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Last Updated: January 6, 2025

Details for Patent: 11,376,251


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Summary for Patent: 11,376,251
Title:Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Abstract: Provided herein are methods of treating or ameliorating a pediatric cholestatic liver disease by non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI) or a pharmaceutically acceptable salt thereof. Also provided are methods for treating or ameliorating a pediatric liver disease, decreasing the levels of serum bile acids or hepatic bile acids, treating or ameliorating pruritis, reducing liver enzymes, or reducing bilirubin comprising non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an ASBTI or a pharmaceutically acceptable salt thereof.
Inventor(s): Gedulin; Bronislava (Del Mar, CA), Grey; Michael (Rancho Sante Fe, CA), O'Donnell; Niall (Encintas, CA)
Assignee: Shire Human Genetic Therapies, Inc. (Lexington, MA)
Application Number:17/498,586
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 11,376,251: A Comprehensive Guide

Introduction

Understanding the scope and claims of a patent is crucial for inventors, researchers, and businesses to navigate the complex landscape of intellectual property. This article will delve into the details of United States Patent 11,376,251, titled "Bile Acid Recycling Inhibitors for Treatment of Pediatric Cholestatic Liver Diseases," and provide a thorough analysis of its claims and the broader patent landscape.

Patent Overview

Patent Number and Title

The patent in question is U.S. Patent 11,376,251, titled "Bile Acid Recycling Inhibitors for Treatment of Pediatric Cholestatic Liver Diseases."

Assignees and Priority Date

The patent is assigned to Shire Human Genetics Therapies Inc., with a priority date of October 28, 2011[5].

Claims Analysis

Independent and Dependent Claims

Patent claims are the heart of any patent, defining the scope of the invention. U.S. Patent 11,376,251 includes both independent and dependent claims.

  • Independent Claims: These claims stand alone and define the invention without reference to other claims. For example, Claim 1 might describe the broadest aspect of the bile acid recycling inhibitors.
  • Dependent Claims: These claims build upon the independent claims, adding specific details or limitations. For instance, Claim 2 might specify a particular compound or method of administration that is a subset of the invention described in Claim 1[5].

Claim Scope and Patentability

The scope of the claims determines the extent of protection granted by the patent. In this case, the claims would cover specific bile acid recycling inhibitors, their compositions, and methods of treating pediatric cholestatic liver diseases. The patentability of these claims would be evaluated based on novelty, non-obviousness, and utility, as per U.S. patent law.

Patent Landscape

Prior Art and Related Patents

To understand the position of U.S. Patent 11,376,251 within the broader patent landscape, it is essential to conduct a thorough prior art search. This involves using resources such as the USPTO's Patent Public Search tool, Global Dossier, and international databases like Espacenet and Patentscope[1][4].

  • Global Dossier: This service allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This can help identify similar inventions and potential overlaps[1].
  • Common Citation Document (CCD): This tool consolidates prior art cited by all participating offices for the family members of a patent application, providing a comprehensive view of the prior art landscape[1].

Competitor Patents

Analyzing competitor patents in the same field can provide valuable insights into the competitive landscape. For instance, other patents related to bile acid recycling inhibitors or treatments for pediatric cholestatic liver diseases can be identified through databases like Google Patents or the USPTO's Patent Claims Research Dataset[3][4].

Search Tools and Resources

USPTO Resources

The USPTO offers several tools for conducting patent searches:

  • Patent Public Search: A modern web-based patent search application that replaced legacy tools like PubEast and PubWest[1].
  • Patent and Trademark Resource Centers (PTRCs): These centers provide local search resources and training in patent search techniques[1].

International Databases

International databases are crucial for a global perspective:

  • Espacenet: Provides access to European and international patent documents, including those from the US[4].
  • Patentscope: Offers full-text search of international patent applications received by WIPO[4].

Legal and Regulatory Considerations

Validity and Infringement

The validity of the patent claims can be challenged based on grounds such as obviousness-type double patenting, lack of written description, or enablement. For example, the case of Allergan USA, Inc. v. MSN Laboratories Private Ltd. highlights the importance of ensuring that claims are patentably distinct and not subject to obviousness-type double patenting[2].

Examination and Prosecution

Understanding the prosecution history of the patent, including any office actions and responses, can provide insights into the patent's strength and potential vulnerabilities. The Patent Examination Data System (PEDS) allows public users to search, view, and download bibliographic data for all publicly available patent applications[1].

Economic and Strategic Implications

Market Impact

The issuance of U.S. Patent 11,376,251 can have significant market implications, particularly in the pharmaceutical industry. It can influence the development of new treatments, licensing agreements, and competitive strategies.

Valuation and Licensing

The value of the patent can be assessed based on its claims, the strength of the patent portfolio, and the market demand for the invention. Companies often use datasets like the USPTO's Patent Claims Research Dataset to analyze the scope and relative value of patents and patent portfolios[3].

Key Takeaways

  • Comprehensive Search: Conduct thorough prior art searches using USPTO and international databases.
  • Claim Analysis: Carefully analyze independent and dependent claims to understand the scope of protection.
  • Legal Considerations: Ensure claims are valid and not subject to obviousness-type double patenting or other challenges.
  • Market Impact: Assess the economic and strategic implications of the patent on the market and competitive landscape.

FAQs

Q: How can I search for prior art related to U.S. Patent 11,376,251?

A: Use the USPTO's Patent Public Search tool, Global Dossier, and international databases like Espacenet and Patentscope to conduct a thorough prior art search[1][4].

Q: What are the key differences between independent and dependent claims in a patent?

A: Independent claims define the invention without reference to other claims, while dependent claims build upon the independent claims, adding specific details or limitations[5].

Q: How can I determine the validity of the claims in U.S. Patent 11,376,251?

A: Evaluate the claims based on novelty, non-obviousness, and utility, and review the prosecution history and any office actions or responses[1][2].

Q: What resources are available for analyzing the economic value of a patent?

A: The USPTO's Patent Claims Research Dataset and other economic research datasets can provide detailed information on claims and patent scope, helping to assess the relative value of patents and patent portfolios[3].

Q: How can I stay updated on changes in patent ownership or assignments related to U.S. Patent 11,376,251?

A: Use the Patent Assignment Search website to search for patent assignments and changes in ownership[1].

Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD.: https://cafc.uscourts.gov/opinions-orders/24-1061.OPINION.8-13-2024_2366074.pdf
  3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. Harvard Business School Library - Patent search: A comparative table of databases: https://asklib.library.hbs.edu/faq/266950
  5. Unified Patents Portal - US-20100055066-A1: https://portal.unifiedpatents.com/patents/patent/US-20100055066-A1

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Drugs Protected by US Patent 11,376,251

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mirum LIVMARLI maralixibat chloride SOLUTION;ORAL 214662-001 Sep 29, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS) ⤷  Subscribe
Mirum LIVMARLI maralixibat chloride SOLUTION;ORAL 214662-001 Sep 29, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,376,251

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2771003 ⤷  Subscribe 2023C/521 Belgium ⤷  Subscribe
European Patent Office 2771003 ⤷  Subscribe 301234 Netherlands ⤷  Subscribe
European Patent Office 2771003 ⤷  Subscribe CA 2023 00017 Denmark ⤷  Subscribe
European Patent Office 2771003 ⤷  Subscribe 122023000029 Germany ⤷  Subscribe
European Patent Office 2771003 ⤷  Subscribe 21/2023 Austria ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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