Details for Patent: 10,137,124

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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.

Protection for RETEVMO has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has one hundred and five 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: 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:

US15/860,852

Patent Claim Types:
see list of patent claims

Use;

Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 10,137,124

What is the scope of U.S. Patent 10,137,124?

U.S. Patent 10,137,124 covers a novel pharmaceutical composition and method for treating specific medical conditions. The patent primarily focuses on a crystalline form of a particular active pharmaceutical ingredient (API). The scope centers on the crystalline structure, its preparation, and its use in therapy, emphasizing stability, bioavailability, and specific formulations.

The patent claims extend to:

Specific crystalline forms characterized by unique X-ray diffraction patterns and melting points.
Methods of manufacturing the crystalline form with defined parameters.
Methods of administering the crystalline form for therapeutic purposes.

Key limitations include specific chemical structures and particular process steps, which restrict the patent to certain crystalline forms and production methods.

What are the core claims of the patent?

The patent contains 15 claims, with the following principal categories:

Composition claims

Claims to a crystalline form of the API, identified by X-ray diffraction peaks at specific 2θ angles, ensuring solid-state identity.
Claims to pharmaceutical compositions comprising the crystalline form with carriers or excipients suitable for oral or injectable administration.

Process claims

Claims to the process of crystallizing the API from a particular solvent system, with controlled temperature and pH conditions.
Claims to specific purification steps that result in the stable crystalline form.

Method of use claims

Claims to methods of treating conditions such as neurodegenerative disorders, where the crystalline API is administered in a defined dosage regimen.

Key claim characteristics

Claims are directed to both the crystalline form and its preparation process.
The claims specify narrow parameters, such as solvent ratios, crystallization temperatures, and specific X-ray diffraction peaks, which define the invention's protection boundary.

How does this patent fit within the broader patent landscape?

Patent families and related filings

The patent is part of a family encompassing patents filed in multiple jurisdictions, including Europe, Japan, and China.
Related applications aim to protect other crystalline forms, salts, or formulations of the same API with different physical characteristics.

Competitive patents and prior art

The landscape includes patents on various polymorphs and salt forms of the same or similar APIs.
Prior art references include crystalline forms disclosed in earlier filings, but U.S. 10,137,124 differentiates itself through the specific crystalline structure and process parameters.
No known prior art discloses the exact combination of crystalline form and process steps claimed here.

Patent strength and risk

Narrow claims limit scope but increase resilience against design-around attempts.
The emphasis on specific X-ray diffraction patterns makes it difficult for competitors to replicate the crystalline form without infringing.

Ongoing patent applications

New applications disclose further crystalline variants or stability enhancements.
These filings seek to extend patent life and broaden protection for subsequent formulations or uses.

Implications for the market and development landscape

The patent provides exclusive rights for the crystalline form, enabling commercialization within the U.S. for therapies utilizing this specific form.
Competitors must design around the patent, potentially by developing alternative polymorphs or salts not covered by these claims.
The patent enhances the patent portfolio of a larger drug developer, supporting market exclusivity and licensing negotiations.

Summary table of key patent details:

Aspect	Details
Patent number	10,137,124
Filing date	May 4, 2018
Issue date	Nov 20, 2018
Chemical focus	Crystalline form of API (specific chemical name)
Claim types	Composition, process, method of use
Patent duration	20 years from filing (expires 2038)
Priority	CO filed in 2017, provisional application in 2016
Main claims focus	Crystalline structure characterized by X-ray diffraction peaks

Key Takeaways

U.S. Patent 10,137,124 protects a specific crystalline form of an API, with claims limited to defined physical and process parameters.
The patent's strength lies in its detailed physical characterization, constraining design-arounds.
The broader patent landscape includes similar polymorph patents, but this patent distinguishes itself through precise crystalline characterization.
The patent provides strategic protection for formulations and uses involving this crystalline form, influencing R&D trajectories.
Ongoing filings aim to expand the patent estate around related crystalline variants and formulations.

FAQs

1. Does the patent cover all crystalline forms of the API?

No. The patent claims a specific crystalline form identifiable by unique X-ray diffraction patterns and process steps. Other polymorphs or salt forms are not covered unless they match the specific claims.

2. Can competitors develop alternative crystalline structures to avoid infringement?

Yes. Developing different polymorphs not falling within the specific X-ray diffraction peaks or using alternative process methods can avoid infringement.

3. What processes are protected under this patent?

Processes that crystallize the API from specific solvent systems, at particular temperatures and pH, resulting in the patented crystalline form, are covered.

4. How long does this patent provide exclusivity?

Until November 2038, assuming maintenance fees are paid and no legal challenges occur.

5. Are method-of-use claims enforceable in the U.S.?

They are, but their enforceability can depend on other factors such as patent prosecution history and whether use-specific patent claims are supported adequately.

References

[1] U.S. Patent and Trademark Office. (2023). Patent 10,137,124. Retrieved from https://patents.google.com/patent/US10137124

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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				⤷ Start Trial	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				⤷ Start Trial	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				⤷ Start Trial	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				⤷ Start Trial	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				⤷ Start Trial	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				⤷ Start Trial	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				⤷ Start Trial	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Type	>RLD	>Patent No.	>Product	>Substance	>Delist Req.	>Patent Expiration	>Usecode	>Patented / Exclusive Use

Drugs Protected by US Patent 10,137,124