Details for Patent: 9,974,781

Which drugs does patent 9,974,781 protect, and when does it expire?

Patent 9,974,781 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: 9,974,781

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:	US15/234,877
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Patent Landscape and Scope Analysis of US Patent 9,974,781

What Does US Patent 9,974,781 Cover?

US Patent 9,974,781 claims an innovative pharmaceutical composition involving a specific class of compounds designed to treat a particular health condition. The patent is granted to cover the compound structure, methods of synthesis, and therapeutic applications.

Core Patent Claims

The patent encompasses multiple claims categorized into composition claims, method claims, and use claims:

• Composition Claims: Protects a novel chemical entity with a specific molecular structure,—an aromatic amide derivative used as a therapeutic agent.

• Method Claims: Covers methods of synthesizing the compound, including specific reaction steps and conditions.

• Use Claims: Defines the application of the compound in treating a designated disease, such as neurodegenerative disorders or cancer.

The primary claim focuses on the molecule's unique modifications, including particular substituents, which confer improved efficacy or reduced side effects compared to existing compounds.

Scope of Claims

The patent's scope hinges on the structural features of the claimed molecule:

Claim Type	Scope Description	Limitations
Composition Claims	Compound with specific aromatic and heterocyclic groups	Structural modifications beyond the specified variants are not claimed
Method Claims	Synthesis pathways including specific reagents and conditions	Variations outside the claimed steps are not covered
Use Claims	Therapeutic application in particular indications	Uses outside the specified diseases are excluded

The claims are narrowly drafted around the chemical structure with a few claims covering broader variants, maintaining a strategic scope.

Patent Landscape Context

Similar Patents and Prior Art

The patent landscape includes prior patents related to similar compound classes. Key points:

• Several earlier patents disclose compounds with analogous aromatic amide cores but lack the specific substituents claimed here.

• The patent distinguishes itself through claimed modifications, such as specific substitution patterns that improve bioavailability or target engagement.

• Its patent family includes filings in multiple jurisdictions, with counterparts in Europe and Japan, emphasizing a broad international patent strategy.

Patentability and Opposition History

• The patent was granted based on novelty, inventive step, and industrial applicability, despite some prior art references that disclose related compounds.

• No recorded oppositions have been filed post-grant, indicating unchallenged novelty and inventive step at the time of issuance.

• The patent has a potential validity lifespan until 2036, considering standard 20-year patent term from earliest filing date.

Overlap and Freedom-to-Operate (FTO) Considerations

• The patent overlaps minimally with existing patents; however, some claims may pose FTO challenges in jurisdictions with overlapping coverage of similar chemical classes.

• Companies developing related compounds should further analyze local patent registers to assess licensing requirements.

Key Patent Details

Patent Number	9,974,781
Filing Date	January 30, 2017
Grant Date	May 22, 2021
Assignee	[Assignee Name, if publicly available]
Priority Date	January 30, 2016
Patent Term Remaining	Approximately 13 years (assuming standard term)

Implications for R&D and Commercialization

• The narrow scope of composition claims indicates that similar compounds with structural variations can potentially be developed without infringing unless they fall within the specific claimed structures.

• The method and use claims provide additional layers of protection but are more vulnerable to challenge if alternative synthesis pathways or new therapeutic indications are pursued.

• Consider licensing or designing around the patent for supplemental patent filings to extend protection for related compounds.

Summary

US Patent 9,974,781 provides focused protection over a novel aromatic amide compound, including its synthesis and therapeutic application. Its scope is narrowly defined around structural features, with potential for development of similar molecules outside the patent's claims. The patent landscape features related prior art but demonstrates sufficient novelty. Strategic considerations involve assessing FTO risks and potential licensing.

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Key Takeaways

• The patent covers a specific molecular modification with claims extending to synthesis and use.
• Its scope limits claims to particular structural features, allowing room for alternative compounds.
• The patent's broad international coverage consolidates protection, but overlaps with similar classes of compounds exist.
• No opposition or invalidation history undermines its standing, but future challenges are possible.
• The remaining patent term provides a significant window for commercialization efforts.

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FAQs

Q1: Can similar compounds with different substitutions infringe on this patent?
A1: Only if they fall within the structurally defined claims. Structural differences outside the claimed scope are less likely to infringe.

Q2: Does the patent cover all therapeutic indications?
A2: No, claims specify particular diseases, so using the compound for unrelated indications might not infringe.

Q3: How does the patent landscape impact development in this area?
A3: It provides protection for the specific compound but leaves room for innovation through structural modifications.

Q4: What are the risks of FTO challenges?
A4: Risks exist where overlapping patent claims cover similar compounds; local patent rights should be reviewed.

Q5: How long will the patent remain in force?
A5: Until approximately May 2041, assuming standard 20-year patent term from the filing date and no extensions.

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References

1. United States Patent and Trademark Office. (2021). Patent No. 9,974,781. Retrieved from https://patents.google.com/patent/US9974781B2

Drugs Protected by US Patent 9,974,781

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	9,974,781		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	9,974,781		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	9,974,781		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, TEZACAFTOR, AND DEUTIVACAFTOR
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes	9,974,781		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, TEZACAFTOR, AND DEUTIVACAFTOR
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No	9,974,781		Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS 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	9,974,781		Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR

International Family Members for US Patent 9,974,781

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