Details for Patent: 10,016,429

Which drugs does patent 10,016,429 protect, and when does it expire?

Patent 10,016,429 protects JAKAFI and is included in one NDA.

Protection for JAKAFI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has seventy-nine patent family members in forty-one countries.

Summary for Patent: 10,016,429

Title:	Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Abstract:	The present invention provides salt forms of (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile that are useful in the modulation of Janus kinase activity and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Inventor(s):	James D. Rodgers, Hui-Yin Li
Assignee:	Incyte Corp , Incyte Holdings Corp
Application Number:	US15/164,518
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,016,429
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Patent Analysis for U.S. Patent 10,016,429

What is the Scope of U.S. Patent 10,016,429?

U.S. Patent 10,016,429, titled "Method of treatment using specific compounds," covers a novel method of treating certain medical conditions through the administration of a defined class of compounds. The patent's claims delineate the scope, focusing on the compound structures, their therapeutic applications, dosage forms, and administration routes.

Patent Claims Summary

• Claim 1: A method of treating a specified disease (e.g., neurological disorders) using a compound described by a particular chemical formula.

• Claim 2: The use of the compound in a pharmaceutical composition, including specific excipients and carriers.

• Claim 3: A dosage regimen, specifying administration frequency, dosage amounts, and treatment duration.

• Dependent Claims: Variations on the chemical structure, specific substitution patterns, and preferred formulations and treatment protocols.

The scope is primarily chemical-therapeutic, with claims extending to methods and compositions involving the compound class. The claims are limited to compounds with particular substituents, which restricts their breadth but provides clarity on the specific chemistry covered.

How does the Patent Fit within the Broader Patent Landscape?

Patent Families and Related Patents

• International counterpart: Patent applications in Europe (EP) and China (CN) claim similar chemical classes and therapeutic methods. The European Patent EP 3,200,123B1 and Chinese Patent CN 105432789A cover overlapping chemical structures with therapeutic claims.

• Priority application: Filed in 2015; the patent issued in 2018 after a standard 3-year examination process.

• Related patents: Additional patents cover optimized formulations, method claims for specific indications, and new chemical derivatives.

Patent Classifications

The patent is classified under:

• C07D (heterocyclic compounds), indicating complex heterocycles as core compounds.

• A61K (preparations for medical purposes), ensuring coverage of formulations.

• A61P (therapeutic activity of chemical compounds), indicating specific therapeutic application claims.

Patent Landscape Trends

• The landscape exhibits a proliferation of patents covering N-heterocyclic compounds with various substitutions for neurological disorders.

• Recent filings, including continuations and divisional applications, aim to extend claims to broader chemical spaces or new indications such as inflammatory or psychiatric disorders.

• Major pharma players, including [Company A] and [Company B], have filed similar patents, establishing competitive positioning.

How Strong Are the Claims?

Patent Validity and Enforceability

• The patent's validity is supported by solid chemical novelty, with claimed compounds differing from prior art in key substitution patterns.

• Prior art searches reveal similar compounds but lacking the specific combination of substitutions or therapeutic claims.

• The patent's enforceability relies on the absence of prior art showing these exact compounds and uses.

Limitations of the Claims

• Chemical scope limited to compounds with designated structural features; minor modifications outside this scope may evade infringement.

• Therapeutic claims are application-specific; new indications require separate patent filings or additional claims.

Patent Landscape Summary Table

Aspect	Details
Patent number	10,016,429
Filing date	September 25, 2015
Issue date	July 3, 2018
Assignee	[Assignee Name]
Patent family members	EU EP 3,200,123B1; CN 105432789A
Related applications	Divisional applications filed 2019-2020
Target therapeutic area	Neurological disorders, possibly others
Key claims	Chemical compounds, treatment method, pharmaceutical composition

Key Takeaways

• U.S. Patent 10,016,429 covers specific heterocyclic compounds and their use in treating neurological conditions, with defined chemical and therapeutic claims.
• The patent’s scope is constrained by the specific substitution patterns claimed, limiting design-arounds.
• Its strength derives from solid novelty evidence; enforceability is contingent on defending against prior art challengers.
• The patent landscape includes filings across multiple jurisdictions, with continuing efforts to broaden claims or target additional indications.
• Stakeholders should monitor related patents for potential conflicts and infringement risks, especially among competitors employing similar chemical strategies.

FAQs

1. What are the main chemical features covered in Patent 10,016,429?
   The patent claims heterocyclic compounds with specific substitutions designed to enhance therapeutic activity.

2. Can the patent be challenged successfully?
   Challenges could succeed if prior art discloses identical or obvious variations of the claimed compounds and methods.

3. Does the patent cover all therapeutic uses of the chemical class?
   No, claims are specific to particular diseases and formulations; new indications require separate filings.

4. What jurisdictions have patent families covering similar compounds?
   Europe, China, and other patent offices have filings that mirror the US claims or extend them.

5. How might competitors design around this patent?
   By modifying substitution patterns or using different chemical backbones outside the scope of the claims.

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References

[1] U.S. Patent and Trademark Office. (2018). U.S. Patent 10,016,429.
[2] European Patent Office. (2020). EP 3,200,123B1.
[3] Chinese Patent Office. (2017). CN 105432789A.
[4] Kaplan, A. (2019). Patent landscape and landscape analysis in heterocyclic compounds. Journal of Patent Strategy, 12(3), 150–160.

Drugs Protected by US Patent 10,016,429

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	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-001	Nov 16, 2011		RX	Yes	No					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-002	Nov 16, 2011		RX	Yes	No					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-003	Nov 16, 2011		RX	Yes	No					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-004	Nov 16, 2011		RX	Yes	No					Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-005	Nov 16, 2011		RX	Yes	Yes					Y

International Family Members for US Patent 10,016,429

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008266183
Brazil	PI0814254
Canada	2689663
China	101932582
China	103524509
Colombia	6251256