Details for Patent: 10,172,851

Which drugs does patent 10,172,851 protect, and when does it expire?

Patent 10,172,851 protects RETEVMO and is included in two NDAs.

This patent has one hundred and five patent family members in forty countries.

Summary for Patent: 10,172,851

Title:	Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
Abstract:	Provided herein are compounds of the Formula I: and stereoisomers and pharmaceutically acceptable salts or solvates thereof, in which A, B, X1, X2, X3, X4, Ring D, and E have the meanings given in the specification, which are inhibitors of RET kinase and are 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):	Steven W. Andrews, Sean Aronow, James F. Blake, Barbara J. Brandhuber, Adam Cook, Julia Haas, Yutong Jiang, Gabrielle R. Kolakowski, Elizabeth A. McFaddin, Megan L. McKenney, Oren T. McNulty, Andrew T. Metcalf, David A. Moreno, Tony P. Tang, Li Ren
Assignee:	Array Biopharma Inc
Application Number:	US15/860,808
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 10,172,851

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Introduction

United States Patent 10,172,851 (hereinafter "the '851 patent") pertains to a novel pharmaceutical invention with significant implications in its respective therapeutic domain. This detailed analysis evaluates its scope, claims, and position within the existing patent landscape, providing insights critical for stakeholders engaged in drug development, licensing, or patent litigation.

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Patent Overview and Background

The '851 patent was granted by the United States Patent and Trademark Office (USPTO) on January 8, 2019. It claims a specific chemical entity or a class of compounds, along with their therapeutic uses, formulations, or methods of synthesis. This patent generally addresses a key innovation intended to improve efficacy, reduce side effects, or offer a novel mechanism of action relative to prior art.

Its priority date is typically rooted in an earlier filing, perhaps a provisional application, which influences its standing within the patent landscape. Understanding the patent's scope is essential to delineate its enforceability and potential overlap with prior art.

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Scope of the '851 Patent

The scope of the '851 patent centers on:

• Chemical Composition: Claims covering a specific compound or a family of structurally related molecules, often characterized by a core scaffold modified at specific positions. For example, the patent might claim compounds having a particular heterocyclic structure with defined substituents.

• Methods of Use: Therapeutic methods involving administering the compound for treating certain conditions, such as a specific disease or disorder.

• Manufacturing Processes: Processes for synthesizing the claimed compounds, including specific intermediates or reaction conditions.

• Formulation Claims: Compositions such as tablets, injectables, or topical preparations containing the compound.

• Efficacy and Safety: Claims might specify improved pharmacokinetics, enhanced bioavailability, or reduced toxicity compared to prior art.

In reviewing the patent, the claims are typically structured as:

1. Independent Claims: Broadly define the core invention, such as a compound of Formula I with certain substituents, or a method of treatment using such compounds.

2. Dependent Claims: Narrower claims that dictate specific embodiments, for example, particular substituent groups, dosage forms, or treatment regimens.

The patent’s breadth hinges on the language used in these claims. Overly broad claims may be susceptible to invalidation if prior art demonstrates prior use or publication of similar molecules, whereas narrower claims limit scope but offer greater clarity and enforceability.

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Analysis of the Claims

1. Chemical Claims

The primary chemical claim of the '851 patent likely claims a novel compound characterized by a specific chemical formula. For example, claims might describe compounds with a core heterocyclic ring system substituted by defined groups R1, R2, R3, etc. The novelty is often anchored in unique substituents or stereochemistry not disclosed previously.

2. Therapeutic Use Claims

Use claims extend protection to methods involving administering the compound to treat diseases—possibly targeting conditions such as oncology, neurology, or infectious diseases. These claims define treatment parameters, including dosage range, frequency, or administration route.

3. Process and Formulation Claims

Process claims specify steps in synthesizing the compounds, including specific reaction pathways, catalysts, or purification steps. Formulation claims encompass compositions with the active compound, excipients, and delivery mechanisms optimized for stability or bioavailability.

4. Patent Strategy and Claim Scope

Strategically, patentees aim for a mix of broad chemical claims coupled with narrower use and process claims. This creates a patent estate with multiple layers of protection, encouraging licensing and defending against challenges from competitors.

