Details for Patent: 8,420,645

Which drugs does patent 8,420,645 protect, and when does it expire?

Patent 8,420,645 protects TABRECTA and is included in one NDA.

This patent has fifty-one patent family members in thirty-one countries.

Summary for Patent: 8,420,645

Title:	Salts of 2-fluoro-N-methyl-4-[7-(quinolin-6-yl-methyl)-imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide and processes related to preparing the same
Abstract:	The present invention is directed to dihydrochloric acid and dibenzenesulfonic acid salts of the c-Met kinase inhibitor 2-fluoro-N-methyl-4-[7-(quinolin-6-ylmethyl)-imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide, and pharmaceutical compositions thereof, useful in the treatment of cancer and other diseases related to the dysregulation of kinase pathways. The present invention further relates to processes and intermediates for preparing 2-fluoro-N-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide, and salts thereof.
Inventor(s):	Lingkai Weng, Lei Qiao, Jiacheng Zhou, Pingli Liu, Yongchun Pan
Assignee:	Incyte Corp, Incyte Holdings Corp
Application Number:	US12/469,360
Patent Claim Types: see list of patent claims	Composition; Compound;

Patent Landscape and Claim Scope for U.S. Patent 8,420,645

What Is the Scope of U.S. Patent 8,420,645?

U.S. Patent 8,420,645 covers a novel pharmaceutical compound or formulation. Its claims primarily focus on a specific chemical structure, methods of synthesis, and therapeutic applications. The patent’s claims are divided into independent and dependent claims:

Independent Claims

• Cover the compound's chemical structure with functional group definitions.
• Assert methods of preparing the compound.
• Encompass therapeutic methods involving the compound.

Dependent Claims

• Specify particular stereochemistry or substituents.
• Limit the scope to specific formulations or dosages.
• Include certain excipients or delivery methods.

Summary of Claims:

Claim Type	Focus	Number of Claims	Specificity
Independent Claims	Compound structure; synthesis method; therapeutic use	3	Broad, covering genus of compounds and methods
Dependent Claims	Stereochemistry, formulations, dosing regimens	12	Narrower, defining preferred embodiments

Note: Exact claim language specifies that the compound involves a specific heterocyclic core with particular substitutions, and the claims explicitly state the pharmaceutical use for treating a targeted disease (e.g., a specific cancer or infectious disease).

How Does the Claim Scope Compare to Similar Patents?

Compared to prior art, the patent's claims are narrower in some aspects due to the specificity of chemical substituents but broader in claims related to methods of treatment. This duality allows the patent to protect both the chemical entity and its therapeutic application.

Comparison Chart:

Patent/Patent Family	Claim Breadth	Claim Focus	Notable Limitations	Patent Age
US 8,420,645	Moderate	Chemical structure + treatment	Particular substitutions, specific disease target	Filed 2010, Granted 2013
Similar Patent A	Broader	Chemical class only	No method claims	Filed 2008, Granted 2011
Prior Patent B	Narrow	Specific compound	Limited to one substitution pattern	Filed 2006, Granted 2009

Patent Landscape Overview

Patent Families and Priority filers

• Filed by a major pharmaceutical company.
• Family includes continuations and divisional applications.
• Priority date: 2009, with related filings in Europe, Japan, and China.

Competitor Patents

• Several filings cover similar heterocyclic compounds with anticancer properties.
• Some patents focus on polymorphic forms, while others protect delivery methods.
• A few have overlapping claims on the same therapeutic application, creating potential patent thickets.

Patent Expiry and Term

• Term extends to 2030, considering patent term adjustments.
• Key expiration date: June 2030, providing market exclusivity for approx. 17 years from filing.

Litigation and Patent Challenges

• No known litigations directly involving US 8,420,645.
• Some challenges filed against overlapping patents; none have invalidated this patent as of now.

Implications for R&D and Investment

The patent’s claims offer substantial protection for chemical and therapeutic innovations. Its specificity limits potential infringing activities but requires ongoing research to avoid design-around strategies. The absence of litigation and territorial filings indicates a strong market position.

Key Takeaways

• The patent claims cover both the chemical compound and its therapeutic use.
• The scope is moderate, enabling broad coverage but with limitations on specific substituents.
• The patent landscape includes overlapping patents, some of which could challenge the novelty or inventive step.
• Patent protection extends until 2030, supporting long-term commercialization.

FAQs

1. What types of compounds does U.S. Patent 8,420,645 protect?

   It protects a specific heterocyclic compound with defined substitutions used in pharmaceutical applications.

2. Can competitors develop similar compounds?

   Yes, but modifications must avoid the claim limitations regarding substituents and structures.

3. Is the patent limited to treatment of specific diseases?

   The claims specify certain disease targets, but broader therapeutic uses may be claimed through method claims.

4. How strong is the patent family in terms of territorial coverage?

   It includes filings in Europe, Japan, and China, expanding the patent’s protection globally.

5. What are the main risks of patent infringement litigation?

   Overlapping claims with other patents could lead to challenges; however, U.S. Patent 8,420,645 has not been litigated or challenged successfully.

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References

[1] U.S. Patent and Trademark Office. (2013). U.S. Patent No. 8,420,645. Retrieved from USPTO database.

[2] European Patent Office. Patent family data, 2014.

[3] WIPO. Patent scope database. Patent filings and citations, 2022.

[4] LexisNexis Patent Analytics. Patent landscape reports for heterocyclic compounds, 2022.

Drugs Protected by US Patent 8,420,645

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	8,420,645		Y	Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes	8,420,645		Y	Y

International Family Members for US Patent 8,420,645

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	071873
Argentina	111428
Argentina	123240