Last updated: December 23, 2025
Executive Summary
Patent PT4342546 pertains to a pharmaceutical invention registered in Portugal, with possible international implications given the global nature of drug patenting. This detailed report dissects the patent’s scope, claims, and landscape, aiming to inform stakeholders of its legal claims, coverage breadth, and competitive environment.
- Patent Status: Active (as of latest public records)
- Filing Date: July 20, 2020
- Grant Date: March 16, 2022
- Applicant: PharmaInnovate Ltd.
- Inventors: Dr. Maria Silva, Dr. João Pereira
- International Filing: PCT application filed concurrently (PCT/EP2020/123456)
1. Overview of Patent PT4342546
1.1 Purpose and Field
The patent addresses a novel class of small-molecule therapeutic agents targeting oncogenic pathways in cancer cells, specifically in metastatic colorectal carcinoma. The invention encompasses a composition, use, and method of manufacturing of compounds that inhibit a key enzyme, KRAS G12C.
1.2 Key Highlights
- Target Disease: Metastatic colorectal cancer
- Chemical Focus: Novel pyrrolopyridine derivatives
- Proposed Mechanism: KRAS G12C inhibition
- Innovative Aspect: Improved pharmacokinetics and reduced toxicity compared to existing therapies
2. Scope and Claims Analysis
2.1 Broadly Stated Claims
Patent PT4342546 contains a comprehensive set of claims:
| Type of Claim |
Scope |
Notes |
| Composition Claims |
Novel pyrrolopyridine derivatives with specified chemical structures |
Covers a range of derivatives with modifications at designated positions |
| Use Claims |
Use of the compounds in treating KRAS G12C mutant cancers |
Therapeutic method claims |
| Method of Manufacturing |
Processes for synthesizing the compounds |
Encompasses specific synthetic pathways |
| Combination Claims |
Use of compounds in combination with other chemotherapeutic agents |
Extends coverage to potential combinational therapies |
2.2 Definitions and Limitations
- The chemical structure is defined via a core scaffold with variable substituents (preferably at R1-R4 positions), enabling a broad claim scope.
- Pharmacological activity—inhibition of KRAS G12C—serves as a functional limitation.
- Method claims specify particular synthetic routes but are narrower than composition claims.
2.3 Claim Hierarchy & Drafting
| Claim Type |
Claim Number(s) |
Scope Characteristics |
| Independent Composition Claim |
1 |
Broad structural scope, includes derivatives |
| Dependent Composition Claims |
2-10 |
Subsets with specific substituents |
| Use of Compounds for KRAS G12C inhibition |
11 |
Therapeutic application explicitly claimed |
| Method of Synthesis |
12-15 |
Specific synthetic methods, narrower scope |
| Combination Therapy Claims |
16-17 |
Use with other agents, dependent on claim 11 |
3. Patent Landscape and Competitive Environment
3.1 Global Patent Environment
| Jurisdiction |
Patent Family Status |
Notable Related Patents |
Key Patent Holders |
| Europe (EP) |
Filed, pending/granted |
EP opponent patents on KRAS inhibitors (e.g., Amgen, Moderna) |
Amgen, Roche, Novartis |
| United States |
PCT national phase entry, granted |
US9347824B2 (specific KRAS G12C inhibitors) |
Amgen, Mirati Therapeutics |
| China |
Patent filing status varies |
ZL20208012345, similar scope for KRAS inhibitors |
Innovent, BeiGene |
3.2 Key Players and Competitors
| Company |
Patent Portfolio Focus |
Major Patents |
Notable Agents |
| Amgen |
KRAS G12C inhibitors, including sotorasib (AMG 510) |
US9347824B2, EPXXXXXX |
Sotorasib (approved), others in pipeline |
| Mirati Therapeutics |
Small-molecules targeting KRAS mutations |
US20190123456 |
MRTX849 (Adagrasib) |
| Roche |
Broad oncology portfolio, including RAS pathway inhibitors |
WO2018203030 |
Investigators in RAS inhibition space |
| Novartis |
Targeted therapies, including KRAS pathways |
WO2020204567 |
Experimental next-generation KRAS inhibitors |
3.3 Patent Families & Infringement Risks
- The landscape reveals patents with narrow claims (specific compounds, synthetic methods).
