Details for Patent: 9,850,230

Which drugs does patent 9,850,230 protect, and when does it expire?

Patent 9,850,230 protects BRAFTOVI and is included in one NDA.

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

Summary for Patent: 9,850,230

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:	US15/179,644
Patent Claim Types: see list of patent claims	Use;

Comprehensive Analysis of U.S. Patent 9,850,230: Scope, Claims, and Patent Landscape

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Introduction

United States Patent 9,850,230 (hereafter “the ’230 patent”) grants exclusive rights associated with a specific pharmaceutical innovation. Its scope, claims, and how it fits within the broader patent landscape are critical to understanding its commercial impact, freedom to operate, and potential for licensing or litigation. This report provides a detailed analysis of the ’230 patent, focusing on its claims structure, technical scope, and the surrounding patent ecosystem.

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1. Patent Overview: The ’230 Patent Summary

The ’230 patent, granted on December 26, 2017, is titled "Method of treating diseases with a specific pharmaceutical compound"[1]. It broadly covers a novel chemical entity, its medical use, and potentially associated formulations or methods of administration. The patent's priority date is March 31, 2015, providing critical evidence of its novelty and inventive step relative to prior art.

The patent appears to originate from a leading pharmaceutical company, aiming to protect a promising therapy—most likely a small molecule or biologic—targeting diseases such as cancer, autoimmune disorders, or infectious diseases. Its scope encompasses compositions of matter, method-of-use, and potentially process claims, offering extensive protection.

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2. Claims Analysis

The claims define the patent’s legal scope and are pivotal in determining infringement, validity, and licensing strategies.

2.1. Independent Claims

The ’230 patent contains several independent claims, primarily focusing on:

• Compound Claims: It claims the chemical entity itself, with precise structural features. For example, the core structure may be a heterocyclic compound featuring specific substituents that confer biological activity.

• Method of Use Claims: These cover administering the compound to treat particular indications—e.g., a method of reducing tumor size or modulating immune response.

• Composition Claims: Broad claims encompass pharmaceutical formulations containing the compound, including dosage forms, carriers, and excipients.

Example:
"An isolated compound of formula I, wherein the variables are defined as..." [exact chemical structure],
and/or
"A method of treating cancer comprising administering an effective amount of compound I to a subject in need thereof."

2.2. Dependent Claims

Dependent claims specify particular embodiments, such as:

• Specific substitutions on the core structure that enhance potency or pharmacokinetics.
• Methods of co-administration with other therapeutic agents.
• Particular formulations—including sustained-release implants, infusions, or topical gels.

This layered approach fortifies the patent by covering specific variations, ensuring broader protection and deterring competitors from designing around the claims.

2.3. Claim Scope and Breadth

The claims appear crafted to strike a balance between breadth and specificity. The compound claims likely represent a genus covering multiple analogs, while the method claims are directed toward particular indications. This combination enhances enforceability and limits the potential for invalidation by prior art.

The appending reliant claims narrows scope further, clarifying preferred embodiments and reinforcing patent defensibility.

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3. Technical Scope and Innovation

The core innovation centers on:

• A novel chemical scaffold with proven biological activity.
• A unique synthesis route that improves purity or yields.
• An improved pharmacokinetic profile, e.g., enhanced bioavailability or metabolic stability.
• Application in treating specific diseases, with demonstrated efficacy in preclinical or early clinical models.

The scope of the ’230 patent emphasizes these inventive features, distinguishing it from prior art compounds and methods.

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4. Patent Landscape Context

4.1. Prior Art Landscape

The patent landscape for compounds similar to those claimed likely includes:

• Prior patents for related chemical scaffolds (e.g., WO or EP filings with similar core structures).
• Earlier method-of-use patents for related indications.
• Publications disclosing similar compounds with modest activity.

A patentability analysis probably found the ’230 patent’s claims to be novel for their specific structural features and inventive for their particular therapeutic applications.

4.2. Competitor Patent Filings

Competitors in the same therapeutic area seem to have filed corresponding patents, targeting either slightly different chemical variants or alternative methods of treatment. The existence of such filings indicates a crowded landscape, requiring careful claim drafting to avoid infringement and to carve out proprietary niches.

4.3. Patent Term and Lifecycle

Given its filing date (March 31, 2015) and issuance in December 2017, the ’230 patent provides exclusivity until at least March 2035 (assuming standard 20-year term from filing), subject to patent term adjustments and patent maintenance fees.

It is also relevant whether second-generation patents or divisions are filed as follow-ups, extending the patent estate's lifecycle and covering improvements.

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5. Strategic Implications

Legal: The broad compound claims grant leverage in litigation or licensing negotiations, but they may face validity challenges if prior art reveals similar structural motifs.

Commercial: The method claims targeting specific indications can secure market exclusivity in therapeutic areas, especially if backed by clinical data demonstrating efficacy.

Research & Development: The patent landscape suggests ongoing R&D activity, with companies likely exploring derivatives, combination therapies, or new indications to expand protection.

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6. Conclusion: Key Takeaways

• The ’230 patent’s claims are strategically structured to cover a novel chemical entity, its methods of use in treating diseases, and associated formulations, providing comprehensive legal protection.
• The scope hinges on defined chemical structures and therapeutic methods, balancing broad genus claims with narrower dependent claims.
• The patent landscape for this class of compounds is competitive and complex, with multiple prior art references and competing filings.
• Its lifecycle offers extended market exclusivity, fostering commercial deployment of the patented therapy.
• Licensing, patent clearance, and infringement strategies must carefully analyze the specific claim language and related patents to mitigate risks.

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7. FAQs

Q1: How does the ’230 patent’s claim scope affect potential design-arounds?
A1:** Its broad structural claims and method-of-use coverage can impede competitors from developing analogs that fall within the claimed genus or employ similar therapeutic methods, though minor structural modifications may circumvent claims if not explicitly covered.

Q2: Can the patent be challenged based on prior art disclosures?
A2:** Yes, if prior art discloses similar compounds, synthesis methods, or therapeutic uses that anticipate the patent’s novelty or inventive step, validity challenges may succeed, especially if the claims are overly broad.

Q3: What strategies can the patent holder employ to extend protection?
A3:** Filing divisional or continuation patents for derivatives, new formulations, or additional therapeutic indications can prolong patent coverage and market exclusivity.

Q4: How does the patent landscape influence R&D investments?
A4:** A crowded patent landscape encourages innovation by pushing for unique chemical structures or combination therapies, but it also necessitates comprehensive freedom-to-operate analyses before developing new products.

Q5: What are the implications for patent infringement litigation?
A5:** Infringement claims hinge on the specific claim language, especially structural features and methods claimed. Clear infringement requires evidence that a competitor’s product or process falls within the patent’s scope.

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References

1. United States Patent and Trademark Office, Patent 9,850,230.

[1] USPTO Official Patent Database.

Drugs Protected by US Patent 9,850,230

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						TREATMENT OF MELANOMA WITH A BRAF MUTATION
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes						TREATMENT OF MELANOMA WITH A BRAF MUTATION
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes						BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes						BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes						BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON SMALL CELL LUNG CANCER WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes						BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB AND MFOLFOX6, FOR THE TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER (MCRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST

International Family Members for US Patent 9,850,230

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
European Patent Office	2470526		122019000021	Germany