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

Last Updated: January 9, 2025

Details for Patent: 10,758,549


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 10,758,549 protect, and when does it expire?

Patent 10,758,549 protects OCALIVA and is included in one NDA.

This patent has thirty-four patent family members in twenty-five countries.

Summary for Patent: 10,758,549
Title:Compositions of obeticholic acid and methods of use
Abstract: The disclosure relates to obeticholic acid formulations with improved stability, dissolution, and/or solubility, methods of preparing the same for use and methods of treating various diseases and conditions.
Inventor(s): Lancaster; Richard Gail (San Diego, CA), Olmstead; Kay K. (Escondido, CA), Kagihiro; Masashi (Suita, JP), Matono; Mitsuhiro (Osaka, JP), Taoka; Ikuko (Toyonaka, JP), Pruzanski; Mark (New York, NY), Shapiro; David (Rancho Santa Fe, CA), Hooshmand-Rad; Roya (San Diego, CA), Pencek; Richard (San Diego, CA), Sciacca; Cathi (San Diego, CA), Eliot; Lise (San Diego, CA), Edwards; Jeffrey (San Diego, CA), MacConell; Leigh A. (Encinitas, CA), Marmon; Tonya K. (San Diego, CA)
Assignee: Intercept Pharmaceuticals, Inc. (New York, NY)
Application Number:16/787,796
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

United States Patent 10,758,549: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 10,758,549, assigned to Intercept Pharmaceuticals, Inc., is a critical component of the patent landscape surrounding obeticholic acid (OCA), a drug used in the treatment of various liver diseases. This patent, along with others in the same family, plays a significant role in defining the intellectual property rights and technological advancements in this field.

Patent Overview

Issuance and Assignee

The patent, titled "Compositions of obeticholic acid and methods of use," was issued on September 1, 2020, and is assigned to Intercept Pharmaceuticals, Inc.[5].

Inventors

The patent lists multiple inventors, including Richard Gail Lancaster, Kay K. Olmstead, Masashi Kagihiro, Mitsuhiro Matono, Ikuko Taoka, Mark Pruzanski, David Shapiro, Roya Hooshmand-Rad, Richard Pencek, Cathi Sciacca, Lise Eliot, Jeffrey Edwards, Leigh A. MacConell, and Tonya K. Marmon[5].

Scope of the Patent

Claims and Subject Matter

The patent covers compositions of obeticholic acid with improved stability, dissolution, and/or solubility. It also includes methods of preparing these compositions and their use in treating various diseases and conditions. The claims are specifically tailored to ensure that the formulations meet certain criteria for pharmaceutical use, such as purity and particle size[5].

Pharmaceutical Compositions

The patent defines "pharmaceutical composition" as a formulation containing obeticholic acid in a form suitable for administration to a subject. This includes specifications on the purity of the compound, with a potency of greater than about 98%[1].

Particle Size and Purity

The patent is part of the "particle size patents" group, which includes U.S. Patent Nos. 10,052,337 and 10,751,349. These patents focus on compositions with very small particles of OCA, ensuring optimal therapeutic efficacy and bioavailability[2].

Claim Constructions

Court Rulings

In the case of Intercept Pharmaceuticals, Inc. vs. Apotex Inc., the court provided constructions for the disputed claim terms. For example, the term "pharmaceutical composition" was defined as a formulation containing obeticholic acid suitable for administration. The court also clarified that the specification of the patent does not refer to the process by which the compound is made but rather to the compound itself[1].

Process vs. Product Claims

The prosecution history of the patent shows that the applicants originally included both product and process claims but elected to proceed with the product claims after a restriction requirement was imposed by the Examiner. This distinction is crucial in understanding the scope of the patent, as it focuses on the product rather than the method of its creation[1].

Patent Landscape

Related Patents

The patent is part of a larger family of patents related to obeticholic acid, including:

  • Purity Patents: U.S. Patent Nos. 9,238,673, 10,047,117, and 10,174,073, which focus on compositions with less than 1% of a particular impurity[2].
  • Particle Size Patents: U.S. Patent Nos. 10,052,337, 10,751,349, and 10,758,549, which relate to compositions with very small particles of OCA[2].

