Details for Patent: 10,555,938

Which drugs does patent 10,555,938 protect, and when does it expire?

Patent 10,555,938 protects JUXTAPID and is included in one NDA.

This patent has twenty-seven patent family members in eighteen countries.

Summary for Patent: 10,555,938

Title:	Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Abstract:	The present invention provides methods and compositions for treating hyperlipidemia and/or hypercholesterolemia comprising administering to the subject an effective amount of an MTP inhibitor to inhibit hyperlipidemia and/or hypercholesterolemia in said subject, wherein said administration comprises an escalating series of doses of the MTP inhibitor. In some embodiments the method comprises administering at least three step-wise, increasing dosages of the MTP inhibitor to the subject. In some embodiments, the method further comprises the administration of one or more other lipid modifying compounds.
Inventor(s):	Rader; Daniel J. (Philadelphia, PA)
Assignee:	The Trustees of the University of Pennsylvania (Philadelphia, PA)
Application Number:	16/030,703
Patent Claim Types: see list of patent claims	Use;

United States Patent 10,555,938: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,555,938, titled "Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects," is a significant patent in the field of pharmaceuticals, particularly in the treatment of lipid-related disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Patent

The patent, issued to treat disorders associated with hyperlipidemia and hypercholesterolemia, involves the use of Microsomal Triglyceride Transfer Protein (MTP) inhibitors. MTP inhibitors are known for their role in reducing lipid transfer activity, which can lead to decreased serum triglyceride and cholesterol levels[4].

Scope of the Patent

The scope of this patent is focused on methods and compositions for treating hyperlipidemia and hypercholesterolemia. Here are the key aspects:

Treatment Methods

• The patent describes methods of administering MTP inhibitors in a step-wise, increasing dosage regimen to ameliorate disorders associated with hyperlipidemia and hypercholesterolemia. This approach is designed to minimize side effects commonly associated with MTP inhibitors[4].

Pharmaceutical Compositions

• The invention includes pharmaceutical compositions containing MTP inhibitors, specifically highlighting compounds like BMS-201038. These compounds have been tested in various animal models and shown to effectively reduce cholesterol levels without significant side effects[4].

Therapeutic Applications

• The patent covers the treatment of subjects suffering from disorders associated with hyperlipidemia and hypercholesterolemia, including conditions like homozygous familial hypercholesterolemia (hoFH)[4].

Claims of the Patent

The claims of the patent are crucial in defining the legal boundaries of the invention. Here are some key claims:

Independent Claims

• Claim 1 typically defines the broadest scope of the invention, which in this case involves methods for treating hyperlipidemia and hypercholesterolemia by administering an MTP inhibitor in a specific dosage regimen[4].

Dependent Claims

• Subsequent claims narrow down the scope by specifying particular aspects of the method, such as the structure of the MTP inhibitor, the dosage levels, and the administration schedule[4].

Kit Claims

• The patent also includes claims for kits that contain pharmaceutical dosage units and instructions for use, which are designed to treat disorders associated with hyperlipidemia and hypercholesterolemia[4].

Patent Landscape

Understanding the patent landscape is essential for assessing the novelty and non-obviousness of the invention, as well as identifying potential competitors and collaborators.

Prior Art

• The patent cites several prior art patents related to MTP inhibitors, such as U.S. Pat. Nos. 5,789,197, 5,883,109, 6,066,653, and 6,492,365. These patents describe earlier work on MTP inhibitors and their applications[4].

International Patent Filings

• The invention may have been filed in other jurisdictions, which can be checked through databases like the World Intellectual Property Organization (WIPO) PATENTSCOPE or the European Patent Office (EPO) esp@cenet[1].

Related Patents

• Other patents in the field of lipid disorder treatments, such as those related to different types of inhibitors or treatment regimens, could be relevant. For example, patents like WO-1998003174-A1, which deals with treating hematologic and solid tumors using different approaches, might be of interest for comparative analysis[5].

Search and Analysis Tools

To conduct a thorough analysis of the patent landscape, several tools and resources are available:

USPTO Patent Public Search

• This tool allows for comprehensive searches of U.S. patents and published patent applications, which can help in identifying prior art and related patents[1].

Global Dossier

• This service provides access to the file histories of related applications from participating IP Offices, which can be useful in understanding the global patent family and citation data[1].

Common Citation Document (CCD)

• The CCD application consolidates prior art cited by multiple offices for the same invention, facilitating a more integrated view of the global patent landscape[1].

Economic and Research Implications

The Patent Claims Research Dataset provided by the USPTO can offer insights into the economic and research trends related to patent claims and scope. This dataset includes detailed information on claims from U.S. patents and applications, which can help in analyzing the scope and impact of the patent in question[3].

Key Takeaways

• Innovative Treatment Regimen: The patent introduces a novel method of administering MTP inhibitors to minimize side effects, which is a significant advancement in the treatment of hyperlipidemia and hypercholesterolemia.
• Comprehensive Claims: The patent includes a range of claims that cover methods, compositions, and kits, ensuring broad protection for the invention.
• Global Patent Landscape: Understanding the global filings and related patents is crucial for navigating the competitive landscape and potential collaborations.
• Economic Impact: The patent's impact can be further analyzed using datasets like the Patent Claims Research Dataset to understand its economic and research implications.

FAQs

What is the primary focus of United States Patent 10,555,938?

The primary focus is on methods and compositions for treating disorders associated with hyperlipidemia and hypercholesterolemia using MTP inhibitors.

How does the patent minimize side effects associated with MTP inhibitors?

The patent describes a step-wise, increasing dosage regimen for administering MTP inhibitors to minimize side effects.

What are some of the key claims in the patent?

The claims include methods for treating hyperlipidemia and hypercholesterolemia, specific structures of MTP inhibitors, dosage levels, and kits containing pharmaceutical dosage units.

How can one conduct a thorough analysis of the patent landscape for this invention?

Using tools like the USPTO Patent Public Search, Global Dossier, and Common Citation Document (CCD) can help in identifying prior art, related patents, and global patent family data.

What economic and research datasets are available to analyze the impact of this patent?

The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents and applications, which can be used to analyze the scope and impact of the patent.

Sources

1. USPTO: Search for patents - USPTO.
2. Unified Patents: WO-2008012056-A1 - Laser Scanning Microscope.
3. USPTO: Patent Claims Research Dataset.
4. Google Patents: US10555938B2 - Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects.
5. Unified Patents: WO-1998003174-A1.

Drugs Protected by US Patent 10,555,938

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-001	Dec 21, 2012		RX	Yes	No	10,555,938					A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012		RX	Yes	No	10,555,938					A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012		RX	Yes	No	10,555,938					A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015		RX	Yes	No	10,555,938					A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015		DISCN	Yes	No	10,555,938					A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015		DISCN	Yes	No	10,555,938					A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES

International Family Members for US Patent 10,555,938

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1725234		CA 2014 00002	Denmark
European Patent Office	1725234		C300634	Netherlands
European Patent Office	1725234		PA2014001	Lithuania
European Patent Office	1725234		C20140001 00107	Estonia
European Patent Office	1725234		14C0003	France
European Patent Office	1725234		1490006-2	Sweden