Patenting genetic materials' unresolved issues and promoting competition in biotechnology

INFORMATION
ECONOMICSAND POLICY
www.elsevier.com/locate/econbase

Information Economics and Policy 16 (2004) 91–112

Patenting genetic materials� unresolved issuesand promoting competition in biotechnology

Charles Lawson *

Australian Center for Intellectual Property in Agriculture, School of Law,

Griffith University, Nathan, Qld 4111, Australia

Abstract

This paper addresses the broader unresolved issues posed by the patenting of genetic ma-

terials that are central to dealing with the tension between the patenting and competition

schemes, namely distinguishing between what has already been �discovered� and economically

useful innovations (including the thresholds for novelty and non-obviousness), the exclusion

of some subject matter from patenting and the restrictions on access to genetic resources to

facilitate further innovation. The possible solutions of raising the threshold patenting stan-

dards, taking advantage of international intellectual property law developments and com-

pulsory licensing are examined as ways to ameliorate the possibly detrimental consequences of

current genetic material patenting practices.

� 2003 Elsevier B.V. All rights reserved.

JEL classification: O31; O34; K21

Keywords: Patent; Genetic materials; Competition; Discovery; Non-obviousness; Access

1. Introduction

The increasing imperative in biotechnology to patent follows the dominant policy

view that the preferred intellectual property regime for commercialising biotech-

nologies based on genetic materials is the patent. This was founded on the �new�policy that government funded research was more likely to be taken up by private

* Tel.: +61-7387-53836; fax: +61-7387-55599.

E-mail address: [email protected] (C. Lawson).

0167-6245/$ - see front matter � 2003 Elsevier B.V. All rights reserved.

doi:10.1016/j.infoecopol.2003.09.006

mail to: [email protected]

92 C. Lawson / Information Economics and Policy 16 (2004) 91–112

commercial interests if it was not freely available, an expectation of economic growth

and competitiveness from new innovations and an apparent correlation between an

index of patent strength and real per-capita income. This imperative also coincided

with the developments in patent law that extended the subject matter of existing

patent laws to include genetic materials (including commodifying both the compo-

sitions and their applications). In Australia, governments have also embraced thepatenting of genetic materials as a key element in establishing a biotechnology in-

dustry with the potential to �deliver productivity, competitiveness and sustainable

benefits� (Commonwealth of Australia, 2000a).

The rights to patent genetic materials are now also entrenched through interna-

tional agreements that impose minimum standard patenting criteria. These devel-

opments reflect the increasing internationalisation of patenting and the new

initiatives to harmonise global patenting practices. The main agreements affecting

Australia are the World Trade Organisation�s (WTO) Trade Related Aspects of In-

tellectual Property Rights Agreement (TRIPs) that established a minimum standard

patenting scheme with application among WTO member states. This is compli-

mented with the Patent Co-operation Treaty that provides applicants with a sim-

plified procedure to initiate patent applications in a number of countries

simultaneously. The Convention on Biological Diversity (CBD) also introduced a

scheme for access to a nation�s genetic resources in exchange for benefit sharing,

including access to new technology. The significance of the CBD is probably a re-

quirement that nations giving access to their genetic resources in exchange for benefitsharing are obliged to recognize the minimum standard intellectual property rights

proscribed by TRIPs, including patents (see Lawson and Pickering, 2002; Lawson

and Downing, 2002). The Australian Patents Act 1990 complies with and is con-

sistent with the minimum standards required by TRIPs and the CBD�s proposed

access to genetic resources scheme.

Overlaying these regimes for patenting under the Patents Act there is an inherent

tension with the pro-competition laws set out in Australia under the Trade Practices

Act 1974:

�Patents are intended to stimulate . . . innovation by offering the possibility

of greater profits than could be obtained if open competition existed. But

the benefits gained from innovation fostered by the existence of the pat-ent system must be balanced against the costs to society caused by the re-

strictions which patents place upon the use of the invention to which they

relate. For while the purpose of the patent system is to provide an incen-

tive to innovation, patents also create entry barriers which prevent or re-

tard the diffusion of innovation by imitation; that is to say, a patent

confers a degree of monopoly power which has inherent anti-competitive

effects. It has both social benefits and social costs� (Commonwealth of

Australia, 1984).

This paper sets out to review some of the policy issues affecting this tension for

patented genetic materials, which are the raw materials for commercialising bio-

technologies. A recent review by Lawson (2002) examined the competition schemes

C. Lawson / Information Economics and Policy 16 (2004) 91–112 93

proposed by the Patents Act as it is applied to broad gene and gene sequence patents

and concluded that the Patent Office and the courts were reading down the

pro-competition principles enshrined in the Patents Act. An examination of the

co-existing competition scheme in the Trade Practices Act found a failure to apply

the Patents Act scheme was unlikely to be ameliorated, as it was the breadth of the

patent that effectively delimited the boundary of the patentee�s exclusion fromthe Trade Practices Act. This paper addresses the broader unresolved issues posed

by the patenting of genetic materials that are central to dealing with the tension

between the patenting and competition schemes. They are distinguishing between

what has already been �discovered� and economically useful innovation (including

the thresholds for novelty and non-obviousness), the exclusion of some subject

matter from patenting and the restrictions on access to genetic resources to facilitate

further innovation. The possible solutions of raising the threshold patenting stan-

dards, taking advantage of international developments and compulsory licensing areexamined as ways to ameliorate the possibly detrimental consequences of genetic

material patenting. The paper concludes that the pro-competition laws in both the

Patents Act and the Trade Practices Act need to be tailored and applied to ensure the

unresolved issues in patenting genetic materials are resolved in a way that promotes

innovation and restricts anti-competitive conduct by genetic material patent holders.

The paper is structured as follows:

• Part 2 reviews the existing laws applying to the patenting of genetic material

compositions and their applications in Australia. Examples are then set outto illustrate that there is a tension between patenting and competition – the

BRCA1 and BRCA2 genes associated with breast cancer and the Hepatitis

C virus diagnostic kits for blood testing. These examples illustrate broad claims

to genetic material compositions and some of the anti-competitive conse-

quences that result from these broad claims. These examples also show that

the tension between patenting and competition is not just theoretical.

