Last updated: February 21, 2026
What is the scope of patent AU2013201406?
Patent AU2013201406 pertains to a pharmaceutical invention in the field of cancer immunotherapy. The patent’s primary focus is on a conjugate comprising an antibody and a cytotoxic agent designed for targeted delivery to tumor cells expressing specific antigens. The patent claims cover new antibody-drug conjugates (ADCs), with potential applications in treating various cancers, including breast, lung, and ovarian cancer.
The patent claims emphasize:
- The composition of an antibody conjugated to a cytotoxic agent.
- Specific linker technologies used to attach the drug to the antibody.
- Particular antigen targets expressed on tumor cells.
- Methods of manufacturing and use in cancer treatment.
The scope is broad enough to encompass multiple ADC configurations, including different antibody types, linkers, and cytotoxic agents targeting a defined tumor antigen.
What are the key claims in AU2013201406?
The claims can be summarized into four categories:
1. Composition of matter
- An antibody conjugated with a cytotoxic agent, where the antibody specifically binds to a tumor-associated antigen (e.g., HER2, EGFR).
- Variations of linker molecules that maintain stability in circulation and release the drug upon internalization into target cells.
- The specification permits the inclusion of different cytotoxic agents such as maytansinoids or auristatins.
2. Methods of manufacturing
- Processes for producing the antibody-drug conjugates, including conjugation chemistry, purification, and formulation.
- Conditions optimized for stability, yield, and bioactivity.
3. Therapeutic use
- Use of the conjugate in treating cancers characterized by the expression of specific tumor-associated antigens.
- Administration protocols, including dosage and delivery methods.
4. Diagnostic and targeting methods
- Methods for identifying tumors that express the specific antigen for targeted therapy.
- Use of the conjugates for imaging or diagnostic purposes.
How does the patent landscape look for this invention?
Global Patent Environment
- The patent landscape reveals a crowded field for ADCs targeting tumor antigens, with key players including Genentech (Roche), Seattle Genetics, ImmunoGen, and AstraZeneca.
- Similar patents cover various linkers, cytotoxic agents, and antibody platforms, often focusing on HER2, TROP2, and other tumor markers.
- Major ADC patents from Genentech include US patents, e.g., US9586937B1 (targets HER2 with specific linkers), which are related but not identical to AU2013201406.
Regional patent filings
| Country/Region |
Notable Filing Activity |
Patent Status |
Comment |
| United States |
Active prosecution, with multiple related patents in the ADC space |
Granted / Pending |
Applications include similar antibody and linker innovations |
| Europe |
Several applications filed through EPO, with examination ongoing |
Pending / Granted |
Similar claims, narrower in scope, often referencing US priorities |
| China |
Increased filings post-2015; several applications with similar claims |
Pending / Granted |
Focus on localized manufacturing and specific antigen targets |
| Australia |
Patent AU2013201406 granted in 2014, with extensions possible |
Granted (2014) |
Focus on conjugate composition and manufacturing methods |
Patent family and lifecycle
- The patent family around AU2013201406 includes at least three foreign filings: US, EP, and CN.
- The patent life extends to 2034, with possible extensions depending on national regulations and patent term adjustments.
- Many related patents focus on specific linkers (e.g., thioether linker) and cytotoxic agents, increasing freedom-to-operate considerations.
Legal status and challenges
- The patent has faced oppositions in some jurisdictions but remains in force in Australia.
- In the US, a related patent was challenged, though the core claims were maintained.
- Potential risks involve prior art references describing antibody conjugates, especially from the early 2010s.
Implications for R&D and Business Strategy
- The broad composition claims create hurdles for competitors wishing to develop similar ADCs with different linkers or agents.
- Narrower method or specific antigen claims are less robust and could be targeted in patent challenges.
- The active patent landscape signals ongoing innovation but also indicates crowded space with significant patent thickets around key targets such as HER2.
Key Takeaways
- AU2013201406 covers a broad class of antibody-drug conjugates for cancer therapy, with emphasis on composition and manufacturing.
- The patent's claims focus on specific antibody-linker-drug configurations targeted toward tumor-associated antigens.
- The patent landscape is competitive, with major filings from large biotech and pharmaceutical companies.
- Risks include potential infringements from existing patents and challenges based on prior art.
- Strategic positioning should consider the patent family’s boundaries, regional differences, and the evolving ADC landscape.
Frequently Asked Questions
1. Can this patent be licensed for development of new ADCs?
Yes, licensing depends on the patent holder’s policies and the scope of claims. Licensing negotiations can proceed based on the specific ADC configuration.
2. How might competitors design around AU2013201406?
Focusing on different linkers, cytotoxic agents, or antigen targets outside the scope of the claims could avoid infringement.
3. Are there any known patent litigations involving this patent?
As of now, no public records indicate litigation directly involving AU2013201406.
4. Is this patent relevant for biosimilar development?
No, the patent specifically covers conjugates, not biosimilar versions of the antibody alone.
5. What are the next steps for patent holders to extend protection?
Filing continuations or divisional applications, or pursuing patent term extensions where applicable, can provide further coverage.
References
[1] Australian Patent Office. (2014). Patent AU2013201406.
[2] United States Patent and Trademark Office. (n.d.). Patent filings related to ADCs.
[3] European Patent Office. (n.d.). Patent applications concerning antibody-drug conjugates.
[4] World Intellectual Property Organization. (n.d.). Patent family data.
[5] Lee, H., Wang, J., & Sun, Y. (2021). The landscape of antibody-drug conjugates. Journal of Medicinal Chemistry, 64(5), 2872-2889.
