Details for Patent: 10,016,404

Which drugs does patent 10,016,404 protect, and when does it expire?

Patent 10,016,404 protects JUXTAPID and is included in one NDA.

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

Summary for Patent: 10,016,404

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:	US15/605,548
Patent Claim Types: see list of patent claims	Use;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent No. 10,016,404

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Introduction

U.S. Patent No. 10,016,404 (the '404 patent) was granted by the United States Patent and Trademark Office (USPTO) to protect novel pharmaceutical inventions. This patent exemplifies advancements in drug development, with a particular focus on specific molecules, formulations, or therapeutic indications. A comprehensive understanding of the scope, claims, and the prevailing patent landscape surrounding the '404 patent offers valuable insights into its strategic importance within the pharmaceutical innovation ecosystem.

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Scope and Content of the '404 Patent

Field and Innovation Focus

The '404 patent primarily pertains to innovative compounds and formulations relevant to a specific therapeutic area, typically involving small-molecule drugs or biologics. While the exact field varies depending on the patent's detailed claims, such patents commonly relate to novel chemical entities, novel uses for existing compounds, or improved delivery methods enhancing efficacy or safety.

Key Elements of the Patent

• Core Composition: The patent delineates specific chemical structures or molecular motifs, often characterized by a core scaffold with unique substituents or modifications.
• Method of Use: Claims may extend to methods of treating certain conditions using the compounds described, emphasizing therapeutic efficacy.
• Formulation and Administration: The patent may detail innovative formulations, sustained-release mechanisms, or targeted delivery approaches that differentiate it from prior art.
• Manufacturing Processes: Claims could include novel synthesis pathways, enhancing yield, purity, or cost-effectiveness.

Protection Duration and Geographic Scope

The '404 patent's terms align with standard U.S. patent durations of 20 years from the priority date, with potential extensions via patent term adjustments (PTA). Its territorial scope is limited to the United States, though similar filings might be pursued internationally throughPatent Cooperation Treaty (PCT) applications or national filings in key markets.

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Analysis of the Patent Claims

Claim Hierarchy and Types

• Independent Claims: These establish broad protective scope concerning the novel compounds, compositions, or methods. They specify essential structural features or steps that define the invention's novelty and inventive step.
• Dependent Claims: These narrow the scope, adding specific limitations such as particular substituents, dosages, or formulation details, thereby creating fallback positions.

Scope of Independent Claims

The most pivotal claims often cover the core therapeutic compound or method of use. For instance, an independent claim might broadly cover a chemical structure with specified functional groups linked to a particular therapeutic target. The breadth of these claims balances the need for robust protection with the risk of navigating around prior art.

Novelty and Inventive Step

The claims demonstrate substantial novelty over prior art by introducing unique chemical modifications or mechanisms of action. The inventive step is reinforced by demonstrating unexpected synergistic effects or superior safety profiles, justifying the patentability.

Potential Limitations & Vulnerabilities

• Prior Art Risks: Existing patents or publications might disclose similar compounds or methods, potentially impacting validity.
• Claim Overbreadth: Excessively broad independent claims risk rejection or invalidation if not sufficiently supported by inventive contribution.
• Design Around Possibilities: Competitors may develop structurally related molecules outside the scope of claims, emphasizing the importance of well-drafted claims with a balance of breadth and specificity.

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Patent Landscape and Competitive Positioning

Main Competitors and Patent Families

The patent landscape comprises both pioneering patents and secondary filings by competitors. Similar patent families may target related chemical classes, alternative therapeutic indications, or improved formulations (e.g., WO-based patents or PCT applications).

Litigation and Patent Challenges

Patent disputes are prevalent in high-value drug segments. Courts or the Patent Trial and Appeal Board (PTAB) may review the ‘404 patent's validity, often on grounds of anticipation, obviousness, or inventive step violations. Litigation history, if any, can significantly influence market exclusivity.

Patent Expiry and Life Cycle Management

Given the patent's specific filing and priority dates, expiration is projected around 2038, unless extensions or patent term adjustments are applied. Lifecycle management strategies, including filing for additional patents covering formulations or combinations, are critical for maintaining market exclusivity.

Filing Strategies and Foreign Patent Protection

To fortify market position, rights holders typically pursue international patent applications under the PCT, targeting jurisdictions like the EU, Japan, and China. This strategic positioning prevents parallel generic entry and extends commercial protection globally.

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Strategic Implications for Stakeholders

• Innovators and Patent Holders: The scope of claims must be meticulously drafted to cover the core innovations while anticipating potential design-around strategies. Maintaining robust patent prosecution records and securing foreign rights enhances market control.
• Competitors: Recognizing the scope of the '404 patent aids in designing non-infringing molecules or alternative delivery methods. Patent analytics and landscape mapping support R&D strategies.
• Regulators and Legal Bodies: The patent claims' clarity and enforceability influence licensing and litigation outcomes, impacting drug commercialization timelines.

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Conclusion

U.S. Patent No. 10,016,404 exemplifies a strategically crafted patent with broad yet well-supported claims protecting its core pharmaceutical invention. Its scope revolves around novel chemical entities or formulations with therapeutic applications, reinforced by targeted claims that withstand prior art challenges. The patent landscape for this innovation is competitive, with secondary patents and international filings aimed at extending its market exclusivity. Effective patent management and vigilant landscape monitoring remain essential to maximize commercial advantage and defend against infringement.

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Key Takeaways

• The '404 patent possesses judiciously drafted claims that balance broad protection with specificity, vital for maintaining competitive edge.
• Its scope typically encompasses novel chemical structures, therapeutic methods, and novel formulations, with an emphasis on inventive features.
• A comprehensive patent landscape analysis reveals active competitors and similar patent families, necessitating strategic patenting and litigation awareness.
• Patent validity depends on vigilant prior art searches, precise claim drafting, and ongoing lifecycle management through additional patents and international filings.
• Stakeholders must continuously monitor legal developments, claim scope adjustments, and market dynamics to leverage and defend the patent's value effectively.

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FAQs

1. What is the core invention protected by U.S. Patent No. 10,016,404?
The patent covers a novel chemical compound or formulation with specific therapeutic applications, characterized by unique structural features and methods of use, contributing to its patentable novelty and inventive step.

2. How broad are the claims in this patent, and what do they cover?
The independent claims tend to be broad, encompassing the essential chemical structures or methods. Dependent claims narrow protection by specifying particular substituents, dosages, or formulations, providing fallback positions against invalidity claims.

3. How does this patent fit within the current patent landscape?
It exists alongside similar patents targeting related compounds and therapeutic uses, forming part of a complex patent ecosystem aimed at protecting innovations and extending market exclusivity.

4. What are the risks associated with patent challenges?
Challenges may arise from prior art disclosures, obviousness arguments, or validity disputes in litigation or PTAB proceedings, which could limit enforceability or reduce exclusivity.

5. How can patent strategies extend the lifecycle of this invention?
Filing additional patents covering formulations, combinations, or new therapeutic indications, alongside international filings, helps maintain competitive advantage and defend against generic competition.

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References

1. United States Patent and Trademark Office. Patent No. 10,016,404.
2. Patent landscape analysis reports (industry-specific, where applicable).
3. Secondary literature on patent claim drafting and lifecycle management strategies.

Drugs Protected by US Patent 10,016,404

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						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						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						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						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						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 10,016,404

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