• Part 3 considers the unresolved issues from extending traditional patenting

concepts to patenting genetic materials and considers these issues in the contextof their impacts on competition. The significance of these issues for competi-

tion is that setting the thresholds for the grant of a patent can, if it is too

low, exclude previously available information from the market and upset the

balance between fixing a market failure by promoting innovation and imposing

anti-competitive practices, and the high social costs associated with restricting

competition. This part also examines the renewed interest in excluding some

subject matter from patenting for broader policy reasons unrelated to compe-

tition (such as ethical considerations) and the ongoing international develop-ment of rules to establish access to the world�s genetic resources necessary

for further innovation.

• Part 4 considers the potential to develop new laws directed towards improving

the interaction between the Patents Act and pro-competition measures (such as

compulsory licenses) and, in particular, the flexibility in TRIPs to introduce

laws that promote social and economic welfare (including technological devel-

opment).


• Part 5 sets out the conclusions that the pro-competition laws in both the Patents

Act and the Trade Practices Act need to be tailored and applied to promote inno-

vation and restrict anti-competitive conduct by genetic material patent holders.

2. Patenting genetic materials

In Australia, a patent under the Patents Act grants the �exclusive rights, during theterm of the patent, to exploit the invention and to authorise another person to ex-

ploit the invention�. This is �personal property . . . capable of assignment and devo-

lution by law�. 1 The term �exploit�, for a product invention, includes �make, hire, sellor otherwise dispose of the product, offer to make, sell, hire or otherwise dispose of

it, use or import it, or keep it for the purpose of doing any of these things�. 2 For a

process invention, the term includes �use the method or process or do any act

mentioned [for the product invention] in respect of a product resulting from such

use�. 3 In competition terms, the �exclusive rights� addressing the market failure are

the period of time during which the innovator may exclude others in order to recover

the development costs, thereby contributing to beneficial innovation by rewarding

investment in new developments (with the added benefit of disclosure of theinnovation).

For patenting genetic material composition inventions (such as DNA, RNA and

polypeptide sequences), the Patent Office and courts set a very, very low threshold in

applying the legislated requirements of invention (see Lawson, 1999) and non-ob-

viousness (see Lawson and Pickering, 2000). A review of patenting criteria suggests

the Patent Office and courts are reading down the threshold patenting criteria in the

Patents Act that is unlikely to be ameliorated by the co-existing pro-competition

scheme in the Trade Practices Act (see Lawson, 2002). This suggests the patentee�s�exclusive rights� are being granted to a very wide range of products and processes for

very limited contributions to economically useful innovation.

The Federal Court has provided general guidance about the limits to patenting

genetic materials. In Genetics Institute Inc v Kirin-Amgen Inc (No. 3), 4 Justice

Heerey found a claim to DNA sequences from human and monkey erythropoietin

and the erythropoietin in other mammals was fairly based on the matter disclosed in

the specification. He applied a test of �whether the specification provided a real and

reasonably clear disclosure of the invention�. The specification disclosed theboundaries to the coding regions, intron/exon sites, protein sequence confirmation, a

full range of biological activity tests and 50 and 30 untranslated regions that described

a wide population of cDNAs. Therefore, he concluded the claims were valid, as a

skilled person would have relied on the information as disclosing the claimed human

1 Section 13.2 Schedule 1.3 Schedule 1.4 Genetics Institute Inc v Kirin-Amgen Inc (No. 3) (1998) 156 Australian Law Reports 30.


cDNA sequence, the claim to human and monkey erythropoietin genes and the

erythropoietin genes in other mammals. Justice Heerey quoted Lord Hoffman in the

House of Lords decision of Biogen:

5 Bio6 (197 IG8 Wi9 [19

�If the invention discloses a principle capable of general application, the

claims may be in correspondingly general terms. The patentee need not

show that he has proved its application in every individual instance.

On the other hand, if the claims include a number of discrete methods

or products, the patentee must enable the invention to be performed in

respect of each of them. . . .� 5

Subsequent Patent Office decisions reflect this same approach, although some

limits appear to be developing that have not yet been reviewed by the Federal Court

(see Lawson and Pickering, 2000).

The law relating to selection patents (and combination patents) referred to by the

Deputy Commissioner in Kirin-Amgen Inc v Board of Regents of the University of

Washington and Genetics Institute Inc 6 may have some limited application. Selection

patents may be granted where an invention applies only to a limited number of

members of a known class – the criteria for a selection patent are that the selectedmembers will provide some substantial advantage and all the selected members

possess the advantage. 7 Combination patents may be granted for a new combina-

tion of known components or integers that have some �substantial exercise of the

inventive faculty�. 8 The potential of these branches of patenting is presently unclear.

However, the legislative requirements are the same for all patents and selection and

combination patents are really an application of the usual rules to a particular style

of claim. Perhaps more importantly, once a composition itself has been claimed and

a new use is discovered for that composition, the new use may be patentable as aprocess. But, notwithstanding that the composition itself is patented, the right to

exclude the process patent holder from using that composition remains with the

original composition patent holder (United States Patent and Trademark Office,

2001). In these circumstances subsequent innovations will be dependent on the

original composition patent holder and any limits that might be placed over the use

of the composition.

Further, in Genetics Institute Inc v Johnson & Johnson 9 the broad claims to the

erythropoietin gene significantly limited a later claim to sequence in the regulatoryregions (50 and 30) of the gene affecting expression rates, stability and glycosylation

patterns, irrespective of the likely selection or combination potential of this newly

disclosed sequence. The claims to potential uses of the composition further limit the

potential of selections and combinations because the claim effectively discloses very

gen Inc v. Medeva plc (1996) 36 Intellectual Property Reports 438 at 455.

96) 33 Intellectual Property Reports 557.

Farben Industrie�s Patents (1930) 47 Reports of Patent Cases 289.

llman v Peterson (1904) 2 Commonwealth Law Reports 1.

