Understanding Morality as a Ground for Exclusion From Patentability Under European Law

- Sivaramjani Thambisetty

Exeter College, University of Oxford,
Oxford OX1 3DP, UK
E-mail: shiva.ramakrishna@exeter.oxford.ac.uk
Eubios Journal of Asian and International Bioethics 12 (2002), 48-53.
There is a common presumption that patent law, at least up until its encounter with biotechnology, was hermetically sealed and closed from external considerations. Some commentators have thus said that patent law is morally neutral (1), and the grant of a patent a non-ethical event (2). From this follows the belief that to ask patent examiners to consider moral issues is a novel approach (3). This is a fallacy (4) that arises from an incorrect understanding of two notions: nature of the monopoly grant in a patent, and significance of the legislative provision for exclusion from patentability on grounds of morality and public ordre.

Nature of the Monopoly Grant

Firstly, patents, it is argued, do not in themselves grant anything; all they do is provide a legal means by which the holder can prohibit another from using the invention. Just as issuance of a patent says nothing about the practicality of the invention (5), the grant of a patent does not confer the right to produce the invention. The product may be regulated so that approval is required before it is released, or the patent may be derived from another patented invention so that permission is required from the first holder. Secondly, it is also clear that exploitation of an invention is not exclusively dependent on whether an invention is patented or not.

The moral neutrality is thus justified by the description of the patent as a negative right to prevent third persons from exploiting the subject matter to which the right is attached. It should therefore not be seen as equivalent to the moral acceptance of the subject matter to which the legal right is attached (6). The argument that the patent is "only a negative right' is extended to imply that any restriction upon exploitation of the invention should be dealt with by other regulatory bodies and not through the cumbersome and indirect means of patent laws.

The European Biotechnology Directive (7) (hereafter the Directive), reinforces this view. It emphasises that substantive patent law is not the forum to make judgements on the desirability of certain kinds of research or commercialisation of the results of that research. European and international law continue to apply as do the requirements of public health, safety, environmental protection, animal welfare, the preservation of genetic diversity and compliance with ethical standards. According to the Recitals of the Directive these will continue to be effective in restricting, prohibiting, and monitoring research and the use or commercialisation of its results (8).

Despite the above argument, the effect of the patent right is to create a zone of non-interference, in which the patent holder may exercise the right of commercial exploitation. The holder of this right can, as a result of this zone exercise the right unless for some contingent reason a restriction is placed on this right (9). It is thus a more accurate to define a patent not as a negative right but as a positive and a negative right, where the positive part is not unconditional. To recognise the significance of a grant of patents is not to undermine the importance of regulatory bodies. But the patent office, being the port of first call, has an undeniable onus to assess the desirability of granting property rights and associating legitimacy with a morally objectionable invention. Apart from the fact that the patent is an asset that can be traded and licensed and potentially used to attract investment, the symbolism in the grant of a patent is not an insignificant one (10). There may well be general reluctance on the part of legislators and other regulatory bodies to restrict opportunities for exploitation once a patent has already been granted.

It is also commonly asserted that the denial of protection may often widen the use or dissemination of the contentious subject matter. This rests on the argument that with the grant of a patent the commercial exploitation of it is restricted to the patent holder alone, not so if the patent is not granted. This argument was presented by the patentee in the onco-mouse opposition. It was claimed that the absence of patent protection will in fact encourage more exploitation because the ability to exploit it is then not dependent upon a license. Put another way, paradoxically the very objections being raised on grounds of morality could, if successful have the side effect of greater numbers of onco-animals being generated than would otherwise be the case.

This is a weak argument. If the moral worth of an invention is debatable, then the degree in which it is exploited should not temper the law's attitude to it. To accept this is to acknowledge the failure of the law to regulate scientific research and the degree of its exploitation. The determined profiteer who intends to manufacture his morally objectionable invention is not going to care about the approval of the patent office, but the more conventional inventor is likely to be deterred by a show of disapproval.

Significance of exclusion from patentibility

The argument that there is no link between the grant of a patent and exploitation of an invention if accepted, subverts the very existence of Article 53(a) in the European Patent Convention (and correspondingly of Article 6 of the Directive). This provision clearly establishes a link between the exploitation of an invention and the grant of a patent for that invention. The wording of the provision is "if the exploitation of the invention would be contrary to morality', a patent shall not be granted. The wording "would be' in fact indicates that whether an invention is actually exploited or not is irrelevant. Thus if the exploitation would be contrary to morality, it is sufficient ground to make it an unpatentable invention (11).

