Stephen Crespi

IPRs UNDER SIEGE-First impressions of the Report of the Commission on Intellectual Property Rights.

INTRODUCTION

In September 2002, the Commission on Intellectual Property Rights (CIPR), a group established by the UK Secretary of State for International Development, published its Report entitled 'Integrating Intellectual Property Rights and Development Policy'. This Report is the work of a team of enthusiasts in the field of legal policy, backed by the able investigators and secretariat of the UK Department for International Development (DFID), and it covers studies undertaken over 16 months involving public and private sectors in both developed and developing countries.

A full appraisal of this Report would require detailed examination of the many proposals for IPR reform contained in it, as well as the opinions cited in its voluminous Reference Lists. It is nevertheless possible to express reservations and criticisms that will immediately strike those who work in the field of IPR procurement day to day and whose possible contributions to this study may not have been assiduously sought in its preparation. The following observations relate primarily to matters of relevance to IPR for pharmaceutical and agrobiotechnological inventions. Copyright and software issues are left for comment by specialists in these fields. These observations are related to specific Chapters of the Report identified by their titles as given therein.

FOREWORD AND OVERVIEW CHAPTER

CIPR had set itself toward the realisation of targets, identified in the The Millenium Development Goals, to reduce world poverty, hunger, and to improve health, and it took as its task "to consider whether and how intellectual property rights (IPRs) could play a role in helping the world to meet these targets-- in particular by reducing poverty, helping to combat disease, improving the health of mothers and children, enhancing access to education and contributing to sustainable development" and also "to consider whether and how they (IPRs) present obstacles to meeting those targets and, if so, how those obstacles can be removed". In approaching a task of such monumental proportions, CIPR has sought to resolve issues of IPR laws which have been the subject of wide controversy over recent decades.

The Foreword to the Report states an expectation that it may not prove comfortable reading for those concerned with IP and this is not surprising in view of the conclusions it reaches. The Foreword also claims that a characteristic of the present era is one of blind adherence to dogma. This remarkable statement will come as a great surprise to a good many people whose perception of reality is quite the reverse, for in today's world no institution seems protected from criticism and no values inherited from the past are exempted from challenge. While institutions cannot claim privilege in this respect they can at least insist that they should not be criticised for failing to yield results that they have not been instituted to provide. Thus the notion permeating this report, namely, that IPR systems are to be judged by some direct impact they are assumed to be capable of having on the poor and needy of this world, clearly overlooks the primary purposes for which such systems have been invented and which are not themselves direct and immediate philanthropic goals. If this fundamental premise on which the entire Report seems to be founded is flawed, the whole Report may be suspect.

The Report recognises at the outset that the justification of IPR systems as commonly asserted in the developed countries, namely, that the availability of legal protection systems stimulates invention and technological development, will not do for countries in which "the necessary human and technical capacity may be absent". Indeed, such systems may only benefit foreign countries which already enjoy these capacities. This cannot be denied. These more fortunate countries have
undoubtedly benefited from the "unprecedented increase in the level, scope, territorial extent and role of IP right protection" in recent decades. In order to discourage the adoption of similarly strong and generous IP protection in the developing countries the Report points to criticisms of current IP laws that have been made by some commentators in the developed countries and it seems to assume that these criticisms are justified, from which follows the recommendation that developing countries should not "get it wrong" by following these trends themselves.

At this point in the Report, therefore, the reader will already be in no doubt that the authors favour a return to, and consolidation of, the relatively weak IPR systems that prevailed in many developing countries before the completion of the Uruguay round of GATT which resulted in the formation of the World Trade Organisation and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Before dealing with the substantive Chapters of the Report, it is possible to make the following critical comments on its opening salvos.

It is presumably common ground on all sides of this debate that the enormous disparity of wealth, health, and opportunity as between developed and developing countries stands as a constant challenge to the consciences of the well-off. But the impelling need to address this centuries-old problem should not overlook the inconvenient fact that it admits of no facile solution and that any solution is inevitably going to be multifactorial. While IPRs, and the ways in which holders of such legal rights choose to exploit them, cannot escape some share of relevance to this problem, we should not be tempted to look for scapegoats to be emasculated or sacrificed in the vague hope that some benefit will thereby inevitably accrue to those in need.

