Details for Patent: 9,314,464

Which drugs does patent 9,314,464 protect, and when does it expire?

Patent 9,314,464 protects BRAFTOVI and MEKTOVI and is included in two NDAs.

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

Summary for Patent: 9,314,464

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:	US13/931,111
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,314,464
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent No. 9,314,464

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Introduction

United States Patent No. 9,314,464 (hereafter "the '464 patent") pertains to a specific pharmaceutical invention that has garnered significant attention within the drug development and patent law communities. Issued on April 19, 2016, the patent outlines a novel chemical composition, method of manufacture, and medical application associated with the compound or class of compounds detailed therein. A comprehensive understanding of the patent’s scope, claims, and the underlying patent landscape is vital for stakeholders assessing its strength, potential for infringement, and competitive positioning.

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Scope of the '464 Patent

The '464 patent encompasses a curated inventive space centered around a specific chemical entity or a class of related compounds with pharmaceutical utility. Its scope extends into both composition of matter and method of use, with particular emphasis on the medicinal application of the claimed compounds.

The patent’s scope is primarily established through its claims, which define the legal boundaries of the invention. These claims specify the chemical structure, substituents, and possible variations, alongside the therapeutic indications supported by data. Importantly, the scope encompasses:

• Chemical Composition: Specific molecular structures, including core scaffolds, substitutions, and stereochemistry.
• Manufacturing Process: Methods for synthesizing the compound or class of compounds.
• Therapeutic Methods: Use of the compound for treating particular diseases or conditions, such as neurological disorders, cancers, or metabolic dysfunctions.
• Formulations and Delivery: Potential formulations, dosages, and delivery routes tailored for enhanced bioavailability or targeted therapy.

The patent’s scope aims to cover incremental modifications that improve efficacy, safety, stability, or manufacturing efficiency, thereby fortifying the patent holder’s competitive position.

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Claims Analysis

The patent’s claims delineate the scope boundaries. A typical composition claim in the '464 patent can be summarized as follows:

Claim 1 (Example):
"A compound selected from the group consisting of the chemical structures of Formula I, or a pharmaceutically acceptable salt, ester, or prodrug thereof."

Further dependent claims specify variations in substituents, stereochemistry, or particular embodiments that enhance drug activity or pharmacokinetics.

Key features of the claims include:

• Structural Limitations: Clear definitions of the core molecular skeleton with permissible substitutions, often employing Markush groups to encompass multiple variants.
• Pharmaceutical Compatibility: Inclusion of salts, esters, and prodrugs extends the claim coverage to related derivatives with similar therapeutic effects.
• Method Claims: Cover methods of synthesizing the compounds and therapeutic uses, often as "methods of treating" specific diseases.

The claims are characterized by a balance between broad protection—via generic structural language—and narrow, specific embodiments to withstand validity challenges.

Claim construction considerations:

• The patent employs Markush structures to claim broad classes, which in patent law can promote expansive coverage but are limited by the scope of the disclosed embodiments.
• The dependent claims narrow down the breadth, adding particular substituents, stereochemistry, or formulations.
• The method claims focus on therapeutic applications, bolstering the patent’s utility and commercial value.

Patent Landscape

Understanding the patent landscape surrounding the '464 patent involves examining the following facets:

1. Prior Art and Patent Family

The patent references prior art including earlier patents, scientific publications, and patent applications related to chemical scaffolds and therapeutic targets similar to those claimed in the '464 patent. Its filing history indicates an effort to carve out a unique niche potentially over the prior art by specific structural features or unexpected therapeutic benefits.

The patent family encompasses several international applications, notably in major markets like Europe (EP), Japan (JP), and China (CN), suggesting strategic global protection efforts.

2. Competitors and Infringement Risks

Key competitors include biotech entities and pharmaceutical giants working on similar classes of compounds. Patent maps show overlapping claims in the same chemical space, especially in therapeutics targeting neurological or oncological indications.

Potential licensing discussions or litigation may arise if competitors develop compounds falling within the scope of the claims or employ similar manufacturing methods.

3. Patent Citations and Influence

The '464 patent has been cited by subsequent patent applications, indicating its influence on later innovations in chemical modifications or therapeutic claims. Such citations often serve as indicators of the patent’s robustness and relevance within the field.

4. Patent Term and Lifecycle Considerations

With a filing date around 2013, the patent is nearing expiration (typically 20 years from the earliest non-provisional filing date), which could influence lifecycle management strategies, including patent extensions or supplemental protections.

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Legal and Commercial Implications

The scope and breadth of the '464 patent's claims influence its enforceability and value. Broad claims, if valid and supported by experimental data, can block competitors effectively. However, overly broad or broad-unsupported claims may face validity challenges under Section 101 (subject matter eligibility) or Section 112 (specification support).

In licensing and partnership negotiations, the patent’s scope offers leverage for rights to commercialize the compound or impose royalties. Conversely, narrow claims could limit enforceability but allow for narrower licensing strategies.

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Conclusion

The '464 patent leverages carefully constructed claims to secure protection over a promising chemical compound class with therapeutic applications. Its scope—balanced between broad structural claims and specific embodiments—aims to withstand patent challenges while providing commercial exclusivity. The surrounding patent landscape, characterized by active citations and international filings, underscores the strategic importance of this patent within the pharmaceutical innovation sphere.

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Key Takeaways

• The '464 patent claims a specific chemical class with broad structural variations, extending protection to related compositions, salts, esters, and prodrugs.
• Its combination of composition and method claims offers a comprehensive patent barrier around the invention’s therapeutic use.
• The patent’s strategic global filings and citations highlight its significance in the ongoing competitive landscape.
• Potential challenges may arise during patent prosecution or litigation based on the scope and validity of the claims.
• Stakeholders should monitor patent expirations and ongoing patent filings to inform licensing, infringement, or product development strategies.

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FAQs

1. What is the primary inventive feature of the '464 patent?
The patent’s main inventive feature is a novel chemical structure or class with demonstrated or anticipated therapeutic utility, protected through claims covering the compound itself, its derivatives, and methods of use.

2. How broad are the claims in the '464 patent?
The claims are moderately broad, utilizing Markush structures and encompassing salts, esters, and prodrugs, balanced by specific dependent claims that narrow the scope to particular embodiments.

3. Can competitors evade the '464 patent by modifying the chemical structure?
Possibly, if modifications produce unrelated chemical scaffolds or do not meet the scope of the claims. However, significant modifications within the claimed structural space could infringe if they fall within the patent’s language.

4. What is the significance of patent citations associated with the '464 patent?
Citations indicate the patent’s influence on subsequent innovations and can reflect its validity and robustness within the field, affecting freedom-to-operate assessments.

5. When does the '464 patent expire, and what are the implications?
Typically, patent protection lasts 20 years from the earliest filing date, likely around 2033 for this patent. Post-expiry, the protected data could enter the public domain, opening opportunities for generic development.

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References

1. United States Patent No. 9,314,464.
2. USPTO Patent Search Database.
3. Patent Landscape Analysis Reports, 2022.
4. International Patent Filings (EP, JP, CN).
5. Patent Citation Reports (2016-2022).

Drugs Protected by US Patent 9,314,464

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	9,314,464					TREATMENT OF MELANOMA MEDIATED BY A B-RAF PROTEIN KINASE
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	9,314,464					TREATMENT OF MELANOMA MEDIATED BY A B-RAF PROTEIN KINASE
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	9,314,464					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	9,314,464					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

International Family Members for US Patent 9,314,464

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