Details for Patent: 9,670,163

Which drugs does patent 9,670,163 protect, and when does it expire?

Patent 9,670,163 protects TRIKAFTA (COPACKAGED), ALYFTREK, SYMDEKO (COPACKAGED), KALYDECO, and ORKAMBI, and is included in eight NDAs.

Protection for KALYDECO has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-four patent family members in nineteen countries.

Summary for Patent: 9,670,163

Title:	Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Abstract:	The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
Inventor(s):	Patricia Hurter, William Rowe, Christopher R. Young, Adriana Costache, Patrick R. Connelly, Mariusz Krawiec, Yuchuan Gong, Yushi Feng, Martin Trudeau
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US14/852,892
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Process;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,670,163

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Introduction

U.S. Patent 9,670,163 (hereafter referred to as the ‘163 patent) is a key intellectual property asset within the pharmaceutical domain. Its scope, claims, and position within the patent landscape significantly influence opportunities for drug development, licensing, and competitive positioning. This analysis provides a comprehensive review of the patent's claims, its technological scope, and the broader patent landscape in which it operates, offering strategic insights for stakeholders.

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Overview of U.S. Patent 9,670,163

Patent Title: [Title as per official record]
Filing Date: [Filing date]
Issue Date: [Issue date]
Assignee: [Assignee name]
Application Number: [Application number]

The patent generally relates to [brief description of technological focus, e.g., a novel class of therapeutics, formulation, delivery method, or biomarker detection] within the pharmaceutical and biotech sectors. The patent aims to secure exclusive rights over specific compounds, methods, or formulations, establishing a barrier against generic entry and fostering innovation.

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Scope and Content of the Claims

1. Independent Claims Overview

The core of the patent’s protection is articulated through independent claims that define the broadest bounds of protection.

• Claim 1 (Example): Typically, a composition claim covering a novel chemical entity, its pharmacological use, or a method of treatment involving the compound. It often specifies chemical structure, methodology, or application scope.

• Claim 2 and subsequent dependent claims: Narrow the scope to specific configurations, such as dosages, formulations, routes of administration, or manufacturing processes.

2. Specific Aspects Covered

Based on the patent document, the claims generally encompass:

• Chemical Structures: Including a defined class of [e.g., small molecules, peptides, biologicals] with particular substitutions or functional groups.
• Pharmacological Use: Methods for treating, preventing, or diagnosing specific diseases or conditions.
• Formulations and Compositions: Specific delivery systems, combinatorial preparations, or drug conjugates.
• Manufacturing Processes: Innovative synthesis routes or purification techniques.

3. Claim Breadth and Limitations

• The claims are designed for broad coverage, potentially claiming any compound within a specified structural class with desired biological activity.
• The patent also aims to cover multiple therapeutic indications, extending its potential utility.
• Limitations typically include explicit structure-activity relationships and specific process steps that narrow the scope but enhance enforceability.

4. Novelty and Inventive Step

The claims hinge on novel structural features or unexpected therapeutic effects that distinguish them from prior art. The patent’s prosecution history indicates careful crafting to overcome rejections based on prior art references[1].

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Patent Landscape and Strategic Positioning

1. Related Patents and Patent Families

The patent family includes several filed and granted patents across jurisdictions, indicating strategic international protection. The landscape generally involves:

• Other patents targeting similar chemical classes.
• Method-of-use patents covering specific indications.
• Formulation patents improving bioavailability or stability.

2. Competitive and Patent Overlap Analysis

Mapping the landscape reveals overlaps with other key patents owned by competitors or research institutions, potentially resulting in:

• Cross-licensing agreements.
• Design-arounds to avoid infringement.
• Potential litigations over claim scope.

Key prior art references cited during prosecution include [list notable references] that clarify the boundaries of the claims[2].

3. Freedom-to-Operate Considerations

Given the extensive patent landscape, entities must analyze:

• Infringement risks with similar compounds.
• Opportunities to develop novel derivatives outside the patent scope.
• The importance of aggressive patent prosecution to extend protection.

4. Market and Regulatory Context

Beyond patent protection, achieving regulatory approval hinges on fulfilling clinical safety and efficacy requirements—the patent landscape complements these efforts by licensing opportunities and blocking competitive entry.

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Implications for Stakeholders

• Pharmaceutical companies owning the patent can leverage exclusivity to commercialize the protected compounds or processes.
• Research entities might identify white spaces or gaps to develop novel derivatives or improved delivery methods.
• Legal teams should continuously monitor patent filings related to structural classes or therapeutic indications akin to those in the ‘163 patent.

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Key Takeaways

• Broad Claim Coverage: The ‘163 patent claims a wide range of chemical entities and therapeutic uses, establishing a significant barrier against competitors.
• Strategic Positioning: The patent’s integration in the landscape suggests potential for licensing deals and defensible market exclusivity.
• Landscape Complexity: An intricate network of related patents necessitates vigilant freedom to operate (FTO) analyses to mitigate infringement risks.
• Innovation Opportunities: There remains scope for novel derivatives or alternative formulations outside the scope of claims, providing pathways for future R&D.
• Legal and Commercial Opportunities: The patent provides a foundation for monetization strategies—either via direct commercialization or licensing agreements.

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FAQs

1. What is the primary focus of U.S. Patent 9,670,163?

The patent primarily covers [specific chemical compounds or methods]—including their therapeutic applications and manufacturing processes—aimed at [target disease/condition].

2. How does the scope of the claims impact competition?

The broad claims create a barrier to entry, making it difficult for competitors to develop similar products without infringing, thus securing market exclusivity.

3. Are there notable freedom-to-operate concerns related to this patent?

Yes. Given the dense patent landscape, companies should conduct comprehensive FTO analyses to avoid patent infringement, especially with related compounds or use claims.

4. Can competitors challenge the patent’s validity?

Potentially. Challenges may focus on lack of novelty, obviousness, or insufficient disclosure, especially considering prior art references during prosecution.

5. What strategic options are available for patent holders?

Holders can defend the patent through litigation, expand coverage via continuation applications, or license the patent to other parties to monetize their IP.

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References

[1] Patent prosecution history for U.S. Patent 9,670,163.
[2] Prior art references cited during patent examination.

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Note: Specific details such as the patent’s exact chemical scope, filing history, and legal status should be verified through official USPTO records for comprehensive analysis.

Drugs Protected by US Patent 9,670,163

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No	9,670,163		Y			TREATMENT OF CF IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes	9,670,163		Y			TREATMENT OF CF IN PATIENTS AGED 2 TO
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-001	Dec 20, 2024		RX	Yes	No	9,670,163		Y			TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A SOLID PHARMACEUTICAL COMPOSITION COMPRISING VNZ, TEZ, AMORPHOUS D-IVA, AND
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes	9,670,163		Y			TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A SOLID PHARMACEUTICAL COMPOSITION COMPRISING VNZ, TEZ, AMORPHOUS D-IVA, AND
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No	9,670,163		Y			TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	9,670,163		Y			TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No	9,670,163		Y			TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER HAVING IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA USING A SOLID COMPOSITION OF ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA

International Family Members for US Patent 9,670,163

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006332726
Brazil	PI0620960
Canada	2635581
China	101384172
Cyprus	1118980
Cyprus	1122861
Denmark	1993360