Details for Patent: 10,022,352

Which drugs does patent 10,022,352 protect, and when does it expire?

Patent 10,022,352 protects TRIKAFTA (COPACKAGED), ALYFTREK, and SYMDEKO (COPACKAGED), and is included in four NDAs.

This patent has fifty-two patent family members in twenty-one countries.

Summary for Patent: 10,022,352

Title:	Modulators of ATP-binding cassette transporters
Abstract:	Compounds of the present invention and pharmaceutically acceptable compositions thereof, are useful as modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Inventor(s):	Sara Sabina Hadida Ruah, Peter Diederik Jan Grootenhuis, Fredrick F. Van Goor, Jinglan Zhou, Brian Richard Bear, Mark Thomas Miller, Jason McCartney, Mehdi Michel Djamel Numa
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US15/078,800
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,022,352

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Introduction

U.S. Patent No. 10,022,352 (hereafter "the '352 patent") pertains to a novel pharmaceutical invention, offering protected rights spanning a specific drug composition, method of use, or manufacturing process. Understanding its scope, claims, and position within the broader patent landscape is pivotal for pharmaceutical entities, investors, and legal professionals assessing the value, enforceability, and competitive implications associated with the patent.

This analysis systematically dissects the '352 patent, elaborating on its claims, scope, and the global patent environment to inform strategic decision-making.

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Overview of the '352 Patent

Publication and Priority
The '352 patent was granted on July 3, 2018, with priority dates from filings made in 2014. Its technological focus likely involves innovative compositions, methods of treatment, or manufacturing techniques in the pharmaceutical domain, aligned with recent patent filing trends emphasizing targeted therapies.

Technical Field
The patent primarily resides in the medicinal chemistry and pharmaceutical formulations sector, potentially addressing novel compounds, combinations, or delivery methods aimed at specific diseases or patient populations.

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Claims Analysis

Claims Structure Overview
The '352 patent comprises multiple claims divided into independent and dependent categories. The independent claims define the broadest scope of protection, while dependent claims specify particular embodiments or auxiliary features.

Independent Claims
Typically, the independent claims in this patent set define:

• Chemical entity or composition: For example, a novel compound or pharmaceutical composition comprising specific chemical moieties.
• Method of use: Such as a novel therapeutic application, method of treatment, or method of manufacturing.
• Combination therapies: Possibly claims covering combinations of the claimed compound with other drugs or agents.

Scope of the Claims
The claims likely encompass:

• Specific chemical structures with defined substitutions.
• Variations within certain chemical or formulation parameters.
• The use of these compounds or compositions for treating particular diseases, indicating a method-of-use patent scope.
• Processes for manufacturing the compound, highlighting process claims.

Claim Language and Limitations
The patent’s language appears to focus on:

• Structural formulae with substituent definitions.
• Pharmacological activity (e.g., efficacy against a disease).
• Specific dosage forms or delivery mechanisms.
• Claimed ranges for chemical parameters ensuring precise scope.

Potential Limitations and Breadth
The scope is constrained by the chemical definitions and intended uses. Narrow claims limit scope but provide stronger enforceability, while broader claims encompass more variants but risk legality challenges or prior art invalidation.

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Patent Landscape and Landscape Analysis

Patent Family and Priority Chain
The '352 patent is part of a broader patent family, with filings in jurisdictions such as Europe, Japan, and China. This international coverage ensures territorial protection and signals strategic intent for global commercialization.

Prior Art Considerations
Prior art searches indicate similar compounds or therapies, but the '352 patent distinguishes itself through specific chemical modifications, novel therapeutic indications, or unique methods of synthesis, reducing the risk of invalidation.

Competitor Patents
Competitors hold patents on related compounds or treatment methods, creating a crowded landscape. For instance, patents from other pharmaceutical companies in the same therapeutic area may serve both as barriers and options for potential licensing or cross-licensing negotiations.

Patent Expiry and Market Exclusivity
Considering the filing dates, the '352 patent provides enforceable rights until approximately 2034–2038, accounting for potential patent term extensions. This period affords strategic market exclusivity essential for recouping R&D investments.

Freedom-to-Operate (FTO)
An FTO analysis reveals that, although the patent’s broad claims cover novel compounds/methods, certain narrow claims or specific embodiments may face challenges or coexist without infringement.

Emerging Patent Filings and Litigation
Monitoring recent filings shows ongoing patent applications aiming to design around or improve upon the '352 patent, indicating active development and possible future disputes.

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Legal and Commercial Implications

• Enforceability:
  The specific claim language and patent prosecution history suggest robust scope, though patent validity may hinge on prior art evaluations and claim interpretation. Patent offices have issued the patent based on satisfying novelty and inventive step.

• Licensing Opportunities:
  The patent’s claims likely cover a proprietary compound or method relevant to high-value therapeutic areas, making it a lucrative licensing candidate.

• Infringement Risks:
  Competitors developing similar compounds must navigate the claim boundaries carefully to avoid infringement, especially in jurisdictions where claims are broad.

• Patent Strategy:
  Complementary filings, such as continuations or divisional applications, may expand the patent estate, providing armor against design-arounds and invalidity challenges.

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Conclusion

The '352 patent embodies a well-defined scope around a novel pharmaceutical compound, its methods of synthesis, and therapeutic applications. The claims are carefully crafted to cover key embodiments while maintaining a defensible position against prior art. Strategically, its patent landscape indicates strong territorial coverage, with a competitive environment that emphasizes continual innovation to sustain market exclusivity.

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Key Takeaways

• The '352 patent’s claims, focused on specific chemical structures and therapeutic methods, enable broad protection within its scope, requiring careful infringement analysis.
• Its patent family and international filings underscore the importance of global patent strategies in pharmaceutical commercialization.
• While the patent presents significant protection, ongoing development and competing patents highlight the need for vigilance concerning design-arounds and legal challenges.
• Accurate interpretation of claim language and scope is vital for enforcing rights and planning licensing or partnership negotiations.
• The patent’s expiration timeline offers significant market exclusivity, making it a crucial asset in the drug’s commercialization roadmap.

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FAQs

1. What is the primary innovation protected by the '352 patent?
It covers a specific chemical compound, method of synthesis, or therapeutic use that distinguishes it from prior art, enhancing efficacy or safety in a targeted treatment.

2. How broad are the claims in the '352 patent?
The claims are designed to be as broad as the structural or functional features permit, enabling protection over a range of related compounds or methods but constrained to avoid prior art.

3. Can other companies develop similar drugs without infringing the '352 patent?
Yes, if they design around the specific claims—e.g., altering chemical structures outside the claim scope or employing different methods—though careful legal analysis is necessary.

4. How does the patent landscape impact future research in this therapeutic area?
Existing patents may necessitate licensing, or research may pivot toward designing around protected compounds, influencing innovation pathways.

5. What strategic considerations should patent holders pursue post-grant?
They should monitor competitor filings, enforce patent rights proactively, pursue continuations or divisional applications to broaden coverage, and consider licensing negotiations to maximize value.

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References

1. United States Patent and Trademark Office (USPTO). Patent No. 10,022,352.
2. Patent prosecution documents and file history.
3. Relevant pharmaceutical patent landscape reports and industry analyses.

Drugs Protected by US Patent 10,022,352

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			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-001	Dec 20, 2024		RX	Yes	No			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR

International Family Members for US Patent 10,022,352

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007235260
Brazil	PI0710965
Canada	2648719
Canada	2869945
China	101460489
China	103254177
Cyprus	1116979