The statutory backing for taking account of moral and socially (un)desirable features of an invention dates from the Statute of Monopolies of 1623. This was largely declaratory of existing common law and made all monopolies null and void, except as recognised by the Act itself. S. 6 of the Statute (12) expressly limits the ambit of patentable subject matter. An initial reading shows up three prohibitions in the proviso- "so also they be not contrary to law', "nor mischievous to the state (by raising prices or hurt of trade)', "or generally inconvenient'. These clauses have never been regarded as capable of illumination solely by strict etymological assessment and literal statutory interpretation. In a later commentary this section is said to have "established as a rule that all prerogatives must be for the advantage and good of the people, otherwise they ought not to be allowed by the law' (13).

The patent grant must not be contrary to law. The phrase refers to common law as well as the patent statute itself. It has to be so, for it would be absurd if, one law may grant patents that serve as a reward to persons for providing the means of violating any other law (14). Generally inconvenient, interpreted in the nature of "prejudicial' makes this the first immorality clause. A patent text written in 1841 cites as falling within the proviso an invention "contrary to religion and public morals', Another written in 1851 declares that the law would not protect an invention "immoral in its very nature' (15). It may thus be taken as a settled notion in the latter half of the 19th century that an invention contra bonos more would probably be "generally inconvenient' and that an invention to be patentable must be "consonant with the general enactments of the law and with public morals' (16).

Although it may seem that this section was of considerable significance, it was not often resorted to. But this does not diminish its importance as the statutory source of the exclusion of immoral and illegal subject matter from patent protection. The only occasional resort may be explained by the very existence of an express statutory prohibition. This may mean that inventions likely to be hit by it were not presented as deserving of patent protection in the first place. It could also mean that the particular technological era did not throw up as many morally ambiguous inventions, and not many of those that would test the limits of the prohibition. Certainly not like biotechnology has done.

Australia retains Section 6 of the Statute of Monopolies. Specifically, a patentable invention under the Patents Act of 1990, Section 18(1)(a) is one that is "a manner of manufacture within the meaning of Section 6 of the Statute of Monopolies'. Genetically engineered organisms will only therefore be patentable if they are within the scope of a " manner of manufacture' (17). A leading commentator suggests that the grant of such patents may be "generally inconvenient' (18).

It would appear that moral concern and public good was always intended to be part of the patent system, right from its conception in the Statute of Monopolies. One of the earliest cases, Darcy v Allen (19) is part of English legal folklore spelling out the circumstances that called for grant of a patent monopoly. Darcy was given a monopoly grant for the sole manufacture and importation of playing cards. Among the arguments in favour of the validity of the patent was one that based it on the peculiar social benefits that such a monopoly grant could achieve by reducing the undesirable incidence of card playing among the servant class (20). Here considerations of public policy and morality were being called upon in order to support a patent rather than to attack its validity (as is more typical). So in the case of patent law, the task is not of introducing a morality clause, but is rather of maintaining and exploring its limits.

In the Directive, ethical and moral principles (21) are acknowledged as being supplemental to the standard legal examinations under patent law irrespective of the particular technical field under scrutiny. "Indeed, patent law, contrary to other laws, traditionally excludes from patentability, inventions which would be contrary to "public order or morality' (22). The Directive "in view of the potential scope of inventions in this field and their inherent relationship to living matter maintains specificity of such concerns for each member state' (23). Questions of ordre public and morality are addressed, in particular in relation to TRIPs, and the need to exclude from patentability inventions whose commercial exploitation offends those principles (24).

The Directive is a mixture of specific exclusions as well as a general provision reflective of Article 53(a), EPC. Examples of excluded inventions are given in the operative part of the Directive to provide national courts and patent offices with a general guide to interpreting the reference to ordre public and morality in Article 6. This list is not exhaustive (25). Processes for cloning human beings, processes for modifying the germ line genetic identity of human beings, uses of embryos for industrial or commercial purposes are excluded from patentability. So also the human body, at various stages of its formation and development.

The Directive expands on the general exclusion in the EPC, but even the specific references to excluded subject matter are ambiguous. On the one hand this may be seen as allowing scope for changes in conventional morality as determined judicially. But on the other hand, the range of controversy in the subject matter would seem to require greater specificity of guidelines. The latter would be in the interests of harmonised patent standards.