IPR is a generic term embracing a diverse group of legal rights designed to protect the outcome of innovative thought and action which will ultimately yield a benefit of an economic or cultural kind in relation to human needs or wants of various kinds. Ultimately is the key word in this context since IPR will not in and of itself produce any impact whatsoever. A patent for an invention, however brilliant, lies fallow unless and until use is made of it. In offering the possibility of legal protection, therefore, the patent system has a relatively passive role in relation to the impact of new technology on any particular country since this must depend solely upon the use made of it by those who own the patent or those who seek to acquire a permissive right under the patent to utilise the protected technology in any particular country. Perhaps this distinction between the right per se and the manner in which the right is exploited (or not exploited) has not been kept fully in mind by the authors when addressing the question of impact on developing countries.

Since the patent system emerges from this Report as the IPR system believed to be most in need of reform it would be useful to recapitulate what its real objectives are, even though these have been explained previously by many authors and many times. Patents have an essentially catalytic function in encouraging and assisting a process that may take place in any event but probably less effectively in their absence. In the field of high-tech in academia or the research-based industries, this process is the transfer of the results of laboratory research into marketable processes and products from which producers and consumers are expected to benefit. From the standpoint of public policy and private interest in this legal system, patents are said to encourage :-
1. disclosure of information as against secrecy
2. investment in R and D.
3. creation of a market for what has been invented.
There are some subsidiary objectives also, notable amongst which is the stimulus to further research leading to alternative technology to compete with the patented technology ("designing around" or "patent-evasion").

None of these objectives has any direct and immediate philanthropic connection. But the basic philosophy of the system is that, by according a time-limited but adequate measure of legal protection to those that embark upon the risky process mentioned above, humankind will indeed benefit from its eventual fruits. This protection is seen by its owners primarily as relevant to the activities of competitors of the same research-based character as themselves but it is also aimed at those who do not shoulder any burden of costly research but hope to exploit any weakness in the innovators' IPR so as to enjoy a free-ride on the results of others'efforts. This type of protection has the support of laws which encourage innovators to operate gainfully and competitively in free markets, so long as this is done fairly and in the broad public interest.

From what has been said above, therefore, it is difficult to see how IPR laws, either as they stand or after they have been tinkered with, can themselves have any of the desired impacts on people, without reference to human actions related to the possession of the permitted rights.
Thus it is futile to snipe at IPR laws because they are only utilisable by those who have the necessary human and technical capacity to do so. How would the abolition or reform of these laws make any difference to this unfortunate fact ?. Neither does it seem relevant to quote statistics on the numbers of US patents granted on biological materials and the cliché of the "anti-commons", which is contestable to say the least. To include, along with these criticisms, the problem of the freedom of research (a matter of current debate in developed countries) creates the impression that the whole litany of objections applied in other contexts is being wheeled into the present debate, though at present they hardly figure as real live issues in the developing countries.

It is impossible to see how the fact that the IP system creates an opportunity (not a right) for the author or inventor to secure a material benefit arising from his contribution to the useful arts can conflict with any human right. It is also difficult to see how IP rights impose "extra costs" on poor people. If what is referred to here is the cost of a drug, for example, it must surely be relevant to point out that people would not have these drugs without the inventive activity that preceded their introduction into medicine. The same point applies to the reference to increasing "cost of access" to those who do not have "knowledge and inventive power". Both these allusions contain much the same confusion as is entailed in the anti-commons argument, as though a patent somehow closes off a remedy that was previously freely available.

The authors "prefer to regard IPRs as instruments of public policy which confer economic privileges on individuals or institutions solely for the purposes of contributing to the greater public good". There is no justification for this peculiar and private interpretation of the nature of IPR. The official authorities that administer the patent law must certainly take public policy into account but this falls far short of characterising IPR as an instrument of public policy to be wielded by the authorities for strategies of their own devising, however benign they may be.

The Overview Chapter concludes with reference to "the lack of recognition of intellectual property rights for the protection of traditional knowledge and folklore", a topic of concern to developing countries. Attempts to set up IPR-like protection for genetic resources and traditional knowledge have been underway for some time by WIPO. But to provide a system of protection based on mere possession of these items will require a sui generis approach which will not be easily grafted on to current IPR laws. Moreover, since such resources and knowledge have been possessed already for long periods of time it is difficult to see in what way the establishment of a new legal protection system will contribute directly to the solution of the long-standing problems of developing countries. Neither is it apparent how the retrograde weakening of post-TRIPS revisions of current IPR laws in these countries will itself achieve benefits (except insofar as it will facilitate evasion of legitimate rights so as to provide a free ride on the backs of those who invent new technology).

