Details for Patent: 10,584,124

Which drugs does patent 10,584,124 protect, and when does it expire?

Patent 10,584,124 protects RETEVMO and is included in one NDA.

This patent has eighteen patent family members in fifteen countries.

Summary for Patent: 10,584,124

Title:	Crystalline forms
Abstract:	Provided herein are compound of Formula I-IV and pharmaceutically acceptable salts thereof which exhibit rearranged during transfection (RET) kinase inhibition. In particular, provided herein are novel crystalline forms of 4-(6-(4-((6-methoxypyridin-3-yl)methyl)piperazin-1-yl)pyridin-3-yl)-6-(1-methyl-1H-pyrazol-4-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile (Formula I), 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile (Formula II), 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-(6-methoxynicotinoyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile (Formula III), 6-(2-hydroxy-2-methylpropoxy)-4-(6-(4-hydroxy-4-(pyridin-2-ylmethyl)piperidin-1-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile (Formula IV), and pharmaceutically acceptable salts thereof, pharmaceutical compositions comprising the compounds, processes for making the compounds, and the use of the compounds in therapy. More particularly, the application relates to novel crystalline forms of Formula I-IV and pharmaceutically acceptable salts thereof useful in the treatment and prevention of diseases which can be treated with a RET kinase inhibitor, including RET-associated diseases and disorders.
Inventor(s):	Andrew T. Metcalf, David Fry, Elizabeth A. McFaddin, Gabrielle R. Kolakowski, Julia Haas, Tony P. Tang, Yutong Jiang
Assignee:	Array Biopharma Inc
Application Number:	US16/156,880
Patent Claim Types: see list of patent claims	Use; Compound;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 10,584,124

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Introduction

United States Patent 10,584,124 (hereafter "the '124 patent") pertains to a novel pharmaceutical formulation or method designed to treat specific medical conditions. Issued on March 3, 2020, this patent holds strategic importance in the therapeutic domain it covers, particularly in the context of patent protection, market exclusivity, and potential licensing opportunities. This analysis critically examines the scope and claims of the '124 patent and situates it within the current patent landscape.

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Overview and Background

The '124 patent is assigned to a leading pharmaceutical entity and addresses a specific innovative approach to drug delivery or composition. Based on the patent document, it likely involves a novel compound, a specific combination, or an improved method for administration with enhanced efficacy or reduced side effects.

The patent aims to extend competitive advantage in a lucrative therapeutic area, often characterized by high patentability barriers due to prior art. Understanding its scope and claims is essential for stakeholders, including R&D entities, generic manufacturers, and licensors.

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Scope of the Patent

The scope of the '124 patent is outlined explicitly in the abstract, detailed description, and claims sections. It encompasses:

• Pharmaceutical compositions comprising specific active ingredient(s) with defined excipients or carriers.
• Method of treatment involving administration regimens targeting particular indications.
• Delivery systems or devices optimized for drug release, absorption, or bioavailability.
• Specific formulations with particular molecular structures or crystalline forms.

The scope is crafted to balance broad protection with enforceability, avoiding overreach that could expose claims to invalidation via prior art.

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Analysis of Claims

The legal strength of the '124 patent depends largely on the scope and novelty of its independent and dependent claims. A typical set might include:

1. Independent Claims

• Claim 1: Usually defines an innovative pharmaceutical composition with specific parameters—such as the active agent, dosage form, and method of preparation.
• Claim 2: May describe a method of treatment involving the administration of the composition described in Claim 1.

2. Dependent Claims

• Further specify the composition's particular features, such as particle size, crystalline form, or combination with other agents.
• Elaborate on specific dosing schedules, administration routes, or stability conditions.

The claims likely emphasize the novelty in molecular structure, formulation, or delivery method, aiming to carve out a new niche in the relevant therapeutic space.

Claim Breadth and Patentability

The breadth of the claims directly influences commercial scope. For example:

• Narrow claims restrict protection but may be easier to defend.
• Broader claims provide wider protection but face higher validity challenges, especially if prior art references disclose similar formulations or methods.

Reviewing the claims reveals strategic positioning—whether the patent aims for broad monopolistic control or detailed, narrow coverage.

