Understanding the Scope and Claims of United States Patent 7,553,479
Introduction
The United States Patent 7,553,479, hereafter referred to as the '479 patent, is a significant patent in the pharmaceutical sector, particularly related to the treatment of iron deficiencies. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
The '479 patent, titled "Pharmaceutical composition in a vial," is owned by AMAG Pharmaceuticals, Inc. and is listed in the FDA's Orange Book, which catalogues patents associated with approved drug products[2].
Claims of the '479 Patent
The '479 patent includes two claims, with Claim 1 being in independent form. This claim is directed to a specific pharmaceutical composition in a vial, designed for the treatment of iron deficiencies in patients with chronic kidney disease. The claims are narrowly defined to ensure the patent's validity and enforceability.
Disclosure and Invention
The disclosure of the '479 patent focuses on a pharmaceutical composition that includes a ferumoxytol formulation. This formulation is critical for the treatment of iron deficiency anemia in patients with chronic kidney disease. The patent details the specific composition and the method of preparation, ensuring that the invention is clearly described and distinguishable from prior art[2].
Continuation and Divisional Applications
The '479 patent is part of a larger patent family that includes continuation and divisional applications. For instance, the '864 patent and the '947 patent are continuation applications of the '597 patent, which shares the same disclosure as the '479 patent. This complex family structure highlights the strategic use of continuation procedures to extend the life and scope of the original patent[2].
Patent Scope and Quality
The scope of the '479 patent is a critical aspect of its analysis. Research suggests that narrower claims, such as those found in the '479 patent, are associated with a higher probability of grant and a shorter examination process. This is because narrower claims are more clearly defined and less likely to overlap with existing patents, reducing the risk of litigation and increasing the clarity of the patent's boundaries[3].
Examination Process
The examination process for the '479 patent would have involved several key steps, including the filing of the patent application, initial examination, and potential continuation procedures. The USPTO's data indicates that about 31% of progenitor applications utilize continuation procedures, which can significantly impact the final scope and allowance rate of the patent[1].
Allowance Rates
The allowance rate for patents like the '479 patent can be influenced by several factors, including the technology field, the entity size of the applicant, and the use of continuation procedures. For utility patents, the overall allowance rate varies, but the first-action allowance rate and the progenitor allowance rate provide insights into the likelihood of a patent being granted without further examination or continuation procedures[1].
Patent Landscape
The patent landscape surrounding the '479 patent is complex and involves multiple related patents. The '498 patent, '479 patent, and '597 patent each have distinct disclosures, while the '864 and '947 patents share the same disclosure as the '597 patent. This landscape is typical in the pharmaceutical industry, where multiple patents are often filed to protect different aspects of a single drug or treatment[2].
Litigation and Enforcement
The '479 patent has been involved in litigation, notably in the case of AMAG Pharmaceuticals, Inc. v. Sandoz, Inc. This case highlights the importance of patent enforcement in protecting intellectual property rights, particularly in the pharmaceutical sector where generic competition can significantly impact market share[2].
Global Patent System
The '479 patent is part of a global patent system that is increasingly interconnected. Tools like the Global Dossier and the Common Citation Document (CCD) facilitate the search and analysis of patent applications across different jurisdictions, ensuring that patent holders can manage their intellectual property rights more effectively[4].
Key Takeaways
- Narrow Claims: The '479 patent's narrow claims contribute to its higher likelihood of grant and shorter examination process.
- Continuation Procedures: The use of continuation and divisional applications extends the patent's life and scope.
- Patent Family: The '479 patent is part of a complex patent family with multiple related patents.
- Litigation: The patent has been involved in significant litigation to protect its intellectual property rights.
- Global Integration: The patent is part of a global system that facilitates cross-jurisdictional patent management.
FAQs
What is the primary invention described in the '479 patent?
The primary invention described in the '479 patent is a pharmaceutical composition in a vial, specifically a ferumoxytol formulation used to treat iron deficiencies in patients with chronic kidney disease.
How does the '479 patent relate to other patents in the AMAG Pharmaceuticals portfolio?
The '479 patent is part of a larger patent family that includes continuation and divisional applications, such as the '864 and '947 patents, which share the same disclosure as the '597 patent.
What is the significance of the '479 patent in the pharmaceutical industry?
The '479 patent is significant because it protects the intellectual property rights for a critical treatment for iron deficiency anemia in patients with chronic kidney disease, and its enforcement helps maintain market exclusivity.
How does the use of continuation procedures impact the '479 patent?
The use of continuation procedures allows the patent holder to extend the life and scope of the original patent, potentially leading to multiple related patents and complicating the calculation of progenitor allowance rates.
What tools are available for searching and analyzing patent applications like the '479 patent?
Tools such as the Global Dossier, Common Citation Document (CCD), and the USPTO Public Search Facility are available for searching and analyzing patent applications across different jurisdictions.
Sources
- Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. Yale Journal of Law and Technology.
- AMAG Pharms., Inc. v. Sandoz, Inc. (2017, July 19). Casetext.
- Patent Claims and Patent Scope (2016, September 29). SSRN.
- Search for patents - USPTO (2018, October 18). United States Patent and Trademark Office.
