Inventive step

6.72 It has been suggested that inventions involving certain types of genetic materials and technologies, particularly genetic sequences, may not satisfy the requirement that claims in a patent must involve an inventive step.

6.73 A 2003 report produced by Professor William Cornish, Dr Margaret Llewelyn and Dr Michael Adcock for the United Kingdom Department of Health (UK Report) commented on the significance of the inventive step requirement in the context of inventions involving genetic materials and technologies:

Patent Offices now lay emphasis on the standard requirement of inventive step (non-obviousness) as the requirement which will do most to retain genetic patenting within acceptable bounds … With the growth of bioinformatics techniques to achieve automated comparison of gene functions between different species, it becomes increasingly difficult to characterise the work as anything other than routine.^[114]

Inventiveness requirement under Australian law

6.74 Patent protection will be granted in Australia only for novel inventions that involve an ‘inventive step’ (in the case of an application for a standard patent),^[115] or an ‘innovative step’ (in the case of an application for an innovation patent).^[116] The discussion below focuses on what is required to satisfy the inventive step requirement to obtain a standard patent.^[117]

6.75 Inventive step is defined in s 7 of the Patents Act and requires a determination of whether an invention would have been obvious to ‘a person skilled in the relevant art’. This assessment is made in light of the ‘common general knowledge’, as it existed in Australia before the priority date of the claim. It may also take into consideration prior art information before the priority date that a person skilled in the art could reasonably be expected to have ascertained, understood and regarded as relevant.^[118]

6.76 In 2002, the High Court considered the inventive step requirement in Aktiebolaget Hässel v Alphapharm Pty Ltd (Alphapharm).^[119] The majority of the Court held that, in assessing whether or not the inventive step requirement has been satisfied, the issue is whether a notional research group in the field ‘would have been led directly as a matter of course to pursue one avenue in the expectation that it might well produce the [claimed compound]’.^[120] The majority found that the results of a ‘routine literature search’ that have not entered into the common general knowledge are not relevant to an assessment of inventiveness.^[121] Further, the majority stated that:

The tracing of a course of action which was complex and detailed, as well as laborious, with a good deal of trial and error, with dead ends and the retracing of steps is not the taking of routine steps to which a hypothetical formulator was taken as a matter of course.^[122]

6.77 The Patents Amendment Act 2001 (Cth) introduced changes to the assessment of the inventive step requirement by allowing ‘mosaicing’ of prior art information during patent examination.^[123] Mosaicing allows a patent examiner to assess the inventive step in light of two or more pieces of prior art information in combination, provided that a person skilled in the relevant art could reasonably have been expected to combine such information.^[124] Prior to the amendment, patent examiners were only permitted to assess the inventive step in light of a single piece of prior art information, alone or combined with common general knowledge in the relevant art in Australia.

Application to genetic materials and technologies

6.78 In 1992, a report of the House of Representatives Standing Committee on Industry, Science and Technology suggested that it was ‘unlikely … that [genetic sequence] patents would pass the test of “non-obviousness” [that is, inventive step]’.^[125]

6.79 Some academic consideration of the inventive step requirement has expressed a similar view. Dr Charles Lawson has argued that the cloning and sequencing of a gene is unlikely to amount to an inventive step because once information about an amino acid sequence is known, the cloning of a gene is the obvious next step to a person skilled in the art of molecular biology, armed with the common general knowledge in the field.^[126]

6.80 To date, however, consideration of how the inventive step requirement applies to gene patent applications has primarily occurred at the Patent Office level, and the courts have had little opportunity to provide guidance on this issue.^[127]

6.81 The Manual indicates that patent examiners should adopt a ‘problem–solution’ approach to the requirement of inventive step.^[128] It instructs patent examiners to consider whether a claimed invention would fail to satisfy the test because ‘the solution would have been obvious to any person of ordinary skill in the art who set out to solve the problem’.^[129] Professor Andrew Christie and Melanie Howlett have stated that under this approach a patent claim will not be regarded as involving an inventive step if, ‘although the essential features of a claim have not been previously disclosed, the claimed features would be obvious to a person skilled in the particular art who set out to solve the problem and those features could be achieved as a matter of routine’.^[130]

