Details for Patent: 10,774,085

Which drugs does patent 10,774,085 protect, and when does it expire?

Patent 10,774,085 protects VITRAKVI and is included in two NDAs.

This patent has one hundred and twelve patent family members in thirty-eight countries.

Summary for Patent: 10,774,085

Title:	Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds
Abstract:	Compounds useful in the synthesis of compounds for treating pain, cancer, inflammation, neurodegenerative disease or Typanosoma cruzi infection in a mammal.
Inventor(s):	Julia Haas, Steven W. Andrews, Yutong Jiang, Gan Zhang
Assignee:	Array Biopharma Inc
Application Number:	US16/044,653
Patent Claim Types: see list of patent claims	Use; Delivery;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 10,774,085

Introduction

United States Patent No. 10,774,085 (hereafter, "the '085 patent") forms a significant intellectual property asset within the pharmaceutical landscape, granted on September 15, 2020. This patent pertains to a novel formulation or method related to a specific therapeutic compound or class, reflecting innovations that seek to improve efficacy, safety, or manufacturing. A thorough understanding of its scope, claims, and the overall patent landscape surrounding it is essential for stakeholders involved in drug development, licensing, or litigation.

This analysis critically examines the patent's claims, the technological scope they establish, and the broader patent landscape, including relevant prior art, competitors' patents, and potential freedom-to-operate considerations.

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Scope and Key Claims of U.S. Patent 10,774,085

1. Overview of the Patent's Core Innovation

The '085 patent claims a pharmaceutical composition, method, or compound with specific attributes designed to address unmet clinical needs, likely involving novel chemical structures, formulations, or delivery mechanisms.

Although the full patent text is comprehensive, the independent claims define the broadest scope, establishing the precise boundaries of exclusivity.

2. Analysis of the Independent Claims

A typical independent claim in the '085 patent (hypothetically, as actual claim language is not provided here) might encompass:

• A chemical compound characterized by a specific core structure and substituted groups aimed at particular pharmacological activity.

• A dosage form or pharmaceutical composition comprising the compound, combined with specific excipients or delivery systems enhancing stability or bioavailability.

• A method of treatment involving administering the compound or formulation to a patient to achieve particular therapeutic outcomes.

Example: Claim 1 may claim a compound of a particular formula, with defined substituents, for treating a specified disease condition, such as a certain type of cancer or neurodegenerative disorder.

3. Scope of the Claims

The claims likely aim to balance breadth and specificity:

• Chemical scope: Claiming a genus of compounds with certain core structures, possibly including Markush groups, that cover multiple derivatives.

• Method scope: Covering various modes of administration (oral, parenteral, topical) and dosing regimens.

• Formulation scope: Encompassing various formulations, such as sustained-release or targeted delivery systems.

The claims’ language determines the extent of monopolization, with broader claims providing wider protection but potentially being more vulnerable to invalidation due to prior art.

4. Dependent Claims and Specific Embodiments

Dependent claims provide narrower, more specific embodiments, such as:

• Specific substituents attached to the core structure.

• Particular dosage ranges.

• Conjugates or prodrugs.

• Specific manufacturing processes.

These serve to solidify the patent's protective scope and fallback positions in case broader claims are challenged.

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Patent Landscape Context

1. Prior Art and Patent Family

The patent’s novelty likely hinges on prior art in four key areas:

• Chemical structure innovation: Existing patents or publications on similar compounds.

• Formulation and delivery: Prior art describing similar pharmaceutical forms.

• Method of use: Previous patents covering therapeutic methods for similar indications.

• Manufacturing processes: Known techniques that have been improved upon or modified.

The '085 patent's applicants may have conducted patent landscaping to identify and navigate around prior art, carving out novel features in the disclosed claims.

2. Relevant Competitors and Patent Ecosystem

Major players in the pharmaceutical sector, involved in similar therapeutic classes, likely hold related patents or applications, such as:

• Patents covering method-of-treatment using analogous compounds.

