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Patenting in biotechnology: a review of the 20th Symposium of ECB81
Journal of Biotechnology 67 (1999) 1 – 11
Review article
Patenting in biotechnology: a review of the 20th Symposium of ECB81 Erno¨ Szarka * Hungarian Patent Office, Garibaldi u. 2., H-1370 Budapest, Hungary Received 23 December 1997; received in revised form 6 April 1998; accepted 9 April 1998
Abstract The patenting of biotechnological inventions is practically in harmony with the general requirements of patent protection. It stands still in the foreground of interests since this is the only technical field where the living material itself may be the subject matter of patents. In consequence ethical problems have arisen first of all in the patenting of human cells and genes in which there is no agreement between R&D firms, patent offices and green movements. This has called for the elaboration of special Directives. On the other hand, patent systems are instrumental in safeguarding biodiversity. This review gives a picture of the patenting situation in biotechnology in the European Patent Office and in Hungary, the host country of the Congress. It also gives practical advice to biotechnological researchers on how to draft the applications and to observe the time limits, as well as on the necessity and possibilities of the deposit of microorganisms. © 1999 Elsevier Science B.V. All rights reserved. Keywords: Patentability in biotechnology; Ethics; Biodiversity; Human genes; Deposit of microorganisms
1. Introduction When the Organizing Committee of the 8th European Congress on Biotechnology 1997 began its activity and defined the subject matter of the * Corresponding author. Fax: +36 1 3311383. 1 Based on the symposium, ‘Patenting in biotechnology’, held at the 8th European Congress on Biotechnology (ECB8) in Budapest, Hungary, August 1997.
symposia to be held, it felt it necessary to give an overview of patenting possibilities in biotechnology to those skilled in that art. Therefore the Committee decided to draw up a plan for a symposium dealing with this topic. In selecting the themes, the following considerations had to be taken into account: (1) The symposium should advise first of all researchers in biotechnology on the possibilities of
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protecting their results of research, as well as on special problems of patenting in biotechnology in the host country, in Europe and all over the world. To patent experts it should provide an opportunity to learn how researchers react to the issues arisen during the symposium, and biotechnological experts should be acquainted with the practical issues and pitfalls of the patenting possibilities. (2) Furthermore, ethical issues that may arise in connection with patenting biotechnological inventions should also be addressed. (3) Biotechnological experts should get an overview of how the intellectual property protection system, first of all the patent system, may serve the maintenance of biodiversity in the world. The speakers were asked to base their lectures on international agreements and rules of law which govern, in particular in Europe, the patenting of the results of biotechnological research. These are the following: European Patent Convention; Budapest Treaty on the recognition of the deposit of microorganisms for the purposes of patent procedure; Convention on biological diversity; Agreement on trade-related aspects of intellectual property rights (TRIPS); Directive on legal protection for biotechnological inventions (not yet in force)2; International Convention for the protection of new varieties of plants (UPOV).
2. Patenting possibilities of biological, especially biotechnological inventions in Hungary The legal practice of the host country, Hungary, could be a good example of a patent system 2 As far as the said Directive is concerned, a political agreement on a Common Position—i.e. the first step to final adoption — concerning the proposed Directive on the legal protection for biotechnological inventions has been reached on 27 November 1997. The Common Position was formally adopted by the Council on 26 February 1998. After, it will be forwarded to the European Parliament for its second reading under the co-decision procedure. It is expected that the second reading would take place in June 1998. Therefore, the final adoption of the Directive would be finalised at the latest in autumn.