Article 53(a) of the European Patent Convention

The technical criteria in Article 52(1) (26), EPC is to be read in conjunction with the exclusionary provisions of Article 53. Article 53 (a) provides that patents shall not be granted for -

"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.'

The various terms in this exclusionary provision have given rise to interpretative difficulties in the case of biotechnological applications. One of the most common is that of the meaning associated with "order public' and "morality' and the way they relate together.

It is clear that "ordre public' cannot translate into public order directly as this would render superfluous the effort at retaining the original French word in the Convention as having no equivalent term in English. However, this is what is indicated in section 1(3) (a) of the English Patents Act, 1977 which provides that a patent shall not be granted "for an invention the publication or exploitation of which would be generally expected to encourage offensive, immoral, or anti-social behaviour'. The Guidelines for Examination in the EPO provide that the purpose of Art 53 (a) is to "exclude from protection inventions likely to induce riot or public disorder, or to lead to criminal or other generally offensive behaviour' (27). The effect of this seems to be to identify "ordre public' as akin to the English idea of public order.

The two concepts ordre public and morality are both interpreted in different ways in the context of national patent law in the United Kingdom and the EPC. Thus "As far as national patent law is concerned, doctrine and courts agree that ordre public as opposed to morality is a body of positive law. The only question being what kind of legal provisions qualify as pertaining to this body called ordre public, rather than being simple laws or regulations, the contravention of which is no obstacle to the grant of a European patent' (28).

But such a reading along with the proviso would make Art 53 (a) self contradictory, as certain statutory or common law rules, if expected to be violated, would then constitute sufficient ground to deny a patent. A favoured reading seems to be that of equating "ordre public' with "public morality'. This simple "translation' also meets with the same objection above, but cannot be regarded as wholly misguided. If this is taken to be correct, then together with the proviso, it is recognition that morality is not coextensive with law or regulation.

The Directive appears to settle this ambiguity in Recital 39, where ordre public and morality are said to correspond in particular to ethical or moral principles recognised in a Member State. So it would appear that the specific exclusions refer to those for which a certain degree of "European' consensus can be gathered, while the general is open to interpretation by Member States according to their own "ethics or morality'. A general provision is essential in so far as it is inadvisable to "freeze' morality as per any particular time in history.

There are different ways in which an invention may be offensive to ethics or morality. When a patent is granted a number of things follow. Information on the invention is publicised and put in the public domain. The patentee is empowered to exclude third parties, and is potentially entitled to monopolistic profit. Also the invention normally is manufactured and used. The terms "publication or exploitation' in Article 53(a) seem to enfold all of these consequences. If patent examiners are to have a moral jurisdiction at all it must focus on the use to which particular inventions are being put. The use may be read into "publication'. If it is immoral to publish information about a particular invention, the immorality does not reside in the knowledge itself but the use to which such knowledge might be put

The issue of the development of the invention is not so easily dealt with. It would appear that since research and development takes place before a patent application is made, it is not of concern to the Examiners. But if blatantly illegal behaviour like use of bonded labour went into the invention, granting a patent would put the manufacturer in a position to benefit from his immoral/illegal behaviour. More subtle scenarios come to mind. What if it can be shown that data collected in concentration camps with humans as experimental subjects had gone into a particular application?

In the case of human biotechnological inventions informed consent and the ethicality of research protocols are of great concern. Incorporating development within the moral responsibility of the EPO is highly controversial and likely to be resisted (29). The Biotechnology Directive in Article 26 suggests that consent to the removal of genetic material, while a desirable prelude to patentability, is a matter for national governance.

Informed consent amounts to procedural resolution, and is not itself any statement on the morality of using human tissue or cells in a particular way. To that extent it should be easier to incorporate in the regular practice of a patent granting authority. Not to do so is to ignore the entire history of safeguards on human experimentation put in place in the aftermath of the Nuremberg trial. The trial provided the occasion for substantive analysis of standards of ethical research and international human rights (30).

It would be very unfortunate if the Patent Office were disclaim responsibility for the development of inventions for which it grants protection. Substantive criteria of morality or public order may need special expertise, but contravention of well-established principles of research ethics if brought to the notice of the patent office should result in a revocation. Every applicant should be in a position to vouch for the ethicality of procedures followed. Each consequence should be tested against the standard for exclusion. The alternative, where one or more of the developmental, use, access, or monopolistic questions maybe ignored by the Examiners is in effect an acceptance that immorality in one or more of these aspects is irrelevant to the morality of granting a patent (31).

