Detailed Analysis of the Scope and Claims of United States Patent 6,664,276
Introduction
United States Patent 6,664,276, titled "Benzimidazole compound crystal," is a significant patent in the pharmaceutical sector, particularly related to the drug dexlansoprazole. This patent, held by Takeda Pharmaceutical Co., Ltd., is crucial for understanding the intellectual property landscape surrounding this medication.
Patent Overview
The patent, issued on December 24, 2003, pertains to a specific crystal form of a benzimidazole compound, which is useful as a pharmaceutical due to its excellent antiulcer and gastric acid secretion-inhibiting actions[4].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are broad and outline the core aspects of the benzimidazole compound crystal.
- Claim 1: This claim typically defines the broadest scope of the invention, often describing the general structure and properties of the benzimidazole compound crystal[4].
Dependent Claims
Dependent claims are narrower and build upon the independent claims. They provide additional details and specifications that further define the invention.
- Dependent Claims: These claims may include specific characteristics such as the crystal form, its melting point, and other physical or chemical properties that distinguish this crystal form from others[4].
Patent Landscape
Related Patents
The patent 6,664,276 is part of a larger portfolio of patents related to dexlansoprazole, including other patents such as U.S. Patent No. 6,462,058, U.S. Patent No. 6,939,971, and U.S. Patent No. 7,790,755. These patents collectively protect various aspects of dexlansoprazole, including different crystal forms and formulations[2].
Infringement and Litigation
Takeda has been involved in several legal actions to protect its patents, including a case against Impax Laboratories, Inc., where Takeda alleged that Impax's ANDA products infringed on several of its patents, including the '276 Patent[2].
Claim Construction and Interpretation
Context of the Entire Patent
Claims are construed in light of the entire patent specification. This means that the context in which a claim term appears, as well as the specification and prosecution history, are crucial for understanding the scope of the claim[1].
Special Definitions and Disclaimers
The specification may provide special definitions or disclaimers that affect the interpretation of claim terms. For example, if the inventor defines a term in a specific way within the specification, this definition governs the interpretation of that term in the claims[1].
Prosecution History
The prosecution history, including arguments and amendments made during patent prosecution, can limit the interpretation of claim terms to exclude interpretations that were disclaimed to obtain allowance of a claim[1].
Definiteness Standards
The claims must be sufficiently "definite" as required by 35 U.S.C. § 112, ¶ 2. This means that those skilled in the art must understand the scope of the claim when read in light of the rest of the specification. The definiteness inquiry focuses on whether the claims particularly point out and distinctly claim the subject matter of the invention[1].
Extrinsic Evidence
Courts may use extrinsic evidence to construe claim terms if necessary, but such evidence must not vary or contradict the terms of the claims. This ensures that the interpretation remains consistent with the patent's intrinsic evidence[1].
Breadth of Patent Scope
The breadth of a patent's scope can be measured by the length and detail of its claims. Generally, longer claims with more details are considered narrower because they provide more specific conditions that must be met for another invention to be considered infringing[3].
Comparison with Other Patents
The '276 Patent, along with other related patents, provides a comprehensive protection strategy for dexlansoprazole. The specific crystal form protected by this patent is distinguished by its superior preservation stability and other unique properties compared to earlier crystal forms[1].
Industry Impact
Pharmaceutical Applications
The benzimidazole compound crystal protected by this patent is crucial for its use in pharmaceuticals, particularly in treating conditions like gastroesophageal reflux disease (GERD). The unique properties of this crystal form enhance the drug's efficacy and stability[4].
Competitive Landscape
The protection offered by this patent and others in the portfolio helps Takeda maintain a competitive edge in the market. It prevents generic manufacturers from producing identical or very similar versions of the drug, thereby safeguarding Takeda's market share[2].
Key Takeaways
- Specific Crystal Form: The patent protects a specific crystal form of a benzimidazole compound with unique properties.
- Comprehensive Protection: Part of a broader portfolio of patents protecting various aspects of dexlansoprazole.
- Legal Actions: Takeda has taken legal actions to enforce this patent against potential infringers.
- Claim Construction: Claims are interpreted in the context of the entire patent specification and prosecution history.
- Definiteness: Claims must be definite and clearly define the subject matter of the invention.
- Industry Impact: The patent is crucial for maintaining Takeda's competitive position in the pharmaceutical market.
FAQs
What is the main subject matter of U.S. Patent 6,664,276?
The main subject matter is a specific crystal form of a benzimidazole compound, which is useful as a pharmaceutical.
How does this patent fit into Takeda's broader patent portfolio?
This patent is part of a larger portfolio that includes other patents related to different crystal forms and formulations of dexlansoprazole.
What legal actions has Takeda taken to protect this patent?
Takeda has initiated legal actions against companies like Impax Laboratories, Inc., alleging infringement of this and other related patents.
How are claims in this patent interpreted?
Claims are interpreted in the context of the entire patent specification and prosecution history to ensure clarity and definiteness.
Why is the breadth of patent scope important?
The breadth of patent scope determines how much protection the patent offers against potential infringers and how easily competitors can design around the patented invention.
Cited Sources
- Takeda Pharm. Co. v. Handa Pharms., LLC - Casetext
- United States Court of Appeals for the Northern District of California - GovInfo
- The Ways We've been Measuring Patent Scope are Wrong - Boston University Law
- US6664276B2 - Benzimidazole compound crystal - Google Patents
