United States Patent 10,519,252: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,519,252, titled "Aqueous Iron Carbohydrate Complexes, Their Production and Medicaments Containing Them," is a significant patent in the field of pharmaceuticals, particularly in the treatment of iron deficiency. This patent, assigned to Vifor International AG, is part of a complex patent family with a long history of filings and continuations.
Background and Priority Dates
The patent has its roots in a German application filed on October 23, 2002 (German Application No. 10249552.1), which later became part of the PCT/EP2003/011596 application filed on October 20, 2003. This international application was then nationalized in the United States, leading to a series of continuations and divisions that ultimately resulted in the issuance of U.S. Patent 10,519,252 on December 29, 2020[4][5].
Scope of the Patent
The patent covers aqueous iron carbohydrate complexes, their production methods, and medicaments containing these complexes. These complexes are designed to treat iron deficiency and related conditions, such as iron-deficiency anemia.
Production Methods
The patent describes a process for preparing aqueous iron carbohydrate complexes by reacting an iron(III) salt with an aqueous solution of a carbohydrate. This method ensures the formation of stable and water-soluble complexes, which are crucial for effective iron supplementation[4].
Medicaments Containing Iron Carbohydrate Complexes
The medicaments covered by this patent include various formulations such as injectable solutions, oral tablets, and capsules. These formulations are designed to provide a stable and bioavailable source of iron, making them effective for treating iron deficiency and related disorders[5].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention.
Independent Claims
The independent claims are critical as they define the broadest scope of the invention. These claims typically cover the aqueous iron carbohydrate complexes, the methods for their production, and the medicaments containing these complexes. For example, Claim 1 might describe the composition of the aqueous iron carbohydrate complex, while Claim 2 might detail the method of preparing this complex[5].
Dependent Claims
Dependent claims further narrow down the scope by adding specific limitations to the independent claims. These claims might include details such as the type of carbohydrate used, the concentration of iron, or specific formulations of the medicaments[5].
Patent Landscape
The patent landscape surrounding U.S. Patent 10,519,252 is complex due to its long history and multiple continuations.
Family of Patents
This patent is part of a large family of patents that include earlier patents such as U.S. Pat. No. 7,612,109, U.S. Pat. No. 9,376,505, and U.S. Pat. No. 8,895,612. Each of these patents contributes to the overall scope and claims of the current patent[4].
Litigation and Validity
The patent has been involved in litigation, particularly in the case of Vifor (International) AG and American Regent, Inc. vs. MYLAN Laboratories Ltd. and Sandoz Inc. This litigation has led to the non-assertion of certain claims, as indicated by the plaintiffs advising the court that they were no longer asserting any claims of U.S. Patent No. 10,519,252[2].
Metrics for Measuring Patent Scope
The scope of this patent can be analyzed using metrics such as independent claim length and independent claim count. These metrics are useful in assessing the breadth and clarity of the patent claims. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Impact on Innovation
The patent's scope and claims can influence innovation in the field of iron supplementation. By defining specific methods and compositions, the patent can either encourage or hinder further research and development. The clarity and validity of the claims are crucial in ensuring that the patent does not overly broaden the scope, which could lead to increased licensing and litigation costs and diminish incentives for innovation[3].
Industry Expert Insights
Industry experts often emphasize the importance of clear and valid patent claims. For instance, "Patents with narrower claims at publication are associated with a higher probability of grant and a shorter examination process," which aligns with the findings in the analysis of patent scope metrics[3].
Statistics and Data
- Patent Maintenance Payments: Patents with narrower claims tend to have lower maintenance payments, indicating a more focused and valid scope[3].
- Forward Citations: The number of forward citations can indicate the impact of the patent on subsequent innovations. U.S. Patent 10,519,252, being part of a large patent family, likely has significant forward citations[3].
Key Takeaways
- Complex Patent History: U.S. Patent 10,519,252 has a complex history with multiple continuations and divisions.
- Scope and Claims: The patent covers aqueous iron carbohydrate complexes, their production methods, and medicaments containing these complexes.
- Patent Landscape: The patent is part of a large family and has been involved in litigation.
- Metrics for Scope: Independent claim length and count are useful metrics for assessing the patent's scope.
- Impact on Innovation: Clear and valid claims are crucial for encouraging innovation in the field.
FAQs
What is the primary subject matter of U.S. Patent 10,519,252?
The primary subject matter is aqueous iron carbohydrate complexes, their production methods, and medicaments containing these complexes.
What is the priority date of this patent?
The priority date is October 23, 2002, based on a German application.
How does the patent's scope affect innovation?
The patent's scope, defined by clear and valid claims, can either encourage or hinder innovation by influencing licensing and litigation costs.
What metrics are used to measure the scope of this patent?
Independent claim length and independent claim count are used to measure the scope.
Has this patent been involved in any litigation?
Yes, it has been involved in litigation, particularly in the case of Vifor (International) AG and American Regent, Inc. vs. MYLAN Laboratories Ltd. and Sandoz Inc.
Cited Sources:
- United States Patent and Trademark Office, "US11123321.pdf" - googleapis.com
- Law.com, "Case 3:19-cv-13955-FLW-DEA Document 189 Filed 06" - Law.com
- SSRN, "Patent Claims and Patent Scope" - papers.ssrn.com
- Justia Patents, "Aqueous iron carbohydrate complexes, their production and ..." - patents.justia.com
- Unified Patents Portal, "US-10519252-B2" - portal.unifiedpatents.com
