United States Patent 9,066,936: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,066,936, titled "Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent," is a significant patent in the pharmaceutical industry. This patent, issued to Takeda Pharmaceuticals, addresses critical issues related to the stability and solubility of a specific pharmaceutical compound. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
The patent pertains to a solid pharmaceutical composition that includes a benzimidazole-7-carboxylate derivative, referred to as compound (I), and a pH control agent. The inventors, Shuji Yoneyama and Yutaka Tanoue, aimed to solve the problem of maintaining the stability and solubility of compound (I), which is unstable in the neutral pH range and has low solubility in the pH range where it is stable[4].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific elements and methods that are protected.
Technical Field
The invention falls within the technical field of pharmaceutical compositions, specifically focusing on solid formulations that require precise control over pH to ensure the stability and dissolution properties of the active ingredient[4].
Objectives
The primary objectives of the patent are:
- To provide a solid pharmaceutical composition that is superior in both stability and dissolution properties of compound (I).
- To offer a method for stabilizing compound (I).
- To improve the dissolution of compound (I)[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention.
Independent Claims
The independent claims are crucial as they stand alone and do not depend on other claims. For example:
- Claim 1 describes a solid pharmaceutical composition comprising compound (I) and a pH control agent, which adjusts or maintains the pH to achieve stability and dissolution properties[4].
Dependent Claims
Dependent claims build upon the independent claims and provide additional specificity. For instance:
- Claim 3 describes a method of stabilizing compound (I) and improving its dissolution by adding a pH control agent with a specific pH range when dissolved or suspended in water[1][4].
Key Terms and Definitions
pH Control Agent
A critical term in the patent is "pH control agent," which is defined as "a substance or combination of substances that adjusts or maintains pH." This term is given its plain and ordinary meaning, emphasizing its role in stabilizing and improving the dissolution of compound (I)[1].
Patent Landscape
The patent landscape surrounding U.S. Patent 9,066,936 involves several key aspects:
Ownership and Licensing
Takeda Pharmaceuticals owns the patent, and Azurity holds an exclusive license to the patent in the United States. This licensing arrangement is significant for commercialization and enforcement of the patent rights[2].
Litigation
The patent has been involved in several litigation cases, particularly against generic drug manufacturers. For example, Takeda and Azurity have sued Teva Inc. for infringement related to the submission of an Abbreviated New Drug Application (ANDA) that allegedly infringes on the '936 patent[2].
Related Patents
The '936 patent is part of a broader portfolio of patents related to pharmaceutical compositions and methods. Other patents, such as U.S. Patent Nos. 9,169,238 and 9,387,249, are also relevant in this context, as they cover related aspects of pharmaceutical formulations and treatment methods[2].
Metrics for Measuring Patent Scope
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Impact on Pharmaceutical Industry
The '936 patent has significant implications for the pharmaceutical industry, particularly in the development of stable and soluble solid pharmaceutical compositions. The use of pH control agents to adjust the pH range of the formulation ensures the effectiveness and safety of the drug product, addressing a critical challenge in pharmaceutical formulation.
"The stability of the drug is extremely important for pharmaceutical products. Even if a pharmaceutical product is effective and safe immediately after production, if the drug is easily decomposed or denatured during distribution, it is not effective and safe as a pharmaceutical product."[4]
Enforcement and Infringement
The enforcement of the '936 patent involves legal actions against entities that infringe on the protected claims. For example, the submission of an ANDA by Teva Inc. that includes a certification regarding the '936 patent constitutes an act of infringement, leading to legal proceedings to protect Takeda's and Azurity's patent rights[2].
Conclusion
U.S. Patent 9,066,936 is a pivotal patent in the pharmaceutical industry, addressing the stability and solubility of a specific benzimidazole-7-carboxylate derivative. The patent's scope, defined by its claims, emphasizes the use of pH control agents to achieve these objectives. The patent landscape, including ownership, licensing, litigation, and related patents, highlights its significance and the ongoing efforts to protect and enforce these intellectual property rights.
Key Takeaways
- Stability and Solubility: The patent solves the problem of maintaining the stability and solubility of compound (I) through the use of pH control agents.
- Claims and Scope: The patent includes specific claims defining the composition and methods for stabilizing and improving the dissolution of compound (I).
- Patent Landscape: The patent is owned by Takeda Pharmaceuticals and licensed exclusively to Azurity in the U.S., with ongoing litigation against generic manufacturers.
- Impact on Industry: The patent is crucial for ensuring the effectiveness and safety of pharmaceutical products by controlling pH in solid formulations.
- Enforcement: The patent is actively enforced through legal actions against infringing entities.
FAQs
What is the main objective of U.S. Patent 9,066,936?
The main objective is to provide a solid pharmaceutical composition that is superior in both stability and dissolution properties of a benzimidazole-7-carboxylate derivative (compound I) through the use of a pH control agent.
Who owns U.S. Patent 9,066,936?
Takeda Pharmaceuticals owns the patent, with Azurity holding an exclusive license in the United States.
What is the role of the pH control agent in the patent?
The pH control agent adjusts or maintains the pH to ensure the stability and dissolution properties of compound (I).
Why is the stability of compound (I) important?
The stability of compound (I) is crucial because it is unstable in the neutral pH range and has low solubility in the pH range where it is stable, affecting the effectiveness and safety of the pharmaceutical product.
What legal actions have been taken to enforce this patent?
Takeda and Azurity have initiated legal proceedings against Teva Inc. for submitting an ANDA that allegedly infringes on the '936 patent.
Sources
- District of Delaware Memorandum Order: "ARBOR PHARMACEUTICALS, LLC and TAKEDA PHARMACEUTICAL COMPANY LIMITED, Plaintiffs, v. LUPIN LIMITED and LUPIN PHARMACEUTICALS, INC., Defendants."
- United States District Court Document: "Civil Action for Infringement of United States Patent Nos. 9,066,936, 9,169,238, and 9,387,249."
- SSRN Paper: "Patent Claims and Patent Scope."
- US Patent Office: "Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent."
