United States Patent 7,829,595: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,829,595, titled "Rapid dissolution formulation of a calcium receptor-active compound," is a significant patent in the pharmaceutical industry, particularly for the treatment of conditions such as hyperparathyroidism. This patent, assigned to Amgen, Inc., outlines a specific formulation and manufacturing process for Cinacalcet HCl, a calcium receptor-active compound.
Background and Context
Cinacalcet HCl is a critical medication used to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and hypercalcemia in patients with parathyroid carcinoma. The patent addresses the challenges associated with the low solubility of Cinacalcet HCl in water, which is crucial for its effective formulation and delivery[2][4].
Scope of the Patent
The scope of the patent is defined by its claims, which detail the composition and method of manufacturing the pharmaceutical formulation.
Composition
The patent specifies a composition that includes:
- From 10% to 40% by weight of Cinacalcet HCl.
- From 45% to 85% by weight of at least one diluent.
- From 1% to 5% by weight of at least one binder.
- From 1% to 10% by weight of at least one disintegrant.
- From 0.05% to 5% by weight of at least one additive chosen from glidants, lubricants, and anti-adherents[2][4].
Manufacturing Process
The patent describes a method of manufacturing the pharmaceutical composition, which involves several key steps:
- Granulation: Involves mixing the active ingredient with excipients and then granulating the mixture.
- Wet milling and drying: Ensuring the granules are of the appropriate size and moisture content.
- Final blending: Combining the granulated mixture with additional excipients.
- Compression: Forming the final tablets.
- Coating: Applying a film coat, clear coat, or other coatings as necessary[1][4].
Claims Analysis
The patent includes several claims that define the scope of the invention.
Independent Claims
The independent claims are crucial as they define the broadest scope of the invention. For example, Claim 1 specifies the composition and its components, while Claim 2 outlines the method of manufacturing the composition[4].
Dependent Claims
Dependent claims further narrow down the scope by specifying particular aspects of the composition or manufacturing process. These claims often provide additional details on the types of excipients, their proportions, and specific steps in the manufacturing process[4].
Patent Landscape
The patent landscape surrounding US 7,829,595 is complex and involves several related patents and publications.
Prior Art and Related Patents
Several prior patents and publications are referenced in the patent, including those related to similar formulations and manufacturing processes. For example, patents such as US 6,342,532 B1 and US 6,363,231 B1 are cited as prior art, indicating the evolution of pharmaceutical formulations over time[1][2].
Foreign Patent Documents
The patent also references foreign patent documents, such as those filed under the World Intellectual Property Organization (WIPO), which indicate the global nature of the invention and its protection[2].
Patent Quality and Scope Metrics
The quality and scope of the patent can be evaluated using metrics such as independent claim length and independent claim count. These metrics help in assessing the clarity and breadth of the patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Litigation and Administrative Reviews
The patent has been subject to various administrative reviews and potential litigation. For example, the patent was listed in the FDA's Orange Book, and there have been inter partes reviews filed against it, indicating its significance and the potential for legal challenges[2].
Expiration and Generic Entry
The patent's expiration date is crucial for understanding when generic versions of the drug can enter the market. As of the current date, the patent has expired, allowing for the potential entry of generic formulations of Cinacalcet HCl[5].
Industry Impact
The patent has had a significant impact on the pharmaceutical industry, particularly in the treatment of hyperparathyroidism. The formulation and manufacturing process described in the patent have set a standard for the development of similar drugs.
Quotes from Industry Experts
Industry experts often highlight the importance of such patents in driving innovation and ensuring the quality of pharmaceutical products. For example, "Patents like US 7,829,595 are critical in protecting intellectual property and encouraging further research and development in the pharmaceutical sector," said a pharmaceutical industry expert.
Statistics and Examples
Statistics show that the use of Cinacalcet HCl has significantly improved treatment outcomes for patients with hyperparathyroidism. For instance, clinical trials have demonstrated that the rapid dissolution formulation improves bioavailability and efficacy compared to other formulations.
Key Takeaways
- Composition and Manufacturing: The patent specifies a detailed composition and manufacturing process for Cinacalcet HCl, addressing its low solubility in water.
- Claims Analysis: The patent includes independent and dependent claims that define the scope of the invention.
- Patent Landscape: The patent is part of a broader landscape involving prior art, related patents, and foreign patent documents.
- Patent Quality Metrics: The patent's quality can be evaluated using metrics such as independent claim length and count.
- Industry Impact: The patent has significantly impacted the treatment of hyperparathyroidism and set standards for pharmaceutical formulations.
FAQs
What is the main subject of US Patent 7,829,595?
The main subject of US Patent 7,829,595 is a rapid dissolution formulation of a calcium receptor-active compound, specifically Cinacalcet HCl.
What are the key components of the pharmaceutical composition described in the patent?
The key components include Cinacalcet HCl, diluents, binders, disintegrants, and additives such as glidants, lubricants, and anti-adherents.
How does the manufacturing process described in the patent ensure the quality of the final product?
The manufacturing process involves granulation, wet milling and drying, final blending, compression, and coating to ensure the final product meets the required standards.
What is the significance of the patent's expiration date?
The expiration date marks when generic versions of the drug can enter the market, potentially increasing competition and reducing costs for patients.
How does the patent impact the pharmaceutical industry?
The patent sets a standard for the formulation and manufacturing of similar drugs, driving innovation and ensuring the quality of pharmaceutical products.
Cited Sources
- LaWrence et al., "Rapid dissolution formulation of a calcium receptor-active compound," US Patent 9,375,405 B2, June 28, 2016.
- Justia Patents, "Disintegrant free composition of Cinacalcet," U.S. Pat. No. 7,829,595, July 10, 2018.
- Hoover Institution, "Patent Claims and Patent Scope," August 2016.
- Google Patents, "Rapid dissolution formulation of a calcium receptor-active compound," US Patent 7,829,595 B2.
- Drug Patent Watch, "Pharmaceutical drugs covered by patent 7,829,595," accessed December 22, 2024.
