United States Patent 5,968,976: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 5,968,976, titled "Pharmaceutical Composition Containing Selected Lanthanum Carbonate Hydrates," is a significant patent in the pharmaceutical industry, particularly in the treatment of hyperphosphatemia in patients with renal failure. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention
The patent, issued on October 19, 1999, describes a pharmaceutical composition containing selected lanthanum carbonate hydrates. These hydrates are administered into the gastrointestinal tract to treat hyperphosphatemia, a condition commonly associated with renal failure[1].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. The '976 patent covers the preparation and use of certain hydrates of lanthanum carbonate in pharmaceutical compositions. Here are some key aspects of the scope:
- Pharmaceutical Composition: The patent specifies the use of selected lanthanum carbonate hydrates in a pharmaceutical composition designed to treat hyperphosphatemia.
- Administration: The hydrates are administered orally, typically in the form of chewable tablets.
- Therapeutic Use: The primary therapeutic use is the treatment of hyperphosphatemia in patients with renal failure[1].
Claims of the Patent
The claims of the '976 patent are crucial as they define the boundaries of the invention. Here are some key claims:
- Claim 1: This claim typically outlines the broadest scope of the invention, often describing the pharmaceutical composition containing selected lanthanum carbonate hydrates.
- Dependent Claims: These claims further specify the details of the composition, such as the particular hydrates used, the method of preparation, and the dosage forms (e.g., chewable tablets)[5].
Patent Landscape
The patent landscape surrounding the '976 patent involves several key players and legal battles.
Litigation and Infringement
The '976 patent has been at the center of several legal disputes. For instance, Shire Pharmaceuticals, the owner of the patent, has taken legal action against several companies for patent infringement. One notable case is against Alkem Laboratories, where Shire alleged that Alkem's submission of an Abbreviated New Drug Application (ANDA) for lanthanum carbonate chewable tablets infringed on the '976 patent[2].
Competing Patents and Applications
Other patents and applications related to lanthanum compounds also shape the patent landscape. For example, the '465 patent, also owned by Shire, covers pharmaceutical formulations comprising lanthanum compounds and has a term that runs through August 26, 2024, with a potential extension[2].
Impact on the Pharmaceutical Industry
The '976 patent has significant implications for the pharmaceutical industry, particularly in the treatment of renal failure-related conditions.
- Market Exclusivity: The patent provides Shire with market exclusivity for the use of lanthanum carbonate hydrates in treating hyperphosphatemia, allowing the company to maintain a competitive edge.
- Innovation: The patent encourages innovation by protecting the intellectual property of companies that invest in research and development of new pharmaceutical compositions.
- Generic Competition: The expiration of the patent or successful challenges by generic manufacturers can lead to increased competition and potentially lower drug prices[2].
Patent Scope Metrics
The scope of the '976 patent can be analyzed using metrics such as independent claim length and independent claim count. These metrics can indicate 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].
Regulatory Aspects
The '976 patent is listed in the Orange Book, a publication by the FDA that lists patents that could be enforced against generic drug manufacturers. Alkem's submission of an ANDA with a paragraph IV certification, which challenges the validity of the '976 patent, highlights the regulatory complexities surrounding this patent[2].
Conclusion and Future Implications
The United States Patent 5,968,976 is a critical patent in the treatment of hyperphosphatemia, with significant implications for both the pharmaceutical industry and patient care.
Key Takeaways
- The patent covers the use of selected lanthanum carbonate hydrates in treating hyperphosphatemia.
- It has been the subject of several legal disputes over patent infringement.
- The patent's scope is defined by its claims, which specify the pharmaceutical composition and its therapeutic use.
- The patent landscape includes competing patents and regulatory challenges.
Frequently Asked Questions (FAQs)
What is the primary use of the pharmaceutical composition described in the '976 patent?
The primary use is the treatment of hyperphosphatemia in patients with renal failure.
Who is the owner of the '976 patent?
The owner of the '976 patent is Shire Pharmaceuticals.
What is the significance of the '976 patent being listed in the Orange Book?
Listing in the Orange Book indicates that the patent could be enforced against generic drug manufacturers, providing Shire with market exclusivity.
What are some of the legal disputes surrounding the '976 patent?
Shire has taken legal action against companies like Alkem Laboratories for submitting ANDAs that allegedly infringe on the '976 patent.
When does the '976 patent expire?
The '976 patent has expired, as it was issued on October 19, 1999, and the typical patent term is 20 years from the filing date.
Cited Sources
- US5968976A - Pharmaceutical composition containing selected lanthanum carbonate hydrates - Google Patents
- 1:11-cv-00206 Document #: 1 Filed: 01/12/11 - Insight.RPXCorp
- Patent Claims and Patent Scope - SSRN
- Assay for lanthanum hydroxy carbonate - Patent 1852695 - EPO
- Case 2:14-cv-07263-BMC Document 1 Filed 12/12/14 - PatentDocs
