United States Patent 10,052,337: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,052,337, hereafter referred to as the '337 Patent, is a crucial component of the patent portfolio related to obeticholic acid, a medication used primarily for the treatment of primary biliary cholangitis (PBC) and other liver diseases. This patent is held by Intercept Pharmaceuticals and is a key part of the intellectual property protecting their drug OCALIVA®.
Background
Obeticholic acid is a farnesoid X receptor agonist that has been approved by the FDA for the treatment of PBC. The '337 Patent, filed on April 26, 2016, is one of several patents that Intercept Pharmaceuticals has secured to protect the formulation, synthesis, and use of obeticholic acid[2][4][5].
Patent Scope and Claims
Claim Construction
The '337 Patent includes several claims that have been subject to legal interpretation. Key terms in these claims have been defined through court orders and legal proceedings. For instance:
- "Pharmaceutical composition" is defined as a "formulation containing obeticholic acid in a form suitable for administration to a subject"[1].
- "Substantially pure solid form of obeticholic acid" 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" has its plain and ordinary meaning, which is "minute portions of matter"[1].
Claim Types
The '337 Patent includes both product and process claims, although the patentees elected to proceed with product claims during the prosecution process. This decision was made due to a restriction requirement imposed by the Examiner, who regarded the product and the process as distinct inventions[1].
Key Claims
Independent Claims
Independent claims in the '337 Patent are critical as they define the broadest scope of the invention. For example:
- Claim 1 of the '337 Patent describes a pharmaceutical composition containing obeticholic acid Form 1, which is defined as non-crystalline obeticholic acid[1].
Dependent Claims
Dependent claims further specify the invention and often add additional limitations to the independent claims. For instance:
- Claim 14 of the '337 Patent, which depends on Claim 11, explicitly refers to the use of jet-milling to reduce the size of obeticholic acid particles. This adds a specific process limitation to the broader claim[1].
Patent Landscape
Related Patents
The '337 Patent is part of a larger family of patents related to obeticholic acid. Other patents in this family include:
- U.S. Patent Nos. 9,238,673 ('673 Patent), 10,047,117 ('117 Patent), 10,174,073 ('073 Patent), 10,751,349 ('349 Patent), and 10,758,549 ('549 Patent)[2][4][5].
Litigation and Enforcement
Intercept Pharmaceuticals has been involved in several legal battles to enforce these patents against generic manufacturers. For example, litigation against Apotex and Lupin has been initiated to prevent the early market entry of generic versions of OCALIVA® before the expiration of the patents-in-suit[2][4][5].
Expiration Dates
The '337 Patent is set to expire on April 26, 2036, which is one of the later expiration dates among the patents protecting OCALIVA®. This extended protection period is crucial for Intercept Pharmaceuticals to maintain market exclusivity for their product[4].
Impact on Generic Manufacturers
Generic manufacturers seeking to market their versions of obeticholic acid must navigate the complex patent landscape. They must either wait for the patents to expire or challenge the validity and enforceability of these patents through legal proceedings. For instance, Lupin’s ANDA submission included a Paragraph IV certification, alleging that the patents-in-suit are invalid, unenforceable, and/or not infringed by their generic product[2][5].
Metrics for Patent Scope
Research on patent scope suggests that metrics such as independent claim length and independent claim count can be used to measure the breadth of patent claims. Narrower claims, as seen in the '337 Patent after the examination process, are associated with a higher probability of grant and a shorter examination process[3].
Conclusion
The United States Patent 10,052,337 is a significant component of the intellectual property portfolio protecting Intercept Pharmaceuticals' drug OCALIVA®. The patent's scope and claims have been carefully defined through legal proceedings, ensuring robust protection for the formulation and use of obeticholic acid. As the patent landscape continues to evolve, understanding the intricacies of these patents is crucial for both innovator companies and generic manufacturers.
Key Takeaways
- The '337 Patent protects the formulation and use of obeticholic acid, a key medication for PBC.
- Key terms such as "pharmaceutical composition" and "substantially pure solid form of obeticholic acid" have been legally defined.
- The patent includes both product and process claims, with a focus on product claims.
- The patent is part of a larger family of patents related to obeticholic acid.
- Litigation has been ongoing to enforce these patents against generic manufacturers.
- The patent is set to expire on April 26, 2036.
FAQs
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What is the main subject of the '337 Patent?
The '337 Patent primarily protects the formulation and use of obeticholic acid, a medication used for treating primary biliary cholangitis (PBC).
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What is the definition of "pharmaceutical composition" in the '337 Patent?
"Pharmaceutical composition" is defined as a "formulation containing obeticholic acid in a form suitable for administration to a subject"[1].
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What is the significance of jet-milling in the '337 Patent?
Jet-milling is a process mentioned in dependent claims, specifically Claim 14, which adds a limitation that the obeticholic acid particles are reduced in size using jet-milling[1].
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When is the '337 Patent set to expire?
The '337 Patent is set to expire on April 26, 2036[4].
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Why is the '337 Patent important for Intercept Pharmaceuticals?
The '337 Patent is crucial for maintaining market exclusivity for OCALIVA®, Intercept Pharmaceuticals' flagship drug, by preventing early market entry of generic versions.
Sources
- District of Delaware. Consolidated Memorandum Order, C.A. No. 20-1105, March 23, 2022.
- United States District Court. Case 1:20-cv-01155-MN Document 11 Filed 11/12/20.
- SSRN. Patent Claims and Patent Scope, September 29, 2016.
- US FDA. Approved Drug Products with Therapeutic Equivalence Evaluations, June 14, 2022.
- RPX Insight. Case 1:20-cv-01215-MN Document 17 Filed 11/20/20.
