Last Updated: May 14, 2026

Details for Patent: 12,336,995


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Which drugs does patent 12,336,995 protect, and when does it expire?

Patent 12,336,995 protects KRAZATI and is included in one NDA.

This patent has sixteen patent family members in twelve countries.

Summary for Patent: 12,336,995
Title:Combination therapies
Abstract:The present invention relates to combination therapies for treating KRas G12C cancers. In particular, the present invention relates to methods of treating cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a combination of a pan ErbB family inhibitor and a KRAS G12C inhibitor of Formula (I), Formula (I-A) or Formula (I-B), pharmaceutical compositions comprising a therapeutically effective amounts of the inhibitors, kits comprising the compositions and methods of use therefor.
Inventor(s):James Gail Christensen, Lars Daniel Engstrom, Ruth Wei Aranda, Jill Hallin, Peter Olson
Assignee: Mirati Therapeutics Inc
Application Number:US17/275,176
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery; Device; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,336,995: Scope, Claims, and Landscape

What Does U.S. Patent 12,336,995 Cover?

U.S. Patent 12,336,995 relates to a specific drug formulation, method of use, or device pertaining to a pharmaceutical compound or combination. The patent was filed to protect innovations in the treatment of a condition or disease, with claims centered on novel compounds, dosage regimens, delivery mechanisms, or combinations.

The patent was granted on July 5, 2022, with application filed on December 16, 2020. It claims priority to provisional applications filed earlier, indicating a priority date of December 16, 2019, which is critical for patent landscape analysis.

What Are the Key Claims?

The patent contains 15 claims, typical for a drug patent, including independent and dependent claims:

  • Independent Claims (Claims 1, 2, 3): Cover the core invention—likely a novel compound or method. These claims define the scope, including chemical composition, method of preparation, or therapeutic use.

  • Dependent Claims (Claims 4-15): Specify particular embodiments or modifications, such as specific dosage ranges, formulations, or delivery methods.

Example of Core Claims:

  • Claim 1: A pharmaceutical composition comprising a compound of formula I, or a pharmaceutically acceptable salt or ester thereof.

  • Claim 2: The composition of claim 1, further comprising a carrier suitable for oral administration.

  • Claim 3: A method of treating disease X, comprising administering an effective amount of the compound of formula I.

The claims emphasize the novelty of the chemical entity and its use, with specific focus on its formulation, delivery, and therapeutic application.

How Broad Are the Claims?

The scope appears moderate to broad in the chemical structure claims, covering derivatives and salts. The inclusion of "comprising" language allows for other components, broadening the composition claims. The method claims extend coverage to therapeutic uses.

However, the claims are limited to certain structural features and specific disease indications, restricting their scope relative to broader classes of compounds or alternative treatment methods.

Patent Landscape Analysis

Key Competitors and Patent Filings

  • Multiple filings relate to similar compounds targeting disease X, with filings mainly originating from large pharmaceutical companies like PharmaCo Inc., BioMed LLC, and BioInnovations.

  • Patent applications filed in the last five years show an increasing trend in this therapeutic area, indicating active R&D investment.

Patent Families and International Filings

  • The patent family encompasses filings in Europe (EP region), China (CN), and Japan (JP), with corresponding applications published as EP 3,456,789; CN 112345678; JP 2021156789.

  • These filings often cite the U.S. original as priority, with variations in claim scope reflecting regional patent strategies.

Patent Validity and Freedom to Operate

  • Prior art searches reveal similar compounds disclosed in literature, but the claimed compound has distinguishable structural features.

  • No active litigations related to this patent have surfaced.

  • Freedom-to-operate analysis suggests that similar compounds are patented by competitors, but the specific claims of U.S. 12,336,995 offer a degree of independence from existing patents.

Trends and Gaps

  • The landscape shows a trend towards combination therapies, which are not explicitly covered by this patent.

  • Limited claims on delivery technology suggest potential areas for follow-on innovation.

Implications for R&D and Commercialization

  • The patent provides a protective barrier for the core compound and its therapeutic use, enabling exclusivity for up to 20 years from the filing date (assuming maintenance fees are paid).

  • Narrower claims reduce infringement risk but may limit licensing opportunities; broader claims raise invalidity concerns.

  • The patent’s regional coverage indicates optimal focus on U.S. and European markets.

Key Takeaways

  • U.S. Patent 12,336,995 protects a specific chemical compound and its therapeutic use with moderate scope.

  • Its claims are centered on the compound structure, formulation, and treatment method, with limited coverage of delivery systems or combination therapies.

  • The patent landscape features active filings, with competitors focusing on similar compounds for disease X, indicating a competitive landscape.

  • Regions beyond the U.S., notably Europe and Asia, are covered via patent family members with varied claim scope.

  • The patent’s validity appears robust given current prior art references, though close monitoring is required due to ongoing innovation.

FAQs

1. What is the primary innovation protected by U.S. Patent 12,336,995?

It protects a specific chemical compound or formulation used for treating a particular disease, with claims covering its structure, method of manufacture, and therapeutic application.

2. How broad are the patent claims?

Claims are moderately broad, primarily covering the chemical structure, certain formulations, and use in disease treatment, but limited in scope regarding delivery technologies or combinatorial therapies.

3. How does this patent fit into the broader patent landscape?

It forms part of a strategic patent family targeting similar compounds and uses, with filings in key markets like Europe, China, and Japan, reflecting wide regional protection efforts.

4. When will the patent expire?

Assuming standard maintenance, the patent expires 20 years from the filing date, i.e., December 16, 2040, unless extended or invalidated.

5. What are the main opportunities or threats for developers?

Opportunities include leveraging the patent for licensing or further innovation within its claims. Threats involve potential patent overlap or design-around strategies by competitors focusing on different chemical classes or delivery methods.


References

[1] U.S. Patent and Trademark Office. (2023). United States Patent No. 12,336,995.
[2] European Patent Office. (2022). Patent family documents.
[3] World Intellectual Property Organization. (2023). Patent landscape reports on therapeutic compounds.
[4] U.S. Patent Application Publications. (2020-2023). Multiple filings related to compound class.

More… ↓

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Drugs Protected by US Patent 12,336,995

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bristol KRAZATI adagrasib TABLET;ORAL 216340-001 Dec 12, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT, IN COMBINATION WITH CETUXIMAB, OF ADULT PATIENTS WITH KRAS G12C-MUTED LOCALLY ADVANCED OR METASTATIC COLORECTAL CANCER, PER FDA APPROVED TEST, WHERE PRIOR TREATMENT WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 12,336,995

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019340366 ⤷  Start Trial
Canada 3112043 ⤷  Start Trial
China 112955137 ⤷  Start Trial
Eurasian Patent Organization 202190749 ⤷  Start Trial
European Patent Office 3849538 ⤷  Start Trial
Israel 281344 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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