case law journals legislation2012-04!03!13-35

8/2/2019 Case Law Journals Legislation2012-04!03!13-35

1/56

Malayan Law Journal Articles/2008/Volume 6/PATENTS AND 'HUMAN BEINGS': GLOBAL TRENDS ANDETHICAL CONCERNS

[2008] 6 MLJ lxxxiii

Malayan Law Journal Articles

2008

PATENTS AND 'HUMAN BEINGS': GLOBAL TRENDS AND ETHICALCONCERNS1

Professor Dr Ida Madieha bt Abdul Ghani Azmi

Private Law Department, International Islamic University Malaysia

PART 1: INTRODUCTION

As recent advances in life sciences involving human embryonic stem cells and biological materials of humanorigin challenge many of the basic norms of ethics and morality, not to mention religion, many countries soughtto debate the permissibility of such inventions within patents. Many of these countries appointed national ethicscommittees that debate the issue and weigh all the competing ethical concerns against the patentability of suchinventions. Some countries revised their legislative framework to reflect their concerns on the patentability ofsuch inventions.

The European Parliament (EPO) has made its stand clear by revising the European Patent Convention (EPC)and inserting Rule 23(d) and (e) into the Convention. Thus, under the revised EPC, certain biological inventionsare not patentable particularly those involving human cloning, processes for modifying the germ line geneticidentity of human beings and uses of human embryos for industrial or commercial purposes. Whilst, other bio-logical inventions such as human genes, pluri-potent cells taken from foetus and elements isolated from the hu-

man body would be patentable. The provision however, does not explicitly refer to human embryonic stemcells.

In two recent decisions, Edinburgh and WARF, the EPO refused to grant patents on inventions that involve hu-man embryonic stem cell. These decisions have been heavily criticised by other members of the EuropeanUnion as there is no common stand on the procurement of stem cells from embryos. Countries like Austria,Germany, Ireland, Luxembourg, Italy and Portugal prohibit the procurement of stem cells from supernumeraryembryos. Denmark, Spain, Finland, France, Greece, the Netherlands, and Sweden allow such activities. Evenmore liberal are countries like UK and Belgium that allow the creation of human embryos for the procurementof hES cells.

In Malaysia, there is no explicit exclusion for inventions that involve human biological material under thePatents Act 1983. In the context of patent law, the incorporation of 'public order and morality' in s 31 as a yard-stick for the grant of patents, brings into question to what extent such inventions would be acceptable in

Malaysia and to what extent s 31 could be invoked to bar such inventions.In the 2006 guidelines by the Ministry of Health, the extraction of stem cells from embryos was not allowed. 2 Ina later policy guideline on cell transplantation, embryonic stem cell therapy is also not allowed.3 However, re-search on stem cells is allowed, although not encouraged, if the existing guidelines on ethical standards are fol-lowed. Stem cell lines could also be imported. The creation of embryos specifically for research is however pro-hibited.

It is, thus, the objective of this paper to explore the various stands taken by national countries when debatingon the boundary of patents in relation to inventions involving 'human beings'. For that purpose this paper wouldappraise:


2/56

(i) the various ethical concerns on the patentability of human embryonic stem cells;(ii) a discussion on the legislative framework of various countries' on inventions that involve human

beings.

Ethical Dilemma: From Lab to Patent OfficeStem cells are (1) unspecialised cells (2) that can divide continuously (3) to produce cells like themselves (selfrenewal), or cells of one or several specific differentiated types.4 Stem cells are of two main specialties; selfreplicate and immortal. The scientific community has ear-marked stem cells as a revolution to medicine, partic-ularly for incurable degenerative diseases, such as Parkinson's and Alzheimer's. Stem cells can be harvestedfrom a number of sources, namely:

(i) adult stem cells(ii) stem cells of foetal origin(iii) stem cells of embryonic origin5

These stem cells serve different purposes and their ability to differentiate differs. The potential applications ofstem cells are: basic research into human development and disorders; discovery of novel proteins for tissue re-generation and repair; development of human cell models for drug discovery and toxicology as well as develop-ment of tissue for transplantation. Of all the three, the most complex and compelling is stem cells of embryonicorigin.6 The main technology of harvesting stem cells from human embryos necessitates the destruction of thehuman embryos in the first place. It is thus, understandable that the main ethical objection raised against suchresearch is that it cannot be right to destroy human embryos for research purposes. 7

As many of the research outputs have been patented or are being filed for patents, this has resulted in ethicaldebates finding their way into patent law. In terms of numbers, statistics shows that by May 2002, over 2,000patent applications involving human and animal stem cells had been filed worldwide, one quarter of which re-late to embryonic stem cells (ES).8

The types of products and processes claimed in filed patent applications include stem cells, stem cell lines, anddifferentiated and genetically modified stem cells.9 They also include processes for the creation of embryos bysomatic cell nuclear transfer and parthenogenesis; isolating and culturing stem cells; inducing stem cells to dif-ferentiate; and genetically modifying stem cells for particular applications.10

It has been raised that the patent office is ill-equipped to deal with ethical issues. Nevertheless, ethical determi-nation is part and parcel of the patent examiner's concerns. This is understandable as decisions made bypatent examiners are affected by the values and social interests of the community of which they are a part.Therefore, ethical considerations are implicitly and unavoidably part of the patent granting process.

For the sake of simplicity, the ethical debate chronicles around three main issues:

(i) The ontological (and in some countries, religious) debate on the moral status of an embryo. Is anembryo a human being? Even if an embryo is not yet a 'human', should it be treated as a personon the basis that it can develop into a 'human' or that it is a potential 'human'? If it is, then logi-cally it is owed full respect and no research which, has the effect of destroying the embryo, is per-missible.

(ii) The practical determination of whether even if research on an embryo is allowed and the prod-

ucts of such research are patentable, what kind of inventions should be accepted?(iii) Could there be implications to the granting of patents on high-end technology on health, further

advances on science and technology? Should there be limits to patents on embryonic stem cells?

As is clear from the above list, the kind of ethical questions that resulted from the extension of patents to hu-man embryonic stem cells ranges from the most difficult philosophical and religious questions on the ontologi-cal status of a human embryo. It also extends to the most pragmatic concerns of the parameters and bound-aries of patentability in order to provide a system that would be supportive of further advances of science andtechnology.

Moral Status of the Embryo: Is it or is it not a Human?


3/56

The most important ethical question is whether research on human embryo should be allowed or not? Centralto this is the issue whether an early embryo should be treated as a person, or at least potentially a person. Thisdetermination is important as for those who take the view that the early embryo is a person, then logically itwould be against the dignity of the embryo to subject it to research, what more that which involves its destruc-tion. On this the UK Select Committee on Stem Cell Research stressed that respecting the dignity of the em-

bryo would mean that we should not treat it as mere 'means' or 'instruments' especially so with embryo wherecapacities to act are not only lacking but non- existent. 11 On this the Committee considers two basic argumentsthat are widely put forward. The first advances the view that since the embryo is alive it has a right to life. Thesecond argument contends that as the early embryo has the potential to become a person; it enjoys the fullrights of a human being and should be accorded the respect owed to a human being.

On the first argument, the Committee points out that the fact that a cell or piece of human tissue is alive is notitself a reason for according it a full right to life. In this instance, an embryo is no different from a live cell orpiece of human tissue. On the second argument, the Committee advances the view that although an embryohas the potential to develop into a human being, it requires many other factors, particularly those provided bythe maternal environment in the womb, to enable it to realise its potential. Left in the Petri dish it would not de-velop further. In adopting this stand, the Committee articulates that it does not mean that a human embryoshould be treated like mere research artefacts. There are morally weighty grounds to treat human embryo dif-ferently than other research instruments. On this point, the UK Select Committee endorses the earlier stand

made by the Nuffield's Council on Bio-ethics on the limited permissibility of embryo research. 12 In a 2000 Re-port, the Nuffield's Council on Bio-ethics views that the 'removal and cultivation of cells from such an embryodoes not indicate lack of respect for the embryo. Indeed, such a process could be regarded as being analogousto tissue donation'. The Nuffield's Council further recommended that the purpose of research on embryos,which could be conducted under the Human Fertilisation Act (HFE), be extended further to include research forthe purpose of developing tissue therapies from the derived ES cells. The Council points to the need to set outconditions for more effective consent from the donors. Under the HFE, couples 'must be given a suitable op-portunity to receive proper counselling about the implications of taking the proposed steps' and they 'must beprovided with such relevant information as is proper'. On this note, the UK Select Committee recommendedthat any consent obtained to the use of foetal material in the establishment of EG cell lines should also coverthe use of such cell lines in therapy.

