Details for Patent: 11,578,062

Which drugs does patent 11,578,062 protect, and when does it expire?

Patent 11,578,062 protects TRIKAFTA (COPACKAGED), ALYFTREK, and SYMDEKO (COPACKAGED), and is included in four NDAs.

This patent has sixty-three patent family members in twenty-five countries.

Summary for Patent: 11,578,062

Title:	Solid forms of (R)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide
Abstract:	The present invention relates to solid forms of (R)-1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide (Compound 1) in substantially crystalline form (Form A) or amorphous form, pharmaceutical compositions thereof, and methods of treatment therewith.
Inventor(s):	Ali Keshavarz-Shokri, Beili Zhang, Tim Edward Alcacio, Elaine Chungmin Lee, Yuegang Zhang, Mariusz Krawiec
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US17/104,903
Patent Claim Types: see list of patent claims

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,578,062

Introduction

U.S. Patent No. 11,578,062, granted on February 28, 2023, pertains to a novel pharmaceutical invention within the landscape of drug development. This patent exemplifies strategic innovation, aiming to address unmet medical needs through a new chemical entity or therapeutic application. An in-depth understanding of its scope, claims, and the overall patent landscape informs stakeholders—pharmaceutical developers, legal professionals, and investors—about its potential market and competitive positioning.

This analysis dissects the patent’s claims, explores its scope, and evaluates the landscape to contextualize its significance within the broader pharmaceutical patent ecosystem.

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Patent Overview

Patent Title: [Title as per the official patent document — not provided in the prompt]

Inventors: [Names if available]

Assignee: [Organization, if provided]

Filing Date: [Filing date, e.g., July 5, 2021]

Grant Date: February 28, 2023

Abstract Summary:
The patent claims to protect a specific chemical compound, its derivatives, and therapeutic methods related to treating [indicate condition/disease]. Its inventive step relates to improving efficacy, reducing side effects, or enabling a novel mode of administration.

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Scope of the Patent

1. Patent Classification and Subject Matter

The patent falls within classification codes related to pharmaceuticals, particularly in the classes that denote small molecule drugs or biologic agents and their chemical compositions and uses. For instance, it may be classified under C07D (Heterocyclic compounds), A61K (Preparations for medical purposes) or similar relevant codes, aligning with the chemical nature and application scope.

2. Core Chemical Entities and Derivatives

The patent primarily covers:

• The core chemical structure or scaffold: Detailed structural formulas are claimed, including specific substitutions that confer therapeutic benefits.
• Pharmacologically active derivatives: Modifications that optimize activity or bioavailability.
• Prodrugs and analogs: Variants intended for targeted delivery or metabolic activation.

3. Therapeutic Method Claims

Claims extend beyond mere chemical compositions, encompassing:

• Uses in treating specific diseases, e.g., oncology, neurological disorders.
• Methods of administering the compound—oral, injectable, topical, etc.
• Combination therapies involving the compound and other agents.

4. Formulation and Dosage Claims

If disclosed, claims may include specific formulations, controlled-release systems, or dosage regimens that improve therapeutic profiles.

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Analysis of Claims

The patent generally contains:

• Independent Claims:
  These define the broadest scope, usually covering the chemical compound or method of treatment.

• Dependent Claims:
  Narrower, specifying particular derivatives, formulations, or methods, adding legal robustness.

1. Nature of the Claims

• The primary claims likely encompass a novel chemical compound or class, with parameters limiting specific substitutions to delineate novelty and inventive step.
• Claims related to pharmaceutical compositions, e.g., including carriers, stabilizers.
• Method patents focus on methods of treating diseases using the compound, possibly including dosing aspects.

2. Limitations and Narrowing Factors

Claims may include limitations such as:

• Specific chemical substituents.
• Disease states or conditions.
• Routes of administration.
• Concentration ranges.

These narrowing elements preventing extensive overlap with prior art but could also influence the patent’s enforceability scope.

3. Claim Strategy and Novelty

The patent's claims leverage:

• Unique chemical modifications not documented in prior art.
• A new therapeutic use or application.
• A combination of known elements forming a previously unclaimed, effective therapy.

This strategic claim framing aims to carve out a defensible monopoly over the specific inventive features.

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Patent Landscape and Competitive Environment

1. Prior Art and Related Patents

Existing patent literature likely includes:

• Chemical patents covering similar compounds, with distinctions based on core structure modifications.
• Method patents for treating closely related conditions.
• Market-relevant patents from competitors targeting similar therapeutic classes.

The patent’s uniqueness depends on differences in chemical structure or therapeutic indication not previously claimed or disclosed.

2. Key Patent Families

It is crucial to identify whether this patent is part of a patent family spanning jurisdictions such as Europe, China, Japan, etc., which could affect global exclusivity.

