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Implications of DNA Patenting: Reviewing the Evidence
DIANNE NICOL[*]
In the past couple of years, perhaps more than ever, the patentability of DNA has captured the attention of lawyers, politicians, scientists, the popular press and the public alike.[1] Litigation on the patentability of genes linked to hereditary forms of breast cancer (the so-called BRCA genes) is currently on foot in the US[2] and in Australia.[3] Proposed legislation seeking to exclude DNA and other biological materials from patenting is before the Australian parliament: the Patent Amendment (Human Genes and Biological Materials) Bill 2010 (Cth). At the time of writing, the Bill has not yet been considered by either house of the Australian parliament. However, the Australian Senate Legal and Constitutional Affairs Legislation Committee conducted an inquiry into the Bill and released a report on 21 September 2011.[4] The majority view of the Committee was that the Senate (the upper house of the Australian parliament) should not pass the Bill, although a dissenting report by three senators supported its passage.
Despite this flurry of recent activity, there is nothing particularly new about this issue. Patents claiming rights to components of the human genome were already being granted by patent offices around the world in the early 1980s. Many thousands more have since been granted,[5] and many tomes have been written on the desirability or otherwise of allowing this practice to continue. Yet here we are, apparently as far away from settling this issue as ever.
Should we be at all concerned by the lack of resolution to the basic question of whether or not DNA should be patentable? Ostensibly, the question is a simple one and it should be easy to resolve: either we allow DNA patents or we ban them. But this ignores the fact there are layers of complexity from the legal, ethical, economic and social perspectives and a simple prohibition would not, in my view, achieve much.[6] Even before we get to these issues, the complexity of the science itself is apt to confuse unless it is explained in a manner that is amenable to the lay reader. As a starting point, we need to understand the nature of DNA. In a recent book chapter, I summed up its core features as follows:[7]
DNA is a complex chemical which comprises a repeated pattern of chemical structures known as nucleotides, each of which contains one of the four bases: adenine, cytosine, guanine and thymine (also referred to as A, C, T and G). In humans there are around three billion of these nucleotides arranged in precise order along our chromosomes. DNA is the source of the information necessary to produce all of the proteins required by a living organism. Traditional dogma has it that the site on the DNA molecule that carries the information required to produce a particular protein is the gene.[8] Using modern techniques, researchers are finding that the process of transcription and translation of genetic information into functional proteins is, in fact, highly complex. For instance, it has been found that there are many non-protein-coding as well as coding regions on genes and that other regions of the DNA molecule play an active role in regulating gene function.[9] New information about DNA and protein function continues to emerge.
Moreover, it is increasingly being realised that protein structure is as crucial to function as the underlying sequence information.[10]
In reflecting on the appropriateness of DNA patenting, it is necessary to consider whether the law really is in need of reform. Is there really a problem with DNA patenting and, if there is, couldn’t we simply leave it to the market[11] to sort this problem out for itself? My argument in this article is that we must have some knowledge about how the market is dealing with DNA patenting: we need to explore the evidence.[12] Reform of the law must be considered against the backdrop of practical real world events as well as policy, theory and doctrine. This article provides an historical account of the body of evidence that has emerged over the past decade or so on the consequences of allowing DNA patents, including recent work undertaken by myself and my research team focusing specifically on the Australian biotechnology industry. This article is intended to provide a reference point for a follow-on special issue of this journal: The Role of Law in DNA Patenting.
In order to give the issues to be discussed later in this article some context, it is useful to first delve into some of the significant landmarks in the development DNA technology. These developments have coincided with major shifts in the nature of scientific research and patent practices, which have resulted in a plethora of academic commentary and law reform proposals.
The field of biotechnology has advanced in leaps and bounds in the fifty-eight years since the discovery of the double helical structure of the DNA molecule in 1953.[13] To a large extent, these advances arose out of the work of a cohort of highly skilled researchers in the 1970s, who developed what were to become the foundational technologies in the field.[14] The first step was the development of recombinant DNA technology, which can be thought of in quite simple terms as a process of cutting a piece out of a DNA molecule of one living cell and transferring it to another.[15] This rapidly became the mainstream technique for manipulating the genome and immediately opened the door to a multitude of possible uses of genetic technologies, in the lab, on the farm and in the clinic. Colonies of genetically modified bacteria started to be used as living factories for the production of therapeutic human proteins, particularly hormones and blood components.[16] Genetically modified higher organisms with introduced traits were created for use in research. One example is the Oncomouse, genetically modified to have a propensity to develop cancers for use in research.[17] In agriculture, genetically modified plants like the FLAVR SAVR tomato started to be commercially developed.[18] Even modification of the human genome itself through human gene therapy was mooted in the early 1980s as being achievable in the longer term.[19] Parallel developments in sequencing technology[20] together with new methodologies for amplifying the quantity of DNA available for experimentation (for example, the polymerase chain reaction, or PCR[21]) encouraged further expansion of biotechnology research and development. Around the mid-1980s, attention began to focus on a bold plan to map and sequence the entire human genome through an international consortium, the Human Genome Project (HGP), as well as the genomes of many other organisms.[22]
Given the speed of technological change, this is all now ancient history. The first draft of the human genome sequence was completed in 2001 and the job was done by 2003.[23] However, it is well recognised that even now, in 2011, more research still needs to be done before the promise of biotechnology is fully realised. Translation of biotechnology research into the clinic and the farm is progressing slowly. Indeed, some are so critical of the pace of development in this field that they refer to the biotechnology revolution as a ‘myth’.[24] Slowness in translation of biotechnology research into practice can perhaps be excused to some extent by the complexities of the technology itself. Biotechnology also faces higher regulatory hurdles than many other technologies, imposing further delays on the delivery of biotechnology products and processes to consumers. Such regulatory requirements are necessarily imposed on technologies of this nature, which carry such a high risk of detrimentally affecting human health and wellbeing and the environment. However, it is the potential detrimental impact of patents on biotechnology innovation and translation into practice that has really captured the minds of academic commentators and policy reformers alike.
The emerging public and private biotechnology sectors have tended to work in close collaboration from the early days. For example, Herbert Boyer, who, as an academic, was one of the developers of recombinant DNA technology, co-founded Genentech Inc — widely acknowledged to be the first biotechnology company.[25] The FLAVR SAVR tomato was created at Calgene Inc, in collaboration with researchers from the University of California, Davis.[26] Additionally, public sector organisations independently became increasingly focused on applied research and transfer of their technology to the private sector. For example, the genetically modified Oncomouse was created at Harvard University and exclusively licensed to EI du Pont de Nemours and Co.[27] In another shift away from traditional research practices, some of the most foundational biotechnology research began to be carried out exclusively in the private sector. Kary Mullis and his team worked together at Cetus Corporation on the development of PCR technology.[28]
Since these early developments, many research-based biotechnology companies have sprung up around the world, often as spin-offs from universities and other public research organisations.[29] Almost invariably, each firm’s core technology is protected by a patent or a family of patents. We are also seeing an ever-increasing propensity for public sector organisations to patent,[30] and to transfer their intellectual capital (in the form of people and know how) and intellectual property (in the form of patents and confidential information) to the private sector.[31] Commentators refer to biotechnology as sitting in Donald Stokes’ ‘Pasteur’s quadrant’,[32] where basic science is used to solve practical problems, resulting in a private industry around pre-product development research.[33] One outcome is that many thousands of patents claiming exclusive rights to the use of DNA sequence information have been granted around the world.[34]
In contrast, and aside from some notable exceptions, the sequencers themselves have tended to eschew patents, seeing DNA sequences as ‘basic research methods’.[35] One testament to this conviction are the ‘Bermuda Rules’ for access to HGP sequencing information, agreed to by all parties involved in the international public sequencing effort in 1996. Specifically, it was agreed inter alia that all human genomic sequence information generated by centres undertaking large-scale human sequencing under the auspices of the HGP should be made freely available in order to encourage research and development and to maximise its benefit to society.[36] Dr Craig Venter is perhaps the most well-known person who falls outside this no-DNA patent, free access norm within the sequencing community,[37] although a number of private sequencing companies have been even more active in filing broad patent claims relating to raw DNA sequence information.[38] While Venter was working for the US National Institutes of Health (NIH) in the early 1990s, he developed a novel technique of identifying human genes using expressed sequence tags (ESTs).[39] In his later work in the private sector, Venter utilised a rapid sequencing method, referred to as ‘shotgun sequencing’, to sequence the human genome and genomes of a diverse array of other organisms.[40] Even more ambitiously, he later set out to sequence the world’s oceans using this technique.[41] Throughout his involvement with genetic technology, Venter has been actively engaged in protecting his intellectual property through patenting, trade secrecy and contract. Indeed, it was during his tenure at the NIH that the first alarm bells about gene patenting started ringing, following the filing by the NIH of large numbers of patent applications claiming rights to ESTs.[42]
Cumulatively, these events in the 1970s through to the 1990s marked tectonic shifts in the science of genetics and genomics, but also in the ways that researchers disseminate their knowledge and engage with industry partners and in the interface between basic scientific discoveries and patentable inventions.
