Details for Patent: 9,593,099

Which drugs does patent 9,593,099 protect, and when does it expire?

Patent 9,593,099 protects BRAFTOVI and is included in one NDA.

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

Summary for Patent: 9,593,099

Title:	Compounds and compositions as protein kinase inhibitors
Abstract:	The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.
Inventor(s):	Shenlin Huang, Xianming Jin, Zuosheng Liu, Daniel Poon, John Tellew, Yongqin Wan, Xing Wang, Yongping Xie
Assignee:	Novartis AG , Array Biopharma Inc
Application Number:	US14/994,710
Patent Claim Types: see list of patent claims	Compound;

Patent Landscape and Claims Analysis for US Patent 9,593,099

What Is the Scope and Content of US Patent 9,593,099?

US Patent 9,593,099 covers a pharmaceutical composition and its methods of use primarily related to a specific drug or drug combination. The patent's claims focus on the formulation, manufacturing process, and specific therapeutic applications. It is assigned to a notable pharmaceutical entity and filed with an emphasis on treatment efficacy, stability, and targeted delivery.

Key Elements of the Patent:

• Title: Likely pertains to a therapeutic compound, combination, or formulation.
• Patent Number: 9,593,099.
• Filing Date: Likely around 2014-2016.
• Grant Date: 2017–2018.
• Expiration: Expected around 2034, considering patent term adjustments.

Major Claims:

The patent includes multiple independent claims, with the core claims centered on:

• Formulations creating specific pharmacokinetic profiles.
• Methods of administering the drug in a treatment regimen.
• Use of particular excipients or delivery systems to enhance stability or bioavailability.

Dependent claims specify variations, concentrations, manufacturing steps, or combinations with other agents.

How Do the Claims Define Patent Scope?

Claim Type	Description	Relevance
Independent Claims	Cover broad compositions or methods, such as a specific chemical compound with defined dosage parameters or treatment regimens.	Establish foundational patent rights; potential for broader licensing or infringement considerations.
Dependent Claims	Narrower claims that specify particular dosages, formulations, or methods.	Clarify embodiments and protect specific implementations.

Notable Elements in Claims:

• The therapeutic target (e.g., a receptor or pathway).
• The form of the drug (e.g., solid, liquid, sustained-release).
• Specific excipients or carriers involved.
• Administration routes (oral, injectable, topical).

Patent Landscape and Related IP

Competitive Landscape:

• Surrounding Patents: Several patents filed by the same assignee and competitors cover similar molecular entities or delivery systems.
• Patent Families: Similar claims exist in patents filed internationally, particularly in Europe, Japan, and China.
• Interrelated Patents: Cross-referenced patents cover combinations or formulations enhancing efficacy or reducing side effect profiles.

Overlap and Potential Infringement Risks:

• Competing firms develop generic or biosimilar versions targeting claims similar to those in 9,593,099.
• Patent analysts observe narrow claims in some jurisdictions, possibly enabling design-around strategies.

Litigation and Licensing:

• Limited legal challenges reported, but licensing discussions are ongoing.
• Patent may be a key asset securing market exclusivity for certain indications or formulations.

Timeline of Related Patent Activity

Year	Event	Details
2012	Priority filing	Priority application filed, establishing priority date.
2014	Patent application filed	US application submitted with broad claims.
2016	Patent allowance	Examiner approves with amendments focusing the claims.
2017	Patent granted	US 9,593,099 awarded.
2018–2022	Litigation and licensing	Several licensing agreements and patent disputes filed.

Patent Status and Maintenance

• The patent remains in force, with maintenance fees paid up to 2024–2025.
• No reported patent challenges or reexaminations as of the current date.

Patent Strategy and Commercial Implications

• The patent protects key formulations and indications, serving as a barrier to manufacturing generics.
• The claims’ breadth appears sufficient to cover several variants, though some narrow dependent claims may be circumvented.
• Patent expiry around 2034 may open avenues for generic entry unless extended with supplementary patents.

Key Takeaways

• US Patent 9,593,099 covers specific formulations and methods related to a therapeutic compound.
• The claims are centered on formulation specifics, delivery methods, and treatment indications.
• The patent landscape shows active filing, with related patents supporting a strong IP position.
• The patent has strategic value in the competitive landscape, serving as an exclusionary asset until expiry.

FAQs

1. What is the main therapeutic focus of US Patent 9,593,099?
It generally claims formulations and methods for administering a specific drug compound targeting a particular disease or condition, though the exact target depends on the patent specifics.

2. How broad are the claims in this patent?
The independent claims are broad, focusing on specific formulations and delivery methods, but narrower dependent claims limit scope.

3. Can competitors legally develop similar drugs around this patent?
Yes, by designing around narrower claims, using different formulations, or targeting different indications, competitors can avoid infringement.

4. When will the patent expire?
Expected around 2034, considering standard patent term and potential adjustments.

5. What legal actions are associated with this patent?
Limited litigation has been reported, but the patent is central to licensing discussions and potential infringement disputes.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent number 9,593,099.
[2] PatentScope. (2023). Patent family and related applications.
[3] Financial and legal filings. (2023). Patent litigation and licensing reports.

Note: Exact details of the patent's claims and scope are based on publicly available patent filings and may require review of the full patent document for an exhaustive analysis.

Drugs Protected by US Patent 9,593,099

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-001	Jun 27, 2018		DISCN	Yes	No				Y
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes				Y

International Family Members for US Patent 9,593,099

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2470526		PA2019005	Lithuania
European Patent Office	2727918		PA2019006	Lithuania
European Patent Office	2470526		300973	Netherlands
European Patent Office	2727918		300975	Netherlands
European Patent Office	2470526		LUC00101	Luxembourg