Source: https://theundisciplined.com/2014/03/04/playing-gods-patent-lawyer-the-challenges-of-patent-law-in-the-field-of-genetics/
Timestamp: 2017-06-24 00:18:34
Document Index: 578119836

Matched Legal Cases: ['§ 101', 'sui generis', 'CJEU ', 'Art. 53', 'Art. 52', 'Art. 53', 'Art. 6', 'Art. 5', 'UKHL ', 'Art. 6', 'Art.52', '§ 8', 'UKHL ']

Playing God(‘s Patent Lawyer): The Challenges of Patent Law in the Field of Genetics | Search
Below is a slightly adapted version of a final paper I wrote for the course Intellectual Property II during my LLM in Innovation, Technology and the Law at the University of Edinburgh. One of the major drawbacks which both I and the examiner noticed about this work was that I clearly bit off more than I could chew for what should have been a 5,000 word essay, by attempting to cover the far too broad area of “genetics”, rather than focussing on a more specific subset of that field. Nonetheless, though it took away from the paper’s ability to discuss some of the finer legal points in detail, it does mean that the paper remains a fairly good short overview of the entire field of patent law and genetics for any who might be interested. Enjoy:
Straddling the fine line between physical property, an informational medium and the building blocks of more complex systems, the field of genetics is particularly challenging for traditional patent law. The language and concepts of patent law can often be difficult to consolidate with the realities of genetic innovation. Arguments rage as to whether genetic processes and genes themselves should be patentable at all;[1] the discovery/invention distinction; the requirements of industrial application and novelty;[2] the inclusion of moral arguments and the limits of the scope of patent law.[3] An interesting distinction is drawn by many, and is reflected in the legal and policy developments in this area, between patents regarding lower life-forms, higher life-forms and human genetic material – all of which leading to a greater lack of clarity and harmony in the patent system.
As in the software industry,[4] many of the problems with applying patent law to the field of genetics arises from the fact that the current patent systems were created over the space of many decades, even centuries, to primarily deal with mechanical inventions, and, as such, the details of software programs or genetic innovation often do not transpose well onto the language and parameters of these systems.[5] Genetic research and discoveries proceed at such a pace that it is difficult for the law and policy to keep up with developments; a key example is the long fought passing of the EU ‘Biotech Directive’,[6] which sought to introduce some level of clarification and harmonisation of biotechnology regulation in Europe, but immediately preceded a breakthrough in isolation of human embryonic stem cells (hESCs),[7] which resulted in a situation where one of the most controversial areas of patentability in genetics was not thoroughly contemplated or covered by the legislation.
Another key area of difficulty in the patenting of genetic technology is the comparatively high level of disharmony between international approaches to the subject. Although there are continued moves within the international patent law community towards further harmonisation,[8] for societal, constitutional, ethical and religious reasons the concept of patenting life-forms or genes can lead to varied and contradictory conclusions, even between similar jurisdictions.[9] Given the often highly international nature of collaborative research projects and large biotechnology firms, this geographical disharmony can lead to bureaucratic nightmares and high levels of legal uncertainty.[10] Such uncertainties can lead to worries from researchers about their freedom to use certain processes,[11] or from investors and rightsholders regarding protection for their inventions.[12]
Biotechnology, Lower Life-forms
The ‘Chakrabarty’ Case
Diamond v Chakrabarty,[13] was a US Supreme Court decision dealing with whether genetically modified organisms could be patented, and one of the earliest and most fundamental cases in this area. Mr Chakrabarty genetically engineered pseudomonas putida bacteria for efficiency in treating oil spills. This was not the first case of its kind, but the one which affirmed at Supreme Court level the basic patentability of life-forms in the US, something which was unclear up to that point and is still opposed by many today.[14] This case’s journey through the United States Patents and Trademarks Office (USPTO) and the courts illustrates the significant lack of clarity and the opposing viewpoints on this matter. At first the Patent Office allowed the claim for a process patent on the method of production, but rejected the claim for the bacterium itself. On appeal it was concluded that 35 USC § 101[15] was not intended to cover living things, even lab-created bacteria. The Court of Customs and Patent Appeals, by a divided vote, reversed this decision on the authority of its prior decision in In re Bergy,[16] which held that “the fact that microorganisms . . . are alive . . . [is] without legal significance”. The question of whether the non-naturally occurring micro-organism could be patented was ultimately referred to the US Supreme Court. On the question of statutory interpretation of Section 101 the Supreme Court held that the engineered bacterium did constitute a ‘manufacture’ or ‘composition of matter’ and, in a 5-4 split, decided it was materially different from anything found in nature and therefore patentable.[17] The dissenting opinions pointed to a presumption that living things could not be patented, demonstrated by the fact that Congress had needed to enact new legislation to allow patents for specific plant varieties.[18]
Significantly, the Court stated that for patent law, the relevant distinction was not between the living and inanimate, but between products of nature and man-made inventions.[19] Fundamental ethical and policy questions arise already at this point, as to whether or not ‘life’ can be patented. Chakrabarty is seen as a the first major step in allowing the patenting and commodification of genetics. The initial decision of the Patents Office shows the tension between the less-controversial idea of allowing ‘process patents’ and the highly-controversial idea of allowing patents over actual living organisms. Strangely, these process patents fit more neatly into the traditional criteria for patentability,[20] while product patents come up against moral exclusions to ‘patenting life’, definitions of ‘composition of matter’, discovery/invention distinctions and questions of novelty. The patenting of lower life-forms might still be considered less controversial than that of higher life-forms or human genetic material due to the generally industrial nature of modified micro-organisms.[21]
