United States Patent 7,951,400: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,951,400, titled "Coated tablet formulation and method," is a crucial patent in the pharmaceutical industry, particularly in the treatment of Type II diabetes. This patent, held by AstraZeneca, has been at the center of several legal battles involving generic drug manufacturers. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Inventors
The patent was issued on May 31, 2011, and is assigned to AstraZeneca AB. It is part of a series of patents related to the formulation and method of coated tablets, specifically for the treatment of Type II diabetes. The inventors listed include several researchers who have contributed significantly to the development of these formulations[4].
Scope of the Patent
The patent covers a specific formulation of coated tablets that are designed to treat Type II diabetes. These tablets typically contain saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, often combined with metformin hydrochloride. The coating layer is a critical component, ensuring the controlled release of the active ingredients.
Key Components
- Coating Layer: The patent describes the use of a coating layer, often made from materials like polyvinyl alcohol, to encapsulate the active ingredients. This layer is crucial for the controlled release of the drug[4].
- Tablet Formulation: The patent details the formulation of the tablets, including the weight and composition of the coating and the core. This ensures that the drug is delivered effectively and safely to the patient[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention. Here are some of the key claims:
Independent Claims
- Claim 1 describes the coated tablet formulation, including the specific composition of the coating layer and the core.
- Claim 2 details the method of preparing the coated tablets, emphasizing the steps involved in applying the coating layer[4].
Dependent Claims
- These claims further specify the materials used in the coating layer, the thickness of the coating, and other specific aspects of the tablet formulation. They build upon the independent claims to provide a more detailed description of the invention[4].
Patent Landscape and Litigation
The patent has been involved in several high-profile litigation cases, particularly against generic drug manufacturers.
Litigation Against Generic Manufacturers
AstraZeneca has filed lawsuits against several generic drug manufacturers, including Aurobindo Pharma Ltd., Sun Pharmaceutical Industries Ltd., Mylan Pharmaceuticals Inc., and others, alleging infringement of the '400 patent. These lawsuits were filed in various U.S. District Courts, including the District of Delaware and the District of New Jersey[1][2].
Paragraph IV Certification
Generic manufacturers have filed Abbreviated New Drug Applications (ANDAs) with the FDA, which included Paragraph IV certifications stating that the '400 patent is invalid, unenforceable, or will not be infringed by their manufacture, use, or sale of saxagliptin tablets. This led to litigation within the statutory 45-day period[2].
Patent Expiration and Regulatory Implications
The '400 patent is set to expire on November 30, 2028. Until then, generic manufacturers cannot market their versions of saxagliptin tablets without facing potential litigation or waiting for the patent to expire. The FDA's approval process for generic drugs is also influenced by the patent status, as seen in the case of Sun Pharmaceutical Industries Ltd., where final approval of their ANDA was contingent on the expiration of the '400 patent[2].
Impact on Pharmaceutical Industry
The '400 patent has significant implications for the pharmaceutical industry, particularly in the area of diabetes treatment.
Innovation and Competition
The patent protects AstraZeneca's proprietary formulation, allowing the company to maintain market exclusivity for its branded product. However, this also limits competition from generic manufacturers, which can delay the availability of more affordable alternatives to patients[3].
Litigation Costs and Patent Quality
The extensive litigation surrounding this patent highlights the complexities and costs associated with patent disputes. The debate over patent quality, including the breadth and clarity of claims, is relevant here. Narrower, clearer claims can reduce litigation costs and promote innovation[3].
Expert Insights and Statistics
Industry experts often emphasize the importance of patent scope and claim clarity. For instance, a study by the Hoover Institution notes that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
"Patent claim scope and claim clarity have been identified as significant concerns for patent quality. Even the basic approach to determining claim meaning has been called into question."
- Hoover Institution[3]
Conclusion
The United States Patent 7,951,400 is a pivotal patent in the pharmaceutical sector, particularly for the treatment of Type II diabetes. Its scope and claims are carefully defined to protect AstraZeneca's proprietary formulation. The patent landscape is marked by significant litigation, which underscores the importance of patent quality and the regulatory environment.
Key Takeaways
- Patent Scope: The patent covers a specific coated tablet formulation for Type II diabetes treatment.
- Claims: The patent includes detailed claims about the composition and method of preparing the coated tablets.
- Litigation: Extensive litigation has been filed against generic manufacturers alleging infringement.
- Regulatory Implications: The patent's expiration date and FDA approval processes are critical for generic drug manufacturers.
- Industry Impact: The patent affects innovation, competition, and the availability of affordable treatments.
Frequently Asked Questions (FAQs)
1. What is the main subject of the United States Patent 7,951,400?
The main subject is a coated tablet formulation and method for treating Type II diabetes.
2. Who is the assignee of the '400 patent?
The assignee is AstraZeneca AB.
3. What is the significance of the coating layer in the patent?
The coating layer is crucial for the controlled release of the active ingredients, ensuring effective and safe delivery of the drug.
4. Why has the '400 patent been involved in significant litigation?
The patent has been involved in litigation due to generic manufacturers filing ANDAs with Paragraph IV certifications, which led to infringement allegations by AstraZeneca.
5. When is the '400 patent set to expire?
The '400 patent is set to expire on November 30, 2028.
Sources:
- Astrazeneca AB v. Aurobindo Pharma Ltd. - Casetext
- Saxagliptin Tablets - FDA
- Patent Claims and Patent Scope - Hoover Institution
- US7951400B2 - Coated tablet formulation and method - Google Patents
- in the united states district court - Patent Docs
