School of Law LW497

Should Patents be Confined to Inanimate Inventions? Tackling the Question from a Legal Perspective.

Student Name: Student ID No.: Course and Year: Lecturer Name: Word Count:

Jason McWalter 09684964 Final Year B. C. L. Dr Joe McGrath / Maureen O'Sullivan 5, 011 (including footnotes, excluding title
page and bibliography)

There is no conversation more boring than the one where everybody agrees. - Michel de Montaigne.1

http://www.brainyquote.com/quotes/authors/m/michel_de_montaigne_5.html. Last Accessed on 17/01/2012.

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Introduction
The above quote by the French philosopher Montaigne expresses his belief that the most interesting areas of life are where the most conflict arises. One would be hard pressed to find a legal microclimate with a greater variance of ideology than the politically charged area of law surrounding the patenting of biotechnological inventions. It has all the ingredients of a good debate because it lies in the border land between philosophy and law which neither philosophers nor lawyers want to deal with. As well as this, its commercial significance is on the rise. According to European Patent Office statistics on granted patents by field of technology, an impressive 17,012 patents were granted on the field of biotechnology alone between 2001 and 2010.2 The central question in this area of law is should patent law be confined to inanimate inventions?. Attempting to answer this question is undoubtedly an incredibly difficult task. However, if it is approached from a primarily legal perspective as opposed to a moral one it becomes much more manageable. This article does not wish to argue the morals of patenting biotechnological inventions, instead its central thesis is that the patent system as it stands is not suited to biotechnology, not as a result of some argument founded on morality but as a result of the fact that it is an inherently inappropriate and a rather out-dated system. It is argued that continuing to grant legal monopolies over living things under such a flawed system is most inappropriate and as a result of this, patents should not be granted on living organisms. In this article the law as it stands will be outlined. Following this, the patent system will be criticised in order to highlight the inappropriateness of its relationship with
2

European Patent Office statistics on patents granted per technical field 2001-2010 available at http://www.epo.org/about-us/statistics/granted-patents.html. Last accessed on 25/02/2012.

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biotechnology. It is argued that this inappropriateness is the reason why patent law should be confined to inanimate inventions. In addition to the central thesis of this article, the various alternatives will be analysed in light of the current systems failings.

The Law on Patents

A patent can be described as a negative right which creates a temporary statutory monopoly over an invention.3 This particular type of right is limited by time (usually twenty years) and territory (the state in which the relevant patent office granted the patent). The relevant domestic legislation on the matter is the Patents Act 1992, as amended, which introduced into Irish law the European Patent Convention and Patent Co-operation Treaty. These set out the three fundamental criteria which must be met for an invention to be patentable. First, the invention must be novel.4 That is, that it does not form part of the state of the art, which is broadly defined in Section 11(2). The rationale for this relatively simple criterion was stated by Oliver J. in Windsurfing International Inc. v Tabur Marine (GB) Ltd (1985).5 He noted how it would be wrong to allow the patentee to prevent an individual from doing what he would have lawfully been allowed to do before the granting of the patent.6 Secondly, it must involve an innovative step.7 This criterion is closely related to the novelty requirement but is a separate criterion. As Clark, Smyth and Hall note, the existence of an
3

http://milcnet.lendac.ie.libgate.library.nuigalway.ie/NXT/gateway.dll?f=templates&fn=default.htm$vid=milcn et:milcnet1. Last accessed on 12/01/12.

4

Section 11(1) of the Patents Act 1992, as amended. Reports of Patent, Design and Trademark Cases 59. Ibid at 77. Section 9 of the Patents Act 1992, as amended.

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innovative step is accessed by determining whether the invention itself would be obvious to an individual skilled in the art at question.8 This is known as non-obviousness in the United States.9 Thirdly, the invention must be susceptible to industrial application. This is referred to as utility in the United States10 and arises if the invention can be made or used in any kind of industry, including agriculture.11

Patent Law With Respect To Living Organisms

Life patents are patents concerning such inventions as genetic engineering or even complete living organisms. As the United States patent granted to Louis Pasteur in 187312 demonstrates, biological material and biological processes were deemed patentable in the late 19th century, long before modern genetic engineering emerged as the commercial dynamo that it is today. Biotechnology is now an important aspect of this area of law and can be defined as the use of living cells and bacteria in industrial and scientific processes.13 The most important law in this particular context is Article 53 of the European Patent Convention. This was transposed onto section 10(a) of the 1992 Act almost word for word and states that: European patents shall not be granted in respect of:
8

