Understanding the Scope and Claims of United States Patent 8,901,349
Introduction
United States Patent 8,901,349, titled "Ferric organic compounds, uses thereof and methods of making same," is a significant patent in the field of pharmaceuticals, particularly related to the development of ferric citrate compounds. This patent, assigned to Panion & BF Biotech, Inc., is part of a series of patents that protect the intellectual property surrounding AURYXIA® (Ferric Citrate) Tablets. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Patent Overview
Inventors and Assignee
The patent was invented by David W.K. Kwok and Nikolay M. Stoynov, and it is assigned to Panion & BF Biotech, Inc.[4].
Filing and Grant Dates
The patent was granted on December 2, 2014, after being filed as part of a series of applications related to ferric organic compounds.
Scope of the Patent
Subject Matter
The patent covers ferric organic compounds, their uses, and the methods for making these compounds. Specifically, it focuses on ferric citrate, which is used in the treatment of iron deficiency and hyperphosphatemia in patients with chronic kidney disease.
Clinical Attributes
Ferric citrate, as described in the patent, has several clinical attributes that make it a valuable treatment option. It is effective in increasing iron levels and reducing phosphate levels in the blood, which is crucial for patients with chronic kidney disease[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the composition of the ferric organic compounds, the methods of preparing these compounds, and their therapeutic uses.
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the specific formulations, dosages, and administration methods of the ferric citrate compounds.
Patent Claims Analysis
Claim Structure
The claims are structured to provide broad protection for the invention while also allowing for specific variations and applications. For example, Claim 1 might define the general composition of the ferric citrate compound, while subsequent claims might specify different aspects such as the method of synthesis or the therapeutic application.
Claim Scope
The scope of the claims is critical in determining the patent's enforceability and the potential for infringement. The claims must be specific enough to define the invention clearly but broad enough to cover various embodiments and applications.
Patent Landscape
Related Patents
The patent 8,901,349 is part of a family of patents related to ferric citrate compounds. Other patents in this family include US Patent Nos. 7,767,851, 8,093,423, 8,299,298, 8,338,642, 8,609,896, and others. These patents collectively protect various aspects of the invention, including different formulations, methods of preparation, and therapeutic uses[4][5].
Litigation and Enforcement
The patents related to AURYXIA® have been involved in several litigation cases, particularly against generic drug manufacturers seeking to market similar products before the expiration of the patents. For instance, Keryx Biopharmaceuticals, Inc. and Panion & BF Biotech, Inc. have sued Teva USA for patent infringement related to the submission of Abbreviated New Drug Applications (ANDAs) for generic versions of AURYXIA®[2][5].
Allowance Rate and Patent Prosecution
General Trends
The allowance rate for patents in the pharmaceutical field, particularly for drugs and medical instruments, has been decreasing over time. According to a study by Carley, Hegde, and Marco, the overall allowance rate for utility patent applications without using continuation procedures was approximately 55.8% between 1996 and 2013. This trend suggests that the USPTO has become more stringent in granting patents, especially in complex fields like pharmaceuticals[1].
Continuation Procedures
The patent prosecution process for 8,901,349 and related patents likely involved continuation procedures, which allow applicants to introduce new subject matter or separate claimed inventions. These procedures can result in a chain of serialized continuations, complicating the calculation of progenitor allowance rates but ensuring comprehensive protection for the invention[1].
Economic and Market Impact
Market Dominance
Patents like 8,901,349 play a crucial role in maintaining market dominance for pharmaceutical companies. By protecting the intellectual property related to AURYXIA®, Panion & BF Biotech, Inc. and Keryx Biopharmaceuticals, Inc. can prevent generic competition and ensure significant revenue streams until the patents expire.
Revenue and Generic Competition
The economic impact of these patents is substantial. For example, Teva Ltd., a leading generic drug company, has significant revenues from generic medicines but faces legal challenges when attempting to enter markets protected by such patents. The litigation and enforcement actions related to these patents highlight the importance of intellectual property in the pharmaceutical industry[2].
Key Takeaways
- Patent Scope and Claims: The patent 8,901,349 covers ferric organic compounds, their uses, and methods of preparation, with specific claims defining the composition, therapeutic uses, and methods of synthesis.
- Related Patents: It is part of a family of patents protecting various aspects of ferric citrate compounds.
- Litigation and Enforcement: The patents have been involved in several litigation cases against generic drug manufacturers.
- Patent Landscape: The pharmaceutical field has seen a decrease in patent allowance rates, with continuation procedures playing a significant role in patent prosecution.
- Economic Impact: These patents are crucial for maintaining market dominance and preventing generic competition, resulting in significant economic benefits for the patent holders.
FAQs
Q: What is the main subject matter of US Patent 8,901,349?
A: The main subject matter is ferric organic compounds, specifically ferric citrate, their uses, and the methods for making these compounds.
Q: Who are the inventors and assignee of the patent?
A: The inventors are David W.K. Kwok and Nikolay M. Stoynov, and the assignee is Panion & BF Biotech, Inc.
Q: What is the clinical use of ferric citrate as described in the patent?
A: Ferric citrate is used in the treatment of iron deficiency and hyperphosphatemia in patients with chronic kidney disease.
Q: How does the patent fit into the broader patent landscape?
A: It is part of a family of patents related to ferric citrate compounds and has been involved in litigation to protect against generic competition.
Q: What is the economic significance of this patent?
A: The patent helps maintain market dominance for the patent holders, preventing generic competition and ensuring significant revenue streams.
Sources
- Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203.
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT. (2019). Case 1:19-cv-00885-UNA Document 1 Filed 05/10/19.
- USPTO. (2017). Patent Claims Research Dataset.
- Kwok, D. W. K., & Stoynov, N. M. (2014). US Patent 8,901,349 B2.
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT. (2019). Case 1:19-cv-00885-UNA Document 1 Filed 05/10/19.