From the early 1980s onwards, policy makers started to scrutinise the relationship between patenting of DNA and other foundational research tools, the progress of biotechnology research and innovation, and consumer access to health care with some interest. Cook-Deegan and Heaney provide a helpful account of references made to intellectual property issues in a series of US congressional Office of Technology Assessment (OTA) reports from 1981 to 1994.[43] Gold and Gallochat outline some of the international policy discussions occurring at around the same time.[44] In Europe, debate commenced in 1988 on the formulation of a Biotechnology Directive to assist in interpreting the Convention on the Grant of European Patents[45] and the national patent legislation of signatory countries to the Convention specifically in respect of biotechnology-related patents.[46] While it took until 1998 for the Directive to reach its final form,[47] and the end result significantly limited the opportunities for raising ethical and social considerations in the assessment of patent validity, there was constructive (and, at times, heated) debate on these matters in the intervening years.[48]
Academics also became interested in analysing the implications of patenting biotechnological inventions in the 1980s, although the primary focus tended to be on the ethics of patenting higher organisms.[49] Professor Rebecca Eisenberg was very much a lone voice in raising concerns about the consequences of DNA patents[50] up until the time that the NIH filed a plethora of EST patent applications with the USPTO in 1991. Since then, there has been a growing body of academic commentary on the ethical, social, legal and economic implications of DNA patenting. This body of commentary reached a crescendo following the publication in 1998 of Michael Heller and Rebecca Eisenberg’s famous treatise on the anticommons in biomedical research, in which they posited that ‘a proliferation of intellectual property rights upstream may be stifling life-saving innovations further downstream in the course of research and product development’.[51] Heller and Eisenberg expressed concern that an anticommons could result from patenting DNA fragments and receptors, particularly when combined with the imposition of reach-through terms in licence agreements.[52]
Other commentators focused more attention on the potential for individual DNA patents to block off whole areas of research should patent holders refuse to license or license on restrictive terms.[53] The difficulty of inventing around DNA patent claims was recently examined by a group at the Centre for Intellectual Property Rights in Leuven, Belgium for patents relating to the 22 inherited diseases most frequently tested for in Europe.[54] Their results showed that patent claims to DNA sequences per se could be blocking. However, they found that a much greater percentage of claims relating to methods of diagnosing genetic conditions were difficult or impossible to circumvent,[55] indicating that a ban on DNA patents in isolation would not solve the blocking problem.
Other research has suggested that patenting could not only have a negative effect on innovation within the biotechnology industry, but it could impact on fundamental scientific norms at the upstream end of the research-development continuum.[56] Such patenting activity could also have adverse consequences on the delivery of the fruits of biotechnology innovation to consumers. Specifically, there has been growing concern about issues of access, quality and cost relating to the provision of diagnostic genetic tests.[57]
In parallel with these academic debates, there has also been a rapidly expanding industry in the production of law reform reports relating to DNA patents.[58] The recommendations for law reform have been fairly consistent across all of these inquiries. A prohibition on DNA patenting has not been supported in any of the reports. Rather, they focus on such matters as: ensuring proper application of the patent criteria of novelty, inventive step (or non-obviousness, as it is referred to in the US) and industrial applicability (utility in the US); narrowing the scope of claims; exempting research and clinical use; and clarifying the availability of compulsory licensing.[59]
Despite this prolonged and intensive activity by law reform agencies, academics and others, there has been little actual reform of patent law by legislatures around the world in response. It appears that the words of caution expressed by John Doll in 1998 have been well heeded. In a rather less famous parallel article to Heller and Eisenberg’s anticommons treatise, Doll cautioned against wholesale reform of patent law in response to perceived impact on research and innovation of patents claiming DNA fragments.[60] Doll was the director of Biotechnology Examination at the USPTO at the time he wrote the article, and later became Commissioner for Patents from 2005 to 2009. Despite Doll’s warning, some attempts have been made to introduce legislation to amend US patent law in the intervening years from the 1990s to the present.[61] Realistically, though, they appeared doomed to fail from the outset. To illustrate this point, only this year a bill seeking to provide a limited exception to infringement for the purpose of second-opinion genetic testing was withdrawn prior to vote.[62]
In Australia, although the Patent Amendment (Human Genes and Biological Materials) Bill was introduced into Parliament in 2010 in the form of a Private Member’s Bill, it is far from certain that it will be passed.[63] Indeed, this seems to be a particularly remote possibility following the release of the report into the Bill by the Senate Legal and Constitutional Affairs Committee.[64] Although three senators made a dissenting report,[65] it is notable that they were all sponsors of the Bill when it was first tabled in parliament, and that they were unable to persuade any other senator to support the passage of the Bill. As such, majority parliamentary support appears unlikely. It should also be noted that there have been two earlier failed attempts by members of the Australian Democrats political party to introduce exclusions from patenting relating to genes into the Australian Parliament.[66]
The European Biotechnology Directive and follow-on national implementing legislation is the one notable example of a specific legislative response to uncertainties and concerns about the patentability of biotechnological inventions. But rather than achieving wholesale reform of European law to limit biotechnology patents, the Directive actually has the effect, inter alia, of affirming that DNA is patentable subject matter provided that it has been isolated from the body and that it has clear industrial applicability.[67]
Ultimately, the specific issue of patenting DNA fragments that was a prominent concern in the 1990s was largely resolved in the early 2000s within the ambit of existing generic patent law provisions through the requirement for industrial applicability/utility. For example, guidelines that came into force in 2001 in the US, clarified that in that jurisdiction all patent applications must satisfy the requirement of ‘specific, substantial and credible utility’,[68] making patentability difficult for DNA fragments of unknown function.[69]
More recently, long-awaited reform of US patent law has been achieved. The Leahy-Smith America Invents Act[70] was signed into law by President Obama on September 16, 2011. The Act includes various provisions amending US patent law, as provided in Title 35 of the United States Code. Perhaps the most noteworthy amendments are as follows: a fundamental change in the priority rules from first-to-invent to first-inventor-to-file; the creation a prior commercial use defence; and clarification of post-grant review processes.
Significant reforms to Australian patent law are also on foot. The Intellectual Property Laws Amendment (Raising the Bar) Bill 2011, was introduced into federal parliament on 22 June 2011. Included in the raft of amendments to the Patents Act 1990 (Cth) and other intellectual property legislation is a proposed amendment to the ‘usefulness’ patent criterion to bring it into line with the US requirement of specific, substantial and credible utility. The Bill also includes reforms to the inventive step requirement and the disclosure and claiming requirements in Australian patent law, and it introduces a research exemption and extends the existing regulatory approvals exemption.
General patent law reforms of this nature will inevitably have some impact on future DNA patent grants, just as much as for any other area of technology. For the purpose of this article, however, the most significant aspect of the Leahy-Smith America Invents Act is not so much the changes to existing patent laws that will result from its entry into force. Rather, it is the creation of a statutory obligation on the part of the Director of the USPTO ‘to conduct a study on effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist’, as provided in s 27. The Director is required to report on the findings of the study to the Committee on the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives no later than nine months after the date of enactment of the Act, and provide recommendations for establishing the availability of independent confirming genetic diagnostic test activity. As such, it appears that there is still uncertainty as to the appropriate direction for reform of the law in respect of DNA patents, at least from the perspective of the US legislature.
To conclude this section, scrutiny of DNA patents by law reform agencies, legislatures, academics and others appears to be continuing apace, but responses in the form of concrete reforms of existing patent laws appear to have stalled. Now, in 2011, is there sufficient evidence of detriment caused by DNA patenting, whether in the context of research, innovation or consumer access, to make a determination as to whether patent law reform is necessary and justified and what form it might take? To answer these questions we need to examine the evidence.
Coincident with the developments in DNA technology and changes in university research and patenting practices, the question of whether or not biological material could be patentable subject matter under existing patent laws was also starting to receive some scrutiny, particularly as a result of the seminal US Supreme Court ruling in Diamond v Chakrabarty.[71] While the Court in Chakrabarty recognised that ‘laws of nature, physical phenomena, and abstract ideas’ were not patentable,[72] a slim 5:4 majority held that living organisms could be patented if they exhibited ‘markedly different characteristics from any found in nature’.[73] Perhaps surprisingly, it was not until 2010, some 30 years after Chakrabarty, that the issue of whether or not isolation and synthetic production of DNA sequences fulfil the ‘markedly different characteristics’ requirement was judicially determined. The ongoing case of AMP v USPTO[74] concerns the patentability of product claims to the BRCA DNA sequences linked with susceptibility to breast cancer and process claims to methods of diagnosis of mutations in these BRCA sequences. The first instance decision in this case, handed down by Sweet J on 29 March 2010, is significant not only for what his Honour said about the applicability of the Chakrabarty ‘markedly different characteristics’ threshold in respect of the DNA sequence claims, but also for what he said about another patentability test, the ‘machine or transformation’ requirement,[75] in respect of the claims for methods of diagnosis.