INTELLECTUAL PROPERTY AND DEVELOPMENT (Chapter 1)

It may be thought a merely semantic criticism to question the opening words of this chapter which describe Intellectual Property as "a form of knowledge which societies have decided can be assigned specific property rights". If IPR were given for knowledge it would be difficult to understand the specific exclusion of patents for "discoveries" in many countries. The traditional forms of IPR with which most of this report deals do not have the character of knowledge as such ; rather are they concerned with the practical application of knowledge or with forms of expression of creative intellectual activity.

It is undeniable that "Few developing countries have been able to develop a strong indigenous technological capability." This would of course be necessary to enable them "to generate their own technology or properly assimilate technology from developed countries." So long as this obtains, even the most ardent supporters of strong IPR must concede that the introduction of strong IPR systems in these countries will benefit the developed country industries more than the local industry. Perhaps the crucial question here is whether strong IPR would encourage technology transfer in the real sense of assisting local technology to develop rather than the mere licensing of rights to those who cannot make proper use of them. This will not happen if and so long as the developed country industries see these countries only as markets for their own produced products.

In discussing the Rationale for IP protection this report touches on the "big issue" of striking the right balance in the scope of protection given by patents. But this is the constant pre-occupation in the tussle between professional patent attorneys and official patent Examiners, and both of these groups are well aware of this as a continuing problem and subject to developing case law, especially for biotechnological inventions. The Report defines a "broad patent " as "one that allows a right that goes considerably beyond the claimed invention itself". This definition is somewhat puzzling since the scope of the patent is governed by the claims and little else. It is also highly tendentious, especially in the example given of the scope of gene patents, in which the claim is not required to be limited by reference to the specific use(s) which the inventors have discovered . Every applicant for a patent and every inventor desires to obtain a patent which is broad enough to protect against the clever evader of the scope of the patent claims that Patent Offices are persuaded finally to allow, after much argument and expenditure of time and cost to the applicant. Little evidence has been produced so far that such patents discourage subsequent innovation. There are of course examples of "excessively broad claims" but the checks and balances built into the procedures of official examination of patent applications are designed to control such excesses as far as possible, and this is subject to review by developing Patent Office guidelines for examination of applications.

The Report notes that the theory that strong IP unleashes innovation does not work for developing countries since their research capacity is weak. It is also true that an IP system involves high transaction costs for their local industries and public authorities but it is not clear how a weak system would reduce such costs.

The notion that IP restricts competition to the detriment of consumers and trade requires much more evidential proof than mere opinions of selected academic economists (given in Box 1.2 of the Chapter). The same comment can be made on the idea, trailed in the Report, that a patent deters others from making improvements on the invention. This idea, expressed by 'The Economist', in 1851, ignores the vigorous competitive character of modern academic and industrial research activity.

This Chapter reviews the Impact of IP on industrial growth by analysing the problem and indicating what is needed for developing countries. But since the function of IP is only to offer the possibility of legal protection to those who innovate, it is based on the presupposition that innovation will take place. In the developed countries the IP system is expected to fund itself by passing much of the cost on to users of the system. It is absurd to say that IP imposes costs on poor people.

To say that globalisation of IP brings the greatest benefit to those who innovate, namely the developed country industry and academic institutions, is simply a consequence of the above reality and is therefore a statement of the obvious. But if it encourages real technology transfer then both donor and recipient of new technology must gain for it to happen at all. The current relative royalty flows between countries is surely another manifestation of the same reality. This would not happen if the recipients did not consider it worthwhile to adopt the protected technology. So why speak of winners and losers ?

IP cannot by itself produce growth. In this report the continued insistence on this test shows the fallacy of judging the system by the wrong mark of efficacy. IP responds in one specific way to the initiatives of innovators and it is these that are the direct determinants of growth.

For reasons given above, the conclusion that industrial growth in developing countries is associated with weak IP is fallacious if association is held to prove causation. If the weak IP provided by the 1970 Patent Act of India contributed to the growth of the Indian pharmaceutical industry the question has to be asked whether this growth was achieved mainly by building on the foundation of others i.e. the real innovators. More to the point, it may have provided no incentive for the local industries to develop their own technological capability. The contention that IP or lack of it has any causative connection with growth cannot be established by mere statistics of numbers of patents and the attitudes to patents on the part of large, small, or medium size companies in different industries. Growth is caused by many factors. To a large extent it is a natural development as mankind advances in scientific knowledge and technological competence, given the human entrepreneurial spirit that will seek to exploit these advances for industrial and commercial purposes.

