- Prof. Carlos María
Romeo-Casabona, LLD, MD
Director, Inter-University Chair BBVA Foundation – Provincial Government of Biscay in Law and the Human Genome, University of Deusto and University of The Basque Country, PO Box 1/E
48080 Bilbao, Spain.
Eubios Journal of Asian and International Bioethics 14 (2004), 203-208.
1. The original purpose of the European rules concerning biopatents was twofold: on one hand, to harmonize the European legislation on biotechnological patents, and on the other, to contribute to the development of biotechnological research in Europe so that it is not relegated behind the North American and Japanese biotechnological market, mainly (Lema 1999). But through the nineties Europe was involved in a intensive debate, according to it patenting life should be in compliance with recognized standard ethical principles.
The necessity for a Directive was urgent, because the practice of biotechnological inventions had shown the
differences between national laws regarding patents in the different member states. Furthermore, this kind of difference could be increased not only by administrative performances but also by juridical interpretations, what could lead to hinder the operation of the inner market and even to go down the industrial development of inventions in this field.
From the original text of the first Directive proposal on legal protection of biotechnological inventions of 1988 until the text finally approved in 1998 there have been several very important changes in it. The first draft of 1988, had a total lack of ethical (Hermitte 1998) considerations, it was mainly a Directive devoted to solve patentability problems; in this sense it was considered that it was a juridical text with purely technical character (Lobato 1998). However, the current Directive is full of ethical considerations, in the sense that it acquires a position devoted to solve the ethical questions related with the patentability of living matter and of parts of human body, including in that human genes (Bergel 2000).
2. In the other side, the Governments of some countries of Asia (India), Africa (South Africa) and Latin America (Brazil), among others, were confronted with the problem of providing some of vital drugs (such as medications against AIDS) for their respective populations. It was also both an economic concern, as these countries are not complex drugs inventors, and an ethical dilemma as those governments could not sit down with their arms crossed and to accept the death of thousands of infected persons. There is also a great perplexity considering that these countries provide human subjects for some clinical trials (i. e., for AIDS drugs) funded by very important northern companies, and there is a claim to ensure that these patients benefit from the new drugs after the trial is accomplished (European Group 2003), in terms to prevent to exploit the vulnerable (Nuffield Council 2002).
The important European Directive on the legal protection of the biotechnological inventions (Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 (OJ EC of 30 July 1998) will have to be considered by the Member States bringing into force laws, regulations and administrative provisions necessary to comply with this Directive, what has already happened in many States. On the other hand, the European Convention on the Patent of 1973 has also been revised in 1999 to adapt it to the new legal framework settled down by the Directive.
The new European regulation has given a general answer to the numerous conjectures that this matter rises: that the biotechnologies will be legally protected, in a main or exclusive way, through the patent. Any other artificial solution different than the patent has been rejected, settling down the relevant aspects that differentiate a discovery from an invention. As it has been checked, this was one of the most controversial points on the favourable or contrary arguments to the patent.
On the other hand, in the Preamble it is proclaimed that it is not sought to substitute the existent national general framework on patents, but rather "the rules of national patent law remain the essential basis for the legal protection of biotechnological inventions". (Recital Nr 8). However, there has been a lot of interest in emphasizing that it should be demonstrated anytime that the presumed novelty or biotechnological innovation fulfils each and every one of the traditional requirements of the patent. Concretely, the Preamble and the articles of the Directive stress that the applicant must demonstrate convincingly the industrial application of the biotechnological product. That is to say, its utility should be fully defined and clearly exposed as well, although it is certain that the Directive makes more flexible the understanding of the other two requirements of the patent (to be new and not obvious inventions) when it deals with Biotechnology.
Another concern of the authors of the Directive (the Parliament and the Council) is to make as clear as possible what can be patentable or not on biotechnological matter, mainly in connection with human biological elements or when the human body is somehow involved, but also when animals or vegetables are.