96] Australian Patent Office 56 (19 November 1996).


broad uses of the sequence. Again, the result in Genetics Institute illustrates the

limited potential of selections and combinations to overcome a broadly claimed

patent over sequence applications, in this case including putting the sequence into

specific host cells and using specific promoters. Here the disclosure of �new� sequenceinformation (the flanking region of the gene) was discounted because there was no

function disclosed, even though the same sequence might be expected to satisfy thepatentability criteria had there been no accepted patent to related sequence (coding

region of the gene) based on a postulated function (such as regulation). In theory,

selection and combination patents may be the solution as suggested by the Deputy

Commissioner in Kirin-Amgen Inc v Board of Regents of the University of Wash-

ington. However, the later decisions show the very limited potential to restrict broad

claims because selections and combinations will have a very, very limited application

to what has already been �invented� and set out in the broad claim (see Lawson and

Pickering, 2000).Thus, as a generalization, the essential features of patents for genetic material

composition inventions (such as DNA, RNA and polypeptide sequence) are that

they �claim� a composition as a class of materials and a range of applications for that

class of compositions as the invention, and it is this �claimed� invention that sets the

limits of their enforceable �exclusive rights�. Significantly, the patent only needs to

disclose how to make and use a single embodiment of the invention, while claiming

broadly other embodiments without having to actually disclose how to make and use

these other embodiments. An abstract example illustrates the character of mostbroadly claimed genetic material composition inventions. Consider a broadly claim

invention disclosing the �invented� composition embodied as the letters NATURE

used as a journal name. Other undisclosed embodiments might include related se-

quences using these letters and their uses as journal names, such as related sequences

like TURN, RATE, UREA, NAT-words, TUR-words, and so on, as well as the uses

of those words in names, sentences, paragraphs, chapters, articles, books, and so on.

As a result of this patenting practice, broadly claimed patents can be enforced

against later inventors across a broad range or products, processes and uses, andpotentially give rise to considerable anti-competitive conduct.

Some recent examples of broad claims to genetic material compositions and the

resulting potential for anti-competitive conduct are illustrated by:

(a) One variant of the BRCA1 gene was isolated and patented in 1995 claiming the

isolated �normal� variant of the BRCA1 gene and various mutations together

with diagnostic tests for detecting other mutants and methods for screening tu-

mors. Myriad Genetics Inc thus owns the patent to the BRCA1 gene (and asserts

ownership over the BRCA2 gene; see Nuffield Council on Bioethics, 2002). Asthe patent holder, Myriad Genetics has started to notify other laboratories using

the genes to cease and send the samples to Myriad Genetics for testing (see gen-

erally Dorozynski, 2001). The test offered by Myriad Genetics costs US$2500,

while others are able to offer the same test for approximately US$680. Signifi-

cantly, Myriad Genetics broadly claimed patent covers both the composition

of the gene and all methods based on comparing a high risk individual�s sequenceto a known �normal� sequence described in the patent specification. The diagnos-


tic test based on the �normal� sequence misses about 10–20% of mutations. A res-

olution of the Members of the European Parliament warned that the patents

�could seriously impede or even completely prevent the further use of existing

cheaper and more effective tests for the breast cancer genes BRCA1 and BRCA2�(see Watson, 2001). These patents are now subject to challenge in Europe.

(b) The Murex Diagnostics Australia Pty Ltd v Chiron Corporation and Ortho Diag-

nostic Systems Inc 10 litigation in Australia involved a dispute between the Chir-

on Corporation and Murex Australia over a Hepatitis C diagnostic kit. The case

was eventually settled out of court and so did not provide a decision. In essence

the dispute involved Chiron�s broadly claimed diagnostic test (including the gene

and nucleotide sequence) for a Hepatitis C strain 1a and Murex Australia�s in-dependently developed diagnostic test for a range of other Hepatitis C strains

not detected by the Chiron test. The effect of a decision in favor of Chiron would

have been to prevent the Murex test being sold in Australia even though it was atest able to identify strains of Hepatitis C the Chiron test could not detect. The

Australian blood supply would have been less reliable as there would have been

no test to identify the Hepatitis C strains, other than 1a, such as the prevalent

strains 2, 3 and 5. The cost of unidentified Hepatitis C infection could be consid-

erable in terms of both the personal anguish of those infected and the costs to the

community through treatment, public health programs, and so on, following in-

fection (see Lawson, 1998).

3. Patenting genetic materials unresolved issues

The intention of the Patents Act and the Trade Practices Act is to promote eco-

nomic benefit by promoting economically useful innovation (the patent) and re-

stricting anti-competitive conduct (the restricted trade practices). The economically

useful innovation that the patent seeks to promote is only the innovations that would

not have been undertaken and that promote further competition for the benefit ofconsumers. This assumes that effective competition and good market information

create a disincentive to innovate (the market failure) as the copying of innovation

without contributing to the innovation costs (the free ride) hurts the innovator. Over

time, prerogative monopolies have been outlawed and patents of invention have

been refined to the basic elements of patentable subject matter (a manner of man-

ufacture) that is new, involves an inventive step (non-obvious), is useful and is de-

scribed in a way that can be followed by others. These measures seek to distinguish

economically useful innovations from other innovations.The expansion of patent law into the field of genetic materials has essentially left

three unresolved issues. Each of these unresolved issues poses significant problems

for competition and do not immediately crystallise in resolving disputes under the

10 Murex Diagnostics Australia Pty Ltd v Chiron Corporation and Ortho Diagnostic Systems Inc

(Federal Court, NG380/1996; Statement of Claim).


pro-competition measures of the Patents Act or Trade Practices Act (or its excep-

tions). The following analysis sets out the unresolved issues. Resolving these disputes

is necessary to ensure that the balance between promoting innovation with limited

restrictions on competition does not unnecessarily entrench anti-competitive prac-

tices to the detriment of consumers.

3.1. The already discovered and the economically useful innovation

A key concern is the boundaries of the patentee�s exclusive rights over the com-

position and its application thereby distinguishing one invention from another and

allowing economically weak potential competitors to enter the market (including

those who can substitute and imitate a patented product or process). For genetic

material compositions and applications under the Patents Act these are issues about

the threshold criteria for patentability – distinguishing discovery from invention andwhere the threshold for novelty and inventive step (non-obviousness) should be set.

Each of these is considered in turn, although the concepts may overlap.

