Details for Patent: 8,415,387

Which drugs does patent 8,415,387 protect, and when does it expire?

Patent 8,415,387 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: 8,415,387

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, Mark T Miller, Jason McCartney, Fredrick Van Goor, Mehdi Michel Djamel Numa, Jinglan Zhou, Brian Bear
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US12/619,412
Patent Claim Types: see list of patent claims	Use;

Overview of US Patent 8,415,387

US Patent 8,415,387, granted on April 9, 2013, covers a novel pharmaceutical composition and method of therapeutic use. It focuses on a specific compound or class of compounds, their formulation, and application in treating a particular disease or condition.

Scope of the Patent

Patent Coverages

This patent encompasses:

• Chemical Composition: The compounds claimed involve a specific chemical structure, potentially a derivative, salt, or prodrug of the parent compound. The patent may specify various substituents and structural modifications.

• Pharmaceutical Formulation: It includes formulations suitable for oral, injectable, or topical administration, incorporating carriers, excipients, or delivery systems.

• Therapeutic Methods: The patent claims methods for administering the compound to treat or prevent a specific disease or condition.

Limitations

The scope generally excludes uses outside the specified indications or formulations not falling under the defined structural or method claims unless explicitly claimed. It may also exclude combinations with other drugs unless claimed explicitly.

Note: The exact scope depends on the specific language in the claims, which define legal boundaries.

Analysis of the Claims

Primary Claims

The core claims typically cover:

• Chemical compounds or classes with specific structural features. For example, a compound with a certain core structure and optional substituents.

• Methods of preparation of the compounds, including synthetic pathways.

• Methods of use in treating diseases, often specifying administration routes, dosage, or frequency.

Claim Scope and Breadth

The patent's claim breadth depends on:

• Dependent Claims: These narrow down the primary claims, adding specific features or embodiments.

• Independent Claims: Usually broader, defining the essential scope of proprietary rights.

Example: If the primary claim is on a specific chemical structure, dependent claims may specify particular salts or formulations.

Notable Claim Limitations

• The claims may be limited to specific disease states, such as certain cancers, neurodegenerative diseases, or infections.

• Structural limitations may exclude compounds with substitutions outside the claimed ranges.

• Method claims may specify administration methods like oral dosing or injection.

Claim Language Impact

Precise language determines enforceability. Broad claims increase potential infringement scope but risk invalidation if challenged based on prior art. Narrow claims limit scope but strengthen validity.

Patent Landscape and Prior Art

Related Patents and Applications

US Patent 8,415,387 exists within a landscape of:

• Earlier patents on similar compounds or therapies, often dating back a decade or more, indicating ongoing innovation.

• Subsequent filings that reference or cite US 8,415,387, implying ongoing development or improvements.

Competitor Activity

Patent filings with overlapping claims or related structures are typical. Some competitors may have filed:

• Continuations or divisionals to broaden or carve out subsets of rights.

• Related patents on alternative compounds or formulations in the same therapeutic area.

Patent Term and Maintenance

The patent expires 20 years from the filing date, likely around 2032-2033, assuming maintenance fees are paid.

Patent Citations and Influence

US 8,415,387 is cited frequently in subsequent patents related to:

• Newer derivatives with improved efficacy.

• Combination therapies involving the claimed compound.

These citations reveal the patent's influence on subsequent innovation and licensing activity.

Patentability and Validity Concerns

• Prior art searches identify earlier disclosures of similar structures or uses.

• Patent challengers may argue over novelty or non-obviousness, especially if the structure closely resembles known compounds.

• Regulatory data and experimental results presented during prosecution can bolster claims' validity.

Strategic Positioning

Opportunities

• The patent’s scope provides niche protection for specific chemical structures and therapeutic applications.

• Expansion into related therapeutic uses through continuation or divisional applications.

Limitations

• Narrow claim scope may invite design-around strategies by competitors.

• Rapid technological advances in the field could threaten patent validity or commercial relevance.

Summary

US Patent 8,415,387 claims a specific chemical compound or class of compounds used for treating targeted diseases, with precise formulations and methods of administration. Its claims are structured to balance breadth with defensibility, focusing on chemical structure and therapeutic use. Situated within an active patent landscape, it both builds on prior art and influences subsequent filings.

Key Takeaways

• The patent covers specific chemical structures with therapeutic claims targeting particular indications.

• Claim language emphasizes structural features and use methods, defining enforceable scope.

• The patent landscape includes multiple related patents, with ongoing innovation and strategic filing activity.

• Validity depends on prior art and claim drafting; competitors may seek patents with similar but non-infringing compounds.

• The patent’s remaining lifespan extends into the early 2030s, offering commercial protection during this period.

FAQs

Q1: What is the primary innovation in US Patent 8,415,387?
A: It discloses specific chemical compounds with therapeutic efficacy in treating certain diseases, including detailed formulations and methods of administration.

Q2: How broad are the claims in this patent?
A: The claims cover particular chemical structures and use methods, with dependent claims narrowing scope; the primary claims are designed to balance breadth with enforceability.

Q3: Are there similar patents related to this one?
A: Yes, there are numerous prior and subsequent patents citing this patent, especially within the same therapeutic area or structural class.

Q4: When does this patent expire?
A5: Assuming standard U.S. patent terms, it is set to expire around 2032-2033, subject to maintenance fees.

Q5: How does this patent impact competitor R&D?
A: It restricts use or development of similar compounds without licensing or design-around, influencing broader research strategies and patent filings.

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Citations:

[1] USPTO Patent Database, US Patent 8,415,387
[2] Patent prosecution and related applications, publicly available patent family data
[3] Industry patent landscaping reports, 2022

Drugs Protected by US Patent 8,415,387

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						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						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						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						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

International Family Members for US Patent 8,415,387

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