It cannot therefore be surprising that the IPR factor does not figure in the statistics of growth rates and investment flows quoted in this Report. If these parameters are not directly influenced by the nature and strength of IPR laws in these countries there still remains a burden of proof that the proposed weakening of IPRs in these countries would achieve improvements in this respect.

This section of the Report concludes that the whole technology transfer agenda goes beyond its remit and with this all can agree. Unravelling the motivation to share technological advance as between competitors or potential competitors in one's own or other countries is not a simple matter. In developed countries, licensing and cross-licensing decisions are usually taken primarily for commercial reasons and in anticipation of benefit to both the donor and recipient parties to the deal. Whether the strengthening of IPR in developing countries as part of the WTO Agreement will itself alone lead to the effective sharing of technology as between the developed and developing countries is by no means a clear-cut issue even for the most devoted protagonist for strong IPRs. It was not necessary for the Report authors to tilt at this windmill since it has not been held out as a justification for TRIPS. But the converse implication that weak IPRs will produce benefit is by no means self-evident.

HEALTH (Chapter 2)

This chapter begins by questioning whether the effect of introducing patent protection may be "to increase the price and decrease the choice of sources of pharmaceuticals". Presumably this question takes as its starting point the assumption that in the absence of patents in any particular country the relevant drugs would somehow be available in these countries. Yet it goes on immediately to concede that "without the incentive of patents it is doubtful the private sector would have invested so much in the discovery and development of medicines, many of which are currently in use both in developed and developing countries". There is also reference to the NGO argument that 20 years of patent protection delays the introduction of inexpensive generic substitutes on which poor people depend. Of course, this latter argument provokes the obvious retort that such substitutes would not exist if the drugs themselves had not been invented. A further background assumption of the authors is that the delivery of profits to the industry is not the prime purpose of IPRs but is subject to the condition that any such profits are used to deliver better health care in the long term. It may seem perverse to question this assumption but it is necessary to point out that the continuous improvement of health care is a desirable consequence of the protective effect of IPR but it is not an explicit condition of its very existence.

It cannot be denied that the lack of technological capacity and infrastructure is an obstacle to affordable health care in these countries. For example, in the recent notorious controversy over the supply of anti-AIDS drugs to the African continent the problem was not simply one of the original reluctance of Big Pharma to supply these drugs at cost (or, as some would demand, at less than cost) or to license generics firms to supply them cheaply. The greater problem was the lack of health care infrastructure to monitor their use. So it is questionable whether the weakening or abolition of IPR can contribute significantly towards the remedy for this glaring inequality between countries.

The next section of this Report, dealing with Research Incentives, is a stark realisation of the problem as far as the private industrial sector is concerned. But the suggestion by the private sector that IPR could stimulate research on the diseases peculiar to the developing countries requires a sizeable grain of salt for its acceptance.

The authors' insistence on the idea that patents have the consequence of "charging higher prices than would otherwise be the case" and that they entail an "extra cost" to the people who need them seems to be based on a fallacy recurring in this Report. These terms and expressions can only be valid as argument if one assumes, and makes comparisons with, a notional state of affairs that might have existed had these drugs been invented and introduced into medicine at "lower prices" because of the absence of any possibility of patent protection. This method of argument is based on an altogether unreal comparison. Whilst admitting that the absence of patent protection for these drugs in many of the developing countries (due to decisions not to file patent applications in these countries) has not thereby made such drugs available in such countries, the Report is determined to find that patents are still implicated in this
unsatisfactory situation. Hence the Report argues that imports into these countries are prevented by the enforcement or threat of enforcement of patents against would-be exporters from the developed countries.

The following section of the Report, dealing with Patents and Prices, repeats the fallacy mentioned above (" ….if a sick person has to pay more for a pharmaceutical product as a result of a patent…."). Admitting that it is difficult to isolate the impact of patents on prices the Report sets up "econometric models" to tackle this point. This part of the Report is most interesting as an academic exercise but it relies mainly on "literature" and predictive analysis to support its main contention, depending as it does on the uncertain behaviour of generic companies in developing countries as the law is tightened to place some restraint on the free-riders.

One cannot quarrel with the next section of this Chapter, dealing with Other Factors Affecting Access and calling for policies which improve access to medicines. One can also agree that IP regimes must not run counter to public health policies, whatever this anodyne statement may mean in practice.

