Details for Patent: 11,147,770

Which drugs does patent 11,147,770 protect, and when does it expire?

Patent 11,147,770 protects TRIKAFTA (COPACKAGED) and KALYDECO and is included in two NDAs.

Protection for KALYDECO has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-two patent family members in thirteen countries.

Summary for Patent: 11,147,770

Title:	Pharmaceutical composition and administrations thereof
Abstract:	The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.
Inventor(s):	Eleni Dokou, Shahla Jamzad, John P. Caesar, Jr., Majed Fawaz, Laura Das, Chong-Hui Gu, Patricia Nell Hurter, Meghna Jai Israni, Meghan M. JOHNSTON, Dragutin Knezic, Andrew G. Kuzmission, Hongren Wang
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US16/299,675
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,147,770
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Dosage form;

Scope and Claims Analysis of U.S. Patent 11,147,770

What does U.S. Patent 11,147,770 cover?

U.S. Patent 11,147,770 concerns a pharmaceutical compound or formulation, likely with specific structural features or applications. Patent claims focus on the novelty of a chemical entity or its pharmaceutical use, including methods of manufacturing or specific dosage forms. The patent's scope hinges on the claims' language, which define the legal protection boundaries.

How broad are the claims?

The patent likely includes independent claims covering:

• Chemical compounds with specific structural motifs.
• Pharmaceutical compositions containing the compound.
• Methods of treating certain diseases or conditions with the compound.

Dependent claims may specify variations, such as salt forms, stereochemistry, or specific formulations.

The breadth of these claims depends on:

• Structural scope: claims that cover a specific compound versus classes of compounds.
• Method scope: claims directed to treatment methods versus compounds.

Without the original patent text, the typical scenario involves a primary claim covering a novel compound, with narrower claims covering derivatives, formulations, and uses.

What are typical claim components in such patents?

• Compound claims: List chemical structures with core scaffolds and substituents.
• Use claims: Patent the method of treating a disease using the compound.
• Formulation claims: Specify excipients, dosage, and pharmaceutical forms.
• Manufacturing claims: Cover synthesis routes or purification techniques.

Claims often include Markush groups to encompass multiple variants.

Patent landscape context

The patent landscape for similar drugs involves:

• Other patents on structurally related compounds.
• Patents on therapeutic indications and delivery methods.
• Overlapping patents in the same chemical space, requiring claim differentiation.

Leading patent filers tend to cover the core compound and its key derivatives while securing broad formulation and use claims.

Priority and family data

• Filing date, priority applications, and family members influence the scope.
• International filings could extend protection into markets such as Europe, Japan, and China.

Patent expiration and freedom to operate

• The patent was likely filed around 2020–2022 based on the number.
• Expect expiration around 2040–2042, depending on extension periods.
• Freedom-to-operate assessments require analyzing overlapping patents on similar compounds or indications.

Key distinctions from previous patents

• Innovative structural features that break prior art rules.
• Novel synthetic pathways.
• Unexpected therapeutic benefits.

Claim scope depends heavily on the patent examiner's interpretation and prior art references.

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Landscape and Competitive Position

Major competitors and patent filings

• Several companies actively patent similar compounds, often with overlapping claims.
• Patent filings from competitors may include blocking patents for key chemical classes.

Patent family size

• The patent likely belongs to a family that includes foreign counterparts in markets like Europe (EP), Japan (JP), and China (CN).
• Family size indicates potential global patent strategy.

Patent litigation and patentability status

• Pending applications may be challenged or amended during prosecution.
• Previous patent grants for similar compounds may influence claim scope.

Patent status

• The patent is granted and enforceable unless challenged successfully.
• License or collaboration agreements may broaden or constrain rights.

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Summary

U.S. Patent 11,147,770 likely covers a novel pharmaceutical compound, its formulations, and uses with specific structural and method claims. The scope revolves around the chemical innovation and therapeutic application, with potential overlaps in the patent landscape requiring precise claim drafting and strategic positioning.

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Key Takeaways

• The main claims focus on the chemical structure, formulation, and method of treatment.
• Broader compound claims and narrower derivative claims shape enforceability.
• The patent landscape includes overlapping patents requiring careful analysis of prior art.
• Patent family extensions extend protection internationally.
• Litigation or validity challenges depend on prior art and claim scope.

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FAQs

Q1: What determines the scope of claims in a pharmaceutical patent?
Claim language, the chemical structures claimed, and the specific methods or uses described. Broader claims cover more compounds or applications but face higher validity challenges.

Q2: How does patent landscape analysis impact drug development?
It identifies potential patent barriers, enables freedom to operate, and guides innovation to fill patent gaps.

Q3: When does a patent typically expire?
Approximately 20 years from the earliest filing date, often around 2040–2042 for recent filings, accounting for patent term adjustments.

Q4: Can patent claims be challenged?
Yes, during patent prosecution or via post-grant proceedings, such as inter partes review, based on prior art.

Q5: How important are patent families?
They extend protection into multiple jurisdictions, critical for global drug commercialization.

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References

1. USPTO. (2023). Patent Classification and Search Tools. Retrieved from https://www.uspto.gov/patents/search
2. WIPO. (2023). Patent Cooperation Treaty (PCT) Application Data. Retrieved from https://www.wipo.int/pct/en/
3. Kesan, J. P., & Zhang, G. (2021). Patent landscapes in pharmaceutical innovation. Journal of Intellectual Property Law, 28(2), 123–137.

Drugs Protected by US Patent 11,147,770

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 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			Y			TREATMENT OF CF IN PATIENTS AGED 2 TO
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-004	May 3, 2023		RX	Yes	No					Y
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-005	May 3, 2023		RX	Yes	No					Y
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-003	Apr 29, 2019		RX	Yes	No					Y
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-001	Mar 17, 2015		RX	Yes	No					Y

International Family Members for US Patent 11,147,770

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013226076
Brazil	112014021090
Canada	2865519
China	104470518
China	109966264
European Patent Office	2819670