3.1.1. Distinguishing discovery from invention

In theory, Australian law maintains a distinction between discoveries that are not

patentable and inventions that are patentable. This distinction has eroded over time

so that �[t]he truth is that the distinction between discovery and invention is not

precise enough to be other than misleading�. In assessing an alleged invention, it is

the whole product or process that must be considered and the inventor �need notshow more than one inventive step in the advance which he has made beyond the

prior limits of the relevant art�. 11

In practice the Patent Office have co-opted the developed patent law reasoning for

isolated biologically active substances and chemical compounds and applied this to

genetic material compositions and their applications. So, an isolated and purified

substance with an industrial use is said not to be a discovery, or product of nature,

because it does not exist in nature in that form. The Patent Office now accepts

anything as patentable subject matter so long as the subject matter �involves atechnical intervention of a technologist applying their inventive ingenuity to produce

something distinguishable from the natural source� (Commonwealth of Australia,

1998a,b). This patenting practice also includes any genetic materials isolated from

�nature�.The issue is that in �nature� the gene, protein or organism is discovered, while

outside that �nature� the same gene, protein or organism with the same function

becomes inventive. In the past the Patent Office maintained a more strict distinction

between discovery and invention. For example, in Ranks Hovis McDougall Ltd’sApplication 12 the Patent Office granted a patent for a pure cultured bacterium on the

basis that an inventive step had been applied to purify the naturally occurring

11 NRDC v Commissioner of Patents (1959) 102 Commonwealth Law Reports 252 at 263–264.12 Ranks Hovis McDougall Ltd�s Application (1976) 46 AOJP 3915.


organism by �producing the variant by some man-controlled microbiological pro-

cess�. Significantly, a patent was refused for the first isolation of the strain of the

naturally occurring bacteria. The effect of eroding the distinction between discovery

and invention is the commodification of genetic material compositions with very

limited contributions to innovation and potentially restricting the uses of the raw

genetic material composition itself by other innovators.In competition terms this is a fundamental issues because the exemption from

competition provided by the patents �exclusive rights� is only justifiable for eco-

nomically useful innovation. The commodification of the genetic composition es-

tablishes the patentee�s property rights (as exclusive rights) and excludes other

potential innovators using that commodified genetic material. The recent Intellectual

Property and Competition Review Committee (Commonwealth of Australia, 2000c)

analysis of patenting genetic materials restated the theoretical distinction between

discovery and invention. However, this does not assist in practically identifyingeconomically useful genetic material based innovation. Routine techniques used to

isolate and identify most genetic materials for which patents are then granted means

that the genetic material compositions and their broad applications (that often have

no substitute or imitation) are being excluded from competition (see for examples

Lawson, 2001; Lawson and Pickering, 2000).

3.1.2. The quantum of technical intervention

For the grant of the patent the invention must be new and not obvious. In effectthis is a comparison of the claimed invention against the existing advances in in-

novation (the prior art). Only those claims that involve enough of an advance and

that would not be obvious to a properly informed skilled worker in the art obtain the

patent�s �exclusive rights�. 13 The courts have grappled with how much innovation is

necessary with the early decisions showing some hesitations to accept isolated genetic

material composition as patentable inventions. The question is essentially a sub-

jective assessment of whether there has been enough invention to justify the patent,

although a legal test seeks to be objective, the cases illustrate the difficulty is inachieving this objectivity. This is significant in competition terms as a lax application

of these tests allows patent protection for knowledge previously accessible to the

market while a too stringent application removes the incentive to innovate and

correct the market failure.

The following examples illustrate the Patent Office�s approach to resolving this

issue and highlight the very low threshold for establishing novelty and inventive step

(non-obviousness):

A. In Synaptic Pharmaceutical Corporation v Astra Aktiebolag 14 a delegate of thePatent Commissioner considered whether dog cDNA clones (known as RDC4

and isolated using probes based on G protein-coupled receptors, including the

13 Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 Commonwealth Law Reports 228.14 Synaptic Pharmaceutical Corporation v Astra Aktiebolag [1998] Australian Patent Office 49 (9

September 1998).


5-HT1A receptor) used to identify a human 5-HT1D receptor gene by standard

techniques was obvious – that is, whether it was a routine cloning strategy to

screen for (human) DNA clones using an uncharacterised (dog) cDNA probe.

Before the 5-HT1D receptor gene was cloned a family of proteins called the 5-

HT receptors was known and some of the 5-HT1D receptor protein functions

had been characterised. Applying the Wellcome Foundation Limited v VR Labo-

ratories (Aust) Pty Ltd 15 obviousness test the delegate determined that despite

the isolation of the dog cDNA using a probe based on the 5-HT1A receptor, a

skilled worker without further characterising the dog cDNA would not have

been led to use this as a probe to isolate a human 5-HT1D receptor gene. There-

fore, the invention was not obvious. The decision was allegedly supported by a

view that the dog cDNA clone was only a �tentative� 5-HT receptor with confir-

matory functional studies necessary for validation, that a skilled worker intend-

ing to clone 5-HT receptors would have used probes based on known receptorsand that a skilled worker would not have used a partly characterised clone to

screen for a known gene. Evidence was presented about the routineness of the

subsequent cloning steps but these were not considered in this decision as the pre-

ceding probe choice was found to be not obvious and therefore there was no need

to consider this evidence.

However, the relatedness of this gene family in mammals (including humans

and dogs) was well known with multiple sequences for known G protein-coupled

receptors including the characterised human 5-HT1A and rat 5-HT1C receptors.The dog RDC4 gene was isolated as a prerequisite with 100% homologous oligo-

nucleotides. This gene had previously been identified using the polymerase chain

reaction and degenerate primers chosen from a compilation of known receptor

genes (including the 5-HT1A and 5-HT1C receptor genes) with high homology to

any known G protein-coupled receptors (especially at the 30 end and including

the human 5-HT1A and rat 5-HT1C receptors) and oriented to the 5-HT1A receptor

gene with the conclusion there was a very high homology between the isolated se-

quences and the previously reported sequences and that the dog RDC4 was clearlyrelated to the 5-HT1A receptor gene. A fragment (1.3 kb) of the RDC4 gene was

used to screen a genomic library (at high stringency, 40 �C and 50% formamide

and washed in 0.1� SSC at 50 �C) and a number of clones were identified which

were described as homologues of the RDC4 gene as well as a related but different

gene designated 5-HT1D. A cDNA corresponding to the 5-HT1D was also isolated

using an oligonucleotide probe derived from the dog RDC4 sequence. Therefore,

it seems Synaptic Pharmaceutical attempted to clone a gene which was highly ho-

mologous to the dog RDC4 gene which was known to have high homology with Gprotein-coupled receptor genes. There was also speculation in the scientific liter-

ature that the gene was a member of a seretonin receptor class because of its sim-

ilarity to the 5-HT1Agene and its difference from other genes (such as RDC7). This

suggests using the RDC4 gene as a probe for further seretonin receptors would be

15 (1980) 148 Commonwealth Law Reports 262.