Clark, Smyth and Hall, Intellectual Property Law in Ireland (Dublin, 3 ed., 2010) at 82. Mills, Biotechnological Inventions: Moral Restraints and Patent Law (Surrey, Revised ed., 2010) at 4. Ibid. http://www.irishstatutebook.ie/1992/en/act/pub/0001/print.html#sec14. Last accessed on 17/01/12.

rd

10

11

12

Garforth, Life as Chemistry or Life as Biology? An Ethic of Patents on Genetically Modified Organisms in Gibson (ed.), Patenting Lives: Life Patents, Culture and Development (Hampshire, 2008) at 39.
13

http://oald8.oxfordlearnersdictionaries.com/dictionary/biotechnology. Last accessed on 23/02/12.

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(a) inventions the publication or exploitation of which would be contrary to "ordre public" or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States; (b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof.14 As the above text demonstrates, this law excludes from patentability any inventions which are contrary to ordre public or morality. This is an unfortunately vague exception for such a highly contented area of law however the European Patent Office has attempted to clarify it somewhat by suggesting the application of a test of whether it is probable that the public in general would regard the invention in question as so abhorrent that the grant of patent rights would be inconceivable.15 As Crawley notes, this exclusionary rule based on morality is only to be used in rare and extreme cases.16 As well as this it should be noted that the European Patent Office jurisprudence on the matter has indicated that the scope of Article 53 is to be given a very restrictive interpretation.17 The European Communities (Legal protection of Biotechnological inventions) Regulations 200018 was introduced for a variety of reasons, but the primary one in this
14

http://www.epo.org/law-practice/legal-texts/html/epc/1973/e/ar53.html. Last accessed on 21/01/12. Clark, Smyth and Hall, Intellectual Property Law in Ireland (Dublin, 3 ed., 2010) at 71.
rd

15

16

Crowley, Ireland's Answer to Europe's Call for Patent Protection for Biotechnological Inventions, (2001) 8(3) Commercial Law Practitioner 51 at 53.
17

Llewelyn, Schrodingers Cat: An Observation on Modern Patent Law in Drahos (ed.), Death of Patents (London, 2005) at 43. Evidence for this is the fact that only one appeal brought before the European Patent Office on the grounds of morality has succeed, that being the so called Edinburgh Patent.
18

SI 247/2000.

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context was complement Article 53 and to provide an indication of good practice.19 Paragraph one of Article 6 of these regulations incorporates and expands on the ordre public and morality principle of the European Patent Convention. It also notes certain biotechnological inventions which are not patentable on grounds of 53(a), for example; A process for cloning human beings. A process for modifying the germ line genetic identity of human beings. The use of human embryos for industrial or commercial purposes. Process for modifying the genetic identity of animals which is likely to cause them suffering without any substantial medical benefit to man or animal, and animals resulting from such a process. The biotechnology directive attempted to alter patent law to cope with biotechnology but as Overwalle notes various issues remain unsettled and call for further reflection and debate.20 Cornish and Llewelyn argue that this so called expansion goes very little beyond the EPOs case law.21 Section 10(1) [b] of the 1992 Act (which is taken from Article 53(b) of the European Patent Convention) sets out the exception to patentability for plant and animal varieties. It should be noted that intellectual property rights are available for plant variety protection under the Plant Varieties (Property Rights) Act 1980. This exception applies to varieties only

19

Llewelyn, Schrodingers Cat: An Observation on Modern Patent Law in Drahos (ed.), Death of Patents (London, 2005) at 40.
20

Overwalle, Legal and Ethical aspects of Bio-Patenting: Critical Analysis of the EU Biotechnology Directive in Drahos (ed.), Death of Patents (London, 2005) at 219.
21

Cornish and Llewelyn, Intellectual Property: Patents, Copyright, Trademarks and Allied Rights (London, 5 ed., 2003) at 836.

th

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and as the case of Hybrid Plants/Lubrizol22 demonstrates, a plant or animal treated by a patentable process can be patentable. As the above text clearly indicates, animate beings are subject to patent law alongside mechanical inventions. However this particular area of law is the target of a spectrum of critical opinions. Through analysis of the patent systems criticisms it will be shown that change is needed.

