You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: June 21, 2025

Details for Patent: 10,047,117


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 10,047,117
Title:Preparation and uses of obeticholic acid
Abstract: The present invention relates to obeticholic acid: ##STR00001## or a pharmaceutically acceptable salt, solvate or amino acid conjugate thereof. Obeticholic acid is useful for the treatment or prevention of a FXR mediated disease or condition, cardiovascular disease or cholestatic liver disease, and for reducing HDL cholesterol, for lowering triglycerides in a mammal, or for inhibition of fibrosis. The present invention also relates to processes for the synthesis of obeticholic acid.
Inventor(s): Steiner; Andre (Raubling, DE), Waenerlund Poulsen; Heidi (Koge, DK), Jolibois; Emilie (Cambridge, GB), Rewolinski; Melissa (San Diego, CA), Gross; Ralf (Raubling, DE), Sharp; Emma (Cambridge, GB), Dubas-Fisher; Fiona (Cambridge, GB), Eberlin; Alex (Cambridge, GB)
Assignee: Intercept Pharmaceuticals, Inc. (New York, NY)
Application Number:14/947,658
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,047,117
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

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

  1. District of Delaware, "20-1105.pdf - District of Delaware," March 4, 2022.
  2. USPTO, "Patent Claims Research Dataset - USPTO," August 28, 2017.
  3. Hoover Institution, "Patent Claims and Patent Scope - Hoover Institution," August 18, 2024.
  4. Pharsight, "Ocaliva patent expiration - Pharsight."
  5. FDA, "Obeticholic Acid Tablets - accessdata.fda.gov," July 19, 2021.

More… ↓

⤷  Try for Free


Drugs Protected by US Patent 10,047,117

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 RX Yes No ⤷  Try for Free ⤷  Try for Free TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) ⤷  Try for Free
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 RX Yes Yes ⤷  Try for Free ⤷  Try for Free TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.