Details for Patent: 11,229,661

Which drugs does patent 11,229,661 protect, and when does it expire?

Patent 11,229,661 protects LIVMARLI and is included in one NDA.

This patent has seventy-five patent family members in twenty-one countries.

Summary for Patent: 11,229,661

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, Grey Michael, "ODonnell Niall"
Assignee:	SHIRE HUMAN GENETIC THERAPIES, INC.
Application Number:	US16679864
Patent Claim Types: see list of patent claims

Understanding the Scope and Claims of a U.S. Patent: A Detailed Analysis of U.S. Patent 11,229,661

Introduction

When analyzing a U.S. patent, it is crucial to understand the scope and claims, as these elements define the intellectual property rights granted to the inventor. This article will delve into the specifics of U.S. Patent 11,229,661, using general principles and examples to illustrate the key points.

What is a Patent?

A patent is a form of intellectual property that gives the inventor the exclusive right to make, use, or sell their invention for a specified period. In the U.S., patents are granted by the U.S. Patent and Trademark Office (USPTO) and must meet criteria such as being novel, nonobvious, and sufficiently useful[1].

Patent Scope and Claims

The scope of a patent is defined by its claims, which are the legal descriptions of the invention. Claims outline what the inventor considers to be their invention and what they seek to protect.

Types of Claims

• Independent Claims: These stand alone and define the invention without reference to other claims.
• Dependent Claims: These refer back to and further limit an independent claim.
• Multiple Dependent Claims: These depend on more than one preceding claim[5].

Analyzing U.S. Patent 11,229,661

To analyze U.S. Patent 11,229,661, we need to look at its claims, description, and any relevant background information.

Claims

The claims section is the most critical part of a patent as it defines the legal boundaries of the invention. Here, you would typically find:

• Independent Claims: These would describe the broadest aspects of the invention.
• Dependent Claims: These would narrow down the invention by adding specific limitations or features.

For example, if U.S. Patent 11,229,661 pertains to a new method for treating a medical condition, the independent claims might describe the general method, while the dependent claims might specify particular steps, ingredients, or equipment used in the method.

Description and Background

The description section provides a detailed explanation of the invention, including how it works, its components, and any prior art that it improves upon. This section helps in understanding the context and the innovative aspects of the invention.

Patent Landscape

The patent landscape includes the broader context of related patents and technological trends.

Technology Areas

Patents are often classified into specific technology areas, such as electrical engineering, mechanical engineering, or chemistry. The USPTO uses the World Intellectual Property Organization (WIPO) classification system, which includes 35 technical fields for international comparisons[1].

Trends and Comparisons

Analyzing the patent landscape involves looking at trends in patenting within the relevant technology area. For instance, if U.S. Patent 11,229,661 is in the field of electrical engineering, you would look at how electrical engineering patents have evolved over time, including any significant increases or decreases in specific subfields like computer technology or digital communication[1].

Legal Considerations

Patents are subject to various legal considerations that can affect their validity and scope.

Presumption of Validity

Each claim of a patent is presumed valid, and this presumption can only be overcome by clear and convincing evidence to the contrary[5].

Obviousness-Type Double Patenting

This doctrine can invalidate a patent if its claims are not patentably distinct from earlier claims in related patents. For example, if a later patent claims essentially the same invention as an earlier patent, it may be subject to obviousness-type double patenting[2].

Data and Statistics

Analyzing patent data can provide insights into the broader patent landscape.

USPTO Data

The USPTO provides detailed data on patent filings and grants, including the number of patents granted by technology area. For instance, in 2018, electrical and mechanical engineering patents made up about 60% of all USPTO patents granted to U.S. inventors[1].

Patent Claims Research Dataset

This dataset, provided by the USPTO, contains detailed information on claims from U.S. patents and applications. It can be used to analyze trends in patent scope and the dependency relationships between claims[3].

Examples and Case Studies

Real-world examples can illustrate how patent scope and claims are analyzed.

Allergan USA, Inc. v. MSN Laboratories Private Ltd.

In this case, the court determined that a patent claim was invalid due to obviousness-type double patenting. The decision highlighted the importance of ensuring that patent claims are distinct from earlier claims in related patents[2].

Key Takeaways

• Claims Define the Invention: The claims section of a patent is crucial as it legally defines the invention.
• Patent Landscape: Understanding the broader technological trends and related patents is essential for analyzing a patent.
• Legal Considerations: Patents are subject to legal doctrines such as the presumption of validity and obviousness-type double patenting.
• Data Analysis: Using datasets like the USPTO's Patent Claims Research Dataset can provide valuable insights into patent trends.

FAQs

1. What is the primary purpose of the claims section in a U.S. patent?

   • The primary purpose of the claims section is to legally define the invention and outline what the inventor seeks to protect.

2. How are patents classified by the USPTO?

   • Patents are classified into 35 technical fields described by the World Intellectual Property Organization (WIPO) for international comparisons.

3. What is the doctrine of obviousness-type double patenting?

   • This doctrine invalidates a patent if its claims are not patentably distinct from earlier claims in related patents.

4. What is the significance of the Patent Claims Research Dataset?

   • This dataset provides detailed information on claims from U.S. patents and applications, helping in the analysis of trends in patent scope and claim dependency.

5. Why is the presumption of validity important in patent law?

   • Each claim of a patent is presumed valid, and this presumption can only be overcome by clear and convincing evidence to the contrary.

Sources

1. Invention: U.S. and Comparative Global Trends - National Science Foundation.
2. ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD. - U.S. Court of Appeals for the Federal Circuit.
3. Patent Claims Research Dataset - U.S. Patent and Trademark Office.
4. Methods for treating cholestasis - Patent US-11229647-B2 - PubChem.
5. 35 USC 282: Presumption of validity; defenses - U.S. House of Representatives.

Drugs Protected by US Patent 11,229,661

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	11,229,661					TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTATIS (PFIC)
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-002	Jul 24, 2024		RX	Yes	Yes	11,229,661					TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)

International Family Members for US Patent 11,229,661

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