worth trying as its homology under stringent hybridisation conditions would be

very likely to distinguish this class of seretonin receptors from other classes in a

highly homologous family of genes. Further, the scientific literature showed

(taught) the screening of libraries with a region of a G protein-coupled receptor

gene would identify further members of the family of genes including the different

classes and that a range of uncharacterised classes existed which required identi-fication and further characterisation. However, the delegate concluded:

16 [19

�Given that the probes used to isolate the RDC4 clone were based on the

5-HT1A receptor and that the RDC4 had a close amino acid sequencesimilarity to the 5-HT1A receptor, the skilled worker would have consid-

ered it, at least, possible that the RDC4 clone was the dog equivalent of

the known 5-HT1A receptor. Without further characterisation of the

RDC4 gene, the skilled worker did not recognise the importance of the

RDC4 and would not have been led to use this gene to isolate the human

5-HT1D receptor gene. As a result, the isolation of the human 5-HT1D re-

ceptor gene, and consequently all the claims, was not obvious at the pri-

ority date in the light of the disclosure in Libert�.

B. In Takeda Chemical Industries v Hoffman-La Roche Aktiengesellschaft 16 a dele-

gate of the Patent Commissioner concluded a range of well characterised protein

purification techniques, which would have been routine experimentation to a

skilled person when applied to the purification of the claimed protein, was notobvious. In finding a skilled worker could not have successfully applied the pu-

rification techniques without an inventive step the delegate said:

�[The opponent] . . . provided evidence of a range of well-known tech-niques available to the skilled worker. However, she did not suggest

any or all of these techniques would have been expected to successfully

purify the protein nor that the skilled worker would have been directly

led to try any particular techniques at the priority date which would pu-

rify the protein. In my opinion, it is not routine experimentation to try

each possible purification technique and combination of techniques to de-

vise a successful purification strategy. Since the opponent has not estab-

lished that the skilled worker would have selected particular techniquesfrom the myriad available to them, I am not convinced that the skilled

worker could have successfully purified recombinant non-glycosylated

human interleukin-2 without an inventive step�.

The protein purification, like manipulating DNA (and RNA), relies on combi-nations of well-established techniques many of them subject to available combina-

tions of techniques, the vagaries of materials suppliers in Australia, the availability

of equipment, and so on, and the preferences of individual skilled persons for par-

ticular techniques and their choice of a particular technique. These decisions suggest

96] Australian Patent Office 3 (18 January 1996).


that unless the party challenging the patent can establish the particular choices,

preferences, techniques, probes, and other details that a skilled worker would con-

sider, in the opinion of the Patent Office, then the particular strategy will very likely

be non-obvious. The task of an opponent is made even more difficult as the nature

and extent of evidence necessary to satisfy the Patent Office is very difficult to pre-

dict. For example, in this case the Patent Commissioner�s delegate even rejected theapplicant�s argument (the party defending its patent claim) that reverse phase HPLC

was the only essential element of the combination of techniques and found anion

exchange column chromatography, gel filtration column chromatography and re-

verse phase HPLC were all essential. Predicting this distinction and the weighting to

be given to particular choices would have been very difficult for any opponent and

shows that the threshold to establish non-obviousness is very easily satisfied by the

person making the patent claims.

While �a scintilla of inventiveness� may be all that is necessary, there must actuallybe some inventiveness. Unfortunately, in practice, this becomes an individual as-

sessment of the facts in the particular matter. The Patents Amendment Act 2001

expanded the prior art base definition to include acts and common general knowl-

edge, anywhere in the world which a person skilled in the art could have been rea-

sonably expected to find, understand and regard as relevant, and also allows for

different pieces of information to be combined in order to assess the prior art base

(Commonwealth of Australia, 2001b). These amendments bring Australian law into

line with the United States and Europe, and might be expected to limit some futureclaims through the publication of sequence data and the techniques used to identify,

isolate and use genetic materials. The Patents Amendment Act 2001 also introduced a

�balance of probabilities� test for the novelty and inventive step requirements rather

than giving the applicant the benefit of any doubt. While this measure promises to

raise the threshold, the practice is unlikely to affect the low threshold of non-obvi-

ousness findings of �fact� by the Patent Office. For example, in Tekada Chemical

Industries v Hoffman-La Roche Aktiengesellschaft 17 a Patent Office delegate even

rejected the patentee�s claim (defending the patent) that only one step in the se-quences of �well known and characterised processes� was essential. Evidence from the

opponent about the range of well-known techniques available to skilled workers,

including the purification of compounds very similar to the subject of the opposition

was rejected. Applying a �balance of probabilities� test to novelty and inventive step is

unlikely to have changed this outcome. Significantly, this conclusion is consistent

with the decision in Genetics Institute Inc v Kirin-Amgen Inc (No. 3). 18 In this case

the parties failed to argue that the �invented� erythropoietin gene was obvious even

though those skilled in the art had postulated that through recombinant DNAtechniques cell lines could be made to produce recombinant erythropoietin from a

gene.

17 [1996] Australian Patent Office 3 (18 January 1996).18 (1998) 156 Australian Law Reports 30.


In competition terms the apparently low threshold for the tests of novelty and

inventive step (non-obviousness) for genetic materials allows patent protection for

knowledge previously accessible to the market. The effect of this is to commodify

knowledge and compositions at the expense of competition, other innovators and to

the detriment of consumers.

