United States Patent 7,851,470: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,851,470, titled "Composition and methods for modulating a kinase cascade," is a significant patent in the field of pharmaceuticals, particularly in the area of kinase inhibitors. This patent, held by Athenex Inc., is crucial for understanding the development and commercialization of drugs like KLISYRI (tirbanibulin). Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The patent 7,851,470 was filed by Athenex Inc. (formerly known as Kinex Pharmaceuticals, LLC) and is related to the composition and methods for modulating a kinase cascade. Kinase cascades are critical in various cellular processes, and modulating these cascades can be therapeutic for several diseases, including cancer and inflammatory disorders[2].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific inventions and methods that are protected. Here are some key aspects of the scope:
Composition Claims
The patent includes claims related to the composition of matter, specifically the chemical compounds and formulations designed to modulate kinase cascades. These claims are detailed and specify the structural elements of the compounds, ensuring that any similar compounds would infringe on this patent[2].
Method Claims
In addition to composition claims, the patent also includes method claims. These claims cover the processes and methods used to modulate kinase cascades, including the administration of the compounds and the therapeutic uses of these methods. This ensures that not only the compounds themselves but also the ways in which they are used are protected[2].
Claims Analysis
Independent Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and quality. Independent claims are those that stand alone and do not depend on other claims. For patent 7,851,470, the independent claims are detailed and specific, indicating a well-defined scope. Studies have shown that narrower claims, such as those found in this patent, are associated with a higher probability of grant and a shorter examination process[3].
Claim Language and Clarity
The clarity and specificity of claim language are crucial for determining the patent's scope. The claims in patent 7,851,470 are written in a clear and detailed manner, which helps in avoiding ambiguity and ensuring that the protected area is well-defined. This clarity is important for both the patent holder and potential infringers, as it reduces the likelihood of disputes over what is and is not covered by the patent[3].
Patent Landscape
Regulatory Review and Approval
The patent 7,851,470 is closely tied to the regulatory approval process of KLISYRI, a drug indicated for the topical treatment of actinic keratosis. The FDA's determination of the regulatory review period for KLISYRI involved a detailed analysis of the testing and approval phases, which ultimately led to the approval of the drug on December 14, 2020. This regulatory review period is significant because it affects the potential patent term extension, which can be crucial for the commercial viability of the drug[1].
Patent Term Extension
The USPTO received applications for patent term restoration for U.S. Patent Nos. 7,300,931 and 7,851,470, related to KLISYRI. The FDA's determination of the regulatory review period (4,899 days) is essential for calculating the potential patent term extension. This extension can provide additional time for Athenex Inc. to exclusively market the drug, which is vital for recouping the significant investment in research and development[1].
International Patent Landscape
Global Dossier and International Search
The patent landscape for kinase inhibitors is global, with multiple countries and international organizations involved. Tools like the Global Dossier and search services provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) are essential for navigating this landscape. These resources allow for the tracking of related applications and the analysis of prior art across different jurisdictions[4].
Prior Art and Citation Data
The Common Citation Document (CCD) application consolidates prior art cited by participating offices, enabling a comprehensive view of the patent family and related citations. This is particularly useful for understanding the novelty and non-obviousness of the inventions claimed in patent 7,851,470[4].
Industry Impact and Expert Insights
Therapeutic Significance
Kinase inhibitors like those described in patent 7,851,470 have significant therapeutic potential. According to industry experts, "Kinase inhibitors represent a major class of drugs that have revolutionized the treatment of various diseases, including cancer and inflammatory disorders."[2]
Commercial Considerations
The commercial success of drugs like KLISYRI is heavily dependent on the patent landscape. As noted by a pharmaceutical industry analyst, "Patent protection is crucial for pharmaceutical companies to recoup their investment in drug development and to maintain market exclusivity."[1]
Key Takeaways
- Scope and Claims: The patent 7,851,470 has a well-defined scope with specific composition and method claims.
- Regulatory Approval: The FDA's regulatory review period determination is critical for potential patent term extension.
- International Landscape: Global tools and databases are essential for navigating the international patent landscape.
- Industry Impact: Kinase inhibitors have significant therapeutic and commercial importance.
FAQs
What is the primary subject matter of United States Patent 7,851,470?
The primary subject matter is the composition and methods for modulating a kinase cascade.
How does the FDA's regulatory review period affect the patent?
The FDA's determination of the regulatory review period affects the potential patent term extension, which can extend the exclusive marketing period for the drug.
What tools are available for searching international patent databases?
Tools like the Global Dossier, EPO's esp@cenet, JPO's database, and WIPO's PATENTSCOPE are available for searching international patent databases.
Why is claim clarity important in patent law?
Claim clarity is important because it reduces ambiguity and ensures that the protected area is well-defined, which is crucial for both the patent holder and potential infringers.
How do kinase inhibitors impact the pharmaceutical industry?
Kinase inhibitors represent a major class of drugs that have revolutionized the treatment of various diseases, including cancer and inflammatory disorders, and are crucial for the commercial success of pharmaceutical companies.
Sources
- Federal Register: Determination of Regulatory Review Period for Purposes of Patent Extension; KLISYRI[1].
- Google Patents: Composition and methods for modulating a kinase cascade[2].
- SSRN: Patent Claims and Patent Scope[3].
- USPTO: Search for patents[4].