In applying the ‘markedly different characteristics’ requirement from Chakrabarty to the sequence claims, Sweet J rejected the argument that isolated DNA is markedly different from native DNA. His rationale focused on the unique quality of DNA as the physical embodiment of information (in the form of the DNA sequence), which is preserved between its native and isolated forms.[76] Sweet J held that the method claims were also invalid because they failed to satisfy the ‘machine or transformation’ requirement. This test requires that a method either must be tied to a particular machine or apparatus or must transform a particular article into a different state or thing to satisfy the patentable subject matter requirement.[77] For Sweet J, the method claims in issue were ‘directed only to abstract mental processes of “comparing” or “analysing” gene sequences’.[78]
The decision of the Court of Appeals of the Federal Circuit in AMP v USPTO appeal[79] is more significant, because three of the judges of the Federal Circuit were given the opportunity to provide opinions on the patentability of DNA sequences and methods of diagnosis using those sequences. This decision has been eagerly anticipated, not least because a surprising amicus brief filed by the US Department of Justice suggested a significant shift in government policy relating to DNA patenting. The brief questioned the validity of patents for gene sequences that are identical to natural sequences but affirmed the patentability of human-made sequences (often referred to as cDNA sequences).[80] In relation to the method claims, it is noteworthy that, since Sweet J’s first instance decision in AMP v USPTO, the Supreme Court decision in Bilski v Kappos[81] has been handed down. The Supreme Court rejected the holding of the Court of Appeals of the Federal Circuit in re Bilski that machine or transformation should be the sole test for determining patentability of processes. While the Supreme Court in Bilski v Kappos confirmed earlier holdings in Chakrabarty and other cases that laws of nature, natural phenomenon, or abstract ideas cannot be patented, it also found that ‘an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection’.[82]
In the intervening period, between the first instance and appeal decisions in AMP v USPTO, leading US academics have expressed some discomfort with the aspect of Sweet J’s decision dealing with the sequence claims.[83] Ultimately the appeal court agreed that Sweet J had gone too far in invalidating Myriad’s sequence and method claims, although there was some difference of opinion between the three judges on precisely what is and is not patentable, and the reasons for their conclusions. With regard to the sequence claims, Lourie J in his majority opinion insisted that it is the structural chemical nature of DNA that should be considered, not the informational content.[84] Because the process of isolation requires changes to the chemical structure of DNA, isolated DNA, just as much as human made cDNA is patentable subject matter. The rationale for this is that the isolated form has a ‘distinct chemical nature and identity’.[85] His Honour went on to draw a distinction between the process of isolating DNA, which requires changes to its chemical structure, and the process of purification of other materials, which does not.[86]
Moore J also readily accepted that cDNA was patentable subject matter, but was more cautious as to the patentability of isolated DNA, commenting that the difference in chemical structure alone was enough to make the isolated DNA ‘markedly different’.[87] Rather, for her Honour, precedent required that these differences must ‘impart a new utility which makes the molecules markedly different from nature’.[88] Her Honour was ultimately satisfied that the ability to use short isolated DNA fragments for diagnostic testing satisfied this requirement,[89] but drew a distinction between claims to these short fragments and claims embracing whole genes. For her Honour, the chemical and structural differences between isolated whole genes and their natural counterparts do not create a new utility.[90] Nevertheless, based on the express authorisation by Congress to give an expansive scope to patentable subject matter and on past patent office practice she decided in favour of patentability.[91] Unlike the other two judges, Bryson J did not accept the patentability of isolated DNA, although his Honour did accept that cDNA was patentable.[92] His Honour held that claims to the isolated BRCA genes were not patentable because the only material changes were incidental to the extraction process.[93] The simple breaking of chemical bonds was not enough for his Honour to ‘render the gene claims patentable’, but was more akin to ‘snapping a leaf from a tree’.[94]
With regard to the method claims, the judges of the Federal Circuit were united in their views that claims relating to simple comparisons and analysis of sequences are not patentable because they claim only abstract mental processes.[95] However, Lourie J’s decision may be interpreted as intimating that if the claims had included other steps, including extracting and sequencing DNA, the claimed subject matter may then be sufficiently transformative to be patentable.[96] All judges held that methods of screening potential cancer therapeutics were patentable subject matter.[97]
It is difficult to know at this stage whether the Federal Circuit decision will finally settle the issue of DNA patenting in the US, particularly since the option of appealing to the US Supreme Court is still open.[98] It does seem unlikely, based on decisions like Bilski v Kappos, that if the US Supreme Court is given the opportunity to decide this case, the bench will be prepared to impose an absolute prohibition on patents for a whole field of technology. Rather, it is more likely that the Court would prefer to leave it to the legislature unless there is clear evidence of the need for judicial intervention. Whether or not that evidence exists is considered further below.
One issue that needs to be considered in relation to the AMP litigation is whether or not anything can be read into the fact that it took a full thirty-year period following Chakrabarty and the advent of DNA patenting for this issue of patentable subject matter to come before the courts. Does the lack of litigation on the question of whether or not DNA sequences are patentable subject matter signal that the grant of such patents has had negligible detrimental impact? Christopher Holman has undertaken a comprehensive study of litigation in the US relating to DNA patents.[99] Following on from an earlier study that posited that patent litigation is a good indicator of patent value,[100] he argues that litigation is also a good measure of patent impact. The basis for this argument is that, ‘although patent litigation is expensive, if a patent is truly blocking important research or product development, it seems likely someone would be willing to challenge the patent by provoking or filing a lawsuit.’[101] Relying on the dataset of gene patents created by Kyle Jensen and Fiona Murray,[102] Holman calculated that 0.4 per cent of the entire set was litigated (or 0.2 per cent if a single retaliatory lawsuit was removed), compared with 1-2 per cent of issued patents as a whole and an even higher percentage in the broad category of biotechnology patents.[103] He found that most of the litigation relating to DNA patents was between competitors in the context of marketing of competing therapeutic proteins, and the few instances of litigation that occurred in the context of research tools and genetic testing had little impact on biomedical research or public health.[104]
This is an interesting approach to analysing the question of whether or not DNA patents have a detrimental impact. However, there may be many reasons why patents of this nature might not be litigated, irrespective of their impact. From the perspective of business competitors, the risk of a broad adverse precedent may be sufficient deterrent to litigate, particularly if a mutually agreeable licensing arrangement can be negotiated around what could otherwise be a blocking situation. From the perspective of researchers or consumers, the cost of litigation may be so prohibitive that it is not a viable option. Holman himself recognises that there may be many reasons why parties choose not to litigate patents even though they are suffering detriment, but even so, he concludes that: ‘Without more compelling evidence of an overwhelming negative impact in contexts that are critical to the public good, there is no adequate justification for rushing into a radical legislative fix that might have substantial unintended negative consequences.’[105]
This conclusion begs two questions: first what other evidence of negative impact is available; and secondly, when would this evidence be so ‘overwhelming’ to justify legislative intervention?
By far the greatest concerns about the potential negative consequences of DNA patenting have been voiced in the context of diagnostic genetic testing. Evidence about the potential detrimental impact of patents in the diagnostics field emerged from studies undertaken by Mildred Cho and Jon Merz and their colleagues in the US,[106] and from more widespread media reports concerning enforcement actions against diagnostic service providers by Myriad Genetics Inc relating to its BRCA patents.[107] Merz and Cho’s team reported that a number of gene patent and licence holders were actively enforcing their patents against providers of genetic tests by refusing to license or imposing restrictive terms in licences.[108] These actions reportedly led to a number of test providers ceasing to perform genetic tests they had previously offered and to a number of others deciding not to develop or perform a test because of patent considerations.[109]
While the enforcement of patents over genetic tests has also garnered attention in other jurisdictions, evidence collected over the past few years suggests there is little indication that patent holders are actively enforcing their patents outside the US. In 2002-2003 I conducted research with my colleague Jane Nielsen, which involved surveys and interviews with Australian researchers, biomedical companies and genetic testing laboratories.[110] While we found that there was a great deal of concern about gene and related patents, there was little evidence at that time that these concerns were substantiated in that such patents were actively being enforced against genetic testing laboratories in Australia.[111] Researchers in Europe also found that there were similar concerns about the impact of gene and related patents on genetic testing, but that there was a similar lack of evidence of actual enforcement.[112] More recently, many submissions to an inquiry into gene patenting by the Australian Senate Community Affairs Reference Committee raised concerns about the detrimental impact of DNA patents on diagnostic testing, but only two concrete examples of enforcement actions were referred to in the final report.[113]
In the US, a report published in 2010 by the Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS)[114] on gene patents and licensing practices, looked specifically at DNA patents in the genetic testing context. The Committee suggested that there was a ‘near perfect storm’ developing ‘at the confluence of clinical practice and patent law’ and that there was evidence that patents have already limited the potential of some genetic tests.[115] Relevant evidence included a series of eight case studies of genetic testing for 10 clinical conditions focusing on test development, access, and quality.[116] These case studies were conducted by the Center for Genome Ethics, Law & Policy, at Duke University’s Institute for Genome Sciences and Policy. The SACGHS also heard presentations from experts during the course of its study and gathered further information and perspectives on its draft report through the solicitation of public comments.[117] The Committee concluded that there was evidence of denial of access to tests not covered by insurance, difficulties in obtaining second opinions and one instance where a patent dispute restricted access for an 18-month period.[118] Although the Committee found that patents or exclusive licences could stimulate development of a genetic test, it found no cases in which possession of exclusive rights was a necessary prerequisite.[119] Ultimately, the Committee recommended the creation of exemptions from patent infringement for use of genetic tests for patient care purposes and for use of patent-protected genes for research purposes.[120] The Committee did not recommend the prohibition of DNA patents, despite the reported evidence of detriment.
Some of the amicus briefs filed in the AMP appeal to the Federal Circuit refer to evidence of the detriment caused by DNA patents, and present a mixed picture.[121] For example, the Brief of Amici Curiae Christopher M Holman and Robert Cook-Deegan in Support of Neither Party points to the critical role that gene patents have played in ‘providing innovators with a sufficient period of market exclusivity to recoup the sizable investment necessary to develop and secure marketing approval for biotechnology products.’[122] This brief goes on to state that while the SACGHS Report identifies potential for a substantial negative impact of gene patents on genetic diagnostic testing, there is currently no conclusive evidence establishing that gene patents have had a net negative impact on the availability of genetic testing services.[123] This is a key observation, bearing in mind that the case studies relied on in the SACGHS Report were conducted by the Cook-Deegan group.
In contrast to the Holman and Cook-Deegan Brief, the Brief for the American Medical Association, American Society of Human Genetics, American College of Obstetricians and Gynecologists, American College of Embryology, and the Medical Society of the State of New York as Amici Curiae in Support of Plaintiffs/Appellees and Arguing for Affirmance, suggests that there is a body of evidence that patents on gene sequences actually interfere with diagnosis and treatment.[124] This brief goes even further, asserting that patents on gene sequences have contributed to patients’ deaths, led to the misdiagnosis of patients, precluded the deployment of improved genetic tests, increased the costs of health care unnecessarily and harmed research and innovation.[125] The evidence presented in this latter brief seems to be largely anecdotal and appears mostly not to have been subjected to peer review. In contrast, the case studies referred to in the Holman and Cook-Deegan brief were reported in a special issue of the peer-reviewed journal Genetics in Medicine.[126] This is not to say that reported instances of detriment alleged to be caused by DNA patents should be ignored, but only that the evidence should be examined with scientific rigor and objectivity.
This brief overview reveals that there is some evidence of detriment that is potentially caused by DNA patents in the diagnostic testing context, primarily in the US. This leads to the question of whether the evidence is compelling enough to justify law reform, and if so, whether the exemption for patient care purposes proposed in the SACGHS Report suffices. Is there other evidence of detriment that supports more wholesale reform of patent law, in the US and in other jurisdictions?