Patenting GM Crops
Even the relatively well established field of GM-crops has caused repeated legal complications. Monsanto v Schmeiser[22] is a leading Supreme Court of Canada case on whether intentionally growing genetically modified plants constitutes ‘use’ of the patented invention of genetically modified plant cells. By a 5-4 majority, the court ruled that it does.[23] This is a serious problem when self-replicating life forms are patented; ‘innocent’ patent infringers may need some form of protection or exemption regarding self-replicating life-forms which have product patents. The point was also raised that the common law indicates farmers should get to keep what enters their land.[24] Stopping farmers from cultivating progeny of plants derived from patented materials clashes with this tradition. Difficulties also arise from the principle that a patent owner holds the rights to a patented entity, even as part of a broader structure or process.[25] Thus, even if patents were not granted for modified plant strains themselves, granting patents to the genes, or certain cells, could, in effect, grant a monopoly over that plant strain. Furthermore, in Hoffman v Monsanto,[26] organic farmers sued Monsanto for contamination of their crops by GM plants, but the court rejected their claims, stating that the seed of patented GM crops was no longer under control of the companies once it had been sold.[27]
From a policy point of view this seems to have given very considerable power to patent holders over their patents, though they are not held as strictly accountable for environmental or health risks. This can be seen in the controversial recent passing of the ‘Monsanto Protection Act’,[28] for a limited time shielding biotech companies, like Monsanto, from the federal courts in case something is found to be harmful in their genetically-modified seeds.[29] The genetic and self-replicating nature of such ‘inventions’ continually leads to such difficulties when trying to shoe-horn them into the traditional patent system.[30] It might be necessary to deal with the issues surrounding patents on self-replicating organisms, and ensure patent owners are reasonably liable for any resulting damage, like the Gene Technology Act adopted by Switzerland.[31] Perhaps a sui generis protection tailored to self-replicating biological entities would be better able to handle the difficulties presented by patenting such genetic material; something akin to the regulatory nature of the Plant Breeders’ Rights Act[32] in Canada.
Higher Life-forms and Transgenic Animals
The Harvard ‘OncoMouse’ is perhaps the best known example of patenting a ‘higher life-form’ and caused its fair share of difficulties regarding patenting in the US, Canada and Europe. In the 2002 Harvard College v Canada decision,[33] the life-form at issue was a transgenic mouse developed at Harvard by inserting a heritable cancer-causing gene into the creature’s DNA, making them highly useful for cancer studies. The respondent sought patents on both the process and the mouse itself, extended to all non-human mammals thus engineered. Much as in the initial decisions of the USPTO in Chakrabarty, the process patent was allowed, but the product claims were rejected and ultimately appealed to the Supreme Court of Canada to decide the patentability of such organisms. Similar to Chakrabarty, was the question of interpretation of Section 2 of the Patent Act,[34] whether such higher life-forms might constitute a ‘manufacture’ or ‘composition of matter’. However, the majority found that unlike micro-organisms, or even modified mouse-eggs,[35] higher life-forms themselves were not patentable.[36]
The dissenting justices did object to the distinction between higher and lower life-forms, on the basis that the legislation did not empower the court to make this distinction or to refuse patent on purely moral grounds.[37] It was particularly interesting to see how the European Patent Office dealt with this issue regarding the morality clauses in EU legislation. To address the ordre public or morality exception, the EPO developed a utilitarian balancing test, which assessed the possible benefits of an invention against negative possibilities, “in this case weighing the suffering of the OncoMice against the expected medical benefits to humanity”.[38] Environmental risks and public unease would also be taken into account, though there was no evidence of moral opposition to the use of mice in cancer research. The EPO found the usefulness of the OncoMouse outweighed the suffering caused to the animal. In the course of the proceedings, the patent was amended to limit it to mice and not all transgenic animals.[39] Mason and Laurie make an interesting point that the “linguistic gymnastics” used in this case by the EPO were to make Europe more attractive to the biotech sector.[40]
Patenting Primate ESC Cloning
A particularly clear example of the difficulties of the ‘higher life-form’ and ‘human’ distinction, as well as overly-broad patents, is evident in the re-examination of the WARF[41] patents. These patents claimed a right to the process of producing Embryonic Stem Cell (ESC)-lines along with a ‘composition of matter’ claim to the ESC-line itself; anyone wishing to develop a ESC- line by any method had to negotiate a license. The phrasing of the patent was for ‘primate’ cell-lines, though this covered human as well, which caused it to encounter problems when applying for protection.[42] In 2006, the patents were challenged in the US, due to restrictive licensing practices, arguing that methods described in the claims were already published as ‘prior art’.[43] Other researchers had already published such methods, but hadn’t actually applied them to human testing at the time, though it was theoretically the same. In March 2007, the USPTO declared the patents invalid, but in March 2008, this was reversed and the validity of all three patents was affirmed.[44]