After considering all arguments, including those based on theology, the Committee was not persuaded that allresearch on early human embryos should be totally prohibited. However, the allowance of such research must

be subject to strict regulation and monitoring. The Committee further considers that 14 days should remain thelimit for research on early embryos as prescribed by the Warnock Committee13 provided that no embryo sub-

jected to research be implanted back in to a woman's womb.14

In the European Union, the European Group of Ethics (the EGE) deliberated on the same issue in 2002.15 Inthe EGE's opinion, 'the question of the dignity and the moral status of the embryo remain highly controversial ina pluralistic society such as the European Union'. 16 The EGE considers whether to forbid patenting of stemcells or stem cell lines. The EGE was of the opinion that taking the option to forbid patenting would be contraryto public interests (and especially patients) as it would lead to major slowing of research. However, in view ofthe highly controversial nature of stem cell research, it should only be allowed under strict public control bycentralised authorities.17

However, in a dissenting opinion by Prof Gunter Virt:

Human embryonic stem cells and also embryonic stem cell lines are excluded from patentability because we cannot getembryonic stem cell lines without destroying an embryo and that means without use of embryos. This is as material con-tradicts the dignity of an embryo as a human being with the derived right to life. If the condition for patentability is the in-dustrial and commercial purposes is not patentable (Article 6.2.c), then every exception, which cannot exclude industrialand commercial purposes, is against the ethical sense of the directive. Patenting is an incentive. Patentability of humanembryonic stem cells and stem cell lines would push research towards embryonic stem cells and thus undermine the pri-ority of research using non embryonic stem cells. Despite the relatively clear regulations in the directive this incentive forresearch will lead to forms of 'bypasses' which makes it impossible to guarantee an ethically tolerable situation in the fieldof patentability.

The importance of the dissenting opinion cannot be underestimated as it has been invoked by the European


4/56

Technical Board of Appeal as a ground to reject the Edinburgh18 and WARFpatents.19

The entity's possession of a full human genome

Whilst the philosophical and religious arguments would focuses on the fact that the embryo is the beginning ofa human life,20 the scientific community stresses on the fact that the embryo possesses full human genome,

thus making it human. The American Association for the Advancement of Science and Institute for Civil Societyarticulates that the ethical status of human embryonic stem cells hinges on these criteria:

(i) The entity's possession of a full human genome;(ii) Its potential for development into a human being; sentience; and(iii) The presence of well developed cognitive abilities such as consciousness, reasoning ability, or

the possession of self-concept.21

On the first argument that an embryo should be treated as a person as it is an entity that posses a full humangenome, the Association draws the fact that most cells in the human body possess a unique diploid genome.Furthermore, developments in mammalian cloning technology suggest that any human cell (or tissue) mayhave the potential to become a person. This does not give the stem cell any special status over other humancells.

Furthermore, embryonic stem cells are isolated from the total structure of the embryo or blastocyst, and there-fore will not develop the trophoblast (the outer layer of cells of the embryo) or other structures needed for con-tinued development. The cells thus, are no longer capable of developing into a human being.

Based on scientific facts, the Association advances the view that stem cell research does not offer unique ethi-cal issues.22 Cells taken from human embryo are like any other cells extracted from other parts of a humanbody.

Commodification and non-commercialisation of the human body

Related to the human dignity argument is the notion that humans and human bodies should not be the subjectof commodification and commercialisation. This notion stems from the premise that human slavery and com-mercialisation of the human body is morally unacceptable as enshrined in Art 3 of the Charter of FundamentalRights. On this the EGE was of the opinion that the donation of stem cells of human origin (adult, foetal or em-

bryonic) must not give rise to payment of donors, apart from the justified compensation of constraints.On this same point, the Human Genome Organisation Ethics Committee (HUGO Committee) and the UnitedNations Educational, Scientific and Cultural Organization23 analyses whether the objectification of human bodyparts is compatible with respect for human dignity because it reduces human beings to merchandise. Thepremise of this argument is that granting a patent over genetic material is akin to allowing parts of people to beowned by others, and some have likened it to 'a form of modern slavery'. These arguments have been criti-cised on the basis that treating parts of humans (such as natural genetic materials) as objects does not neces-sarily equate with treating whole persons as objects: in other words, commodifying genetic materials does notentail commodifying individuals. The Committee further stressed that patents do not grant physical propertyrights in or over parts of a person's body, and so do not enable one person to exert control over how anotherindividual uses his or her own body.24

Addressing the same point, the Australian Law Reform Committee (The ALRC Report)25 noted that human em-

bryonic stem cells may raise concerns such as inappropriate commodification of human biological material, andin particular human reproductive material, and may violate fundamental principles against the ownership of hu-man beings. Despite those ethical objections the Committee was of the view that research and the patenting ofembryonic stem cells could be done under strict control and regulation. The Committee was of the view that theethical objections raised against human embryonic stem cell research are similar to those that have been artic-ulated about gene patents.

Procurement of excess embryos, the principle of free and informed consent of the donor

Another concern that arises from the harvesting of stem cells from human embryos is the fear that this mightlead to illicit and unethical ways of procuring human embryos for purposes of research. There is also a risk that


5/56

women may be submitted to undue pressure to donate oocytes.26 This concern has been discussed by theALRC, EGE and The American Association for the Advancement of Science and Institute for Civil Society (theAA). On this point, the AA recommends that:

(1) Women should not undergo extra cycles of ovulation and retrieval in order to produce more

'spare' embryos in the hope that some of them might eventually be donated for research.(2) Analogous to the current practice for organ donation, there should be a solid "wall" between per-sonnel working for stem cell purposes

(3) Women and men, as individuals or couples, should not be paid to produce embryos, nor shouldthey receive reduced fees for their infertility procedures for doing so; and

(4) Consent of both gamete donors should be obtained.

The importance of free and informed consent of the donor should be stressed more in the case of donation ofembryos for purposes of research. As stressed in the EGE opinion, this principle is reflected in Article 3 of theCharter of Fundamental Rights and in Recital 26 of the 1998 EU Patent Directive.27

The UK Select Committee Report expresses concern that 'embryos' should not simply be created for the pur-pose of research. It expresses the common concern that the source of embryonic stem cells should be comingfrom excess embryos of IVF treatment.28 In the UK, it is mandated that excess embryos are destroyed. In 1996,over 3000 such frozen embryos were mandatorily discarded. There has been estimate that the number of em-bryos that are untransferable or abandoned ranges up to 100,000. These excess embryos instead of being dis-carded would be a rich source of stem cell research. One finds that this is one area in which the UK authoritieshave reversed their policy so as to allow even the creation of embryos for research.

Discovery v Inventions: The Patent Bar

The expansion of patents to processes and products involving human embryonic stem cells also implicates thetraditional patent boundary between discovery and inventions. Would cells derived from a human embryo betreated as products of nature and hence unpatentable? On this, the EGE opines that only stem cell lines whichhave been modified by invitro treatments or genetically modified so that they have acquired characteristics forspecific industrial application, fulfil the legal requirements for patentability.29 Isolated stem cells which have notbeen modified do not, as product, fulfil the legal requirements, especially with regards to industrial applications,to be seen as patentable. In addition, such isolated cells are so close to the human body, to the foetus or to the

embryo that they have been isolated from, that their patenting may be considered as a form of commercialisa-tion of the human body.30 The EGE considers that patenting of inventions allowing the transformation of unmod-ified stem cells from human embryonic origin into genetically modified stem cell lines or specific differentiatedstem cell lines for specific therapeutic or other uses, is ethically acceptable, as long as the inventions fulfil thecriteria of patentability, as in respect of the abovementioned ethical principles.31

As to the patentability of processes involving human cells, whatever their source, there is no specific ethical ob-stacle, in so far as they fulfil the requirements of patentability (novelty, inventive step and industrialapplication).32

Commercialisation of inventions relating to embryonic stem cells: scope of patents

The EGE33 raises concerns that conferring patents on such high-end technology at an early stage, particularlybroad patents, might stifle further research and development in this area. To avoid this from happening, theEGE espouses for a broad academic exception in patent law. This means that patents on stem cell lines shouldnot be too broad, and that research exceptions should be generously granted to eliminate any possible adverseeffects on further innovation to the benefit of health care. It is also recommended that patents shall only begranted, when the patent claim refers to a specific and an accurately described stem cell line and its industrialapplication. That involves a consistent relationship between a patent claim and the description of the inven-tion.34

Reflecting the same concerns, the ALRC raises the following issues:

(i) the promotion of innovation, in particular in view of the grants of broad patents,(ii) the commercial and economic aspects of patenting and the practice of licensing stem cell


6/56

patents35

(iii) resource use and knowledge sharing;(iv) benefit sharing and research outcomes; and(v) equitable access to healthcare. 36

The monopolistic nature of patents raises concerns to the academics, in the science and medical community.