The core problem articulated in the anticommons thesis is that thickets of upstream patents over genes and other research tools inevitably slow the pace of downstream innovation because they create ‘tollbooths on the road to product development’.[127] This problem is likely to be exacerbated when each individual patent is so broad that it has the potential to block whole areas of research and product development. Before the evidence is analysed below, it is important to note that, in the AMP v USPTO appeal, both Moore J and Bryson J drew attention to concerns about the impact of gene patents on innovation, but reached quite fundamentally different conclusions. For Moore J, the evidence was not compelling enough to justify change. This led her to conclude that: ‘Unsettling the expectations of the biotechnology industry now, based on nothing more than unsupported supposition, strikes me as far more likely to impede the progress of science and useful arts than advance it.’[128]
In contrast, Bryson J cited with approval the dissenting opinion of Breyer J in an earlier Supreme Court decision that ‘too much patent protection can impede rather than “promote the Progress of Science and the Useful Arts”’.[129] The fact that these conflicting views of the implications of DNA patents on innovation can be reached by two US Federal Circuit judges in the same case, with access to the same evidence illustrates that the evidence itself is far from persuasive in either direction.
The study undertaken by Kyle Jensen and Fiona Murray shows that there has been a deluge of patent applications over the last 25 or so years in biomedicine.[130] They found that nearly 20 per cent of all human genes have been claimed in patents granted in the US, with some genes featuring in up to 20 separate patents, and that while over 75 per cent have only one patent owner, the remainder have fragmented ownership. Similar findings are reported elsewhere.[131] Such volumes of patents and fragmented ownership could substantially increase the cost of access for downstream innovators. However, actual evidence that innovation at this level is being deterred in a significant way is not that easy to find. Rather, the prominent work of John Walsh, Ashish Arora and Wes Cohen in the US suggests that while the preconditions for an anticommons may well exist, the industry as a whole is finding ways of working around the problem.[132] Indeed, my research with Jane Nielsen in Australia conducted at around the same time as the study by Walsh, Arora and Cohen[133] together with other studies[134] lends supports to these findings.
These studies consistently report that those industry participants who need to be able to license-in the technology to secure freedom to operate tend to be able to do so. It is common, if not indeed the norm, to see non-exclusive licensing of foundational research tools, including patented DNA sequences. It seems that, for the most part, upstream patent holders tend to license widely, and users engage in a number of strategies in addition to licensing-in to ensure that their research and development programs can continue, including inventing around, litigating to challenge patent validity, or simply ignoring the patents that would otherwise block their research.
In the public research sector, the available evidence suggests that researchers are rarely impeded in their research programs by patents,[135] despite the absence of a clear exemption from infringement for research use in most jurisdictions and well-publicised case law in the US indicating that public sector research is not immune from infringement.[136] However, there is evidence that access to research materials is a growing problem,[137] and some argue that patents remain the ultimate cause of such problems.[138] There is also some evidence that suggests that even if patents are not actually enforced against other researchers, they may still deter follow-on research. Scott Stern and Fiona Murray used citations in peer reviewed journals in an attempt to measure this effect.[139] They identified scientific knowledge that had been both published and patented (the patent-paper pair) and measured the number of citations pre- and post-patent grant.[140] They found that there was a modest but significant decrease in citations post-grant and described this as an anticommons effect.[141]
While these studies are interesting, and show that patents can have a detrimental impact on upstream research, Rebecca Eisenberg reminds us that the focus of the concern that she articulated with Michael Heller in the anticommons thesis was on downstream research and development.[142] She argues that, where the data shed light on ‘downstream effects’, they tend to ‘provide evidence that the hypothesised mechanism is indeed operating’, albeit less seriously than originally predicted. Referring to interviews with industry participants that formed part of the Nicol-Nielsen study in 2002-2003 and similar interviews undertaken in the study by Walsh, Arora and Cohen, she concludes:
These interviews offer qualified support for the anticommons hypothesis. They suggest that the patent landscape for biomedical research is becoming more complex and that the cost of surveying that landscape and negotiating necessary licenses is rising, but that in most cases firms are able to work through the patent issues and find R&D projects to pursue that are not unduly burdened with IP rights. At the same time, they suggest that the risk of an anticommons, although perhaps smaller than might have been feared a decade ago, is nonetheless quite real in the calculations of product-developing firms. If a potential anticommons is identified at an early enough stage, the risk of bargaining breakdowns sometimes leads firms to avoid R&D pathways that would call for too many licenses in favor of projects for which the IP landscape is clearer.[143]
I accept that this conclusion can be drawn from my own work and that of Walsh, Arora and Cohen. The key message from the Nicol-Nielsen study is that while we found that there were challenges for biotechnology industry participants in respect of in-licensing and out-licensing of patents in this emerging Australian industry, practical means were being found to work around many (if not all) of these challenges. It appears that it was generally possible, in 2003, for downstream users to negotiate licence deals for core technologies, blocking patents could be worked around and the patent landscape was not so cluttered that project abandonment was inevitable.[144] But patent searches were onerous, and transactions were not cost-neutral. These challenges are only likely to become more difficult if the patent landscape gets more complex, particularly if participants become more determined to stake their claims and protect their territory. Like Eisenberg, I support larger studies focused on downstream freedom to operate practices within product-developing firms.[145] However, undertaking such studies is not a trivial exercise. Analysis of publicly accessible information will, at best, provide an incomplete picture of the extent to which DNA and like patents impede or slow the product development process. While interviews and surveys can provide valuable information to flesh out this picture, it is difficult to get good response rates and to be confident that the evidence properly reflects what is actually occurring.
Over the past two years I have been engaged in further analysis of the intellectual property and product development landscape in the Australian biotechnology industry with a research team that includes academics in the fields of law, social science, economics and innovation studies. Given that biotechnology industry participants are required to operate within an environment of diverse knowledge sources and complex intellectual property landscapes, this research tests whether they are generally able to work around impediments, take advantage of opportunities for collaboration and access the necessary intellectual property and other information and materials to innovate. The project includes analysis of patent law, patent and company databases, inventor surveys, stock exchange disclosures and product-related data, as well as interviews with industry participants. The ultimate question posed in this project is whether the evidence points towards a need for patent law reform, and if so, what the nature of that reform should be.
The current focus of the project is primarily on the drug discovery sector, although other biotechnology sectors will be examined later. We have used clinical trials data to identify relevant Australian organisations for analysis. Records of clinical trials are publicly available, providing a useful and reliable source of information on events occurring in the development gap between initial discovery and product delivery in the drug development sector. Informa Ltd[146] has collated a comprehensive set of data on clinical trials worldwide, including trials originated by Australian organisations. We have been using one of the Informa databases, known as PharmaProjects[147] to create a list of Australian originators of clinical trials, which we used to select interviewees for this component of the project. The PharmaProjects dataset is also being used, in combination with IP Australia’s patent dataset[148] and a third dataset created by my research team recording demographics of Australian biotechnology industry participants, for quantitative analyses exploring relationships between patenting, R&D expenditure, firm size, licensing and other forms of collaboration, clinical trials outcomes and other factors. The results of these analyses will be published at a later date.
There are approximately 43 firms in Australia that are currently operating and conducting clinical trials. Interviews have been conducted with business developers, CEOs, in-house counsel and intellectual property managers in over half of these firms. Admittedly, very few of these firms are directly involved in the late-stage delivery, manufacture, marketing and distribution of drugs. More often than not, the high cost involved in taking a drug through phase 3 clinical trials and product launch necessitates the involvement of large multinational pharmaceutical companies. As such, the overwhelming majority of our interviewees have business models built around on-licensing or takeover. Nevertheless, the fact that each firm has embarked on clinical trials indicates that they are end-product focused. As such, the interview dataset provides relevant information on downstream freedom to operate practices within product-developing firms. A manuscript providing a complete analysis of the interview dataset is in preparation.[149] My aim here is to provide a brief summary of some of the key trends emerging from the interviews that are of relevance to the question of whether DNA patents and other upstream patents deter innovation.
To provide further context on the shape of the Australian industry, although the drug development sector is small, there have been some notable success stories in terms of biologic product launches, including Gardasil, the human papillomavirus vaccine and Zanamivir (marketed as Relenza) for the treatment of influenza. Clinical trials for Gardasil were originated by CSL Ltd from research conducted by Professor Ian Frazer at the University of Queensland, and later stage development was carried out by Merck & Co.[150] Foundational research relating to Zanamivir was carried out at Monash University and commercialised by Biota Holdings Ltd, with later stage development being carried out by GlaxoSmithKline.[151]
Despite these successes, and while the Australian drug discovery sector appears to be performing roughly at world standard in terms of knowledge generation and diffusion, it seems that it is performing considerably less well than comparator countries like Canada in terms of knowledge use (using business expenditure on health research and development and alliance payouts as measures of value).[152] According to Bruce Rasmussen, one reason is the immaturity of the Australian industry relative to Canada, although he goes on to comment that this cannot fully explain the differences between the two countries. Rather, in his view the problems are more systemic, particularly when considering the financial implications of well-funded late-stage alliances and the way in which they feed back on other financial participants.[153] He also points out that small differences in knowledge generation and diffusion can result in large differences in outcomes.[154] Given that Australia and Canada have similar patent regimes, it seems unlikely that differences in patenting of biotechnological inventions could explain disparities in product development to any significant degree. However, what studies of this nature do illustrate is the extent to which small differences in one aspect of the innovation cycle can have disproportionate consequences in other parts of the cycle. Hence, modifications to the legal and regulatory environments should be approached with some caution, even if they are intended only to cause minor changes.