conforming to the European laws and regulations, including the possibilities of the protection of biotechnological inventions (Szarka and PetzStifter, 1997). The Hungarian patent system was 100 years old in 1996. The Hungarian Patent Law has been continuously developed according to the Paris Convention for the Protection of Industrial Property. The latest Patent Law (no. XXXIII, 1995) entered into force on 1 January 1996. In 1991, Hungary and the European Union concluded a Provisional Association Agreement according to which Hungary undertook to ask for her accession to the European Patent Organisation. The relevant request was submitted at the end of 1996. Due to Hungary’s resolute intention of accession, the new Hungarian Patent Law was created in such a way as to be in full conformity with the European Patent Convention. The most important change was the appearance of product protection with respect to pharmaceuticals, foodstuffs and chemically produced products. The same relates to products produced biotechnologically and to microorganisms per se. Applications relating to biotechnological inventions are examined in line with the practice of the European Patent Office, not only because the relevant laws comply with each other, but also because most examiners of the Hungarian Patent Office had an opportunity to study personally the methods of the European Patent Office. Therefore it is highly probable that the examination of a biotechnological application will lead to the same result in both Offices, except for certain differences of opinion of the individual examiners. Protectability of new plant varieties and animal breeds is a peculiarity of the Hungarian patent system. Under the European Patent Convention these are excluded from patent protection, therefore plant breeders may usually enforce their rights within the framework of a special plant variety protection system. These rights may be obtained in conformity with the provisions of the UPOV Convention. In Hungary the protection of plant varieties is regulated in a special chapter of the Patent Law. This chapter fully conforms to the UPOV Convention.
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No international agreement provides for the protection of animal breeds, each country tries to afford some form of protection on its own. Hungary also grants patent protection for animal breeds, which is regulated in another special chapter of the Patent Law. The criteria of patentability of biotechnological inventions, plant varieties and animal breeds may be distinguished as follows: inventions (including those relating to biotechnology): novelty, inventive activity and industrial application; plant varieties: distinctness, uniformity, stability, novelty, denomination suitable for registration; animal breeds: distinctness, novelty, reproducibility; denomination suitable for registration. The article of Szarka and Posteiner-Toldi (1996) also gives an overview of the protectability of biotechnological inventions.
3. The deposit of micro-organisms under the Budapest Treaty Another set of topics encompasses the necessity and possibilities of the deposit of microorganisms (Ilardi, 1997). Disclosure of an invention is a necessary requirement which enables an invention to be eligible for patent protection. Where an invention relates to the application of a microorganism which is not available to the public, the disclosure of the invention is insufficient. Some decades ago, this problem was solved by prescribing the deposit of microorganisms not available to the public in a culture collection. This meant that the deposit had to be repeated in each country concerned, and only some countries recognized deposit in the culture collection of another country. The Budapest Treaty was brought about on 28 April 1977 in order to solve this issue. Forty States were party to this Treaty in the middle of 1997. Under the Treaty, a deposit made in a duly accredited culture collection of any of the contracting States is valid in each contracting State. The Treaty provides for the accreditation conditions of culture collections, technical requirements of deposits, the obligatory period of storage and the furnishing of samples of the deposited mi-
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croorganisms to third parties. The purpose of deposit is to make the microorganism concerned available to the public, however, without any opportunity to use it unlawfully. The World Intellectual Property Organization keeps a record of the accredited depositary authorities, which themselves define the range of microorganisms which they accept for deposit and establish the fees for deposit and for storage. Further details of the legal and technical issues of deposits may be read in Weitz (1993), Moufang (1995), and Jaenichen (1996). 4. Intellectual property in support of biodiversity It is the responsibility of scientists to hand down the Earth to the descendants in the same biological condition as it was inherited from their parents. The patent systems have to support this idea (Straus, 1997). It is in the interest of mankind to safeguard the biodiversity of the Earth. At the same time it is also important for it to exploit in a sustainable manner and to its own benefit the natural resources, including genetic resources of the world. The ensuing technological progress offers considerable advantages to humanity. In order to meet this double objective, the Convention on Biological Diversity was signed on 5 June 1992, at Rio de Janeiro by the representatives of 150 countries. However, the hopes that by this the controversy on the access, exploitation and preservation of the world genetic resources would end, have not come true. Nobody questions the necessity of providing effective means and instruments for preserving biodiversity, which is concentrated first of all in the tropics, but there is no agreement as to the means to be employed. The basic principle of the Convention accepted by all contracting parties, according to which each State has the sovereign right to dispose of its own genetic resources, is by all means a step forward. Thus, the former doctrine that genetic resources, irrespective of their geographical location, belong to the common heritage of mankind, that is they may be freely exploited, vanished definitely. Characteristic of this doctrine was free-of-charge use and the so-called ‘biopiracy’.