6.82 A study by Christie and Howlett comparing the approaches of the Trilateral Patent Offices^[131] and IP Australia in assessing patent applications claiming partial DNA sequences, such as expressed sequence tags (ESTs), concluded that IP Australia’s approach to inventive step exhibited similarities with the approaches of the EPO and JPO.^[132] Christie and Howlett concluded that Australian patent examiners do not, as a general matter, consider that the ‘application of standard techniques and practice in the art to isolate and sequence a gene from the tissue of interest’ constitutes an inventive step, unless ‘the isolated sequence possesses an unexpected property that provides an advantageous effect’.^[133]

Inventiveness requirement in other jurisdictions

6.83 A report of the United Kingdom’s Nuffield Council on Bioethics (Nuffield Council) in 2002 considered that the technological advances in DNA sequencing may mean that isolating a genetic sequence can no longer be regarded as inventive, as it is a routine and industrialised process.^[134] In the Nuffield Council’s view, once a gene associated with a disease is identified, the use of the genetic sequence in gene therapy is obvious—particularly when such use is claimed on a purely speculative basis—and should seldom be protected by gene patents.^[135]

6.84 Under European patent law, the inventiveness requirement will not be satisfied by an invention involving isolated genetic sequences that have a structure closely related to existing sequences with a known function.^[136] The EPO has stated that ‘sequences as well as all other chemical compounds should solve a technical problem in a non-obvious manner to be recognised as inventive’.^[137] The EPO will regard a genetic invention as involving an inventive step only ‘if the applicant can demonstrate that obtaining the sequence was in fact a technical achievement or that they have discovered a new or unexpected property associated with the gene’.^[138]

6.85 In the United States, the requirement of inventive step (known there as ‘non-obviousness’) has been applied in a different manner to inventions involving genetic sequences. Under United States law, a claimed genetic sequence may not be obvious even if the prior art discloses both the structure of the protein for which the gene codes and the general methods for isolating a gene encoding a known protein.^[139]

6.86 In adopting this approach, the United States Court of Appeals for the Federal Circuit has stated that ‘the redundancy of the genetic code permits one to hypothesize an enormous number of DNA sequences coding for the protein’.^[140] The Court considered that, in the absence of prior art information suggesting a particular DNA sequence encoded the relevant protein, a person skilled in the relevant art could not know the structure of that sequence without conducting appropriate experiments.^[141] Further, the Court indicated that the existence of a general method of isolating genetic sequences is ‘essentially irrelevant’.^[142]

6.87 This approach means that the non-obviousness requirement under United States law may be easier to satisfy for inventions involving genetic sequences than in Europe. The Nuffield Council has criticised the United States approach as setting the threshold for inventiveness in relation to genetic inventions too low: ‘the outcome of any complex procedure which could not have been predicted in advance, however familiar the procedure, will be judged inventive’.^[143] Similarly, the United States National Research Council has criticised the Court of Appeals for the Federal Circuit for creating ‘a per se rule that the obviousness of obtaining the gene could never be relevant to patentability’.^[144] The National Research Council has encouraged the USPTO to assess the obviousness of such inventions according to the general test of whether the invention was obtained by a route that was obvious to try, coupled with a reasonable expectation of success.^[145]

Submissions and consultations

6.88 A number of submissions from healthcare and research sector organisations argued that the identification of genetic sequences or the linking of identified genetic sequences to a particular disease do not involve an inventive step.^[146] These submissions considered that the only inventiveness involved in an isolated genetic sequence, or its association with a particular biological function or dysfunction, is the method by which this information is derived. Given that sequencing techniques, linkage disequilibrium analysis, and gene mapping—among other techniques—are now well known in the genetics field, these submissions considered that the method by which the information is derived could not be inventive. A few submissions suggested that, although identification of genetic sequences may have had the required inventiveness in the past, this is no longer true.^[147]

6.89 The Department of Health and Ageing and ACIPA submitted that the standard for inventiveness under Australian law should be raised.^[148] The Department of Health and Ageing commented that the current test for inventiveness ‘places too much emphasis on the diligence and determination of the inventor’.^[149] ACIPA supported an approach to the inventive step requirement in line with that proposed by the United States Federal Trade Commission, namely, that the standard of a hypothetical person skilled in the relevant art should take greater account of the creativity and problem solving skills characteristic of such people.^[150]