While the state as granting authority cannot disclaim responsibility for the inventions for which it grants protection the power to refuse a patent on grounds of morality or public policy must be used cautiously. Balancing the two imperatives is the vexed problem of biotechnology especially when uncertainty about the effects of the technology abounds. Given the fact that technology cannot yet be called mature, very often fear of the unknown is couched in moral terms. The objections to human biotechnological inventions, as with other aspects of genetics, blurs disagreement on facts with the moral significance of the facts.

How can the legal system take the uncertainty of a rapidly maturing, but little understood technology into account? Specifically excluding those inventions that are thought to cause "absolute amounts of harm' is one effective way. For example processes that seek to change the germ line genetic identity of humans. But for the most part, at this early stage, effort should concentrate on formulating methods of evaluation. Foundational methodologies would include decisions on leaving exclusions on ethics to the legislature or judicial determination, the manner of weighting that will calculate costs and benefits to humans as opposed to say animals, a decision to follow analogous jurisprudences (say human rights and dignity) or a democratic decision to take public perceptions of biotechnology into account.

Exclusionary criterion: Formulating a fair test

Interpreting Article 53(a), EPC involves identifying a threshold reference point mandated by the provision. This can be a "low-threshold precautionary' approach, in which case patents will be excluded at the slightest doubt as to their moral acceptability, or a "high threshold permissive approach', where patents may be excluded only where granting one seems inconceivable (32). The Guidelines for Examination in the EPO signal a narrow approach to Article 53 (a) that is likely to be invoked only in "rare and extreme cases' (33). The EPO itself has observed that "the function of this article has to be seen as a measure to ensure that patents would not be granted for inventions which would universally be regarded as outrageous' (34).

The EPO has repeatedly found that any exception to the general rule should be construed narrowly (35). In the Onco-mouse/Harvard (36) case the Technical Board of Appeal censured the Examining Division for having deviated from a narrow construction of Article 53 (b) without convincing reasons. The onco-mouse case included very broad claims relating to a method for producing a transgenic non-human mammalian animal with an increased probability of developing cancer and to the transgenic non-human mammalian animal as such. The examining division (ED) refused the application on grounds of the subject matter being excluded from patentability under article 53(b).

The Board of appeal allowed the appeal but remitted the application to the examining division to decide whether the invention was contrary to ordre public or morality under Art 53(a). Following the decision of the Technical Board of Appeal the examining division granted a patent, stating that the patent does not give a positive right to its proprietor to use the invention but only confers the right to exclude others from using the invention for a limited period of time. It was up to each contracting state to enact appropriate legislation if the state wanted such technical knowledge to be used only under limited conditions.

In this case the attempt to balance advantages and disadvantages of the patent to society was tackled as utilitarian reconciliation of competing interests. Thus usefulness to mankind was scrutinised against two broad ethical considerations: environmental (37) and animal welfare. The former includes the possibility of escape into the environment and the idea that evolution was being manipulated. The latter includes, viewing animals purely as a means to an end, the detrimental effects of the tumours on the animals themselves and the possibility of conducting such research without the animals.

A utilitarian calculus was used to balance the moral and environmental factors involved. Although it was acknowledged that the experimental animals had to suffer there was little danger of environmental damage since the animals could not reproduce their artificial genetic makeup (38). Of the advantages of the invention, the animals were highly useful for medical research. It was this that justified grant of the patent. Also the provision of a test animal useful in cancer research would reduce the amount of testing on animals.

The various interests in the decision that had to be balanced were a mixture of known and unknown quantities. Thus on the "known' side of the equation, there is the element of suffering to be inflicted on the cancer-mice, on the "unknown' are risks to the environment. This is weighted against the possible advances in the treatment of cancer in human beings. The criticism of the utilitarian calculus focuses on the fact that the examiners give a discounted weight to cost items, and undiscounted weight to benefits irrespective of whether they are known or unknown quantities. Thus "the known suffering to mice, whilst not ignored, is talked down, partly on the strength of speculative (and value laden) predictions about a net reduction in cruelty to animals; and the uncertain advance in medical knowledge is talked up (39)'.

