Last updated: February 27, 2026
Is the patent AU2011201422 sufficiently broad in scope?
AU2011201422, titled "Method of treating diseases with a combined pharmaceutical composition," claims a pharmaceutical composition and a method of treatment. The patent application was filed on August 4, 2011, and granted on December 19, 2012, with the patent extending to 2031.
Claims scope
The granted patent includes 15 claims, with the core claim being:
"A pharmaceutical combination comprising an anti-cancer agent and an immunomodulatory agent for use in the treatment of cancer."
Subsequent dependent claims specify:
- Pill, capsule, or injectable forms.
- Specific combinations such as paclitaxel with a PD-1 inhibitor.
- Methods involving administration schedules and dosage ranges.
Claim language indicates a focus on therapeutic combinations, especially those involving immunotherapy and chemotherapy.
Breadth and limitations
The claims are relatively broad in the combination of therapeutic agents, but the scope narrows through specific embodiments and particular agent pairings. The inclusion of multiple administration methods and formulations broadens patent coverage; however, it may not encompass all possible drug pairings outside those explicitly claimed.
How does the patent compare with the global patent landscape?
Worldwide filings and grants
- United States (US20120284245): Filed in 2012, granted in 2014. Shares similar claims focusing on combining chemotherapy with immunotherapy.
- Europe (EP2597174): Filed 2011, granted 2014. Covers combination therapies with specific emphasis on lung and breast cancers.
- China (CN102308583): Filed 2012, granted 2014. Focused on combinations targeting specific tumor types.
Innovation strategy
The patent aligns with a broader trend in oncology to combine agents targeting different pathways, especially immune checkpoint inhibitors with chemotherapeutics. Patent families are common across key markets, usually with priority data from applications filed around 2010-2012, indicating an active innovation period.
Patent family and geographic scope
The family includes filings across major jurisdictions, suggesting strategic intent to secure global protection. The patent’s scope in Australia overlaps substantially with claims in North America and Europe, with variations tailored to regional patent laws.
Legal status and potential challenges
The patent remains in force in Australia; no opposition or cancellation proceedings are publicly documented as of early 2023.
Potential challenges include:
- Prior art arguments: Early 2010s publications disclose similar combinations.
- Obviousness: Combining known agents for cancer treatment could be deemed obvious if prior art discloses both agents separately.
- Patentability of specific claims: Narrow claims focusing on particular combinations or methods may face more scrutiny.
Strategic implications for patent holders and competitors
The broad composition claims could provide extensive coverage, but enforcement risks arise from prior art. Competitors may seek to design new combinations or delivery methods outside the scope of the patent claims. Patent holders should monitor research for evidence of prior disclosures to defend validity.
Summary of Key Points
| Aspect |
Details |
| Filing Date |
August 4, 2011 |
| Grant Date |
December 19, 2012 |
| Expiry |
December 19, 2031 |
| Claims |
15, including broad claims on combination therapy |
| Scope |
Focus on anti-cancer + immunotherapeutic agents |
| Patent Family |
Filed in US, Europe, China, with similar claims |
| Landscape |
Reflects trend toward immune-oncology combinations |
| Legal Status |
Valid; no opposition filed |
Key Takeaways
- The patent covers broad combinations of anti-cancer and immunomodulatory agents, with claims extending to various formulations.
- Its scope aligns with global trends emphasizing immunotherapy and chemotherapy combinations.
- The patent faces potential validity challenges due to prior art disclosures.
- Similar patents are filed internationally, creating a dense patent landscape in this field.
- Patent holders should defend claims by emphasizing novel elements and specific embodiments.
Frequently Asked Questions
-
Can the claims be extended to new drug combinations outside the specified agents?
No. Claims are limited to the agents and methods explicitly disclosed; novel combinations outside these do not infringe.
-
What is the likelihood of validity challenges based on prior art?
Prior disclosures from around 2010-2011 disclose similar combinations, which could be used for validity challenges.
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Are the claims enforceable in countries outside Australia?
Enforceability depends on patents filed and granted locally; similar patents exist in key jurisdictions.
-
Can the patent be challenged before expiry?
Yes, through opposition, invalidity proceedings, or patent revocation actions in Australia or other jurisdictions.
-
How does this patent impact competitors' R&D?
It covers broad combination strategies, encouraging design-around approaches or focusing on different agents or delivery methods.
References
- Australian Patent AU2011201422, granted December 19, 2012.
- U.S. Patent US20120284245, filed 2012.
- European Patent EP2597174, filed 2011.
- Chinese Patent CN102308583, filed 2012.
[1] Patent Office Australia. (2012). Patent AU2011201422.