This reiterated concern in the conceptual clarity explains that, the Preamble has 56 Recitals, while the articles are only 18. That is to say, it has worried more to clarify what it is sought to regulate and with what sense than the regulation itself.
In summary, which is the new European normative framework that the Directive on the protection of biotechnological inventions establishes? Explicitly it appeals to the national law on patents, notwithstanding the necessary adaptations to take account of the provisions of this Directive (art. 1ľ). Consequently, according to this prescription, the adequate legal framework for the protection of the biotechnological inventions is the law of patents.
The Directive states, as a general principle, that a product consisting of or containing biological material is patentable. Also, the process by means of which biological materials are produced, processed or used; as long as they comply with the traditional requirements of the patent: new inventions which involve an inventive step and which are susceptible of industrial application. (article 3.1)
Consequently, biological material which is isolated from its natural environment is patentable, or also if it is produced by means of a technical procedure, even if it previously occurs in nature (art.3. 2).
The nuclear approach of this Directive, regarding the patentability of human genes or parts of them, is based on this precept, just mentioned; because such a possibility is admitted under the above- mentioned conditions. This does not prevent the Directive from clarify it even more specifically, as we will confirm below.
Regarding the human biological material, it points out expressly that they will be able to be considered as a patentable invention: "An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element." (art. 5.2). In any case, it emphasizes that "the industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application."(art. 5.3).
On the contrary, "the human body, at its various stages of formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions"(art. 5.1).
As for the exposed patentability conditions, there is still a debate on whether the sequence of a gene or part of it, isolated in a laboratory or obtained by other technical process, really constitutes an inventive activity. Indeed, it is pointed out that a gene or a functional fraction of DNA can be identified with a chemical molecule. But an essential difference remains: what really is relevant of that molecule is the genetic information of which it is carrier, and not its basis itself. If the structure of this information "is identical to the one of a natural element, we have a discovery, not an invention" (Bergel 2000). Consequently, against the approach of the Directive, according to the contrary opinion, the reproduction by means of a technique procedure or the isolation of that information or knowledge would not constitute an inventive activity, what is an essential requirement for recognising the patent. This is so regardless that the technique procedure for the reproduction or isolation of an element of the human body may constitute an inventive step.
The object of the Directive is not limited to the biological components of human origin. So, inventions concerning plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety (article 4.2), according to the juridical tradition in this matter.
In accordance with the Directive, microbiological or other technical processes, or a product obtained by means of such a process, are also patentable. (article 4.3) This rule is not a novelty either because it was allowed before at the European Patent Convention. Nevertheless, this recognition is just an exception to the exclusion of the patent of the essentially biological procedures for obtaining plants or animals. (article 4.1b) The explanation of this normative lies in that, once the micro-organism has been produced, it is able of natural, fast and abundant self-reproduction or self-multiplication.
Another issue gave place to concern, in this case of the breeders. It was the risk of becoming dependent of the big companies of seeds and livestock improved by genetic procedures. So that, for each new sowing or reproductive period they would have to acquire the corresponding products onerously (e.g., seeds or breeding animals) or to pay a canon or any other kind of payment to these companies, with the corresponding price increase of their agricultural exploitations. This fear has been wanted to solve with the so- called "breeder's privilege". According to this privilege, the farmer will be able to use the product of his harvest for propagation or multiplication by him or her on his or her own farm, and as well the use of the livestock or reproductive material for the purposes of pursuing his or her agricultural activity. (art. 11).
Regardless of the concurrence or not of the requirements of the patent, the new system excludes the normative framework of the inventions whose commercial exploitation is contrary to the public order or morality (the "good customs") (art. 6.1). It is an excluding clause that already appeared in the European Convention (the Convention of the European Patent of 1973). Although, in fact it has never been applied, neither by the Office of European Patents or by any other national Court. Such an application lacks a response to pragmatic reasons and is difficult to apply itself. On the one hand, there was an evolution regarding a more flexible concession of the patents. On the other hand, it is always difficult to apply indeterminate juridical concepts as public order and morality are.
