Biotechnology & Pharmaceutical Law

Stephens Lawyers & Consultants has been working with emerging and established biotech, pharmaceutical and complimentary medicine companies and research institutes for over 20 years – assisting them to navigate the complex regulatory regime.

In Australia, clinical trials and the import, export, manufacture and supply of therapeutic goods (such as medicines, medical devices and complimentary medicines and nutritional supplements) are regulated under the Therapeutic Goods Act. The laws are complex. In some cases, foods, cosmetics and other products may also be “therapeutic goods” requiring approval of the regulator, the Therapeutic Goods Administration, and compliance with the Therapeutic Goods Act and Therapeutic Goods Advertising Code and the Australian Consumer Law.

Intellectual Property associated with biotech, pharmaceutical, health and medical products requires ongoing protection to maximise returns. Stephens Lawyers & Consultants develops and implements strategies for intellectual property protection and commercialisation through patents, copyright, confidential information/trade secrets and commercial agreements.

Stephens Lawyers & Consultants’ extensive litigation practice enables us to represent individuals and companies in cases involving patent, copyright and trade mark infringement claims and disputes involving the ownership of intellectual property and unauthorised use or disclosure of confidential information/trade secrets.

Advertising of Health Services – New Advertising Guidelines – Is your advertising compliant? (July 2023)

Directors’ and Officers’ Liability for breaches of the Australian Therapeutic Goods Act (Legal Update – October 2022)

Advertising of Therapeutic Goods in Australia – Are your advertising campaigns compliant?   (Legal Update – 11 October 2022)

Therapeutic Goods Regulation and Advertising Compliance

Intellectual Property Commercialisation – Therapeutic Goods

Intellectual Property & Patent Litigation – Therapeutic Goods

Clinical Trial Compliance