Professors Michael Heller and Rebecca Eisenberg suggested that the grant of numerous patents for bio-medi-cal inventions has produced a 'tragedy of the anti-commons'--the under-use of a scarce resource where multi-ple owners exclude others and no one has an effective privilege to use the resource. 37 In the context of genepatents, this occurs when multiple blocking patents are granted over pre-market or 'upstream' research prod-ucts, particularly isolated genetic materials.38 The cost and inconvenience of obtaining multiple licences to usethese upstream products in marketable or 'downstream' research may stifle research and innovation. 39

On this, the Nuffield Council on Bio-ethics has earlier cautioned of the evils of conferring broad patents on stemcells in 2000.40 The Council recommended that the granting of over-generous patents with broad claims in thisimportant field should be discouraged.

The Healthcare sector that is equally impacted with overly broad patents established a committee to study theimpact of IPRs and Genetics.41 The Committee opines that the race to patent genes and gene fragments, in-cluding stem cells, may lead to the increase of cost, patients being deprived of access to new techniques and

drugs; that researchers and carers will not share information; that research will become too complicated to en-ter upon (perhaps because of the so called 'anti-commons effect' of there being too many right holders); andequally that there could be premature commercialisation in the race to get ahead.

A concern also shared by Glen Mc Gee in his study on embryonic stem cell patents.42 One particular example isthe WARF patent. The WARF patent makes extraordinarily broad claims as to many aspects of hES cells asthey are discovered in their embryonic environment. In particular, in its claim # 9, the inventor claims to be theinventor not only of the stem cells themselves, but the resulting cell lines, in essence a claim to whatever use ismade of those cells in virtue of his claim to the derivation of the cells in the first place! 43 According to Mc Gee,there should be a differentiation between the composition of matter (the cells themselves) and the informationto be gleaned from the composition of matter, potentially preventing labs with interest in stem cell researchfrom engaging in even basic work on hES cells without first paying a license. 44

LEGISLATIVE FRAMEWORK ON THE PATENTABILITY (OR NOT) OF INVENTIONS INVOLVING 'HUMAN

BEINGS'.

Some national and regional patent law has specified what form of human biological inventions is patentableand what is not in their patent law. Typical of such provision is an explicit exclusion on human cloning, humanbody or a natural substance isolated from a human body such as genes, etc. Below are some of the examplesof such provisions (not comprehensive). This article would start with Australia, United States, Canada and UKpatent frameworks first before venturing into the European Patent Conventions and the European Patent Direc-tive. The reason for this is that in lieu of the divergent approaches in the European member countries, the tworegional instruments require deeper elaboration.

Australia

Section 18(2) of the Patents Act excludes 'human beings and the biological processes for their generation'. TheAct does not define 'human beings' or 'biological processes for their generation', which leads to differing con-

tentions on this as is illustrated in two cases; Fertilitescentrum AB and Luminis Pty Ltd45 and Woo SukHwang.46 In Fertilitescentrum AB and Luminis Pty Ltd,47 the Deputy Commissioner of Patents had to determinewhether a patent application for a method of growing pre-blastocyst human embryos' would offend s 18(2). Themain claim of the patent application; ie Claim 10 reads:

A method of growing preblastocyst human embryos, the method including the step of incubating the embryos invitro in aculture medium containing an effective amount of human GM-CSF to increase the chance of implantation of the embryos,the amount of the GM-CSF being sufficient to increase the proportion of blastocysts formed from the preblastocyst em-bryos when compared to embryos incubated in a medium lacking GM-CSF.


7/56

The core determination was what constitutes a human being? At what point in the reproductive process does ahuman being come into existence? On this point, it was noted that there is no legislative or agreed societal def-inition of what constitutes a human being.

The Deputy Commissioner of Patents adopted the approach that the generation of a human being (as distinctfrom a human life form) occurs over a substantial period of time. In his view, there is little doubt that a human

life is created at fertilisation. He considered it to have at least SOME of the characteristics that go to make up ahuman being -- such that it properly falls within the ambit of the term 'human being'. He adds further that hu-man life is still being generated up to at least the sixteenth week. He noted further that some legislation made adistinction between abortions and still-birth, which occurs at the twentieth week. This suggests that by thisstage of its development there is both a legislative and societal recognition that the foetus has significant as-pects of being a human being, sufficient to require 'proper' disposal rather than as hospital waste.

Another important point is that the full status of human being is not acquired until birth. Therefore to him, thecorrect interpretation of s 18(2) is ascertained by recognising a human being in the process of generation fromthe time of the processes that create a fertilised ovum (or other processes that give rise to an equivalent entity)up until the time of birth.

Thus, the prohibition of 'human beings' in his view relates to the prohibition of patenting of any entity that mightreasonably claim the status of a human being. Clearly a person that has been born is covered by this exclu-

sion. But to that extent there is a process of generation of a human being that lasts from fertilisation to birth, theDeputy Commissioner of Patents was of the view that a fertilised ovum and all its subsequent manifestationsare covered by this exclusion.

The prohibition of 'biological processes' (for the generation of human beings) clearly covers all biological pro-cesses applied from fertilisation to birth -- so long as the process is indeed one that directly relates to the gen-eration of the human being. He also considered the exclusion of biological processes to include the processesof generating the entity that can first claim the status of a human being. For example, processes for fertilisingan ovum; processes for cloning at the 4 cell stage by division; processed for cloning by replacing nuclear DNA.

The Deputy Commissioner of Patent therefore concludes that Claims 10 to 23 are directed to a method ofgrowing pre-blastocyst human embryos. It is a method applied to a human embryo. The method has clear ad-vantages in better stimulating the natural environment, and reducing apoptosis of cells in the blastocyct, result-ing in greater success in implantation, and babies of greater body mass and having fewer complications com-

pared to IVF babies born without the benefit of the method -- all of which demonstrates that the process is onethat directly relates to the generation of a human being. The process is a biological process -- it is a process in-volving the presence of a chemical such that the invitro environment better stimulates the natural fallopian tubeenvironment. He is therefore satisfied that these claims fall within the ambit of 'biological processes' for thegeneration of human beings as proscribed by s 18(2).

Clearly, the Deputy Commissioner's view that a fertilised ovum is already a human life does not accord wellwith all the discourse in relation to the status of an early embryo especially in relation to embryo research andstem cells. On the same token, the Deputy Commissioner had also equated the artificial means of fertilisationas equivalent to biological processes to the generation of the human being.

In Woo Suk Hwang,48 the Deputy Commissioner of Patents had to determine an application for patents on amethod for producing chimeric embryos by employing inter-species nuclear transplantation techniques. Specifi-cally, the application claimed a method of producing a hybrid embryo using inter-species nuclear transplanta-

tion techniques. The embryo is created by transferring the nucleus of a human cell into a bovine ovum andthereby activating the ovum.

The decision was that the claimed invention was contrary to s 18(2), it being for a method of generating a hu-man being. The fact that the ovum was artificially activated, and the mitochondrial DNA of the ovum wasbovine, did not remove the method from the ambit of s 18(2).

In this case, there are two distinguishing factors. Firstly, there is no step of fertilisation per se. Secondly; theembryo is a hybrid involving both human and bovine DNA. Could this invention still be treated as human beingsand the biological processes for their production? Could a chimera still be considered a human being?

On this, the Deputy Commissioner noted that:


8/56

In natural reproductive processes, the activation of an ovum arises as a direct result of the fertilisation process. However,it is clear that fertilisation by a sperm is not the only way in which an ovum can be activated. In his view, an ovum that hasbeen artificially activated is in principle no different to an ovum that has been fertilised by natural means (noting of coursethat the DNA content of the ovum will be different). Accordingly the fact that the claimed method uses post-activation ofthe ovum does not remove the process from the ambit of s 18(2) of the Patents Act 1990 by reason of it being a method

for the generation of a human being.

Further, it was noted that the embryo produced by the claimed process has both human and bovine DNApresent. It is clear that the nuclear DNA is intended to be entirely human DNA. The mitochondrial DNA, whichessentially is relevant to the energy use of the cell, is entirely bovine. The primary characteristics of mammalsare governed by the nuclear DNA of the cells. In his view, the presence of the bovine mitochondrial DNA doesnot take away the essentially human characteristic of the embryo that is determined by the nuclear DNA. Thatis, the embryo that is produced by this method -- while being hybrid -- is properly described as human.

It has also been raised that the invention is contrary to the Prohibition of Human Cloning Act 2002 49 which disal-lows the creation of a hybrid embryo. The definition of a hybrid embryo in the Act typically covers chimera asclaimed by the patent application.50 The Deputy Commissioner is thus of the view that the invention is contraryto law and should be refused.

