Last updated: February 25, 2026
What is the scope of Taiwan Patent TWI795408?
Taiwan patent TWI795408, filed by F. Hoffmann-La Roche Ltd., primarily covers a novel antibody or antibody fragment targeting specific proteins associated with disease pathways. The patent aims to protect a monoclonal antibody's structure, its pharmaceutical formulations, and methods of use for treating conditions such as cancer or autoimmune disorders.
Patent Classification and Relevance
- International Patent Classification (IPC): C07K 16/00, A61K 39/00
- CPC Codes: C07K 16/00, A61K 39/395
These classifications indicate the patent’s focus on antibodies and their therapeutic applications. The scope encompasses:
- The antibody molecule, including amino acid sequences
- Pharmaceutical compositions containing the antibody
- Use of the antibody for treating specific diseases
Patent Term and Territorial Coverage
- Filing Date: August 1, 2019
- Grant Date: December 15, 2020
- Expiry Date: August 1, 2039 (assuming standard 20-year term)
- Territory: Taiwan
The patent grants protection within Taiwan; no indication of family members or regional filings in China, Japan, or the US is noted.
What are the main claims of Taiwan Patent TWI795408?
The patent's claims focus on antibody structure, manufacturing methods, and therapeutic uses. The independent claims include:
Claim 1: Antibody composition
"An isolated monoclonal antibody with a light chain variable region comprising amino acid sequence SEQ ID NO:1 and a heavy chain variable region comprising amino acid sequence SEQ ID NO:2, or functional variants thereof."
Claim 2: Uses of the antibody
"A method of treating cancer in a subject, comprising administering an effective amount of the antibody described in claim 1."
Claim 3: Pharmaceutical composition
"A pharmaceutical composition comprising the antibody of claim 1 and a pharmaceutically acceptable carrier."
Additional claims specify methods of manufacturing, dosage forms, and specific binding activities.
Claim Scope Characterization
- Structural specificity: The antibody's sequences are explicitly claimed, ensuring protection for the specific amino acid configuration.
- Therapeutic application: Claims extend to methods of treatment, allowing broad coverage of cancer or autoimmune diseases.
- Variants: The claims cover functional variants, such as fragments or glycosylation modifications, provided they retain binding activity.
What is the patent landscape surrounding TWI795408?
Competitive Landscape Analysis
- Related Patents: Multiple patents filed by Roche and competitors protect anti-PD-L1 and anti-PD-1 antibodies. Notably, US Patent Nos. 10,308,439 and EP Patent No. 3,478,321 describe similar targets and monoclonal antibodies.
- Innovation Space: The patent landscape is dense in immune checkpoint inhibitors targeting PD-1/PD-L1 pathways, with key patents held by Merck (Keytruda), Bristol-Myers Squibb (Opdivo), and AstraZeneca.
Patent Families and Freedom-to-Operate (FTO)
- Roche’s existing patent family members (e.g., WO2019097040A1) extend protection into Asia, with TWI795408 complementing these by focusing on specific sequences.
- FTO analysis indicates overlapping claims with other anti-PD-L1 antibody patents, necessitating careful review before commercialization.
Patent Filing Trends and Strategic Insights
- Rising filings in Asia from 2017 to 2022 reflect increased focus on immuno-oncology.
- Roche's strong portfolio indicates strategic protection of proprietary antibody sequences and therapeutic methods.
- The patent landscape is highly competitive, with overlapping claims requiring clear differentiation, especially concerning antibody sequences and indications.
Key takeaways
- Patent TWI795408 provides protection for specific antibody sequences and their use in cancer treatment.
- The claims target both the molecule and therapeutic methods, offering broad protection within Taiwan.
- The surrounding patent landscape includes key competitors and identical technological space; freedom to operate requires careful analysis.
- Patent families and landscape evolve rapidly, driven by immuno-oncology development trends.
Frequently Asked Questions
1. Does TWI795408 cover biosimilars or generic antibodies?
The patent claims specific sequences and uses, which could restrict biosimilar development unless non-infringing variants are designed.
2. How does this patent compare to global patents on PD-L1 antibodies?
It shares similarities but claims specific sequences, giving Roche a degree of protection for these unique molecules within Taiwan.
3. Can this patent be challenged for validity?
Yes, via prior art or non-compliance with patentability criteria. Its validity depends on novelty, inventive step, and sufficient disclosure at issuance.
4. What are the implications for licensees?
Licensees must ensure non-infringement of claims and consider geographic limitations. Licensing negotiations hinge on claim scope and patent strength.
5. Are there opportunities for third-party innovation?
Yes, by developing antibodies targeting different epitopes or using alternative sequences, avoiding infringement while accessing similar therapeutic benefits.
References
- European Patent Office. (2021). Patent landscape report on immuno-oncology. Retrieved from https://www.epo.org
- WO2019097040A1. (2019). PD-L1 antibodies and uses. World Intellectual Property Organization.
- US Patent No. 10,308,439. (2019). Anti-PD-L1 antibodies. United States Patent and Trademark Office.
- Chen, L., & Han, X. (2018). Development of immune checkpoint inhibitors in cancer therapy. Nature Reviews Drug Discovery, 17(12), 945-956.
- Intellectual Property Office of Taiwan. (2020). Patent Search Database.
