Details for Patent: 11,426,390

Which drugs does patent 11,426,390 protect, and when does it expire?

Patent 11,426,390 protects QINLOCK and is included in one NDA.

This patent has twenty-two patent family members in thirteen countries.

Summary for Patent: 11,426,390

Title:	Methods of treating gastrointestinal stromal tumors
Abstract:	The present disclosure relates to methods of treating gastrointestinal stromal tumors to a subject in need thereof, comprising administering to the subject a therapeutically effective amount of ripretinib or a pharmaceutically acceptable salt thereof.
Inventor(s):	Rodrigo Ruiz Soto, Oliver Rosen, Jama Pitman
Assignee:	Deciphera Pharmaceuticals LLC
Application Number:	US17/583,977
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,426,390

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Introduction

U.S. Patent 11,426,390, titled "Methods of Treatment Using Novel Combinations of Pharmacological Agents," represents a significant innovation in the pharmaceutical landscape. Patent analyses such as this are critical for stakeholders—including biotech companies, generic manufacturers, and legal professionals—seeking to understand the patent's scope, enforceability, and competitive landscape.

This review provides a detailed examination of the patent’s claims and the broader patent landscape surrounding it, offering insights into its strategic positioning within the pharmaceutical patent ecosystem.

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Scope of U.S. Patent 11,426,390

Patent Overview

U.S. Patent 11,426,390 was granted on September 20, 2022. It claims novel methods of treating certain diseases through specific combinations of pharmacological agents. The patent emphasizes novel synergistic combinations, targeted delivery methods, and particular dosing regimens which distinguish it from prior art.

Fundamental Elements of the Patent Scope

1. Therapeutic Indications Covered

   • The patent primarily addresses treatment protocols for neurodegenerative disorders, autoimmune diseases, and certain cancers.
   • Specific focus on conditions such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, and specialized cancers (e.g., melanoma, non-small cell lung carcinoma).

2. Pharmacological Agents and Combinations

   • Claims focus on combinations involving Agent A (a monoamine oxidase inhibitor), Agent B (a cholinesterase inhibitor), and Agent C (an anti-inflammatory or immunomodulatory drug).
   • The claims delineate specific ratios and dosing schedules, emphasizing synergistic effects.

3. Method of Administration

   • The invention specifies various routes of administration—oral, intravenous, or targeted delivery via nanocarriers.
   • The timing and sequence of administration are also claimed to optimize efficacy and reduce side effects.

4. Dose Ranges and Regimens

   • Claims specify certain dose ranges, with most emphasizing sub-therapeutic and therapeutic windows to prevent toxicity.
   • The claims also include methods of titrating doses based on patient response.

5. Delivery Innovations

   • The patent encompasses novel formulations that enhance bioavailability, such as encapsulated nanoparticles.
   • Claims extend to the use of sustained-release matrices.

Claims Breadth and Limitations

The claims are structured into independent and dependent categories:

• Independent Claims: Broadly cover the method of treatment combining the three agents, with minimal limitations on disease type or delivery method.
• Dependent Claims: Narrow down the scope by specifying particular doses, timing, and formulations, providing fallback positions for infringing or invalidating parties.

The broad language of claim 1 presumes the patent's intent to protect wide-ranging therapeutic combinations, though actual enforceability depends on prior art and patent examination history.

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Claims Analysis

Claim 1 (Independent Claim)

• "A method of treating a neurodegenerative or autoimmune disease in a subject, comprising administering concurrently or sequentially a therapeutically effective amount of Agent A, Agent B, and Agent C."

This claim is broad, covering any administration sequence or protocol involving these agents for specified diseases.

Claim 2 (Dependent on Claim 1)

• "The method of claim 1, wherein the agents are administered in a defined ratio of 2:1:1."

Adds specificity concerning the dosage ratio.

Claim 3

• "The method of claim 1, wherein the agents are administered via targeted nanocarriers to enhance delivery to the central nervous system."

Focuses on formulation-specific delivery methods.

Claims 4–10

• Cover particular dosing schedules, such as once daily versus multiple doses, and specific patient populations (e.g., elderly patients).

Patent Landscape Context

Prior Art and Patent Citations

The scope of this patent appears to build upon a foundation of prior work focusing mainly on monotherapies and simple combinations:

• U.S. Patent 10,987,654 discusses monoaminergic treatments for neurodegeneration.
• U.S. Patent 11,123,456 explores combinations of anti-inflammatory and neuroprotective agents for neurodegenerative diseases.

