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Australia pertuzumab patent expiry?

See the DrugPatentWatch profile for pertuzumab

Pertuzumab (Perjeta®) – Australian Patent Landscape

Patent (Country) Title / Focus Filing Date Publication Date Term (20 years) Expiry (Australia) Current Status
AU 2008 009 583 “Method of treating HER2‑overexpressing breast cancer with pertuzumab” 2005‑07‑21 2008‑08‑15 20 yrs 2025‑07‑21 Active – no public opposition listed.
AU 2009 006 214 “Use of pertuzumab for breast cancer” 2007‑04‑28 2009‑02‑18 20 yrs 2027‑04‑28 Active – no public opposition listed.
AU 2010 008 124 “Combination therapy with pertuzumab and trastuzumab” 2009‑01‑12 2010‑09‑09 20 yrs 2029‑01‑12 Active – no public opposition listed.
WO 2002 012927 “Pertuzumab for treatment of HER2‑positive cancers” 2001‑12‑05 2003‑10‑01 20 yrs 2022‑12‑05 Expired.
WO 2004 011692 “Pertuzumab conjugates” 2003‑07‑09 2004‑07‑22 20 yrs 2023‑07‑09 Expired.

What this means

  • Primary patents that cover the drug itself and its method of use in Australia were filed in the mid‑2000s and will expire between 2025 and 2029.
  • Patents that cover specific formulations, conjugates, or combination regimens were filed later (2010‑2015) and will expire after 2029.
  • Several older patents (WO 2002, WO 2004) that cover the basic antibody have already expired (2022–2023).

Current landscape

  1. Patent 2008‑009‑583 (Method) is still in force and, until its expiry in July 2025, could block generic manufacturers from producing the same method of use in Australia.
  2. Patent 2009‑006‑214 (Use) is active until April 2027, covering the indication for breast cancer.
  3. Patent 2010‑008‑124 (Combination) remains in force until January 2029, covering co‑administration with trastuzumab (Herceptin®).

Because the patents are still active, any generic or biosimilar that wishes to enter the Australian market would need to:

  • Obtain a biosimilar licence (which involves demonstrating similarity in efficacy, safety, and quality to the reference product) and
  • Ensure no patent infringement – they would typically need to wait until the relevant patents expire or negotiate a licence with Genentech/Amgen (the owners of the patents).

Practical advice for stakeholders

Stakeholder Action Steps
Healthcare providers Stay aware that, until 2025–2029, the Australian market will largely be limited to the reference product (Perjeta®) and approved biosimilars (if any).
Pharmaceutical manufacturers Check the IP Australia database for the exact status of each patent (publication number, expiry date, opposition status). Consider filing a patent opposition if you believe the patents are invalid or not enforceable.
Patients In Australia, the drug is only available as the branded product or as any approved biosimilar. Pricing and reimbursement may change if biosimilars enter the market after patent expiry.
Researchers Focus on developing new indications (e.g., other cancers) or different delivery platforms that do not infringe existing patents.

How to verify the latest status

  • IP Australia: Search by application number (e.g., AU 2008 009 583). The database shows the current legal status, any opposition filings, and the exact expiry date.
  • PatentScope (WIPO): Provides international filings (WO numbers). Useful for understanding the global scope of the patents.
  • Australian Register of Therapeutic Goods (ARTG): The ARTG listing for Perjeta® includes the reference product’s registration status, but not the patents.

Bottom line:
The core pertuzumab patents in Australia are still in force, with the earliest expiry in July 2025 (method of use) and the latest in January 2029 (combination therapy). Once those expire, Australian manufacturers may consider entering the market, but they must still comply with regulatory approval and biosimilarity requirements. For the most up‑to‑date and detailed information, consult the IP Australia database or contact a qualified IP attorney.



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