In addressing Policy Implications and the available Policy Options the report begins with the WTO Ministerial Meeting in Doha, November 2001, and the "Doha Declaration" that "TRIPS should not prevent countries from taking measures to protect public health". This is a well-argued section which recognises that the use of compulsory licences and other policy options lead into "uncharted waters". Striking the proper balance between the role of local industry to supply the national market and the need in some cases to import drugs when little or no manufacturing capacity exists in the developing country is clearly challenging. This report places the burden upon the TRIPS Council to provide an expeditious solution of this problem. There must also be some control on the permissibility of the compulsory licence holder to export to other countries. The Report is therefore to be applauded in its lucid identification of problems that may flow from whatever policies are adopted. These are all addressed in the following sections of the Report but in most cases one is left with the general exhortation to find solutions of them.

The conclusion that "the main way that developing countries can use IPRs to address public health issues is to ensure that their legislation provides for appropriate standards and practices", does not get us very far toward the desired remedies. But the objectives proposed by the authors to achieve these ends are simply to tighten up standards of compliance with the principles of the IPR system in developed countries viz. reasonable scope of patent claims, non-blocking of further research, and restraining undesirable exploitation by bad patent holders. And when they advise against allowing patents for first and second medical uses of known products, according to the European pattern under the EPC, in addition to their existing ban on patents for diagnostic, therapeutic, and surgical procedures, the justification for this attitude is missing altogether.

As might be expected, the authors are keen to extend the encouragement of generic companies to jump the gun before patent expiry for securing marketing approval of their own versions of the patented products (the Bolar exception in US law) and to allow these companies to rely, for the approval of these versions, on data provided by the patent owners in respect of their own originating products. This recommendation may perhaps be seen by some as an acceptable levelling of the playing field between the strong and the weak but the view of the research-based industry may be less accommodating. But whether the Least Developed Countries (LDCs) that have already implemented TRIPS Article 27 in respect of pharmaceutical products should be encouraged to withdraw this and take advantage of the Doha extension to 2011 for re-introduction is questionable.

CHAPTER 3--Agriculture and Genetic Resources

This chapter is an informative and much-needed exposition of the many international aspects of this subject, including the development of the relevant International Conventions concerning IPR (patents and Plant Variety Protection, PVP, under UPOV), Biodiversity preservation, TRIPS, and the International Treaty on Plant Genetic Resources (ITPGR).

Looking at the effects of IPR systems, the report quotes a study showing "little evidence of an increased range of plant materials available to farmers or increased innovation as a result of PVP protection". The emphasis here is especially upon poor farmers. Once again, it has to be pointed out that the existence of an IPR system cannot of itself achieve these desirable objectives without the necessary motivation of the innovators. For these, many factors govern the decision to introduce new plant material into agricultural practice quite independently of their IPR potential.

The suggestion that UPOV 1991 permits farmers to use saved seed on their own holdings needs to be clarified. This previously prevailing "farmer's privilege" is now controlled by national PVP laws and, if introduced therein, is qualified by the requirement to pay a reduced royalty on such use. Neither is it correct to imply that the so-called "breeder's privilege" or "research exemption" (freedom to breed further varieties from the PVP-protected variety) permits free commercialisation of the new variety. This is because the protection under UPOV 1991extends also to "essentially derived varieties" e.g to varieties containing virtually the whole genome of the protected variety from which the derived variety has been obtained. The relevance of the EU Directive 98/44/EC on this point is also more complex than the Report states.

Based on the authors' conclusion that "At present there appears to be little evidence that providing patent protection for biotechnology-related inventions is really in the interests of the majority of developing countries which have little or no capability in this technology.", the Chapter concludes with a list of recommendations that would limit the scope of IPR for agricultural biotechnology in these countries.

TRADITIONAL KNOWLEDGE AND GEOGRAPHICAL INDICATIONS (Chapter 4)

This chapter begins with reference to "biopiracy" a word much in vogue with the usual protest groups. There is said to be no accepted definition of this term but the authors nevertheless give some examples of what it covers, and they cite the well-worn examples of misguided attempts to patent such knowledge, including turmeric, neem, and others. Most of these have been resolved after the full facts have been revealed. Precisely how India was in any way harmed by a US patent on the use of turmeric for wound healing, taken out by US workers of Indian origin, has never been clear and why the Indian Government felt obliged to have it revoked at a cost to them of $10,000 is also obscure, apart from the scandal felt by their own people at this misappropriation of traditional knowledge.

