United States Patent 10,174,073: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,174,073, hereafter referred to as the '073 Patent, is part of a series of patents held by Intercept Pharmaceuticals, Inc., related to the pharmaceutical product OCALIVA® (obeticholic acid). This patent is crucial in the context of pharmaceutical intellectual property, particularly in the realm of generic drug approvals and patent infringement litigation.
Background
OCALIVA®, or obeticholic acid, is a medication used primarily for the treatment of primary biliary cholangitis (PBC) and other liver diseases. The '073 Patent, filed on April 25, 2017, is one of several patents that protect the formulation, composition, and manufacturing processes of obeticholic acid.
Scope of the Patent
Claims Overview
The '073 Patent includes various claims that define the scope of protection for obeticholic acid formulations. Here are some key aspects:
-
Pharmaceutical Composition: The patent claims cover formulations containing obeticholic acid in a form suitable for administration to a subject. This includes specific solid forms and particle sizes that are critical for the drug's efficacy and stability[1][2][4].
-
Particle Size and Form: The claims specify the use of jet-milled particles, which are particles reduced in size using jet-milling. This process is essential for achieving the desired particle size and distribution, which affects the drug's bioavailability and performance[1][4].
-
Solid Forms: The patent describes solid forms of obeticholic acid, including non-crystalline forms (Form 1) and substantially pure solid forms with a potency of greater than about 95%[1][2].
Claim Constructions
In patent litigation, the construction of claim terms is crucial for determining infringement and validity. Here are some key constructions related to the '073 Patent:
-
"Obeticholic Acid Form 1": This term means "non-crystalline obeticholic acid"[1].
-
"Substantially Pure Solid Form of Obeticholic Acid": This term 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].
Patent Landscape
The '073 Patent is part of a broader patent landscape that includes several other patents related to obeticholic acid. Here are some key patents and their relationships:
-
U.S. Patent Nos. 9,238,673 ('673 Patent), 10,047,117 ('117 Patent), 10,052,337 ('337 Patent), 10,751,349 ('349 Patent), and 10,758,549 ('549 Patent): These patents, along with the '073 Patent, form a suite of patents that protect various aspects of obeticholic acid, including formulations, manufacturing processes, and specific solid forms[2][4][5].
-
RE48,286 (RE286 Patent): This is a reissue patent that contains claims substantially identical to those of the original U.S. Patent No. 7,138,390 and constitutes a continuation of that patent[2][5].
Litigation and Generic Approvals
The '073 Patent has been involved in several litigation cases related to generic drug approvals. Here are some key points:
-
Abbreviated New Drug Applications (ANDAs): Generic drug manufacturers, such as Lupin and Optimus, have submitted ANDAs to the FDA seeking approval to market generic versions of OCALIVA® before the expiration of the patents-in-suit. These submissions include Paragraph IV certifications alleging that the patents are invalid, unenforceable, and/or not infringed by the proposed generic products[2][4][5].
-
Infringement Litigation: Intercept Pharmaceuticals has initiated litigation against these generic manufacturers, seeking injunctive relief, attorneys’ fees, and other relief to prevent infringement of the patents-in-suit[2][4][5].
Expiration Dates
Understanding the expiration dates of these patents is crucial for both the original patent holder and potential generic manufacturers:
- U.S. Patent No. 10,174,073: This patent is set to expire on June 17, 2033[3][4].
Impact on Generic Drug Market
The '073 Patent, along with other related patents, significantly impacts the timeline for generic versions of OCALIVA® to enter the market. Generic manufacturers must either wait for the patents to expire or successfully challenge the patents through litigation to gain approval for their products.
Key Takeaways
- The '073 Patent protects specific formulations and manufacturing processes of obeticholic acid.
- Claim constructions are critical in determining the scope of protection and potential infringement.
- The patent is part of a broader suite of patents protecting OCALIVA®.
- Litigation involving ANDAs and Paragraph IV certifications is ongoing.
- Expiration dates of these patents are crucial for market entry of generic versions.
FAQs
What is the primary use of obeticholic acid protected by the '073 Patent?
Obeticholic acid, protected by the '073 Patent, is primarily used for the treatment of primary biliary cholangitis (PBC) and other liver diseases.
What is the significance of jet-milling in the '073 Patent?
Jet-milling is a process used to reduce the size of particles, which is essential for achieving the desired particle size and distribution of obeticholic acid, affecting its bioavailability and performance.
What are the key claim terms and their constructions in the '073 Patent?
Key claim terms include "obeticholic acid Form 1" (non-crystalline obeticholic acid), "substantially pure solid form of obeticholic acid" (solid form with a potency of greater than about 95%), and "particles" (minute portions of matter).
Which other patents are related to the '073 Patent?
The '073 Patent is related to U.S. Patent Nos. 9,238,673, 10,047,117, 10,052,337, 10,751,349, and 10,758,549, as well as the RE48,286 Patent.
What is the impact of the '073 Patent on generic drug approvals?
The '073 Patent, along with other related patents, delays the entry of generic versions of OCALIVA® into the market until the patents expire or are successfully challenged through litigation.
Cited Sources:
- District of Delaware: "20-1105.pdf - District of Delaware" - March 23, 2022.
- RPX Insight: "in the united states district court - RPX Insight" - November 12, 2020.
- FDA: "Obeticholic Acid Tablets - accessdata.fda.gov" - April 22, 2021.
- FDA: "II US FOOD & DRUG - accessdata.fda.gov" - June 14, 2022.
- RPX Insight: "in the united states district court - RPX Insight" - November 20, 2020.