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The Convention imposes certain rights and obligations both on the developing country and the industrialized country members. The countries, in the territory of which the genetic resources may be found, have to create conditions, e.g. legislation, to facilitate access to these genetic resources by other contracting parties. At the same time access to, and transfer of, advanced technology must be made easier for the developing countries. Whether access to genetic forms or to advanced technologies is concerned, mutual agreement and respect for the eventual intellectual property rights are important prerequisites. One of the basic principles of the system is that the countries disposing of genetic resources must be adequately compensated for the use thereof, that is they must have a share in the profit gained. The Convention contains a number of financial and administrative provisions serving the purposes of the Convention. These are instrumental in the in situ and ex situ conservation of genetic resources, in the maintenance of agricultural research centres keeping the plant genetic resources, in the establishment of a permanent Secretariat, etc. The Biodiversity Convention came in for a great deal of criticism. The main points of criticism were the following: (1) The Convention does not take due account of the interest of the private sector. The obligation to transfer and provide access to advanced technologies coerces, rather than encourage the transfer of technology from the private sector of industrialized countries to developing countries, leaving a free market system out of consideration. (2) The Governments of developing countries were given the power to restrict the whole system of intellectual property protection, to obtain and distribute privately owned technology possibly without due countervalue. The unjustified use of compulsory licenses may also be feared. (3) The products of biotechnology are regulated differently than other products. (4) The Convention is poorly drafted, its terms are not clear enough. (5) Most of the countries possessing genetic resources are not party to the Paris Convention,
thus the protection of intellectual property is not adequately ensured. As to the future of the Biodiversity Convention, the industrialized countries—both the USA and the European countries—are of the view that the Convention may only be viable if the following conditions are met: (1) The rights and obligations imposed by the Convention on the contracting parties may not be contrary to intellectual property rights ensured either by patents or by plant variety rights. (2) Access to genetic resources (mainly by developing countries) transfer of technology (on the part of developed countries) must be provided on the basis of mutual agreement in which the conditions of free competition prevail. (3) The contracting parties have to provide a similar level of protection of intellectual property rights in their respective countries, the enforcement of which may not be restricted. In spite of its many defects, the Convention is the first serious step to safeguard the biodiversity of the world. This is very important as far as the future of the Earth is concerned, not only because we want to preserve the varieties, but also because of the advantages they may offer to industry and research institutes whose researches bring about new products, new drugs and create new working places. Once the Convention complies with the patent and plant variety provisions, it could serve the purpose for which it was designed. The following articles provide detailed information on the preservation of biodiversity with the aid of patent systems: Sedjo (1992), Straus (1993), and Crespi and Straus (1996).