In Europe however, the final decision in Nov 2008 excluded inventions which necessarily involved embryo destruction.[45] The method was for preparing ESCs from primate blastocysts, which could clearly be extended to human embryos and the EPO Examination Division found that “[t]he use of an embryo as starting material for the generation of a product of industrial application is considered equal to industrial use of this embryo”.[46] This came from a broad interpretation of Article 53(a) and Rule 23d(c) of the EPC,[47] meaning that hESC-lines[48] only obtainable through destruction of embryos are also not patentable, rather than simply commercial uses of embryos as such.[49] Similar issues arose with the ‘Edinburgh patent’,[50] which was originally granted by the EPO in respect of ‘animal transgenic stem cells’, but worries existed that it might extend to human cloning and as such the patent was amended to exclude mention of hESCs, although it still covered other modified human and animal stem cells.[51]
Property Rights and Entitlement to Patenting
The Californian Moore case[52] is an important influence on public policy regarding patient ownership of products derived from human genetic material. Moore was a leukaemia patient who consented to a splenectomy, but following its removal, without his consent, doctors developed a cell line from his T-cells, which they patented in 1984. They then negotiated lucrative contracts for “exclusive access to the materials and research performed on the cell line and products derived from it”.[53] Moore sued the doctors and the University; the Supreme Court, found that he had no proprietary interest in the ‘product’ for a claim of conversion. The Court looked at closely fiduciary duty and the requirement of informed consent, finding informed consent lacking but still that Moore had no proprietary right to profits from the patent. The majority were worried the chilling effect such a duty to investigate the ‘consensual pedigree’ of all human genetic material could have on scientists.[54] Mosk J dissented, stating that Moore could have been denied some property rights and given others.[55]
In the similar Greenberg case,[56] plaintiff families had supplied tissue to advance research into Canavan’s disease, hoping to promote accessible prenatal testing. Dr Matalon identified the Canavan gene in 1993, developed screening tests at Miami Children’s Hospital (MCH) and applied to patent the gene and the diagnostic tests in 1994. The families sued, claiming breach of informed consent and fiduciary duty for failure to disclose the intention to patent the gene and tests. The court dismissed their claims regarding consent and fiduciary duties, but did uphold the claim of unjust enrichment at the expense of the donors of tissue, stating “the facts paint a picture of a continuing research collaboration that involved plaintiffs also investing time and significant resources.”[57] Both of these cases show the difficulties raised for patent law in deciding who is entitled to register a patent derived from human biomaterial and seem to show a lack of avenues for aggrieved patients to claim against the patent holder.
hESC patents raise further potential for conflict with Article 6 of the EU Biotech Directive,[58] which it prohibits ‘uses of human embryos for industrial or commercial purposes’. The Directive does not, however, define ’embryo’, which itself has lead to difficulties.[59] In Quintavalle the House of Lords took a purposive interpretation of the UK HFEA,[60] and held that Parliament could not have intended to exclude organisms created with SCNT[61] from the meaning of ’embryo’.[62] Similarly, in the Brüstle case[63] the CJEU declined to clearly define ’embryo’.[64] Questions like this further illustrate that there are serious challenges to patent law in determining what is patentable and to what extent, which simply do not exist in more traditional fields of industry. With the Edinburgh Patent, as mentioned above, the Opposition Division noted two interpretations of Article 53(a) in conjunction with Rule 23d(c) of the European Patent Convention; narrowly, to mean that only commercial uses of human embryos as such are excluded from patentability; or broadly, to mean that hESCs attained directly/indirectly through embryo destruction are also unpatentable.[65]
This approach is particularly broad given that embryonic stem cells are not in fact embryos, nor capable of becoming embryos, and as such use of them is not direct commercial use of embryos.[66] ‘Processes for obtaining stem cells from an embryo’ seem to fall under Article 6 of the Biotech Directive because it is direct use of an embryo similar to that in the Edinburgh patent, which “… raises the issue of whether this is an accurate or appropriate understanding of the term ‘use’ in the context of patent law.”[67] ‘Totipotent'[68] cells are not patentable because the human body at the various stages of its formation and development is excluded from patentability by Paragraph 3(a) of Schedule A2 to the Patents Act 1977.[69] Realistically, this is unlikely to be practically problematic as stem cell lines are developed from cells at the pluripotent,[70] rather than totipotent, stage; the only practical way to prove totipotency being to attempt to grow an embryo from the cells.[71] Furthermore it should be noted that at EU level “[i]solated stem cells which have not been modified do not, as product [sic], fulfil the legal requirements, especially with regards to industrial applications [sic], to be seen as patentable”,[72] in addition to the UK’s strict prohibitions on patentability. As seen from the worries present in the WARF and Edinburgh Patent cases, expanding patent protection to human genetic material, particularly embryos or hESC-lines, is particularly problematic both from a legal and ethical perspective. In addition to this, much opposition to patentability is misdirected opposition to the technology itself; “In particular, there is a consistent failure to distinguish concerns about scientific or technical advances per se from those about the grant of a patent over the products and processes arising from such advances.”[73] For example, many confuse anti-hESC arguments with anti-patentability-of-hESC arguments.