3.2. Exclusions from patenting

There is an ongoing policy debate about the ownership of biological tissues, and

patenting is central to the debate. As Caufield et al. (1996) say:

19 (20

�As with the growth of genetic technology itself, the current legal and ad-

ministrative practice of simply applying the traditional patent law princi-

ples has progressed in a largely unchecked and ad hoc manner. Therefore,

a re-examination and clarification of these principles, and the effect of

their application, is clearly warranted. To this end, it is submitted that

any patent policy should consider a broad range of issues including, inter

alia: the purpose behind intellectual property regimes; the various mech-

anisms which could be used to modify the current system; the ramifica-tions of any policy on past and future patents; the influence of the

policy on research and industry; the legal loopholes which may under-

mine the implementation of any policy; and, perhaps most importantly,

how ethical and moral concerns can be addressed�.

The current Patents Act does make provision for an assessment of the broader

policy debates about patenting, albeit in language that it nearly 400 years old! In

applying the threshold requirements in the Patents Act there is a question of whether

the subject matter is excluded from patentability because it falls within the provisoset out in Section 6 of the Statute of Monopolies. That is, the �manner of manu-

facture� must not �be not contrary to the law or mischievous to the state by raising

prices of commodities at home, or hurt trade, or generally inconvenient�. The PatentOffice does not make this assessment and the courts have generally ignored the issue,

or accept the invention as a �manner of manufacture�, and suggested that it is for the

Parliament to articulate a contrary policy (see Lawson, 2002).

Interestingly, Chief Justice Black and Justice Lehane in Bristol-Myers Squibb v

FH Faulding & Co Ltd 19 warned that in excluding methods of medical treatmentfrom patentability there is the �insurmountable problem� to logically distinguish

between allowing a patentable product for treating humans while disallowing pat-

entability for a method of treatment. This approach highlights the likely tensions in

patenting genetic materials between ethics that �aspires to an ideal of optimum be-

havior and conduct� and law that represents a �basic minimum standard of human

behavior acceptable in society� (Fletcher and Wertz, 1990). How this is to be resolved

00) 97 Federal Court Reports 524.


for patenting genetic materials remains unclear, although this debate has gained new

significance with the Australian Law Reform Commission and Australian Health

Ethics Committee recently announcing a review of intellectual property rights over

genetic materials and genetic related technologies with a report due in June 2004.

The �ethical issues� debate is subject to ongoing political analysis with an uncertain

outcome as a result of the diverse cultural and other non-economic factors central tothe debate (although these might be limited in the predominant neo-liberal ethic

among the pro-patenting developed nations). In competition terms, excluding sub-

ject matter from patenting other than for reasons that promote competition and

innovation undermines the rubric that patenting corrects a market failure. Assuming

this is correct, innovation relying on genetic materials that have been excluded from

patenting will be discouraged because of the hurt caused by free riders, with the

consequent long term economic detriment from failed innovation opportunities. The

unfolding debate about access to patented pharmaceuticals by the developing na-tions should test the pro-competition credentials of patenting.

3.3. Access to genetic resources

The valuable genetic resources necessary for innovation are predominantly found

in developing nations that seek access to economic and technology benefits in ex-

change for access to their genetic resources. The rights to patent genetic materials are

now subject to regimes for access to the genetic resources of states with tied intel-

lectual property restrictions set out in the CBD (see Lawson and Pickering, 2002;

Stoianoff, 1998) (and also the International Treaty on Plant Genetic Resources for

Food and Agriculture). The CBD�s stated objective is �the conservation of biological

diversity, the sustainable use of its components and the fair and equitable sharing ofthe benefits arising out of the utilisation of genetic resources�. The CBD has also

reaffirmed a state�s sovereign rights over genetic materials within its jurisdiction and

leaves the regulation of access to each state. The Conference of Parties to the CBD

recently adopted guidelines on access to genetic resources and benefit sharing

(Conference of Parties, 2001; known as the Bonn Guidelines). In Australia, the

Environment Protection and Biodiversity Conservation Act enacted measures to

control access to �biological resources� in �Commonwealth areas� consistent with the

CBD�s access regime (and Bonn Guidelines), and regulations have been proposedthat introduce a contract-based access regime that deals with intellectual property

rights over the accessed resources as a part of the access contract (see Common-

wealth of Australia, 2000b; Lawson and Pickering, 1998, 2002). However, the likely

consequence of the CBD, and the interaction between the CBD and TRIPs, will be

that the states providing access to their genetic resources will need to adopt, at least,

the minimum TRIPs patenting standards in order to derive the benefits of the CBD�sproposed benefit sharing regimes (see Lawson and Pickering, 2001; Lawson and

Downing, 2002).It is not certain that relying on the contract-based access to the genetic resources

will deliver the sharing of benefits (and in particular, the transferred intellectual

property protected technology) contemplated by the CBD and the Environment


Protection and Biodiversity Conservation Act 1999 for genetic materials. The key

problem is that, in practice, the CBD definition of �genetic resources� leaves out

biochemicals, ex situ holdings acquired before December 1993, and applies only to

some marine resources.

In the absence of the Conference of the Parties and the CBD�s Secretariat pro-

viding a definitive explanation of the term �genetic resource�, a number of Con-tracting Parties, like Australia, have adopted access regimes with a broader scope

than the CBD�s definition and include �genetic resources and derivatives�. While this

approach may addresses the inadequacies in the CBD�s terminology, the concern is

that the access regimes adopted by states may be better suited to the �derivatives�(like �biochemicals�) rather than the �genetic resources� by failing to take into account

the impact of genetic material patents on the proposed access regimes. In short:

�The objective of controlling access is to capture the economic benefits

from the use of genetic materials and products derived from Australia�sdiverse and valuable genetic resources. We contend the proposed scheme

is undermined by the operation of the Patents Act which grants patents

over broad classes of genetic materials. This practice overlooks the diver-sity that makes Australia�s genetic resources useful and valuable with the

consequence that the Australian community will not share the economic

benefits from exploiting Australia�s unique genetic resources, as (i) the

patent rights to exploit this resource are obtained independently of the

proposed controlled access to the genetic resources, and (ii) the benefits

of the genetic resource commodified by the patent are being predomi-

nantly captured by non-resident patent holders� (Lawson and Pickering,

2002).

