6.1 Concerns about gene patents may be divided into two broad categories. The first involves objections to gene patents on the basis that inventions involving genetic materials and technologies do not satisfy the requirements for patentability under Australian law. The second relates to concerns about the way in which gene patents are exploited, and the way in which inventions covered by such patents are commercialised.

6.2 This chapter and Chapter 7 address issues in the first category. This chapter considers the requirements for patentability and the application of each requirement to inventions involving genetic materials and technologies. Chapter 7 considers whether existing exclusions from patentable subject matter are applicable to any types of inventions involving genetic materials and technologies and whether the Patents Act 1990 (Cth) (Patents Act) should provide additional exclusions from patentability. Later chapters of this Report address concerns about the exploitation of gene patents.

6.3 To provide a context for the discussion in this chapter, it is instructive to understand the types of inventions claimed in gene patents. The following is a selected list of inventions involving genetic materials and technologies for which IP Australia has granted patent protection:

  • synthetic genetic or DNA sequences;

  • mutant forms and fragments of genetic sequences (including polymorphisms);

  • isolated or recombinant DNA coding for a sequence of a gene;

  • proteins expressed by a gene;

  • vectors containing a gene;

  • probes for a gene;

  • methods of transformation using a gene;

  • host cells, higher plants or animals carrying a gene; and

  • recombinant DNA methods—such as polymerase chain reaction (PCR) and novel expression systems.[1]

[1] IP Australia, Australian Patents for: Microorganisms; Cell Lines; Hybridomas; Related Biological Materials and their Use; & Genetically Manipulated Organisms, < specific/biotech.pdf> at 16 June 2004.