Understanding the Scope and Claims of United States Patent 10,047,117
Introduction
The United States Patent 10,047,117, hereafter referred to as the '117 patent, is part of a series of patents related to obeticholic acid, a drug used in the treatment of certain liver diseases. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background on Obeticholic Acid
Obeticholic acid is a synthetic bile acid analog used primarily in the treatment of primary biliary cholangitis (PBC) and other liver conditions. The drug is marketed under the brand name Ocaliva and is protected by a suite of patents, including the '117 patent[4].
Patent Scope and Claims
Definition of Key Terms
The '117 patent, along with other related patents, involves specific definitions of key terms that are crucial for understanding its scope.
- "Obeticholic acid Form 1": This term refers to "non-crystalline obeticholic acid"[1].
- "Substantially pure solid form of obeticholic acid": This means a solid form of obeticholic acid with a potency of greater than about 95%, taking into account impurities, including solvents and water[1].
- "Particles": This term has its plain and ordinary meaning, which is "minute portions of matter"[1].
Claim Construction
The construction of claims in the '117 patent is critical for determining its scope. The court's rulings on disputed claim terms provide clarity:
- The specification of the patent may reveal special definitions given to claim terms by the patentee, which can differ from their ordinary meaning. However, the inventor’s lexicography governs in such cases[1].
- Claims are not read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction[1].
Specific Claims of the '117 Patent
Claim 1
Claim 1 of the '117 patent typically defines the core invention, which in this case involves a substantially pure solid form of obeticholic acid. This claim is pivotal as it sets the foundation for the patent's scope.
Dependency of Claims
The '117 patent includes multiple claims, some of which depend on others. For example, dependent claims may add specific processes or characteristics to the core invention defined in the independent claims. The dependency relationship between claims is crucial for understanding the full scope of the patent[2].
Prosecution History and Context
Role of Prosecution History
The prosecution history of the patent, including any amendments, arguments, and communications with the patent office, is essential for interpreting the claims. This history can provide insights into the intent of the patentee and any limitations or clarifications made during the patent application process[1].
Expert Declarations and References
Expert declarations and other references submitted during the litigation process can also influence the interpretation of claim terms. These documents help in understanding the technical context and the specific meanings attributed to key terms by the inventors and experts in the field[1].
Patent Landscape
Related Patents
The '117 patent is part of a family of patents related to obeticholic acid, including the '337, '349, '549, and RE48,286 patents. These patents collectively protect various aspects of the drug, such as its formulation, manufacturing processes, and specific forms of the active ingredient[5].
Expiration Dates
Understanding the expiration dates of these patents is crucial for assessing the overall patent landscape. For instance, the '117 patent is set to expire on September 6, 2033, while other related patents have different expiration dates, ranging from 2027 to 2036[5].
Impact on Generic Launch
The expiration of these patents will have significant implications for the generic launch of obeticholic acid. Companies like Dr. Reddy's Laboratories Limited have filed Abbreviated New Drug Applications (ANDAs) with paragraph III certifications, indicating they will not market their generic versions before the patents expire[5].
Metrics for Measuring Patent Scope
Independent Claim Length and Count
Research on patent scope often uses metrics such as independent claim length and count to assess the breadth and clarity of patents. These metrics can help in evaluating whether the '117 patent and its related patents are overly broad or clear in their claims[3].
Challenges and Criticisms
Patent Quality and Clarity
Debates over patent quality often highlight issues with patent scope and claim clarity. The '117 patent and similar patents have to navigate these challenges, ensuring that their claims are clear and not overly broad, which could impede innovation and lead to increased litigation costs[3].
Conclusion
The '117 patent is a critical component of the intellectual property protection for obeticholic acid. Understanding its scope, claims, and the broader patent landscape is essential for both the patent holders and potential generic manufacturers. The definitions of key terms, the dependency of claims, and the prosecution history all play vital roles in defining the patent's boundaries.
Key Takeaways
- The '117 patent protects a substantially pure solid form of obeticholic acid.
- Key terms such as "obeticholic acid Form 1" and "particles" have specific definitions.
- The patent's scope is influenced by its prosecution history and expert declarations.
- The patent is part of a family of patents with varying expiration dates.
- The expiration of these patents will impact the generic launch of obeticholic acid.
- Metrics like independent claim length and count are used to assess patent scope.
FAQs
Q: What is the main subject of the '117 patent?
A: The '117 patent primarily protects a substantially pure solid form of obeticholic acid.
Q: How are key terms defined in the '117 patent?
A: Key terms such as "obeticholic acid Form 1" and "particles" are defined specifically within the patent, with "obeticholic acid Form 1" meaning "non-crystalline obeticholic acid" and "particles" meaning "minute portions of matter"[1].
Q: What is the role of the prosecution history in interpreting the '117 patent?
A: The prosecution history, including amendments and communications with the patent office, helps in understanding the intent of the patentee and any limitations or clarifications made during the patent application process[1].
Q: How do related patents impact the '117 patent?
A: Related patents, such as the '337, '349, and '549 patents, collectively protect various aspects of obeticholic acid, and their expiration dates influence the overall patent landscape[5].
Q: What are the implications of the '117 patent's expiration for generic manufacturers?
A: The expiration of the '117 patent and related patents will allow generic manufacturers to market their versions of obeticholic acid, provided they comply with regulatory requirements and do not infringe on any remaining patents[5].
Sources
- District of Delaware, "20-1105.pdf - District of Delaware," March 4, 2022.
- USPTO, "Patent Claims Research Dataset - USPTO," August 28, 2017.
- Hoover Institution, "Patent Claims and Patent Scope - Hoover Institution," August 18, 2024.
- Pharsight, "Ocaliva patent expiration - Pharsight."
- FDA, "Obeticholic Acid Tablets - accessdata.fda.gov," July 19, 2021.