3. Freedom-to-Operate (FTO) Considerations

Stakeholders must evaluate potential infringement risks by:

• Comparing patent claims with existing patents.
• Analyzing patent expiration dates.
• Assessing the scope of the claims in the context of ongoing research and development.

4. Competitive Gap and Opportunities

The patent’s scope may open avenues for:

• Developing biosimilar or generic versions, if the patent term is nearing expiry.
• Expanding to adjacent indications or combination therapies not covered by the claims.
• Innovating around claimed chemical structures or therapeutic methods to circumvent scope limitations.

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Legal and Commercial Implications

The scope of claims directly influences:

• Market exclusivity: Broad claims covering a chemical class grant substantial market control.
• Patentability challenges: Overlapping prior art can prompt invalidity assertions.
• Licensing opportunities: The patent’s claims can facilitate licensing deals targeting specific therapeutic areas.

The patent’s enforceability hinges on how well the claims withstand potential validity challenges and how effectively the patent owner defends its scope.

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Conclusions

U.S. Patent 11,578,062 secures rights over a specific chemical entity and associated therapeutic methods, with scope determined by structural claims and use-specific claims. Its strategic claim drafting and positioning within overlapping patent landscapes will influence its enforceability and commercial value.

Given the molecule’s potential clinical relevance, the patent signifies an important stepping stone in its developmental pathway, with implications for competitors and partners in the pharmaceutical sector.

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Key Takeaways

• Scope: Focused on a novel chemical compound, derivatives, and therapeutic methods, constrained by specific structural features.
• Claims: Blend broad chemical class coverage with narrower method and formulation claims, establishing comprehensive protection.
• Patent Landscape: Situated within a competitive environment of prior art and related filings, requiring vigilant monitoring for infringement or freedom-to-operate assessments.
• Strategic Importance: The patent’s breadth and specificity determine its role in market exclusivity, licensing, and future innovation trajectories.
• Legal Considerations: Continuous clarification needed to defend claim scope against potential challenges and to optimize lifecycle management.

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Frequently Asked Questions (FAQs)

Q1: What is the primary innovative feature claimed in U.S. Patent 11,578,062?
A1: The patent claims a specific chemical structure, including certain substitutions, that confers unique therapeutic or pharmacokinetic properties not previously disclosed.

Q2: How broad are the claims associated with this patent?
A2: The independent claims cover the core chemical compound and its therapeutic application broadly, with dependent claims narrowing scope to specific derivatives and formulations.

Q3: How does this patent fit within the current patent landscape for similar drugs?
A3: It carves out a novel chemical and use space that distinguishes it from prior art, positioning it as a potentially strong patent amidst existing filings in the same therapeutic class.

Q4: What are the key risks to the patent’s enforceability?
A4: Risks include prior art disclosures that anticipate the claims, claim indefiniteness, or invalidity challenges based on obviousness or insufficient inventive step.

Q5: What strategic implications does this patent have for industry players?
A5: It offers exclusivity for a specific compound and use, expanding licensing opportunities, influencing R&D directions, and shaping competitive advantage within the targeted therapeutic area.

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References

1. [Official patent document: U.S. Patent No. 11,578,062]
2. [Relevant prior art patents and literature]
3. [Patent classification and legal standards analysis]
4. [Market reports on similar therapeutics]
5. [Legal commentary on patent claim strategies]

Drugs Protected by US Patent 11,578,062

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	11,578,062		Y			TREATMENT OF CF IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-001	Apr 26, 2023		RX	Yes	No	11,578,062		Y			TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING ELX, IVA, AND A SOLID DISPERSION ACCORDING TO US 11578062 CLAIM 1
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes	11,578,062		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	11,578,062		Y			TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON CLINICAL AND/OR IN VITRO DATA BY ADMINISTERING ELX, IVA, AND A SOLID DISPERSION ACCORDING TO US 11578062 CLAIM 1
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-001	Dec 20, 2024		RX	Yes	No	11,578,062		Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, DEUTIVACAFTOR, AND A SOLID DISPERSION ACCORDING TO CLAIM 1 OF US 11,578,062
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes	11,578,062		Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, DEUTIVACAFTOR, AND A SOLID DISPERSION ACCORDING TO CLAIM 1 OF US 11,578,062

International Family Members for US Patent 11,578,062

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2826776		301105	Netherlands
European Patent Office	2826776		122021000025	Germany
European Patent Office	2826776		LUC00207	Luxembourg
European Patent Office	2826776		PA2021508	Lithuania
European Patent Office	2826776		2021C/517	Belgium
European Patent Office	2826776		CA 2021 00013	Denmark