5. Patents for human cells and genes Since scientists can intervene in biological systems and the genes, the means of inheritance cannot only be determined but also manipulated, more and more ethical problems arise in connection with the patent protection of biotechnological inventions and there are more and more disputes between scientists, patent offices and the ‘green’ movements which have become political organizations. Lately the debate about the
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patentability of human cells and genes has become acute and it does not weaken on other fields of biotechnological inventions either (Byrne, 1997: Patents for Human Cells and Genes). The European patent system provides legal protection for inventions in all fields of technology, including biotechnology, if this invention is new, involves an inventive step and is susceptible to industrial application. The disclosure of the invention must enable a person skilled in the art to carry out the invention without undue difficulty. Since the end of the 1940s, patents have been granted routinely for inventions involving the use of microorganisms, first of all in the production of antibiotics or in the food fermentation industry. In the following decades patenting of these procedures has not caused any public concern, and opposition on ethical basis to biotechnological inventions has not been characteristic. Opposition to patents relating to biotechnological inventions, or rather certain types of such inventions, became more frequent at the beginning of the 1980s when the green movements, just because of the possible manipulation of materials transmitting life, have strengthened and have become a political force. The patenting of new plants and animals produced by means of genetic engineering has also evoked protests in the form of either demonstrations or opposition and revocation procedures within legal frameworks. This was, however, only a mild opening compared with the protests that emerged when patent applications involved biological material derived from humans, first of all human cells and genes, or the use thereof. In the opposition and revocation procedures before the European Patent Office, biotechnological patents were attacked on three legal grounds. The first was prohibition of patenting plant varieties under Article 53(b) of the EPC. It was partly on this ground that in the Plant Genetic System case the grant of a patent for herbicide-resistant plants could be opposed reasoning that these were actually plant varieties. This legal ground is, however, not applicable when products comprising or processes using human cells or genes are concerned. Article 53(a) excludes the grant of European patents in respect of inventions which are con-
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trary to morality or ‘ordre public’. Such attacks give the EPO much trouble. Neither morality nor ‘ordre public’ are precisely definable notions, and it is not the task of a patent office to determine their nature since they are not patent-law notions. Patents in themselves do not mean that a product or process is permitted since they are only tools of competition, and the refusal or revocation of a patent is not a ground for prohibiting a product or a process. It is, then, not in the field of patenting that the restriction of morally contestable processes or products is efficient. The European Patent Office is generally of this opinion, but careful considerations are frequently required, for example in the Harvard Mouse case where the sufferings of the animal had to be compared with the advantages caused to mankind. Much more relevant is the Relaxin case which concerns the patenting of genes and genomic fragments encoding for H2 relaxin. Here the gene is isolated from pregnant women, and the opponent is of the opinion that a human state (pregnancy) is immorally used in a technical process which is aimed at gaining profit. This violates human dignity and in such a case patent protection would mean a modern form of slavery. This argument is based on the principle that patents transmit the proprietary rights of physical objects, in the present case, genes in possession of a person. The object of the patent is, however, immaterial—it is the right to exploit a technical disclosure. Therefore the Opposition Division of the EPO decided that patents relating to DNA encoding for any human gene do not grant any right to the patentee to human beings or their parts. On this ground it did not admit the opposition and upheld the patent. The fact that under the practice of the European Patent Office human genes and their use are patentable does not mean that basic human rights may be violated. It is unlawful to isolate genes or cells from a human body without the consent of the person concerned. This derives from the basic human right that any person may freely dispose of his/her own body. This has nothing to do with the issue whether already isolated cells and genes and their use may be regarded as
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patentable subject matters. Irrespective of the patentability of human cells and genes, there still remain unsettled questions concerning the ownership of biological materials taken from humans by researchers. There is little hope that this issue will be removed from the agenda. The granting of patents for human cells and genes evoked in the public strong emotions that are not easily tempered by the niceties of legal reasoning. Several opponents are of the opinion that since genes occur in nature they may be discovered but not invented, and according to Article 52(2) of the EPC discoveries cannot be regarded as inventions. The redrafted directive on legal protection for biotechnological inventions takes the point of view that the human body and its elements in their natural state are not patentable, but an invention capable of industrial application which relates to an element isolated from the human body or otherwise produced by means of a technical process must be patentable, even if the structure of that element is identical to that of a natural element. Further details on the patentability of human cells and genes may be found in the lecture by Gugerell (1997), and in the book by Vogel and Grunwald (1994).
