Novelty

6.59 An Australian patent will only be granted for an invention that is ‘novel’. In other words, the invention must be new.^[92] The novelty of each claim in a patent application is assessed against the ‘prior art base’ that comprises publicly available ‘prior art information’ as it existed at the ‘priority date’ of the relevant patent claim.^[93]

6.60 The prior art base includes information that is made publicly available in a document or a related series of documents, or through doing an act or a related series of acts, as well as information contained in a published patent application that has an earlier priority date than the application under examination.^[94] Separate disclosures of an invention in more than one document, or by more than one act, will only be considered together if the relationship between the documents or the acts is such that a person skilled in the relevant art would treat them as a single source of information.^[95]

6.61 The test applied to determine whether an invention is novel is known as the ‘reverse infringement’ test.^[96] The prior art information must disclose all of the features of an invention—or all of the essential features—in clear, unequivocal and unmistakable terms in order for the invention at issue to lack novelty.

6.62 Whether or not a disclosure relating to an invention is ‘publicly available’ has been the subject of much judicial consideration.^[97] Public availability may exist even if the disclosure was limited to a small number of people;^[98] or was contained in a foreign language document that could be understood only by an expert in the field;^[99] or if a limited number of embodiments of the invention were distributed to members of the public on a non-confidential basis.^[100]

6.63 IP Australia has indicated that the novelty requirement will be satisfied in relation to inventions covering biological materials—including genes, genetic sequences and DNA—if the claimed invention is ‘new in the sense of not being previously publicly available’.^[101]

6.64 Patent laws in other jurisdictions express the novelty requirement in similar terms to the Patents Act.^[102] The assessment of the novelty of inventions involving genetic materials and technologies in these jurisdictions does not appear to have raised issues that are materially different from those that arise under Australian patent law.

Submissions and consultations

6.65 The ALRC received a range of submissions from participants in the research and healthcare sectors suggesting that isolated genetic materials, and genetic sequences in particular, are not novel.^[103] For example, the Royal College of Pathologists of Australasia (RCPA) submitted that:

Natural materials are only novel in the sense that they have not previously been discovered by humans. Natural DNA sequences are the result of over a billion years of evolution and exist independent of inventors.^[104]

6.66 However, other submissions considered that isolated genetic materials are capable of satisfying the novelty requirement for patentability, in the same manner as other naturally occurring products that have been isolated and purified, and do not raise any particular issues that might not be raised by inventions over other types of technologies.^[105] These submissions noted that genetic materials do not exist in nature in an isolated or purified form; and human intervention is required to achieve this. For example, GlaxoSmithKline submitted that:

Genetic material, or DNA, is simply a chemical compound. To the extent that it can be regarded as a natural product, obtained by isolating it from nature, there is ample precedent for patenting natural products … Furthermore, DNA which is the subject of patent claims is frequently claimed as cDNA (complementary DNA) which is a copy of the genomic DNA but lacking the interspersed intron sequences. cDNA does not occur naturally (except in rare cases where a gene is not interrupted by introns) and is novel for that reason alone.^[106]

6.67 Similarly, IP Australia submitted that:

In order to be acceptable, patent claims must not include within their scope anything which occurs already, either artificially or naturally. As a consequence, patents are not granted for genetic materials which already exist in the body of any living thing. The same principle applies to all chemical compounds which have been newly isolated from nature.^[107]

6.68 A few submissions specifically stated that the current test for novelty does not require reform.^[108] Dr Amanda McBratney and others commented that, as a result of amendments to the definition of prior art information in the Patents Act in 2001, Australia’s novelty requirements are comparable to those in the United States and Europe.^[109] They, therefore, considered that ‘no further upward adjustment to accommodate gene-related inventions is necessary’.^[110] McBratney and others also submitted that changes to IP Australia’s current approach in assessing the novelty of genetic materials and technologies are undesirable because they would represent a ‘departure from the internationally accepted approach’.^[111]

6.69 However, the Australian Centre for Intellectual Property in Agriculture (ACIPA) submitted that the Patents Act should be amended to raise the standard for novelty, but did not propose specific reforms in this regard.^[112]

ALRC’s views

6.70 Inventions involving genetic materials and technologies do not appear to raise any special issues regarding the application of the novelty requirement. Many submissions suggested that genetic materials in a pure and isolated form are not new because they are discoveries of pre-existing material. For the reasons considered earlier in this chapter, the ALRC is not persuaded that this approach should be adopted. The fact that genetic materials exist in nature in combination with other biological material does not mean that genetic materials are ‘previously available’, and therefore not novel, for the purposes of patent law.^[113]

6.71 However, if an invention involving genetic material has been previously disclosed or described in prior art information—for example through one of the available databases of gene sequence information—then the novelty requirement might not be satisfied. The novelty of genetic inventions can only be determined for each patent application on a case-by-case basis in light of the prior art and should not be based on a priori assumptions relating to the field of technology.