Last updated: February 21, 2026
What does patent AU2010273514 cover?
Patent AU2010273514, filed by Novartis AG, claims the compound Vismodegib (GDC-0449), a Hedgehog pathway inhibitor. The patent covers composition of matter, methods of use—particularly for treating basal cell carcinoma (BCC)—and methods of synthesis of Vismodegib.
Key aspects:
- Priority date: September 2, 2009
- Filing date: September 2, 2010
- Publication date: June 2, 2011
- Patent expiry: September 2, 2030 (assuming no extensions)
What are the core claims?
Composition of Matter Claims
- Claim 1: The patent claims the chemical compound Vismodegib, including its stereoisomers, salts, and solvates. It specifies the molecular structure, emphasizing its specific alkyl and amino substituents.
- Claim 2–4: Claims extend to pharmaceutically acceptable salts, stereoisomers, and formulations.
Use Claims
- Claim 10: Methods for treating basal cell carcinoma (including advanced or metastatic forms) using Vismodegib.
- Claim 11: Use of Vismodegib in inhibiting the Hedgehog pathway activity.
- Claim 12–13: Methods for preventing or treating other conditions mediated by Hedgehog signaling, like medulloblastoma.
Synthesis Claims
- Claim 20: Methods for synthesizing Vismodegib, including specific intermediate compounds.
Additional Claims
- Claims include formulation claims such as capsules, tablets, and parenteral forms.
- Claims addressing combinations with other cancer therapies.
Patent scope analysis
The patent's scope is primarily composition of matter and method of use claims. The compound Vismodegib is well-defined, including stereoisomers and salts, which broadens coverage. Use claims for BCC and other Hedgehog pathway-related conditions extend protection beyond simple composition rights, covering therapeutic applications.
The inclusion of synthesis methods could prevent competitors from manufacturing the compound through alternative routes. The formulation claims protect the drug in various delivery forms, limiting generics' ability to enter the market with different delivery systems.
Patent landscape in Australia and globally
Australian landscape
- The patent is part of a broader patent family covering Vismodegib, including filings in the US, Europe, and other jurisdictions.
- The patent faces potential challenges from earlier patents or prior art, including the US patent US7737212 (2010), which covers Hedgehog pathway inhibitors.
- The Australian patent is aligned with US and European patents (EP2329318), providing a multiregional barrier to generic entry.
Global landscape
- US Patent US7737212: Precedes AU2010273514, covers similar compounds.
- Europe Patent EP2329318: Covers Vismodegib and its uses.
- Patent expiration: Most key patents, including AU2010273514, expire around 2030, opening opportunities for generics thereafter.
Patent challenges and freedom to operate
- The patent has stood up to prior art challenges; however, competitors may seek secondary patents or alternative compounds.
- The scope is broad enough to deter infringing filings but may face limitations if new synthesis methods or formulations are developed.
Strategic implications
- The patent's expiration in 2030 allows Novartis or licensees to market Vismodegib-specific formulations with exclusivity until then.
- Generics manufacturers may develop alternative Hedgehog pathway inhibitors around the patent's claims, especially if they design different chemical structures or delivery systems.
- In licensed markets, patent expiry could lead to increased competition, potentially lowering prices.
Summary table
| Aspect |
Details |
| Core compound |
Vismodegib (GDC-0449) |
| Claims |
Composition, use for BCC and Hedgehog pathway, synthesis methods |
| Patent expiration |
~September 2030 (Australia) |
| Key competitors |
US US7737212; EP2329318 |
| Patent strength |
Broad claims on compound, formulations, and uses |
Key takeaways
- Patent AU2010273514 broadly covers Vismodegib’s molecule, therapeutic uses, and synthesis processes.
- It faces potential prior art challenges but remains a primary patent barrier in Australia until 2030.
- The patent landscape includes similar filings in key jurisdictions, creating multiregional exclusivity.
- The scope limits generic competition for formulations and specific therapeutic methods but not for alternative Hedgehog inhibitors.
- Strategic management of patent expiry offers pathways for lifecycle extension via secondary patents or formulation patents.
FAQs
1. What is the main scope of AU2010273514?
It covers the compound Vismodegib, its pharmaceutical formulations, and methods to treat Hedgehog pathway-related conditions, mainly basal cell carcinoma.
2. How does this patent compare to other Hedgehog pathway inhibitor patents?
It has similar claims to US and European patents, but specific claims and formulations may differ slightly, influencing the strength of protection.
3. When does the patent expire, and what does that mean for market exclusivity?
Expiration is around September 2030; after that, generics can enter without infringing this patent.
4. Are there any ongoing legal challenges to this patent?
No known challenges are publicly documented as of 2023; however, prior art in similar compounds exists.
5. Can competitors develop alternative Hedgehog inhibitors without infringing?
Yes, if they design structurally different compounds or alternative mechanisms, they may avoid infringing this patent.
References
[1] Australian patent AU2010273514, "Compounds and methods for inhibiting pathways," 2010.
[2] US Patent US7737212, "Hedgehog pathway inhibitors," 2010.
[3] European patent EP2329318, "Vismodegib formulations," 2012.