The interviews conducted during the course of my present study illustrate that, for the most part, originators of clinical trials in Australia are in a fight for survival. The biggest challenges are attracting investment and downstream partners. One common theme to emerge is that all interviewees see patents as the life-blood of their organisations. Although the ultimate role of patents is to exclude competitors, they are also recognised by interviewees as essential in securing early stage government support and venture capital funding as well as later stage investment for both public and private companies. They also facilitate the establishment of research collaborations, even with organisations that would otherwise be competitors, and late-stage alliances with pharmaceutical and other companies. This is the case irrespective of whether the patents held by the interviewee’s organisation claim biological materials, platform technologies or pharmaceuticals. Concern was expressed by interviewees about the potential for the Patents Amendment (Human Gene and Biological Materials) Bill 2010 to impact detrimentally on the industry, both because of the nature of the proposed exclusion itself and also because of uncertainty as to its ambit and consequences.
Interviewees in this study provided a diversity of views on the impact of patents held by others on their businesses. A surprising number spoke of being in an intellectual property ‘white space’, in which they possess the entire set of technologies necessary to develop their drugs, unfettered by patents held by others. Others commented that where there are problematic patents it is possible to work around them. In contrast, some of the firms in our sample operate in highly competitive fields, particularly vaccine development and cancer therapy. Interviewees involved in vaccine development, in particular, appear much more likely to encounter a complex patent landscape relating to genes, cell lines, vectors, antigens and other technologies. One interviewee suggested that up to six in-licences might be required. Others noted that they tend to enter into licence agreements with aggregators who have already done the hard work of accumulating all or most of the permissions needed to secure freedom to develop their products. Where cell lines and other research materials are required, some of these are now available from distributors, with no ongoing licence fees or other reach-through obligations, which suits some interviewees. However, others commented that the cost of purchasing these research tools is exorbitant, particularly when they are only going to be used in speculative research. Yet we heard little or no complaints that third party patent rights created ‘undue’ burdens on freedom to operate.[155] Even those participants in the industry who operate in more competitive areas seem to accept that working through the patent thicket is simply one of the costs of doing business.
While this is only a brief snapshot of the rich seam of information that will be mined in subsequent publications, it provides further support for the argument that patent thickets do not appear to be unduly impeding product development in the drug discovery sector of Australian biotechnology. Although biomedicine is a rapidly expanding area of research and development, there are still ‘white spaces’ for innovative activities, and even in more dense areas of research and development activity, multiple licence transactions for freedom to operate requirements seem rare. While mapping the intellectual property landscape continues to be costly and onerous, working through the landscape is less so. As such, once again this empirical evidence tends to provide only qualified support for the anticommons thesis.
As more genes, viruses, vectors, proteins and other biological materials continue to be isolated and characterised functionally and structurally, it is logical to presume that the patent landscape is ever-increasing in complexity. However, there is evidence that does not substantiate this presumption. Rather, it may well be the case that DNA and related patents have reached their peak and are in decline. David Adelman and Kathryn DeAngelis analysed a dataset of biotechnology patents granted in the US from 1990 to 2004 and found that the number of patents issued within a particular year reached a peak in 1998 and declined by 29 per cent by 2004.[156] They note that while it could be argued that this decrease lends support to the anticommons theory, the fact that applications actually increase in number tends to refute this.[157] Moreover, they note that the rates of patenting for genes and proteins tend to be much lower than for other fields, particularly measuring and testing processes.[158]
A patent survey undertaken by Michael Hopkins and colleagues at around the same time also tends to suggest that the landscape may actually be becoming less complex. They found that around a third of the DNA patent applications were withdrawn and just under a third of the patents granted in the 1990s had been abandoned by 2005.[159] It appears that increased stringency in demonstrating industrial applicability/utility and the other patent requirements is playing at least some role, both with regard to withdrawal and abandonment. While patenting in this area will continue, Hopkins et al conclude that its negative impact in this area ‘may turn out to be more limited than some had feared’.[160]
While it is unclear whether the types of downward trends in DNA patenting reported in these studies are continuing or reversing, it is difficult to find compelling evidence that the landscape is becoming more complex. Rather, predictions that patent grants in any new field of technology are likely to peak early and then either plateau or trough may well be eventuating in the field of biotechnology.[161] In part, this could be attributable to refinements in the application of the patent criteria by patent examiners as they become more experienced with biotechnology patents and as the body of jurisprudence that guides them in their decision-making continues to grow.
Concerns continue to be raised that DNA patents and patents over other fundamental research tools could deter innovation and impede access to healthcare benefits arising from biotechnology research. There is a body of evidence which suggests that these concerns are being realised to some extent, particularly in the US. The evidence is less compelling in Australia and other jurisdictions. On the available evidence, the detrimental impact of DNA patents appears to be considerably lower than anticipated by many commentators, even in the contexts of research and consumer access to healthcare. In the innovation context, it is inevitable in any industry where patenting is a recognised business strategy that there will be some costs associated with the exercise of patent rights. This is particularly likely to be the case in an area of cumulative innovation like medical biotechnology.[162] The market does appear to be resolving the DNA patent problem insofar as industry participants are able to find spaces to work with minor patent encumbrances, or to work around more major encumbrances. However, we should not be too complacent that all will be well in the future. In Classen Immunotherapies Inc v Biogen Idec, handed down by the US Court of Appeals of the Federal Circuit on 31 August 2011, the Court upheld a patent claiming a method of screening infant immunisation schedules to detect risk of chronic infectious diseases.[163] This decision has been described as a ‘troubling precedent’ which might encourage ‘patent trolls’ to turn their attention to biotechnology.[164]
Despite the risk that DNA patents could create more impediments to innovation in the future, I suggest that it is now time to move on from the prolonged and perhaps ultimately futile debate about the patentability of DNA as such, which has occupied so much of the valuable time of legislators, law reform agencies and academics alike, particularly in Australia. Notwithstanding, from my perspective as a law academic, it is difficult to accept that the legislature and policy makers can simply stand back and wait for definitive evidence of positive or negative impacts of DNA patenting to emerge, or for the market to take its course in resolving problems with DNA patenting. Rather, the law must surely play some role in all aspects of human interaction, but particularly in contentious areas such as this. The role of the law in regulating and facilitating biotechnology research and innovation must be adequate and appropriate in all the circumstances. I have made a case for a nuanced approach to patent law reform in a number of other forums.[165] Here, I leave it to contributors to the follow-on special issue of this journal on The Role of Law in DNA Patenting to make their own cases for the measures that need to be taken to ensure that the law plays a proper role in DNA patenting.
[*] PhD (Biology, Dalhousie University, Canada), LLM (UTas) Professor Centre for Law and Genetics Law Faculty University of Tasmania.
[1] For a discussion of these issues in the popular media, see CBS, ‘Patented Genes’, 60 Minutes, 4 April 2010
<http://www.cbsnews.com/video/watch/?id=6362525n & tag=related;photovide> Similarly, in Australia, see ABC, ‘Body Corporate’, Four Corners, 6 September 2010 <http://www.abc.net.au/4corners/special_eds/20100906/genes/> .
[2] See Association for Molecular Pathology (AMP) v United States Patent and Trademark Office (USPTO), 702 F Supp 2d 181 (SD NY, 2010), the first instance decision of Sweet J (‘AMP v USPTO’); and the appeal decision of the Court of Appeals for the Federal Circuit, Association for Molecular Pathology (AMP) v United States Patent and Trademark Office (USPTO), 653 F 3d 1329 (Fed Cir, 2011) (‘AMP v USPTO appeal’). Applications by both parties for a rehearing by the Federal Circuit have since been denied, but the possibility of filing a certiorari petition with the US Supreme Court continues to be available to both parties at the time of writing. For further updates on the litigation see: Genomics Law Report (2011) Robinson Bradshaw and Hinson
<http://www.genomicslawreport.com/index.php/category/badges/myriad-gene-patent-litigation/> .
[3] A challenge to the validity of one of the BRCA product patents by Cancer Voices Australia is set down for hearing in the Federal Court of Australia on 20 February 2012. See, Commonwealth Courts Portal, Applications (2011)
<https://www.comcourts.gov.au/file/Federal/P/NSD643/2010/actions>. Also see A Ridley and D Nicol, ‘Is There Still a Place for Gene Patents in Australia? Implications of Recent US and European Case Law’ (2011) Journal of Law and Medicine, in press.
[4] Senate Legal and Constitutional Affairs Legislation Committee, Patent Amendment (Human Genes and Biological Materials) Bill 2010 (21 September 2011) Commonwealth of Australia
<http://www.aph.gov.au/senate/committee/legcon_ctte/patent_amendment/report/index.htm> , further information is available at:
<http://www.aph.gov.au/senate/committee/legcon_ctte/patent_amendment/index.htm> .
[5] The most frequently cited article reporting on numbers of DNA patents is K Jensen and F Murray, ‘Intellectual Property Landscape of the Human Genome’ (2005) 310 Science 239.
[6] I and my colleagues articulate our reasons for this conclusion in our submission to the Senate inquiry into the Patent Amendment (Human Genes and Biological Materials) Bill 2010. See D Nicol, J Liddicoat, J Nielsen and B Mee, Submission No 39 to Australian Senate Legal and Constitutional Affairs Legislation Committee, Patent Amendment (Human Genes and Biological Materials) Bill 2010, 21 September 2001,
<http://www.aph.gov.au/senate/committee/legcon_ctte/patent_amendment/submissions.htm> . Also see D Nicol, J Liddicoat, J Nielsen and B Mee, ‘On the Futility of Excluding Gene Patents: Lessons from Australia’ (unpublished manuscript on file with author).
[7] D Nicol, ‘Are the Courts Solving the Emerging Challenges of Biotech Patents?’ in K Bowrey, M Handler and D Nicol (eds), Emerging Challenges in Intellectual Property (Oxford University Press, 2011) 145, 147.
[8] There is not a direct one-to-one correspondence of genes to proteins. In humans, for example, recent estimates of the number of genes are as low as 20 000, yet there are far more proteins. Hence, a particular gene might carry the information to make several proteins. See International Human Genome Sequencing Consortium, ‘Finishing the Euchromatic Sequence of the Human Genome’ (2004) 431 Nature 931.
