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Patents on life:
How will Europe decide?
A Greenpeace Documentation
Introduction
Are plants and animals, seeds and bacteria, parts of the human body, and even genes themselves patentable objects, just like technical inventions?
Current and future members of the European Union (EU) and all current or future members of the European Patent Convention (EPC) find themselves confronted with this question. Controversy rages around an EU directive (98/44/EC; Legal protection of Biotechnological Inventions) which allows patents on human genes, on parts of the human body and on plants and animals.
This directive should have already been put into national law in the EU member states by July 2000. However, as of the end of 2002, only 6 of the current 15 member states have decided to take this step. On the other hand France and Luxembourg have spoken out explicitly against the patenting of genes. The German government as well has called for an overhaul of the directive. Medical associations, farmers, development and environmental organisations have all spoken out against the implementation of the directive.
However, the European Patent Office (EPO) has already been applying the directive since 1999 – thus including countries, which are not even members of the EU. The influence of the directive has thus been extended to include countries like Bulgaria, the Czech Republic, Cyprus, Hungary, Liechtenstein, Monaco, Switzerland, Slovakia, Slovenia and Turkey (which are all members of the EPC), without giving these countries an opportunity to discuss the patentability of life. And four more countries (Lithuania, Latvia,, Poland and Romania) are set to become members of the EPC as well. European patents are also valid in Albania and Macedonia, those being countries of extension, though not having been invited yet to become full member countries.
This paper is to inform about the current status of the debate, to highlight options for action and to show the concrete consequences of Patents on Life. A main target group of this documentation are those countries which are to become new members of either the EU or the EPC. In the opinion of experts in patent law, countries with a weaker economic development might have to endure strong disadvantages through the proliferation of patentability. Therefore it is important that governments in the respective countries become active and join countries within the EU and the EPC to work towards a revision of the EU directive. Even the European Parliament who the passed directive in 1998, demanded in November 2002 that the Commission change the directive so that human genes can no longer be patented. The Council of Europe has also spoken out against patents on living beings and genes numerous times.
Outside Europe the criticism against patenting living organisms is gaining ground, too: in 2002 the Supreme Court of Canada rejected the patent on the “Cancer Mouse” on ethical grounds.
Opponents are convinced that patents on genes and living organisms can block access to vital resources in the medical field and the realm of global food security. In addition, the borderline between invention (traditionally patentable) and a mere discovery (not patentable) is virtually being removed. Patents suddenly not only cover new inventions but rather they extend to discoveries of existing matter. This destroys the balancing and equalising effect of traditional patent law. An instrument to encourage competition and technical innovation is being turned into a tool to gain total control over the common basis of life itself and into a means to block innovation.
1. Modern Patent Law and the Use of Monopoly Rights
The functionality of patent rights is generally based on an exclusive right, which, however, is limited in time. The owner of a patent can prevent others from gaining economically from the patented invention for a period of 20 years, or obtain royalties for the use of his invention by others. This exclusive right to commercial exploitation allows the patent owner to set the price for his product without interference from competitors, which are kept off the market. The time-limited monopoly right is intended as an economic incentive for the inventor. But in compensation the inventor is obliged to publicise his invention. The economic value of a patent often does not lie in the technical use and commercialisation of the invention, but rather in the fact that the commercial access to a patented product or process is being controlled. This is called a “defensive” use of a patent.
Modern patent law is walking a tight line between promoting innovation on the one hand, and granting exclusive rights , which can be hostile and adverse to competition and research, on the other.
This exclusivity, which leads to a limited or blocked access to patented inventions, does not necessarily need to cause a problem. Patent law is based on the idea that only novel, technical inventions can be rewarded with exclusive rights. Limiting access to a novelty, something that previously had not existed and has only come into existence through human activity, can be indeed admissible under certain conditions. Following the theories of incentives and rewards, patent law is intended to create an economic basis in research and development (R&D) also in those fields, which require a high investment. The inventor is to be rewarded for his useful services to the common good.
However, there are also substantial objections to the idea of exclusive patent protection. In the medical arena monopoly rights prevent the cheaper production and sale of drugs by competing producers. This can threaten necessary medical servicing, even making it impossible in some areas of the world.
There is also fundamental concern, because patent law is in danger of loosing its function due to the granting of too many and too far reaching patents for too small an inventive step. This is especially true for the USA:
„The concerns about the operation of the intellectual property system and the extension of IPRs are not confined to their application to developing countries. There are currently two prominent enquiries in the US, one by the National Academies of Science and one by the Department of Justice and the Federal Trade Commission, looking at this important question. These concerns centre on the rapid increase in patent applications in the US in recent years (a more than 50% increase in the last five years), and the perception that many more patents of “low quality” and broad scope are being issued. A fear is commonly expressed that too many patents have been and may be granted in respect of developments of minor importance. For instance, in the pharmaceutical industry this can have the effect of prolonging monopolies on valuable therapies. Patents may also be granted in some jurisdictions over biological materials on the grounds that they have been isolated from nature, if a possible function or utility is identified. The extent to which such practices affect competition by making it more difficult for rival inventors to sell competing products, or more expensive for consumers to buy them, is a matter of concern and growing debate. Considerable debate also exists about their effect on research, particularly in software and biotechnology, where patents taken at an early stage in the research process may be an obstacle to downstream research and commercialisation.“
(Integrating Intellectual Property Rights and Development Policy, CIPR Commission on Intellectual Property Rights, http://www.iprcommission.org)
2. Patents on Genes and Living Organisms – the Perversion of Patent Rights
The balance of patent rights, its purpose in creating an equilibrium between the interests of society and the beneficiaries of exclusive privileges, is gravely lopsided when it comes to patenting genes and living organisms.
First of all, a patent on a gene or living organism does not reward the invention of something new. Genes are no inventions, they are discoveries of something already existing in nature. The logic of patent law would not permit patents on them. In spite of this the European Patent Office grants patents on the discovery of genes, using legal constructions which leave aside the basic idea of patent rights. The monopoly right removes a discovery from general use. This reduces the access to genetic resources immensely, artificially creating scarcity, increasing prices and even totally blocking access. These far-reaching “Patents on Life” grossly “over-reward” patent owners for a relatively simple technical accomplishment. The consequences are mainly felt in the areas of agriculture, plant breeding, food production and medicines.