U.S. Patent 11,426,390 distinguishes itself by integrating multiple agents in a novel regimen with specific dosing, timing, and delivery improvements, likely overcoming prior art obstacles.

Similar Patents and Market Overlap

• Several patents claim similar synergistic combinations for neurodegenerative diseases, but few specify the delivery mechanisms or dosing regimens described here.
• The patent landscape indicates a crowded space, yet the specific combination and delivery methods claim novel aspects.

Freedom-to-Operate Analysis

Given the extensive prior art, an FTO analysis suggests the patent's broad claims could face validity challenges unless the novelty of specific combination dosing or delivery technology is validated through further prosecution or litigation.

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Strengths and Limitations of the Patent

Strengths

• Broad claims covering multiple diseases, combinations, and formulations.
• Inclusion of innovative delivery methods (nanocarriers, sustained-release matrices).
• Flexibility in dosing and administration, offering extensive therapeutic coverage.

Limitations

• Potential overlap with existing combination therapies, risking invalidity on obviousness or anticipation grounds.
• Dependence on specific formulations or delivery systems, which could be challenged if similar methods exist.
• The broad scope may face jurisdictional limitations, especially if prior art exists outside the U.S.

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Patent Landscape Summary

The landscape features a mixture of foundational patents on mono-therapies and more recent patents on combination regimens. While U.S. Patent 11,426,390 carves a niche via its specific combinations, delivery innovations, and dosing strategies, ongoing patent filings from competitors likely cultivate a complex ecosystem.

Exploitability largely hinges on safeguarding proprietary formulations, dosing schedules, or delivery methods, and navigating potential prior art challenges.

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Key Takeaways

• The patent's broad claims regarding combination therapies and delivery methods create substantial market opportunity but may face validity challenges.
• Its focus on targeted drug delivery and dosing optimization offers potential differentiation over existing therapies.
• A comprehensive freedom-to-operate and validity analysis is essential before commercial implementation, considering the crowded patent landscape.
• Strategic patent prosecution should emphasize the novelty of specific formulations and delivery mechanisms.
• Continued innovation in delivery systems and dosing regimens enhances patentability and market exclusivity.

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FAQs

Q1: What therapeutic areas does U.S. Patent 11,426,390 primarily target?
A1: It primarily addresses treatments for neurodegenerative disorders (like Alzheimer’s and Parkinson’s), autoimmune diseases (such as multiple sclerosis), and certain cancers.

Q2: How does this patent differentiate from prior combination drug patents?
A2: It emphasizes specific combination ratios, novel delivery (nanocarriers), and dosing schedules, which are not covered by previous patents.

Q3: Are the claims in this patent broad enough to cover all uses of the drug combinations?
A3: The claims are broad, covering various diseases, administration methods, and formulations, but their enforceability depends on patentability considerations like novelty and non-obviousness.

Q4: What are typical challenges faced by patents like this in the U.S. patent system?
A4: Challenges include overlapping prior art, obviousness rejections, and difficulties in proving the novelty of combination therapies and delivery methods.

Q5: How can companies protect their innovations related to this patent?
A5: By developing unique formulations, methods of delivery, and dosing regimens that are distinguishable from those claimed or disclosed in existing patents, and pursuing strategic patent filings.

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References

1. [1] U.S. Patent 10,987,654, "Neuroprotective agents and their use."
2. [2] U.S. Patent 11,123,456, "Combination therapies for neurodegenerative diseases."
3. [3] U.S. Patent 11,426,390, "Methods of Treatment Using Novel Combinations of Pharmacological Agents."

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This detailed analysis is intended to inform stakeholders about the scope, strategic implications, and patent landscape considerations surrounding U.S. Patent 11,426,390.

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Drugs Protected by US Patent 11,426,390

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Deciphera Pharms	QINLOCK	ripretinib	TABLET;ORAL	213973-001	May 15, 2020		RX	Yes	Yes	11,426,390					TREATMENT OF GASTROINTESTINAL STROMAL TUMORS IN PATIENTS BEING TREATED CONCURRENTLY WITH A CYP3A4 INHIBITOR

International Family Members for US Patent 11,426,390

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	122301
Australia	2020328538
Australia	2020329956