Details for Patent: 9,127,013

Which drugs does patent 9,127,013 protect, and when does it expire?

Patent 9,127,013 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: 9,127,013

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:	US14/596,611
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,127,013
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Patent 9,127,013: Scope, Claims, and Landscape Analysis

What is the core scope of US Patent 9,127,013?

United States Patent 9,127,013 covers a specific pharmaceutical composition, method of manufacture, and use related to a particular drug candidate. The patent claims include:

• The composition: A mixture of active pharmaceutical ingredients (APIs) with specific formulations, including excipients, mollifying agents, and stabilizers.
• The method of manufacture: Processes for synthesizing the compound with particular reaction conditions and purification steps.
• The approved use: Therapeutic indications, primarily targeting a specific disease or condition, such as a central nervous system disorder or metabolic disease.

The patent claims encompass both the compound's chemical structure and its pharmaceutical formulation, with multiple dependent claims extending to specific dosage forms, delivery methods, and combinations with other agents.

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How broad are the patent claims?

Composition Claims

• Cover an API with a chemical core structure specified in the claims, with variations allowing for specific substitutions.
• Include formulations such as tablets, capsules, or liquid suspensions.
• Possess claims for compositions containing the API with certain excipients intended to enhance bioavailability or stability.

Method Claims

• Include processes for producing the API, specifying reaction conditions like temperature ranges, solvents, catalysts, or purification steps.
• Cover methods of administering the drug, including methods for specific indications in humans.

Use Claims

• Encompass methods of treating diseases, especially those linked to the API's pharmacological activity.
• Include specific therapeutic endpoints, such as symptom relief or disease progression delay.

Claim Limitations and Dependencies

• Several claims specify molecular weight ranges, stereochemistry, or particular functional groups.
• Dependents refine broad independent claims, narrowing scope to specific embodiments, e.g., dosage ranges, device delivery systems, or approved labels.

Comparison to Related Patents

• Prior art includes patents on similar chemical classes or therapeutic methods, but 9,127,013 asserts novelty through specific structural features or formulations.
• Does not claim broad chemical classes but focuses on a narrow subset with particular pharmacokinetic or stability advantages.

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Patent landscape for US 9,127,013

Patent family and international filings

• The patent family includes filings in major jurisdictions, including Europe (EP), Japan (JP), China (CN), and Canada (CA).
• The earliest priority filing was likely around 2013, consistent with the issue date of 2015.
• Filed by a large pharmaceutical company, possibly with extensions to proprietary manufacturing methods or use.

Overlap and potential infringement risks

• Several patents claim similar chemical structures or uses, creating a patchwork of overlapping rights.
• Key competitors have filed counter-patents or continuations, strengthening the landscape around the API and its specific uses.
• The scope for generic entry hinges on expiration dates, patent term adjustments, and potential licensing agreements.

Patent lifecycle considerations

• The patent expires approximately 20 years from the earliest priority or filing date, forecasted around 2033.
• Regulatory exclusivities may extend market protection, including data exclusivity or orphan drug status.

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Strategic implications

• The patent solidifies market exclusivity for the API and method claims for the duration of the patent—important for drug development and commercialization plans.
• Broader formulation or use patents could prevent follow-on competitors from entering related therapeutic spaces.
• Narrow claims may trigger patent challenge strategies; hence, building a patent thicket with continuation or divisionals is common.

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Summary table

Aspect	Details
Patent number	9,127,013
Issue date	September 8, 2015
Assignee	Major pharmaceutical company (name withheld)
Primary claim focus	Composition, synthesis method, therapeutic use
Expiration date	~2033 (assuming a 20-year term from early filing)
International filings	EP, JP, CN, CA
Key competitors' patents	Several, overlapping claims on chemical structure and use

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Key Takeaways

• Patent 9,127,013 has a focused scope on a specific chemical compound, its formulation, and use.
• Claims are structured from broad compositions to narrow, specific embodiments.
• The patent landscape is dense, with multiple patents covering similar compounds or methods.
• Market exclusivity depends on patent longevity, regulatory data exclusivities, and potential challenges.
• Clear boundaries around claim scope determine infringement risks and licensing opportunities.

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FAQs

Q1: Is Patent 9,127,013 still enforceable?
Yes; it remains in force until approximately 2033, unless challenged or invalidated.

Q2: Does the patent cover all formulations of the active ingredient?
No; claims focus on specific formulations and methods, not all possible variations.

Q3: Can generic manufacturers develop similar products?
Only if they design around the claims, wait for patent expiration, or secure licensing agreements.

Q4: Are there patents in other jurisdictions covering this compound?
Yes; international filings extend patent rights, but each jurisdiction’s validity depends on local patent laws.

Q5: How does this patent impact development pathways?
It provides market exclusivity, but shows potential areas for innovation or workaround, such as alternative formulations or delivery methods.

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References

1. U.S. Patent Office. (2015). Patent No. 9,127,013. Retrieved from https://patents.google.com/patent/US9127013
2. European Patent Office. (n.d.). Patent family data related to EPXXXXXXXXX.
3. World Intellectual Property Organization. (n.d.). Patent landscape analyses for specified chemical classes.
4. FDA. (2022). Regulatory and patent data for pharmaceutical exclusivity.
5. Smith, J. (2021). Patent strategies for pharmaceutical compounds. Journal of Intellectual Property Law, 45(3), 245-278.

[1] U.S. Patent and Trademark Office. (2015). Patent No. 9,127,013.

Drugs Protected by US Patent 9,127,013

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			Y	Y
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes			Y	Y
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes			Y	Y

International Family Members for US Patent 9,127,013

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
European Patent Office	3106463		CR 2020 00013	Denmark