6.90 Some submissions were also critical of the way IP Australia appears to apply the inventive step requirement to inventions involving genetic materials and technologies and, in particular, genetic sequences. The RCPA submitted:

The test for inventiveness … now rests entirely on whether the sequence of a particular gene was not obvious. The test will apply in most instances because the sequence of bases of an unknown gene cannot be known before it was isolated.^[151]

6.91 However, McBratney and others stated:

in light of High Court authority [in Alphapharm], it is not valid to judge the obviousness of an invention by the fact that the avenue of research was obvious to try. A fortiori, whether those methods were complicated or required little work will be irrelevant; it is the invention as claimed that matters. The ease with which sequences are generated with today’s technology should therefore not be seen as ipso facto depriving a new molecule of patentability.^[152]

6.92 The Centre for Law and Genetics commented that the amendments to the Patents Act in 2001 ‘significantly increased the stringency’ of the inventive step requirements’ and that further amendments are currently inappropriate.^[153]

6.93 Some submissions emphasised that whether a genetic invention represents an inventive step over the prior art can only be determined on a case-by-case basis. These submissions commented that determinations as to inventiveness should not be based on assumptions about the current state of the art in the field of technology to which the invention relates. For example, GlaxoSmithKline submitted:

Certainly, the issue of whether identification or isolation of genetic material today is inventive/innovative will be affected by advances in sequencing technology and may perhaps mean that it is more difficult to meet the relevant test. However, each case must be assessed on its merits and while the way in which an invention was made is a relevant consideration for the assessment of inventive step, it is not the only or the determinative one: what is important is what the patent contributes over the prior art, not how the invention was made.^[154]

6.94 IP Australia indicated that, as a matter of practice, few gene patents are associated with processes for isolating genetic material and identifying genetic sequences, and that only a small number of gene patents are now granted on the basis that the means of identifying and isolating genetic material was inventive. IP Australia submitted:

the inventive or innovative step of most granted patents is now associated with what can be achieved by using the isolated and identified genetic material. There continues to be innovation in the purpose for which a given polynucleotide can be put. The employment of a standard process of isolating genetic material does not automatically render unpatentable an application directed to a use of the genetic material. Similarly, isolating and identifying any type of chemical compound through standard techniques does necessarily render unpatentable an application directed to the use of the compound. Hence, patents continue to be granted by IP Australia and the major IP offices for genes and parts thereof, on the basis that the applicant has inventively or innovatively determined a useful property associated with the gene or part thereof.^[155]

ALRC’s views

6.95 Some submissions to the Inquiry revealed a concern that the inventive step requirement is not sufficiently stringent, at least with respect to genetic materials and technologies.^[156] However, the ALRC does not consider that any changes are currently required to the inventive step or innovative step requirement in the Patents Act, nor to how those requirements are applied by IP Australia to inventions involving genetic materials and technologies.

6.96 The ALRC agrees with those submissions that emphasised the importance of an inventive step analysis being conducted on a case-by-case basis, and of not relying on a priori assumptions about inventiveness based on the field of technology to which the claimed invention relates. It appears that IP Australia typically requires more than the identification and isolation of a genetic sequence to grant a gene patent, in line with the current state of the art in the genetics field. Recent changes to the definition of prior art information in the Patents Act will also allow patent examiners greater access to prior art material in assessing the inventiveness of a particular genetic invention claimed in a patent application. The evolution of searching and cross-referencing systems in electronic databases is likely to result in links between documents being more readily established and may, therefore, lead to a more expansive interpretation of the information that is relevant in assessing the inventiveness of a patent application.^[157]

6.97 To the extent that the concerns expressed in submissions relate to the stringency with which IP Australia applies the inventive step requirement to gene patent applications, the ALRC recommends reforms in other chapters of this Report. In particular, in Chapter 8 the ALRC recommends procedures to assist patent examiners in assessing gene patent applications, including enhancing the education and training of patent examiners in areas of technology relevant to their particular specialty, and developing examination guidelines relating to biotechnological inventions.^[158]