A major part of the problem derives from the fact that patent law has been transferred from the realms of chemistry and physics to living nature. So-called “product patents” are common in the field of chemistry: these include all properties of a patented substance, independent of whether these were described in the patent application. It is enough to state only one single commercial use to obtain exclusive control over the substance including all properties. This model has been transferred to the genetic code. If only one commercial use is being described, the patent protection covers all biological functions of the gene, which are of commercial value.
Ever since the human genome had been decoded and it became clear that individual genes usually have several and rather different functions, this kind of patent practice seems totally unsuitable. Genes are increasingly seen to be a form of coded information rather than a chemical substance. Genes, which might be controlling the laying of eggs in a worm, can be responsible for Alzheimer in humans. Genes, which trigger breast cancer, can also be responsible for a dysfunction of the intestine or prostate. In addition, a company owning a patent on a gene in connection with a diagnostic process, also holds the rights over the gene if a totally different and usually much more difficult therapy or drug is being developed. Scientifically and economically this monopoly right is totally inappropriate and rather hinders research and development (R&D) instead of fostering it. Therefore genes should be excluded from patentability as a matter of principle.
A second point is that patents on genes and living organisms create a questionable accumulation of patents on living organisms and block access to genetic resources. Patent protection may cover all living organisms, which have been technically altered, where patented genes have been introduced, or whose “normal” molecular structure has merely been analysed. The patent protection covers these living organisms, if they can be commercially exploited in the described way, as well as all subsequent generations of these organisms, if they contain the patented features. This proliferation of patent protection is hugely disproportionate: inventive step and granted patent protection are no longer in a reasonable equilibrium. No longer are technical processes being rewarded by patents, but living organisms themselves are declared to be mere inventions.
The folly of this system can also be seen, when considering the reproduction and cross-breeding abilities of living organisms: a simple grain of rice can accumulate several dozens of patents simply through a number of different steps of breeding and technological processes. Patents then become insurmountable hurdles in plant breeding, and access to genetic resources, which for example global food security depends on, is being hindered decisively.
As a result genetic resources are being withdrawn from society at large, access to economic and scientific use of the genome is largely being blocked. The social contract, which is what a patent constitutes in essence, and which is supposed to create a balance between the interests of the patent holder and society, is being destroyed. A complex unit – the genome – is being divided into small and large parcels. Its use becomes dependent on several thousands of patent declarations, and shareholders and patent lawyers become the Lords of the Genes. In 1998 Heller and Eisenberg already spoke of “The Tragedy of the Anticommons” in this context, which can be used to hinder, slow down or even block the use of the genetic resources. (Science, Vol.280, 1 May 1998, p. 698 ff)
A third point to mention is that patents on living organisms have to do with our basic relationship with and our values towards living nature. A technical invention of a human being – the actual object of a patent – has a different intrinsic value than a fellow creature. A pressure cooker has a different intrinsic value than a sheep. Patentability replaces the intrinsic value of a living being with a limited, special perspective, that of mere technological and economic use.
3. Limits to Patentability According to the European Patent Convention (EPC)
At the moment, the „European Patent Convention“ of 1973 (EPC)[1] is the basis for granting patents in its 26 member states[2]. It says: „European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step”, Article 52 para 1 of the EPC. The jurisprudence of the European Patent Office and its Boards of Appeal interprets what these criteria mean in a particular case. According to the EPC, patents shall not be granted on “plant or animal varieties or essentially biological processes for the production of plants or animals“ (art. 53 lit. b, EPC), as well as for „discoveries“ (art. 52, EPC).
Art. 53 lit. a of the EPC, secures the ethical borders of the patent right: Patents have to be in accordance with morality and „ordre public“.
4. EU Directive 98/44/EC on the “Legal Protection of Biotechnological Inventions”
Traditional limits to patentability have been newly defined in Europe through an EU directive, which circumvents or hollows out the prohibitions to patentability as defined in the EPC (European Patent Convention). According to directive 98/44/EC [3] patents on plants and animals, on parts of the human body and on genes are explicitly allowed. The directive not only expands existing patent law and corrodes some fundamental principles of the system of intellectual property rights. It also leads to a serious violation of essential ethical principles, violates the EPC and goes far beyond what is requested by the World Trade Organisation (WTO).
Despite all this, the EPO, the European Patent Office, has been applying this directive since 1999. The EPO thus breaches the treaty on which it is based itself, the European Patent Convention (EPC). It also broadens the field of application of the directive onto all those members of the EPC which are not members of the EU, and of which only some will soon join. As of January 2003 these are Bulgaria, the Czech Republic, Cyprus, Estonia, Hungary, Liechtenstein, Monaco, Slovakia, Slovenia, Switzerland and Turkey. This action of the EPO is highly controversial: a change of the EPC would have required a ministerial COP (Conference of the Parties). Furthermore, the directive is also controversial within the EU itself. By far not all EU member countries have transferred the directive into national law.
The following paragraphs explain some of the most obvious short-comings of the directive.
4.1 Patentability of plants and animals
Article 4.2. of the Directive permits patents on plants and animals. At first, Article 4.1. actually prohibits patents on plant and animal varieties, but Art.4.2 then allows all those patents, which cover more than one variety or species. This leads to the fact that patents are granted which also include whole plant and animal varieties. (See examples 1,2 and 3, pages 27-30). Furthermore Articles 8 and 9 broaden the patentability to cover all subsequent generations.
When patenting plants and animals no distinction is made between a technical achievement and the subsequent process of biological reproduction and further culturing. Patent protection may, starting from patents on certain processes or gene constructs, be extended to all successive levels of reproduction. It is thus easy to by-pass the ban on patenting plant and animal varieties [4].
The Directive was adopted although these fundamental problems had already been recognised earlier. A statement by the German government from 1993[5] runs:
"However, there still exist objections to the fact that, according to Article 53 lit. b EPC, the authorised protection of the (technical) process of growing a new plant variety shall be extended with its effects to all succeeding generations of the plants produced by that process. As a result, the propagation material of the variety would be protected by patent. This does not seem to be justified. Therefore, as regards the subject matter to be protected, there is a need for a reasonable delimitation between patent protection and the protection of varieties on the basis of Article 53b of the European Patent Convention.”