Expiration Dates

The patent is set to expire on April 26, 2036, along with other patents in the particle size group. This expiration date is significant for generic manufacturers and competitors who may seek to enter the market with therapeutically equivalent versions of Ocaliva after the patent protection period ends[4][5].

Inequitable Conduct Allegations

Background

Defendants in the Intercept Pharmaceuticals, Inc. vs. Apotex Inc. case alleged inequitable conduct during the prosecution of the patents. For the particle size patents, including U.S. Patent 10,758,549, the allegations centered on whether Intercept, through its prosecution counsel and named inventors, withheld or misrepresented information to the PTO. The court focused on allegations against Richard Lancaster, one of the named inventors[2].

Specific Allegations

The allegations involved the production of batches of OCA in 2004 and 2005 and whether these batches were made using a process disclosed in prior art. The court required specific evidence to support the claims of inequitable conduct, including who, what, when, where, and how the material misrepresentation or omission occurred[2].

Impact on Innovation and Competition

Patent Scope and Quality

The debate over patent quality and scope is relevant here. Patents with narrower claims, such as those in the particle size group, are generally associated with a higher probability of grant and shorter examination processes. This can influence innovation by providing clearer boundaries for competitors and encouraging further research and development[3].

Generic Competition

Currently, there is no therapeutically equivalent generic version of Ocaliva available in the United States. The expiration of the patents, including U.S. Patent 10,758,549, will open the market to generic competition, potentially reducing costs and increasing access to the drug[5].

Key Takeaways

  • Patent Scope: The patent covers compositions of obeticholic acid with improved stability, dissolution, and solubility, focusing on particle size.
  • Claim Constructions: The court defined key terms, emphasizing the product over the process.
  • Related Patents: Part of a family of patents including purity and particle size patents.
  • Expiration Dates: Set to expire on April 26, 2036.
  • Inequitable Conduct: Allegations focused on whether Intercept withheld or misrepresented information during patent prosecution.
  • Impact on Innovation: Narrower claims can encourage innovation and clearer competition boundaries.

FAQs

Q: What is the main subject matter of U.S. Patent 10,758,549?

A: The patent covers compositions of obeticholic acid with improved stability, dissolution, and/or solubility, and methods of preparing and using these compositions.

Q: Who are the inventors listed on U.S. Patent 10,758,549?

A: The patent lists multiple inventors, including Richard Gail Lancaster, Kay K. Olmstead, and several others.

Q: What is the significance of the court's ruling on claim constructions in this patent?

A: The court's ruling clarified that the patent focuses on the product (obeticholic acid formulations) rather than the process of creating it.

Q: What are the expiration dates for U.S. Patent 10,758,549 and related patents?

A: The patent is set to expire on April 26, 2036, along with other patents in the particle size group.

Q: Have there been any allegations of inequitable conduct related to this patent?

A: Yes, defendants alleged inequitable conduct during the prosecution of the patent, focusing on whether Intercept withheld or misrepresented information to the PTO.

Sources

  1. District of Delaware: Intercept Pharmaceuticals, Inc., and Intercept Pharma Europe Ltd., Plaintiff, v. Apotex Inc., and Apotex Corp., LLC, Defendants. C.A. No. 20-1105 CONSOLIDATED MEMORANDUM ORDER.
  2. Casetext: Intercept Pharm. v. Apotex Inc., C. A. 20-1105-MN.
  3. SSRN: Patent Claims and Patent Scope.
  4. FDA: ANDA 215017 Page 2.
  5. Drugs.com: Generic Ocaliva Availability.

More… ↓

⤷  Subscribe


Drugs Protected by US Patent 10,758,549

Showing 1 to 2 of 2 entries

International Family Members for US Patent 10,758,549

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Argentina 104427 ⤷  Subscribe
Australia 2016255045 ⤷  Subscribe
Australia 2020205315 ⤷  Subscribe
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 3 of 3 entries

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.