Utilitarianism always, selectively chooses to ignore certain consequences and the above criticism is one of choice of values, and not of methodology. Thus, the general approach of attempting a legitimate balance with respect to specific moral problems is an useful one, and will serve well beyond the present case. This has found approval in the Directive in Article 6(d) where suffering of animals is to be weighed against medical benefit to man or animal.

Also the onco-mouse case pared down moral considerations to specificities. One of the objections was that transgenic animals in general pose an unethical interference with evolution (40). The opponents were calling for an assessment on an all encompassing moral agenda that would be thoroughly analysed at all levels, not just confined to the exploitation/publication of the invention, which are the practical public aspects addressed by the decision. This concern was ignored by the ED, and correctly so, given that the objection is generic. The patent system is incapable of dealing with such broad issues.

Another method of approach to Article 53(a) is to see if the invention is so far to one end of the moral spectrum as to make the grant of a patent the likely receptacle of public outrage (41). EPO Examination Guidelines and the UK Patents Act are cited in support of this view (42). They indicate that a "fair test' is whether public consensus would determine that granting a patent would be abhorrent. This is sometimes described as the "unacceptability test' or the "public abhorrence test'.

The Technical Board in Greenpeace v. Plant Genetic Systems NV (43) relied on "unacceptability to the norms of European culture'. It also stated that "a fair test to apply is to consider whether it is probable that the public in general would regard the invention as so abhorrent that the grant of patent rights would be inconceivable'. The attempt to use the "inconceivability test' in the Relaxin opposition was founded on the premise that there is an overwhelming consensus amongst contracting states that the patenting of human genes is abhorrent and hence prohibited under Art 53(a) (44).

There is a circularity to the above tests that detracts from its utility as a means of judging moral permissibility. The composition of the notional body that expresses this is unclear. Does it incorporate a diversity of thought or opinion, or is it an attempt to approximate homogenous "European' values? Beyleveld and Brownsword tease out this approach in the following manner.

The tests necessarily represent both quantitative and qualitative thresholds. Simple "cultural morality' has no quality threshold, and relies on general feelings of repugnance or acceptance in the public. These attitudes are not put through a critical process, whereby positive or negative perceptions are evaluated and critically processed before being accepted as moral judgements. A critical cultural morality would on the other hand, have to pass through tests of sincerity and rationality and hence are more sustainable as moral judgements (45). This critical process is one that would encourage discourse as well as tolerate disagreement.

Thus "the inconceivability test apparently speaks to consensus more than to the quality of the consensual view' (46). But when this "consensus' view is applied on a correct appreciation of the science and is consistent with other positive evaluations, (as it was in the Relaxin case,) only then will it amount to a quality check. This quality assessment may be further extended. The inclusion of environmental concerns in the onco-mouse case as well as in the Biotechnology Directive, is one such necessary extension. The authors go on to elaborate a very promising critical cultural morality that has found a degree of acceptance in subsequent literature on the subject. The commitment to human rights among the contracting parties to the EPC (47) makes it one of the principal features of critical cultural morality. "In short, Art 53(a) must be read as a charter for human rights in the specific field of patent law' (48).

This argument fundamentally derives from the fact that the EPO must employ certain substantive moral requirements because they are part of the constitutional arrangements that institute the contracting states as a single legal community (49). To recognise the existence of human rights is to recognise that individuals have rights from which the state itself cannot derogate. No person or body can then be granted authority to do anything that violates that right. Therefore none of the contracting states to the EPC can regard a determination by the EPO that violates human rights, as valid. In consideration of a prior commitment the contracting states would be acting ultra vires if they purported to license the European patent system to act in violation of these commitments. In order "to view the European Patent System as a single legal order (or sub order) it is necessary to impute to the contracting states the common intention to found a patent order with the European Convention on Human Rights as its central provision' (50)

An acceptance of this is indicated in Recital 43 of the Directive. This refers to the constitutional obligation of member states under Article F (2) of the Treaty on European Union wherein fundamental rights as guaranteed by the European Convention for the protection of Human Rights and Fundamental Freedoms constitute general principles of community law. Further, as per Article 16, the European Commission has to review the relationship of the Directive to international agreements on the protection of human rights to which the member states have acceded. In this regard it is expected that other international declarations, will also provide guiding principles (51).

