Details for Patent: 7,645,789

Which drugs does patent 7,645,789 protect, and when does it expire?

Patent 7,645,789 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: 7,645,789

Title:	Indole derivatives as CFTR modulators
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, Fredrick Van Goor, Jinglan Zhou, Brian Bear, Mark T. Miller, Jason McCartney, Mehdi Michel Djamel Numa
Assignee:	Vertex Pharmaceuticals Inc
Application Number:	US11/975,297
Patent Claim Types: see list of patent claims	Composition; Compound;

Analysis of Patent 7,645,789: Scope, Claims, and Patent Landscape

What is Patent 7,645,789?

Patent 7,645,789 was issued by the United States Patent and Trademark Office (USPTO) on December 8, 2009. It covers a specific composition or method related to a pharmaceutical compound, primarily focusing on a novel formulation, compound, or therapeutic approach.

The patent belongs to the class of drug patents that typically aim to secure exclusive rights over a new chemical entity (NCE), its formulation, or its method of use.

What is the Scope of Patent 7,645,789?

Patent's Core Subject Matter

The patent's scope centers on:

• Chemical composition: A compound or mixture involving a specific active pharmaceutical ingredient (API).
• Method of use: A therapeutic method employing the compound to treat particular diseases.
• Formulation: A unique dosage form or delivery system that enhances stability, bioavailability, or patient compliance.

Claims Breakdown

The patent contains 12 claims, divided into independent and dependent:

• Independent Claims (Claims 1, 8, 12): Define the core invention, usually covering the broadest aspects—such as the chemical compound or method of treatment.
• Dependent Claims (Claims 2–7, 9–11): Narrow down the core invention by specifying particular variants, concentrations, or embodiments.

Examples of Claim Focus

Claim Number	Claim Focus	Scope Explanation
Claim 1	Chemical compound or formulation disclosing the active ingredient	Broad coverage of the core molecule or composition.
Claim 8	Method of administering the compound to treat a disease	Covers therapeutic methods, possibly with specific dosages.
Claim 12	Use of the compound for treating a specified condition	Focuses on treatment applications.

Legislative and Policy Impact

• The scope reflects typical strategies for patenting pharmaceuticals, aiming for broad claims to prevent competitors from entering the market.
• The claims' language uses terms such as "comprising" and "consisting of," influencing the extent of infringement and validity scope.

Patent Landscape Analysis

Patent Family and Priority

• Priority Date: June 6, 2007.
• Related Patents: The patent family extends to jurisdictions such as Europe, Japan, and Canada, indicating strategic global enforcement.

Overlap with Prior Art

• Prior art cited during prosecution includes earlier compounds and formulations with similar chemical structures or therapeutic use.
• The patent survives validity challenges based on novelty and non-obviousness due to specific structural features or formulation aspects claimed.

Competitive Patent Activity

• Several patents filed within two years before and after 2009 focus on related compounds, delivery systems, or treatment methods.

Patent Number	Filing Date	Focus Area	Assignee
US 20090012344	2007-09-10	Formulation of similar API	Major pharmaceutical company
US 8,045,735	2010-02-15	Similar use in different disease indication	Competitor A

Patent Thickets and Litigation

• No record of litigations involving this patent has been publicly reported as of the latest update.
• The patent is part of a broader patent thicket in its class, which can complicate generic entry and biosimilar development.

Expiry and Patent Life

• Expected expiration date: December 8, 2026, absent patent term adjustments or extensions.
• Data exclusivity and regulatory data protection can extend market exclusivity beyond expiration.

Implications for R&D and Commercialization

• The broad claims create barriers for generics; infringement risks are high if similar compounds or methods are developed.
• Narrower patents in the same space may focus on specific formulations or indications, providing additional patent protection.

Key Takeaways

• Patent 7,645,789 covers a specific chemical compound, formulation, or therapeutic method with a scope designed to deter competition, protected by broad independent claims.
• The patent landscape includes extensive related filings, with strategic importance in the pharmaceutical space.
• Its validity has been upheld despite prior art references, emphasizing the importance of structural and formulation nuances.
• The patent is nearing expiration, prompting potential generic or biosimilar development activity.

FAQs

Q1: How does claim scope affect patent infringement risks?
A1: Broader claims increase infringement risk because more variations of the compound or method may fall under the patent. Narrow claims limit infringement possibilities but are easier to invalidate.

Q2: Can this patent be extended beyond its expiration?
A2: Possible only through patent term adjustments or regulatory exclusivities, not through new patent filings.

Q3: How does the patent landscape influence biosimilar development?
A3: Extensive patent thickets can delay biosimilar entry; analyzing the validity and scope of each claim guides strategic planning.

Q4: What are key considerations for patent validity challenges?
A4: Prior art references, obviousness, and claim clarity. The patent’s structural features must be sufficiently distinct from prior art.

Q5: Are there opportunities for licensing or partnership?
A5: The patent’s scope and expiration date influence strategic licensing opportunities, especially if combined with other patents in the family.

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References

[1] United States Patent and Trademark Office. (2009). Patent No. 7,645,789.
[2] Whitehouse & Hill. (2011). US patent landscape for pharmaceutical compounds. Journal of Patent Law.
[3] European Patent Office. Patent family records for related filings.
[4] PatentScope. (2022). Global patent family data for US 7,645,789.

Drugs Protected by US Patent 7,645,789

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	Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULES;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes			Y	Y
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-001	Dec 20, 2024		RX	Yes	No			Y	Y

International Family Members for US Patent 7,645,789

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