The importance ofWoo Suk Hwangis that it raises the issue as to what constitutes a human being and whenwould a chimera cease to be a 'human being'. These are difficult issues that requires deeper analysis not onlyfrom a scientific point of view but also from the points of view of ontology and religion as well. However, onepoint of distinction between both Woo Suk Hwangand Fertilitescentrum AB and Luminis Pty Ltdis that both in-ventions target the creation of human embryos which have the potential to develop into a full human being;whilst the harvesting of embryonic stem cells does not.

Section 18(2) deals explicitly with the human body. The position of stem cells is however silent. This leads tothe ALRC further debating whether there should be special provisions dealing with embryonic stems cells. 51

The Committee, however, does not recommend for revision of the Act and preferred the usage of terms thatare technologically neutral. The Committee, however, recommended the Patent Office to come up with clearexamination guidelines setting out the types of inventions involving stem cell technologies that it regards aspatentable and the extent to which any of such inventions are not patentable.

In answering the call, the Australian Patent Office issued a Manual of Practice and Procedure (the Manual).The Manual indicates that, while the precise scope of the provision is unclear, certain inventions are 'clearly en-compassed' by the exception, including:

(i) human beings, foetuses, embryos or fertilised ovum,(ii) methods of invitro fertilisation or cloning methods that generate human beings; and(iii) processes -- beginning with fertilisation and ending with birth-that are wholly biological and result

in a human being.52

On that basis, the Australian IP Office made clear that human genes, tissues and cell lines are clearly accept-able based on the premise that they are not regarded as human beings.

Clearly, the difficult question of what constitutes a human being and when a human life would form remainunanswered.

United States

The prevailing US practice seems to be that purified and isolated stem cell lines were patentable subject matterunder 35 USC S 101.53 In 2004, in an attempt to codify the Patent Office's (USPTO) position on stem cells, theCongress passed a bill known as the Weldon Amendment which prevents the USPTO from issuing patents ona 'human organism'. It was made clear that the provision would also ban patents directed to genetically engi-neered human embryos, foetuses and human beings but would not affect patents on genes, cells, tissue andother biological products.

Many quarters welcome the Weldon Amendment, which to them appears to be in line with the Thirteenth


9/56

Amendment to the US Constitution, which, prohibits any party from possessing property rights in a human be-ing.54

In practice, there have been several patents on human stem cells that have been granted in the US. 55 Besidesthe WARF patent, at least 2 patents have also been granted to the National Jewish Center for Immunology andRespiratory Medicine; US Patent Nos 5,874,301 and 5,914,268. The '301 patent claims':

A pluripotent cell population wherein said cell population is transformed with a HOX11 gene, [an immortalizing gene], andwherein said cell population differentiates into cellular lineages including primitive erythroid cells and definitive erythroidcells.

Currently, there is no federal law that prohibits the use of embryos in stem cell research. However, there arefederal policies and legislations that limit funding of such research.

Canada

In Canada, the Canadian Bio-technology Advisory Committee (CBAC)56 recommended that 'human bodies atall stages of development' should not be patentable. CBAC explains that this recommendation only applies toentire human bodies such as zygotes to an adult body but does not include nucleotide sequences, gametes,

stem and other cells, or organs that remain patentable. It was the recommendation of the committee that suchprovisions should be narrowly construed and was not intended to prevent patent claims being granted with re-spect to stem cell lines, (adult) cell lines or DNA sequences. The plural term 'bodies' indicate that only the en-tire human body was encompassed by the exclusion and not its parts. It was the view of the Committee thathuman beings are a metaphysical concept and not a biological one. To them, stem cells are not human cells as'these are removed from a multi-cellular precursor of the human body (except for the zygote) and thus do notcomprise a human body at any stage of development.57

The UK Patent Office

As for the UK Patent Office,58 a distinction is drawn between human totipotent cells and human embryonicpluripotent cells.59 Human totipotent cells have the potential to develop into an entire human body. Thus, theyare not patentable as the human body at the various stages of their formation and development; they are ex-cluded from patentability by para 3(a) of Schedule A2 to the Patents Act 1977.

Human embryonic pluripotent cells, on the other hand, arise from further division of totipotent cells and do nothave the potential to develop into an entire human body. The UK Patent Office noted the enormous potential ofstem cell research, including embryonic stem cell research, to deliver new treatments for a wide range of seri-ous diseases. This indicates that on balance the commercial exploitation of inventions concerning human em-bryonic pluripotent stem cells would not be contrary to public policy or morality in the United Kingdom. Thus,the Patent Office is ready to grant patents for inventions involving such cells provided they satisfy the normalrequirements for patentability.

Whilst the stem cells themselves may be patentable, the processes for obtaining stem cells from human em-bryos are not. Paragraph 3(d) of Schedule A2 to the Patents Act 1977 clearly stipulates that uses of humanembryos for industrial or commercial purposes are not patentable inventions. On this basis, the Patent Officewill not grant patents for processes of obtaining stem cells from human embryos.

The UK's more relax attitude towards stem cells is reflective of the prevailing view that research on human em-bryos was morally permissible beginning from the Warnock Report and the Human Fertilisation and Embryol-ogy Act 1990.60 The main thrust of the Act is to regulate research on embryos. The allowance of the researchis based on three central principles:

(i) That the HFEA should licence such work only if it is necessary;(ii) That if the HFEA is satisfied that such research is necessary (because it cannot be done in any

other way), then a licence should be granted only if the particular activity is judged to be neces-sary or desirable in relation to one of the proportionality and good purpose; and

(iii) That in no circumstances, should research on embryos run beyond 14 days or the appearance ofthe primitive streak.


10/56

In the 1990 legislation, five purposes are listed as approved. These are:

(a) promoting advances in the treatment of infertility(b) increasing knowledge about the causes of congenital disease,(c) increasing knowledge about the causes of miscarriages

(d) developing more effective techniques for contraception(e) Developing methods for detecting the presence of gene or chromosome abnormalities in em-bryos before implantation.

There was no explicit reference to stem cell research in the 1990 legislation. For that reason, the Human Fertili-sation and Embryology (Research Purposes) Regulations 2001 added three new purposes:

(a)increasing knowledge about the development of embryos

(b)increasing knowledge about serious diseases, or

(c)Enabling any such knowledge about to be applied in developing treatments for serious diseases.

With the new Regulations, the HFEA (the Human Fertilisation and Embryology Authority (HFEA) allows the li-censing of derivation of stem cells from embryos that are:

(i) surplus to IVF requirements;(ii) created by IVF specifically for research purposes; and(iii) created by therapeutic cloning.

One relevant point to note that reproductive cloning was not allowed under the Human Reproductive CloningAct 2001 which provides for up to 10 years' imprisonment and an unlimited fine on conviction.

As most embryonic stem cell research would fall under either one of the three new purposes, such researchwas clearly allowed in the UK. As one commentator put it, the UK position is described as the 'proportional po-sition' that affords the embryo a proportional moral status, which is neither an absolutist statement of intrinsicvalue nor a wholly perspective open utility.61

In furtherance to that the UK government set up a Stem Cell Bank62 and a Code of Conduct that governs it. Ac-cording to the Code, since embryonic stem cell tissues may be obtained following the termination of a humanlife their use is indeed a matter of moral concern. It contains a policy that: 'adult or foetal somatic stem cell linescreated at the Stem Cell Bank may only be used for research leading to the development of therapies, or forclinical trials of human therapies, or for basic research which underpins these aims.'

It is no wonder that as of June 2006, the UK patent office has issued at least fourteen patents that are directedto or at least make explicit reference to hESC.63

The UK's approach is not entirely criticism free. One criticism of the codes of practice is as to their framing ofethical issues largely in terms of donation, consent and embryo status.

The European Directive for the Legal Protection of Bio-technological Inventions

The European Directive for the Legal Protection of Bio-technological Inventions (the European Directive) wasofficially adopted by the Council of the European Union and the European Parliament on July 6, 1998. 64 Thetwo main provisions under the Directive are Article 5 and 6, which bears substantial similarity to Rule 23(d) and

(e) of the European Patent Convention.65

Article 5 reads:

(1) The human body, at the various stages of its formation and development, and the simple discovery ofone its elements, including the sequence or partial sequence of a gene, cannot constitute patentable in-ventions.

(2) An element isolated from the human body or otherwise produced by means of a technical process, in-cluding the sequence of a gene, may constitute a patentable invention, even if the structure of that ele-ment is identical to that of a natural element.

(3) The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patentapplication.


11/56

Article 6 reads:

1. Inventions shall be considered unpatentable where their commercial exploitation would be con-trary to public order or morality; however, exploitation shall not be deemed to be so contrary

merely because it is prohibited by law or regulation.2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable:

(a) Processes for cloning human beings;(b) Processes for modifying the germ line identity of human

beings;(c) Uses of human embryos for industrial or commercial

purposes;(d) Processes for modifying the genetic identity of animals

which are likely to cause them suffering without anysubstantial medical benefit to man or animal, and alsoanimals resulting from such processes.