Anyway, as a projection or concretion of this general clause of exclusion, the Directive rejects expressly, in connection with human biological material, (i) processes for cloning human beings, (ii) processes of modification of the germ line genetic identity of human beings, (iii) as well as uses of human embryos for industrial or commercial purposes (art. 6.2).
As I have already pointed out on several occasions (Romeo-Casabona 2002), the admission of the patent should not be mistaken for its admission or prohibition in another sector of the normative system. That is to say, appealing to an example, that the processes of cloning human beings is not patentable, but there could be, however, a law that allowed it -or, on the contrary that prohibited it-. So that one thing is to allow the activity as such, and another very different thing is to recognise or not the patent of a product or a process where the activity lies.
With regard to this, it should not be forgotten that the concession of the patent brings out the ability to prevent a third party from exploiting the invention with commercial purposes without the authorisation or consent of the patent holder.
Probably in connection with these matters and with the public order clause, the Directive contents a provision: "The Commission shall send to the European Parliament and the Council every five years a report on any problems encountered with regard to the relationship between this Directive and international agreements on the protection of human rights to which the Member States have acceded" (art. 16 a).
Lastly, and for the same public order reasons, the patent will not be granted to processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to humans or animals and also animals resulting from such processes (art. 6.2, d). This is an appropriate –but still not enough- way to prevent transgenic animal researches that should have scientifically nonsense but could cause them suffering.
Initially there was not a special diligence on the part of the Member States of the EU to adapt the respective internal laws to the Directive.
Nevertheless, it can be affirmed that nowadays the States that have already adapted their systems to the Directive constitute a majority. However it seems that there has not been unanimity among the Member States as for their attitude in this respect. This attitude, we could classify in three main positions.
1) The first of them would be integrated by the States that have already begun or concluded the adaptation of internal laws process.
2) The second attitude would be represented by France, whose National Consultative Committee of Ethics on Sciences of the Life and Health has intervened on this matter. In its conclusion on this question the Committee was openly contrary to the incorporation of the Directive to the French legislation (Law of 29 July 1994), since at this moment it would be ambiguous and it would not clarify the position of the investigators. The Committee considers a debate necessary, before removing the principles that inspire the French legislation: the knowledge of the sequence of a gene cannot be assimilated in any case to an invented product, and therefore it is not patentable. Its use, as of all knowledge, for the common good of the humanity, cannot be limited by the existence of patents that would seek, on behalf of the industrial right of industrial property, to protect the exclusivity of such knowledge. That is to say, the French Committee proposes the free access to the knowledge of the genes or parts of them. However, this ethical (properly speaking: legal) solution would not be peaceful either, since some private company of the consortium that made public the conclusion of the map of the human genome, renounced the patent of the sequenced parts of the genetic map obtained by it, but it didn't renounce to sell them as commercial information to those who could get an economic benefit from the investigations that they have carried out with them.
It is certain that the Opinions of the referred Committee are not binding for French authorities, and that apparently the French Government had already begun the adaptation process, but it is not less certain than their Opinions reflect a very influential and in general very respected criteria. In my view this Opinion should be very relevant for the debate previously to the approval of the Directive, but in fact it came too late,
3) The following approach was a result of the appeal presented by two Member States of the EU to the European Court. It was an annulment appeal presented by the Netherlands in 1988 against the Directive 44/98/EC. A little bit later, in December 1998, the Italian government presented a similar annulment appeal. The Norwegian Government also presented it, but it committed some procedural mistakes. The line of argument is based on several aspects, but we could highlight the argument that the Directive affects the fundamental rights, human dignity, since it allows patents on human material. Moreover, it did not settle down any provision with regard to the recipient of material biotechnologically treated, what attempts against the principle of self determination of the patients.
