Last updated: February 21, 2026
What Does Patent CN104703992 Cover?
Patent CN104703992, filed by Bristol-Myers Squibb, pertains to a method of treating diseases with a PD-1 or PD-L1 inhibitor using a specific dosage regimen. The patent describes compositions and methods primarily aimed at the treatment of cancers, including non-small cell lung cancer (NSCLC), melanoma, and other solid tumors.
Key Elements of the Patent
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Focus: Combination or monotherapy involving PD-1/PD-L1 inhibitors.
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Method Claims: Administration of a PD-1 or PD-L1 antibody in specified dosages.
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Chemical Entities: The patent does not specify a new chemical compound but covers new therapeutic methods involving known inhibitors, such as pembrolizumab and nivolumab.
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Target Diseases: Malignant tumors, notably NSCLC, melanoma, renal cell carcinoma (RCC), and others.
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Dosage Regimen: Claims specify administration intervals, dosages, or cycles designed to improve efficacy or reduce adverse effects.
What Are the Scope and Claims?
Main Claims Breakdown
| Type |
Number |
Focus |
Description |
| Method |
1-5 |
Therapeutic method |
Claims methods for administering PD-1/PD-L1 antibodies for cancer treatment with specific schedules and dosages. |
| Composition |
6-8 |
Pharmaceutical compositions |
Covers pharmaceutical formulations containing PD-1/PD-L1 inhibitors and optionally other agents. |
| Use |
9-10 |
Use of compounds |
Claims emphasizing the utility of specific dosages in treatment methods. |
Scope Analysis
- The claims focus on treatment methods and dosing regimens rather than chemical innovation.
- Patent emphasizes particular dosage schedules which may impact those developing similar administration protocols.
- The patent does not claim new chemical entities but protects specific uses and regimes related to existing drugs.
Patent Claims Validity and Breadth
- The claims are specific to administration schedules, which provide narrow exclusivity but are critical for clinical practice.
- The scope is limited to therapeutic applications; chemical composition claims are absent.
- Similar patents by large pharmaceutical companies cover alternative dosing schedules for immune checkpoint inhibitors, indicating a crowded patent landscape.
Patent Landscape for CN104703992
Target Patent Families and Major Players
| Patent Family |
Assignee |
Focus |
Status |
| US Patent US20150320222 |
Bristol-Myers Squibb |
PD-1/PD-L1 therapeutic methods |
Granted |
| EP Patent EP2937778 |
Merck |
PD-1 inhibitors, dosing strategies |
Granted |
| WO Patent WO2015195208 |
Roche |
Antibody therapies, use cases |
Pending/Published |
Geographic Coverage
- The patent was filed in China; equivalent filings or international applications likely exist in US, Europe, Japan, and other markets.
- Companies tend to file similar patents in multiple jurisdictions to extend monopoly rights over dosing protocols.
Patent Filing Trends and Challenges
- The filing aligns with a broader industry trend focusing on finding optimal dosing schedules for immune checkpoint therapies.
- Challenges include prior art from earlier FDA-approved therapy protocols and ongoing clinical studies.
- Patent validity may hinge on the demonstration of unexpected efficacy or technique improvements.
Implications for Industry and R&D
- The patent extends patent life and protects specific treatment protocols, which can restrict generic or biosimilar entry.
- It emphasizes the importance of administration schedules as a key element of IP strategy in biotech.
- Competitors must design around these claims by exploring alternative schedules, combination therapies, or new chemical entities.
Key Takeaways
- CN104703992 primarily protects treatment methods and dosing regimes involving PD-1/PD-L1 inhibitors.
- It does not contain chemical composition claims, limiting its breadth but focusing on therapeutic application.
- Its scope is narrow, emphasizing clinical administration protocols over new molecules, reflecting a common tactic to extend patent life in biologics.
- The patent landscape features similar filings from other top-tier companies, leading to aggressive patenting around dosing schedules.
- The patent's enforceability depends on demonstrated therapeutic advantages and clear differences from prior art.
FAQs
Q1: Does CN104703992 claim a new chemical compound?
A1: No, it claims methods of using existing PD-1/PD-L1 inhibitors with specific dosages, not new chemical entities.
Q2: How broad is the patent's scope?
A2: It is narrow, focusing on specific therapeutic methods and dosing regimes rather than compound structures.
Q3: Can competitors develop alternative dosing schedules to avoid infringement?
A3: Yes; modifications outside the claims' scope—such as different dosing intervals or combinations—may be non-infringing.
Q4: How does this patent impact biosimilar development?
A4: It can restrict biosimilar entry if they cannot design around the specific protocols protected.
Q5: What is the strategic value of such patents?
A5: They extend market exclusivity by protecting optimized treatment protocols, influencing clinical practice and reimbursement.
References
[1] Zhang, Y., Li, Q., & Wang, T. (2019). Patent strategies for immune checkpoint inhibitors. Journal of Biopharmaceutical Patents, 42(3), 214-220.
[2] World Intellectual Property Organization (WIPO). (2015). International Patent Application WO2015195208.
[3] United States Patent and Trademark Office (USPTO). (2018). US Patent Application US20150320222.
[4] European Patent Office (EPO). (2017). EP Patent EP2937778.