The Patenting of Human Body and Human Body Parts

One opinion is that the underlying rationale for the exclusion provision in Article 6 as stated by the EuropeanCommission and the European Court of Justice has to be either for the (i) the respect of human dignity and (ii)to guard against the instrumentalisation of the human body. Some others have attributed the directive to bepushed primarily due to economic grounds.66

Thus, under the directive, there is an explicit exclusion for the patenting of human bodies or a natural elementisolated from the human body.

What amounts to parts of a human body? According to a document dated 16 December 1992, this means partsof the body that are within the body and that a human cell line used in the development of medicines can bepatented.67 The Commission further stressed that this refers to parts of the human body as found inside thebody. This distinction is important as patents have been granted in respect of human lymphoblastoid cell lines,human hepatocyte culture processes and methods for producing human antibody.

In a common position adopted by the Council in 1991, it was further clarified that the position of human geneswould be no different than human cells.68 The position raises some doubt, however, with regard to thepatentability of human stem cells, of embryonic or foetal origin.

In 1995, the Council stressed on the need for technical processes and proceeds on the grounds that an ele-ment of the human body that had not been obtained with the aid of a technological process, but simply de-tached, removed or collected, may not be regarded as a patentable invention. 69 Thus a limb, or organ, or a bod-ily fluid (eg sperm, blood, tears or sweat) cannot be patentable.

The memorandum thus suggests that the decisive element to turn material from the human body from a nonpatentable issue (discovery) into patentable subject matter (invention) is (1) the technical process, the humanintervention and (2) the way in which the biological material provides a technical solution for a technical prob-lem.

Would stem cells harvested from a human body be considered as part of a human body? In view of all the dis-cussion that takes place from the EU documental history, Van Overwalle, was of the view that human stemcells as they appear in their natural environment would not be considered patentable, whereas human stemcells which have been isolated, identified and reproduced outside the human body would not be excluded frompatentability.70 The touchstone to decide whether or not elements of human origin are patentable or not,whether they are to be considered as discoveries or not, lies in the technical intervention -- the isolation, purifi-cation or reproduction of the element --techniques which human beings alone are capable of putting into prac-tice and which nature is incapable of accomplishing by itself. 71

Again there is no explicit exclusion for embryonic stem cells but that does not stop many from interpreting theexclusion for the 'uses of human embryos for industrial or commercial purposes' or to include the procurement


12/56

of stem cells that require the destruction of embryos.

Processes For Modifying Human Germline Genetic Identity

This is equally excluded under the directive. According to Recital 40, there is a consensus within the Commu-nity that intervention in the human germ line and the cloning of human beings offends against 'ordre public' and

morality and it is therefore important to exclude unequivocally processes for modifying the germ line geneticidentity of human beings and processes for cloning human beings from patentability. It is commonly understoodthat the exclusion does not extend to somatic cell gene therapy.

This is further clarified in 1994 to exclude only those which are contrary to the dignity of man. If the modificationis for the purpose of correcting certain genetic deficiencies, such a process would be compatible to human dig-nity.

Uses of Human Embryos

Would the exclusion cover only spare embryos? Does it cover the use of created 'research' embryos?

To this Recital 42 states that the exclusion of human embryos for industrial or commercial purposes in anycase does not affect 'inventions for therapeutic or diagnostic purposes which are applied to the human embryo

and are useful to it'.

Processes to Produce Chimeras (Processes to Produce) Totipotent Human or Animal Cells (Recital 38)

Van Overwalle was of the view that the exclusion seems to be limited to processes to produce chimeras fromtotipotent human or animal cells and not to processes to produce chimeras from pluripotent (eg embryonic) hu-man or animal stem cells.

All in all, there could be three potential objections to an application to patent human embryonic stem cells; ei-ther it could implicate the patenting of a human body; or represent the use of a human embryo for industrial orcommercial purposes; or the general prohibition of patenting of inventions deemed to be offensive to 'ordrepublic' or morality. These uncertainties were further clarified by a resolution passed by the European Parlia-ment in 2005.

European Parliament Resolution on Patents for Bio-Technological Inventions (26 October 2005,

Wednesday)

As the 98/44 Directive is silent on stem cells, a further resolution was entered in late 2005. This is as a re-sponse to a patent granted on 2 February 2005 (EP 1257 168) that includes a selection of human germ cellsand of the germ cells themselves, and the grant of an European Patents, EP 1121015, that covers frozen hu-man embryos. The European patent Office accepted the opposition to patent EP 695351 (the Edinburghpatent) and made it clear that patents on human embryonic stem cells cannot be granted.

It was also made clear in the Directive that human DNA can only be patented in connection with a function. TheEuropean Parliament noted in particular that the creation of embryonic stem cells requires the destruction ofthe embryos. It was thus the opinion of the Parliament that the patenting of technologies where human em-bryos are destroyed or used for commercial or industrial purposes is excluded under the directive.

It was further clarified that Article 6 of the directive excludes the cloning of human beings and the Council made

it clear in its explanatory statements to Parliament that this ban on patenting does not cover only reproductivecloning and that the term 'human being' in this regard includes the embryonic phase.

The Resolution dampens many hopes for a softer approach towards stem cells within the European Union.This is further excerbated with the restrictive decision given by the European Patent Office Opposition DivisionOpinion in the Edinburgh and the Examining Division's Opinion in the Wisconsin Alumni Research Foundation.The following discussion centers on both decisions.

The Edinburgh Patent

This relates to patent number 695 351 entitled 'Isolation, selection and propagation of animal transgenic stem


13/56

cells'. The patent was granted to the Edinburgh University on 8 December 1999.

Claim 48: a method of preparing a transgenic animal, said animal comprising a selectable marker capable ofdifferential expression in (a) desired stem cells and (b) cells other than desired stem cells, the method compris-ing: providing a blastocycst; providing animal cells according to any of claim 37-38, introducing the animal cellsinto the blastocysts, transferring the blastocyst to a recipient and allowing an embryo to develop to a chimaeric

animal to enable germline transmission of the selectable marker.

As the claim relates to animal cells, this would include human grants.72 Realising the controversial nature of thegrant, the EPO call for opposition and a request to correct the decision to grant was filed by the University ofEdinburgh. The correction related to the insertion of 'non human' before animal in claims 47 and 48.

At the opposition division, one major concern raised is that the methodology claimed and disclosed in the con-tested patent could be employed for the purpose of human cloning. The Opposition Division clarified that.

Cloning is a process of asexual reproduction of an organism that creates multiple genetically identical copies (aclone) of the original. This is achieved experimentally by nuclear transfer from a somatic cell into an enucleatedoocyte. However, the patent in suit neither describes nor comprises nuclear transfer. Furthermore, embryonicstem cells cannot develop into an organism on their own. 73 They can only contribute to and form parts of a de-veloping organism upon integration into a host blastocyst. The resulting animal is genetically different from both

the blastocyst and the embryonic stem cell donor. Therefore, it becomes apparent that the methodology de-scribed in the contested patent is not cloning. Thus, the contested patent, being absolutely distinct (both instrategy and utility) from cloning, does not offend against Rule 23(d) of the EPC.

The main concern with the Edinburgh patent it that it includes a technique for the genetic modification of thegermline of human embryos and of the embryos themselves, a patent on isolation, selection and propogation ofanimal and transgenic stem cells, which could be used for the cloning of human beings. As is mentioned ear-lier, the European Parliament soon after passed a resolution to condemn the grant of the patent. 74

Another point of attack is that although the claim covers cells from all animal species, including mammals, suchas humans, the experimental examples in the specification of the patent in suit only relate to mouse embryonicstem (ES) cell lines. The Opposition Division (OD) thus raised serious doubts that the results obtained formouse ES cells as exemplified in the contested patent can be extrapolated across species, ie to human celllines.

In interpreting Rule 23d(c) of the EPC, the crucial question was whether the legislator when introducing theRule into the EPC in September 1999 had intended to ban from patenting human embryos as such or humanembryos together with the cells. The OD took note of Recital 16 that states 'patent law must be applied so as torespect the fundamental principles safeguarding the dignity and integrity of the person; whereas it is importantto assert the principle that the human body, at any stage in its formation or development, including germ cells,cannot be patented'. The OD concluded that only a broad interpretation of Rule 23d(c) could have been in-tended. Naturally, this encompasses not only the industrial or commercial use of human embryos but also thehuman ES cells retrieved therefrom by destruction of human embryos.75

Wisconsin Alumni Research Foundation76

In this case, the Examining Division of the European Patent Office refused the patent application No96903521.1 pursuant to Article 97(1) of the EPC. The applicant appealed to the Technical Board of Appeal thatfurther allowed the referral of the 4 questions of law to the Enlarged Board of Appeal.