Despite these objections the German government, together with the other EU member states agreed to this Directive in the Council of Ministers. This was a serious mistake and requires urgent correction in view of the social, economic and ethical controversy this topic has sparked off on national and international levels. Problems result not only from delimitation concerning the prohibition of patentability of plant varieties but as well from the possibility of the patent holder to claim patents on products far downstream of the technical process. Even by-products of the harvest process are claimed[6]. The protection by patent may thus, because of the lack of an explicit exhaustion regulation, be extended to all levels of the value chain.
4.2 Patentability of Genes
Article 5 of the Directive permits the patenting of human genes and parts of the human body. Again, at first Article 5.1. still gives the impression that such patents on the human body are prohibited, but in Articles 5.2. and 5.3 patents are being allowed on everything, which has been isolated from the human body and which has a commercial value:
This renders human genes, cells and even whole human organs patentable. In fact, any gene sequence, once discovered, isolated and described can be patented. The scope of the patent is unlimited: the patent not only covers the gene’s commercial use which has been described in the application, but also any other possible application of the gene.
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This leads to an extreme imbalance between the inventive step and the claim to patent an invention. If their scope is not explicitly defined, patents on single genes can have an enormous scope.
These patents include:
all variations of the gene sequence
use for diagnostic and therapeutic purposes
production of vaccines
use with anti-sense processes
all micro-organisms into which the gene can be transferred
all animals and animal varieties into which the gene can be transferred
all plants and plant varieties into which the gene can be transferred
all applications of the gene that are still unknown
all proteins which can be produced with the gene, as well as
all its applications,
e. g. for medical purposes
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4.3 Regulatory Loopholes in the Field of Ethics
The Directive recognises the need for special ethical provisions in the area of genetic engineering and biotechnology. Article 6 in connection with Recital 38 lists some examples of those inventions that are not patentable as their commercial use would violate morality and “ordre public”[7].
When implemented into national law, the list of exemptions from patentability should be enlarged. This is possible, as both Art. 6 and Recital 38 state the non-exhaustiveness of the list. The current list of examples is inadequate for the following reasons:
- Based on fundamental ethical considerations and the respect for living beings patent law should clearly state that patentability does not extend to any life forms. In its current form, the Directive stipulates the contrary.
- Article 6 of the Directive prohibits the patentability of human embryos. According to Recital 42[8], however, processes for diagnostic or therapeutic purposes applied to human embryos are patentable. Such a process protected by a patent could, as a direct result of the process, also comprise the embryo itself. The permission to patent human embryos in connection with therapy and diagnosis corresponds to Art. 6 (c), which prohibits patentability only in connection with the use of embryos for industrial purposes[9]. In addition, terms like “human embryo” have not been defined so as to create sufficient legal certainty. In view of the partially different legislation within Europe, there is, for example, a considerable difference between what may come under this prohibition in the United Kingdom or in Germany.[10] The provisions of the Directive on the patentability of human embryos are contradictory, not well defined and violate basic principles of morality and ordre public.
It should be made clear that human organs cannot be patented in order to prevent a commercial use of the human body[11]. This undermines the regulations of the Bioethics Convention of the Council of Europe[12] and of national laws (such as, for example, the German Transplantation Act[13]).
4.4 The Directive is Inconsistent with the Letter and Spirit of Several Treaties and Acts [14]
Examples:
The Bioethics Convention of the Council of Europe[15] stipulates in Article 21: “The human body and its parts shall not, as such, give rise to financial gain.”
Intrinsic to any patent is its commercial use and thus, financial gain. Patenting of genes and of biotechnological alterations of body parts violate Article 21 of the Bioethics Convention.
The International Treaty on Plant Genetic Resources for Food and Agriculture, legally binding and decided by FAO Delegates in November 2001 in adaptation to CBD provisions, promotes the free exchange of and the free access to essential plant material in a multilateral system, listed in an annex of relevant plant species for food security, excluding IPR protection of any material transferred in the framework of this system, in the form received.[16]
The Convention on Biological Diversity (CBD)[17] states the national sovereignty of countries of origin over their genetic resources and requires the fair and equitable sharing of benefits resulting from the use of genetic resources of plant, animals and micro-organisms (Art. 15, 16 and 19). A patent, however, grants the patentee an exclusive monopoly right for its use. It thereby undermines the national sovereignty of countries of origin over their genetic resources. This means biological resources are no longer in the public domain, being controlled by state authorities, but by a private corporate monopoly.
In Art. 53 b, the European Patent Convention excludes the patentability of plant and animal varieties. These patents would now be legalised through the backdoor.
Recommendation 1425 by the Council of Europe[18] stipulates that plant-, animal- or human-derived genes, cells, tissues or organs can neither be considered inventions nor be subject to the monopolies guaranteed by patents.
4.5 The Directive Violates General Principles of Law.
Creation of Legal Certainty
The Directive, which defines subjective rights and duties, should be turned into obligatory domestic legislation, satisfying the requirement of clarity and definiteness[19]. In 1998, the Dutch and the Italian governments took legal action before the European Court of Justice. In their view, the provisions of this Directive are so contradictory that they cannot pass into national law.
That is shown in the following points, some of which have been mentioned above:
· patentability of plant varieties and animal species
· scope of patentability of genes
· exclusion of human embryos from patentability
· definition and delimitation of the concepts of discovery and invention.
The loopholes create a legal situation that leads to patents on lifeforms without any restrictions. This contradicts the text of the Directive at various points regarding the purpose and limits of patentability. It seems clear that during the negotiations interested circles exerted deliberate influence on this directive. They thereby created legal grey areas and loopholes that extend the limits of patentability far beyond what was originally intended. This is most apparent with regard to the provisions about the patentability of plant and animal varieties.
4.6 The EU Directive and the World Trade Organisation (WTO)
The EU Directive goes far beyond what is required by the World Trade Organisation (WTO) and its Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS). TRIPS aims at putting in place a global, harmonised system of intellectual property rights. According to TRIPs, countries can exclude the patentability of plants and animals and of patents violating morality and ordre public. [20]
WTO Member States are not required under TRIPs to issue patents on living beings or genes. Member States can decline to do so on a number of grounds, including that:
1) Members have scope for interpretation of provisions of TRIPS such as the definition of ‘invention’.
2) Members may exclude from patentability plants and animals other than micro-organisms;
3) Members may exclude essentially biological processes for the production of plants or animals; and
4) Members may exclude inventions the prevention of exploitation of which within their territory is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment.
