Details for Patent: 10,137,124

Which drugs does patent 10,137,124 protect, and when does it expire?

Patent 10,137,124 protects RETEVMO and is included in two NDAs.

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

Summary for Patent: 10,137,124

Title:	Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors
Abstract:	Provided herein are compounds of the Formula I: ##STR00001## and stereoisomers and pharmaceutically acceptable salts or solvates thereof, in which A, B, X.sup.1, X.sup.2, X.sup.3, X.sup.4, 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):	Andrews; Steven W. (Boulder, CO), Aronow; Sean (Boulder, CO), Blake; James F. (Boulder, CO), Brandhuber; Barbara J. (Boulder, CO), Cook; Adam (Boulder, CO), Haas; Julia (Boulder, CO), Jiang; Yutong (Boulder, CO), Kolakowski; Gabrielle R. (Boulder, CO), McFaddin; Elizabeth A. (Boulder, CO), McKenney; Megan L. (Boulder, CO), McNulty; Oren T. (Boulder, CO), Metcalf; Andrew T. (Boulder, CO), Moreno; David A. (Boulder, CO), Tang; Tony P. (Boulder, CO), Ren; Li (Boulder, CO)
Assignee:	Array BioPharma Inc. (Boulder, CO)
Application Number:	15/860,852
Patent Claim Types: see list of patent claims	Use;

Understanding the Scope and Claims of United States Patent 10,137,124: A Detailed Analysis

Introduction

Patent US-10137124-B2, titled "Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors," is a significant patent in the pharmaceutical sector, particularly in the field of oncology. This article will delve into the details of this patent, including its claims, the patent landscape, and the broader implications for innovation and intellectual property.

Background on Patent US-10137124-B2

Overview of the Invention

Patent US-10137124-B2 describes a class of substituted pyrazolo[1,5-a]pyridine compounds that act as inhibitors of the RET (rearranged during transfection) kinase. RET kinase is a receptor tyrosine kinase involved in various cellular processes, and its dysregulation is associated with several types of cancer, including medullary thyroid cancer and non-small cell lung cancer[4].

Importance in Oncology

The invention is crucial in the field of oncology as it provides new therapeutic agents for targeting RET kinase, which is a validated target for cancer treatment. These compounds have the potential to offer more effective and targeted therapies for patients with cancers driven by RET alterations.

Claims of the Patent

Claim Structure

The patent includes a series of claims that define the scope of the invention. These claims are structured to comply with the requirements of U.S. patent law, which mandates that claims "particularly point out" and "distinctly claim" the subject matter of the invention[5].

Independent and Dependent Claims

The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding additional limitations. For example, Claim 1 might define a broad class of substituted pyrazolo[1,5-a]pyridine compounds, while subsequent dependent claims might specify particular substituents or structural features.

Subjective Claims Terms

In drafting patents, especially those involving complex chemical structures, subjective terms may be unavoidable. To ensure clarity, the patent includes numerous and meaningful examples of the compounds and their synthesis methods. This approach helps in striking a balance between the inherent limitations of language and the need for clear notice of what is claimed[5].

Patent Landscape

Technology Area

The patent falls under the chemical and pharmaceutical technology area, one of the broad categories used by the USPTO and WIPO for classifying patents. This area has seen significant growth in recent years, driven by advancements in biotechnology and pharmaceutical research[1].

Industry Affiliation

Patents in the pharmaceutical sector are often granted to R&D-performing firms and academic institutions. The data from the NCSES Business R&D Survey indicates that firms in the pharmaceutical industry are among the top recipients of patents, reflecting their high levels of R&D investment[1].

Global Trends

Globally, the trend in patenting in the pharmaceutical sector is characterized by an increase in filings related to targeted therapies and precision medicine. This trend is driven by the need for more effective and personalized treatments, and patents like US-10137124-B2 are at the forefront of this innovation[1].

Legal and Regulatory Aspects

Obviousness-Type Double Patenting

The patent landscape is also influenced by legal decisions such as those related to obviousness-type double patenting. Recent rulings, such as the Federal Circuit's decision in Allergan USA, Inc. v. MSN Laboratories Private Ltd., clarify the application of this doctrine, ensuring that patentees cannot extend the life of a patent by obtaining a second patent on a patentably indistinct invention[2].

