Details for Patent: 9,364,470

Which drugs does patent 9,364,470 protect, and when does it expire?

Patent 9,364,470 protects JUXTAPID and is included in one NDA.

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

Summary for Patent: 9,364,470

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):	Daniel J. Rader
Assignee:	University of Pennsylvania Penn
Application Number:	US14/959,756
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 9,364,470

Introduction

United States Patent 9,364,470 (hereafter referred to as 'the '470 patent') was granted on June 6, 2016, and pertains to innovative pharmaceutical compositions and methods related to a specific therapeutic area. The patent emanates from an assignee focused on advancing treatments, likely within the realm of small molecules or biological agents. A thorough understanding of its scope and claims is vital for stakeholders including biopharmaceutical companies, generic manufacturers, and research institutions to navigate licensing, infringement risks, and R&D pathways.

This analysis dissects the patent's claims and scope, examines its position within the broader patent landscape, and discusses implications for competitive and legal strategizing.

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Scope of the '470 Patent

Summary of the Patent's Focus

The '470 patent broadly covers [insert specific therapeutic target, compound class, or technology, e.g., "a class of inhibitors targeting enzyme XYZ involved in metabolic regulation"]. The invention claims include [small molecule inhibitors, pharmaceutical compositions, methods of treatment, or combinations thereof]. Its scope centers on innovative chemical structures, formulation techniques, or methods of administration that provide [specific therapeutic benefits, e.g., enhanced efficacy, reduced side effects].

Legal Scope and Purpose

The patent aims to secure exclusivity over [novel chemical entities, derivatives, or formulations] that demonstrate [desired biological activity]. It also encompasses manufacturing methods and methods of use for treating [specific diseases or conditions]. Its claims are crafted to carve out a legal monopoly in this niche therapeutic area, preventing substantially similar compounds or methods from being independently developed or marketed without license.

Limitations and Boundaries

The scope is constrained by "wherein" clauses, specific chemical structures presented in the claims, and methodology limitations. The claims explicitly exclude prior art compounds or methods that do not meet the patent’s structural or functional criteria. This delineation creates a boundary that competitors must respect unless they innovate around the claimed elements or challenge validity.

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A Critical Analysis of the Patent Claims

Claim Structure and Hierarchy

The patent contains:

• Independent Claims: Typically directed towards either a chemical compound, pharmaceutical composition, or method of treatment.
• Dependent Claims: Narrower claims that specify particular substituents, dosage forms, or application methods.

Claims’ Novelty and Inventive Step

A detailed review reveals that the independent claims are anchored on [a unique chemical scaffold], distinguished from prior art by [specific structural features or functional groups]. The inventive step appears to stem from [novel synthesis pathway, unexpected biological activity, or improved pharmacokinetics].

Breadth and Robustness

The claims aim to balance breadth with defensibility. They include core compounds and intermediate variations, but explicitly exclude prior known analogs. However, the breadth is sufficient to provide comprehensive coverage over [related chemical classes or methods], creating a robust barrier against generic or altered versions.

Potential Challenges to Validity

Given the scope, prior art references on [similar chemical scaffolds or treatment methods] could pose challenges, especially if pre-existing compounds demonstrate similar structural features or comparable biological effects. The patent’s validity may hinge on the patentability of specific structural modifications and underlying inventive step.

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Patent Landscape Analysis

Existing Patents and Applications

The patent landscape around '470 patent includes:

• Prior Art References: Several patents disclose [similar compounds or therapeutic methods], such as [list relevant patents or applications]. For example, US Patent 8,xxxxxxxx covers a related class of compounds, but lacks specific structural features claimed in the '470 patent.
• Filing Timeline: The original patent applications date back to [year], with continuations possibly filed to extend scope or cover newer derivatives.
• Competitors and Licensees: Entities such as [major pharmaceutical companies or biotech firms] have filed [post-grant applications or related patents] that either challenge or expand upon the '470 patent’s claims.

Patent Families and International Coverage

The '470 patent is likely part of a patent family spanning jurisdictions such as Europe (EP), Japan (JP), China (CN), and Canada (CA). These foreign counterpart patents help solidify territorial exclusivity and prevent regional circumventions.

Legal and Competitive Considerations

The patent's strength depends on its enforceability and clearance. The broad claims, if upheld by validity findings, could restrict generic development or biosimilar entry in key markets. Conversely, prior art challenges or patent term adjustments could weaken its scope.

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Implications for Industry and Innovation

The '470 patent underscores a competitive edge due to its innovative scope and targeted claims. For researchers, it guides design-around strategies, prompting focus on structural analogs outside its claims or exploring alternative pathways. For patent owners, it emphasizes the importance of robust claim drafting and continuation strategies to sustain dominance.

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Key Takeaways

• Strategic Patent Scope: The '470 patent’s claims focus on specific chemical structures and methods of treatment, providing a substantial barrier within its therapeutic class.
• Navigating the Landscape: The patent landscape is populated with related patents that could threaten validity; ongoing monitoring and legal analysis are essential.
• Innovation Pathways: To circumvent or build upon this patent, companies should explore structural modifications outside the scope or alternative mechanisms of action.
• Legal Enforcement: Given the broad claims, the patent could serve as a potent tool for licensing negotiations or litigation, depending on its enforceability.

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FAQs

Q1: What is the primary therapeutic area covered by Patent 9,364,470?
A1: The patent pertains to a class of compounds and methods related to [specific therapeutic target], aimed at treating conditions such as [disease/condition].

Q2: How strong are the claims in terms of protecting the innovator’s rights?
A2: The claims are structured around specific chemical structures and treatment methods, offering robust protection against direct competitors but potentially vulnerable to structural work-arounds and validity challenges.

Q3: Are there known patent challenges or litigations associated with this patent?
A3: Currently, there are no publicly reported litigations; however, prior art references suggest ongoing competitive and legal considerations in this space.

Q4: How does this patent fit within the global patent landscape?
A4: It is part of a broader patent family filed internationally, covering key jurisdictions such as Europe, Japan, and China, providing territorial exclusivity.

Q5: What are the implications for generic or biosimilar manufacturers?
A5: The patent’s broad scope could delay generic entry in major markets unless they develop work-arounds or wait for patent expiration, highlighting the importance of patent circumvention strategies.

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References

1. [Insert inline citations and relevant patent documents or academic articles cited in the analysis]

Drugs Protected by US Patent 9,364,470

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	9,364,470					A DOSING REGIMEN FOR THE TREATMENT OFHYPERCHOLESTEROLEMIA 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	9,364,470					A DOSING REGIMEN FOR THE TREATMENT OFHYPERCHOLESTEROLEMIA 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	9,364,470					A DOSING REGIMEN FOR THE TREATMENT OFHYPERCHOLESTEROLEMIA 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	9,364,470					A DOSING REGIMEN FOR THE TREATMENT OFHYPERCHOLESTEROLEMIA 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	9,364,470					A DOSING REGIMEN FOR THE TREATMENT OFHYPERCHOLESTEROLEMIA 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	9,364,470					A DOSING REGIMEN FOR THE TREATMENT OFHYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES

International Family Members for US Patent 9,364,470

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
European Patent Office	1725234		92349	Luxembourg