Criticism of Patent Law

Criticisms of the current patent system are varied and widespread. For starters, there are intrinsic moral objections to biotechnology itself from various organisations and religious groups. Next, there does not appear to be a consensus as to what the definition of morality is or what position it holds with respect to the patentability of biotechnological inventions. As well as this, there is much academic debate as to the role morality should play in this particular rubric of law and even if it should have a part to play at all. In this section of the article some of the more crucial criticisms are examined and their merit accessed.

Morality and Article 53: Thambisetty notes that the relationship between law and morality is particularly fraught in the sphere of patent law.23 It is clear that morality plays an important role in
22

(1990) European Patent Office Reports 173. Lenk, Hoppe and Andorno, Ethics and Law of Intellectual Property (Hampshire, 2007) at 247.

23

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patents concerning life. It finds itself intertwined with patent law as a result of entering the theoretical door that is Article 53 of the European Patent Convention. As a result of this considerable attention must be given to it and its application. Some academic commentators such as Mills hold the view that Article 53(a) is not an appropriate mechanism24 for determining the exceptions to patentability. His argument is based on the common sense reasoning that patent law regulates a commercial area and as a result should not have the scope of its ambit expanded beyond this. Another justification for his belief lies in the unclear nature of the jurisprudence of the European Patent Office as to the meaning and application of Article 53. An important case in this context is the Harvard/Oncomouse25case, in which the strength of Article 53(a) was considered. It concerned a genetically modified mouse for the purpose of cancer research. Here, a balance test was applied which involved the careful weighing up of the suffering of animals and possible risks to the environment on the one hand, and the invention's usefulness to mankind on the other.26 In this case the refusal of the initial patent application was overturned, however it was stressed that the judgement concerned the present case alone and that a different position may be reached with respect to another transgenic animal. This decision was subsequently appealed which lead to the case of

Harvard/Transgenic Animal27 which concerned in particular Rule 23d(d) of the European Patent Convention 1973, now Rule 28(d) of the European Patent Convention 2000. This states that inventions that are unpatentable include processes for modifying the genetic

24

Mills, Biotechnological Inventions: Moral Restraints and Patent Law (Surrey, Revised ed., 2010) at 56. (1991) European Patent Office Reports 501. http://www.epo.org/law-practice/case-law-appeals/pdf/t900019ep1.pdf at 21. Last accessed on 28/01/12. (2005) European Patent Office Reports 31.

25

26

27

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identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.28 This rule is important for patenting life and as Clarke, Smyth and Hall note, it either acts as an alternative or addition29 to Article 53, depending on the facts of the case. In the case of Howard Florey/Relaxin30 the application of Article 53(a) was again at play. The case concerned a patent which had been granted for a genetically engineered hormone which was opposed to by 26 named persons.31 In its decision, the Opposition Division concluded that under Article 53(a) an invention concerning a human gene was not an exception to patentability because it would not be universally regarded as outrageous.32 Mills believes this test to be more sensible33 than the balance test applied in the Onco-mouse case because it limits the power of the European Patent Office by declaring the consensus amongst the concerned states at the primary controlling factor. The case of Plant Genetic Systems N.V et al34concerned genetically modified plant cells and plants. The Board in this case observed that a "balancing exercise"35 as used in the Onco-mouse case was not the only way of assessing patentability with regard to Article 53(a) but just one possible way. In this case it was held that the patent in question did not fall
28

http://documents.epo.org/projects/babylon/eponet.nsf/0/7bacb229e032863dc12577ec004ada98/$FILE/EPC _14th_edition.pdf at 332. Last accessed on 29/01/12.

29

Clark, Smyth and Hall, Intellectual Property Law in Ireland (Dublin, 3 ed., 2010) at 72.

rd

30

(1995) European Patent Office Reports 541. Available at http://www.epo.org/law-practice/case-lawappeals/pdf/t950272eu2.pdf Last accessed on 29/01/12.
31

Ibid at 7. Ibid at 2. Mills, Biotechnological Inventions: Moral Restraints and Patent Law (Surrey, Revised ed., 2010) at 62.

32

33

34

(1995) European Patent Office Reports 357. Available at http://www.epo.org/law-practice/case-lawappeals/pdf/t930356ex1.pdf Last accessed on 29/01/2012.
35

Ibid at 31. Point 18.8.