Patent Term Adjustments

Patent term adjustments (PTA) can also impact the patent landscape. The Federal Circuit has held that when evaluating obviousness-type double patenting, the relevant expiration date includes any PTA. This ensures that patents are not unfairly extended beyond their intended term[2].

Economic and R&D Implications

R&D Investment

The development of compounds like those described in US-10137124-B2 requires significant R&D investment. Firms in the pharmaceutical industry, which are among the highest R&D spenders, benefit from the exclusive rights granted by patents to recoup their investment and fund further research[1].

Patent Scope and Innovation

The scope of a patent, as defined by its claims, is crucial for innovation. A well-crafted patent provides clear notice of what is claimed, encouraging further innovation while preventing others from making, using, or selling the same invention. The Patent Claims Research Dataset by the USPTO provides detailed information on patent claims and scope, helping in the analysis of patent trends and innovation patterns[3].

Key Takeaways

• Invention Overview: US-10137124-B2 describes substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors, significant in oncology.
• Claims Structure: The patent includes independent and dependent claims, with a focus on clarity and specificity.
• Patent Landscape: The patent is part of the growing trend in pharmaceutical and biotechnology patents, driven by R&D investments.
• Legal Aspects: Recent legal decisions clarify the application of obviousness-type double patenting and patent term adjustments.
• Economic Implications: The patent supports R&D investment and innovation in the pharmaceutical sector.

FAQs

What is the main subject matter of US-10137124-B2?

The main subject matter of US-10137124-B2 is a class of substituted pyrazolo[1,5-a]pyridine compounds that act as inhibitors of the RET kinase.

Why are RET kinase inhibitors important in oncology?

RET kinase inhibitors are important because they target a validated therapeutic target for various types of cancer, including medullary thyroid cancer and non-small cell lung cancer.

How do patent claims ensure clarity and specificity?

Patent claims ensure clarity and specificity by particularly pointing out and distinctly claiming the subject matter of the invention, often with the inclusion of numerous and meaningful examples.

What is the significance of the Federal Circuit's decision in Allergan USA, Inc. v. MSN Laboratories Private Ltd.?

The decision clarifies the application of obviousness-type double patenting, preventing patentees from extending the life of a patent by obtaining a second patent on a patentably indistinct invention.

How does R&D investment impact the development of pharmaceutical patents?

R&D investment is crucial for the development of pharmaceutical patents, as it allows firms to recoup their investment and fund further research through the exclusive rights granted by patents.

Sources

1. National Science Foundation. Invention: U.S. and Comparative Global Trends. January 15, 2020.
2. Whitecase. Federal Circuit Limits the Application of Obviousness-Type Double Patenting for Patents in the Same Family. August 15, 2024.
3. United States Patent and Trademark Office. Patent Claims Research Dataset. August 28, 2017.
4. PubChem. Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors. US-10137124-B2.
5. Buchanan Ingersoll & Rooney PC. Practical Advice for Drafting Patents with Subjective Claims Terms. January 31, 2017.

Recent additions to Drugs Protected by US Patent 10,137,124

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	10,137,124					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	10,137,124					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	10,137,124					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	10,137,124					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
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes	10,137,124					U-3451	TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND 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	213246	May 8, 2020	RX	Yes	10,137,124					U-3452	TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND 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
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE	213246	May 8, 2020	RX	Yes	10,137,124					U-3453	TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAVE PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS

Drugs Protected by US Patent 10,137,124

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	10,137,124					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	10,137,124					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	10,137,124					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	10,137,124					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
Eli Lilly And Co	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes	10,137,124					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	213246-002	May 8, 2020		RX	Yes	Yes	10,137,124					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	213246-002	May 8, 2020		RX	Yes	Yes	10,137,124					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 10,137,124

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	109919
Argentina	109920
Australia	2017342022
Australia	2017342027
Brazil	112019007143
Brazil	112019007144
Canada	3039760