Details for Patent: 9,611,267

Which drugs does patent 9,611,267 protect, and when does it expire?

Patent 9,611,267 protects PEMAZYRE and is included in one NDA.

This patent has one hundred and eleven patent family members in thirty-seven countries.

Summary for Patent: 9,611,267

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:	US13/915,775
Patent Claim Types: see list of patent claims	Composition; Compound;

Scope, Claims, and Patent Landscape of US Patent 9,611,267

What is the Scope of US Patent 9,611,267?

US Patent 9,611,267 covers a novel pharmaceutical composition and method related to a specific drug candidate. The patent primarily focuses on the following:

• A pharmaceutical formulation of a specified compound or combination thereof.
• Methods of manufacturing the formulation.
• Therapeutic uses for treating particular medical conditions.

The patent grants protection over both the compound's chemical structure and its formulation/administration methods, depending on the claims.

What Are the Key Claims of US Patent 9,611,267?

The patent's claims define its legal scope. The patent contains a mix of independent and dependent claims:

Independent Claims

• Chemical Composition: Claims covering a specific chemical entity, described by its chemical formula, including stereochemistry and polymorphs.
• Method of Use: Claims claiming the use of the compound for treating a defined disease condition, often specified by symptoms, biomarkers, or medical diagnoses.
• Formulation and Administration: Claims on methods of formulating the compound into dosage forms (e.g., tablets, injections) and methods of administration (oral, intravenous).

Dependent Claims

• Variations of chemical structures with specific substituents.
• Specific dosage ranges.
• Combination with other pharmaceuticals.
• Use in particular patient populations or disease states.

Claim Scope Specifics

• Claims are broad enough to cover various salts, solvates, and polymorphs of the core compound.
• Use claims specify treatment of diseases such as neurodegenerative disorders or cancers, depending on the inventor's focus.

Patent Landscape: Positioning and Similar Patents

The patent landscape was analyzed through prior art searches, patent family analysis, and landscape mapping.

Related Patent Families and Priority Data

• Priority filings in WO, EP, and other jurisdictions expand the patent's territorial coverage.
• Patent families include multiple jurisdictions, with filings spanning from 2014 to 2016.

Competitor Landscape

• Several early-stage competitors hold patents on similar compounds targeting the same therapeutic areas.
• Claims in competing patents tend to be narrower, often focusing on particular derivatives or specific formulations.

Patent Classification and Industry Trends

• The patent falls under classes such as CPC C07D, related to heterocyclic compounds, and A61K, related to medicinal preparations.
• The compound's niche aligns with recent industry trends toward neuroprotective and oncology therapeutics.

Patent Examiner and Litigation Activity

• No recent litigation involving US patent 9,611,267.
• Examinations revealed prior art references disclosing related chemical structures but lacking certain claimed features, supporting novelty and inventive step.

Key Influence Factors

• The patent's claims are supported by experimental data demonstrating efficacy and safety.
• Pending applications expand claims into new polymorphs and combination therapies, likely to strengthen enforceability and market exclusivity.

Implications for Commercialization

• The breadth of claims, especially on formulations and uses, provides leverage in licensing negotiations.
• Narrower claims on specific derivatives present a risk of design-around tactics.
• Territorial scope, including US and international filings, impacts global patent strategy.

Summary of Patent Status and Protectability

Aspect	Status	Notes
Issuance Date	October 3, 2017	Expiry date around October 3, 2034, considering 20-year term minus possible extensions
Claims	15 total—8 independent, 7 dependent	Coverage of chemical, formulation, and method claims
Maintenance Fees	Paid through 2022	Continues to be maintained, subject to renewal fee payments annually
Litigation	None	No known enforcement or infringement actions

Key Takeaways

• US patent 9,611,267 claims a chemically defined drug with specific formulation and therapeutic use claims.
• Its broad chemical claims cover multiple derivatives, salts, and polymorphs.
• The patent landscape features related filings in multiple jurisdictions, with competitor patents targeting similar therapeutic areas.
• The patent's commercial enforceability is supported by experimental data and its strategic international filings.
• The patent expires in 2034, providing a window for market exclusivity with potential extensions or supplemental protection.

FAQs

1. Does the patent cover all formulations of the drug?
No. It primarily claims specific formulations and methods, but variations not explicitly claimed might not be covered.

2. Can competitors develop similar compounds outside the patent scope?
Yes. Narrower or differentiated compounds that do not infringe on the chemical or use claims can be developed.

3. How does the patent's international coverage impact global commercialization?
Patent families in WO and EP cover key markets, enabling regional exclusivity, but enforceability depends on local patent laws.

4. Are there any ongoing patent disputes linked to this patent?
No current litigations are publicly known.

5. What is the patent's strategic relevance for R&D?
It safeguards a specific chemical entity and its uses, making it crucial for maintaining competitive advantage in its therapeutic niche.

References

1. U.S. Patent and Trademark Office. (2017). US Patent 9,611,267.
2. Patent landscape reports and related filings (public databases).
3. Industry trend reports on drug patenting in neurodegenerative and oncology therapeutics.

Drugs Protected by US Patent 9,611,267

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	9,611,267		Y	Y
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-002	Apr 17, 2020		RX	Yes	No	9,611,267		Y	Y
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736-003	Apr 17, 2020		RX	Yes	Yes	9,611,267		Y	Y

International Family Members for US Patent 9,611,267

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