In competition terms, access to genetic resources in Australia is a potentially

significant imposition on the likely benefits delivered by patents because the domestic

benefits from patenting are likely to be only derivative benefits, the incentives to

invent are likely to be overwhelmed by the disincentives generated for non-patent

holders (the �tragedy of the anti-commons�) and products and processes developed

domestically relying on Australia�s unique genetic resources will have a significant

barrier to entry imposed by the broadly claimed patents (held by non-residents) in

the foreign markets.

4. The way ahead. . .

There are a number of options available to address any imbalance between the

pro-innovation objectives of the Patents Act and the pro-competition objectives of

the Trade Practices Act. These include raising the threshold patenting requirements,taking advantage of the TRIPs agreement to introduce laws directed towards pro-

moting effective competition in the exploitation of patented genetic material com-

positions (including laws that promote the social and economic welfare) and


introducing an effective compulsory licensing scheme. The following analysis ex-

amines each of these issues.

4.1. Raising the Patents Act threshold requirements

A partial solution to limiting the possible detrimental effects of broad genetic

materials composition and composition application patents may be to make Aus-tralia�s patenting scheme more rigorous (see Lawson and Pickering, 2002). This

might be achieved through refinements to the present patenting scheme and con-

sistent with TRIPs (and the benefit-sharing and technology transfer scheme pro-

posed by the CBD). These binding agreements mean some form of patenting scheme

for inventions must apply in Australia, which recognises, according to Article 27 of

TRIPs, inventions without discriminating as to the field of technology. Failure to

comply with TRIPs will attract trade retaliation and compensation measures that

could be expected to damage the economy, including in areas that might not berelated to the intellectual property dispute in issue. While there is an opportunity to

benefit from technology transfer in exchange for access to Australia�s unique and

valuable genetic resources this requires the �adequate and effective protection of

intellectual property rights� in the transferred technology. This presumably means

the broader scheme of intellectual property rights proposed by TRIPs, rather than

just Article 27. It is the broader scheme of intellectual property rights proposed by

TRIPs that provides considerable latitude for Australia to implement patent laws

and other measures which could limit the potential detrimental consequences ofbroad genetic material composition and composition application claims (see

Lawson, 2000).

In effect Article 27 of TRIPs specifies that national laws must provide exclusive

rights for inventions that are novel, inventive (non-obvious) and have an industrial

application (utility), subject to some limited exceptions for the protection of ordre

public or morality, methods of human and animal treatment, plants and animals (but

not micro-organisms) and for biological processes for producing plants and animals

(but not technical processes) (see Nicol and Nielsen, 2001). These terms are notdefined, leaving considerable scope for interpretation, so long as there is no dis-

crimination as to field of technology. It is open to the Parliament, the courts and the

Patent Office to take advantage of this �flexibility� in the scope of Article 27�s lan-

guage and raise the threshold requirements of newness, novelty and inventive step

(non-obviousness), without discriminating as to the field of technology, when

amending or interpreting Section 18 of the Patents Act. Further, Parliament might

rely on the Article 27 exclusions and specifically limit the scope of patentability, such

as excluding methods of human and animal treatment, plants and animals.

4.2. Taking advantage of TRIPs

Articles 7 and 8 of TRIPs set out the objectives and principles of TRIPs. These

Articles arguably allow TRIPs to be implemented in a way that takes into account


broader policy objectives, some of which might not be related to patenting. Despite

the different perspectives of the developed and developing and least developed

member states, most member states consider TRIPs is sufficiently �flexible� to enable

member states to implement their TRIPs obligations as well as their public policy

objectives. The majority consensus appears to be:

�. . .we remain committed to [the] implementation of the TRIPs Agree-

ment based on its proper and flexible interpretation and in accordance

with the objectives and principles contained in Arts 7 and 8 . . . Some pro-

visions of the TRIPs Agreement may elicit different interpretations. This�room to manoeuvre� served the purpose of accommodating different po-

sitions held by members at the time of negotiation of the Agreement. We

strongly believe that nothing in the TRIPs Agreement reduces the range

of options available to governments to promote and protect public

health, as well as other overarching public policy objectives� (Councilfor Trade-Related Aspects of Intellectual Property Rights, 2001).

In relying on these TRIPs provisions to limit a domestic patent scheme, the

wording of any legislation would need to be very carefully chosen and the groundsfor reliance on the TRIPs exceptions very clearly articulated (and probably sup-

ported by well developed and targeted socio-economic and technological develop-

ment policies). This is necessary primarily to avoid undue trade retaliation. This

does, however, provide considerable scope for creative pro-competitive laws that do

not run foul of TRIPs.

4.3. Compulsory licensing

The Patents Act provides that the Federal Court or Supreme Court may order a

compulsory license if: �(a) the reasonable requirements of the public with respect to

the patented invention have not been satisfied; and (b) the patentee has given no

satisfactory reason for failing to exploit the patent�. The compulsory license is not

exclusive, may be assigned �only in connection with an enterprise or goodwill in

connection with which the license is used� and is subject to any other terms specified

by the court. Further, before making an order, �the court must be satisfied that theapplicant has tried for a reasonable period, but without success, to obtain from the

patentee . . . an authorisation to work the invention on reasonable terms and con-

ditions�, and where another patent would be infringed by the compulsory licensed

patent then the court must be �further satisfied that the patented invention involves

an important technical advance of considerable economic significance on the in-

vention (other invention) to which the other patent relates�. Where a compulsory

license is ordered a royalty is payable as �such amount as is agreed� between the

parties, or �such amount as is determined by a prescribed court to be just and rea-sonable having regard to the economic value of the license�. The compulsory license

may be revoked if �(a) the patentee and the licensee are agreed, or the court on

application made by either party finds, that the circumstances that justified the grant


of the license have ceased to exist and are unlikely to recur; and (b) the legitimate

interests of the licensee are not likely to be adversely affected by the revocation�.An earlier and similar provision to the existing Patents Act compulsory licensing

provisions was considered by the High Court in Fastening Supplies Pty Ltd v Olin

Mathieson Chemical Corporation 20 and seems likely to inform any interpretation by

courts of the existing provisions. In that case the patentee sought to prevent thepetitioner from selling an imported bolt tool and an account for the tools already

sold. The petitioner responded by seeking a compulsory licence. The petitioner had

attempted to enter a licensing agreement but was refused as an exclusive licensing

arrangement already existed and the exclusive licensee would not sub-license. The

High Court refused to grant the compulsory licence even though the court accepted

that, at the time of the petition the invention was being manufactured overseas, the

tool was not available to the public in Australia. The definitive evidence accepted by

the court was that the exclusive licensee in Australia had good reasons for failing tosupply the tool to the public in Australia and had acted reasonably by attempting to

develop a tool to be profitably manufactured in Australia, and that this was not a

belated response to the petition.