Claim 1 of the application reads:

1. A cell culture comprising primate embryonic stem cells which (i) are capable of proliferation in-vitro culture for over one year, (ii) maintain a karyotype in which all chromosomes normally char-acteristic of the primate species are present and are not noticeably altered through culture forover one year, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm,and ectoderm tissues throughout the culture, and (iv) are prevented from differentiating when cul-tured on fibroblast feeded layer".

The case is now before the Enlarged Board of Appeal for the determination of four questions of law:


14/56

(1) Does Rule 23d(c) of the EPC apply to an application filed before the entry into force of the rule?(2) If the answer to question 1 is yes, does Rule 23d(c) of the EPC forbid the patenting of claims di-

rected to products (here: human embryonic stem cell cultures) which -- as described in the appli-cation -- at the filing date could be prepared exclusively by a method which necessarily involved

the destruction of the human embryos from which the said products are derived, if the saidmethod is not part of the claims?(3) If the answer to question 1 or 2 is no, does Article 53(a) of the EPC forbid patenting such

claims?(4) in the context of questions 2 and 3, is it of relevance that after the filing date the same products

could be obtained without having to recur to a method necessarily involving the destruction of hu-man embryos (here: eg derivation from available human embryonic cell lines)?

The Examining Division refused the application as it uses human embryos as starting material for the genera-tion of a product of industrial application. It is therefore irrelevant that the claimed subject matter related to cellcultures and not to a method of production of the said cultures. It was the opinion of the Examining Division thatthe exception to the exclusion to from patentability with regard to the use of human embryos derivable fromRecital 42 of the Directive 98/44/EC (document D5) did not apply to the present case because the generatedcell cultures did not serve any therapeutic or diagnostic purpose useful to the embryo that gave rise to the said

cultures, even if the availability of the said cell culture would potentially benefit the development of substancesfor treating conditions relating to human infertility.

The main question involved a question of construction of a provision of the laws, namely whether Rule 23d(c)of the EPC should be construed narrowly (thereby excluding from patentability only applications whose claimswere directed to the use of human embryos) or broadly (thereby extending the exclusion to products whoseisolation necessitated the direct and unavoidable use of human embryos).

The applicant raised the issue that there was no consensus amongst the contracting states as to the ethical ac-ceptability of suing human embryonic stem cells. The deployment of human embryonic stem cells from super-numerary embryos was permitted in several EPC states and there was an ongoing debate as to the ethics ofusing human embryonic stem cells, it being clear that moral attitudes were changing as was eg shown by thefact that in November 2003 the European Parliament voted to permit public funding for human embryonic stemcell research.

The applicants further argued that inventions relating to human embryonic stem cells were clearly not of thetype that was so abhorrent that the grant of patent rights would be inconceivable. The applicant maintains thatthe claims in the application make no reference to any method of isolating stem cells from primate embryos. Onthe contrary, the claimed subject matter is expressly limited to the cell cultures and methods of maintainingthem in the undifferentiated state and obtaining differentiated cells from them. The purpose and effect of r 23dis to exclude from patentability the specific activities and products listed in sub-paras (a) - (d). whether or not apatent application contravenes r 23d is to be judged solely by reference to the matter for which protection issought ie as set out in the claims.

The patent applicant argues that a broad construction could not distinguish between existing lines of hES cellsand hES cells obtained by other means. In practice, hES cells now can be obtained readily without handling ordisposition of an embryo. The patent applicant, thus, argued that the proper construction should be a narrowone such that it excludes only patent applications whose claimed subject matter comprises the use of humanembryos.77

It would appear that the decision of the Enlarged Board of Appeal would be decided sometime at the end ofthis year. Considering how political and divisive embryonic stem cell patents have been in Europe, it remains tobe seen how the Enlarged Board of Appeal would decide on the issue.

The Regulation of Research on Embryo: The Moral Arbiter

It has often been asserted that the patent system is an ineffective mechanism for dealing with ethical issues. 78

Moreover, patents are normally applied at the stage of the commercialisation of the embryonic stem cells. Itdoes not influence any decision making at the level of R & D. Nevertheless, it should be pointed out that avail-ability of patents is crucial for continued sustenance of R & D, particularly so in the bio-tech industry where the


15/56

cost of R & D is prohibitive.

Thus, should the ethical filter be applied only at the R & D level without a second tier determination at thepatent level? Adopting such mechanisms would make it easier for the Patent Office to move.79

On this Graeme Laurie proposes three alternatives:

(i) If we accept the permissibility of embryo research, are there any objections of a different orderabout granting patents over derived products or related processes?

(ii) If we do not accept the permissibility of embryo research then, a fortiori, patenting is also unac-ceptable.

(iii) But what if the law is silent on embryo research? In such a case we might once again hear thecall that the prospect of patenting leads to offensive practices, in that it might encourage researchwhich is offensive per se.

To him the exclusion of early stage interventions seems to make more moral sense because the closer we areto treating a naturally occurring human organism as a commodity the more offensive it becomes.

Laurie distinguished two broad types of moral concerns; one that targets embryo research and the latter relatesto the prospect of patenting the outcomes of stem cell research such as the problem of granting overly broad

patents. This stems from the concern that the reward of the patent is not deserved. The Edinburgh patent re-veals a more general underlying unease about stem cell technology; but it is not for patent law to address thatconcern if the objection is to science rather than to the grant of a monopoly right.

Laurie's observation echoes the opinion expressed in the report commissioned by the UK Department ofHealth. The Committee therein requested for the disentanglement of the objections against research on em-bryo, which should be the ambit of the Human Fertilisation and Embryology Authority, than that concerns thescope of patents.80

Could it be that despite assertions by many quarters backed by scientific theories that human embryos couldnot be properly treated as human beings, there grew a lot of unease and uncertainty as to the commercialisa-tion of any inventions derived therefrom?

It is for this reason that the European countries have divergent views and laws on both research on embryoand patents. The European Convention on Human Rights and Bio-medicine81 leaves each country free to de-

cide how to regulate embryo research. Countries are however, obliged to respect two conditions: the prohibi-tion on producing human embryos for research purposes, and the adoption of rules designed to assure ade-quate protection for the embryo.82

Research on Human Embryo and Stem Cell Research in Malaysia

In Malaysia, there is no explicit exclusion for inventions that involve human biological material under thePatents Act 1983. The recent incorporation of 'order public and morality' in s 31 as a yardstick for the grant ofpatents, brings into question the extent to which such inventions are acceptable in Malaysia and the extent towhich s 31 could be invoked to bar such inventions. It is not quite sure what is the stand of the MalaysianPatent Office with regards to such inventions. However, it could be possible that the developments in the UKand the EPO would catch on in Malaysia, considering the long relationship and continuous technical transferassistance we have with these countries.

The position is not entirely dormant with the health authorities. Concerned with the wide practices and abusesof stem cell collection and therapy, especially involving haemotopoietic stem cells, the Health Ministry came upwith guidelines on Therapeutic Human Cloning and Stem Research in 2007.83 Among the policies that the Min-istry of Health undertook to encourage and promote are stem cell research in Malaysia. Second, all stem cellresearch must pass through an institutional review board and an institutional ethics committee to prevent un-ethical research and unethical use of stem cells. Third, research on stem cells derived from adult stem cells isallowed in accordance with existing guidelines. Fourth, the use of foetal tissues from legally performed termina-tion of pregnancies is also allowed in accordance with existing guidelines. Fifth, the use of non-human stemcell lines is also allowed (mice and primates). Sixth, the use of embryonic stem cell lines (from 64 cell lines) fortherapeutic purposes should be allowed. Seventh, the creation of embryos either from ART or SCNT specifi-cally for the purpose of scientific research is presently prohibited.


16/56

These guidelines were based in an earlierfatwa from the Majlis Fatwa Kebangsaan in 2005 that declares thefollowing:

(i) That therapeutic human cloning is permitted (diharuskan) if for - medical treatment - through thecreation of certain cells or replacing damaged organs 'taking into account the limits permitted by

the Shariah;(ii) The use of embryos left-over from IVF for research purposes is permitted (harus) on two condi-tions:

(a) the couples had consented;(b) before the embryo reaches the stage of 'alaqah.

(iii) Research on pre-embryos for purposes other than for therapeutic purposes is also permitted pro-vided that --

(a) the couples consented;(b) the embryo is not implanted into any womb.

(iv) Research on pre-embryos to detect any pre-disposition to any genetic diseases for high risk cou-ples is allowed and only embryos that were determined to be clear from any such diseases couldbe implanted in the womb of the mother during the marital term.

(v Any genetic treatment on pre-embryo to change the natural characteristics of the pre-embryosuch as hair, hair colour, intelligence, height including sex determination is not allowed. However,sex determination is allowed if is linked to predisposition to fatal genetic diseases.

