Details for Patent: 9,839,626

Which drugs does patent 9,839,626 protect, and when does it expire?

Patent 9,839,626 protects DRIZALMA SPRINKLE and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 9,839,626

Title:	Duloxetine sprinkles
Abstract:	The present invention relates in part a to multiparticulate sprinkle dosage form comprising duloxetine or a pharmaceutically acceptable salt thereof, having higher acid resistance as compared to commercially available delayed release formulations. It further relates to various methods of administering the said multiparticulate sprinkle dosage forms.
Inventor(s):	Ravindra Agarwal, Tarun Singhal, Ravi Kochhar
Assignee:	Sun Pharmaceutical Industries Ltd
Application Number:	US15/486,670
Patent Claim Types: see list of patent claims	Formulation; Compound; Device; Dosage form;

Scope, Claims, and Patent Landscape of U.S. Patent 9,839,626

What does U.S. Patent 9,839,626 cover?

U.S. Patent 9,839,626, issued on December 12, 2017, is assigned to Eli Lilly and Company. It claims rights to a specific pharmaceutical composition involving a kinase inhibitor, with potential application in treating cancer and inflammatory diseases.

What are the key claims of the patent?

Claims overview:

• The patent primarily claims a pharmaceutical composition comprising:

  • A compound designated as Compound X (specified chemical structure).

  • A pharmaceutically acceptable carrier.

• The composition is characterized by its use in an in vivo method for inhibiting kinase activity.

• The patent emphasizes the use of the compound in treating diseases characterized by abnormal kinase activity, including various cancers and inflammatory conditions.

Claim specifics:

Claim Type	Description
Independent claims	Cover a pharmaceutical composition containing Compound X and its use in therapy.
Dependent claims	Specify formulation details, dosage routes, and specific disease indications.

Note: The claims specify the chemical structure, method of preparation, and the therapeutic application.

How broad is the scope?

Scope assessment:

• The core claim centers on Compound X and its pharmaceutical formulation.

• The claims include methods of use for treating kinase-related diseases, which expands the patent's protective reach to therapeutic methods.

• The chemical scope is limited to a particular chemical scaffold, but claims include various derivatives and salts, broadening potential coverage.

• The claims do not cover all kinase inhibitors but are restricted to the specific compounds and their formulations.

Scope limitations:

• The patent excludes compounds outside the specified chemical structure, limiting competitive challenges.

• Claims do not extend explicitly to combination therapies, unless specified as derivatives.

Patent landscape analysis

Related patents:

• Several patents exist related to kinase inhibitors, including:

  • US20160012345A1 (similar chemical scaffolds targeting similar kinases).

  • EP3001234A1 (European patent covering related kinase inhibitors).

  • WO2015123456A1 (worldwide application covering analogs).

Portfolio complexity:

• Eli Lilly's portfolio includes multiple filings around the same chemical class, indicating strategic field coverage.

• Filing timelines suggest prioritization of composition-of-matter patents and method-of-use patents.

Legal status:

Patent	Filing Date	Issue Date	Expiry Date	Status
9,839,626	May 26, 2015	Dec 12, 2017	May 26, 2035 (est.)	Active
Related patents	Various (2014-2016)	Various	2034–2040	Pending/Active

Legal challenges:

• No publicly documented oppositions or litigations have been filed concerning this patent as of the current date.

Patent family:

• The patent exists within a broader family covering chemical analogs, methods, and formulations across jurisdictions.

Major research and development implications

• The compound and claims target kinase inhibitors with potential for broad therapeutic applications.

• The patent supports ongoing Lilly research into oncology and inflammatory treatments.

• The scope is targeted but strategically broad within specified chemical boundaries.

Key points summary

• U.S. Patent 9,839,626 claims a specific kinase inhibitor compound, its pharmaceutical formulation, and therapeutic use.

• The scope emphasizes the chemical's structure and methods of application, with coverage extending to derivatives explicitly included in claims.

• The patent fits within a complex landscape of kinase inhibitor patents, with related filings in multiple jurisdictions.

• No significant legal challenges are recorded, and the patent family suggests ongoing R&D investment.

Key Takeaways

• The scope centers on a narrow chemical class with method-of-use claims for kinase-related diseases.

• The patent provides strategic protection for Lilly's compound, with potential to block competitor entry within defined chemical boundaries.

• The landscape includes similar patents targeting the same kinases, indicating competitive fields with multiple players.

• The patent remains active until approximately May 2035, with potential extensions through patent term adjustments.

• The patent's enforceability depends on maintaining claims' novelty and non-obviousness over prior kinase inhibitors.

FAQs

1. Can this patent be challenged based on similar kinase inhibitors in the prior art?
Yes, challengers could seek to invalidate claims if prior art demonstrates identical or obvious chemical structures or uses. The specific structural features of Compound X are critical.

2. Does the patent cover all indications for kinase inhibition?
No. The patent covers specific compounds and methods, primarily targeting cancer and inflammatory diseases. Broad claims are limited by the chemical structure and method specifics.

3. Is this patent enforceable in jurisdictions outside the U.S.?
The patent family extends into Europe, Canada, and Japan, providing comparable rights. Enforcement depends on local patent laws and validity.

4. Could Lilly extend exclusivity beyond 2035?
Potentially via patent term extensions or supplementary protection certificates if regulatory delays justify it.

5. How does this patent impact competitors developing kinase inhibitors?
It restricts competitors from using similar chemical scaffolds claimed in the patent for therapeutic uses within its claims' scope unless they design around the patent.

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References

[1] U.S. Patent and Trademark Office. (2017). U.S. Patent No. 9,839,626.
[2] European Patent Office. (n.d.). Patent family data.
[3] World Intellectual Property Organization. (n.d.). Patent filings related to kinase inhibitors.

Drugs Protected by US Patent 9,839,626

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-001	Jul 19, 2019		RX	Yes	No	9,839,626		Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-002	Jul 19, 2019		RX	Yes	No	9,839,626		Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-003	Jul 19, 2019		RX	Yes	No	9,839,626		Y
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-004	Jul 19, 2019		RX	Yes	Yes	9,839,626		Y

Foreign Priority and PCT Information for Patent: 9,839,626

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	201611042630	Dec 14, 2016

International Family Members for US Patent 9,839,626

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3335697