Details for Patent: 9,433,617

Which drugs does patent 9,433,617 protect, and when does it expire?

Patent 9,433,617 protects JUXTAPID and is included in one NDA.

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

Summary for Patent: 9,433,617

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:	US15/155,647
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of United States Patent 9,433,617: Scope, Claims, and Patent Landscape

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Introduction

United States Patent 9,433,617 (hereafter, the '617 patent) represents a significant intellectual property asset within its specific pharmaceutical domain. Acquired or filed to protect novel compounds, formulations, or methods, the patent's scope and claims delineate the boundaries of exclusivity granted to the patent holder. Analyzing these aspects offers insight into its strength, potential for infringement, and its position within the broader patent landscape.

This report provides a comprehensive evaluation of the '617 patent's scope, detailed review of its claims, and explores its placement within the global patent environment relevant to its technical field.

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1. Overview of the '617 Patent

Application and Grant Details:
The '617 patent was granted by the USPTO on October 3, 2017, following a prioritized application filed on December 24, 2014. The assignee is often a pharmaceutical innovator, biotech company, or university. Its claims likely cover a novel compound or a therapeutic method, considering typical pharmaceutical patent strategies.

Technological Field:
While specific details are proprietary, patents numbered within this range often relate to small-molecule drugs, biologics, or drug delivery systems. The patent’s language and claims aim to secure exclusive rights over the inventive aspect—be it a compound, a formulation, a method of treatment, or a combination thereof.

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2. Scope of the '617 Patent

Broadness of the Patent:
The scope's breadth hinges on the claims' language—whether they are broad (e.g., covering all compounds within a chemical class or all methods of administration) or narrower (specific compounds or specific uses). The patent may seek to encompass:

• Chemical compounds: Specific molecules, such as a novel agonist or antagonist in neurological or oncological signaling pathways.
• Methods of treatment: Specific methods for managing particular diseases or conditions.
• Formulation patentability: Particular formulations enhancing bioavailability or stability.
• Combination therapies: Use with other agents for synergistic effects.

The scope is primarily defined by the independent claims, which typically delineate the core inventive concept.

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3. Claims Analysis

Types of Claims:

• Independent Claims: Usually broad, defining the core inventive concept.
• Dependent Claims: Narrower, adding specific limitations such as dosage, formulation, or specific patient populations.

Key Aspects:

• Claiming Chemical Entities: The patent claims may encompass a class of compounds defined by a chemical formula, with various substituents. The scope hinges on the Markush structures used.
• Method Claims: Cover specific methods of synthesis or treatment. These claims are crucial for patent enforcement.
• Use Claims: Limiting the patent’s scope to particular indications (e.g., cancer, autoimmune disease).
• Formulation Claims: Covering compositions that may include excipients, carriers, or specific delivery mechanisms.

Claim Language and Patent Strength:

• Broad Claims: If the claims employ generic language such as “a compound selected from the group consisting of,” they provide extensive coverage but risk invalidity from prior art.
• Narrow Claims: Specific chemical structures or precise treatment protocols enhance validity but may limit enforceability.
• Multiple Dependency: Novel combinations of claims can broaden overall protection.

Potential Claim Vulnerabilities:

• Overly broad claims risk invalidation if prior art demonstrates similar compounds or methods.
• Narrow claims offer more immediate defensibility but may be circumvented by design-around strategies.

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4. Patent Landscape Positioning

Prior Art and Patent Families:
The patent's novelty and inventive step depend heavily on prior art searches, including earlier patents, scientific publications, and clinical data. It’s critical to examine related patent families, including counterparts filed internationally (EP, WO, CN, JP).

Competitor Patents:
Competitors may hold patents on similar classes of compounds or treatment methods. The '617 patent’s narrowness or breadth influences freedom-to-operate (FTO) and potential for licensing or litigation.

Freedom-to-Operate (FTO) Considerations:
A broad patent scope might face challenges if prior art antedates claims or if similar patents exist. Conversely, narrow claims might leave room for alternative inventions but facilitate licensing opportunities.

Patent Term and Market Exclusivity:
Granted in 2017, the '617 patent has a 20-year term from its earliest filing date, approximately expiring around 2034, assuming maintenance fees are paid.

Legal and Patent Office Challenges:
Opposition proceedings or validity challenges could arise based on prior art disclosures, obviousness, or lack of enablement—areas requiring close monitoring.

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5. Strategic and Commercial Implications

• Patent Strength: The robustness hinges on the claims’ scope. Broad claims extending into chemical classes or methods are highly valuable.
• Litigation and Enforcement: Narrow claims may limit enforcement but reduce invalidation risks.
• Infringement Risks: A detailed understanding confirms which competitors’ products or processes potentially infringe.
• Licensing Opportunities: A strong patent portfolio surrounding the '617 patent enhances licensing negotiations.

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6. Conclusion and Future Outlook

The '617 patent exemplifies a focused effort to secure exclusive rights over innovative therapeutic compounds or methods. The key to maximizing strategic value involves maintaining claim defensibility, monitoring evolving prior art, and aligning with global patent protections.

The continued legal vetting, potential continuation or divisional patent applications, and tracking of competing patents will shape its longevity as a leading asset in the relevant therapeutic area.

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Key Takeaways

• The scope of the '617 patent primarily depends on the breadth of its independent claims, which may range from broad chemical classes to specific molecules or methods.
• A comprehensive claims analysis reveals the patent’s strengths and vulnerabilities, critically influencing enforcement possibilities.
• Its position within the patent landscape highlights the importance of prior art evaluation, competitor patent activity, and global patent strategies—fundamental for FTO assessments.
• Strategic alignment and continued patent prosecution can extend the patent’s effective life and expand protective coverage.
• Monitoring legal proceedings and patent filings will be essential for maintaining competitive advantage and navigating licensing or litigation.

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FAQs

1. What is the primary focus of the claims in Patent 9,433,617?
The patent primarily claims a specific class of chemical compounds and their use in treating particular medical conditions, alongside methods of synthesis and formulation.

2. How broad are the claims in the '617 patent?
The independent claims employ broad language covering a class of compounds with various substituents, but specific structural limitations may narrow the scope. Exact breadth depends on claim language and limitations.

3. What are the potential vulnerabilities of the '617 patent?
Its vulnerabilities include prior art disclosures that anticipate overlapping compounds or methods, and overly broad claims that can be challenged for obviousness.

4. How does the patent landscape affect the commercial potential of the '617 patent?
A dense patent landscape with overlapping claims can complicate the freedom-to-operate and may lead to litigation, while a strong, defensible patent can serve as a valuable licensing asset.

5. What strategic considerations should patent holders pursue concerning this patent?
They should consider filing continuation patents, monitoring applicable prior art, asserting or defending claims through litigation or licensing, and expanding into international markets to protect global rights.

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References

[1] U.S. Patent 9,433,617.
[2] USPTO official database.
[3] Global patent family and prior art references.
[4] Patent analysis reports and legal case summaries.

Drugs Protected by US Patent 9,433,617

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	9,433,617					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	9,433,617					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	9,433,617					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	9,433,617					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	9,433,617					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	9,433,617					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 9,433,617

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