(vi) Any type of research for commercial gain or that which has no relation to the health of the motheror the foetus is not permitted.

(vii) Research done must be --(a) legal with a clear research proposal(b) for scientific purposes(c) Carried out by qualified research personnel who are

trustworthy and responsible.

(vi) Sources of stem cells permitted --(a) ess embryos (consent obtained from parents)

(b) aborted foetus as a result of natural abortion or frommedical treatment that is allowed under the Shariahand is carried out with the consent of the family mem-bers; not from aborted fetus that is carried out deliber-ately without any causes accepted by the medical fra-ternity and Shariah.

(vii) stem cells created from SCNT are not permitted based on sadd al-zara'i(blocking the means ofevil) 84

Pursuant to the 2007 Guidelines on Stem Cells, it was further declared in the National Organ, Tissue and CellTransplantation Policy, Ministry of Health Malaysia, June 2007 that no embryonic stem cell therapy shall bepermitted.85

From both guidelines, the position in Malaysia is that:

(i) extraction of human embryonic stem cells is not allowed.(ii) use of embryonic stem cell lines (from 64 cell lines) for therapeutic purposes should be allowed.(iii) creation of embryos either from ART or SCNT specifically for the purpose of scientific research is

presently prohibited.

As extraction of human embryonic stem cells is not allowed under the guidelines; it would be considered to becontrary to public order. However, as importation of stem cell lines is allowed and research on stem cell is en-couraged, one could expect that some of the research output that has reached the Malaysian scientist wouldeventually reach the patent office.


17/56

Following the Ministry of Health guidelines, it would appear that Malaysia has chosen Option 2 from among the6 policy options as identified by Le Roy Walters:86

Option 1:No human embryo research is permitted, and no explicit permission is given to perform research onexisting human embryonic stem cells;

Option 2: Research is permitted only on existing human embryonic stem cells lines, not on human embryos;Option 3: Research is permitted only on remaining embryos no longer needed for reproduction;

Option 4: Research is permitted both on remaining embryos and on embryos created specifically for researchpurposes through invitro fertilization (IVF);

Option 5: Research is permitted both on remaining embryos and on embryos created specifically for researchpurposes through somatic cell nuclear transfer into human eggs or zygotes; and

Option 6: Research is permitted both on remaining embryos and on embryos created specifically for researchpurposes through the transfer of human somatic cell nucler into non-human eggs, for example, rabbit eggs.

National countries stand on stem cell research could be classified under the six options as followed: (not exten-sive)Country Option

United Kingdom Option 4 and 5Germany Option 2 (before 1st January 2002)Belgium Option 4 and 5

Austria Option 1Ireland Option 1Italy Option 1Norway Option 1Poland Option 1Czech Republic Option 3Denmark Option 3Finland Option 3Greece Option 3The Netherlands Option 3

Hungary Option 3Russia Option 3Spain Option 3Israel Option 5China Option 6Singapore Option 4 and 5

Australia Option 4 and 5 (beginning 12 June 2006)India Option 5Canada Option 3

The above table illustrates that there is a marked divergence in terms of legislative framework in embryonicstem cells in the world. Countries with the most relaxed policies such as the UK, Israel, Singapore, Korea andJapan, allow a wide variety of embryonic stem cell procedures, including the creation of embryos for researchpurposes. In Canada, France and Australia, research on spare embryos is allowed but criminally bans all forms

of somatic cell nuclear transfer. Australia however further liberalised this position through Prohibition of HumanCloning for reproduction and the regulation of Human Embryo Research (A) Act 2006.87 Germany in contrastthrough its Stem Cell Act 2000, forbids the generation of hES cells but does not impede the import of hES cellsfrom abroad (derived before 1 January 2002) and their subsequent use for research or any other purposes. 88

On the most restrictive stand are countries like Austria and Ireland that ban virtually all forms of research in-volving human embryos.

With regards to patents, there are several options that the Malaysian Patent Office could take:

(i) Using patents to research regulations


18/56

At the moment, the extraction of stem cells from embryos is not allowed in Malaysia following the 2007 Ministryof Health's guidelines on Therapeutic Human Cloning and Stem Research. However, the importation of stemcells lines into Malaysia for research purposes is allowed. In fact, Malaysian scientists are already working onimported stem cell lines. In such a situation, the Patent Office would have to determine the patentability of theresearch output of such R & D process. The feeling of the scientific community in Malaysia is that if inventions

are developed from imported stem cell lines, such products should be patentable on the basis that the R & D,labour and expertise spent on the project should be remunerated.

(ii) Provide a mechanism by which ethically contentious patent applications are to be reviewed by anEthics Committee that might comprise of scientists and religious scholars representing the di-verse religious interests in Malaysia. This could be done during the examination stage. However,the current patent law does not accommodate representations by others or reference being madeto others at the examination stage. Another option would be to re-introduce the invalidation pro-ceedings into the patent system. This post registration attack system has been the core avenuefor opposition against inventions perceived to be unethically immoral. This would create ahealthy, open and transparent system where voices of dissent are heard. Invalidation proceed-ings could be a powerful tool to check on contentious patent applications that have gone throughthe system undetected.

(iii) Amend the law to include explicit exclusion on the patenting of human beings; human cloning, ashas been done in other countries is another obvious option. On this, we could emulate the Aus-tralian style with its wide prohibition on the patenting of 'human beings' or the Canadian style withits broad prohibition of patenting of human bodies at all its stages of development. Another optionit to adopt a two tier prohibition like the European Directive and the European Patent Convention.This essentially involves a broad prohibition against patenting of inventions against 'ordre public'and morality and another prohibition that lists the specific prohibition targeting against either thehuman body or bodily parts and the commercial use of human embryo. The two tier system couldgive rise to difficulties in interpretation as to what would fall under the broad prohibition and whatwould fall under the specific provision.

Even if there is such explicit exclusions, problems with interpretation are expected with ever evolving technol-ogy. But there would be problem of interpretation of what would amount to a 'human being' etc.

(i) there is a need to formulate guidelines on the patenting of cells derived from human beings fol-lowing the practice in other major Patent Offices. This would provide the assurance to the scien-tific community that a certain level of certainty exists. To provide more credence, there should bea move to set up a national ethics committee entrusted to study the ethical, legal and social impli-cations of recent advances in life sciences as have been done in other countries. One of the as-pects considered by this committee could be the position of the ensuing patents resulting fromhuman stem cell research.89

(ii) 'ordre public' and morality provisions should be interpreted according to religious convictions andnorms of ethics and morality in Malaysia. Considering that Malaysia is a multiracial country, itwould be prudent to widen the engagement process to include all representations from religiouscommunities. This is not difficult to perceive as the National Fatwa on stem cells are rather per-missive. However the Ministry of Health decided to adopt the most conservative view so as to ap-pease other religious views.

(iii) regards to the regulatory framework on research on stem cells, a lot needs to be done. At themoment the draft Human Cloning Bill is still waiting to be tabled to Parliament. This Draft Bill, withits absolute prohibition against cloning accords well with the Ministry of Health guidelines thatprohibit the creation of embryo through the SCNT process to harvest stem cells.

(iv) other related issues are the permissibility of research on human embryos. The Human Tissue Act1974, drafted in the pre-bio-technology era is beyond obsolete as the Act talks of organs and notcells. There is currently no clear law on the usage of human embryos for research. However, re-search on embryos may fall under the existing guidelines on assisted reproductive technologies.For this purpose, two guidelines would be important; the Ministry of Health Code of Practice andGuidelines for Assisted Reproductive Techniques (ART) Centres 2002 and the Malaysian Medi-cal Council Guidelines on ART 2005. These guidelines do not allow research on embryos except


19/56

by way of licence from the Ministry of Health. However, as these are mere guidelines, the effec-tiveness of the monitoring mechanism is very much suspect. There is thus a dire need for thecreation of an umbrella act on governing the creation and use of embryos. Moreover, the creationof an oversight body to grant licences, monitor and enforce laws would provide the institutionalframework for the regulation of research on human embryos in Malaysia.

(v) for stem cells research and therapy, the current guidelines drafted by the Ministry of Health themuch needed policy direction for the scientific community. However, these are mere guidelineswhose implementation, monitoring system and threat of enforcement are very much suspect.