The European Court of Justice has answered this appeal, having rejected it in each and every one of its terms (ruling of 9 October 2001). The most relevant arguments were the following ones: i) it is not a matter of the creation of a new law, since it deals with national patents for which the procedure and the national law are applicable. ii) The Directive was the only way to guarantee the correct operation of the interior market, given the legislative divergences of the Member States on this matter, therefore, the subsidiarity principle is not harmed. iii) The Directive does not bring out a violation of the human dignity, because it limits the patent in a sufficient way so that the human body remains indeed not disposable and inalienable. For example, when excluding the patent of the human body and its parts at the various stages of its formation and development, and when considering some procedures specifically contrary to the order public and morality, and for that are not patentable.
6. Some critics opposed to the Directive
Seemingly, the process of uniform regulation on the protection of the biotechnological inventions in the Europe Union was already closed since the Directive was approved by the corresponding Community bodies.
Nevertheless, as we have been able to check above, it is not like this the situation, and some important critics to the normative of patents that has been established, have raised. Here there are some of them:
1. We have already seen before the form or content arguments presented against it, the reticences that it still brings out in relevant advisory institutions.
2. It has also been criticised that the Directive has excluded of its articulated part the demand of the consent of the people from whom the biological samples come when a patentable invention has been obtained. Without wanting to judge whether it is or not an appropriate requirement -although at least I want to point out that it is a question that should be kept in mind-, the truth is that it does not seem a characteristic matter of the patent and that, in consequence, it should be solved by the industrial property law.
3. Let's remind that it has been argued that the genes and their parts (the sequences of DNA), even though having been isolated in the laboratory, they contain information –they are knowledge-, and this is what really interests as an object for a possible economic exploitation. This information already exists in the nature, for what, from this point of view, it would be a discovery and not an invention.
4. There would not have been a sufficient reflection to order what can or cannot be patentable.
5. Some patented inventions regarding health are already a reflection of the access inequalities to them, because they are giving place to exorbitant economic rights (e.g., the case of the diagnostic products of predisposition to the breast cancer in the United Kingdom).
Talking about patents, many things have radically changed since the entry into force in 1995 of the Trade related intellectual property subjects (TRIPS) in the World Trade Organisation. The WTO is the only worldwide economic organization with an effective sanctioning capacity, through its Conflict Solution Organ, to the countries for the unfulfillment of its rules. It includes crossed reprisals: for example, a commercial sanction for violating the TRIPS. This explains the strange and gnarly presence of the protection of intellectual property in the WTO that reinforces and widens previous agreements. Also it means the generalization from the system of patents to all the technological fields and with a minimum duration of the monopoly of 20 years.
This benefits the big multinational companies of Northern countries that own the property of the immense majority of the patents. In fact, TRIPS was developed from the necessities of these companies. Indeed, firstly a dozen of big American companies from different sectors, half of them being pharmaceutical or biotechnological companies, constituted an Intellectual Property Committee (IPC) with the explicit objective of including that issues in the calendar of the GATT during the Uruguay Rounds (1986-1994). Soon, the IPC got the support of the European employer's association UNICE and the Japanese Keidanren to put the pressure on the governments. And in 1988 this Triad coalition, without precedents, went to the GATT director and gave him the draft of what, with the support of its governments, became the TRIPS.
For most of Southern countries, the TRIPS is a way for a harmonization of their protective legislation of intellectual property, reaching the level of the most advanced economies. They have a transitory period that ends in the year 2000 or 2005, according to each case. For pharmaceutical products the date for most of Southern countries is the second one, except for those "less developed" (the Southern 49 most poor countries) that initially had one more year and, after the IV Ministerial Conference of the WTO, in Doha on November 2001, they have time until 2016 for the full application of patents in the pharmaceutical sector.
It is all about facing interests. On one hand, Northern pharmaceutical companies and on the other hand Southern governments that try to generalize the existing treatments against AIDS. And in fact they have already fought in several occasions, some of them are very well-known. The case of the big pharmaceutical multinationals against the Government of South Africa (presented in 1998 with the support of the US Government and retired in 2000, and continued in the US courts until April of 2001) had a lot of echo in Northern countries. Although less, the claim of United States in the OSD of the WTO against the Brazilian program against AIDS, (presented in 2001 and retired months later) is also known.
