There are various mechanisms in the Patents Act to permit access to patented genetic inventions without the consent of the patent or licence holder. Part G examines the Crown use and compulsory licensing provisions.
Crown use provisions are an important mechanism through which government and its agencies may, in specific cases, address concerns that gene patents are hindering research or the provision of healthcare. Chapter 26 notes that these provisions are rarely used, but suggests that they constitute an important safeguard in helping to ensure that patent protection does not adversely affect significant public interests. The ALRC recommends that policies should be developed about the circumstances in which it is appropriate for government to invoke Crown use for the purposes of promoting human health.
Chapter 27 considers the compulsory licensing provisions of the Patents Act. Compulsory licences are another mechanism with potential to facilitate access to patented genetic materials and technologies for use in research and the provision of healthcare. However, few, if any, compulsory licences have been granted under Australian law. A court may grant a compulsory licence in limited circumstances if it is satisfied that the ‘reasonable requirements of the public’ with respect to the patented invention have not been satisfied; and the patent holder has not given a satisfactory reason for failing to exploit the patent. The ALRC recommends reforms to add a competition-based test to the grounds for awarding a licence, and to clarify the scope of the current test.