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within the ambit of Article 53(a).36 Mills argues that this decision suggests that the acceptability of tests set out by the European Patent Office is suspect and that, as a result, a clear set of definitions are needed with respect to the meaning of ordre public and morality.37 It should be pointed out that the meaning of morality found in Article 53 may not be as unclear as the above case law demonstrates. Paragraph two of Section 6 of Directive 98/44/EC expands what is meant by ordre public and morality by giving examples of what is considered unpatentable. The recitals of this directive also help expand what is meant by Article 53, for example, recital 38 of 98/44/EC notes that a process to produce chimeras from the germ cells or totipotent cells of humans and animals is excluded from patentability. However, it should be noted that Mills holds the view that the Directive simply perpetuates the shortcomings38 of Article 53. The controversial area of the use of human embryos has for all intents and purposes been declared to be contrary to public order and morality through the decision in Brstle v Greenpeace39 In this case, Greenpeace argued that the patent held by Mr Brstle (which concerned isolated and purified neural precursor cells produced from human embryos) was contrary to the provisions of Directive 98/44/EC and so the Bundespatentgericht (Federal Patent Court of Germany) held the patent to be invalid. This decision also seemingly cleared up the area of the patentability of human animal chimeras, as human embryos are needed for the development of chimeras. A chimera can be defined as an organism with different cell populations derived from different zygotes of the same or

36

Ibid at 31. Point 19. Mills, Biotechnological Inventions: Moral Restraints and Patent Law (Surrey, Revised ed., 2010) at 68. Ibid at 153. Case C-34/10.

37

38

39

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different species, occurring spontaneously or produced artificially.40 This highly controversial area of law demonstrates what is clearly against ordre public and morality. Despite these small clarifications there is an unwanted air of uncertainty. Mills quite rightly believes that Article 53(a) does not protect biotechnological inventions adequately due to air of uncertainty surrounding its case law. This uncertainty may be quite damaging especially with respect to the fact that patentees may not know if their created inventions are legal. The meaning of ordre public and morality could be distilled from the relevant jurisprudence, but unfortunately the case law appears to be too varied to do so. As the concept of intention in criminal law shows, distilling definitions from numerous judgements can lead to confusing results.41 The Existence of a Presumption of Patentability: Llewelyn holds the belief that an exclusionary rule based on morality is so fundamental that it need not be stated directly and that there should be an overreaching presumption that patents are only granted over morally appropriate inventions.42 Despite this, she propounds the argument that with respect to animate inventions there exists a presumption of patentability in our current patent system.43 One argument in favour of this point of view is the fact that only the Edinburgh Patent has been a successful appeal based on the morality exclusion. Another is the fact that the European Patent Office seems to be

40

http://medical-dictionary.thefreedictionary.com/chimera Last accessed on 12/02/2012.

41

Coffey, Codifying the Meaning of Intention in the Criminal Law, (2009) 73 Journal of Criminal Law 394 at 395. This relates to the definition of intention with respect to murder, which was in effect distilled from case law, yielding confusing results.
42

Llewelyn, Schrodingers Cat: An Observation on Modern Patent Law in Drahos (ed.), Death of Patents (London, 2005) at 39.
43

Ibid at 42.

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having its cake and eating it44 with respect to the fact that where an invention is not prohibited by law then this can serve as evidence as to why is should not be excluded on morality grounds but where an invention is illegal, this is deemed to be irrelevant for the purposed of the morality exclusion rule. Llewelyn refers to the decision in Leland Stanford/ Modified Animal45 in support of her argument. It would appear that she is correct when she states that the taint of the presumption of patentability is tangible.46 Macqueen, Waelde and Laurie also note the existence of the increasing presumption in favour of patentability.47 The Unsuitable Nature of the Classic Approach of Patent Law: Garforth believes that patent law is not suitable for living organisms effectively stating that Article 53 is simply not living up to its job. Following an analysis of her so called triptych of science, ethics and law with respect to biotechnology she came to the conclusion that the language of patent law is not suitable for living organisms.48 She feels that this particular area of law essentially requires that living organisms animate nature to be reduced to chemical descriptions in order to fall within the ambit of patentable subject matter. She argues that this rather simplistic representation of life is unethical due to the fact that it misrepresents the true nature of life.49 This type of belief is known as vitalism and is subject to vast criticism by the scientific community as well as other academic fields. For example Huxley once mocked vitalism by arguing that water is not the way it is as a result of
44

Ibid at 43. (2002) European Patent Office Reports 2.