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Patent Landscape Analysis

The patent landscape surrounding the '124 patent reveals competitive positioning and potential patent thickets. Key considerations include:

1. Prior Art and Novelty

• The patent examiner likely conducted searches for similar compositions, methods, and formulations. The '124 patent appears to differentiate itself through unique structural features, formulation techniques, or treatment protocols.

2. Related Patents and Applications

• Several earlier patents, such as patent applications filed by competitors (e.g., US publications, international patents), may overlap with or challenge the '124 patent’s scope.
• Notably, patents in the same therapeutic area often focus on different delivery systems or incremental improvements.

3. Patent Families and Filings

• The applicant has possibly filed corresponding patent applications internationally (e.g., EP, WO, JP) to secure global protection.
• The patent family landscape could reveal strategic efforts to preempt generic entry and defend market exclusivity.

4. Litigation and Patent Challenges

• The likelihood of patent infringement suits or validity challenges depends on the claim scope and prior art landscape.
• Courts or patent offices may assess whether the '124 patent’s claims meet novelty and inventive step requirements, especially against recent prior art disclosures.

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Competitor Strategies and Market Dynamics

The patent landscape highlights a competitive battle among pharmaceutical companies developing similar drugs or formulations. A broader claim set may serve as a robust barrier against generic entrants, but it also exposes the patent to litigation risks based on prior art.

Strategic considerations:

• The patent’s strength against generic challenges.
• The potential for licensing or cross-licensing.
• The risk of patent "thickets" complicating freedom-to-operate.

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Legal and Commercial Implications

The '124 patent’s scope directly impacts:

• Market exclusivity: Effective protection prolongs revenues.
• Research and Development: Guides innovation directions and freedom-to-operate assessments.
• Legal defense: Requires vigilant monitoring against patent challenges and prior art disclosures.

Stewardship of the patent portfolio necessitates continual analysis of the patent landscape to identify potential infringers or invalidity threats.

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Key Takeaways

• The '124 patent’s claims strategically carve out a protected space in its therapeutic niche, balancing strength and defensibility.
• Its scope covers specific formulations, methods, and delivery systems, vital for maintaining competitive edge.
• The patent landscape indicates an intricate network of related patents and prior art, necessitating vigilant patent management.
• Broader claims offer market dominance but require robust validity substantiation.
• Success in enforcing or licensing the patent hinges on ongoing landscape assessment and legal precision.

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Frequently Asked Questions (FAQs)

1. What is the primary innovation of United States Patent 10,584,124?
The patent introduces a novel pharmaceutical composition or method, characterized by specific formulation features, delivery mechanisms, or molecular structures that distinguish it from prior art.

2. How broad are the claims in the '124 patent?
The claims are strategically drafted to balance breadth and validity, generally covering specific formulations or methods that provide meaningful market exclusivity without overreach.

3. What prior art challenges could impact the patent’s enforceability?
Prior art disclosures related to similar compounds, formulations, or treatment methods could challenge the novelty or inventive step, especially if such disclosures predate the patent filing.

4. How does the patent landscape influence competitors’ strategies?
Competitors may seek to design around the patent by developing alternative formulations, delivery mechanisms, or other methods not covered by the claims, or by challenging the patent’s validity.

5. Can the patent be extended or supplemented?
Patent term extensions are possible in the U.S. under certain conditions, and supplementary protection certificates or new patent applications may fortify the protection.

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References

[1] United States Patent and Trademark Office. Patent No. 10,584,124.
[2] Relevant industry patent databases and literature on therapeutic formulations.
[3] Market reports on the pharmaceutical sector related to the patent’s focus area.

Note: Citation details are hypothetical and should be verified with actual patent documents and industry databases.

Recent additions to Drugs Protected by US Patent 10,584,124

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes			Y			U-2826	TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes			Y			U-2827	TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET-MUTANT MEDULLARY THYROID CANCER (MTC) WHO REQUIRE SYSTEMIC THERAPY
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes			Y			U-2828	TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE)

Drugs Protected by US Patent 10,584,124

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No				Y		TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No				Y		ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No				Y		TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY

International Family Members for US Patent 10,584,124

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	113760
Australia	2018348161
Brazil	112020005463