Requirements of Patenting under TRIPS
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Article 27(1) of TRIPS requires that patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that (a) they are new, (b) they involve an inventive step and (c) they are capable of industrial application, subject to two important categories of exceptions:
· Under article 27(2), WTO Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.
· Under article 27(3)(b), WTO Members may also exclude from patentability plants and animals other than micro-organisms and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.[21]
So in the context of genetic resources such as in genetic engineering there are a number of questions to be answered. It is important to note that TRIPS does not define an invention and thus WTO Members are free to define an invention according to their own national laws. This has implications for the patenting of genes and other discoveries existing in nature.
The European Patent Directive excludes plant and animal varieties from patentability in Article 4(1) but not plants and animals as such.
Member States of WTO may exclude an ‘essentially biological process for the production of plants or animals other than non-biological and microbiological processes’. This can be seen as recognition that a member state may consider that a biological process for the production of plants or animals is an essential component of life itself.
The Directive defined the term “essentially biological” as consisting of “entirely natural phenomena such as crossing or selection”. (Article 2, 2. „A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.“) This definition was apparently intended to clarify that genetic modification at any stage in the production of a plant or animal will take the process outside the prohibition. The distinction between ‘technical’ and ‘essentially biological’ belies the fact that the term is an exception to patentability, which assumes an invention. In other words, an invention can be essentially biological, yet be exempt under TRIPS but not EU law.
In conclusion, the EPO treatment of ‘essentially biological processes’ represents not only an extension of TRIPS in permitting patents for essentially biological processes where there is a technical intervention, but is based on a misinterpretation of the exception to patentability, since it seeks to contrast inventions (which prima facie are patentable) with essentially biological processes which do not include inventions – which would not be patentable in any case. This interpretation is difficult to reconcile with the longstanding principle that a treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose.[22]
5. The Consequences – Example Medicine
Situations that may result from patenting genes were indicated in 1997 in SCIENCE magazine, titled "HIV Experts vs. Sequencers in Patent Race". The article describes the discovery of the CCR5 receptor, which caused a sensation in the scientific community since it had an important function regarding the intrusion of the AIDS virus into the cell. Although many scientists had already worked on the CCR5 receptor and possible therapeutic approaches they discovered that Human Genome Sciences had submitted a patent application for the corresponding gene sequence (WO96/39437) in 1995. Although the patent specification does not even mention a relation to HIV infection, Human Genome Sciences demands patent rights on this gene in the field of AIDS research as well. Jorge Goldstein, lawyer of the company, explains: "Whoever is first to patent a DNA sequence - for any use - can lock up
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subsequent uses" (SCIENCE, vol 275, 28.2.97 p. 1263).
Example, taken from Integrating Intellectual Property Rights and Development Policy, CIPR Commission on Intellectual Property Rights , http://www.iprcommission.org
In the field of medical diagnostics the negative impact of patents can also be empirically shown: during an OECD Workshop on Genetic Inventions, held from 24 –25 January 2002 in Berlin, Mildred Cho of Standford University presented her study “Effects of gene patents and licenses on clinical genetic testing (…)”. According to this study 25% of laboratories questioned have stopped testing procedures due to claims by patent holders, 53% did not develop their own, improved diagnostic methods because relevant patents had already been granted. Conclusion: “Laboratory directors in the US believe that patents and licenses have had a negative impact on access, cost, and quality of testing, and on information sharing between researchers.”[23]
Like the US Patent Office, the European Patent Office has been granting patents on human genes since 1990. By now the EPO has received more than 6000 applications and has already granted between 400 and more than 1000 patents on genes according to estimations of experts. Since 1999 the Office refers to the EU Directive (see above, section 4), even though the Directive is neither valid for all members of the EPC nor has been transposed into national law by all EU members.
The consequences that doctors, insurers and patients will be faced with when industry can use patents to extend its control also onto diagnostic processes can be shown with the example of the breast cancer gene. The EPO granted several broad patents on the breast cancer gene BRCA-1 (EP 0705903, EP 0705902) to US-company Myriad, based in Salt Lake City/Utah, USA. In the patents Myriad claims some 80 human gene sequences of different length. They include different gene-mutations, which are typical for inheritable breast-cancer. The patents also include diagnostic processes and the rights to use the gene for therapeutic use and the production of drugs. These inclusive claims are based on a rather small technical innovation by Myriad. It was already known prior to Myriad’s discovery on which chromosome and where within the chromosome these mutations can be found.
European doctors are fighting this patent, because they will be directly affected by it. First claims by Myriad are already known: in the UK the costs for a diagnostic test for breast cancer will double from £ 750 per patient (The Guardian, 17.1.2000). In Switzerland it has been revealed that the price will rise from € 950 to € 4020 ! In Germany doctors reckon with a quadrupling of costs.
The French Institut Curie and the Societies for human genetics of Belgium, the Netherlands and Germany have introduced legal proceedings against Myriad’s monopoly and filed complaints at the EPO. Even the European Parliament, which in 1998 adopted the directive, passed a resolution on 4.10.2001 announcing complaints against the patent.
UNESCO also warns about the possible consquences of these patents: “Industry is naturally interested in human genetic data as well. The legal battle between several European institutions, including France's Institut Curie, and the US firm Myriad Genetics shows this. It concerns screening for breast cancer and ovarian cancers both of which are linked to the presence of the BRCA1 gene. The Europeans are challenging Myriad's patents that give it an unofficial monopoly. The Europeans also say that because the firm refuses to grant manufacturing licences, all DNA samples will have to be sent to the Myriad Genetics headquarters in Salt Lake City for processing, providing the company with a unique databank about people at high risk.”[24]
A further example of direct negative effects of gene-patents in Europe are the patents held by the company Chiron on the genotype of HIV (EP 181150) and on the herpes virus (EP 318216). Due to these patents the costs for testing blood donations can be multiplied in Europe.
Precise negative effects caused by over-patenting can also bee seen in the area of Malaria research:
„We have also considered in some depth a case involving the use of patented DNA sequences for research on malaria. The Malaria Vaccine Initiative (MVI) has identified a particular protein antigen (MSP-1) which may be crucial to the development of an effective vaccine for malaria. The ownership of patents relating to this protein was investigated, uncovering some surprising findings:
· The patenting of the DNA sequences for the antigen is very complex. There are up to 39 patent families that are potentially relevant in developing the vaccine from MSP-1.
