape around protein kinase inhibitors is highly competitive and densely populated. Several prior patents and applications relate to similar compounds and uses. For instance, patents such as US 6,037,136 A and US 6,204,467 B1, cited in the patent, describe other protein kinase inhibitors and their applications[2].
International Filings and Family Members
The patent is part of an international patent family, with filings in various jurisdictions. International Preliminary Reports on Patentability and International Search Reports are available for related international applications, indicating a global strategy for patent protection[2].
Regulatory and Legal Considerations
Patent Term Extensions
Array BioPharma Inc. has sought patent term extensions for this and related patents under 35 U.S.C. § 156, due to regulatory review periods associated with FDA approvals. However, the USPTO has clarified that only one patent can be extended for the same regulatory review period for any product, limiting the potential for multiple extensions[1].
Court Rulings and Interpretations
The Federal Circuit has provided guidance on the interpretation of patent term extensions, emphasizing that Congress did not intend to compensate for the loss of term for all patents affected by a regulatory review period. This limits the ability to extend multiple patents based on the same product approval[1].
Economic and Strategic Implications
Market Impact
The development and patenting of protein kinase inhibitors have significant market implications, particularly in the oncology sector. These compounds can offer new treatment options and potentially disrupt existing markets dominated by other therapies.
Competitive Landscape
The competitive landscape in this field is intense, with multiple pharmaceutical companies developing similar inhibitors. The patent landscape is crucial for companies to navigate, ensuring they do not infringe on existing patents while also protecting their own innovations.
Search and Analysis Tools
USPTO Resources
The USPTO provides several tools for searching and analyzing patents, including the Patent Public Search tool, Global Dossier, and the Patent Examination Data System (PEDS). These resources are essential for understanding the patent landscape and conducting thorough searches to avoid infringement[4].
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset offers detailed information on claims from US patents and applications, which can be used to analyze the scope and breadth of patent claims in the field of protein kinase inhibitors[3].
Key Takeaways
- Specific Compounds and Compositions: The patent covers specific chemical compounds and compositions designed to inhibit protein kinases.
- Method of Use: The patent includes methods for using these compounds in the treatment of diseases such as cancer.
- Regulatory Considerations: Only one patent can be extended for the same regulatory review period for any product.
- Competitive Landscape: The field of protein kinase inhibitors is highly competitive, with multiple companies developing similar therapies.
- Search and Analysis Tools: Utilizing USPTO resources and datasets is crucial for navigating the patent landscape.
FAQs
What is the main subject of United States Patent 9,593,099?
The main subject is compounds and compositions that act as protein kinase inhibitors.
Who is the assignee of this patent?
The assignee is Array BioPharma, Inc.
What is the significance of protein kinase inhibitors in medicine?
Protein kinase inhibitors are significant in the treatment of diseases such as cancer, where they can inhibit abnormal kinase activity.
Can multiple patents be extended for the same regulatory review period?
No, according to 35 U.S.C. § 156, only one patent can be extended for the same regulatory review period for any product.
What tools are available for searching and analyzing patents related to this field?
Tools include the USPTO's Patent Public Search, Global Dossier, PEDS, and the Patent Claims Research Dataset.
Cited Sources
- Lisa M. Hemmendinger, Ph.D. In Re: Patent Term Extension Banner & Witcoff, Ltd.
- United States Patent No.: US 9,593,099 B2
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
