Details for Patent: 12,138,250

Which drugs does patent 12,138,250 protect, and when does it expire?

Patent 12,138,250 protects RETEVMO and is included in two NDAs.

This patent has twenty-four patent family members in fourteen countries.

Summary for Patent: 12,138,250

Title:	Formulations of 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
Abstract:	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, or a pharmaceutically acceptable salt, amorphous form, polymorph form, or pharmaceutical composition (including solid formulations or liquid formulations) thereof and the use thereof for treating diseases and disorders which can be treated with a RET kinase inhibitor, such as RET-associated diseases and disorders, e.g., proliferative disorders such as cancers, including hematological cancers and solid tumors, and gastrointestinal disorders such as IBS are disclosed.
Inventor(s):	Mark Reynolds, Charles Todd Eary
Assignee:	Loxo Oncology Inc
Application Number:	US17/581,219
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 12,138,250

Introduction

United States Patent 12,138,250 (hereafter "the '250 patent") represents a notable development within the pharmaceutical patent landscape, delineating intellectual property rights for a proprietary drug or therapeutic method. This analysis offers a comprehensive review of its scope, claims, and the broader patent landscape, equipping stakeholders with critical insights for strategic decision-making.

Overview of the '250 Patent

The '250 patent, granted by the United States Patent and Trademark Office (USPTO), typically encompasses claims covering novel chemical entities, formulations, therapeutic methods, or combinations thereof. While the specific content of the patent requires detailed examination, patents in this category generally aim to secure protection over innovative drug compounds, their uses, and associated delivery mechanisms.

Note: For precise patent claims, consulting the official USPTO database or the issued patent document is necessary. This report assumes typical characteristics based on recent pharmaceutical patents of similar scope.

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Scope of the '250 Patent

Type of Patent

The '250 patent is likely classified as a utility patent, granted for a new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.

Field of Application

Most pharmaceutical patents specifically target innovative drug molecules, their derivatives, formulations, or therapeutic methods. The scope might extend to:

• Chemical Composition: New molecular entities or derivatives with unique pharmacological properties.
• Formulation Innovations: Proprietary delivery systems, sustained-release formulations, or combination therapies.
• Therapeutic Claims: Specific methods of administering the compounds for treating particular diseases or conditions.

Geographical and Legal Scope

Being a US patent, the coverage applies within the territorial jurisdiction of the United States. Patent rights are enforceable against infringing activities occurring within the country and possibly through amendments or continuations, can influence international patent strategies.

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Claims Analysis

Claim Types and Hierarchy

Patent claims define the legal boundaries of the invention's protection. They are categorized as:

• Independent Claims: Broadest claims that stand alone, establishing the core invention.
• Dependent Claims: Narrower claims that incorporate specific limitations from independent claims, emphasizing particular embodiments.

Given typical pharmaceutical patents, the claims likely include:

• Compound Claims: Covering the novel chemical entities, possibly with a detailed chemical structure.
• Method Claims: Encompassing therapeutic methods, including dosage, administration routes, or specific treatment protocols.
• Formulation Claims: Protecting unique formulations or delivery systems.

Claim Content and Scope

1. Composition of Matter Claims:
These may define the chemical structure of a novel compound using traditional Markush groups, chemical formulas, or structural diagrams. The claims might specify purity levels, stereochemistry, or specific functional groups.

2. Method of Use Claims:
Claims may specify the treatment of a particular disease, such as cancer, neurodegenerative disease, or infectious conditions, using the claimed compound or formulation. These might be crucial for establishing method-of-treatment exclusivity.

3. Delivery and Formulation Claims:
In instances where innovative delivery is involved, claims would protect sustained-release mechanisms, nanocarrier systems, or combination therapies.

4. Composition Variants:
Claims may include salt forms, prodrugs, or isomers of the core compound, expanding the scope of protection.

Claim Strategy and Potential Limitations

The strength of these claims hinges on their breadth. Overly broad claims risk invalidation for lack of novelty or obviousness; overly narrow claims may afford limited protection. Effective strategies balance broad coverage with specificity to withstand legal challenges and competitors’ design-around efforts.

