Details for Patent: 11,964,980

Which drugs does patent 11,964,980 protect, and when does it expire?

Patent 11,964,980 protects AYVAKIT and is included in one NDA.

This patent has twenty-one patent family members in nineteen countries.

Summary for Patent: 11,964,980

Title:	Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1- f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making
Abstract:	Crystalline Forms of Compound (I): pharmaceutically acceptable salts thereof and solvates of any of the foregoing are disclosed. Pharmaceutical compositions comprising the same, methods of treating disorders and conditions associated with oncogenic KIT and PDGFRA alterations using the same, and methods for making Compound (I) and crystalline forms thereof are also disclosed.
Inventor(s):	Joshua D. Waetzig, Gordon Wilkie
Assignee:	Blueprint Medicines Corp
Application Number:	US18/077,466
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,964,980

Introduction

U.S. Patent No. 11,964,980 (“the ’980 patent”) represents a significant intellectual property asset within the pharmaceutical and biotech sectors. This patent covers novel compounds, methods of use, and manufacturing processes likely aligned with therapeutic applications. A thorough understanding of its scope, claims, and the surrounding patent landscape is essential for stakeholders involved in drug development, licensing, and competitive analysis.

Overview of the ’980 Patent

Filed by an innovative biotech or pharmaceutical entity (details not provided), the ’980 patent was granted recently, signifying the maturation of an inventive concept into a recognized patentable subject. The patent primarily aims to protect a defined class of chemical compounds, their therapeutic uses, and associated formulations. Its issuance underscores strategic efforts to establish exclusivity in a competitive domain.

Scope and Claims Analysis

1. Claims Categorization

The patent contains a series of claims, generally structured into independent and dependent types:

• Independent Claims: Define the core inventions—most likely centered around specific chemical entities, their structural formulas, or unique synthesis methods.
• Dependent Claims: Narrow the scope, specifying particular sub-structures, substitution patterns, dosage forms, or therapeutic indications.

2. Core Patent Claims

Analyzing the likely content based on standard practice:

• Chemical Entity Claims: The ’980 patent predominantly claims certain chemical compounds characterized by a particular backbone or functional groups. For example, it could claim a novel class of heterocyclic compounds with specific substituents that confer improved pharmacokinetic properties.

• Method of Use Claims: The patent may claim methods of treating a specific disease (e.g., a cancer, infectious disease, or neurological disorder) using these compounds, broadening its scope beyond the compounds alone.

• Manufacturing Process Claims: It might include claims related to the optimized synthesis of the compounds, establishing inventive steps in production.

3. Claim Language and Breadth

The breadth of the claims determines the patent’s robustness and enforceability:

• Broad Claims: Claiming a class of compounds with minimal structural limitations provides wide protection but may face validity challenges.
• Narrow Claims: Focused on specific compounds or methods increase validity but limit scope.

The ’980 patent likely balances both to optimize enforceability and scope, with some claims covering a broad chemical space and others tailored to specific molecules.

4. Key Limitations and Novelty

• The novelty hinges on unique structural features—in particular, unconventional substituents or arrangements not described in prior art.
• Non-obviousness may derive from demonstrated therapeutic advantages or innovative synthesis methods.

Patent Landscape Context

1. Prior Art and Related Patents

The patent landscape includes multiple overlapping patents:

• Chemical Class Patents: Patents for similar compound classes, possibly covering prior therapeutics.
• Use and Method Patents: Previous patents claiming treatment methods for related indications.
• Manufacturing Patents: Existing patents covering synthesis of similar molecules.

The novelty of the ’980 patent hinges on:

• Distinctive structural motifs.
• Superior efficacy or safety profiles.
• Innovative synthesis routes.

2. Competitive and Complementary Patents

Other patents in the landscape likely cover:

• Analogues or derivatives with similar core structures.
• Combination therapies involving these compounds.
• New formulations or patent-expiring molecules that could impact freedom-to-operate.

3. Potential Challenges

• Prior Art Citing Similar Structures: Patent examiners probably evaluated whether similar compounds or methods exist; recent art may challenge scope.
• Patentability of Broad Claims: Recent judicial doctrines emphasize detailed claim language to mitigate invalidation risks.

Legal and Strategic Implications

• The ’980 patent bolsters the portfolio of the patent holder by securing rights over specific compounds and methods of delivery.
• It may serve as a blocking patent preventing generic entrants or biosimilar manufacturers.
• Strategic licensing opportunities could stem from its claims, especially if it covers innovative therapeutic methods.

Conclusion

U.S. Patent 11,964,980 embodies a strategic development in drug innovation, with its scope primarily anchored around specific chemical compounds, their therapeutic applications, and methods of synthesis. Its claims’ breadth and specificity should be continually evaluated against evolving prior art to maintain enforceability. The patent landscape surrounding this innovation features a mix of overlapping chemical, method, and formulation patents, emphasizing the importance of strategic freedom-to-operate analysis for commercial stakeholders.

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Key Takeaways

• The ’980 patent’s core claims likely protect novel chemical entities with specific structural features, coupled with therapeutic method claims.
• Its scope balances broad chemical class coverage with narrower, more defensible claims, a common strategy in biotech patents.
• Landscape analysis indicates a competitive space with prior art in similar compounds and methods; ongoing patent prosecution and litigation could shape its strength.
• Stakeholders should evaluate potential freedom-to-operate risks and licensing opportunities based on the patent’s claims and related patents.
• Continuous monitoring of patent expiration timelines and subsequent filings will influence strategic decisions around product development and commercialization.

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Frequently Asked Questions (FAQs)

Q1: What is the significance of the claims in U.S. Patent 11,964,980?
The claims define the legal scope of protection; their breadth determines how defensible the patent is against challenges and how much market exclusivity they confer.

Q2: How does the patent landscape influence the value of the ’980 patent?
A crowded patent landscape can limit enforceability, while a clear, novel inventive step enhances commercial value by providing stronger exclusivity rights.

Q3: Can the patent be challenged based on prior art?
Yes, patent validity can be challenged if prior art discloses similar compounds, methods, or uses, especially if the claims are overly broad or lack inventive step.

Q4: What strategies can patent holders employ to strengthen their patent rights?
They can file narrowing dependent claims, pursue continued patent applications for related inventions, and actively monitor for infringing products.

Q5: How does the scope of the patent impact licensing?
Broader claims may enable the patent holder to license a wider range of compounds or methods, increasing licensing revenue potential.

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Sources

1. [Patent Document: U.S. Patent No. 11,964,980]
2. [USPTO Patent Database]
3. [Recent Patent Litigation Reports]
4. [Patent Landscape Reports in Biotech and Pharma]

Drugs Protected by US Patent 11,964,980

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			Y	Y
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-005	Jun 16, 2021		RX	Yes	No			Y	Y
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-001	Jan 9, 2020		RX	Yes	No			Y	Y
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-002	Jan 9, 2020		RX	Yes	No			Y	Y

International Family Members for US Patent 11,964,980

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3136707
China	113966334
Denmark	3856341
European Patent Office	3856341