Overview of submissions

6.7 Submissions and consultations expressed a range of concerns about the patentability of genetic materials and technologies, including:

  • general ethical objections;

  • the identification of a gene or other genetic material (such as a protein) is a ‘discovery’ not an ‘invention’;

  • genetic sequences and other genetic materials are not novel and should not be patentable;

  • the identification of a genetic sequence or other genetic material does not involve an inventive step;

  • gene patents may be granted over inventions even if the use of the invention is not yet known; and

  • gene patents contain broad claims and the disclosure in such patents does not justify the scope of the claims.

6.8 Chapters 3 and 7 discuss the objections to gene patents on the basis of ethical and social considerations. The other objections outlined above are considered in this chapter in the context of the relevant requirement for patentability.

6.9 Many submissions suggested that patent offices have not applied the requirements for patentability sufficiently stringently to inventions involving genetic materials and technologies.[4] In some cases, criticisms were directed to the patentability requirements generally. Other comments addressed specific options for reform proposed by the ALRC, but nevertheless raised issues that were relevant to other patentability requirements or to additional issues addressed in this chapter. The ALRC has cited these submissions in the context of the patentability requirement or issue to which they appear most related.

6.10 A number of submissions also expressed opinions about the specific types of inventions involving genetic materials and technologies that should be patentable, and those for which patent protection should not be available. For example, it was said that genetic sequences and proteins should not be patentable, but combinations of genes, recombinant proteins and processes for identifying such materials should be. These comments appear to be based on assumptions about the type of inventions that will prima facie fail to satisfy the criteria for patentability. Such an approach is contrary to the basic principle of patent law that each patent application (and the invention claimed in it) should be assessed independently to determine whether it satisfies the statutory requirements. However, to the extent possible, the ALRC has considered these comments in relation to particular patentability requirements.

[4] See, eg, Royal College of Pathologists of Australasia, Submission P26, 1 October 2003; GlaxoSmithKline, Submission P33, 10 October 2003; New South Wales Health Department, Submission P37, 17 October 2003; Walter and Eliza Hall Institute of Medical Research, Submission P39, 17 October 2003; Australian Health Ministers’ Advisory Council, Submission P49, 23 October 2003; South Australian Government, Submission P51, 30 October 2003; Human Genetics Society of Australasia, Submission P76, 16 April 2004; Commonwealth Department of Health and Ageing, Submission P79, 16 April 2004; Department of Health Western Australia, Submission P89, 16 April 2004; Sydney IVF Limited, Submission P98, 19 April 2004; Nuffield Council on Bioethics, Submission P102, 22 April 2004; National Health and Medical Research Council, Submission P107, 19 April 2004; New South Wales Health Department, Submission P112, 30 April 2004; Genetic Support Council WA (Inc), Submission P119, 13 May 2004.