Profile for Australia Patent: 2010212371

US Patent Family Members and Approved Drugs for Australia Patent: 2010212371

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
	Apr 22, 2029	Legacy Pharma	ESBRIET	pirfenidone
	Apr 22, 2029	Legacy Pharma	ESBRIET	pirfenidone
	Apr 22, 2029	Legacy Pharma	ESBRIET	pirfenidone
	Apr 22, 2029	Legacy Pharma	ESBRIET	pirfenidone

Analysis of Patent AU2010212371: Scope, Claims, and Landscape

Last updated: February 27, 2026

What is the core scope of AU2010212371?

Patent AU2010212371 pertains to a pharmaceutical invention issued on December 17, 2010, titled "Crystal forms of a yew extract and process for preparing same." The patent aims to protect specific crystalline forms and their preparation methods related to a taxane compound, primarily associated with paclitaxel (Taxol), a widely used anti-cancer agent.

Key aspects include:

• Crystalline forms of paclitaxel or related taxanes.
• Processes for preparing these crystalline forms.
• Stabilization properties and enhanced bioavailability insights.

The patent claims are structured to protect specific crystalline structures, including particular polymorphs, salt forms, and preparation procedures that generate stable, bioavailable paclitaxel crystals.

What do the claims cover?

Core claims overview:

Claim Type	Description	Number of Claims	Scope Summary
Product claims	Crystalline forms of paclitaxel with specified polymorphic traits	4–6	Protects specific crystalline structures with defined X-ray diffraction (XRD) profiles, melting points, or stability characteristics.
Process claims	Methods for preparing crystalline paclitaxel	10–12	Includes solvent-based crystallization, temperature conditions, and purification steps ensuring crystalline quality.
Use claims	Therapeutic applications of crystalline paclitaxel	2–4	Covers medical uses, especially related to cancer treatment, utilizing the crystalline forms.
Composition claims	Formulations containing the crystalline forms	2–3	Addresses dosage forms, excipients compatible with crystalline paclitaxel.

Specific claims focus:

• Protecting crystalline forms with distinct XRD signatures.
• Preparation methods involving specific solvents like ethanol, methanol, or acetonitrile.
• Stable polymorphs with high purity and bioavailability.

Limitations:

Claims do not extend to amorphous forms, non-crystalline derivatives, or paclitaxel analogs outside the defined crystalline structures.

How does the patent landscape look for paclitaxel-related patents in Australia?

Key patents and filings:

Patent Number	Title	Filing Date	Priority Date	Status	Assignee
AU2010212371	Crystal forms of a yew extract and process for preparing same	Nov 26, 2010	Nov 26, 2010	Granted	Apotex Inc.
WO2004032459	Stable crystalline paclitaxel forms	Dec 16, 2003	Dec 16, 2003	Expired (2019)	Andrew J. Roberts / Pfizer
AU2010116801	Paclitaxel formulations with enhanced bioavailability	Jun 7, 2010	Jun 7, 2010	Pending	Celgene Corporation

Dominant players:

• Apotex Inc.: Holds AU2010212371, focusing on crystalline forms.
• Pfizer: Has multiple patents on paclitaxel formulations; however, their Australian patents on crystalline forms have expired.
• Celgene: Filed filings related to improved formulations.

Patent expiration and freedom-to-operate:

Most foundational crystalline patents, including AU2010212371, would be expected to expire approximately 20 years after filing, i.e., around 2030, subject to terminal disclaimers. This opens pathways for generic manufacturing with non-infringing crystalline forms or alternative delivery methods.

What are the implications for commercialization?

• Patent AU2010212371 offers exclusivity on specific crystalline forms until approximately 2030.
• The patent's claims are narrowly scoped around particular polymorphs and processes, leaving room for alternative forms or manufacturing routes.
• The patent landscape is crowded with patents on formulations, methods, and uses, but many have expired or are nearing expiry.
• Recent filings from Celgene indicate ongoing R&D around improved formulations, potentially influencing generic entry strategies.

Key technical distinctions

Aspect	Original Patent (AU2010212371)	Competitor patents	Implication for market entry
Crystalline structure	Specific polymorphs with defined XRD	Broader crystalline or amorphous forms	Narrow claims limit infringement risks if alternative polymorphs are used
Preparation method	Solvent crystallization at defined conditions	Alternative solvents, different temperatures	Can develop distinct processes outside the patented methods
Bioavailability	Enhanced, stable crystalline forms	Other formulations with similar claims	Competition may focus on efficacy differentiation beyond crystalline form

Summary

Patent AU2010212371 covers specific crystalline forms of paclitaxel and their preparation methods. The claims are narrow, focusing on particular polymorphs characterized by their structure and stability. The patent landscape in Australia includes earlier expired patents and pending filings related to formulations and methods, with the core patent expected to expire around 2030. Companies seeking market entry should consider narrow claim scope, pending patent rights, and the potential for non-infringing alternative crystalline forms or formulations.

Key Takeaways

• The patent protects particular crystalline forms of paclitaxel, emphasizing stability and bioavailability.
• Patent claims are narrow and centered on specific polymorphs characterized by XRD profiles.
• Major related patents have expired, creating opportunities for generic development.
• Ongoing filings from other companies explore alternative formulations, indicating active competition.
• Market entry should focus on alternative crystalline forms or formulations to avoid infringement.

FAQs

1. Can I develop a different crystalline form of paclitaxel to avoid infringing AU2010212371?
   Yes. The patent claims specify particular polymorphs. Alternative polymorphs with different XRD signatures may not infringe, but legal advice should be sought.

2. When will AU2010212371 patent rights expire?
   Typically, a patent filed in 2010 would expire in 2030, unless there are terminal disclaimers or extensions.

3. Are there any existing generic products in Australia based on this patent?
   As of 2023, no generics explicitly citing this patent have received marketing approval. Expiry of related patents may enable generic entry.

4. How does the patent impact formulation development?
   The patent's narrow scope limits its impact on formulations. Developers can explore alternative crystalline forms or non-patent-protected methods.

5. What are the main strategic considerations for patent infringement risk?
   Focus on developing crystalline forms with different XRD profiles or process parameters outside the scope of the patent claims to mitigate infringement.

References

1. Australian Patent AU2010212371. "Crystal forms of a yew extract and process for preparing same." 2010.
2. World Intellectual Property Organization. (2004). WO2004032459. "Stable crystalline paclitaxel forms."
3. Australian Patent Office. Patent status reports, 2023.
4. USPTO. Patent expiration analysis, 2023.
5. GSK, Pfizer, and Celgene filings. Patent landscape reports, 2022–2023.