United States Patent 7,790,755: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,790,755, titled "Controlled Release Preparation," is a significant patent held by Takeda Pharmaceutical Company Limited. This patent, issued on September 7, 2010, pertains to a controlled release preparation that utilizes a unique mechanism to deliver active ingredients, particularly imidazoles, in a controlled manner. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Inventors
The patent was filed on October 15, 2003, as an international application under the Patent Cooperation Treaty (PCT) and later entered the U.S. phase, resulting in the issuance of U.S. Patent No. 7,790,755. The inventors listed are Yohko Akiyama, Takashi Kurasawa, Hiroto Bando, and Naoki Nagahara, all from Osaka, Japan[2][5].
Scope of the Patent
The patent describes a controlled release preparation designed to release an active ingredient in a manner that is both delayed and sustained. This is particularly useful for drugs that need to be released at specific times or rates to maintain therapeutic efficacy. The preparation involves the use of two different types of enteric coatings, which ensure that the drug is released in a dual-delayed manner. This technology is crucial for managing conditions such as heartburn and other gastrointestinal disorders[2][4].
Claims of the Patent
The patent includes several claims that define the scope of the invention. Here are some key aspects:
- Claim 1: This claim describes the controlled release preparation comprising an active ingredient, a first enteric coating layer, and a second enteric coating layer. The first layer dissolves at a pH higher than that of the stomach, and the second layer dissolves at a pH lower than that of the small intestine but higher than that of the stomach[2][5].
- Subsequent Claims: These claims further detail the composition, including the types of active ingredients (specifically imidazoles like dexlansoprazole), the materials used for the enteric coatings, and the method of preparation.
Claim Construction and Interpretation
Claim construction is a critical aspect of patent law, as it determines the scope of what is protected by the patent. For U.S. Patent 7,790,755, claim construction would involve analyzing the claim terms in the context of the entire patent specification, including any special definitions provided by the inventors and the prosecution history of the patent. Courts would ensure that the claims are construed to reflect the inventor's intent and the teachings of the specification, without reading limitations from the specification into the claims unnecessarily[4].
Patent Landscape
Related Patents
Takeda Pharmaceutical Company Limited holds a portfolio of patents related to controlled release preparations and specific compounds like dexlansoprazole. Other relevant patents include U.S. Patent No. 6,462,058, U.S. Patent No. 6,664,276, U.S. Patent No. 6,939,971, and U.S. Patent No. 7,737,282, which pertain to different aspects of dexlansoprazole formulations and crystal forms[4].
Litigation History
The patent has been involved in several litigation cases, particularly in the context of Abbreviated New Drug Applications (ANDAs) filed by generic drug manufacturers. For instance, Takeda Pharmaceutical Co., Ltd. v. Handa Pharmaceuticals, Inc. and Takeda Pharmaceutical Co., Ltd. v. TWI Pharmaceuticals, Inc. are notable cases where the patent's validity and infringement were contested. These cases highlight the importance of precise claim construction and the interpretation of patent scope in legal disputes[1][4].
Patent Scope Metrics
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics can indicate the breadth and clarity of the patent claims. For U.S. Patent 7,790,755, the claims are relatively specific, focusing on a dual-delayed release mechanism, which suggests a narrower but well-defined scope. This specificity can reduce the likelihood of litigation and improve the patent's overall quality[3].
Indefiniteness Standards
The patent must meet the definiteness standards set forth in 35 U.S.C. § 112, ¶ 2, which requires that the claims "particularly point out and distinctly claim the subject matter which the applicant regards as his invention." The claims in U.S. Patent 7,790,755 are detailed and specific, ensuring that those skilled in the art can understand the scope of the invention without ambiguity[4].
Practical Implications
The controlled release preparation described in U.S. Patent 7,790,755 has significant practical implications for pharmaceutical formulations. It allows for the development of drugs that can be taken once a day but still provide therapeutic benefits over an extended period, such as preventing nighttime heartburn. This technology enhances patient compliance and improves the efficacy of the medication.
Industry Impact
The patent's impact on the pharmaceutical industry is substantial. It sets a standard for controlled release formulations, particularly for drugs like dexlansoprazole, which are widely used for treating gastrointestinal disorders. The patent also influences the development of generic versions of these drugs, as generic manufacturers must ensure their formulations do not infringe on Takeda's patented technology.
Conclusion
U.S. Patent 7,790,755 is a critical patent in the field of controlled release pharmaceutical preparations. Its specific claims and detailed description ensure a clear understanding of the invention's scope, which is essential for both legal and practical purposes. The patent's involvement in various litigation cases underscores its importance and the need for precise claim construction.
Key Takeaways
- Controlled Release Mechanism: The patent describes a dual-delayed release mechanism using two types of enteric coatings.
- Specific Claims: The claims are detailed and specific, focusing on the composition and method of preparation.
- Litigation History: The patent has been involved in several litigation cases related to ANDAs.
- Patent Scope Metrics: The patent's scope is relatively narrow but well-defined.
- Indefiniteness Standards: The claims meet the definiteness standards required by U.S. patent law.
- Practical Implications: The technology enhances patient compliance and improves drug efficacy.
FAQs
Q1: What is the main invention described in U.S. Patent 7,790,755?
The main invention is a controlled release preparation that uses a dual-delayed release mechanism to deliver active ingredients, particularly imidazoles.
Q2: Who are the inventors of U.S. Patent 7,790,755?
The inventors are Yohko Akiyama, Takashi Kurasawa, Hiroto Bando, and Naoki Nagahara.
Q3: What is the significance of the dual-delayed release mechanism?
The mechanism ensures that the drug is released at specific times, enhancing patient compliance and improving therapeutic efficacy.
Q4: Has U.S. Patent 7,790,755 been involved in any litigation?
Yes, it has been involved in several litigation cases related to Abbreviated New Drug Applications (ANDAs).
Q5: How is the scope of U.S. Patent 7,790,755 measured?
The scope is measured using metrics such as independent claim length and independent claim count, indicating a relatively narrow but well-defined scope.
Sources
- Takeda Pharmaceutical Co., Ltd. v. TWI Pharmaceuticals, Inc. - Casetext
- United States Patent - US007790755B2 - Google Patents
- Patent Claims and Patent Scope - Hoover Institution
- Takeda Pharm. Co. v. Handa Pharms., LLC - Casetext
- US7790755B2 - Controlled release preparation - Google Patents