45

46

Llewelyn, Schrodingers Cat: An Observation on Modern Patent Law in Drahos (ed.), Death of Patents (London, 2005) at 45.
47

Macqueen, Waelde and Laurie, Contemporary Intellectual Property: Law and Policy (Oxford, 2008) at 425.

48

Garforth, Life as Chemistry or Life as Biology? An Ethic of Patents on Genetically Modified Organisms in Gibson (ed.), Patenting Lives: Life Patents, Culture and Development (Hampshire, 2008) at 52.
49

Ibid at 52.

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its aquosity.50 Despite this the argument does have some merit. Critics such as Mills argue that patent laws more mechanical nature does not suit areas such as biotechnology. 51 If one ignores the rather unrealistic true nature of life aspect of the argument, the fact that biotechnological inventions do not suit the mechanical outlook of patent authorities is quite clear. Is The European Patent Office an Appropriate Judge of Morality? One would find it difficult to find merit in an argument that patent office examiners are the appropriate people to deal with concerns of morality. It would be practically impossible to argue that any particular field of knowledge is an appropriate judge of moral character. Cornish and Llewelyn believe correctly that patent office examiners lack any expertise to form the appropriate judgement, so some other body should do so.52 Emmot holds the view that patent lawyers are not appropriate moral and ethical judges because they tend to approach issues such as this in a reductionist way.53 This is a major flaw with the patent system as it stands. The Vague Nature of Morality: Within the context of biotechnology, morality is an amalgamation of conflicting opinions as to what is right. As Cornish and Llewelyn state, it comprises of irresoluble

50

http://aleph0.clarku.edu/huxley/comm/PMG/PBofL.html at paragraph 16. Last accessed on 03/03/2012.

51

Mills, Moral Considerations Need Not Inform Law's Response to Biotechnology, (2000) 18 Irish Law Times 218 at 219.
52

Cornish and Llewelyn, Intellectual Property: Patents, Copyright, Trademarks and Allied Rights (London, 5 ed., 2003) at 833.
53

th

Sterckx, Biotechnology, Patents and Morality (Aldershot, 1997) at 192.

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conflicts of ideology.54 As a result it would be incredible difficult to find a position on which everybody can agree with. If this wasnt bad enough, even if some hypothetical perfect position was attainable, morality changes over time, especially with respect to a speedily developing area such as biotechnology. The Patent System as an Inherently Flawed One: As the above arguments show, biotechnology is causing patent law great difficulty. However some academics consider the patent system to be flawed and unnecessary. As Correa states more and more voices can be heard criticising...the concepts underpinning patent law.55 Sterckx sets out and critically analyses what he believes to be the three separate grounds for justifying the patent system. The first justification is named natural rights and implies that man has a natural right to his own ideas.56 The second justification is that of distributive justice57 and the third and most convincing justification for the patent system is the economic justification.58 His arguments against the patent system are most convincing and it is argued hare that the patents systems inability to deal with biotechnology underlines the fact that it is a flawed system.

Possible Routes of Change

54

Cornish and Llewelyn, Intellectual Property: Patents, Copyright, Trademarks and Allied Rights (London, 5 ed., 2003) at 833.
55

th

Correa, The GATT Agreement on Trade-related Aspects of Intellectual Property Rights: New Standards for Patent Protection, (1994) European Intellectual Property Law Review 327.
56

Sterckx, The Ethics of Patenting Uneasy Justifications in Drahos (ed.), Death of Patents (London, 2005) at 178.
57

Ibid at 188. Ibid at 193.

58

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As Holyoak and Torremans propound, the cutting edge of biotechnology is not well protected by the patent system.59 As a result of this widespread belief change is certainly needed. However, debate arises as to the form this change should take. With respect to the European Patent Offices varied jurisprudence and the uncertain nature of the concept of morality, Mills states that what is required to combat this major shortcoming is effective harmonizing legislation with respect to the criteria of patentability and a consensus on the part of the member states as to the role morality should play in this area of law.60 There is a strong indication that a clarification of policy may be of benefit to this complicated area of law, but is it necessary? The potential benefits of broad definitions must be considered before a well-informed opinion can be created. The fast-moving nature of biotechnology indicates that the future is rather uncertain, so a broad definition of morality may actually have its benefits over a more fixed policy, such as the one desired by Mills. One way of looking at it is that a broad policy may improve the laws ability to deal with biotechnology in the future. In Plant Genetic Systems N.V et al the board noted that although it may be difficult to judge whether or not the invention in question is contrary is subject to ordre public or morality, each case is based on its merits.61 This is may be beneficial when one considers the varied nature of biotechnology and its rapid development rate. It could be argued that if the notions of morality and ordre public are clearly defined then say, for example, in ten years time, biotechnology may have reached the point where a more narrow definition of the principles of Article 53(a) may be outdated to some extent.
59