6. Ethical issues of patenting biotechnological inventions at the European Patent Office Disputes about ethical issues do not facilitate it for patent offices to decide on patenting biotechnological inventions. It is very difficult to keep the balance of the various interests, in particular between the preservation of the freedom of research, the maintenance of the competitiveness of biotechnological industry in the given country or on the given field and moral issues, first of all the question to what extent mankind may intervene in the biological order of the Earth and its living things, including human beings. The European Patent Office is faced with the same problems (Schatz, 1997a: Ethical issues of patenting biotechnological inventions of the European Patent Office).
In biotechnology, as in other fields of technology, patent protection is an indispensable means to promote industrial innovation and economic growth. In order that Europe should not lag behind the USA and Japan, the European patent system has to encourage biotechnological researches. Since 1980, about 15000 European patent applications have been filed for biotechnological inventions, 1000 thereof for transgenic plants, 300 for transgenic animals and more than 2000 DNA sequences isolated from the human body. The objects of biotechnology, including genetic engineering, serve the welfare of humanity. By means of plant breeding, the aesthetic and consumption value of foodstuffs originating from plants may be enhanced. The average yield may be increased under identical conditions. Resistance to parasites and to herbicides may be developed. As to animal husbandry, productivity and quality may be improved in the case of mammals, poultry and fishes alike. By gene transplantation animals (e.g. sheep) may be involved in drug production, while by means of microorganisms modified by human (or mammal) genes, human protein fragments (e.g. relaxin, tissue plasminogenic activator) may be produced in large quantities—and the possibilities are still before us. While the European Patent Office is clearly of the opinion that the subject matters of biotechnology are usually patentable if the requirements of novelty, inventive step and industrial application are met, it is to be admitted that the most ethical and moral issues may arise in this field. Although the European Patent Office applies the general criteria of patentability to biotechnology-related inventions, plenty of special problems arise, which rarely characterize the other fields of technology, and there are also more grounds for refusal. The first problem is the distinction between discoveries and inventions. Under Article 52(2) of the EPC, discoveries cannot be regarded as inventions. Mere sequencing of a genome belongs to the category of discoveries, thus, it is not patentable. The situation is different where a DNA sequence or a gene encoding for a protein is isolated from nature by technical means and is
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made available for the purposes of industrial production. Thus, it amounts to a novel technical teaching that is industrially applicable. The second problem is the issue of therapeutic methods. Article 52(4) excludes from patent protection methods for treatment of the human or animal body and therapeutic and diagnostic methods practised on the human or animal body. This exclusion serves the purpose that the treatment of the human or animal body would be free of any restriction by patent rights. The third problem stems from Article 53(b) of the EPC, according to which plant or animal varieties or essentially biological processes for the production of plants or animals shall not be granted patent protection. However, this provision does not apply to microbiological processes or the products thereof. This exception goes back to the Strasbourg Convention of 1968, and is aimed at excluding non-reproducible, traditional breeding processes (crossing, selection) from patent protection. Genetic engineering has already superseded this argument because its processes are reproducible and not ‘essentially biological’. This also holds true to the production of plant varieties and animal breeds. As regards the exclusion of plant and animal varieties from patent protection, the EPO faces serious legal problems. If this exclusion was initially explained by the need that the end products of the unpatentable, ‘essentially biological’ processes could not be patented either, the explanation is already obsolete since, as was mentioned above, technical processes are also involved in the production of plant varieties and animal breeds. At the time of creating either the Strasbourg Convention or Article 53(b) of the EPC, one could not even imagine the possibilities which are now offered by genetic engineering. This is why heavy controversies had developed even within the EPO until the final decisions were made (Anonymous, 1996). The fourth problem arises in connection with inventions whose publication or exploitation would be contrary to ‘ordre public’ or morality (Article 53(a) EPC). In the 25-year history of the EPO, during which about 400000 patents have been granted, there was no precedent for a refusal