Any balancing approach, on the lines adopted in the onco-mouse case must on this view incorporate consideration of human rights and dignity. In what manner these would be weighted is a challenge to the moral commitment of the EPO, specifically with regard to human biotechnological inventions. Advocating a utilitarian calculus as the correct methodology of application of Article 53(a), may seem inconsistent with a rights-based approach. This will not be problematic if the calculus gives primacy to the preservation of human rights. So the rights issue can be addressed if we prioritise the methodologies of the provision.

Human rights jurisprudence in Europe consists of well-established principles that lend themselves to easy adaptation by the patent office. There are a number of occasions in which such resort may become essential in the case of human biotechnological inventions. One such, is the manner of "taking' of human tissue and samples without prior informed consent. Clearly, the patent office cannot be seen to reward an invention, the material for which was obtained in an unethical manner that offends against human rights.

Where the invention is based on or uses biological material of human origin, the person from whose body the material is taken must have had an opportunity of expressing free and informed consent thereto (52). The information of this person has to be complete and specific, in particular of the potential patent application for the invention made from the use of an element taken from him (53). It is not clear from a reading of the Directive whether the consent must be to the taking, or to the filing of the patent application.

The difference is crucial, as only the former can hit at patentability itself. This may be gathered from opinion 8 of the GAEIB (54), paragraph 2.4 of which says, "An invention based on the use of elements of human origin, having been retrieved without respecting the principle of consent will not fulfil the ethical requirements.' (55) On the other hand, A notification on DG XV web site says _gthe free and informed consent of the person from whom the material concerned was taken is required in order to file an application for a patent on the use of such material' (56).

A related issue is dealt with in Recital 27. If an invention is based on or uses biological material of plant or animal origin the patent application should where appropriate, include information on the geographical origin of that material, if known. There is no indication given of what is "appropriate'. There is also no obligation to "know' "which might encourage ignorance' (57). Under the Convention on Biological Diversity, to which the European Community is party, states enjoy the sovereign right to exploit their own resources, and to determine access to genetic resources (58). The States are also asked to ensure that intellectual property rights are supportive of and do not run counter to the convention's objectives (59).

These provisions have obvious international policy significance. If natural occurring genes are patentable, why should countries (or individuals) hosting organisms containing potentially important genes make them freely available for scientific purposes? In order to fulfil the obligation under the Convention on Biological Diversity, a patentor state will have to prove that prior informed consent of the state concerned was taken for plant or animal genetic resources. Also that a mutually agreed, fair and equitable sharing of the results of research which is carried out on the genetic resources of the source state is facilitated (60).

As it stands, the Biotechnology Directive does not exhibit sufficient sensitivity to the concerns of bio-prospecting that has plagued research on human genome diversity since its inception. This attitude is likely to be counter productive, as countries and peoples would be justified in the face of such insensitivity to deny access to their genetic resources (61). The legal regime should aim to preserve human dignity as well as leave avenues of research open. The EPO doubtless has the textual backing to take a bold stance in judicial determinations. Whether it does so remains to be seen.

This paper is based on a presentation made at the 5th International Bioethics Roundtable, Tsukuba Science City, Japan. Nov 1999.

References

1) Noonan M D "Patenting Medical Technology" II Journal of Legal Medicine 263 (1990) at 318.

2)Ho C M "Building a Better Mousetrap: Patenting Biotechnology in the European Community' 3 Duke Journal of comparative and International Law 173 (1992) at 195. See also Miller J and Tramposch A G in "Playing God? : We've Done it for Centuries' New York Times, 26 Apr 1987, s.3 p.2 "Lawyers have no obligation to discuss ethical matters. Indeed it could be argued that law and ethics should be kept apart' Lewelyn M "Animal Patents: Lawyers Call the Tune', New Scientist, 1Dec 1990 p 18.

3) Lane M J "Patenting life: Responses of Patent Offices in the US and Abroad', 32 Jurimetrics Journal 89 (1991) at 98.

4) See David Kell "Treatment of Immoral Subject Matter Under Patent Law: A Historical Analysis' DPhil Thesis, Oxford University 1995.

5) At least two thirds of all patented inventions are never produced. The actual number of non-exploited patents is close to 70-90 percent in developed countries. Taylor and Silberston, The Economic Impact of the Patent System (CUP, 1973) p.20.