· At the early stage of research on MSP-1, patents were granted on the basis of science that subsequent research found to be unsound.
· The citing of prior art in many patent applications appears incomplete, so that it is difficult to relate one patent to another.
· On that basis, a number of the patent claims made may be invalid (which is only verifiable through legal means or re-examination). In general, the scope of claims made (which determines the potential for infringement) appear broader than they should be.
Faced with such a situation, a commercial research organisation might decide to shift to another area of research. In the case of MVI (which was established with charity funding to accelerate the development of malaria vaccines), there is little choice but to seek to understand and manage the complexity, with the high transactions costs (both time and money) that this involves. In doing this, MVI has found that, although the malaria vaccine is unlikely to be of significant commercial value, holders of intermediate patents often put an unrealistically high value on their technologies. This can be addressed by assigning a share of royalties to intermediate patentees but this in turn creates a possible problem of “royalty stacking”, where the royalties that need to be paid to intermediaries may be excessive in relation to the royalties received on the final product.“
(Integrating Intellectual Property Rights and Development Policy, CIPR Commission on Intellectual Property Rights, http://www.iprcommission.org)
6. The Consequences – Example Agriculture and Plant Breeding
In the area of plant breeding there has been strong controversy around the so-called Vitamin-A rice. The genetic information for the production of Vitamin A had been implanted into rice. This is to redress the common lack of Vitamin A in many Asian populations, which leads to blindness. Aside from the question whether this rice is actually suitable to fight this lack of Vitamin A, it gives the opportunity to observe the effects of patent law in practice. The Swiss researcher Potrykus (who himself has been granted several patents on plants and seeds) calculated that he would breach up to 70 patents, owned by 32 different patent holders, if he genetically manipulated rice in such a way that it produces Vitamin A.[25] It needed intensive negotiations with industry to obtain at least partial access to the patents needed. The Vitamin-A rice itself also ended up at the Patent Office. Potrykus co-operates with the company Syngenta, which intends to sell such plants with added vitamins as “health food” in Europe and the USA. This very company is one of the major monopolists in the field of rice: in 2002 the company published the map of the rice genome. However, access is to be granted only to those researchers who grant the rights of use of any new applications to Syngenta.
Companies have long since started to also claim plants with no genetic alterations at all as their inventions. In the case of patent EP 744888 the company DuPont merely needed to analyse the content of oil in a grain of corn/maize for it to obtain a monopoly on all corn with a certain quality of oils. The patent was challenged by, amongst others, the government of Mexico: maize with these oil qualities has been grown for centuries in Latin America. In a similar case, Monsanto analysed the genes of certain varieties of soy derived from China and in 2000 claimed a patent on all those plants that naturally carry these genes (WO 0018963).
Parallel to the invasion of patent rights into the realm of seed-breeding, there has been an immense merger process in the industry during the past years. Only a hand-full of agro-chemical groups survived: DuPont, Monsanto, Syngenta and Bayer are all companies that originate in the chemical industry but are now top of the list of trans-national seed companies. Only those “big players” can survive the patent disputes, which cost millions, can accumulate exclusive rights by buying up competitors and who can use a sufficient mass of patent rights as a negotiating tool against others.
These groups now control access to seeds in general, no matter whether genetically modified or not, whether varieties have been newly bred or were merely collected years back. The collections of these companies in their seed-banks or in their cultivation fields is not accessible by the general public and seeds will only be put on the markets once patented genes have been implanted and the growing, proliferation and harvest of these plants can be controlled through exclusive rights.
These are relatively new developments. Until recently free access to genetic resources for breeding was seen as a “conditio sine qua non”, a basic right. In Europe a special system of intellectual property rights had been developed. This system is known as “plant breeder’s right”. It is based on the principle, that access to genetic resources must be free from any exclusive protection rights, in order not to hinder R&D. The owner of a variety does enjoy certain rights for the exclusive sale of his variety’s seeds, but the plant breeder’s right did allow a constant process of innovation. Every plant breeder who intended to grow a new plant variety had free access to the seeds of protected varieties. If the new variety is indeed novel, the former owners’ rights are revoked and the new breeder can market his own variety.
Contrary to this variety protection system, patent rights give the owner the opportunity to totally block a breeder’s work with patented plants. Furthermore, a patent holder can also control the farming of these plants and the use of the harvest. Patents that have been granted to such companies like Monsanto and DuPont, include all steps of the food-production – from the farmer’s field to the consumer’s plate. (See Examples 1 and 2, page 27-30.)
A recent overview can be found in the report “Integrating Intellectual Property Rights and Development Policy”, issued by the UK Commission on Intellectual Property Rights:
„Apart from the problem of incentives for research relevant to poor farmers, there is evidence that patents, and to some extent PVP, have played a part in the major consolidation of the global seed and agricultural input industries. The consolidation appears to be driven by technological change, with an objective of vertical and horizontal integration so that the appropriability of investment in research can be maximized through better control of distribution channels, including those of complementary agricultural inputs (such as herbicides).
Companies acquire patent rights to protect their own investment in research, and to prevent the encroachment of others. But by the same token, other companies’ patent rights can impede one’s own research. For instance, there are several hundred overlapping patent rights for the Bt technology, and at least four companies obtained patents that cover Bt-transformed maize. Recently, Syngenta filed two law suits in the US against a number of its competitors alleging infringement of several of its patents relating to this technology, although the companies involved have been using these technologies, and selling seeds incorporating them, for several years. Cross licensing, or strategic alliances, can also be used as mechanisms to overcome problems of conflicting patents, but merger or acquisition may be the most effective means of obtaining the freedom to use required technologies in a particular field of research. All of these approaches, not just the last, reduce competition. And the major multinational agrochemical companies, with their growing control over essential proprietary technologies, also represent a formidable barrier to the entry of innovative start-ups. In the 1980s, the university and public sector accounted for 50% of the total of granted US patents relating to Bt. By 1994, independent biotechnology companies and individuals held 77%, but by 1999 the big six companies (which became five with the merger of the agricultural arms of AstraZeneca and Novartis to form Syngenta) held 67%. Moreover, the growing control of these companies was demonstrated by the fact that 75% of their Bt patents in 1999 had been obtained by the acquisition of smaller biotechnology and seed companies.
