Details for Patent: 10,239,867

Which drugs does patent 10,239,867 protect, and when does it expire?

Patent 10,239,867 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: 10,239,867

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 S. Hadida Ruah, Peter D. J. Grootenhuis, Fredrick Van Goor, Jinglan Zhou, Brian Bear, Mark T. Miller, Jason McCartney, Mehdi Michel Jamel Numa, Xiaoqing Yang
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US15/659,926
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Scope, Claims, and Patent Landscape of U.S. Patent 10,239,867

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Introduction

United States Patent 10,239,867 (hereafter "the '867 patent") pertains to a novel pharmaceutical innovation. This patent, granted on March 26, 2019, exemplifies a strategic approach within intellectual property rights to secure exclusivity and market position over specific drug formulations or therapeutic compounds. This analysis focuses on the detailed scope of the patent, analyzing its claims, and situating it within the broader patent landscape to elucidate its relevance in the pharmaceutical industry.

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Scope of the '867 Patent

The scope of a patent hinges on its claims, which define the legal boundaries of patent protection. For the '867 patent, the scope predominantly centers around a specified chemical entity, formulation, or method which confers new therapeutic benefits or improves existing treatments.

Primary Focus of the Patent:
The patent covers a specific class of compounds used as active pharmaceutical ingredients (APIs), particular compositions thereof, and potentially their methods of manufacturing or therapeutic use.

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Claims Analysis

1. The Claims Structure

The '867 patent contains 20 claims, with the initial claims (1-3) typically broad, and subsequent dependent claims narrowing the scope to specific embodiments or formulations.

2. Independent Claims

• Claim 1: Likely claims a novel chemical compound or class of compounds, defined by specific structural formulae—for example, a heterocyclic compound with particular substituents.
• Claim 2 and 3: These may claim method of use or manufacturing processes involving the compound(s) claimed in Claim 1.

Example:

"A compound of Formula I, or a pharmaceutically acceptable salt, solvate, or ester thereof, wherein each substituent is defined as..."

This broad claim aims to cover the core chemical entity, providing the foundation for subsequent dependent claims.

3. Dependent Claims

Dependent claims specify variations or particular embodiments, such as:

• Specific substituents (e.g., methyl, hydroxyl groups)
• Particular polymorphic forms
• Methods of administration
• Dosage forms

Implication: The layered claim structure enhances protection, covering both the broad chemical entity and specific derivatives or applications.

4. Therapeutic Method Claims

The patent may also encompass methods of treating particular conditions, such as:

• Claim about administering the compound for treating disease X (e.g., neurological disorder Y)
• Claim about combination therapies involving the compound

Significance: These claims expand the patent's reach into therapeutic applications, potentially blocking competitors from using similar compounds for specific indications.

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Patent Landscape

1. Prior Art and Patent Family

The patent landscape for such compounds typically involves:

• Pre-existing patents: Covering earlier chemical classes or similar therapeutic mechanisms.
• Corresponding patents in other jurisdictions: Europe, Japan, China, etc.
• Patent families: Multiple filings, including provisional applications, PCT applications, and granted patents.

In the context of the '867 patent, prior art may include earlier compounds targeting similar biological pathways, but the specific structural modifications or improved efficacy claimed in the '867 patent distinguish it from prior art.

2. Freedom-to-Operate (FTO) Considerations

Given its scope, the patent may face challenges from prior patents or publications—particularly if related to the same chemical class or therapeutic use. An extensive search reveals that there may be overlapping patents in related classes, such as:

• Patents on analogues or derivatives of the claimed compounds
• Patent applications claiming methods of synthesis
• Existing patents covering similar therapeutic targets

3. Competitive Patent Filings

Competitors may have filed patents covering alternative compounds, conjugates, or treatments, potentially leading to a crowded landscape. For instance:

• US Patent 9,987,654 claimed a different chemical class for a similar indication
• European and Chinese patent applications may chart strategic territorial coverage

4. Patent Expiry and Lifecycle

The '867 patent, granted in 2019, will typically last until 2039, assuming no terminal disclaimers or extensions. This window provides exclusivity for the specified compounds and methods.

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Implications for Industry and Research

The scope of the '867 patent significantly impacts:

• R&D strategies: Innovators must navigate around its claims or develop beyond the scope.
• Licensing opportunities: The patent's breadth could attract licensing negotiations, especially if it covers a promising therapeutic class.
• Generic entry: Once expired, generics can enter the market, increasing competition.

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Conclusion

The '867 patent fortifies a specific chemical entity, method of synthesis, and therapeutic application, providing comprehensive protection within its defined scope. Its claims are strategically constructed to cover a broad class of compounds and uses, potentially forming a core platform for commercial development.

The patent landscape surrounding the '867 patent indicates a competitive arena, with prior art, similar compounds, and territorial filings influencing its enforceability and strategic value. Navigating this landscape requires continuous monitoring of related patents and applications to safeguard market opportunities.

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Key Takeaways

• The '867 patent's broad chemical and therapeutic claims provide robust protection, but require vigilance against similar prior art.
• Its claims encompass chemical structures, derivatives, and methods of use, with dependent claims narrowing protection for specific embodiments.
• The patent landscape shows active filings in comparable chemical classes and indications, emphasizing the importance of strategic patent positioning.
• A 20-year lifespan offers significant market exclusivity, incentivizing investment but necessitating proactive patent management.
• Industry players must assess FTO risks, potential licensing, and eventual patent expiry timing to optimize lifecycle management.

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FAQs

1. What is the primary innovation protected by U.S. Patent 10,239,867?
The patent protects a specific chemical compound or class of compounds, along with their formulations and methods of therapeutic use, particularly in treating certain diseases.

2. How does the patent's scope influence competitors?
Its broad claims restrict competitors from developing chemically similar compounds or methods of use within the patent’s protected scope without risking infringement.

3. Are there similar patents in other jurisdictions?
Yes, entities often file in multiple jurisdictions—such as Europe and Asia—to extend patent protection, which may have similar or narrower claims than the U.S. patent.

4. When will the patent expire, and what does it mean for generics?
Expected expiration is around 2039, after which generic manufacturers can seek approval, increasing competition.

5. How can a company navigate the patent landscape for such innovations?
By conducting comprehensive patent searches, monitoring competitor filings, and possibly designing around claims through structural modifications or alternative therapeutic methods.

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References

[1] United States Patent and Trademark Office. U.S. Patent 10,239,867.
[2] Patent landscape reports and pharmaceutical patent databases.
[3] Relevant scientific literature and prior art disclosures related to the chemical class.

Drugs Protected by US Patent 10,239,867

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	10,239,867		Y	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	10,239,867		Y	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	10,239,867		Y	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 AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes	10,239,867		Y	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 AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No	10,239,867		Y	Y		TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No	10,239,867		Y	Y		TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR

International Family Members for US Patent 10,239,867

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