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or revocation on this ground, and the situation is almost the same at the national offices and courts. This may be due to the following reasons. Here, it is not the patentability of the subject matter of the invention, but its exploitation, that is at stake. An invention should not be grasped in a manner that it is not patentable because there is some use which is not permissible. It is patentable if at least one use is allowable. Article 53(a) EPC applies almost exclusively in cases where an invention cannot be patented due to its inherent nature, e.g. a letter bomb. However, patent protection is not sought for such inventions, they are kept secret. The notions of ‘ordre public’ and morality are not precisely defined in Article 53(a) EPC. That which was not specified by the legislator, cannot be specified by the executive body either. ‘Ordre public’ and morality are not notions of the patent law. Their meaning is determined by other legislation or by the moral judgement in the given country. Those who are for ‘no patents on life’ or who oppose the application or patent on other ethical considerations must be aware that it is not the technological potential but its exploitation that is covered by such ethical considerations. A patent per se does not mean that the claimed invention will actually be used. According to the concept of ‘ordre public’ in terms of patent law, the exploitation of an invention is only contrary to ‘ordre public’ if it is prohibited by law. The limits to morality in patent law context are, however, set by ethical norms which are established in the individual professional fields. In 1995 the Technical Board of Appeal of the EPO stated in a decision, that there did not exist any uniform European concept with respect to ‘ordre public’ or morality. Therefore the EPO has to undertake to define the content of these notions and to use them. Thus, the EPO combines to a certain extent the role of the legislator and of the judge. To put it briefly, the notion of ‘ordre public’ includes the safeguarding of public security, the protection of the physical integration of individuals and also encompasses the protection of the environment. As to morality, for the purposes of the EPO, European culture is decisive.
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Inventions whose exploitation does not comply with the presently accepted standards of attitude concerning European culture must be excluded from patent protection since they are contrary to morality. Although the Technical Board of Appeal outlined a certain concept in respect of ‘ordre public’ and morality, it is not probable that the examiners of the EPO will often undertake to decide on such issues since, as was mentioned earlier, it rarely occurs that the subject matter of an invention may be excluded from patent protection with absolute certainty. Decisions may perhaps be expected when the exploitation of the invention would seriously jeopardize the environment. However, no other norm may be used to assess the technological risks of biotechnological inventions than in the case of inventions in other fields of technology. In connection with the said fourth problem certain conclusions may be drawn which may be summarized as follows: (1) The claim ‘no patents on life’ cannot possibly be satisfied by Article 53(a) EPC. (2) Article 53(a) EPC should not be construed as providing a legal basis for the control and prevention of technological hazards. (3) To the extent that the claim ‘no patents on life’ implies that inventions, the exploitation of which would not be contrary to ‘ordre public’ and morality, should nevertheless be excluded from patentability, it is founded on a misconception of patent law, of its function in society and of the nature of the rights conferred by a patent. (4) Excepting the subject matter of biotechnological inventions, such as human genes or transgenic plants or animals or technical processes for their production, from patentability in Europe would not impede their production, trade or use in Europe but would rather destroy the competitiveness of European industry in the field of biotechnology. (5) Those holding the view that the making, the trading and the use of transgenic plants or animals or of medicaments derived from human genes is not morally permissible must campaign for their prohibition, not for their exclusion from patentability.
In connection with these topics, further information may be obtained from certain pertinent publications (Schatz, 1996, 1997b; Crespi, 1997; Aharonian, 1997). The symposium ended with two short papers in which practising patent attorneys called the attention of biotechnological researchers to pitfalls that may arise in the course of the patenting procedure (Petho¨ and Molna´r, 1997; Szentpe´teri, 1997). Thus, in addition to general theoretical and ethical issues, the biotechnological researchers could obtain a picture of the practical patenting problems as well. 7. Recombinant erithropoietin: lessons from a worldwide patent litigation In the first case a worldwide patent litigation is concerned, with particular emphasis on the points which may be interesting for biotechnological researchers. The parties ‘A’ and ‘B’ are involved in a lawsuit relating to recombinant erythropoietin. Erythropoietin is an important blood protein stimulating the production of red blood cells, thus, it can effectively be used for the treatment of anaemia. The lecture analysed the stages of the long-lasting litigation in the USA, Europe and Asia. The main reasons of litigation in this case are characteristic of the field of biotechnological inventions: (1) use of patented biotechnological materials; (2) sufficiency of disclosure; (3) importance of depositing microorganisms; (4) appropriate indication of inventive step. These are the issues of which applicants of biotechnological inventions have to take care first of all in order not to be exposed to litigation, and on which opponents may centre their attacks most easily. 8. Legal problems and traps of patenting inventions arising from diversity of different patent systems and legislation In the second case those problems are addressed that may arise from the diversity of legislation and legal practice of different countries.