As mentioned above, diagnostic testing is a controversial area for patenting, both for legal reasons, such as the EPC, Article 53(c) exclusion of “[…] diagnostic methods practised on the human or animal body”, as well as more general policy concerns that diagnostic tools should be available to all and not under monopoly control. The most infamous case in this area is that of Myriad Genetics and their restrictive licensing of the BRCA1 and BRCA2 breast cancer diagnostic tests,[74] which led to a European Parliament resolution calling on the EPO to reconsider the patents over these tests.[75] This case showed the dangers of, and opposition to, allowing patenting of certain practices and genetic ‘products’ which the scientific community expect to be left unpatentable/unpatented;
“Since the genes have been described in the mid-nineties, many European laboratories have set up BRCA1 and BRCA2 testing. Early in the spring of 2001, the news spread among the European genetic diagnostic community that a patent had been granted on the BRCA1 gene. Until then, most geneticists in Europe had neither worried nor considered that genes and genetic tests could become exclusive intellectual property of a laboratory or a company.”[76]
One reason why the patent system clashes with genetics is that genes and genetic sequences have a unique informational nature unlike other chemicals, and often cannot be invented around, causing a ‘double’ monopoly.[77] This is dangerous if diagnostic testing is only possible through one method, but there are also questions of novelty and industrial application; association between a gene and a genetic disease is essentially a mere discovery and not a patentable invention in Europe, as per the Nuffield Council on Bioethics; “despite the effort involved, we consider that the isolation of BRCA1 was essentially a discovery, the application of which was useful.”[78] The BRCA patents however failed on more technical issues regarding priority dates and disclosure and not an overarching policy against such patents. One solution is to extend the exemption from patentability provided by Art. 53(c) to identification of a disease-linked genetic mutation. Tied into these worries and human dignity, is the availability of treatments to patients, and the question as to whether or not it is right to allow often restrictive patents be wielded over new technologies which could be of great medical benefit, such using haematopoietic stem cells to treat blood disorders and leukaemia.[79][80]
Geographical Disarray
One of the key differences between the US and other systems stems from 35 United States Code Section 100(a) which defines the term ‘invention’ to mean ‘invention or discovery‘, providing at 101; “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, …” This goes against the position elsewhere that a mere discovery should not be patentable, only the application of discoveries or inventions in their own right. Likewise, although the TRIPS Article 27.2 says that members may exclude inventions from patentability to protect ordre public or morality,[82] this is merely permissive, and there is little room for morality in US patent law.[83]
In Lowell v Lewis,[84] Story J proscribed certain inventions as immoral and unpatentable is they were “injurious to the well being, good policy, or sound morals of society.” However, since then this requirement has waned significantly; in Juicy Whip, Inc v Orange Bang, Inc,[85] the Court dismissed moral concerns as redundant, stating “the principle that inventions are invalid if they are principally designed to serve immoral or illegal purposes has not been applied broadly in recent years.”[86] As such, there is no basis in US patent law for the USPTO or a court to deny patent protection to morally controversial genetic innovations. The Patent Act 1952 sets out patentability requirements and the burden is on the USPTO or a court to show that a claim does not meet the statutory requirements. There is no morality clause and so the system is more likely, at least at first instance, to grant controversial patents over genetic inventions or discoveries.[87] This follows a tradition of US liberalism and a hands-off approach to morals.[88]
In Canada, Article 2 of the Patent Act[89] is similar to the US section 101 but does not expressly define ‘invention’ to include ‘discovery’. Invention covers “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter.”[90] The Supreme Court of Canada in the OncoMouse decision took a much more restricted view of the scope of patentability than the US courts. It concluded that lower life-forms such as bacteria were patentable, but that this did not extend to higher life-forms. They stated that patenting higher life-forms would involve be a radical departure from the traditional patent regime and thus legislative intervention would be needed to allow this, as the Act as it stood did not expressly allow that such higher life-forms were patentable. Though the dissent mentioned it was not their place to draw a scientific or legal distinction between lower and higher life-forms,[91] the majority justified the distinction based on common sense and refused the patent on the OncoMouse, which had been successfully patented in the US and was somewhat restrictedly protected in Europe.
Art. 52-57 EPC set out that an invention must be novel, inventive, non-obvious and industrially applicable as well as fully disclosed and clear at the priority date.[92] Importantly, there is a prohibition on patents for inventions the exploitation of which would be contrary to morality or ordre public, also specifically excluding methods of treatment or diagnostics of the human or animal body and of mere discoveries.[93] This framework is more restrictive than that of the US, based on the above-mentioned European Patent Convention and Biotech Directive.[94] EPC Art. 53(a) states; “European patents shall not be granted in respect of inventions the commercial exploitation of which would be contrary to ordre public or morality”. Similarly, Art. 6 of the Biotech Directive states; “inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality”.[95] This shows a clear enshrinement of morality in European law which is not found in Canadian law and positively rejected by US law, further complicating matters is cases such as OncoMouse and Myriad Genetics where technologies have a worldwide application.
