Early Patentee Notification Proposal Submission

Written by Claude Haiku 4.5 from the extracted text on 27 Feb 2026. It can miss or misread redacted and scanned pages. Check the source before relying on it.

In November 2020, ACCC Chair Rod Sims submitted formal correspondence to the Department of Health opposing proposed amendments to the Therapeutic Goods Act contained in the Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020, Schedule 5. The proposed amendments would require generic and biosimilar manufacturers to notify patent originators of market entry approximately one year earlier than existing requirements. The ACCC argued the reform would delay or prevent generic and biosimilar market entry, reduce price competition, and maintain elevated medicine costs for both PBS and non-PBS products, ultimately harming consumers and the Commonwealth. The letter represents internal ACCC policy analysis and advocacy regarding pharmaceutical regulatory reform, with correspondence copied to Treasury officials.