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.