United States Patent 8,377,921: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,377,921, titled "Compounds and compositions as protein kinase inhibitors," is a significant patent in the pharmaceutical sector, particularly in the field of cancer treatment. This patent, assigned to IRM LLC, covers novel pyrimidine and pyridine derivatives and their use as protein kinase inhibitors. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent was filed on July 18, 2011, and granted on February 19, 2013. It is associated with the drug ceritinib, marketed under the name ZYKADIA, which is used for the treatment of non-small cell lung cancer (NSCLC) with a specific genetic mutation[4][5].
Scope of the Patent
Claim Structure
The patent includes a series of claims that define the scope of the invention. These claims are categorized into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims further limit the scope of the independent claims.
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Independent Claims: These claims describe the novel compounds, specifically pyrimidine and pyridine derivatives, and their pharmaceutical compositions. For example, Claim 1 describes a compound of a specific structural formula, which is a key aspect of the invention[4].
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Dependent Claims: These claims provide additional details and limitations to the independent claims. They may include specific substituents, methods of preparation, and uses of the compounds.
Claim Language and Metrics
The scope of the patent can also be analyzed using metrics such as independent claim length and independent claim count. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. The examination process often narrows the scope of patent claims in terms of both claim length and claim count[3].
Claims Analysis
Compound Claims
The patent claims cover a range of compounds, including those with specific functional groups and structural elements. For instance, the claims describe compounds with isopropoxy, phenyl, and methyl groups, among others. These compounds are designed to inhibit protein kinases, which are enzymes involved in various cellular processes, including those related to cancer[4].
Pharmaceutical Compositions
The patent also claims pharmaceutical compositions containing these compounds. These compositions are formulated for various routes of administration and are intended for the treatment of diseases such as non-small cell lung carcinoma, anaplastic large-cell lymphoma, and neuroblastoma[4].
Methods of Use
The claims extend to methods of using these compounds and compositions for therapeutic purposes. This includes the treatment of specific cancers and other diseases where protein kinase inhibition is beneficial[4].
Patent Landscape
Related Patents and Applications
The patent landscape surrounding US 8,377,921 includes other patents and applications related to protein kinase inhibitors and cancer treatments. For example, patents filed by Novartis AG, such as US 7,964,592, also cover ceritinib and its use in treating cancer. These patents are part of a broader family of patents that collectively protect the intellectual property related to ceritinib[2][5].
International Patent Family
The patent is part of an international patent family, with corresponding applications filed in various countries. Tools like the Global Dossier and Common Citation Document (CCD) can be used to track the status and citations of these related applications across different intellectual property offices[1].
Regulatory Environment
The patent term extension applications for US 8,377,921 and related patents are significant in the regulatory environment. These extensions, filed under 35 U.S.C. § 156, are related to the regulatory review period of the drug by the FDA. The FDA's determination of the regulatory review period and the subsequent patent term extension are crucial for maintaining the exclusivity of the drug in the market[2][5].
Search and Analysis Tools
To conduct a thorough analysis of the patent landscape, several tools are available:
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Patent Public Search: This tool provides enhanced access to prior art and is useful for searching existing patents and published patent applications[1].
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Global Dossier: This service allows users to view the file histories of related applications from participating IP Offices, which is helpful in understanding the international patent family[1].
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Common Citation Document (CCD): This application consolidates citation data from participating IP Offices, enabling a comprehensive view of the prior art cited for the patent family[1].
Key Takeaways
- Scope and Claims: The patent covers novel pyrimidine and pyridine derivatives as protein kinase inhibitors, along with their pharmaceutical compositions and methods of use.
- Patent Landscape: The patent is part of a broader family of patents related to ceritinib and is subject to international patent filings and regulatory extensions.
- Regulatory Environment: The patent term extension is critical for maintaining exclusivity, and tools like the Global Dossier and CCD are essential for tracking the international patent family.
- Search and Analysis Tools: Utilizing tools like Patent Public Search, Global Dossier, and CCD is vital for a comprehensive analysis of the patent landscape.
FAQs
What is the main subject of United States Patent 8,377,921?
The main subject of this patent is the novel pyrimidine and pyridine derivatives and their use as protein kinase inhibitors, particularly in the treatment of cancer.
What is the drug associated with this patent?
The drug associated with this patent is ceritinib, marketed under the name ZYKADIA, used for treating non-small cell lung cancer (NSCLC) with a specific genetic mutation.
How can one track the international patent family of this patent?
Tools like the Global Dossier and Common Citation Document (CCD) can be used to track the status and citations of related applications across different intellectual property offices.
What is the significance of the patent term extension for this patent?
The patent term extension, filed under 35 U.S.C. § 156, is related to the regulatory review period of the drug by the FDA and is crucial for maintaining the exclusivity of the drug in the market.
What tools are available for conducting a thorough analysis of the patent landscape?
Tools such as Patent Public Search, Global Dossier, and Common Citation Document (CCD) are available for conducting a thorough analysis of the patent landscape.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- FDA U.S. FOOD & DRUG Re: ZYKADIA Patent: https://downloads.regulations.gov/FDA-2015-E-2655-0007/attachment_1.pdf
- Patent Claims and Patent Scope - Hoover Institution: https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf
- US8377921B2 - Compounds and compositions as protein kinase inhibitors - Google Patents: https://patents.google.com/patent/US8377921B2/en
- Patent Extension Application for ZYKADIA™ Patent No. 8,377,921: https://www.regulations.gov/docket/FDA-2015-E-2656
