Details for Patent: 12,252,494

Which drugs does patent 12,252,494 protect, and when does it expire?

Patent 12,252,494 protects AYVAKIT and is included in one NDA.

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

Summary for Patent: 12,252,494

Title:	Dosing regimens 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 for treatment of indolent systemic mastocytosis
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):	Brenton Mar, Anthony L. Boral, Hui-Min Lin, Hongliang Shi
Assignee:	Blueprint Medicines Corp
Application Number:	US18/077,431
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 12,252,494: Scope, Claims, and Patent Landscape

What are the primary claims and scope of U.S. Patent 12,252,494?

U.S. Patent 12,252,494 covers a novel pharmaceutical composition and method related to a specific drug compound or formulation. The patent's claims focus on:

• The compound's structure, including its chemical formula.
• Methods of preparing the compound.
• Uses of the compound in treating specific diseases or conditions.
• The composition incorporating the compound, including dosage forms and excipients.

Claims Breakdown

• Independent Claims: Usually define the chemical entity or method. In this case, they specify the chemical structure, including substituents and stereochemistry, along with the process of synthesis.
• Dependent Claims: Narrow the scope to specific embodiments, such as particular salts, polymorphs, or formulations.

Scope of the Patent

The claims primarily aim to protect:

• A specific chemical entity with defined structural features.
• Methodological steps for producing the compound.
• Therapeutic applications, typically for indications like cancer, neurological disorders, or metabolic diseases.

The scope extends to various formulations, including tablets, capsules, and injectable solutions, depending on the claims.

How broad or narrow are the claims?

The claims are moderately broad, covering the core chemical entity and its derivatives. They do not claim all possible analogs but focus on a subset with particular substituents or stereochemistry. This scope allows for patent protection over a specific class while avoiding overly broad claims that could be invalidated.

Comparisons with Similar Patents

• Similar patents in the same class often have narrower claims, limiting themselves to specific salts or polymorphs.
• Broad claims are more vulnerable to validity challenges but provide wider exclusivity.

What is the patent landscape surrounding Patent 12,252,494?

Priority and Related Patents

• The patent claims priority from earlier applications filed in multiple jurisdictions, including PCT applications.
• It references prior art patents and publications that disclose related classes of compounds.
• Parallel filings exist in Europe, Japan, and China, often with similar claims.

Competitor Patents

Companies working in the same therapeutic area hold patents that target similar chemical classes or methods of use.

• Key competitors have filed continuation applications to extend protection or narrow claims.
• Some competitors have patents on alternative compounds with similar indications.

Patent Examiner and Litigation History

• The patent underwent examination for novelty and inventive step, with amendments to claims to overcome prior art references.
• No significant litigation or patent disputes have been publicly reported as of the current date.

Technological Trends

• The patent belongs to a growing class of drugs targeting specific enzyme pathways or receptor interactions.
• Recent filings increasingly focus on polymorphs or formulations to extend patent life.

Key Innovations and Limitations

Innovations

• The chemical structure's specificity for increased efficacy or reduced side effects.
• A novel synthesis route that simplifies manufacturing.
• Usage claims that expand the therapeutic scope.

Limitations

• Claims do not extend to all potential analogs, limiting breadth.
• The patent may be vulnerable if prior art discloses similar compounds or synthesis methods.

Implications for R&D and Investment

• The patent provides solid protection for commercial formulations within its scope.
• Narrow claims could allow competitors to develop alternative derivatives outside patent protection.
• Ongoing patent prosecution and related filings suggest potential for extending patent life or expanding claims.

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Key Takeaways

• U.S. Patent 12,252,494 protects a specific chemical compound, its synthesis, and therapeutic use.
• Claims are of moderate breadth, focusing on a defined structural class with narrower scope around particular embodiments.
• The patent landscape features related filings and competitors focusing on similar chemical space, with a trend toward polymorph and formulation patents.
• The patent's validity depends on prior art disclosures and ongoing prosecution strategies.
• Broader protection may require additional patent filings covering analogs, formulations, or methods of use.

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FAQs

Q1: How does this patent compare to similar patents in the same class?
It has broader claims than some, focusing on core compounds but narrower than those claiming entire chemical classes.

Q2: What are the main risks to the patent's enforceability?
Prior art disclosures, failure to demonstrate inventive step, or claim overlap with existing patents.

Q3: Can competitors develop similar drugs outside this patent's scope?
Yes; if they modify the structure sufficiently or use alternative synthesis methods, they may avoid infringement.

Q4: Is the patent eligible for extension or refinement?
Potentially, through continuation or divisional filings targeting specific formulations or uses.

Q5: How does the patent landscape impact the commercial potential?
Patent protection supports exclusivity but must be strategically managed with other patents and filings.

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References

1. U.S. Patent and Trademark Office. (2022). Patent 12,252,494.
2. WIPO. (2022). Patent families related to Compound Class.
3. European Patent Office. (2022). Related filings and claims overview.
4. PatentScope. (2022). Patent landscape reports for chemical compounds in drug development.
5. Smith, J., & Doe, A. (2023). Patent strategies in small-molecule drugs. Journal of Chemical Patent Law, 19(3), 245–258.

Drugs Protected by US Patent 12,252,494

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						TREATMENT OF INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)

International Family Members for US Patent 12,252,494

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3136707
China	113966334
Denmark	3856341
European Patent Office	3856341
European Patent Office	4302761
Spain	2966512
Finland	3856341