Australia Country Report

In 2004, the Australia Law Reform Commission (“ALRC”) published a report, titled Genes and Ingenuity: Gene Patenting and Human Health (the “ALRC Report”), on the impact of Australian patenting laws and practices on research and commercialization of genetic testing and cost-effective access to the Australian health care system. The ALRC Report was the result of an extensive investigation involving community consultation conducted over an eighteen month period. In additional to presenting the ALRC’s findings, the ALRC Report also offers recommendations based on their findings

Patent Rights and Genetic Patents in Australia

The Australian legal system grants two types of patents for inventions: “standard patents” and “innovation patents.” Standard patents are granted for term periods of 20 years and are considered “the basic form of patent protection for inventions” in Australia. On the other hand, innovation patents are “intended to provide protection for ‘lower-level’ inventions for which standard patent protection is not available” and are granted for term periods of 8 years. Similar to the U.S. patent law system, Australian patent holders are granted the exclusive rights to “make, hire, sell . . . offer to make, sell, hire, or otherwise dispose of [the invention], use, import, or keep it for the purpose of doing any of these things.” Upon grant of a patent, Australian holders have no obligation to use their exclusive rights, or license there invention to others for use. Notably, there is no current provision in Australian patent law for compulsory licensing, however, the ALRC notes in the Report that a compulsory licensing scheme could be created that models the country’s copyright compulsory licensing provisions.

The ALRC Report indicated that patents tend to be granted for: “isolated genetic material that has been separated from the human body or manufactured synthetically,” “methods or products used in testing for mutations in a gene or genetic sequence,” and “general methods for identifying genetic sequences, mutations, or deletions in an individual’s genetic sequence.” Importantly, the claims associated with isolated genetic material or diagnostic methods “may cover all uses of that material” and “often include diagnostic or predictive testing for genetic conditions.”

According to a genetics society , which maintains a register of genetic tests that the ALRC Report relies on, there are approximately 220 genetic tests available in Australia. These tests are conducted by 44 laboratories across the country. Of those 220, approximately thirty percent, or 60 of 220, were identified to be associated with patent rights.

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