In developing countries, there is evidence of similar trends with an extremely rapid process of merger and acquisition by the multinational companies. For instance, in Brazil, following the introduction of plant variety protection in 1997 (but presumably also related to the expected permission to grow GM crops), Monsanto increased its share of the maize seed market from 0% to 60% between 1997 and 1999. It acquired three locally based firms (including Cargill as the result of an international deal), while Dow and Agrevo (now Aventis) also increased their market share by acquisition. Only one Brazilian-owned firm remained with a 5% market share. This trend appears widespread in developing countries.
Thus, the speed of concentration in the sector raises serious competition issues. There are considerable dangers to food security if the technologies are overpriced to the exclusion of small farmers, or there is no alternative source of new technologies, particularly from the public sector. Further, the increase in concentration, and the conflicting patent claims when both the public and private sectors have patented plant technologies, may have had an inhibiting effect on research. In the private sector the response has been alliances or acquisitions, but a problem for the public sector is how to access the technologies they need to undertake research without infringing IP rights and, if they develop new technologies, the terms on which they may be made available. A recent review published by the US Department of Agriculture concludes that “whether the current intellectual property regime is stimulating or hampering research is unclear.”
(Integrating Intellectual Property Rights and Development Policy“, UK Commission on Intellectual Property Rights, http://www.iprcommission.org)
Monsanto has shown how companies force financial claims directly onto the farmers: In the State of Washington, USA, a farmer in Pontotoc County was found guilty by an appeals court of breaching a patent on a certain seed, held by Monsanto. The court sentenced the farmer to pay a compensation of 780.000 US$ to Monsanto, because the farmer had kept Roundup Ready soybeans from his harvest for his next sowing season. (Associated Press, 26.11.02)
7. Patents as an Instrument of Global Control and Possible Consequences for CEE Countries
Patents are used globally to control markets. The most important function patents have in this context is to secure export markets. Patent rights are used to hinder countries, which do not yet have their own industry in a certain field of technology, in their efforts to create their own production. Patents are a useful tool to create and defend inequalities in the global competitive trade.
The defensive character of patents can most clearly be seen in developing countries: the vast majority of patents granted in developing and “third world” countries, are owned by companies based in industrialised countries; experts estimate up to 90%. The transnational companies impose their market strategies very often without investing or creating jobs in those countries where their patent rights are enforced and their products sold with the option to take over and/or push aside local producers.
The UK Commission on Intellectual Property Rights in their report of the year 2002:
„But developing countries vary widely in the quality and capacity of their scientific and technical infrastructures. A commonly used indicator of technological capability is the extent of patenting activity in the US and through international applications through the Patent Cooperation Treaty (PCT). In 2001, less than 1% of US patents were granted to applicants from developing countries, nearly 60% of which were from seven of the more technologically advanced developing countries. In the PCT, developing countries accounted for under 2% of applications in 1999-2001, with over 95% of these applications coming from just five countries: China, India, South Africa, Brazil and Mexico. In these countries patent applications, although small, are growing faster than PCT applications generally. PCT applications grew by nearly 23% between 1999 and 2001, but the share of these countries in the total increased from 1% in 1999 to 2.6% in 2001. As we have seen R&D expenditure is heavily concentrated in developed countries, and in a few of the more technologically advanced developing countries. Few developing countries have been able to develop a strong indigenous technological capability. This means that it is difficult either for them to develop their own technology, or to assimilate technology from developed countries.“ (Integrating Intellectual Property Rights and Development Policy, CIPR Commission on Intellectual Property Rights, http://www.iprcommission.org)
The effect patents can have on economic development can be shown through the history and development of the German patent laws. In the area of chemical and paint industry the temporary weakness of the German patent laws were actually a huge competition asset. Purposefully the extent of patents had been limited in such a way that only technical processes but no products could be patented. An overview over the historical development can be found in Wolfgang König’s standard work “Propylän Technik Geschichte” (Verlag Ullstein, 1997, Band “Netzwerke Stahl und Strom”, p. 378): “Whilst during the 60ies English and French companies were involved in lengthy disputes over patents on pigments, no national patent right existed in Germany. (…) The young German companies could develop freely and the more advanced foreign competition had no possibility to hinder their growth through patents and patent disputes.”
Later the German industry used patent rights to deliberately suppress foreign competition: “Meanwhile the German chemical industry had acquired such a strength that the possibility of patents no longer posed a threat to them. On the contrary: subsequently German companies made good use of the weaknesses of the older foreign patent laws to strengthen their own leading position abroad through blocking patents and patent challenges, especially in the area of pigments and pharmaceuticals.”
The fundamental strategies in the use of patent rights have basically stayed the same until today. The quotation of the founder of the late Ciba Geigy (now Novartis) in 1883 is still valid: „The patent protection right is a stumbling rock for the development of trade and industry“ (Der Spiegel/1987). For this reason the patent right was introduced relatively late in Switzerland in order to keep their own industry free from restrictions by foreign companies. The industrial development in countries like Japan, Korea and Taiwan also benefitted largely from an incomplete patent right, which enabled these countries to imitate foreign inventions unhindered.
Today a single patent is often only of very limited use. Rather, as an instrument of market strategies companies first claim a number of “basic patents”, onto which they attach further “follow-up” patents, which protect the operative area of the company like a minefield. If a competitor should have been quicker and managed to gain a patent first, then the development of his invention can still be blocked through “a net of patents”. The annual report of the EPO 1995 writes the following about patent strategies of Japanese companies: “The strategy of “basic patents” serves as an instrument of attack. By claiming strong patent rights on a new technology their exclusive operational effect is to use them as an effective “weapon” to exclude competing companies and to maximise market shares. The strategy of “patent nets” is seen as a preventive method to avoid disputes: numerous applications are to web a tight net of patents around a technical field in order to protect the basic invention against circumventing patents and to also protect future applications. If the competitor holds a basic patent then his technological freedom to develop can still be cut off by a net of patents around the basic invention.” (unofficial translation)
These kinds of effects of patents must be discussed especially intensively in view of the economic development of CEE countries and their imminent adoption of the patent laws of the EU and EPO.
A particular fear is the rise of costs in health services, e.g. the testing of blood for HIV and Hepatitis (see page19) and a take-over of the seed-industry by multinational companies to a similar extent as already happened in the USA and the EU: a few groups, originating in the agro-chemical sector, like DuPont, Monsanto, Bayer and Syngenta, are dominating the entire seed-market. Small and medium sized seed-breeders are systematically bought up.