OncoMouse was the first application in which the EPO exercised the morality clause of Article 53.[96] Later the EPO confirmed in Relaxin[97] that the morality provision should only be applied to prevent the grant of patents that would universally be regarded as outrageous, and made clear that ‘DNA is not life’.[98] The UK Patents Act 1977, Section 1(2)(a),[99] would deem most claims on human genetic subject matter unpatentable as a discovery rather than an invention. Nonetheless the Gowers Review indicated that as much as 20% of the human DNA sequences known have been patented around the world.[100]
Many suggest that “[t]he primary purpose of our patent system is not reward of the individual but the advancement of the arts and sciences”,[101] but that the current situation favours commercial interests over public benefit.[102] There have been moves towards ‘open source’ science, inspired by the software industry,[103] though some worry that this might create further legal complications.[104] It seems that modifications an manipulations of the existing systems are the most realistic way to deal with the challenges faced by genetics and patent law. Perhaps the best way forward is a more careful examination process and clarification of the boundaries of patentability, as suggested by Mason and Laurie.[105] Much can be done to recalibrate the system short of “scrapping the patent regime and its complex international framework (which is a well nigh impossible proposition)”.[106]
[1] While it is possible, even likely, that such protection spurs on research and development into these potentially beneficial areas, these arguments often overlook or give too little weight to the possibility of such research being motivated by altruistic goals and/or the possibilities of protecting such work in ways other than traditional patent law. See R Dresser, “Ethical and Legal Issues in Patenting New Animal Life”, (1988), Jurimetrics, Vol 28(4), 399-435, at 403. See also E Marshall, “Can Human Genes Be Patented?”, (17 Apr 2013), ScienceInsider, available at; http://news.sciencemag.org/scienceinsider/2013/04/can-human-genes-be-patented.html (last retrieved on 22 Apr 2013)
[2] Art. 5(3) of the ‘Biotech Directive’, Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, Official Journal L 213 , 30/07/1998 P. 0013 – 0021; “The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application”.
[3] Francis Collins, director of the National Center for Human genome Research even stated that; “Patenting is not a moral issue; it’s a legal issue”, see S Janasoff, Designs on Nature: Science and Democracy in Europe and the United States, (2005), Princeton Univeristy Press, New Jersey, at 209. See also M Rimmer, A McLennan, Intellectual Property and Emerging Technologies: The New Biology, (2012), Edward Elgar Publishing Inc, at 87-90.
[4] See C Shapiro, “Navigating the Patent Thicket: Cross Licenses, Patent
Pools, and Standard Setting”, in A B Jaffe, J Lerner and S Stern eds, Innovation Policy and the Economy, Volume 1, (2001), MIT Press, 119-150.
[5] In Diamond v Chakrabarty, 447 US 303 (1980), the warning from the dissent was to heed the caveat of Parker v Flook, 437 US 584, 437 US 596 (1978), and “proceed cautiously when asked to extend patent law into areas wholly unforeseen by Congress”.
[6] Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, Official Journal L 213 , 30/07/1998 P. 0013 – 0021, as mentioned in supra note 2.
[7] “The fact that the Directive makes no specific mention of this subject matter is not surprising since the possibility of deriving human stem cells from embryos only arose in the year in which the Directive was eventually adopted”, G Laurie, “Patenting stem cells of human origin”, (2004), EIPR, Vol 26(2), 59-66, at 59, citing J A Thomson et al, “Embryonic Stem Cell Lines Derived from Human Blastocysts”, (1998), Science, Vol 282, 1145-1147. doi: 10.1126/science.282.5391.1145
[8] The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), WIPO (World Intellectual Property Organisation), see http://www.wipo.int/patentscope/en/ (last retrieved on 22 Apr 2013)
[9] Despite similar systems, the US and Canada came to very different conclusions on the OncoMouse decisions, which will be discussed in greater detail below. See in particular Harvard College v Canada (Commissioner of Patents), [2002] 4 SCR 45, 2002 SCC 76, at paras 2 and 34.
[10] J E Bessen, “Patent Thickets: Strategic Patenting of Complex Technologies”, (Mar 2003), available at SSRN: http://ssrn.com/abstract=327760 or http://dx.doi.org/10.2139/ssrn.327760 (last retrieved on 22 Apr 2013)
[11] G Matthijs, “The European opposition against the BRCA gene patents”, (2006), Fam Cancer, Vol 5(1), 95-102, at 97.
[12] A Katsnelson, “Russian biotech needs better patent protection”, (5 Aug 2004), Nature Biotechnology: BioEntrepeneur, available at http://www.nature.com/bioent/2004/040801/full/bioent823.html (last retrieved on 22 Apr 2013). doi:10.1038/bioent823 . See also E Burrone, “Patents at the Core: the Biotech Business”, (2006), WIPO, available at http://www.wipo.int/sme/en/documents/patents_biotech.htm (last retrieved on 22 Apr 2013)
[13] Diamond v Chakrabarty, 447 US 303 (1980), as mentioned in supra note 5.
[14] G Quinn, “June 16, 2010: 30th Anniversary of Diamond v. Chakrabarty”, (16 Jun 2010), IPWatchDog, available at; http://www.ipwatchdog.com/2010/06/16/june-16-2010-30th-anniversary-of-diamond-v-chakrabarty/id=11268/ (last retrieved on 22 Apr 2013)
[15] United States Code (USC), Title 35 – Patents, Section 101.
