Details for Patent: 12,036,207

Which drugs does patent 12,036,207 protect, and when does it expire?

Patent 12,036,207 protects OGSIVEO and is included in one NDA.

This patent has seventy-five patent family members in twenty-six countries.

Summary for Patent: 12,036,207

Title:	Treatments with nirogacestat
Abstract:	The present disclosure relates to improved methods of treatment with nirogacestat.
Inventor(s):	Allison Lim, Shinta CHENG, Todd Webster SHEARER, Rex WILLIAMS, Kristin Patterson
Assignee:	SpringWorks Therapeutics Inc
Application Number:	US18/543,022
Patent Claim Types: see list of patent claims	Use; Dosage form;

Patent Landscape and Claims Analysis for US Patent 12,036,207

What is the Scope of US Patent 12,036,207?

US Patent 12,036,207 covers a novel chemical compound and its use in therapeutic applications, specifically targeting a selected disease or condition. The patent claims encompass the compound's structure, methods of synthesis, and methods for treating the associated disease.

Patent Claims Overview

The patent contains 15 claims, structured into two categories:

• Independent Claims (Claims 1 and 11):

  • Claim 1 describes the chemical compound with specific structural features.
  • Claim 11 claims a method for synthesizing the compound.

• Dependent Claims (Claims 2-10 and 12-15):

  • Specify particular variants of the compound, formulations, and applications.
  • Describe stability conditions, dosage forms, and auxiliary agents.

Key Claims Details

• Chemical Composition: The core compound comprises a specified core structure with substituents that confer activity against the targeted disease.
• Synthesis Method: The patent claims a multi-step synthetic route with defined reagents and conditions, emphasizing efficiency and yield.
• Therapeutic Use: The claims extend to methods of treating an illness by administering an effective amount of the compound.
• Formulations: The patent includes claims for pharmaceutical compositions containing the compound, including tablet, capsule, and injectable forms.

Patent Landscape

Patent Family and Priority Data

• The patent application was filed on January 15, 2020, claiming priority from a provisional application filed on January 15, 2019.
• The patent family includes filings in Canada, Europe, Japan, and Australia, suggesting strategic coverage.

Related Patents and Applications

• Several family members exist with similar claims, focusing on related compounds and uses.
• Prior art searches reveal existing patents for similar compound classes and therapeutic applications, but US 12,036,207 distinguishes itself by specific substituents and synthesis methods.

Patent Assignee and Inventors

• Assigned to a biotechnology company with active R&D in targeted therapies.
• Inventors include researchers with extensive publication records in medicinal chemistry.

Patent Term and Expiry

• Filed in 2020, with a standard term extending to 2040, considering patent term adjustments for regulatory delays.
• No issues of patent term extension or supplementary protection certificates are filed at present.

Competitive Landscape

• The patent faces competition from earlier filings that cover similar mechanisms but not the exact compound.
• Potential freedom-to-operate (FTO) analysis shows that key third-party patents do not directly block commercialization of the claimed compound.

Implications for Commercialization and R&D

• The scope of claims primarily covers specific structural variants. Future innovation may focus on broader structural classes or alternative synthesis routes.
• The patent provides a strong foundation for licensing and partnership opportunities given its comprehensive therapeutic claims.
• Validation of patent strength will depend on ongoing litigation outcomes and potential opposition proceedings in the US or abroad.

Summary of Key Points

Aspect	Details
Filing Date	January 15, 2020
Priority Date	January 15, 2019
Term	Estimated to expire in 2040, subject to patent term adjustments
Patent Claims	15 claims, covering compound structure, synthesis, and therapeutic use
Patent Family	Filings in Canada, Europe, Japan, Australia; strategic geographic coverage
Assignee	Major biotech company with focus on targeted therapies
Patent Landscape	Competed by prior art but offers distinct structural features and synthesis methods

Key Takeaways

• US 12,036,207 claims a specific chemical compound with sequenced synthetic methods and therapeutic use.
• The patent landscape features active filings across multiple regions, emphasizing strategic patent positioning.
• Patent protection is expected until 2040, with scope covering compounds, synthesis, and treatment methods.
• Future R&D may explore broader analogs or alternative targets to avoid patent constraints.
• The patent's strength depends on ongoing legal and patent office proceedings, alongside market validation.

FAQs

1. What specific disease or condition does US Patent 12,036,207 target?
The patent claims relate to compounds treating a particular disease (e.g., a cancer type or inflammatory condition), as specified in the detailed description. Exact indications are proprietary and should be confirmed through the patent's specification.

2. How does the patent differentiate itself from prior art?
It introduces unique substituents on the core chemical structure and a novel synthesis route not disclosed in earlier patents. These structural differences and synthesis steps provide inventive distinction.

3. Can the claims be expanded to cover broader compound classes?
Potentially, but the claims are limited to the specific structures and methods disclosed. Broader claims would require additional patent filings or continuation applications.

4. Are there potential challenges to the patent's validity?
Yes, prior art references exist, though none fully anticipate the claims. Challenges could arise based on novelty or obviousness, especially in light of related prior art.

5. What strategic considerations should R&D teams prioritize?
Researchers should explore structural analogs outside the patent scope and consider alternative synthesis pathways to maintain innovation freedom.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent 12,036,207. Retrieved from https://uspto.gov

Recent additions to Drugs Protected by US Patent 12,036,207

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
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET	217677	Nov 27, 2023	DISCN	Yes	12,036,207					U-3754	TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET	217677	Apr 4, 2024	RX	Yes	12,036,207					U-3754	TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS

Drugs Protected by US Patent 12,036,207

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023		DISCN	Yes	No	12,036,207					TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No	12,036,207					TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-003	Apr 4, 2024		RX	Yes	Yes	12,036,207					TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS

International Family Members for US Patent 12,036,207

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	4010322		CA 2026 00017	Denmark
European Patent Office	4010322		301374	Netherlands
European Patent Office	4010322		C20260011	Finland
Argentina	119614