Holyoak and Torremans, Intellectual Property Law (Oxford, 5 ed., 2008) at 93. Mills, Biotechnological Inventions: Moral Restraints and Patent Law (Surrey, Revised ed., 2010) at 80.

th

60

61

(1995) European Patent Office Reports 357. Available at http://www.epo.org/law-practice/case-lawappeals/pdf/t930356ex1.pdf. Point 13 at 19. Last accessed on 29/01/2012.

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As some of the above arguments demonstrate, the broad nature of Article 53(a) can defend itself to some extent. However, it is argued here that the above defences are too few and far between and are stretched at best. It would appear that harmonisation would benefit the fraught relationship between morality and patent law, but is it the most appropriate form of change? One major flaw with the harmonisation argument is that if it was so straightforward to reach a consensus as to the meaning and role of morality, it would have been done already. The fact of the matter is that a consensus is difficult enough to reach between two people let alone between 38 member states. On top of this, the notion of morality changes nearly as much as time itself! Another possible alternative to the status quo is by excluding living organisms from patentability. As Emmot said only by excluding such living material from patentability can we ever finally resolve the morality issue.62 Although there is some merit in this statement it is not necessarily the case as a more appropriate alternative might exist, namely adopting positions more analogous to the American one. Mills propounds the view that the laws response to new technologies such as biotechnology need not necessarily be informed by ethical and moral considerations. 63 This is, in effect, the American position. Intellectual property law in America is largely similar to its European counterpart, however it has some significant differences, especially with respect to the role of morality in patent law. The most important difference for the purposes of this essay is the fact that inherently problematic moral considerations are not included in patent

62

Sterckx, The Ethics of Patenting Uneasy Justifications in Drahos (ed.), Death of Patents (London, 2005) at 195.
63

Mills, Moral Considerations Need Not Inform Law's Response to Biotechnology , (2000) 18 Irish Law Times 218 at 222.

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law, this position flows from the Supreme Court decision in the case of Chakrabarty.64 This means that the law treats biotechnological inventions the same way as a standard mechanical one. As well as this, intellectual property law is of a constitutional nature in America so the criteria of patentability are laid down by the judiciary. In Millss view, this makes it more malleable65 than European patent law. This in turn affords greater protection to biotechnological invention and leads to greater uniformity in the application of patent law. This argument should be contrasted to the jurisprudence of the European Patent Office. Mills believes that the comparable experience in America shows how Europe might proceedor have proceeded better.66 Schapira expresses his opinion excellently in his quote the American view should be the world view. There are plenty of possible legal rights which could substitute patent rights, for example Keane suggests the use of a sui generis right similar to that created for the legal protection of topographies of semi-conductor chips.67 A more drastic measure would be to remove that patent system outright, on the basis of its arguably weak justifications. These methods of change are most unlikely considering the historical strength of the patent system and the many corporations who wish to keep it alive. It would appear that the most appropriate route of change would be to adopt positions resembling the American one. This would remove the complicated issues surrounding morality, afford greater protection to biotechnological inventions and would allow Europe to challenge America in a commercial sense.

64

Diamond v. Chakrabarty, 447 U.S. 303 (1980).

65

Mills, Biotechnological Inventions: Moral Restraints and Patent Law (Surrey, Revised ed., 2010) at 50. Ibid at 196. Keane, The Patentability of Biotechnological Inventions, (1992) 10 Irish Law Times 139 at 144.

66

67

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Conclusion
Clearly, the area of biotechnology is causing patent law considerable difficulty. This is primarily a result of Article 53(a) and the vague concepts contained within it. As well as this the patent system suffers from an inappropriate presumption of patentability, a mechanical or reductionist outlook, the vagueness of the concept of morality and the fact that patent lawyers are not appropriate moral judges. Biotechnology has also lead to some academics analysing the justifications for the patent system to discover that they are not as well-grounded as one might expect. It has been argued that patented inventions do not get the same level of protection as their American counterparts and that the air of uncertainty surrounding the jurisprudence of the European Patent Office is most inappropriate. As a result of this it is unwise to grant patents on animate inventions until such a time as the patent system in Europe is changed to cope with biotechnology. The desire for change seems to be a universally held opinion. The next question is what form this change should take. This next step will undoubtedly involve moral considerations from across the board. However, following a brief analysis of the potential options it would appear that the American route of change would be the most beneficial. If this alteration was to occur biotechnology would fit much more easily into patent law and as a result patents on biotechnology would be appropriate. This alternative would also side-step the practically insurmountable obstacle of moral considerations. However, until such a change is implemented patents should be confined to inanimate objects. Thank You for Reading.

