Understanding the Scope and Claims of United States Patent 9,238,029
Introduction to Patent 9,238,029
United States Patent 9,238,029, issued on January 17, 2016, is associated with Dexlansoprazole Delayed-Release Capsules, a medication used to treat conditions such as gastroesophageal reflux disease (GERD) and other stomach acid-related disorders. This patent is part of a broader landscape involving pharmaceutical patents, particularly those related to proton pump inhibitors (PPIs).
Patent Overview
The patent in question is held by Takeda Pharmaceutical Co., Ltd., and its subsidiaries. It is one of several patents related to Dexlansoprazole, a PPI that works by reducing the amount of acid produced in the stomach.
Claims and Scope
Key Claims
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
- Composition Claims: These claims describe the specific formulation of Dexlansoprazole Delayed-Release Capsules, including the active ingredient, excipients, and the delayed-release mechanism[1].
- Method of Use Claims: These claims outline the methods for treating various conditions using the patented formulation. This includes dosing regimens and specific patient populations[1].
Scope of Protection
The scope of the patent is defined by its claims, which are intended to protect the unique aspects of the invention. In this case, the patent protects not only the composition of the capsules but also the specific methods of use and administration.
Patent Landscape
Related Patents
The patent landscape for Dexlansoprazole includes several other patents that cover various aspects of the drug and its formulations. For example:
- Patent 8,173,158: This patent, among others, is listed in the approval letter for the ANDA (Abbreviated New Drug Application) of Dexlansoprazole Delayed-Release Capsules, indicating a complex web of intellectual property rights surrounding this drug[1].
- Patent 9,233,103: Another patent in the series, this one extends the protection to different aspects of the formulation and use of Dexlansoprazole[1].
Litigation and Challenges
The patent landscape is also marked by litigation and challenges. For instance, Par Pharmaceutical Inc. filed paragraph IV certifications stating that the patents, including the '029 patent, are invalid, unenforceable, or will not be infringed by their manufacture, use, or sale of generic versions of Dexlansoprazole Delayed-Release Capsules[1].
Patent Validity and Enforcement
Legal Challenges
Patent validity is often a point of contention, especially in the pharmaceutical industry. The '029 patent, like others, faces challenges regarding its validity and enforceability. For example, the litigation between Takeda and Par Pharmaceutical Inc. highlights the complexities involved in defending patent rights against generic manufacturers[1].
Judicial Decisions
Judicial decisions play a crucial role in defining the validity and scope of patents. In a similar context, the case of Astellas Pharma, Inc. v. Sandoz Inc. illustrates how courts can interpret patent claims and determine their validity under various sections of the U.S. patent law, such as 35 U.S.C. ยง 112[4].
Metrics for Measuring Patent Scope
Claim Length and Count
Research suggests that metrics such as independent claim length and independent claim count can be used to measure patent scope. These metrics can provide insights into the breadth and clarity of patent claims, which are crucial in assessing patent quality and potential litigation risks[3].
Impact on Innovation
Patent Quality and Innovation
The quality of patents, including their scope and validity, can significantly impact innovation. Overly broad or unclear patents can lead to increased litigation and licensing costs, which may deter innovation. Conversely, well-defined and valid patents can provide clear incentives for further research and development[3].
Conclusion
The United States Patent 9,238,029 is part of a complex patent landscape surrounding Dexlansoprazole Delayed-Release Capsules. Understanding its claims, scope, and the broader patent landscape is crucial for navigating the legal and regulatory environment in the pharmaceutical industry.
Key Takeaways
- Patent Claims: The patent includes composition and method of use claims that define its scope.
- Related Patents: Several other patents cover different aspects of Dexlansoprazole formulations and uses.
- Litigation: The patent faces challenges from generic manufacturers, highlighting the importance of patent validity and enforceability.
- Metrics for Patent Scope: Independent claim length and count can be used to measure patent scope and quality.
- Impact on Innovation: Patent quality and clarity are essential for fostering innovation in the pharmaceutical industry.
FAQs
Q: What is the primary use of Dexlansoprazole Delayed-Release Capsules?
A: Dexlansoprazole Delayed-Release Capsules are primarily used to treat conditions such as gastroesophageal reflux disease (GERD) and other stomach acid-related disorders.
Q: What are the key claims of United States Patent 9,238,029?
A: The key claims include composition claims describing the formulation of the capsules and method of use claims outlining the treatment regimens.
Q: Why is patent validity important in the pharmaceutical industry?
A: Patent validity is crucial because it determines the enforceability of patent rights, which can impact the ability to prevent generic competition and protect innovation.
Q: How do metrics like independent claim length and count affect patent scope?
A: These metrics can indicate the breadth and clarity of patent claims, influencing the likelihood of patent grant and the length of the examination process.
Q: What is the significance of litigation in the context of pharmaceutical patents?
A: Litigation can determine the validity and enforceability of patents, affecting the market entry of generic drugs and the financial stability of pharmaceutical companies.