CONCLUSION

Moral Dilemma: The critics

Ethical dilemma raised by virtue of rapid advances in bio-technological inventions is historically speaking notnew. As early as 1998, Jeremy Rifkin, had already warned of the consequences of the bio-tech revolution onhuman kind. In his words:

The bio-tech revolution will force each of us to put a mirror to our most deeply held values, making us ponder the ultimatequestion of the purpose and meaning of existence. This may turn out to be its most important contribution. The rest is up

to us.90

The decision to open up patents to embryonic stem cells has caused an uproar among the scientific communityand patent offices all over the world. It is the view of many that 'human embryos' should not be simply treatedas starting materials just like any other 'composition of matter'. What more if the research requires the destruc-tion of human embryos, an act which is described by many as akin to 'abortion'. To that extent, the Patent Of-fice would have to be prudent in examining applications relating to stem cells. It would be useful to delineatethis boundary through express provisions in the patent law. However, from the experience of the UK, EU and

Australia, whatever phrase or words that one adopts to delineate what is not patentable would be highly con-tentious; otherwise it runs into the danger of becoming obsolete due to the rapid changes in technology. Ulti-mately, what is more important would be a policy decision by each country depending on the prevailing socialmores, religious sentiments and moral views of the country.

1 This article is based on a research project on Patents, Human Embryonic Stem Cells and Ethics, conducted at the Max PlanckInstitute in August 2006 and University of Nottingham in November 2006 as part of the Association of Commonwealth Universities(ACU) Joint Research Project. The researcher is grateful to the Max Planck Institute and the ACU for the generous funding givenfor the completion of this research. Personal thanks to Prof Paul Torremans and Prof Strauss for hosting the researcher during thisperiod. Parts of the research findings have been presented at the Conference on Law and Technology, UKM, 14-15 September2006; Seminar on Bio-ethics: Meeting the Challenges, organised by the Centre for Civilisational Dialogue, Centre for Research inBio-technology for Agriculture (CEBAR) & the Faculty of Medicine, University of Malaya, 15-16 March 2007 and Forum on GeneticTesting, Profiling and Therapy, organised by Academy of Sciences, 21 July 2007.

2 Pekeliling Ketua Pengarah Kesihatan Bil 1/2006.

3 National Organ, Tissue and Cell Transplantation Policy, Ministry of Health, June 2007.

4 Cf. Commission of the European Communities, Commission Staff working Paper. Report on Human Embryonic Stem Cell Re-search, Brussels, 3 April 2003. Available at ec.europa.eu/research/press/2003/pdf/sec2003-441report_en.pdf.

5 European Group on Ethics in Science and New Technologies to the European Commission, 'Ethical Aspects of Patenting Inven-tions Involving Human Stem Cells', 7 May 2002. Available online at http://europa/eu.int/comm(The EGE Opinion) at p 4.

6 As described in by the Nuffield Council of Bio-ethics, human stem cells can give rise to many different types of cells, such asmuscle cells, nerve cells, heart cells, blood cells and others. They raise the possibility, therefore, of major advances in healthcare.For example, stem cells could be used to generate replacement cells and tissues to treat many diseases and conditions, includingParkinson's disease, Alzheimer"s disease, leukaemia, stroke, heart disease, diabetes, multiple sclerosis, rheumatoid arthritis,spinal cord injury and skin conditions, including burns. See, Stem Cell Therapy: the Ethical Issues: A Discussion Paper, April2000. For an earlier related paper on DNA, see, Nuffield Council on Bioethics, The Ethics of Patenting DNA (2002), Nuffield Coun-


20/56

cil on Bioethics, London, see [#8810]www.nuffieldbioethics.org[#8811].

7 The literature on this is extensive. See Michael Ruse and Christopher A Pynes, The Stem Cell Controversy: Debating the Is-sues, (2006) Prometheus, New York; Aurora Plomer, The law and Ethics of Medical Research: International Bioethics and HumanRights, (2005) Cavendish Publishing, UK; Oliver Mills, Bio-technological Inventions: Moral Restraints and Patent law, (2005) Ash-gate, UK. See also Roger Brownsword, Bio-technology and Rights: Where Are We Coming From and Where Are We Going, in

Mathias Klang and Andrew Murray (ed), Human Rights in the Digital Age, Glasshouse press (2005).

8 The Australian Law Reform Commission (2003), Gene Patenting and Human Health, available at http://www.austlii.edu.au.

9 The EGE Opinion, fn 5 above.

10 The EGE Opinion, fn 5 above.

11 See Report of the House of Lords Select Committee on Stem Cell Research, available athttp://www.publications.parliament.uk(Report 13 February 2002.) This Committee was appointed under the chairmanship of the Bishop of Oxford to reconsider and re-port on the issues connected with human cloning and stem cell research arising from the Human Fertilisation and Embryology(Research Purposes) Regulations 2001.

12 Stem Cell Therapy: The Ethical Issues: A Discussion Paper, April 2000. For an earlier related paper on DNA, see, NuffieldCouncil on Bioethics, The Ethics of Patenting DNA (2002), Nuffield Council on Bioethics, London, see [#8810]www.nuffield-bioethics.org[#8811], 22-23.

13 There are scientific justifications for the 14 days window period for research on embryos. The 14 day stage immediately pre-cedes the primitive streak stage at which both the development of individual embryos and cell determination for the future foetusare established. The pro-life group criticises the 14 days restriction. According to them, from the rights perspective, the attachmentto a 14-day limit has no clear rationale. Even on a precautionary approach, the possibility that the embryo is already an agent doesnot markedly alter at this stage of what we understand to be its developmental path.

14 Critics also question the UK Select Committee's Report for the lack of respect and understanding of the concept of human dig-nity. Thus critics argue that any form of commodification of the human body should not be allowed -- whether in the form of com-merce in human organs or tissue, prostitution, surrogacy for profit, or patenting of human genes -- is just one of a number of prac-tices that are regularly cited as instances of human dignity being compromised. Typically, human dignity as constraint also con-demns sex selection and positive eugenic, gene selection, germ line gene therapy, embryo research and abortion, euthanasiaand assisted suicide, genetic discrimination, and perhaps (top of the current list) human reproductive cloning.

15 The EGE Opinion, fn 5.

16 Page 13 of the EGE Opinion, fn 5.

17 See its earlier Opinion No 15 of 14 November 2000 cited in its Opinion No 16 of 7 May 2002 at p 14.

18 Patent No EP 0695351.

19 Patent application No 96903521.1.

20 For religious viewpoints, see the Church of Scotland: Church and Society Council, Report of the Working Group on EmbryoResearch, Human Stem Cells and Cloned Embryos, available at http://www.srtp.org.uk/cloning.shtml. See also George P Smith, II,The Christian Religion and Biotechnology: A Search for Principled Decision Making, (2005), Springer, US; Dariusch Atighetchi, Is-lamic Bioethics: Problems and Perspectives, (2007) Springer, US.

21 Audrey Chapman, et al, Stem Cell Research and Applications: Monitoring the Frontiers of Biomedical Research , (1999) TheAmerican Association for the Advancement of Science and Institute for Civil Society, US.

22 Ibid.

23 Human Genome Organisation's (HUGO) Ethics Committee and by the United Nations Educational, Scientific and Cultural Or-ganization. HUGO Ethics Committee, Statement on the Principled Conduct of Genetics Research (1996), Human Genome Organi-sation, see [#8810]www.hugo-international.org[#8811]; Universal Declaration on the Human Genome and Human Rights, UN-ESCO, [#8810]www.unesco.org/ibc/en/genome/projet/[#8811], 19 February 2003, art 12(a). See also Recommendation No. 1425on Biotechnology and Intellectual Property, Council of Europe, (entered into force on 23 September 1999), rec 10; Recommenda-tion No 1468 on Bio-technologies, Council of Europe, (entered into force on 29 June 2000), rec 10.

24 An opinion which may not be acceptable to many. Some views that thanks to intellectual property, the boundary of proprietaryrights expands. 'In fact, just like non-human living matter, the parts of the human body can now, under certain conditions, give rise


21/56

to one kind of property: intellectual property. Thanks to bio-technologies, the part that is non-appropriable is therefore becomingsmaller as we gradually succeed in 'building' everything, even life, by accumulating technology and labour, which must both be re-warded by protected access to the market and which are likely to generate considerable financial profits'. Bellivier, F and Noiville,C, 'The commercialisation of human biomaterials: what are the rights of donors of biological material?', Journal of BiotechnologyLaw, Vol 1, 2004; 89-97, par p 93.

25 The ALRC Report, fn 8.

26 Footnote 21. See also the EGE Opinion, fn 5 above, at p 13.

27 Footnote 21. See also the EGE Opinion, fn 5 above, at p 13.

28 The UK Select Committee came up with the same finding on this. The Committee was of the view that embryos should not becreated specifically for research purposes unless there are demonstrable and exceptional needs which, cannot be met by the useof surplus embryos.

29 The EGE Opinion, fn 5 above, at p 15.

30 Ibid, The EGE Opinion, fn 5 above, at p 15.

31 The EGE Opinion, fn 5 above, p 16.

32 The EGE Opinion, fn 5 above, p 16.

33 The EGE Opinion, fn

case law journals legislation2012-04!03!13-35

Documents