The present Patents Act compulsory licensing provisions are constructed more

broadly than the earlier provision. However, the same terms �unfairly prejudiced�,�reasonable terms� and �reasonable extent� will still require interpretation. Despite the

apparently broad application of the compulsory licensing provisions, and in par-

ticular the definition of the �reasonable requirements of the public�, they have notbeen relied on to any extent in Australia. This might be because they are either (a)

too restrictive – too difficult to prove, hedged with qualifications and discretion and

too expensive to seek, or (b) very effective – inducing patentees to license in fear of a

compulsory license and forfeiture. However, the significant procedural ruling in

Fastening Supplies was the court�s view that the �reasonable requirements of the

public� was to be assessed at the time of hearing, rather than at the time the petition

was lodged. This delay allows the patentee to take immediate action to satisfy the

�reasonable requirements of the public� and effectively undermine the petition. Theconsequence of this is to impose a considerable economic penalty on the petitioner,

especially where a patent holder has a preformed strategy to address the court�s likelyinquiry about a belated response to the petition. This penalty is the financial costs to

the petitioner for bringing the petition with very limited prospects of being able to

access and exploit the patented invention in order to recover those costs because the

patentee will make the patented product or process available to the public before the

hearing. Fastening Supplies illustrates this and shows that actions after the petition

was lodged and before the hearing are significant: �Ramset, by manufacture inAustralia as already described, is now in the process of meeting Australian

requirements and has the capacity to do so�.

20 (1969) 119 Commonwealth Law Reports 572.


The recent Intellectual Property and Competition Review Committee (Com-

monwealth of Australia, 2000c) set out their view of the intended purpose of com-

pulsory licenses:

�We accept that, at a conceptual level, there may be instances where a

compulsory access right is warranted. These include situations in which

bargaining between parties is not able to achieve an outcome or, more

importantly, situations in which the access right acts as a pro-competitive

remedy that tempers the exclusivity that the patent right primarily pro-

vides. Experience in other jurisdictions with compulsory licenses, mostnotably the United States and Canada, demonstrates that these can, in

carefully defined circumstances, lead to more efficient and immediate out-

comes without harming long-term incentives to innovate. Indeed, the

threat of compulsory licensing may lead to innovations being worked

sooner and more widely than they would otherwise have been�.

The Committee recommended replacing the existing Section 135 with a series of

conditions that if satisfied would require the order of a compulsory license. These

conditions include that access to the patented invention is required for competitionin a relevant market, that there is a public interest in enhanced competition, that the

reasonable requirements for access have not been met and that the order would not

compromise the legitimate interests of the patent owner. There was no clear indi-

cation of how the broad terms of the conditions might be interpreted, although the

Committee did consider the requirement for competition in a relevant market would

mean there was no other option for competition in that market. The Government

response to the Committee�s report (Commonwealth of Australia, 2001a) gave �inprinciple� support, and rejected a competition test alone, instead opting for the ex-isting requirements together with a competition test.

Unfortunately, neither the Intellectual Property and Competition Review Com-

mittee nor the Government�s response dealt with the terminology of the provision or

the procedural limits on exercising the compulsory license provisions in the Patents

Act. Until this procedural anomaly is addressed the compulsory licensing provisions

will arguably continue to be ineffective.

5. Conclusions

The existing competition schemes set out in the Patents Act and the Trade

Practices Act are unlikely to prevent anti-competitive conduct by a patent holder

within the �purpose and scope� of the patent claim (see Lawson, 2002). Pro-compe-

tition laws in both the Patents Act and the Trade Practices Act therefore need to be

tailored and applied to ensure the unresolved issues in patenting genetic materials are

resolved in a way that promotes innovation and restricts anti-competitive conduct bygenetic material patent holders. In Australia, the apparent benefits of patenting need

to be considered in the context of the political economy because economies that

move beyond the poorest stage (like Australia) have a greater ability to imitate new


technologies and may benefit from more rigorously applied (or weaker) patent

schemes. In contrast, very well developed economies (like the United States) benefit

from less rigorously applied (or very strong and generous) patent schemes. A strong

and generous patent scheme may therefore not be in Australia�s best interests and a

more rigorous and weaker patent scheme that promotes follow-on innovation at

the expense of the first-to-invent�s broad patent might be more appropriate toAustralia.

However, in developing approaches to deal with the ongoing tensions between

patents and pro-competition laws, the observations of McCarthy (1985) are worthy

of particular note:

�[T]here is no �objective truth� to be found in the tension and conflict be-

tween intellectual property and antitrust. While many legal scholars have

sought to find a �unified field theory� which will serve as a legal tool to

resolve all such conflicts, no one has yet succeeded. It is probably delusive

to even search for such a thing . . . I think that all that is at work is the

personal preference as to societal and economic values of the judges

who decide the cases�.

If this is correct then finding ways to deal with the tension that take into account

the particular circumstances of each case and tailor a solution seem preferable. This

suggests compulsory licensing should be considered further with developments

around the world providing guidance to the Australian government�s announced

initiatives (once the interpretation and procedural anomaly have been addressed). In

developing these solutions the broader concerns about promoting social and eco-

nomic welfare (including technological development) as articulated by the objects

and principles of TRIPs should be addressed.

Acknowledgements

This paper draws on previously published materials and recently submitted

manuscripts for the purposes of providing a comprehensive overview for the

workshop. I acknowledge the contribution of Dr Catherine Pickering, Dr Barbara

Hocking and Susan Downing for their assistance and contribution to the materials

presented in this paper. The views expressed in this paper are entirely myresponsibility.

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