[16] In re Bergy, 563 F.2d 1031, 1038 (1977).
[17] “Here, by contrast, the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under 101”, Supra note 5, at 447 US 310.
[18] Ibid, at 447 US 319.
[19] Ibid, at 447 US 313.
[20]However, see J Timothy, J D McCoy, “LeTourneau award: Biomedical process patents: Should they be restricted by ethical Limitations?”, (1992), Journal of Legal Medicine, Vol 13(4), 501-519.
[21] Genetically modified organisms such as the oil-spill-cleaning bacterium in Chakrabarty then to fall into the ‘White’ (industrial biotechnology), ‘Blue’ (marine biotechnology) or ‘Green’ (agricultural biotechnology) categories of biotechnology rather than ‘Red’, (medical biotechnology), into which much human and mammal biotechnology falls.
[22] Monsanto Canada Inc v Schmeiser, [2004] 1 SCR 902, 2004 SCC 34.
[23] Early in the case the question arose of what happens when farmers’ fields are accidentally contaminated with patented seed, though by the time it went to trial, these claims had been dropped, the court only considered the crops which Schmeiser had intentionally concentrated and planted, to which he did not put forward any defence of accidental contamination. See A McHughen, R Wager, “Popular misconceptions: agricultural biotechnology”,(Dec 2010), N Biotechnol, Vol 27(6), 724-8.
[24] Supra note 22, para 96.
[25] Ibid, para 43. See also para 78, “It is no defense to say that the thing actually used was not patented, but only one of its components.”
[26] Hoffman v Monsanto Canada Inc, [2005] 7 WWR 665 and [2007] 6 WWR 387.
[27] Hoffman v Monsanto Canada Inc, [2007] 6 WWR 387, para 67.
[28] Section 735 of HR 933, (a rather sneaky rider on a spending bill).
[29] For a rather sensationalist, conspiracy-theorist opposition to this move, see; “Congress Passes “Monsanto Rider”, Pushing Genetically Modified Foods Onto Our Plates”, available at; http://www.zerohedge.com/contributed/2013-03-29/congress-passes-%E2%80%9Cmonsanto-rider%E2%80%9D-pushing-genetically-modified-foods-our-plate (last retrieved on 22 Apr 2013) or for a more reasonable analysis see M Rivlin-Nadler, “What Is the So-Called ‘Monsanto Protection Act’? Is It Eeeeeevil?”, (30 Mar 2013), Gawker, available at; http://gawker.com/5993042/what-is-the-so+called-monsanto-protection-act-is-it-eeeeeevil (last retrieved on 22 Apr 2013)
[30] For more opposition to Monsanto, see the recent petition “Monsanto v Mother Earth”, at; http://www.avaaz.org/en/monsanto_vs_mother_earth_loc/?ffHbibb&pv=27 (last retrieved on 22 Apr 2013)
[31] P Cullet, “Case Law Analysis – Monsanto v Schmeiser: A Landmark Decision concerning Farmer Liability and Transgenic Contamination”, (2005) Journal of Environmental Law, Vol 17(1), 83-108 at 106.
[32] Plant Breeders’ Rights Act (S.C. 1990, c. 20).
[33] Harvard College v Canada (Commissioner of Patents), [2002] 4 SCR 45, 2002 SCC 76. As mentioned in supra note 9.
[34] Patent Act, RSC 1985, c P-4, s 2.
[35] Supra note 33, paras 85 and 162.
[36] Ibid, para 206.
[37] Ibid, paras 52-53 and 90.
[38] WIPO, “Bioethics and Patent Law: The Case of the Oncomouse”, (Jun 2006), WIPO Magazine, available at; http://www.wipo.int/wipo_magazine/en/2006/03/article_0006.html (last retrieved on 22 Apr 2013)
[40] J K Mason, G Laurie, Mason and McCall Smith’s: Law and Medical Ethics, 8th ed, (2011), Oxford University Press, para 14.52.
[41] Wisconsin Alumni Research Foundation.
[42] S Sterckx, J Cockbain, “Assessing the Morality of the Commercial Exploitation of Inventions Concerning Uses of Human Embryos and the Relevance of Moral Complicity: Comments on the EPO’s WARF Decision”, (2010), SCRIPTed, Vol 7(1), 83, available at; http://www.law.ed.ac.uk/ahrc/script-ed/vol7-1/sterckx.asp (last retrieved on 22 Apr 2013)
[43] J Conley, A W Dobson, D Vorhaus, “WARF Reexamination Takes Another Bite Out of Biotech Patents”, (19 May 2010), Genomics Law Report, available at; http://www.genomicslawreport.com/index.php/2010/05/19/warf-biotech-patents/ (last retrieved on 22 Apr 2013)
[44] E C Hayden, ” Stem-cell patents confirmed”, (17 Mar 2008), Nature, Vol 452, 265, available at; http://www.nature.com/news/2008/080317/full/452265b.html (last retrieved on 22 Apr 2013) doi: doi:10.1038/452265b
[45] Supra note 40, paras 14.60 -14.62.
