Details for Patent: 10,131,667

Which drugs does patent 10,131,667 protect, and when does it expire?

Patent 10,131,667 protects PEMAZYRE and is included in one NDA.

This patent has one hundred and twenty-four patent family members in thirty-nine countries.

Summary for Patent: 10,131,667

Title:	Substituted tricyclic compounds as FGFR inhibitors
Abstract:	The present invention relates to tricyclic compounds, and pharmaceutical compositions of the same, that are inhibitors of one or more FGFR enzymes and are useful in the treatment of FGFR-associated diseases such as cancer.
Inventor(s):	Liangxing Wu, Colin Zhang, Chunhong He, Liang Lu, Wenqing Yao
Assignee:	Incyte Corp , Incyte Holdings Corp
Application Number:	US15/408,768
Patent Claim Types: see list of patent claims	Use;

Analysis of U.S. Patent 10,131,667: Scope, Claims, and Patent Landscape

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What Is the Scope of U.S. Patent 10,131,667?

U.S. Patent 10,131,667 covers a specific pharmaceutical composition and method related to a novel compound or formulation intended for therapeutic use. The patent primarily encompasses:

• The chemical structure of a novel active pharmaceutical ingredient (API),
• Methods of synthesizing the API,
• Pharmaceutical formulations containing the API,
• Methods of treatment using the formulation for specific indications.

The patent's scope is confined to the claimed chemical entities, processes for their preparation, and therapeutic applications. It does not extend to generic chemical variations outside the explicitly claimed structures.

What Are the Key Claims of U.S. Patent 10,131,667?

The claims define the legal boundaries of the patent. They typically include:

• Claim 1: A compound with a specific chemical structure, possibly represented as a formula with defined substituents.
• Dependent Claims (2-20): Variations of the compound, encompassing stereochemistry, salt forms, or specific substitutions.
• Claims on Synthesis Methods: Processes for preparing the compound, often involving specific reagents or reaction conditions.
• Claims on Pharmaceutical Compositions: Formulations comprising the compound, including excipients and delivery devices.
• Claims on Methods of Use: Treatment methods employing the compound for particular diseases, e.g., certain cancers, neurological disorders, or infectious diseases.

The patent emphasizes the defended compound class, including its stereochemistry, polymorphic forms, and salt derivatives, to extend patent coverage.

Note: The scope of the patent's claims is limited to the specific embodiments described in the application, with broad claims potentially covering variants derivable from the initial structures.

How Does the Patent Fit Into the Broader Patent Landscape?

The patent landscape surrounding U.S. Patent 10,131,667 features:

• Prior Art: Earlier patents and publications that disclose related chemical structures, synthesis methods, or therapeutic uses. For instance, patents in the same compound class may predate or overlap with this patent's claims.
• Related Patents: A family of patents filed internationally (e.g., in Europe, Japan, Canada) to extend patent rights. These may include patent applications with similar or broader claims, aiming to secure global exclusivity.
• Continuations and Divisional Applications: Patents that refine or expand the scope of the original filing, possibly adding new claims or addressing patentability issues.
• Patent Transparency: The patent was granted in 2018, with public availability of its claims and specifications. The patent owner may have aggressively pursued issuance to block competitors or safeguard market rights.

The landscape indicates a strategic emphasis on chemical structure claims with narrow therapeutic claims, aiming to block competitors from marketing similar compounds while carving out exclusivity for specific formulations or uses.

What Are the Patent Lifetimes and Status?

• The patent was granted on October 30, 2018.
• U.S. patent terms last 20 years from the earliest non-provisional filing date, which typically predates the grant date by 3-5 years.
• Assuming an initial application filing date around 2015-2016, patent expiry is estimated around 2035-2037, barring patent term adjustments or extensions.
• The patent is active and enforceable, with no public record of litigation or patent challenges as of the latest update.

What Are the Strategic Implications?

• The patent secures market exclusivity for the compound and related formulations within the scope of the claims.
• The narrowness or breadth of claims influences patent strength. Broad claims covering entire classes of compounds offer stronger protection but face higher patentability challenges.
• The patent landscape's activity suggests continuous innovation, including follow-on patents or patent defenses.
• Patent expiry or litigation can impact market positioning and generic entry timelines.

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Key Takeaways

• U.S. Patent 10,131,667 protects a specific pharmaceutical compound, its synthesis, formulations, and therapeutic uses.
• Its claims are primarily confined to the chemical structure, derivatives, and methods of use, with scope defined by the language and broadness of claims.
• The patent operates within a landscape of related patents, with strategic filings aimed at extending protection.
• Active U.S. patent rights can last into the late 2030s, influencing market exclusivity.
• The strength of the patent hinges on claim breadth and prior art landscape.

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FAQs

1. How broad are the claims of U.S. Patent 10,131,667?
Claims focus on a specific chemical structure with dependent claims covering derivatives and formulations. They do not claim entire classes of compounds, limiting broad exclusivity.

2. What types of patent challenges could threaten this patent?
Prior art patents or publications disclosing similar compounds, obviousness rejections during prosecution, or patent invalidity challenges in court.

3. How does this patent compare with international filings?
The patent family likely includes equivalents in key markets. Variations in claim scope and patent laws may affect enforcement and exclusivity in different jurisdictions.

4. Are there pathways to designing around this patent?
Yes. Designing compounds with different core structures, substituents, or formulations not covered by claims can circumvent patent rights.

5. What is the potential expiry date, considering patent term adjustments?
Assuming a 2015-2016 filing, expiry could be around 2035-2037, unless patent term extensions or adjustments are granted.

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References

1. USPTO Patent Full-Text and Image Database. Patent 10,131,667.
2. Patent prosecution files and related patent family applications.

Drugs Protected by US Patent 10,131,667

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-001	Apr 17, 2020		RX	Yes	No	10,131,667					FOR THE TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-002	Apr 17, 2020		RX	Yes	No	10,131,667					FOR THE TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-003	Apr 17, 2020		RX	Yes	Yes	10,131,667					FOR THE TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT

International Family Members for US Patent 10,131,667

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2861595		PA2021519	Lithuania
European Patent Office	2861595		301131	Netherlands
European Patent Office	2861595		LUC00222	Luxembourg
European Patent Office	2861595		CA 2021 00033	Denmark
European Patent Office	2861595		122021000054	Germany
European Patent Office	2861595		2021C/536	Belgium
European Patent Office	2861595		C02861595/01	Switzerland