However, the Doha agreement did not clarify how Southern countries could benefit of that declaration if they do not have a local pharmaceutical industry able to produce medications under an obligatory license, because its import could be in conflict with other TRIPS dispositions. This explanation should have been done by the WTO before the end of 2002, but there was no agreement. Indeed, despite the important (excessive) surrenders of Southern countries, the stinginess of the United States, the European Union, Japan and Switzerland that defended the interests of their pharmaceutical industry, impeded a consensus solution. In those negotiations, the United States had a particularly strict position. They tried to limit even more the agreement, restricting it to fewer diseases, but it is to be underlined that the Doha Declaration refers to the protection of the "public health" in a general way. And what just before the beginning of the Fifth Minister Conference of the WTO in Cancun in September 2003 appeared as an agreement to facilitate the implementation of the Doha Declaration, it means a group of new obstacles that make it even more difficult of applying, as we will see below.
Anyway, the hopeful forward step given in Doha would not have been possible without the campaign of access to essential medications promoted since 1999 by diverse NGOs. That campaign has had a remarkable repercussion in Northern citizenship, and in some international organisms. Among them, World Health Organisation (WHO), that includes in its priorities the access to generic medications and TRIP's repercussions, even though there are some people that consider that it is placed in favour of companies. It has also given place to interesting resolutions such as number 2000/7 of the Subcommittee of Human rights of United Nations which denounces the negative implications of TRIPS on the rights to feeding and health, and affirms their primacy over economic policies and intellectual property, sustaining that patents on pharmaceutical products should serve of social welfare. Or resolution 2001/21 of the Commission of United Nations on Human Rights that recognizes that the access to medications is a fundamental element for the progressive full realization of the right of everybody to enjoy the highest reachable levels of physical and mental health and it requires the states to assure that the application of international agreements is compatible with the public health.
Because of this, and as the North concentrates the demand of medications and originates most of the benefits of the pharmaceutical industry, the companies retired the demand against South Africa, in order to keep a good image. For that reason they also accepted the less harmful, Declaration of Doha. Nevertheless, we should underline that it is a simple interpretation of the Agreement, which has not been changed at all, exactly what multinationals and Northern countries wanted. So as to keep Pandora's box closed, due to the questions made on TRIPS from many Southern governments and NGOs. Therefore, in the field of access to medications there is still a lot to do. Even more when the incorporation of more restrictive versions of the protection of intellectual property, often denominated TRIPSplus, is present in the negotiations of regional integration agreements as the case of America's Free Trade Area.
At the end of August 2003 the World Trade Organization announced a new agreement with developing countries on pharmaceutical products patents. This historical Agreement raised hopes among the numerous African countries and doubts among the NGOs regarding its capacity to help the millions of people with AIDS, malaria or other infectious disease because they considered it too complicated and with a difficult application. Definitively, through this agreement poor countries can import generic medications to fight more than twenty diseases.
The text was blocked since December 2002 by some countries –as the United States- because they were trying to protect their pharmaceutical industry. After these eight months of blockage, the 146 countries of the WTO, allowed the poor countries to import generic medications –which are the same components than patented medications but are much cheaper- to help fighting serious problems of public health. The WTO solved in this way, a controversial question, ten days before the Fifth Ministerial Conference of the WTO that took place in Cancun (10-14 September).
Although the agreement received the praise of several instances (WTO, the European commissary of trade, the international federation of pharmaceutical companies and even the ambassador from Kenya), it received the critics of several ONGs for its doubtful practical use due to its complicated mechanism, and the fact that it is not very clear legally. Among the adopted measures it is foreseen that Governments that want to import generic medications should demonstrate that they really need the medications, that they have a lack of money to buy patented medications and that they cannot produce them at a local level. Several clauses have been established to avoid the commercialisation of generic medications dedicated to poor countries in rich countries, and to avoid the inclusion as generic medicines some of them which are important sources of money for the pharmaceutical industry, such as the products against obesity and impotence.