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Bibliography
Books: Clark, Smyth and Hall, Intellectual Property Law in Ireland (Dublin, 3rd ed., 2010) Mills, Biotechnological Inventions: Moral Restraints and Patent Law (Surrey, Revised ed., 2010) Garforth, Life as Chemistry or Life as Biology? An Ethic of Patents on Genetically Modified Organisms in Gibson (ed.), Patenting Lives: Life Patents, Culture and Development (Hampshire, 2008) Llewelyn, Schrodingers Cat: An Observation on Modern Patent Law in Drahos (ed.), Death of Patents (London, 2005) Overwalle, Legal and Ethical aspects of Bio-Patenting: Critical Analysis of the EU Biotechnology Directive in Drahos (ed.), Death of Patents (London, 2005) Cornish and Llewelyn, Intellectual Property: Patents, Copyright, Trademarks and Allied Rights (London, 5th ed., 2003) Lenk, Hoppe and Andorno, Ethics and Law of Intellectual Property (Hampshire, 2007) at 247 Macqueen, Waelde and Laurie, Contemporary Intellectual Property: Law and Policy (Oxford, 2008) Sterckx, Biotechnology, Patents and Morality (Aldershot, 1997) Sterckx, The Ethics of Patenting Uneasy Justifications in Drahos (ed.), Death of Patents (London, 2005) at 178

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Holyoak and Torremans, Intellectual Property Law (Oxford, 5th ed., 2008)

Articles: Crowley, Ireland's Answer to Europe's Call for Patent Protection for Biotechnological Inventions, (2001) 8(3) Commercial Law Practitioner 51 Coffey, Codifying the Meaning of Intention in the Criminal Law, (2009) 73 Journal of Criminal Law 394 Mills, Moral Considerations Need Not Inform Law's Response to Biotechnology, (2000) 18 Irish Law Times 218 Correa, The GATT Agreement on Trade-related Aspects of Intellectual Property Rights: New Standards for Patent Protection, (1994) European Intellectual Property Law Review 327 Keane, The Patentability of Biotechnological Inventions, (1992) 10 Irish Law Times 139

Cases: Windsurfing International Inc. v Tabur Marine (GB) Ltd (1985) Reports of Patent, Design and Trademark Cases 59 Hybrid Plants/Lubrizol (1990) European Patent Office Reports 173 Harvard/Oncomouse (1991) European Patent Office Reports 501 Harvard/Transgenic Animal (2005) European Patent Office Reports 31

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Howard Florey/Relaxin (1995) European Patent Office Reports 541 Plant Genetic Systems N.V et al (1995) European Patent Office Reports 357 Brstle v Greenpeace Case C-34/10. Leland Stanford/ Modified Animal (2002) European Patent Office Reports 2 Diamond v. Chakrabarty, 447 U.S. 303 (1980)

Websites: http://www.brainyquote.com/quotes/authors/m/michel_de_montaigne_5.html http://www.epo.org/about-us/statistics/granted-patents.html http://milcnet.lendac.ie.libgate.library.nuigalway.ie/NXT/gateway.dll?f=templates&fn=defaul t.htm$vid=milcnet:milcnet1 http://www.irishstatutebook.ie/1992/en/act/pub/0001/print.html#sec14 http://oald8.oxfordlearnersdictionaries.com/dictionary/biotechnology http://www.epo.org/law-practice/legal-texts/html/epc/1973/e/ar53.html http://www.epo.org/law-practice/case-law-appeals/pdf/t900019ep1.pdf http://documents.epo.org/projects/babylon/eponet.nsf/0/7bacb229e032863dc12577ec004ada9 8/$FILE/EPC_14th_edition.pdf http://medical-dictionary.thefreedictionary.com/chimera http://aleph0.clarku.edu/huxley/comm/PMG/PBofL.html

Jason McWalter

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