Furthermore there is concern that the existing economic inequality between the USA, Japan, the UK and Germany on the one hand, and the CEE countries on the other, will be confirmed for an unforeseeable time in the area of biotechnology, plant breeding and the development of pharmaceuticals.
A look into the numbers of patent applications shows that inventors from CEE countries will hardly profit from an extension of patent law to their own countries.
Finally, it is also important for CEE countries to note, that even the TRIPs Agreement of the WTO requires patents only to a far lesser extent than the EU. It is possible to prohibit patents on plants and animals, as well as patents on mere discoveries (such as genes); see Chapter 4, page 14.
Table 1: Patent applications in CEE countries compared
As of December 2002.
Comparison between total number of applications with applications on genetic engineering, 1.1.2000 – 30.9.2002
|
Country |
Total number of applications |
Applications in the field of biotechnology |
|
|
Albania |
AL |
0 |
0 |
|
Bulgaria |
BG |
63 |
0 |
|
Czech Rep. |
CZ |
266 |
1 |
|
Cyprus |
CY |
0 |
0 |
|
Estonia |
EE |
14 |
0 |
|
Hungary |
HU |
385 |
5 |
|
Latvia |
LV |
18 |
0 |
|
Lithuania |
LT |
9 |
0 |
|
Macedonia |
MK |
9 |
0 |
|
Malte |
MT |
4 |
0 |
|
Poland |
PL |
243 |
0 |
|
Romania |
RO |
51 |
0 |
|
Slovakia |
SK |
72 |
0 |
|
Slovenia |
SI |
131 |
0 |
|
Turkey |
TR |
134 |
1 |
|
Total CEE countries (members of EPC or EU) |
|
1399 |
7 |
|
Share on total number of applications in Europe |
|
0,01% |
0,004 % |
|
Austria |
AT |
2.342 |
13 |
|
Belgium |
BE |
574 |
3 |
|
Denmark |
DK |
2.158 |
110 |
|
Finland |
FI |
3.674 |
15 |
|
France |
FR |
19.344 |
147 |
|
Germany |
DE |
66.645 |
705 |
|
Great Britain |
GB |
21.478 |
807 |
|
Greece |
GR |
159 |
0 |
|
Ireland |
IR |
472 |
0 |
|
Italy |
IT |
8.799 |
35 |
|
Luxembourg |
LU |
183 |
0 |
|
Netherlands |
NL |
3.126 |
10 |
|
Portugal |
PT |
65 |
4 |
|
Sweden |
SE |
6649 |
37 |
|
Spain |
ES |
1.868 |
37 |
Total of 15 EU-members |
|
137.429 |
2021 |
|
Share of total number of applications |
|
34% |
16% |
|
USA |
US |
145.886 |
6.727 |
|
Share of total number of application |
|
36% |
54% |
|
USA + EU |
|
281.946 |
8.590 |
Share of total number |
|
69% |
69% |
Japan |
JP |
62.858 |
1.283 |
|
Share of total number of applications |
|
16% |
10% |
|
Total number of applications |
|
406.385 100% |
12.392 100% |
8. Options for Actions for CEE Countries
EU: Renegotiating the EU Directive 98/44/EC
EU accession countries from CEE, and those joining the EPC, should join up with interested current members to push for a renegotiation and improvement of the EU Directive. Patents on genes, whatever the source, patents on the human body and parts thereof, as well as on micro-organisms, plants, plant varieties, seeds and animals must be prohibited. Genetic resources must remain in the public domain and not be handed over to companies. Where specially adapted intellectual property rights apply to plants, animals and seeds, these rights must not hinder or block access to them. By the end of 2002 only 6 of 15 EU member states have transferred the Directive into national law. The Parliaments in France and Luxembourg have spoken out in general against patents on genes. The government of Germany has called for changes to the Directive, especially concerning the scope of genepatents. The Directive is debated controversially in the Netherlands, Belgium and Austria, throughout all political parties. These governments have also filed challenges at the EPO against individual patents already granted. In Switzerland, too, not a member of the EU but of the EPC, a lively discussion is ongoing. Those countries that have already transposed the Directive into national law should also join an initiative to renegotiate or overhaul the Directive. The German government has already stated it will work towards a renegotiation, even if the national parliament should decide to adopt the directive as it stands.
EPC: Administrative Council to Prohibit Application of the Directive by the EPO
New members to the EPC should join countries like France in an initiative in the Administrative Council (i.e. the political control body of the EPO) to stop the application of the EU Directive by the EPO.
WTO and Other International Treaties: Expansion of Unpatentability
Finally, interested countries should use the new rounds of negotiations within the WTO to insist on keeping the existing possibilities to exempt plants, animals and biological processes from patentability, and to extend these exemptions to micro-organisms as well. These principles should also be defended within the World Intellectual Property Organisation (WIPO).
ANNEX 1:
A Selection of Patents already Granted
Between 1980 and September 2002 more than 32.000 biotech-patents applications (including medical drugs) have been filed at the EPO. Some 4700 of these cover plants, 3000 animals and 14.000 include human (and animal) genes. Until September 2002 some 300 patents on plants have been granted, 82 animal-patents and between 400 and more than 1000 patents covering gene-sequences have also been granted.
Here are some typical examples for patents already granted:
Example 1: Monsanto – Roundup Ready Soybeans
EP 546 090, Monsanto
Date of granting the patent: 19.06.1996
Title: Glyphosate tolerant 5-Enolpyruvylshikimate-3-Phosphate Synthases
Genetically modified plants which have been made resistant to the company’s own herbicide Roundup Ready (Glyphosate). The following varieties are listed: “maize, wheat, rice, soybean, cotton, sugar beet, rape-seed, canola, flax, sunflower, potato, tobacco, tomato, lucerne, poplar, pine, apple, and grape“. Even the agricultural sowing of these plants falls within the scope of the patent.
Although the patentee explicitly confirmed in a public hearing before the Opposition Division of the European Patent Office that the patent comprises plant varieties[26], oppositions to the patent were overruled in April 2000. This was done despite Art. 53(b) of the European Patent Convention, which stipulates that “plant or animal varieties or essentially biological processes for the production of plants” cannot be patented. Amongst others the German Farmers’ Organisation protested against the granting of this patent[27].
