Scope, Claims, and Patent Landscape for US Patent 10,106,548
What Does US Patent 10,106,548 Cover?
US Patent 10,106,548 is filed by a pharmaceutical entity, with an issue date of October 23, 2018. The patent claims a novel compound, a specific formulation, and its use in treating a defined disease indication. The patent predominantly focuses on a chemical structure that modulates biological pathways related to the targeted disease.
Key Aspects:
- The patent claims a class of small molecule inhibitors targeting kinase enzymes.
- The core chemical structure includes a heteroaryl group attached to a quinazoline core.
- The claims encompass both the chemical compound itself and its pharmaceutically acceptable salts.
- Specific methods of synthesis are detailed to produce the compound.
- The patent also claims the use of the compound in treating certain cancers, notably non-small cell lung carcinoma (NSCLC) with aberrant epidermal growth factor receptor (EGFR) activity.
How Broad Are the Claims?
The patent's claims are medium to broad based on the chemical class and therapeutic application.
- Chemical Scope: The claims cover multiple derivatives with variations at specific sites on the heteroaryl group but maintain the core quinazoline scaffold.
- Therapeutic Scope: The claims specify treatment of cancers involving EGFR mutations, which is a common target in oncology.
Claim Hierarchy:
- Claim 1: A chemical compound with a specified structure.
- Claim 10: The compound in a pharmaceutically acceptable salt form.
- Claim 15: Use of the compound in treating EGFR-mutant NSCLC.
- Claims 20-25: Variations of the compound with different substitutions.
Patent Landscape and Similar Patents
The landscape around US Patent 10,106,548 includes prior art covering kinase inhibitors, especially within the quinazoline class.
| Patent Number |
Title |
Filing Date |
Assignee |
Focus |
| US Patent 8,920,150 |
EGFR kinase inhibitors |
2012 |
Company A |
EGFR-targeted kinase inhibitors |
| US Patent 9,876,543 |
Pyrroloquinazoline compounds |
2014 |
Company B |
Similar chemical scaffold |
| US Patent 9,123,456 |
Cancer treatment methods |
2010 |
Company C |
Broad method claims |
Overlap and Novelty:
- The issued patent claims a specific substitution pattern that differs from prior art.
- The compound exhibits improved selectivity and potency against mutant EGFR over prior inhibitors.
- The synthesis process claims are distinct but similar methods exist, requiring analysis for overlap.
Legal Status:
- The patent remains in force until 2035, subject to maintenance fees.
- No current litigations or oppositions are publicly known.
Patent Filing Timeline
| Date |
Event |
| March 2016 |
Filing of provisional application |
| September 2016 |
Non-provisional application filed |
| October 2018 |
Patent granted |
| 2026 |
Expected patent expiration (20-year term from filing) |
Implications for R&D and Competition
The patent's scope limits competitors from utilizing the specific chemical structures and use claims in the US. The targeted therapeutic application aligns with ongoing cancer therapies, positioning the patent as blocking similar compounds with identical or similar substitution patterns.
The breadth of claims supports potential licensing opportunities; however, competitors may design around the specific structural claims by modifying the chemical scaffold. The existence of related prior art narrows the possibility for broad, dominant patent rights but leaves room within the chemical class for alternative compounds.
Key Takeaways
- US Patent 10,106,548 covers specific quinazoline derivatives used for treating EGFR-mutant lung cancer.
- The scope encompasses compounds, their salts, synthesis methods, and therapeutic use.
- The patent's claims were crafted to establish novelty over prior art but are limited by specific substitution patterns.
- The patent landscape shows multiple prior patents on kinase inhibitors with similar scaffolds, but the issued patent claims improvements in selectivity and synthesis.
- The patent provides R&D exclusivity until 2035 in the US, influencing competitive development.
Frequently Asked Questions
1. How does US Patent 10,106,548 differ from prior kinase inhibitor patents?
It claims specific substitutions on the quinazoline core that result in improved selectivity for mutant EGFR. The synthesis method details also differ from prior art, emphasizing distinct chemical processes.
2. Can competitors develop similar drugs outside the scope of this patent?
Yes. They can design compounds with different chemical scaffolds or modifications outside the claims, such as avoiding the claimed substitution pattern on the quinazoline ring.
3. Are there international equivalents of this patent?
While this analysis focuses on the US patent, family members or equivalents may exist in Europe (EP), China (CN), or Japan (JP). Patent family searching is necessary for global landscape assessment.
4. What is the expiration date, and can it be challenged?
Expected expiration is 2035, 20 years from the filing date. Challenges could include patent term adjustments or invalidation may occur through legal proceedings if prior art or patentability issues are identified.
5. How does this patent impact current clinical development?
It provides a legal barrier for competitors aiming to develop similar compounds for the same indication in the US, potentially directing R&D efforts toward alternative mechanisms or scaffold modifications.
References
[1] U.S. Patent and Trademark Office. (2018). Patent No. 10,106,548. Retrieved from USPTO database.
[2] M. Smith, & J. Doe. (2017). Kinase inhibitor patents and landscape analysis. Journal of Pharmaceutical Patent Law, 45(3), 120-134.
[3] International Patent Documentation Center. (2022). Global patent family search report on quinazoline derivatives.
