Understanding the Scope and Claims of United States Patent 7,893,074
Introduction
United States Patent 7,893,074, titled "2,4-PYRIMIDINEDIAMINES USEFUL IN THE TREATMENT OF NEOPLASTIC DISEASES, INFLAMMATORY AND IMMUNE SYSTEM DISORDERS," was granted on February 22, 2011. This patent is significant in the pharmaceutical industry, particularly in the development of treatments for various diseases. Here is a detailed analysis of its scope, claims, and the broader patent landscape.
Inventors and Assignees
The patent was invented by a team of researchers including Carlos Garcia-Echeverria, Takanori Kanazawa, Eiji Kawahara, Keiichi Masuya, Naoko Matsuura, Takahiro Miyake, Osamu Ohmori, Ichiro Umemura, Ruo Steensma, Greg Chopiuk, Jiqing Jiang, Yongqin Wan, Qiang Ding, Qiong Zhang, Nathanael Schiander Gray, and Donald Karanewsky. The assignees of the patent are Novartis AG and IRM LLC[1].
Patent Scope
The patent covers novel pyrimidine derivatives and their use in the treatment of neoplastic diseases, inflammatory, and immune system disorders. The compounds described have valuable pharmacological properties, making them potential candidates for various therapeutic applications.
Chemical Structure
The patent details the chemical structure of the pyrimidine derivatives, which are defined by the formula I. The significance of each substituent (R0, R6, R1, R2, etc.) is outlined, with preferences for certain groups such as Co-oaryl, Cso-heteroaryl, C-12cycloalkyl, or Coheterocycloalkyl[1].
Pharmacological Properties
The compounds are described as having valuable pharmacological properties, which are crucial for their therapeutic use. These properties are likely related to their ability to inhibit specific biological targets involved in disease processes.
Claims
The patent includes 9 claims that define the scope of the invention. Here are some key aspects of these claims:
Claim 1
Claim 1 is typically the broadest claim and defines the general structure of the pyrimidine derivatives. It sets the foundation for the subsequent claims by specifying the core chemical structure and the substituents that can be attached to it[1].
Dependent Claims
The dependent claims (Claims 2-9) narrow down the scope by specifying particular substituents, their positions, and other structural details. These claims provide a more detailed description of the preferred embodiments of the invention[1].
Patent Landscape
Related Patents
The patent cites several other patents and publications related to similar compounds and their uses. These include patents such as US 6,593,326 B1 and US 7,514,446 B2, which also deal with pharmaceutical compounds and their therapeutic applications[1].
Patent Scope Metrics
Research on patent scope, such as the work by Marco, Alan C., and Sarnoff, Joshua D., highlights the importance of metrics like independent claim length and independent claim count in measuring patent scope. These metrics can indicate the breadth and clarity of the patent claims, which are crucial for understanding the patent's impact on innovation and competition[3].
Litigation and Enforcement
The patent landscape is also influenced by litigation and enforcement practices. For instance, the USPTO's proposed changes to terminal disclaimer practices aim to reduce barriers to market entry and lower litigation costs by narrowing validity disputes and focusing claim construction hearings[5].
Impact on Pharmaceutical Industry
Therapeutic Applications
The compounds described in the patent have potential therapeutic applications in treating neoplastic diseases, inflammatory conditions, and immune system disorders. This aligns with the broader trend in pharmaceutical research, where targeted therapies are increasingly important[1].
Exclusivity and Generic Competition
The approval and exclusivity period for new chemical entities (NCEs) are critical in the pharmaceutical industry. The FDA's regulations on NCE exclusivity ensure that a new drug has a period of market exclusivity, which can be up to five years, or more if certain conditions are met. This exclusivity period is crucial for the economic viability of new drug development[4].
Future Implications
Regulatory Changes
Proposed changes by the USPTO, such as the new terminal disclaimer practices, could significantly impact how patents are prosecuted, licensed, and litigated. These changes are intended to promote competition and reduce litigation costs, which could affect the strategy and operations of pharmaceutical companies[5].
Innovation and Competition
The patent's scope and claims, along with broader patent landscape trends, influence innovation and competition in the pharmaceutical sector. Narrower claims at publication, for example, are associated with a higher probability of grant and a shorter examination process, which can accelerate the development and approval of new treatments[3].
Key Takeaways
- Novel Pyrimidine Derivatives: The patent covers new pyrimidine derivatives with potential therapeutic uses in treating neoplastic diseases, inflammatory conditions, and immune system disorders.
- Pharmacological Properties: The compounds have valuable pharmacological properties, making them candidates for various therapeutic applications.
- Claims Structure: The patent includes 9 claims that define the scope of the invention, with Claim 1 being the broadest and subsequent claims narrowing down the scope.
- Patent Landscape: The patent is part of a larger landscape influenced by related patents, litigation practices, and regulatory changes.
- Impact on Industry: The patent affects the pharmaceutical industry by providing new therapeutic options and influencing market exclusivity and competition.
FAQs
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What is the main subject of United States Patent 7,893,074?
- The main subject is novel pyrimidine derivatives and their use in treating neoplastic diseases, inflammatory conditions, and immune system disorders.
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Who are the inventors and assignees of the patent?
- The inventors include Carlos Garcia-Echeverria, Takanori Kanazawa, and others. The assignees are Novartis AG and IRM LLC.
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What are the key pharmacological properties of the compounds described in the patent?
- The compounds have valuable pharmacological properties, although the specific details are outlined in the patent's claims and descriptions.
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How do regulatory changes affect the patent landscape?
- Regulatory changes, such as the proposed terminal disclaimer practices, can impact prosecution, licensing, and litigation strategies, promoting competition and reducing litigation costs.
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What is the significance of the FDA's regulations on new chemical entities (NCEs)?
- The FDA's regulations ensure market exclusivity for NCEs, which is crucial for the economic viability of new drug development and affects generic competition.
Sources
- United States Patent and Trademark Office. 2,4-PYRIMIDINEDIAMINES USEFUL IN THE TREATMENT OF NEOPLASTIC DISEASES, INFLAMMATORY AND IMMUNE SYSTEM DISORDERS. US 7,893,074 B2, February 22, 2011.
- USPTO. Patent Claims Research Dataset. August 28, 2017.
- Marco, Alan C., Sarnoff, Joshua D., and deGrazia, Charles. Patent Claims and Patent Scope. SSRN, September 29, 2016.
- Seyfarth Shaw LLP. The BioLoquitur Bulletin: Drugs Available in 2018 For Generic Competition. 2018.
- Stern Kessler Goldstein & Fox P.L.L.C. United States Patent and Trademark Office Proposes Changes to Terminal Disclaimer Practice. May 17, 2024.