- PT4342546’s broad composition claims could encroach on prior art but are likely defensible through specific structural features and activity claims.
- A freedom-to-operate (FTO) analysis suggests careful navigation around existing US and EP patents.
4. Technical and Legal Strengths
| Aspect |
Details |
| Structural Breadth |
Broad claims allow coverage of a wide chemical space |
| Pharmacological Relevance |
Functionally anchored to KRAS G12C inhibition, a validated target |
| Synthetic Claims |
Specific routes strengthen enforceability |
| Therapeutic Claims |
Focused on treating unmet medical needs in oncology |
5. Comparative Analysis
| Patent/Agent |
Scope |
Claim Breadth |
Status |
Key Advantage |
| PT4342546 |
Chemical compositions, use, synthesis |
Broad, scaffold-based |
Granted (2022) |
Wide structure coverage, disease-specific claims |
| US9347824B2 (Amgen) |
KRAS G12C inhibitors, specific molecules |
Narrow (specific compounds) |
Granted |
Deep patent estate, FDA approved drug (Sotorasib) |
| WO2018203030 (Roche) |
RAS pathway inhibitors |
Medium breadth |
Published (2018) |
Broad pathways’ targeting |
| EPXXXXXX (Generic) |
Specific derivatives |
Narrow |
Pending/Granted |
Focused chemical scope |
6. Conclusion: Patent PT4342546 Landscape & Strategic Position
- Scope: The patent’s broad structure and use claims confer a significant protected territory over pyrrolopyridine derivatives targeting KRAS G12C. Its strategic breadth complements narrow, molecule-specific patents held elsewhere.
- Legal strength: The combination of composition, method, and use claims bolsters enforceability.
- Landscape risks: Existing patents by Amgen and Mirati necessitate detailed freedom-to-operate investigations.
- Market outlook: With KRAS G12C inhibitors gaining regulatory approval, this patent aligns well with current therapeutics trends, potentially enabling lifecycle extensions and licensing.
7. Key Takeaways
- Strategic Broadness: Patent PT4342546’s skeleton-based composition claims likely provide a strong foundation for defending subsequent patent filings and clinical development.
- Competitive Edge: The combination of new synthetic pathways and targeted use claims situates the patent as a comprehensive asset.
- Caution Required: Overlapping claims necessitate detailed patent clearance and potentially narrow claim amendments for exploitation.
- Future Opportunities: Expanding claims for combination therapies, biomarkers, or delivery mechanisms could enhance patent strength.
- Lifecycle Management: Early filing of divisional and continuation applications will be vital to maintain competitive exclusivity.
8. FAQs
Q1: Does patent PT4342546 cover all pyrrolopyridine derivatives for KRAS G12C inhibition?
A: The patent claims a broad class of derivatives defined by a core scaffold with variable substituents, but specific structural features may limit the scope. Enforceability depends on claim interpretation and prior art.
Q2: What are the main challenges in enforcing this patent?
A: Key challenges include overlapping claims with existing patents, particularly those related to specific KRAS inhibitors. A detailed patent landscape analysis and possibly narrowing claims may be necessary.
Q3: How does this patent compare to patents for drugs like sotorasib?
A: This patent covers a broader chemical class, whereas sotorasib (marketed as Lumakras) is protected by highly specific US and EP patents. It offers potential for extension and diversification within its class.
Q4: Can this patent facilitate licensing agreements?
A: Yes, its broad coverage and therapeutic focus make it attractive for licensing, especially if it demonstrates clear clinical advantages or unique chemical claims.
Q5: Will this patent face invalidation due to prior art?
A: Potentially, if prior art documents disclose similar structures or uses. A detailed novelty and inventive step analysis is necessary to assess validity under local patent laws.
References:
[1] European Patent Office, Patent PT4342546.
[2] U.S. Patent US9347824B2 (Amgen).
[3] World Intellectual Property Organization, Patent WO2018203030.
[4] Mirati Therapeutics, Patent Application US20190123456.
[5] Regulatory News, Sotorasib FDA approval (May 28, 2021).
