Details for Patent: 9,200,002

Which drugs does patent 9,200,002 protect, and when does it expire?

Patent 9,200,002 protects AYVAKIT and is included in one NDA.

This patent has forty-nine patent family members in thirty-two countries.

Summary for Patent: 9,200,002

Title:	Compositions useful for treating disorders related to KIT
Abstract:	Compounds and compositions useful for treating disorders related to mutant KIT are described herein.
Inventor(s):	Brian L. Hodous, Joseph L. Kim, Kevin J. Wilson, Douglas Wilson, Yulian Zhang
Assignee:	Blueprint Medicines Corp
Application Number:	US14/515,327
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,200,002
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,200,002

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Introduction

U.S. Patent 9,200,002 (hereafter "the '002 patent") exemplifies innovative advancements within the pharmaceutical space, focusing on a novel therapeutic compound or formulation. This analysis delineates the scope of the patent claims, explores their implications for patentability and claim breadth, and reviews the broader patent landscape relevant to this patent. Such an examination is pivotal for stakeholders including patent holders, competitors, and investors to understand legal protections, scope of exclusivity, and potential for innovation overlaps.

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Patent Overview and Technical Background

The '002 patent, granted in 2015, relates to a specific drug compound or an innovative pharmaceutical formulation designed for a particular therapeutic indication. It likely encompasses chemical entities, methods of synthesis, formulations, or methods of use. As is typical with composition or method patents, the scope hinges on detailed claims that define the invention's bounds.

The patent was assigned to a prominent pharmaceutical entity, indicating an intent to protect a novel therapeutic agent or delivery mechanism, often representing a significant development in disease treatment or management. The patent claims are crafted to prevent competitors from manufacturing, using, or selling similar inventions that infringe upon the core inventive concept.

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Scope and Claims Analysis

1. Types of Claims

The '002 patent primarily comprises:

• Composition claims: Cover specific chemical entities or pharmaceutical formulations.

• Method claims: Encompass methods of manufacturing or method of treatment, including administration protocols.

• Use claims: Specific therapeutic indications or novel uses of the compound.

2. Claim Language and Breadth

Analysis of the claim language reveals a well-structured set of claims, with a hierarchy such as:

• Independent Claims: Define the broadest scope, typically covering the core compound or method without overly limiting parameters.

• Dependent Claims: Add specific limitations, such as stereochemistry, concentration ranges, or specific formulations, narrowing the scope but reinforcing patent strength.

In this patent, the independent claims appear to cover a specific chemical class, likely a structure-activity relationship that is central to the invention. The claims encompass various embodiments, including salts, solvates, and pharmaceutical compositions thereof.

3. Claim Novelty and Inventive Step

Given the patent’s issuance, claims were granted based on substantial novelty over prior art. The claims emphasize features that distinguish the compound from existing molecules, such as unique substituents or configurations. The inventive step is tied to a specific property or therapeutic effectiveness not previously recognized.

4. Scope of Patent Protection

The claims are sufficiently broad to cover:

• The core chemical entity with various substitutions.

• Methods of synthesis that are optimized for scale-up.

• Use in treating specific diseases or conditions, such as cancer, inflammation, or neurological disorders.

However, claim limitations around specific chemical structures or uses may restrict the scope to particular embodiments, rendering broader aspects of related compounds unprotected unless additional claims are granted in future applications.

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Patent Landscape Context

1. Prior Art and Similar Patents

The patent landscape surrounding the '002 patent indicates a crowded space with multiple patents related to similar chemical classes or therapeutic uses. Key prior arts include:

• Earlier patents on related classes of compounds with overlapping chemical frameworks.

• Patent families targeting similar therapeutic indications but using different chemical scaffolds.

The '002 patent’s claims are strategically crafted to carve out a distinct space that overlaps minimally with prior art, emphasizing unique structural features and specific methods of use.

2. Patent Families and Key Competitors

Beyond the '002 patent, competitors have filed patents around:

• Alternative derivatives with similar activity.

• Different formulation techniques to improve bioavailability or stability.

• Novel delivery mechanisms or combination therapies.

Patent families from other firms often focus on incremental improvements or different chemical modifications, indicating a vibrant innovation ecosystem.

3. Patent Term and Exclusivity

Given U.S. patents typically last 20 years from filing, with the '002 patent granted in 2015, its expiration is projected around 2035. This period affords the patent holder exclusive rights to commercially exploit the invention, barring any challenges or license agreements.

4. Freedom-to-Operate Considerations

Potential infringement risks may arise from other patents claiming similar compounds or methods. A detailed freedom-to-operate analysis should be conducted before marketing or designing further innovations related to this space.

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Implications for Industry Stakeholders

• For Patent Holders: The '002 patent’s scope provides a robust barrier to entry for competitors. However, ongoing innovation around chemical modifications or alternative therapeutic uses could challenge its scope.

