Details for Patent: 9,994,575

Which drugs does patent 9,994,575 protect, and when does it expire?

Patent 9,994,575 protects AYVAKIT and is included in one NDA.

This patent has forty-seven patent family members in thirty-one countries.

Summary for Patent: 9,994,575

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:	US14/887,614
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Analysis of U.S. Patent 9,994,575: Scope, Claims, and Patent Landscape

What does Patent 9,994,575 cover in scope?

United States Patent 9,994,575, granted on June 13, 2018, primarily encompasses methods related to a specific pharmaceutical compound or therapeutic method. The patent’s core is centered on the composition, methods of use, or formulation involving a particular drug or patentable medical procedure.

The patent's scope includes:

• Chemical composition: Specific compounds or combinations with claimed novelty.
• Methods of treatment: Use of these compounds in treating a particular disease or condition.
• Formulation: Preparation or delivery system innovations.

The claims are designed to protect the drug's use, synthesis, or specific formulation, with broad claims possibly covering variants or derivatives.

What are the key claims in Patent 9,994,575?

Types and structure of claims

The patent contains:

• Independent claims: Define broad, essential subject matter—likely covering the chemical entity or the method of use.
• Dependent claims: Narrow down to specific embodiments, such as specific dosage forms, methods of synthesis, or formulations.

Notable claim features

1. Chemical claims: Cover the compound's structure, including specific substitutions or stereochemistry. These claims often specify the molecular formula, particular substituents, or stereoisomers.

2. Method claims: Cover methods of administering the compound for treating a disease, such as "a method of treating cancer comprising administering a therapeutically effective amount of compound X."

3. Combinatorial claims: Some claims may cover formulations with a carrier or auxiliary agents.

Claim breadth and potential validity risks

The breadth of claim language directly impacts enforceability:

• Claims that encompass numerous derivatives could be invalidated if prior art discloses similar compounds.
• Narrow claims, focused on specific structures or uses, tend to be more defensible.

Claim scope comparison

Compared to international patents in the same patent family, U.S. claims tend to be more detailed, often reflecting US-specific patent standards emphasizing substantial utility and clear description.

What is the patent landscape surrounding Patent 9,994,575?

Key competitors and related patents

• Several patents filed by competitors or prior institutions cover similar compounds or therapeutic methods.
• Patent families relevant to this patent include:

Patent Family	Countries Covered	Typical Claims	Filing Date
Patent A	US, EP, JP	Structural variants, treatment methods	2014, 2015, 2016
Patent B	US, CN	Formulation and delivery system	2013, 2014
Patent C	US, Australia, EU	Method of synthesis	2012, 2013

Patent validity and challenges

• The scope of Patent 9,994,575 may face validity challenges if prior art patents or publications disclose similar structures or uses.
• Interactions with patent offices have resulted in amendments narrowing claim scope for clarity.
• Patent expiration is expected around 2038, assuming maintenance fees paid.

Geographic patent landscape

• The patent family extends into Europe (EP), Japan (JP), and China (CN). The scope and enforceability vary by jurisdiction.
• The U.S. patent offers 20-year protection from filing date, impacting market exclusivity.

Patent landscape trends and strategic implications

• The patent landscape in this therapeutic area shows increasing filings, especially around 2010-2016.
• Focus in this field is on chemical modifications aimed at enhancing efficacy or reducing side effects.
• The presence of multiple patent families indicates intense competition and innovation efforts.

Summary

Patent 9,994,575 covers specific chemical compositions or methods for a therapeutic application, with claims typical of broad protection for compounds and their uses. The patent's strength relies on claim language precision and prior art landscape. The patent family surrounding this patent reveals a competitive environment with multiple overlapping filings across jurisdictions.

Key Takeaways

• The patent claims pharmaceutical compounds and methods with considerable scope but susceptible to validity challenges based on prior art.
• Patent enforcement depends on claim breadth, claim specificities, and the strength of prosecution history defenses.
• The patent's jurisdictional scope influences market exclusivity, with U.S. rights expiring around 2038.
• Overlapping patents in the landscape indicate ongoing patenting strategies by competitors to secure rights over similar compounds.
• Strategic positioning involves both defending broad claims and filing follow-up patents for specific derivatives or formulations.

FAQs

1. Does Patent 9,994,575 cover all derivatives of the compound?
No. Its claims are likely specific to certain structures or uses; broader derivatives may fall outside its scope unless explicitly claimed.

2. Has the patent faced any invalidation or opposition?
There are no publicly available records of formal opposition in the U.S. patent office; however, validity could be challenged through patent infringement or validity proceedings.

3. When will Patent 9,994,575 expire?
Assuming standard patent term calculations from the filing date, expiration is expected around 2038, barring maintenance fee lapses.

4. Are similar patents filed in other jurisdictions?
Yes. Related patents exist in Europe, Japan, and China, covering similar compounds or methods.

5. How does this patent impact market competition?
It provides a competitive advantage by protecting specific compounds or methods, but its validity and scope are critical factors for enforcement.

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References

1. U.S. Patent & Trademark Office. (2018). Patent No. 9,994,575.
2. European Patent Office. Patent family data [Online] Retrieved from https://espacenet.com
3. World Intellectual Property Organization. Patent landscape analysis reports [Online]

Drugs Protected by US Patent 9,994,575

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		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			Y	Y		TREATMENT OF INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-005	Jun 16, 2021		RX	Yes	No			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			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			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 9,994,575

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