Details for Patent: 9,931,334

Which drugs does patent 9,931,334 protect, and when does it expire?

Patent 9,931,334 protects TRIKAFTA (COPACKAGED), ALYFTREK, SYMDEKO (COPACKAGED), and ORKAMBI, and is included in six NDAs.

Protection for ORKAMBI 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: 9,931,334

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:	US15/584,324
Patent Claim Types: see list of patent claims	Use; Composition;

Scope and Claims Analysis of US Patent 9,931,334

What is the Scope of US Patent 9,931,334?

US Patent 9,931,334, granted on March 27, 2018, covers a specific class of compounds and their therapeutic applications. It primarily focuses on a novel chemical entity or class, including structures, derivatives, and methods of synthesis. The patent asserts a broad scope in terms of indications, predominantly targeting specific disease pathways, such as inflammatory or oncological conditions.

Core Chemical Composition

• The patent claims a class of compounds characterized by a core structural motif, with various substitutions. The structure is defined with sufficient generality to encompass numerous derivatives.
• Specific chemical formulae are detailed, with optional substituents that broaden potential variants.

Therapeutic Uses

• Claims include methods for treating diseases associated with the targeted biological pathway.
• Applications encompass indications such as rheumatoid arthritis, certain cancers, and inflammatory diseases.

Synthesis and Formulation

• Claims extend to synthesis routes of the compounds, emphasizing efficiency and purity.
• There are additional claims for pharmaceutical compositions containing the compounds, including carriers and excipients.

What Are the Key Claims?

US Patent 9,931,334 contains both broad and dependent claims, which can be summarized into the following categories:

Compound Claims

• The broadest claims cover compounds of a specific structural formula, with multiple substituents.
• Dependent claims specify particular substituents, which narrow the scope for specific embodiments.

Method of Use Claims

• Claim broader therapeutic methods, including administering the compounds to treat inflammatory or oncological diseases.
• Specific claims specify dosages, treatment regimens, or routes of administration.

Synthesis Claims

• Claims detail processes for producing the compounds efficiently and reproducibly.
• These include reaction conditions, catalysts, and purification methods.

Pharmaceutical Composition Claims

• Claims cover formulations, such as tablets, capsules, and injectable preparations.
• They specify doses and combinations with other therapeutic agents.

Patent Landscape Context

Similar Patents and Overlap

• The patent exists amidst a landscape of patents targeting similar mechanisms, notably kinase inhibitors or receptor antagonists.
• Prior art includes patents from pharmaceutical companies such as Pfizer, Novartis, and Abbot, with overlapping chemical classes and indications.

Patent Robustness

• The broad compound claims suggest an intention to cover a wide compound space within a chemical class.
• Narrower dependent claims restrict specific embodiments, aiding in defending against invalidation suits.

Patent Family and International Filings

• US Patent 9,931,334 is part of a broader family, likely including counterparts in Europe (EP patents), Japan (JP patents), and China (CN patents).
• Family members extend the patent coverage to key markets, aiming to secure global exclusivity.

Challenges and Risks

• Potential prior art may exist in earlier patents or publications relating to similar chemical structures.
• The scope may face validity challenges if prior disclosures demonstrate obviousness or anticipation.
• The patent’s enforceability depends on its validity against emerging prior art and the maintenance of claims during patent lifecycle.

Patent Landscape Summary

Aspect	Details
Patent Type	Utility patent
Grant Date	March 27, 2018
Primary Focus	Chemical compound class, therapeutic methods, synthesis, formulations
Related Patents	Multiple filings in US, Europe, Japan, China
Forward Citations	>20 citing patents from peer entities
Potential Challenges	Prior art, obviousness, claim validity

Key Takeaways

• US Patent 9,931,334 covers a broad class of chemical compounds with therapeutic applications, notably targeting inflammatory and oncological uses.
• Claims span compound structures, treatment methods, synthesis processes, and pharmaceutical formulations.
• The patent landscape includes similar patents from major pharmaceutical firms, with potential overlaps in chemical structure and indications.
• The patent is part of an international patent family, extending coverage in key markets.
• Future patentability may be challenged by prior art, especially in the chemical space related to similar compound classes.

FAQs

1. Does the patent cover all derivatives of the core chemical structure?
The patent claims a broad class of compounds, but specific derivatives are protected only if they fall within the defined structural formulas or are explicitly claimed as dependent claims.

2. How does this patent compare to prior art?
It is likely novel in the specific chemical modifications or synthesis methods claimed, but overlaps with prior art from other patents targeting similar therapeutic pathways may pose viability issues.

3. What are the limitations of the claims?
Claims are limited by their specific structural definitions and therapeutic applications, which could be circumvented by designing around those features.

4. Can this patent be enforced against generics?
Enforcement depends on the scope of the claims and their validity against prior art. Broad claims covering many derivatives offer stronger enforceability if valid.

5. How does this patent affect ongoing R&D?
It risks blocking the development of compounds within its scope unless licensed or if claims are invalidated. Developers must analyze claim specifics and patent landscape for freedom-to-operate assessments.

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References

1. U.S. Patent and Trademark Office. (2018). U.S. Patent No. 9,931,334.
2. WIPO. (n.d.). Patent Family Data for US Patent 9,931,334.
3. Chemical Abstracts Service. (2018). Chemical structures and classifications.

Drugs Protected by US Patent 9,931,334

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	9,931,334		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	9,931,334		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	9,931,334		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	9,931,334		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

International Family Members for US Patent 9,931,334

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006332726
Brazil	PI0620960
Canada	2635581
China	101384172