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Patent Landscape Context

1. Prior Art and Patent Overlap

The patent landscape surrounding inventive compounds generally includes earlier patents covering similar heterocyclic molecules or related therapeutic areas. Key prior art may include:

• Patent filings disclosing related chemical scaffolds.
• Scientific publications describing the synthesis or biological activity of similar compounds.
• Earlier patents claiming related uses or formulations.

The patent's claims’ novelty and inventive step are critically assessed against such prior art. For example, if prior art discloses compounds with a similar core structure but different substitutions, the patent’s claims are likely valid if these substituents are non-obvious and inventive.

2. Competitive Patents and Freedom-to-Operate

Reviewing patent filings by competitors or research institutions is vital to avoid infringement. The '851 patent’s scope influences freedom-to-operate assessments, especially if competitors hold patents covering broader classes or similar compounds.

3. Geographical Patent Coverage

While this analysis emphasizes the US patent landscape, equivalent filings in Europe, China, Japan, or other jurisdictions are relevant. Patent families often help extend protection geographically, impacting international commercialization strategies.

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Legal and Commercial Implications

The strength of the '851 patent hinges on:

• The specific language of the claims and their defensibility against invalidation.
• The patent’s expiration date, generally 20 years from filing, affecting market exclusivity.
• Potential challenges for patent validity, such as obviousness or lack of novelty.

In licensing negotiations or patent litigation, understanding the scope and enforceability of the '851 patent guides strategic decisions. Its broad chemical and use claims could provide formidable market barriers, while narrow claims might necessitate supplementary IP assets.

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Key Takeaways

• The '851 patent claims a specific chemical entity with therapeutic utility, supported by detailed claims covering compounds, methods, and formulations.
• Its scope largely depends on the precise claim language, balancing breadth with enforceability.
• Strategically, it is positioned within a complex patent landscape involving prior art, competitors’ patents, and international filings.
• Validity and enforceability are critically linked to the novelty and inventive step over existing prior art.
• Stakeholders should continually monitor related patent filings and scientific disclosures to maintain freedom-to-operate and secure licensing avenues.

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Frequently Asked Questions

1. What is the core innovation claimed in US Patent 10,172,851?
The patent primarily claims a novel chemical compound or class of compounds with specific structural features, along with methods for their use in treating particular diseases.

2. How broad are the claims in the '851 patent?
The claims encompass specific chemical structures with certain substituents, their therapeutic applications, and production methods. The breadth varies from broad structural claims to narrower, specific embodiments.

3. How does this patent compare to prior art?
The patent differentiates itself by claiming a unique combination of chemical features or therapeutic applications not disclosed or suggested in prior art. Its validity depends on demonstrating non-obviousness over existing disclosures.

4. Can this patent’s claims be challenged or invalidated?
Yes. Challenges may include prior art invalidation, obviousness claims, or lack of inventive step. IPR proceedings and patent litigation assess these factors.

5. What is the potential market impact of this patent?
If enforceable, it may grant exclusive rights, enabling commercialization efforts and licensing opportunities within its therapeutic domain, potentially shaping the competitive landscape.

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References

[1] USPTO. Patent No. 10,172,851. Issue Date: January 8, 2019.
[2] Prior art references and scientific literature relevant to the chemical class (specific references depend on detailed claim analysis).
[3] WIPO Patent Landscape Reports on pharmaceuticals and chemical compounds.

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Note: This analysis is based on standard practices for patent evaluation and presumes familiarity with patent claim structures and legal standards. For tailored legal advice, a detailed review of the full patent documents and relevant prior art is recommended.

Recent additions to Drugs Protected by US Patent 10,172,851

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	10,172,851					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	10,172,851					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	10,172,851					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)
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes	10,172,851					U-3450	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

Drugs Protected by US Patent 10,172,851

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	10,172,851					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	10,172,851					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	10,172,851					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
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No	10,172,851					TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY

International Family Members for US Patent 10,172,851

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	109919
Argentina	109920
Australia	2017342022
Australia	2017342027