• Composition patents in overlapping chemical spaces.

• Delivery systems targeting similar conditions.

The patent landscape is dynamic, with overlapping rights necessitating careful freedom-to-operate analyses especially if commercialized products are involved.

3. Patent Examination and Patentability

The patent examiner would assess the claims regarding novelty, non-obviousness, and utility, considering prior art references, including:

• Scientific publications.

• Existing patents.

• Patent applications published prior to the priority date.

The '085 patent's claims are probably drafted narrowly enough to avoid prior art challenges while maintaining commercial relevance.

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Implications and Strategic Considerations

1. Enforcement and Licensing

The scope of the '085 patent informs potential enforcement strategies or licensing negotiations. Broad claims enable the patent owner to deter competitors in a sizeable chemical or therapeutic space but may face validity challenges if prior art is closely aligned.

2. Potential Challenges

Competitors could file:

• Inter partes reviews to challenge the patent's validity, focusing on prior art, particularly if the claims are broad.

• Design-around patents by developing structurally or functionally distinct compounds or formulations.

3. Patent Term and Lifecycle

Given the patent term typically lasts 20 years from filing, existing patent estates may see expiration in the coming years, impacting exclusivity and commercialization planning.

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Concluding Remarks

The '085 patent secures a strategically significant position within its therapeutic and chemical space. Its claims likely encompass a broad class of compounds and formulations aimed at addressing specific unmet clinical needs, with dependent claims sharpening protection around particular embodiments.

For industry stakeholders, understanding the precise scope—both in terms of chemical structure and method of use—is crucial for navigating innovation, licensing opportunities, or potential challenges.

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Key Takeaways

• The scope of U.S. Patent 10,774,085 primarily hinges on well-defined independent claims covering specific compounds, formulations, or methods.

• Effective patent landscaping reveals the patent’s position within a complex ecosystem of prior art and similar rights, influencing enforceability and freedom-to-operate decisions.

• Drafting strategies favor claims that are broad enough to deter competitors while sufficiently supported by inventive steps to withstand validity challenges.

• Monitoring the patent landscape and keeping abreast of potential patent expirations are essential for maximizing commercial opportunities.

• Licensing and enforcement must be tailored based on the detailed claim scope, particularly in crowded therapeutic categories with overlapping intellectual property rights.

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FAQs

1. What is the primary novelty claimed in U.S. Patent 10,774,085?
   The patent primarily claims a novel chemical compound or formulation with specific structural features and therapeutic applications, setting it apart from prior art through inventive modifications.

2. How broad are the claims in the '085 patent?
   The claims likely encompass a genus of compounds with certain core structures, various formulations, and methods of treatment, though dependent claims narrow the scope for specific embodiments.

3. Can competitors develop similar compounds without infringing the '085 patent?
   If competitors modify the chemical structure to fall outside the scope of the claims (design-around), they may avoid infringement; however, this depends on claim language and patent prosecution history.

4. What are the main risks to the validity of this patent?
   Challenges may arise from prior art disclosures that disclose similar compounds or methods, or if the claims are found to lack novelty or inventive step during validity proceedings.

5. What strategic considerations should patent holders consider regarding this patent?
   They should monitor competing patents, evaluate potential licensing or enforcement, consider patent term management, and develop new claims as the patent's life progresses.

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Sources:

[1] United States Patent and Trademark Office. U.S. Patent No. 10,774,085.
[2] Patent landscape reports and medicinal chemistry literature related to the patent's active compounds and therapeutic indications.

Drugs Protected by US Patent 10,774,085

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No	10,774,085					METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes	10,774,085					METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	10,774,085					METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION

International Family Members for US Patent 10,774,085

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3106463		301033	Netherlands
European Patent Office	3106463		PA2020504	Lithuania
European Patent Office	3106463		CA 2020 00013	Denmark
European Patent Office	3106463		122020000012	Germany
European Patent Office	3106463		LUC00150	Luxembourg
European Patent Office	3106463		2020C/507	Belgium