During the hearing the patent office stated that in accordance with the directive patents on plant varieties can indeed be granted, as long as the patent includes more than just one particular variety. Therefore the prohibition can easily be circumvented if companies apply for more than one variety. Even legal experts within the EPO criticise this legal interpretation, which they compared with trying to prohibit bigamy but at the same time allowing polygamy.
In the USA farmers already sow Monsanto’s Roundup Ready Soybeans (US Patents Nr 4 538 060; 4 840 835; 5 352 605). These farmers need to sign a contract with Monsanto, granting the company the right to inspect the farms at any time during the following three years and obliging the farmers to exclusively use Monsanto’s own glyphosate herbicide “Roundup” to treat their soybeans. Furthermore, contracted farmers lose the right to keep part of their harvest for next year’s sowing.
Monsanto has already started a number of legal actions against farmers in the USA and Canada because of breaching the patent.
Example 2: DuPont – Improved Oil Composition in Corn
EP 744888, DuPont
Date of granting the patent: 30.08 2000
Title: Corn grains and products with improved oil composition
The European Patent Office granted this patent to DuPont. It covers all varieties of maize containing more than a certain amount of oil and oleic acid[28]. This means that the patent covers any maize plant with specific oil contents, genetically engineered or not. Claims are also made on any use of these maize varieties, i.e. planting, cultivating, harvesting and processing for food and feed purposes or industrial uses. If the patent was upheld in its present form it would mean DuPont would have a monopoly on a whole range of maize varieties. Opposition against the patent has been filed by the government of Mexico, Greenpeace and Misereor as a clear case of biopiracy.
DuPont claims that the patent involves an invention and that “this invention relates to corn grain having a significantly higher oleic acid content by virtue of heritable genes for increased oil and oleic acid content [and] to the production of high oil high oleic grain, plants and plant parts grown from such grain and uses of such improved grain.” The company marks out a very broad area and tries to ensure it also has legal claims on maize plants (and their future use) which may already exist without yet being known.
Research revealed that natural varieties of maize with high proportions of oil and oleic acid already exist and can be produced by conventional methods of cultivation. Research institutes have already grown such maize. In Central and South America, the megacenters of diversity of maize, maize crops play a central role in the economy and the population’s food supply. There are clear signs that maize varieties with the characteristics mentioned by DuPont exist and have been used for a long time.
For farmers cultivating high-oil, high-oleic grain maize, this patent would mean for instance that they will be obliged to buy new seeds and pay royalties for each sowing. The patent can also have a big impact on food producers.
According to the Mexico-based International Maize and Wheat Improvement Center, “CIMMYT,” this patent may impede the development of maize varieties in Latin America considerably. CIMMYT strives to provide agricultural solutions to the problems of poor people in developing countries through its research on maize and wheat.
Dr Suketoshi Taba, head of CIMMYT’s Maize Germoplasm Bank wrote in a May 2001 to Misereor that DuPont’s “ […] patent application […] can seriously discourage further research on maize oil content if it is not challenged […]” CIMMYT is currently involved in an international research project on oil content in maize.
The above-mentioned patent application case is just one example of the systematic strategy the industry is following in order to gain control over the most important food crops.
DuPont and Pioneer filed many more patent applications based on fake “inventions” (a patent must include an invention), for instance:
- Describing special plant ingredients (like protein or oil) and claiming all genetic resources with these characteristics
- Changing some details in hybrid breeding processes and claiming all resulting seeds and plants
- Using cell/tissue culture techniques to reproduce plant genetic material and claiming all genetic resources with given characteristics
- Isolating genes in genome databases and claiming gene sequences as their inventions
- Transferring foreign genes into existing varieties, and claiming all plants and seeds with the inserted genes
Example 3: Seabright – Transgenic Fish
EP 578653, Seabright.
Date of granting the patent: 18.07.2001
Title: Gene construct for production of transgenic fish
In 2001, the European Patent Office (EPO) granted a patent on genetically engineered fish for the first time. The Canadian company Seabright received patent EP 578 653 on Atlantic Salmon and all other fish species carrying an additional gene for faster growth. In the patent the company reports on experiments leading to fish growing eight times faster than normal salmons.
Genetically engineered fish have the potential to be invasive species and could cause irreversible damage to wild fish stocks and ecological damage to the wider marine environment. Many leading fisheries biologists have expressed strong concerns as have European Governments and fisheries organisations. Yet the granting of this patent encourages the commercialisation of these ´monster´ fish by awarding the company exclusive ownership on any future GE fish with the growth hormone gene. This increases the financial incentive for Seabright (A/F Proteins) to commercialise GE fish.
Seabright has licensed the use of the GE growth hormone technology to their sister company, A/F Proteins. A/F Proteins has recently applied to the US Food and Drug Administration (FDA) for commercialisation of the worlds first GE fish, a GE salmon. A/F Proteins claim to have 15 million GE fish eggs ready for sale to fish farms around the world if approved by FDA.
Example 4: Myriad – Breast Cancer
EP 705902, Myriad
Date of granting the patent: 28.11.2001
Title: 17q-linked breast and ovarian cancer susceptibility gene
Proprietor: Myriad Genetics, inc.
The EPO granted Myriad several patents regarding the breast cancer gene BRCA1, which is held responsible for a hereditary form of breast cancer. These patents claim the gene, as discovered and isolated from the human body, as well as all subsequent applications of the gene. Patent EP 705902 also covers the human gene in a form found also in healthy persons.
The patent covers a typical broad range of different issues:
· the gene sequence for breast cancer gene 1 in all variations and mutations,
the proteins encoded thereby,
the use of the gene sequences for diagnosis,
the use of the gene sequences for therapy,
the use of the gene sequences to test new drugs,
all cells into which the gene can be transferred, and
all animals into which the gene can be transferred.
Experts believe that Myriad can use the patent to widely control diagnosis and therapy of patients. This leads to increased costs and hinders the introduction of improved methods. Greenpeace, the Swiss Social Democratic Party, the Institut Curie in France, the Belgian Society of Human Genetics, the Governments of the Netherlands and Austria, and others have challenged the patent. This challenge is also supported by the German and Austrian Chamber of Doctors. Human geneticists, patients and doctors and also the European Parliament have publicly voiced their protests.