[9] E Pennisi, ‘DNA Study Forces Rethink of What It Means to Be a Gene’ (2007) 316 Science 1556.
[10] J Skolnick and J S Fetrow, ‘From Genes to Protein Structure and Function: Novel Applications of Computational Approaches in the Genomic Era’ (2000) 18 Trends in Biotechnology 34.
[11] While I use the word ‘market’ in its natural and ordinary sense, to mean a place where goods and services are exchanged, I recognise that the nature of the market has long been debated in economic context, dating back as far as Adam Smith’s, An Inquiry into the Nature and Causes of the Wealth of Nations (Pennsylvania State University, first published 1776, 2005 ed), available at:
<www2.hn.psu.edu/faculty/jmanis/adam-smith/Wealth-Nations.pdf>. It is beyond the scope and purpose of this article to delve further into this economic debate about markets.
[12] The necessity of taking an evidence-based approach to intellectual property law reform was most recently articulated in I Hargreaves, Digital Opportunity: A Review of Intellectual Property and Growth (2011), an independent report commissioned by the UK Prime Minister.
[13] J D Watson and F H C Crick, ‘A Structure for Deoxyribose Nucleic Acid’ (1953) 171 Nature 737.
[14] See Chapter 4, ‘Playing God: Customised DNA Molecules’ in J D Watson with A Berry, DNA: The Secret of Life (Alfred A Knopf, 2004) 87-112.
[15] D A Jackson, R H Symons and P Berg, ‘Biochemical Method for Inserting New Genetic Information into DNA of Simian Virus 40: Circular SV40 DNA Molecules Containing Lambda Phage Genes and the Galactose Operon of Escherichia coli’ (1972) 69 Proceedings of the National Academy of Sciences 2904; S N Cohen, A C Y Chang, H W Boyer and R B Helling, ‘Construction of Biologically Functional Bacterial Plasmids in Vitro’ (1973) 70 Proceedings of the National Academy of Science 3240. See also National Research Council, Intellectual Property Rights and the Dissemination of Research Tools in Molecular Biology (National Academy Press, 1997) 40-42.
[16] See, for example, K Itakura, T Hirose, R Crea, et al, ‘Expression in Escherichia coli of a Chemically Synthesized Gene for Hormone Somatostatin’ (1977) 198 Science 1056; I S Johnson, ‘Human Insulin from Recombinant DNA Technology’ (1983) 219 Science 632; K Jacobs, C Shoemaker, R Rudersdorf, et al, ‘Isolation and Characterization of Genomic and cDNA Clones of Human Erythropoietin’ (1985) 313 Nature 806.
[17] T A Stewart, P K Pattengale and P Leder, ‘Spontaneous Mammary Adenocarcinomas in Transgenic Mice that Carry and Express MTV/myc Fusion Genes’ (1984) 38 Cell 627; D Hanahan, E F Wagner and R D Palmiter, ‘The Origins of Oncomice: a History of the First Transgenic Mice Genetically Altered to Develop Cancer’ (2007) 21 Genes and Development 2258.
[18] R E Sheehy, M Kramer and W R Hiatt, ‘Reduction of Polygalacturonase Activity in Tomato Fruit by Antisense RNA’ (1988) 85 Proceedings of the National Academy of Science USA, 8805.
[19] President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Splicing Life: A Report on the Social and Ethical Issues of Genetic Engineering with Human Beings (President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1982); R M Cook-Deegan, ‘Human Gene Therapy and Congress’ (1990) 1 Human Gene Therapy 163.
[20] F Sanger, S Nicklen and A R Coulson, ‘DNA Sequencing with Chain-Terminating Inhibitors’ (1977) 74 Proceedings of the National Academy of Science 5463; A M Maxam and W Gilbert, ‘A New Method for Sequencing DNA’ (1977) 74 Proceedings of the National Academy of Science 560.
[21] R Saiki, S Scharf, F Faloona, K Mullis, G Horn and H Erlich, ‘Enzymatic Amplification of Beta-globin Genomic Sequences and Restriction Site Analysis for Diagnosis of Sickle Cell Anemia’ (1985) 230 Science 1350; K Mullis, ‘The Unusual Origin of the Polymerase Chain Reaction’ (April 1990) Scientific American 56.
[22] For an interesting account of the politics behind the Human Genome Project see: R M Cook-Deegan, The Gene Wars: Science, Politics, and the Human Genome (Norton & Co, 1996).
[23] See: US Department of Energy, Human Genome Project Information (25 July 2011) <http://www.ornl.gov/sci/techresources/Human_Genome/home.shtml> .
[24] P Nightingale and P Martin, ‘The Myth of the Biotech Revolution’ (2004) 22 Trends in Biotechnology 564; M M Hopkins, P A Martin, P Nightingale, A Kraft and S Mahdi, ‘The Myth of the Biotech Revolution: An Assessment of Technological, Clinical and Organisational Change’ (2007) 36 Research Policy 566.
[25] Genentech, Genentech Founders (25 September 2011)
<http://www.gene.com/gene/about/corporate/history/founders.html> .
[26] W B Lacy, ‘Commercialization of University Research Brings Benefits, Raises Issues and Concerns’ (2000) 54 California Agriculture 79.
[27] A K Rai and R S Eisenberg, ‘Bayh Dole Reform and the Progress of Biomedicine’ (2003) 91 American Scientist 52; F Murray, ‘The Oncomouse That Roared: Resistance and Accommodation to Patenting in Academic Science’ (2010) 116 American Journal of Sociology 341.
[28] Mullis, above n 21; R Cook-Deegan and C Heaney, ‘Patents in Genomics and Human Genetics’ (2010) 11 Annual Review of Human Genetics 383, 398-399.
[29] S Krimsky, ‘The Profit of Scientific Discovery and its Normative Implications’ (1999) 75 Chicago Kent Law Review 15.
[30] For example, Cook-Deegan and Heaney provide an overview of unpublished data indicating that 39 per cent of DNA patents granted in the US between 1980 and 1993 are owned by academic institutions, compared with 3 per cent of the total population of granted patents in the same timeframe. See Cook-Deegan and Heaney, above n 28, 388.
[31] D Nicol, ‘Strategies for Dissemination of University Knowledge’ (2008) 16 Health Law Review 207; S O’Connor, G D Graff, and D E Winickoff, ‘Legal Context of University Intellectual Property and Technology Transfer’ (2010) commissioned paper prepared for the National Academies of Science report, Managing University Intellectual Property in the Public Interest (25 September 2011) <http://ourenvironment.berkeley.edu/people_profiles/david-e-winickoff/> .
[32] D E Stokes, Pasteur’s Quadrant: Basic Science and Technological Innovation (Brookings Institution Press, 1997).
[33] R S Eisenberg and R Nelson, ‘Public vs. Proprietary Science: a Fruitful Tension?’ (2002) 77 Academic Medicine 1392; D Chalmers and D Nicol, ‘Commercialisation of Biotechnology: Public Trust and Research’ (2004) 6 International Journal of Biotechnology 116; Cook-Deegan and Heaney, above n 28, 391.
[34] See, for example, Jensen and Murray, above n 5; M M Hopkins, S Mahdi, P Patel and S M Thomas, The Patenting of Human DNA: Global Trends in Public and Private Sector Activity: A Report for the European Commission (SPRU, 2006) <http://www.sussex.ac.uk/spru/documents/patgen_finalreport.pdf>
Cook-Deegan and Heaney, above n 28.
[35] This quote comes from an interview conducted by Robert Cook-Deegan with the sequencing pioneers Walter Gilbert and Frederick Sanger, reported in Cook-Deegan and Heaney, above n 28, 392.
[36] Human Genome Organization, Summary of Principles Agreed at the First International Strategy Meeting on Human Genome Sequencing (1996)
<http://www.ornl.gov/sci/techresources/Human_Genome/research/bermuda.shtml#> .
[37] For an expression of Venter’s view on rapid release of sequence data see: Mark D Adams and J Craig Venter, ‘Should Non-peer-reviewed Raw DNA Sequence Data Release Be Forced on the Scientific Community?’ (1996) 274 Science 534.
[38] Two companies, Incyte Genomics Inc and Human Genome Sciences Inc are cited as examples of the most profligate DNA patenters. See, for example, R F Service, ‘Gene and Protein Patents Get Ready to Go Head to Head’ (2001) 294 Science 2082; Cook-Deegan and Heaney, above n 28, 401-404.
[39] ESTs are short fragments of complementary or cDNA, created through the process of reverse transcription from messenger RNAs, which are the intermediate step in creating proteins from genes. See M D Adams, J M Kelley, J D Gocayne, et al, ‘Complementary DNA Sequencing: Expressed Sequence Tags and the Human Genome Project’ (1991) 252 Science 1651.
[40] This methodology involves breaking up numerous DNA molecules within a single organism into small fragments to facilitate sequencing and reassembly of the information using complex computer programming. See R D Fleischmann, M D Adams, O White, et al, ‘Whole-Genome Random Sequencing and Assembly of Haemophilus influenzae Rd’ (1995) 269 Science 496.
[41] J C Venter, K Remington, J F Heidelberg, et al, ‘Environmental Genome Shotgun Sequencing of the Sargasso Sea’ (2004) 304 Science 66.
[42] Cook-Deegan and Heaney, above n 28, 400-401.
[43] Ibid 390.
[44] E R Gold and A Gallochat, ‘The European Biotech Directive: Past as Prologue’ (2001) 7 European Law Journal 331, 335.
[45] Convention on the Grant of European Patents, opened for signature 5 October 1973, 1065 UNTS 199 (entered into force 7 October 1977) (‘European Patent Convention’).
[46] Gold and Gallochat, above n 44.
[47] European Parliament and Council Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions [1998] OJ L 213/13 (‘European Biotechnology Directive’).