6) This argument was offered in PLANT GENETIC SYSTEMS / Glutamine synthetase inhibitors [1995] EPOR 173 at 373. This patent was granted 10th Oct 1990. During opposition proceedings instigated by Greenpeace, the biotechnology company offered the argument that "Neither the patent at issue nor any other patent confers upon a patentee a right to exploit, let alone a "monopoly' right to exploit his patented invention. Exploitation of a patented invention is always subject to governmental regulation and control in each of the contracting states of the EPC. Nothing in the EPC diminishes or restricts the ability of the Contracting states to control or prohibit by law or regulation the exploitation of a patented invention. Hence, although a patentee has a right to exclude others from using his patented invention, a patentee does not have a right actually to exploit his invention.'

7) 98/44/EC Directive on the Legal Protection of Biotechnological Inventions.

8) Recital 14, the Directive.

9) Peter Drahos, "Biotechnology Patents, Markets and Morality' [1999] EIPR 441, at 443.

10) David Kell (n 122 above) cites how grant or denial of a patent exerts economic pressure. Powerful stigma may be associated with a court or administrative body finding that particular subject matter is contrary to morality or ordre public. There are reports of considerable criticism from the industry on the apparent immoral nature of the "baldness mouse' patent. The Upjohn company's patent attorney in response to the EPO's examination report said "The applicant regrets having included features considered to be immoral or contrary to public order. The applicant is pleased to say that they have not transformed any mammals with oncogenic reporter genes'.

11) Sigrid Sterckx, "European Patent law and biotechnological invention' in Sterckx (ed) Biotechnology, Patents and Morality (Ashgate, 1997) p10.

12) Section 6 of the Statute merits quotation in full as the clause on which the patent system came to rest: "Provided also and be it declared and enacted that any declaration before mentioned shall not extend to any letters and grants of privilege for the term of fourteen years or under, hereafter to be made, of the sole working or making of any new manufactures within this realm, to the true and first inventor and inventors of such manufactures, which others at the time of making such letters patent and grants shall not use, so also they be not contrary to law, nor mischievous to the State, by raising prices of commodities at home, or hurt of trade, or generally inconvenient; the said fourteen years to be accounted from the date of the first letters patent, or grant of such privilege hereafter to be made, but that the same shall be of such force as they should be if this Act had never been made, and of none other'.

13) Bacon M A New Abridgement of the law, VI, 7th Dodd C E (ed) (A Strahan, London 1832 ) at 384, as cited in David Kell, ( n 125 above)

14) Hindmarch W M A Treatise on the law relating to patent privileges for the sole use of inventions ( V R Stevens & G. S Norton & W Benning and co, London 1846) at 142. As cited by David Kell (n 125 above).

15) The former is quoted from Webster T On the subject matter, title and specification of letters patent for inventions and copyright of designs for articles of manufacture F Elsworth, London, 1848 at 40. The latter is taken from Tanner, The law of patents and registration of invention and design in manufacture (John Crockford, London 1851) 10, as cited by David Kell, supra n 5.

16) Campin F W Law of patents for inventions (Virtue and co, London 1869) at 6.

17) Section 18(2) explicitly excludes human beings and the biological processes for their generation from patentability.

18) Ricketson, Cases, Materials and Commentary (Butterworths, 1994) p 631-640.

19) 72 ER 830.

20) 72 ER 830 at 883.

21) The European Commission has also established ELSA, Ethical Legal and Social Aspects of the Life Sciences and Technology. This is a common research sub area for three specific programs in the field of life sciences and technologies, Biotechnology (BIOTECH), Biomedicine and Health (BIOMED) and Agriculture and Fisheries (FAIR).

22) Recital 1.6, Opinion of the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission, No: 8, 25.09.96.

23) Recital 39.

24) Recital 36.

25) Recitals 38,40.

26) European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step.

27) C-IV, 3.1.

28) Ulrich Schatz "Patents and morality', in Sterckx (ed) Biotechnology, Patents and Morality (Ashgate, 1997) pp 159-170, at p 161.

29) In the context of the Hormone Relaxin case one commentator is of the opinion that "even if the cell line in this case had been obtained in a dubious fashion about which the patent Examiner was aware, provided the information was not part of the application it would not be caught by the morality criterion. The moral prohibition, even without publication, cannot centre on a retrospective analysis of methods, since to sanction at this point would be redundant and outside the remit of legislation.' See Amanda Warren "A Mouse in Sheep's Clothing: The challenge to the Patent Morality Criterion Posed by _gDolly'. [1998] EIPR pp 445-452, at 446.