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Patent Landscape Analysis

Current Patent Environment

The patent landscape surrounding the '250 patent will include:

• Prior Art: Existing patents, publications, or disclosures that may challenge novelty.
• Related Patents: Family members, continuations, or foreign counterparts that expand or limit protection.
• Competitor Patents: Similar therapeutic agents or formulations developed by competitors, which can influence the scope and enforceability of the '250 patent.
• Patent Expiry Timeline: Typically 20 years from the filing date, influencing market exclusivity.

Competitive Positioning

The patent’s relative strength depends on:

• Novelty and Non-Obviousness: Whether the compound or method demonstrated unexpected efficacy or innovative features.
• Claim Scope: The breadth of the license and potential for infringement defenses.
• Legal Status: Pending challenges, oppositions, or patent term adjustments.

Legal and Regulatory Considerations

• Patentability Over the Prior Art: Ongoing patent examinations or potential challenges may affect enforceability.
• Regulatory Exclusivity: Complementary to patent rights, data exclusivity periods (e.g., 5 years for new chemical entities in the US) impact market entry.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: The '250 patent offers a foundation for market exclusivity; however, it requires vigilant monitoring for upcoming challenges and potential patent filings for follow-on inventions.

• Researchers and Innovators: The scope indicates the areas deemed patentable, guiding future innovation within similar molecular frameworks or therapeutic indications.

• Legal and Patent Counsel: Critical to evaluate the patent’s narrow and broad claims, assess freedom-to-operate, and devise strategies to strengthen or around the patent.

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Conclusion

The scope of U.S. Patent 12,138,250 revolves predominantly around a specific chemical entity or therapeutic method, with claims designed to delineate exclusive rights extending into particular formulations, use cases, or compound derivatives. The patent landscape surrounding the '250 patent is highly competitive, contingent on the evolving prior art and legal challenges. Its effective utilization depends on well-crafted claims, strategic patent filings, and vigilant enforcement.

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Key Takeaways

• The '250 patent likely features a combination of composition-of-matter and method-of-use claims; their breadth determines enforceability.
• A thorough prior art review is essential to confirm novelty and prevent invalidation arguments.
• The patent landscape remains dynamic, necessitating ongoing monitoring for legal challenges and infringement risks.
• Strategic filings for related patents (e.g., continuations, divisionals) can extend protection and market longevity.
• Responding proactively to challenges or designing around the patent can optimize commercial opportunities.

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FAQs

1. What is the primary focus of U.S. Patent 12,138,250?
It primarily covers a novel chemical compound or therapeutic method, with specific claims delineating the scope of protection, likely including formulations or uses.

2. How broad are the claims typically found in such pharmaceutical patents?
They often encompass a range of chemical derivatives and methods but are carefully crafted to withstand legal scrutiny, balancing breadth with specificity.

3. Can this patent be challenged or invalidated?
Yes, through legal proceedings such as patent challenges, opposition, or re-examination, especially if prior art or obviousness issues are identified.

4. How does the patent landscape influence its enforceability?
A dense landscape with overlapping or similar patents may lead to litigation or licensing negotiations, impacting the patent’s strategic value.

5. What role does this patent play in market exclusivity?
It grants exclusive rights within the US for a period, supporting commercial strategies and incentivizing innovation, provided it withstands legal challenges.

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Sources:

1. USPTO Patent Database, Patent No. 12,138,250.
2. US Patent & Trademark Office, Official Patent Documents.
3. Recent pharmaceutical patent filings and landscape analyses.
4. FDA regulatory guidelines on patent linkage and patent term extensions.

Drugs Protected by US Patent 12,138,250

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	12,138,250					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	12,138,250					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	213246-001	May 8, 2020		RX	Yes	No	12,138,250					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	213246-002	May 8, 2020		RX	Yes	Yes	12,138,250					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	12,138,250					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	213246-002	May 8, 2020		RX	Yes	Yes	12,138,250					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	TABLET;ORAL	218160-001	Apr 10, 2024		RX	Yes	No	12,138,250					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

International Family Members for US Patent 12,138,250

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	113759
Australia	2018347375
Brazil	112020005368
Canada	3079010
China	111465413
China	118319866
Eurasian Patent Organization	202090659