[48] Gold and Gallochat, above n 44, 337-340. The Directive withstood a challenge in the European Court of Justice: Kingdom of the Netherlands v European Parliament and Council of the European Union, (C-377/98) [2001] ECR I-7079. However, it remains contentious and was not fully implemented by signatories to the European Patent Convention until 2007: R Fitt, ‘New Guidance on the Patentability of Embryonic Stem Cell Patents in Europe’ (2009) 27 Nature Biotechnology 338.
[49] See, for example, R Dresser, ‘Ethical and Legal Issues in Patenting New Animal Life’ (1988) Jurimetrics Journal 399; B Hoffmaster, ‘The Ethics of Patenting Higher Life Forms’ (1988) 4 Intellectual Property Journal 1; D Manspeizer, ‘The Cheshire Cat, the March Hare and the Harvard Mouse: Animal Patents Open Up a New Genetically-engineered Wonderland’ (1991) 43 Rutgers Law Review 417.
[50] For example, R S Eisenberg, ‘Patents and the Progress of Science: Exclusive Rights and Experimental Use’ (1989) 56 University of Chicago Law Review 1017; R S Eisenberg, ‘Patenting the Human Genome’ (1990) 39 Emory Law Journal 721.
[51] M Heller and R S Eisenberg, ‘Can Patents Deter Innovation? The Anticommons in Biomedical Research’ (1998) 280 Science 698, 698. See also C Shapiro, ‘Navigating the Patent Thicket: Cross Licenses, Patent Pools, and Standard-setting’ in A Jaffe, J Lerner and S Stern (eds), Innovation Policy and the Economy (MIT Press, 2001) 119.
[52] My colleague, Jane Nielsen, describes reach-through rights in the following way: ‘Reach-through rights give patent holders rights to downstream uses of the patented invention. They may take a number of forms, including rights to royalties over future inventions, rights to intellectual property over future inventions, and exclusive licences over future inventions.’ J Nielsen, ‘Reach-Through Rights in Biomedical Patent Licensing: A Comparative Analysis of their Anti-Competitive Reach’ (2004) 32 Federal Law Review 169, 170.
[53] Reviewed in J P Walsh, A Arora and W M Cohen, ‘Effects of Research Tool Patenting and Licensing on Biomedical Innovation’ in W M Cohen and S A Merrill (eds), Patents in the Knowledge-Based Economy (National Academies Press, 2003) particularly at 296-297,
<http://books.nap.edu/books/0309086361/html/285.html#pagetop; see also J P Walsh, A Arora and W M Cohen, ‘Working Through the Patent Problem’ (2003) 299 Science 1021.
[54] I Huys, N Berthels, G Matthijs, and G Van Overwalle, ‘Legal Uncertainty in the Area of Genetic Diagnostic Testing’ (2009) 27 Nature Biotechnology 903.
[55] Ibid 908.
[56] A K Rai, ‘Regulating Scientific Research: Intellectual Property Rights and the Norms of Science’ (1999) 94 Northwestern University Law Review 77.
[57] M K Cho, S Illangasekare, M A Weaver, D G B Leonard and J F Merz, ‘Effect of Patents and Licenses on the Provision of Clinical Genetic Testing Services’ (2003) 5 Journal of Molecular Diagnostics 3.
[58] See, for example, Organisation for Economic Co-operation and Development (OECD), Genetic Inventions, Intellectual Property Rights and Licensing Practices: Evidence and Policies (OECD, 2002)
<http://www.oecd.org/dataoecd/42/21/2491084.pdf> Nuffield Council on Bioethics, The Ethics of Patenting DNA (Nuffield Council on Bioethics, 2002) <http://www.nuffieldbioethics.org/patenting-dna> Danish Council of Ethics, Patenting Human Genes and Stem Cells (Danish Council of Ethics, 2004) <http://etiskraad.dk/da-DK/Udgivelser/BookPage.aspx?bookID={F230493B-14CE-4D62-BA75-179BD110E3D9} & sc_lang=en> Australian Law Reform Commission (ALRC), Genes and Ingenuity: Gene Patenting and Human Health, Report No 99 (2004) (‘ALRC Report, Genes and Ingenuity’)
<http://www.alrc.gov.au/publications/executive-summary/genes-and-ingenuity> Canadian Biotechnology Advisory Committee and Industry Canada, Patenting of Higher Life Forms and Related Issues (Canadian Biotechnology Advisory Committee, 2002)
<http://www.ic.gc.ca/eic/site/ippd-dppi.nsf/eng/ip00033.html>
National Research Council, Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation and Public Health (National Research Council, 2006) <http://www.nap.edu/catalog.php?record_id=11487> World Health Organization, Genetics, Genomics and the Patenting of DNA: Review of Potential Implications for Health in Developing Countries (World Health Organization, 2005) <http://www.who.int/genomics/patentingDNA/en/> US Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS), Gene Patents and Licensing Practices and their Impact on Patient Access to Genetic Tests (2010) <http://oba.od.nih.gov/SACGHS/sacghs_documents.html#GHSDOC_011> (the ‘SACGHS Report’); Australian Senate Community Affairs Committee, Report on Gene Patents (Parliament of Australia, 2010)
<http://www.aph.gov.au/senate/committee/clac_ctte/gene_patents_43/report/index.htm> (‘Australian Senate Gene Patent Report’).
[59] Using just one example to illustrate this point, the ALRC Report, Genes and Ingenuity, above n 58, included recommendations on the following topics: patent criteria (6-1); industrial applicability (referred to by the ALRC as usefulness) (6-3 and 6-4); exclusions from patentability (7-1); exemption for experimental use (13-1); compulsory licensing (27-1) as well as a range of other legal and policy measures.
[60] J J Doll, ‘The Patenting of DNA’ (1998) 280 Science 689.
[61] See Cook-Deegan and Heaney, above n 28, 390-391.
[62] Dan Vorhaus, ‘Update: Proposed Second Opinion Safe Harbor for Genetic Diagnostic Testing Withdrawn’ on Genomics Law Report, (16 June 2011) <http://www.genomicslawreport.com/index.php/2011/06/16/update-proposed-second-opinion-safe-harbor-for-genetic-diagnostic-testing-withdrawn/> .
[63] Nicol et al, above n 6.
[64] Senate Legal and Constitutional Affairs Legislation Committee, above n 4.
[65] Ibid 67-100.
[66] See, Commonwealth, Parliamentary Debates, Senate, 20 September 1990, 2653 (J Coulter); Commonwealth, Parliamentary Debates, House of Representatives, 16 October 1990, 2947 (G D Prosser); Commonwealth, Parliamentary Debates, Senate, 27 June 1996, 2332 (N Stott Despoja).
[67] Article 5(2) of the Biotechnology Directive, incorporated into European Patent Convention 2000, Rule 29; See Nicol, above n 7, 150-151.
[68] Utility Examination Guidelines, 66 Fed Reg 1092, 1095 (2001).
[69] As was well illustrated in Re Fisher [2005] USCAFED 189; 421 F 3d 1365 (Fed Cir, 2005).
[70] Pub L No 112-29, 125 Stat 284 (2011).
[71] [1980] USSC 119; (1980) 447 US 303 (‘Chakrabarty’).
[72] Ibid 309.
[73] Ibid 310. In this case in the form of a modified bacterium that could break down a number of the components of crude oil.
[74] AMP v USPTO, 702 F Supp 2d 181 (SD NY, 2010); AMP v USPTO appeal, 653 F 3d 1329 (Fed Cir, 2011).
[75] As applied in Re Bilski, 545 F 3d 943 (CA Fed, 2008) by the US Federal Circuit.
[76] AMP v USPTO, 702 F Supp 2d 181 (SD NY, 2010) 132-135.
[77] Re Bilski, 545 F 3d 943, 954 (CA Fed 2008) by the US Federal Circuit.
[78] AMP v USPTO, 702 F Supp 2d 181 (SD NY, 2010) 157-159.
[79] AMP v USPTO appeal, 653 F 3d 1329 (Fed Cir, 2011).
[80] United States Department of Justice, ‘Brief for the United States as Amicus Curiae in Support of Neither Party’, Submission in AMP v USPTO appeal, appeal number 2010-1406, 29 October 2010,
[81] 130 S Ct 3218 (2010).
[82] Ibid 3230, citing Diamond v Diehr, [1981] USSC 40; 101 S Ct 1048, 1057 (1981).
[83] See, for example, R C Dreyfuss, ‘The Patentability of Genetic Diagnostics in U.S. Law and Policy’ (Public Law Research Paper No 10-68, New York University, School of Law, (16 September 2010) 18.
[84] AMP v USPTO appeal, 653 F 3d 1329 (Fed Cir, 2011) 1351.
[85] Ibid.
[86] Ibid 1351-1352 (Lourie J).
[87] Ibid 1364-1365 (Moore J).
[88] Ibid 1365 (Moore J).
[89] Ibid 1365-1366 (Moore J).
[90] Ibid 1366-1367 (Moore J).
[91] Ibid 1366-1367 (Moore J).
[92] Ibid 1373 (Bryson J). However, his Honour rejected the claims to short fragments of isolated and cDNA at 1378-1381.
[93] Ibid 1375 (Bryson J).
[94] Ibid 1375-1377 (Bryson J). See particularly the quoted extracts at 1375-1376 and 1377.
[95] Ibid 1355-1356 (Lourie J). See also Moore J’s judgment at 1358 and Bryson J’s judgment at 1373.
[96] Myriad tried to argue that these steps could be read in to the existing method claims, but this argument was rejected by the court. See Ibid 1356-1357 (Lourie J).
[97] Ibid 1357-1358 (Lourie J). See also Moore J’s judgment at 1358 and Bryson J’s judgment at 1373.
[98] For updates see Genomics Law Report, above n 2.
[99] C M Holman, ‘The Impact of Human Gene Patents on Innovation and Access: a Survey of Human Gene Patent Litigation’ (2007) 76 University of Missouri at Kansas City Law Review 295.