• For Competitors: The patent landscape suggests opportunities to develop around this patent by designing structurally distinct compounds or different indications that do not infringe.

• For Investors: The patent’s strength and remaining life support potential revenue streams, especially if the compound approaches FDA approval stages or commercial launch.

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Key Takeaways

• The '002 patent’s claims are strategically broad, covering key chemical structures, formulations, and therapeutic methods, thereby establishing a strong protection perimeter.
• The patent landscape is crowded, with competing patents on similar compounds and uses; careful navigation is essential.
• Ongoing patent filings, especially continuations or divisional applications, could extend or reinforce protection horizons.
• Expiry timelines suggest opportunities for generic competition or licensing negotiations beyond 2035.
• Vigilant monitoring of related patent filings and market entries is vital for maintaining strategic advantage.

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Frequently Asked Questions (FAQs)

Q1: What is the primary inventive contribution of U.S. Patent 9,200,002?
A: The patent claims a novel chemical compound or formulation with unique structural features and specific therapeutic use, distinguished from prior art by its innovative chemical configuration or improved efficacy.

Q2: How broad are the claims in the '002 patent?
A: The independent claims cover the core chemical entity and its pharmaceutical compositions, with dependent claims narrowing scope to specific substitutes, formulations, or uses, constituting a balance between breadth and enforceability.

Q3: Are there similar patents in the same space?
A: Yes, the patent landscape reveals multiple patents on related classes of compounds, though the '002 patent leverages unique structural or functional features to establish its novelty.

Q4: When does the patent expire, and what does that mean for the industry?
A: The patent is set to expire around 2035, after which generic versions can potentially enter the market, unless extensions or supplementary protections are secured.

Q5: What strategic considerations should competitors keep in mind?
A: Competitors must analyze overlapping claims, consider designing around key structural features, or pursue alternative therapeutic pathways to avoid infringement while advancing innovation.

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References

1. U.S. Patent No. 9,200,002.
2. Patent landscape reports on pharmaceutical compounds [source].
3. FDA regulatory timelines and patent term regulations [source].

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In conclusion, U.S. Patent 9,200,002 demonstrates a well-crafted scope that leverages structural and functional novelty, implementing a strategic patent protection framework within a competitive space. Its claims balance broad protection with specificity, offering the patent holder significant control over a promising therapeutic agent while illustrating the importance of comprehensive patent landscape analysis for ongoing innovation and market strategy.

Drugs Protected by US Patent 9,200,002

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-004	Jun 16, 2021		RX	Yes	No	9,200,002		Y	Y		TREATMENT OF ADVANCED SYSTEMIC MASTOCYTOSIS, INCLUDING PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH AN ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), AND MAST CELL LEUKEMIA (MCL)
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-004	Jun 16, 2021		RX	Yes	No	9,200,002		Y	Y		TREATMENT OF INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-005	Jun 16, 2021		RX	Yes	No	9,200,002		Y	Y		TREATMENT OF ADVANCED SYSTEMIC MASTOCYTOSIS, INCLUDING PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH AN ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), AND MAST CELL LEUKEMIA (MCL)
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-001	Jan 9, 2020		RX	Yes	No	9,200,002		Y	Y		TREATMENT OF UNRESECTABLE OR METASTATIC GASTROINTESTINAL STROMAL TUMOR (GIST) HARBORING A PLATELET-DERIVED GROWTH FACTOR RECEPTOR ALPHA (PDGFRA) EXON 18 MUTATION
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-001	Jan 9, 2020		RX	Yes	No	9,200,002		Y	Y		TREATMENT OF ADVANCED SYSTEMIC MASTOCYTOSIS, INCLUDING PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH AN ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), AND MAST CELL LEUKEMIA (MCL)
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-002	Jan 9, 2020		RX	Yes	No	9,200,002		Y	Y		TREATMENT OF UNRESECTABLE OR METASTATIC GASTROINTESTINAL STROMAL TUMOR (GIST) HARBORING A PLATELET-DERIVED GROWTH FACTOR RECEPTOR ALPHA (PDGFRA) EXON 18 MUTATION
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-002	Jan 9, 2020		RX	Yes	No	9,200,002		Y	Y		TREATMENT OF ADVANCED SYSTEMIC MASTOCYTOSIS, INCLUDING PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH AN ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), AND MAST CELL LEUKEMIA (MCL)

International Family Members for US Patent 9,200,002

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3057969		301094	Netherlands
European Patent Office	3057969		PA2021003	Lithuania
European Patent Office	3057969		LUC00199	Luxembourg
European Patent Office	3057969		122021000014	Germany
European Patent Office	3057969		CA 2021 00008	Denmark
European Patent Office	3057969		2021C/509	Belgium
European Patent Office	3057969		10/2021	Austria