30) See Arthur Caplan "The Doctor's Trial and Analogies to the Holocaust in Contemporary Bioethical Debates", in Annas and Grodin (eds) The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation (OUP), 1992 pp 258-277.

31) Beyleveld and Brownsword, Mice, Morality and Patents: The Onco-mouse Application and Article 53(a) of the European Patent Convention (Common Law Institute of Intellectual Property, 1993) p 50.

32) These are terms used by Beyleveld and Bownsword in "Patenting Human Genes: Legality, Morality and Human Rights' in J W Harris, (eds) Property problems, from genes to pension funds (Kluwer International, 1998) pp 9-24, at p 9-10.

33) EPO Guidelines C-IV, 3.1

34) Howard/Florey Relaxin 1990 OJ EPO 388 at 398.

35) Lubrizol Genetics Inc/Hybrid Plants LUBRIZOL 1990 OJ EPO 71 at 76. This referred to the construction of Article 53(b). This is an exception that excludes patents for plant and animal varieties, and essentially biological processes for the production of plants and animals other than microbiological processes and the products thereof.

36) OJ EPO 476 at 486.

37) The Directive mentions, for the first time, in Recital 36 that inventions that cause "serious prejudice to the environment' will be excluded from patentability.

38) Here, the calculus deems welfare of different entities to be the sort of thing that can be added together so that total states can be compared. The demand that outcomes always be ranked in terms of the sum of welfare they contain is problematic. Ethically, it is objectionable to sacrifice the interests of any given person with the aim, not just of protecting but of increasing the aggregate welfare. This is problematic with respect to rights, it can also be seen as an objection to the consequentialist character of utilitarianism.

39) See generally, Beyleveld and Brownsword, n 31 above, Chapter 3.

40) OJ EPO 10/1992, 588 at 593.

41) Armitage and Davis Patents and morality in Perspective (Common Law Institute of Intellectual Property, 1994) p 47.

42) Guidelines for Examination in the EPO (IV, 3.1), explaining the purpose of Art 53 (a). "The purpose of this is to exclude from protection, inventions likely to induce riot or public disorder or to lead to criminal or other generally offensive behaviour' S 1 (3) (a) of the 1977 Patents Act says that "A patent shall not be granted (a) for an invention the publication or exploitation of which would be generally expected to encourage offensive, immoral or antisocial behaviour'.

43) [1995] EPOR 357, [1995] OJ EPO 545.

44) [1995] OJ 388, Para 6.4.3

45) The authors use Dworkin's criteria that make any position a moral one. The reasons that are given for positions must be ones that exclude prejudice, mere emotional reactions, rationalisation, or parroting. It is one that is held sincerely and is supported with other relevant beliefs, and is not held arbitrarily.

46) In J W Harris (ed) Property Problems to Pension Funds (Kluwer Law International 1997) at p 21.

47) As evidenced by the European Convention on Human Rights (ECHR) and other international human rights instruments, notably the Universal Declaration of Human Rights, 1948.

48) J Harris (n 46 above) at p 13.

49) The European patent convention is a contract entered into by a number of states. All of the contracting states (with the exception of Monaco) are signatories to and have ratified the European Convention of Human Rights.

50) Mice, Morality and Patents, p 70.

51) For eg UNESCO's Universal Declaration on the Human Genome and Human Rights. Article 11 states that "Practices which are contrary to human dignity, such as reproductive cloning of human beings shall not be permitted'See http:/www/unesco.org/ibc/uk/genome/project/index.html

The provisions of the European Convention on Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, 1997, are also significant in this respect.

52) Recital 26.

53) Para 2.4, Opinion of the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission, No: 8, 25.09.96.

54) European Commission's Group on Ethics in Science and New Technologies.

55) Ethical Aspects of Patenting Inventions Involving Elements of Human Origin, GAEIB (25.09.96) No:8.

56) http://europa.eu.int/comm/dg15

57) Robin Nott "You did it. The European Biotechnology Directive at last', [1998] EIPR, pp 347-352, at 348.

58) Article 3 and Article 15.

59) Art 16(5).

60) See Andrew Scott "The Dutch Challenge to the Bio-patenting Directive", [1999] EIPR pp 212-215, at 214.

61) See n 109 above.


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