Again, this Chapter is usefully informative of current ideas and proposals for some form of legal protection for indigenous peoples in this respect.
IPR practitioners will generally support proposals for a system for returning benefit to indigenous communities, where this is possible and workable, without feeling themselves impelled to invent them. The suggestion to build digital libraries of traditional knowledge as search material available to patent Offices will presumably command wide assent if it will help to avoid unfortunate past mistakes.

The proposal that patent applications disclose the geographical origin of genetic resources from which inventions have been developed will also be accepted as reasonable to the extent that it is both necessary and possible (the authors note that true origins are often obscure or often involve multiple sources over the course of time). Applicants for patents must always approach the Patent Office with "clean hands" and disclose important background information so that proper official examination of the application can be performed. This latter principle is already enshrined in some patent laws under the requirement for full disclosure of information as to known prior art. In all patent laws it is necessary to disclose sources of materials required for performance (the "enabling disclosure" requirement). However, there may well be some doubt as to whether the obligation to provide proof of permission to gain initial access to these resources will be workable within normal patent procedure. This certainly requires a cautionary approach at the present time and is probably best handled by the bioprospectors (a much better term than 'biopirates') at the outset of the original project.

PATENT REFORM (Chapter 6)

From the viewpoint of those who work professionally in IPR, this Chapter goes to the crux of the matter in advising developing countries to avoid following the ways in which patent practice has evolved in the developed countries. The authors nail their colours clearly to the mast in their proposed exclusions from and restrictions on patentability listed in Box 6.1 of the Report. These are :-

EXCLUSIONS of patents on:-
(i) diagnostic, therapeutic, and surgical methods for the treatment of humans and animals
(ii) plants and animals, micro-organisms (unless restricted).
(iii) computer programs and business methods

AVOIDANCE of patents on :-
(iv) New uses of known products
(v) plant varieties, genetic material.

ENCOURAGEMENT of :-
(vi) international exhaustion of rights.
(vii) Compulsory licences.
(viii) Research exemption and Bolar type exception.
(ix) Strict patent examination of novelty,inventiveness, industrial activity (utility), scope of claims.
(x) Low cost Opposition procedures.

Although some of the listed exclusions already exist in many developed countries, others clearly discriminate against the pharmaceutical and agrobiotechnology industries and must be seen as contrary to the TRIPS Agreement. The authors are here promoting an ideological standpoint of their own and it is difficult to divine just how their recommended dilution of available patent protection will ameliorate the lot of the developing countries. For example, and as would perhaps be expected, objection is taken to absolute product protection, mirroring the recently published discussion paper of the Nuffield Council on Bioethics, entitled 'The Ethics of Patenting DNA'. It is also not at all clear why developing countries are advised not to introduce 'new use' patents. This presumably refers to the well-known 'use' patents permitted under European patent law. These have claims directed to the first medical use discovered for known compounds or to the special form of 'use claim' allowed by the EPO Enlarged Board of Appeal to cover second and subsequent medical 'indications'. Patents of this type are somewhat controversial as to their application and they are considered by some as problematical as regards enforcement possibilities, but on the whole they are regarded as rather harmless. If unrestricted product claims are to be forbidden it would seem that claims to second uses of genes would also be ruled out by these authors.

At this point, therefore, the IPR practitioner may well feel that the Report has reached its denoument and that subsequent Chapters will not contribute further to the debate or be compulsive reading. His feelings may be not so much of discomfiture as of despondency at the negative tone of the Report as a whole.

CONCLUSION

The overall impression given by this Report is that, despite the usual acknowledgement of the value and broad legitimacy of IPR, the authors for the most part regard it as a necessary evil to be judged only by its directly observable impact on society at large. But between the public and the IPR systems per se there lie the business decisions of the innovative creators as to what products and services are to be supplied, including what and where and at what commercially reasonable cost, and it is these that influence the ultimate realities experienced by patients and consumers, whether these are IPR protected or not. In proposing a reversion to the restricted types of patent protection prevailing in developing countries pre-TRIPS, the authors fail to establish how such a move could be instrumental in solving these countries' problems. Weak IP protection did not help them before (except insofar as it promoted the "piracy" of inventions made by the research based industries in the developed world) and it failed to provide any incentive to develop local industrial innovation in bioscience in spite of the many outstanding bioscientists working in the public sector in these countries. For the patent practitioner it is difficult to avoid the conclusion that attacking IPR is the soft option which has little bearing on meeting those real targets listed at the beginning of this Report.