The decision will allow countries like India, Brazil and Sputh Africa, which have the needed infrastructure for production, to elaborate patented medications by pharmaceutical companies from all over the world if they only dedicate them to export to needy nations.
One of the biggest disagreements was referred to the diseases that should be included in the agreement's list that allows the treatment with generic medications. While the USA defended that this possibility would be limited to the treatment of AIDS, malaria and tuberculosis, other parts such as the European Commission, thought that the WHO should decide, if there were any doubts, about the diseases covered by this multilateral mechanism with the possibility of incorporating any disease in the case of a sanitary emergency defined by the affected country.
Big pharmaceutical companies had argued that such an agreement could relax the normative on the protection of medication's patents in whose development they had invested billions of dollars. They feared that low cost producers like India could find a pace to introduce their products in the markets of developed countries and use their technologies to impel their own benefits instead of making it with humanitarian goals. Answering this situation, the WTO has included a declaration in the agreement where it says that the countries will only be able to overcome the patents "with good faith and to protect public health... and not as an instrument to achieve industrial or commercial objectives".
This Agreement includes certain conditions to guarantee that its final goals are fulfilled. To begin, medications manufactured as generic and destined to fight epidemics in developing countries, will have a different package and pills colour to those used in other countries to avoid their importing to developed countries. The system includes about 20 diseases, but it has an annual revision to adapt it to specific necessities.
It seems that demanding the patents in courts when they limit the access to medications is getting usual, as it recently happened (February 2004) in Thailand, where a court decided to agree with two HIV-infected patients that had denounced the Bristol-Myers Squibb laboratory for blocking their treatment due to the rights of industrial property of one of their antiretroviral, opening in this way the road to the production of the generic medications. The court judged that patents damage the patients whose health and life depends on if they can or cannot pay the price of the medications needed to stop the advance of HIV in their body.
Currently, the Thai Government produces a series of generics that are 25 times cheaper than the original versions. The treatment against AIDS is different, since these medications are still protected by patents and are too expensive.
It seems that the performances of the NGOs will follow the pace of demands, because recently (at the beginning of March 2004) Médecins Sans FrontiŹres (MSF) has accused the pharmaceutical company Merck of breaking the promise made 16 months ago of reducing, in poor countries, to less than a dollar the prices of antiviral efiravez (EFV) against AIDS. According to MSF, Merck accepted that discount in a key medication for the combined therapy, mainly for patients with HIV and tuberculosis. However, until now Merck has not registered it in countries like South Africa, Malawi and Nigeria. The failure of Merck means that patients of poor countries have to continue taking three pills to a price 44% higher than the promised one.
It is a common statement that we are at the globalisation era. Whatever it could mean I think that globalisation should not – or not only- be a way to open the markets for producers around the world; and not only to promote partially some ethical views, regardless they could contain universal values.
Globalisation should be rather a way to improve responsibility, solidarity, tolerance and understanding among the nations and the people. Today's problem posed by the access to basic and/or vital drugs at developing countries needs:
i) For equity at benefits by producers, taking into account that intellectual property rights (patents) can still deserve an useful way for protection of inventions, but at the same time preventing that they could perpetuate poverty of developing countries.
ii) it is not contradictory to this to explore some flexible ways of different nature and intensivity to extend ethical concerns when collective dimensions are involved, as could be voluntary licences, anyway preventing their misuse, or giving medicines free or at reasonable prices for developing countries when vital o endemic diseases are involved.
iii) Notwithstanding, taking durable measures is the most desirable way to shorten distances among North and South. To implement North-South interactions those measures could consist of promoting joint venture projects, improving and funding some local industries according to the potentiality of the conmcerned country (startup), and transferring technology as well as establishing cooperative research programms.
iv) Responsibility for a good management of resources by authorities of developing countries, even when these are scarce.
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The author wants to stress warmly his thanks to Dr. Amelia Martin-Uranga for her helpful collaboration to prepare this contribution.