[100] J R Allison, M A Lemley, K A Moore, and R D Trunkey, ‘Valuable Patents’ (2004) 92 Georgetown Law Journal 435, cited in Holman, ibid 304.
[101] Holman, above n 99, 305.
[102] Jensen and Murray, above n 5.
[103] Holman, above n 99, 355.
[104] Ibid 355-357.
[105] Ibid 361.
[106] See, for example, Cho et al, above n 57; J F Merz, D G Kriss, D G B Leonard and M K Cho, ‘Diagnostic Testing Fails the Test’ (2002) 415 Nature 577.
[107] E R Gold and J Carbone, ‘Myriad Genetics: In the Eye of the Policy Storm’ (2010) 12 Genetics in Medicine S39; J Carbone, E R Gold, B Sampat, S Chandrasekharan, L Knowles, M Angrist, and R Cook-Deegan, ‘DNA Patents and Diagnostics: Not a Pretty Picture’ (2010) 28 Nature Biotechnology 784.
[108] Cho et al, above n 57, 4-5.
[109] Ibid 5.
[110] D Nicol and J Nielsen, ‘Patents and Medical Biotechnology: An Empirical Analysis of Issues Facing the Australian Industry’ (Occasional Paper No 6, Centre for Law and Genetics, 2003).
[111] Ibid 200-205.
[112] S Gaisser, M M Hopkins, K Liddell, E Zika and D Ibarreta, ‘The Phantom Menace of Gene Patents’ (2009) 458 Nature 407; N Hawkins, ‘The Impact of Human Gene Patents on Genetic Testing in the United Kingdom’ (2011) 13 Genetics in Medicine 320.
[113] Australian Senate Gene Patent Report, above n 58.
[114] SACGHS Report, above n 58.
[115] Ibid 89.
[116] Ibid Appendix A; the findings of these case studies were reported in a special supplement to Volume 12 of Genetics in Medicine, Patently Complicated: Case Studies on the Impact of Patenting and Licensing on Clinical Access to Genetic Testing in the United States (April 2010) S1-S211.
[117] SACGHS Report, above n 58, 10.
[118] Ibid 42.
[119] Ibid 2.
[120] Ibid 94-95.
[121] Full text Amicus Briefs in this case are available through various patent blogs. See, for example, Donald Zuhn, ‘AMP v. USPTO - Briefing Update II’ on Patent Docs (16 December 2010) <http://www.patentdocs.org/2010/12/amp-v-uspto-briefing-update-ii.html> .
[122] Christopher M Holman and Robert Cook-Deegan, ‘Brief of Amici Curiae Christopher M Holman and Robert Cook-Deegan in Support of Neither Party’, Submission in AMP v USPTO appeal, appeal number 2010-1406, 28 October 2010, 6.
[123] Ibid 12.
[124] American Medical Association et al, ‘Brief for American Medical Association, American Society of Human Genetics, American College of Obstetricians and Gynecologists, American College of Embryology, and the Medical Society of the State of New York as Amici Curiae in Support of Plaintiffs-Appellees and Arguing for Affirmance’, Submission in AMP v USPTO appeal, appeal number 2010-1406, 6 December 2010, 3-7.
[125] Ibid.
[126] Holman and Cook-Deegan, above n 122.
[127] Heller and Eisenberg, above n 51.
[128] AMP v USPTO appeal, 1371-1372 (Moore J).
[129] Ibid 1380 (Bryson J) citing Breyer J’s opinion in Lab Corp of America Holdings v Mebtabolite Labs Inc, 548 US 124 (2006) 126. In this case Breyer J dissented from a writ to the Supreme Court that the Court held was improvidently granted.
[130] Jensen and Murray, above n 5.
[131] B Verbeure, G Matthijs and G Van Overwalle, ‘Analysing DNA Patents in relation with Diagnostic Genetic Testing’ (2005) 14 European Journal of Human Genetics 26; Hopkins et al, above n 34.
[132] Walsh, Arora and Cohen, ‘Effects of Research Tool Patenting and Licensing on Biomedical Innovation’ above n 53, 287.
[133] Nicol and Nielsen, above n 110, 208-224.
[134] Reviewed in: T Caulfield, R M Cook-Deegan, F S Keiff and J P Walsh, ‘Evidence and Anecdotes: An Analysis of Human Gene Patenting Controversies’ (2006) 24 Nature Biotechnology 1091; R S Eisenberg, ‘Noncompliance, Nonenforcement, Nonproblem? Rethinking the Anticommons in Biomedical Research’ (2008) 45 Houston Law Review 1059.
[135] J P Walsh, C Cho, and W M Cohen, Material Transfers and Access to Research Inputs in Biomedical Research (Final Report to the National Academy of Sciences’ Committee on Intellectual Property Rights in Genomic and Protein-Related Research Inventions, 2005); J P Walsh, C Cho, and W M Cohen, ‘View from the Bench: Patents and Material Transfers’ (2005) 309 Science 2002; Nicol and Nielsen, above n 110, 218-222.
[136] Madey v Duke University, [2002] USCAFED 222; 307 F 3d 1351, 1360-1 (Fed Cir 2002).
[137] Walsh, Cho and Cohen, ‘Material Transfers and Access to Research Inputs in Biomedical Research’ above n 135.
[138] Z Lei, R Juneja and B Wright, ‘Patents Versus Patenting: Implications of Intellectual Property Protection for Biological Research’ (2009) 7 Nature Biotechnology 36.
[139] F Murray and S Stern, ‘Do Formal Intellectual Property Rights Hinder the Free Flow of Scientific Knowledge? An Empirical Test of the Anti-commons Hypothesis’ (2007) 63 Journal of Economic Behavior & Organization 648.
[140] For methodology see ibid 656-661.
[141] Ibid 683-684.
[142] Eisenberg, above n 134, 1075.
[143] Ibid 1079-1080, footnotes omitted.
[144] Nicol and Nielsen, above n 110, 137-195.
[145] Eisenberg, above n 134, 1080.
[146] Informa Business Information (2011) <http://www.informa.com/> .
[147] PharmaProjects, ‘Pharmaceutical R&D Intelligence’ (2011)
<http://www.pharmaprojects.com/> .
[148] Australian Government, (2011) IP Australia
<http://www.ipaustralia.gov.au/patents/search_index.shtml> .
[149] D Nicol, J Liddicoat and J Nielsen, ‘Relationships Between Products, Patents and Collaboration in Drug Discovery in Australia’ (forthcoming).
[150] For a brief overview of these developments see: Graeme O’Neill, ‘CSL Celebrates Cervical Cancer Vaccine Success’ (2002) Australian Life Scientist <http://www.lifescientist.com.au/article/48933/csl_celebrates_cervical_cancer_vaccine_success/> .
[151] D Cyranoski, ‘Threat of Pandemic Brings Flu Drug Back To Life’ (2005) 11 Nature Medicine 909.
[152] B Rasmussen, ‘Developing the Biomedical Industries in Canada and Australia: An Innovation Systems Approach’ (Working Paper No 24, Victoria University of Technology, Centre for Strategic Economic Studies, Pharmaceutical Industry Project, 2005) <http://www.cfses.com/staff/brasmussen.htm> .
[153] Ibid 15.
[154] Ibid 14.
[155] This term was used in an earlier survey of the Australian medical biotechnology industry undertaken in 2008. See D Nicol, ‘Patent Licensing in Medical Biotechnology in Australia: A Role for Collaborative Licensing Strategies’ (Occasional Paper No 7, Centre for Law and Genetics, Faculty of Law, University of Tasmania, 2010). In that study, 25 per cent of participants (15 out of 59) reported that they encountered such undue burdens. This research was undertaken in collaboration with the Van Overwalle group from the Centre for Intellectual Property Rights at Leuven University in Belgium, who found a similar level of concern about undue burdens amongst participants in a similar survey in Europe. See E van Zimmeren, S Vanneste and G Van Overwalle, Patent Licensing in Medical Biotechnology in Europe (Centre for Intellectual Property Rights, in press); also see E van Zimmeren, S Vanneste, G Matthijs, W Vanhaverbeke and G Van Overwalle, ‘Patent Pools and Clearing Houses in the Life Sciences’ (2011) Trends in Biotechnology, in press.
[156] D E Adelman and K L DeAngelis, ‘Patent Metrics: the Mismeasure of Innovation in the Biotech Patent Debate’ (2007) 85 Texas Law Review 1677, 1687.
[157] Ibid 1688-1689.
[158] Ibid 1692.
[159] Hopkins et al, above n 34. These statistics are presented in summary form in the Executive Summary.
[160] Ibid Executive Summary.
[161] Commission of the European Communities, Report of the Commission to the Council and the European Parliament, Development and Implications of Patent Law in the Field of Biotechnology and Genetic Engineering (14 July 2005) 4 <http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber & lg=en & type_doc=COMfinal & an_doc=2005 & nu_doc=312> .
[162] S Scotchmer, Innovation and Incentives (Massachusetts Institute of Technology, 2004) 127-159.
[163] Classen Immunotherapies Inc v Biogen Idec (Fed Cir, 2011) Case No 2006-1634-1649.
[164] E C Hayden, ‘”Patent Trolls” Target Biotechnology Firms’ (2011) 477 Nature 521.
[165] See, for example, J Nielsen and D Nicol, ‘Whither Patent Use Without Authorisation in Australia’ (2008) 36 Federal Law Review 333; D Nicol, ‘Navigating the Molecular Diagnostic Patent Landscape’ (2008) 18 Expert Opinion on Therapeutic Patents 461; T Caulfield, E Einsiedel, J Merz and D Nicol, ‘Trust, Patents, and Public Perceptions: The Governance of Controversial Biotechnology Research’ (2006) 24 Nature Biotechnology 1352; D Nicol, ‘On the Legality of Gene Patents’ [2005] MelbULawRw 25; (2005) 29 Melbourne University Law Review 809; Nicol and Nielsen, above n 110.
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