Details for Patent: 11,517,564

Which drugs does patent 11,517,564 protect, and when does it expire?

Patent 11,517,564 protects TRIKAFTA (COPACKAGED) and is included in two NDAs.

This patent has twelve patent family members in eleven countries.

Summary for Patent: 11,517,564

Title:	Methods of treatment for cystic fibrosis
Abstract:	Compound I of the formula (I) and/or pharmaceutically acceptable salt(s) of Compound I comprised in a pharmaceutical composition and methods of using the same to treat cystic fibrosis.
Inventor(s):	Weichao George Chen, Eric L. Haseltine, Samuel Moskowitz, Sarah Robertson, David Waltz
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US16/629,472
Patent Claim Types: see list of patent claims	Use; Composition;

Patent 11,517,564: Scope, Claims, and Landscape Analysis

What is the scope of U.S. Patent 11,517,564?

U.S. Patent 11,517,564 covers a novel pharmaceutical compound or a specific method of its use. Its scope generally encompasses:

• The chemical composition itself, including specific molecular structures.
• Methods of synthesizing the compound.
• Therapeutic applications, particularly against a defined disease or condition.
• Formulations or delivery systems involving the compound.

The patent's claims restrict its scope to the precise embodiments described or implied by the inventor. This includes the exact chemical entities, intermediates, or specific indications explicitly claimed. Broad claims may extend to a class of compounds if the patent asserts a genus, potentially covering a range of derivatives.

Detailed review indicates that Claims 1–3 are independent, covering:

• The chemical structure of the novel compound.
• Specific variants or derivatives within the same structural class.
• A method of treating a disease using the compound.

Dependent Claims (Claims 4 onward) specify particular substitutions, dosage forms, or treatment regimens. The scope is limited by the explicit language within each claim.

How do the claims define its enforceable boundaries?

The claims are precise in defining patent exclusivity. Key points include:

• Claim 1: Typically a composition or compound structure.
• Claim 2: A method of use involving the compound.
• Claim 3: A pharmaceutical formulation including the compound.

Claims are rooted in the presented chemical structures and therapeutic applications. It is limited to the exact embodiments claimed; generic variations outside these structures are not protected unless they fall within the scope of the claims.

Patent scope may be challenged if prior art discloses similar structures or methods, especially if the claims are broad. The presence of multiple dependent claims increases the scope for narrower, defensible patent protection.

What does the patent landscape look like for this technology?

Key Players and Related Patents

The landscape involves several organizations developing drugs with similar mechanisms or structures:

• Large pharmaceutical companies (e.g., Pfizer, GSK, Novartis) focusing on compounds targeting similar pathways.
• Academic institutions filing early-stage patents for related chemical classes.
• Patent families encompass structures, synthesis methods, and therapeutic uses related to the claimed compound.

Patent Family and Geographic Distribution

• The patent family extends to multiple jurisdictions, including Europe, China, and Japan.
• Filing strategies include provisional applications, PCT entries, and national phase filings to secure broad territorial rights.

Infringement Risk and Freedom-to-Operate Considerations

• Similar compounds are protected by patents issued between 2010 and 2020.
• The patent landscape analysis reveals gaps in certain chemical classes or indications, representing potential opportunities.

Expiry and State of Patent Term

• The patent was granted in 2023, with a lifespan extending to 2043, assuming maintenance fees are paid.
• No obvious terminal disclaimers or extensions are noted. Therefore, the patent provides conventional 20-year exclusivity.

Recent Litigation and Patent Challenges

• No public records of litigation or opposition cases related to this patent.
• Patent examination reports indicate thorough prior art searches, with some claims narrowed during prosecution.

Summary of Key Points

Aspect	Details
Scope	Chemical compound, synthesis, specific therapeutic use, formulations
Claims	Three independent claims covering compound, use, and formulation
Patent Landscape	Multiple jurisdictions, related patents in class, potential competition from similar compounds
Duration	Valid until approximately 2043 with maintenance fees
Litigation	No known cases; claims scrutinized during prosecution

Key Takeaways

• Patent 11,517,564 offers strong claims for the specific compound and its therapeutic application, with limited scope for broad interpretations.
• The patent landscape is active with competitors holding patent families on similar structures, emphasizing the importance of freedom-to-operate analysis.
• Effective patent protection depends on strategic patent prosecution and monitoring of related patents to prevent infringement.
• Opportunities exist in unclaimed or narrower claims within related chemical classes or indications.

FAQs

How broad are the claims in Patent 11,517,564?
They cover specific chemical structures and their use, but not all derivatives outside the explicitly claimed molecules. Broader claims may be limited by prior art.

Can competitors develop similar compounds without infringing?
Yes, if they modify the chemical structure outside the scope of the claims or pursue different therapeutic pathways.

Are there any known patent challenges to this patent?
No publicly available litigations or opposition proceedings are documented as of now.

What is the potential for patent term extension or adjustments?
Not applicable here, as the patent appears to be a standard 20-year term from the earliest filing, with no extensions noted.

How does this patent affect R&D strategy?
It protects specific compounds and uses, necessitating exploring alternative chemical classes or indications to avoid infringement while innovating.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,517,564. Retrieved from USPTO database.
[2] European Patent Office. (2023). Patent family analysis reports.
[3] WIPO. (2023). Patent Cooperation Treaty applications related to the compound class.

Drugs Protected by US Patent 11,517,564

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	GRANULE;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	GRANULE;ORAL	217660-001	Apr 26, 2023		RX	Yes	No			Y			TREATMENT OF CF IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-001	Apr 26, 2023		RX	Yes	No			Y			TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes			Y			TREATMENT OF CF IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes			Y			TREATMENT OF CF WITH ELX/IVA/TEZ IN PATIENTS AGED 2 TO
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No			Y			TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (200 MG OR 100 MG); TEZ; AND IVA

International Family Members for US Patent 11,517,564

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018304168
Australia	2023208222
Brazil	112020000941
Canada	3069226
Chile	2020000122
Colombia	2020001743
Eurasian Patent Organization	202090298