[46] H L McQueen et al, Contemporary Intellectual Property: Law and Policy, 2nd ed, (2011), Oxford University Press, para 12.57.
[47] G2/06 Comment by the President of the European patent Office (September 2006), available at http://www.cipa.org.uk/download/epo_warf.pdf (last retrieved on 22 Apr 2013) at p 37.
[48] ‘Human’ Embryonic Stem Cell Lines.
[49] G Laurie, “Patenting stem cells of human origin”, (2004), EIPR, Vol 26(2), 59-66, at 60-62, as mentioned in supra note 7.
[50] Patent No. EP 0695351, ibid, at 62. See also R Osterwalder, “”Edinburgh” patent limited after European Patent Office opposition hearing”, (26 Jul 2002), Times Higher Education, available at; http://www.timeshighereducation.co.uk/news/edinburgh-patent-limited-after-european-patent-office-opposition-hearing/170621.article (last retrieved on 22 Apr 2013)
[51] M Herder, “Proliferating Patent Problems with Human Embryonic Stem Cell Research?”, (2006) Bioethical Inquiry, Vol 3, 69-79, at 73. doi: 10.1007/s11673-006-9005-6
[52] Moore v Regents of the University of California, (51 Cal. 3d 120; 271 Cal. Rptr. 146; 793 P.2d 479)
[53] Ibid, at 51 Cal. 3d 127.
[54] Ibid, at 51 Cal. 3d 135 and 147.
[55] Ibid, at 51 Cal. 3d 175.
[56] Greenberg v Miami Children’s Hospital Research Institute Inc, 264 F. Supp. 2d 1064 (S.D. Fla. 2003).
[58] Supra note 6. Specifically;
[59] R v Secretary of State for Health (Respondent) ex parte Quintavalle (on behalf of Pro-Life Alliance) (Appellant) [2003] UKHL 13, [2003] 2 All ER 113.
[60] Human Fertilisation and Embryology Act 1990.
[61] Somatic cell nuclear transfer, also called cell nuclear transfer (CNR).
[62] J K Mason, “Clones and Cell Nuclear Replacements: A Quintavalle Saga”, (2003), Edinburgh Law Review, Vol 7, 379-387.
[63] Oliver Brüstle v Greenpeace eV, (Reference for a preliminary ruling: Bundesgerichtshof – Germany.
Directive 98/44/EC – Article 6(2)(c) – Legal protection of biotechnological inventions – Extraction of precursor cells from human embryonic stem cells – Patentability – Exclusion of ‘uses of human embryos for industrial or commercial purposes’ – Concepts of ‘human embryo’ and ‘use for industrial or commercial purposes’), Case C-34/10.
[64] S Williams, “Brustle v. Greenpeace: The Court of Justice of the European Union Interprets the Term Human Embryo Widely, Restricting Member States’ Discretion to Pass National Patent Legislation for Biotechnological Inventions”, (2011), Tul J Int’l & Comp L, Vol 20, 571, at 577-581.
[65] Supra note 49, at 62.
[66] Ibid, at 63, Table 1. One can see from this table that what might be termed early stage interventions are those to be excluded from patent protection.
[67] Ibid, at 63.
[68] “Totipotency is the ability of a single cell to divide and produce all the differentiated cells in an organism, including extraembryonic tissues”, from “Regenerative Medicine Glossary”, (Jul 2009), Regenerative Medicine, Vol 4(4s), S30, doi:10.2217/rme.09.s1
[69] “The following are not patentable inventions –
(a) the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene;”
See also UK Patent Office Practice Notice “Inventions involving human embryonic stem cells”, (April 2003), available at: http://www.patent.gov.uk/patent/notices/practice/stemcells.htm (last retrieved on 22 Apr 2013)
[70] “…having the ability to develop into all cell lineages, except those related to extraembryonic tissues”, from “Cell Therapy and Regenerative Medicine Glossary”, (May 2012), Regenerative Medicine, Vol 7(3s), S65.
[71] Supra note 67.
[72] European Group on Ethics in Science and New Technologies, “Ethical Aspects of Patenting Inventions Involving Human Stem Cells”, (7 May 2002), Opinion No.16, para 2.3.
[73] Supra note 49, at 65.
[74] For another concise summary see supra note 46, para 12.68. For the recent developments regarding the reevaluation of these patents in the US see N Stordahl, “BRCA1 and BRCA2 Gene Patent Debate Reaches the U.S. Supreme Court: Why Everyone Should Care”, (8 Apr 2013), Huffington Post, available at; http://www.huffingtonpost.com/nancy-stordahl/brca1-and-brca2-gene-patents_b_3015595.html?utm_hp_ref=tw (last retrieved on 22 Apr 2013) and R McKie, “Gene wars: the last-ditch battle over who owns the rights to our DNA”, (21 Apr 2013), The Guardian, available at;
http://www.guardian.co.uk/science/2013/apr/21/using-genetics-to-fight-disease?CMP=twt_gu (last retrieved on 22 Apr 2013)
[75] European Parliament, Resolution on the Patenting of BRCA1 and BRCA2 (‘Breast Cancer’) Genes (4 October 2001, B5-0633, 0641, 0651 and 0663/2001)
[76] Supra note 11.
[77] G Matthijs, D Halley, “European-wide opposition against the breast cancer gene patents”, (2002), Eur J Hum Genet, Vol 10, 783-785.
[78] Nuffield Council on Bioethics, “The ethics of patenting DNA, a discussion paper”, para 5.10, available via http://www.nuffieldbioethics.org/patenting-dna (last retrieved on 22 Apr 2013)
[79] A L Lennard, G H Jackson, “Science, Medicine and the Future: Stem Cell Transplantation”, (2000), British Medical Journal, Vol 321, 433-437.
[80] Similarly, T-cells have been genetically reengineered to fight cancer. See R J Brentjens et al, “CD19-Targeted T Cells Rapidly Induce Molecular Remissions in Adults with Chemotherapy-Refractory Acute Lymphoblastic Leukemia”, (20 Mar 2013), Sci Transl Med, Vol 5, 177. doi: 10.1126/scitranslmed.3005930; see also A Coghlan, “Gene Therapy Cures Leukemia in Eight Days”, (26 Mar 2013), New Scientist, available at; http://www.newscientist.com/article/mg21729104.100-gene-therapy-cures-leukaemia-in-eight-days.html (last retrieved on 22 Apr 2013)
[81] The basic standards of patentability is the US is found in 35 USC, paras 101-103, in the UK in the Patents Act 1977, s1(1) and at European level with the European Patent Convention (2000). Some international harmonisation comes also from the TRIPS Agreement.
[82] Article 27(2) of the TRIPs Agreement; “Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.”
[83] Though the USPTO considered that inventions around human/non-human chimera may not be patentable, on moral grounds. See USPTO, “Media Advisory, 98-06”, (1 Apr 1998), available at; http://www.uspto.gov/news/pr/1998/98-06.jsp (last retrieved on 22 Apr 2013)
[84] Lowell v Lewis, 15 Fed. Cas. 1018 (CCD Mass. 1817).
[85] Juicy Whip Inc v Orange Bang Inc, 185 F.3d 1364 (Fed. Cir. 1999); 51 U.S.P.Q.2d (BNA) 1700.
[87] M A Bagley, “A global controversy: The role of morality in biotechnology patent law”, in P Yu ed, Intellectual Property and Information Wealth, (2007), Praeger Press.
[88] See D K Miller, “A Patent on the Conscious: A Theoretical Perspective of the Law on Patentable Life”, (2009), Standford Journal of Animal Law and Policy, Vol 2, 144-162, at 150.
[89] Supra note 34.
[90] Ibid, s 2.
[91] Supra note 37.
[92] Supra note 11, at 98.
[93] Regarding the European position of discoveries, see Biotech Directive, (supra note 6) Recital 16, states; “… it is important to assert the principle that the human body, at any stage in its formation or development, including germ cells, and the simple discovery of one of its elements or one of its products, including the sequence or partial sequence of a human gene, cannot be patented; whereas these principles are in line with the criteria of patentability proper to patent law, whereby a mere discovery cannot be patented;”
[94] Supra note 6. Specifically;
For Art. 6 see supra note 58.
[95] Supra note 58.
[96] T19/90, Harvard/Onco-mouse, [1990] EPOR 501 (Technical Board of Appeal 3.3.2 Oct. 3, 1990).
[97] Howard Florey/Relaxin [1995] EPOR 541.
[98] Ibid cited by J K Mason and G Laurie (supra note 40), para 14.53.
[99] With comparable statement in Art.52(2) EPC 2000.
[100] Supra note 46, para 12.8
[101] Believe it or not, this comment comes from US case law; “[t]he primary purpose of our patent system is not reward of the individual but the advancement of the arts and sciences. Its inducement is directed to disclosure of advances in knowledge which will be beneficial to society; it is not a certificate of merit, but an incentive to disclosure.”, from Sinclair & Carroll Co v Interchemical Corp, 325 U.S. 327, 330-31 (1945). See US Constitution, Art. I, § 8, cl. 8.
[102] “One of the most hotly contested issues in the field of intellectual property law is the extent to which legally created rights may be inhibiting, rather than promoting, scientific research. Although intellectual property rights are designed to encourage scientific progress, over- proliferation or distortion of any optimal arrangement of rights could create bottlenecks that obstruct the flow of research,” from R Feldman, K Nelson, “Open Source, Open Access, and Open Transfer: Market Approaches to Research Bottlenecks”, (2008) Northwestern Journal of Technology & Intellectual Property, Vol 7(1), 14-32.
[103] See A Mockus, R T Fielding, J D Herbsleb, “Two case studies of open source software development: Apache and Mozilla”, (Jul 2002), Vol 11(3), 309-346.
[104] R Feldman, “The Open Source Biotechnology Movement: Is it Patent Misuse?”, (2004) Minnesota Journal of Law, Science & Technology, Vol 6, 117.
[105] Supra note 40. [106] S Harmon, book review of; G Van Overwalle ed, Gene Patents and Public Health, (2007), Bruylant, available at http://www.law.ed.ac.uk/ahrc/script-ed/vol5-3/sh_review.asp (last retrieved on 22 Apr 2013)
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News, Websites and Blogs
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