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Table 1 Nonpatentable and patentable inventions Nonpatentable inventions
Patentable inventions
(a) Not novel, not inventive, not completely disclosed, not feasible for industrial application (b) Discovery (straightforward expansion of knowledge; reference to its occurrence)
(a) Novel, inventive, completely disclosed, feasible for industrial application (b) Discoveries which result in an enabling technical teaching, e.g. plasmids, viruses, microorganisms, products of nature; e.g. insulin or morphine (c) Methods for the medical treatment of humans or animals, (c) Working means for the medical treatment of man or e.g. somatic gene therapy; conventional procedures (‘analogous animals, e.g. pharmaceuticals for somatic gene therapy; methods’) for preparing known compounds. In some countries antisense oligonucleotides; DNA sequences with specified these are also patentable functions; antibodies; vaccines (d) Methods for the treatment of humans or animals by surgery (d) Diagnostic substances (working means) for carrying out or therapy, and diagnostic methods practised on the human or diagnostic methods on man or animals; ESTs, e.g. for animal body. In some countries these are also patentable identification genes, or expression studies of different tissues; inventive methods of preparing known or new compounds (e) Plant varieties. In some countries, as in Hungary, these are (e) Genetically modified plants, plant cells, seeds patentable under a special chapter of the patent law (f) Animal varieties. In some countries, as in Hungary, these are (f) Animals, e.g. molluscs, oysters, genetically modified patentable under a special chapter of the patent law mammals (mice, etc.); mammalian, animal cells, hybridoma cells (g) Essentially biological (nontechnical) processes for the (g) Technical, e.g. genetic engineering, methods (i.e. production of plants or animals processes) of creating modified plants and animals and varieties; cloning procedures (h) Inventions contrary to ‘public order’ or morality when (h) Inventions not contrary to ‘public order’ or morality published or exploited when published or exploited
Once an invention is made, the patenting procedures start at different times in the different countries. National and regional patent laws and legal practices are slightly, or sometimes considerably different. Consequently, the grant of a patent in one country cannot serve as a guarantee that a patent will be granted in the same extent in another country—there may occur limitations, even refusals. Once a patent has been granted, competitors may have, everywhere, an opportunity to invalidate the patent. However, the manner of invalidation varies from country to country — it may take the form of either opposition, or revocation or the combination thereof. Accordingly, biotechnological researchers claiming patent protection for their inventions, as well as their patent attorneys must be very careful to avoid any mistake that may lead to invalidation. In addition to the requirements of disclosure outlined in the previous lecture, the different time
limits in the different patent systems, the date of publication of relevant scientific articles, etc. must be taken into account.
9. Conclusion The patenting of biotechnological inventions is practically in harmony with the general requirements of patent protection. However, there are two reasons for which this field has been the focus of interest for decades. The first is that in the case of biotechnological patents the living material itself may be the subject matter of the patent. The second is the resultant ethical problem: to what extent science may intervene in life and in what respect patent systems may control that process. It was due to the special character of biotechnological patents that the Directive on legal protection for biotechnological inventions was drafted in the European Communities. The fact that this
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directive has a past of 7 years shows that many people deem it superfluous, since patent laws may well be adapted to biotechnological patents; and those who do not regard it as superfluous can hardly agree upon the contents. However, it can never be left out of consideration that inventions brought about in the field of biotechnology, like inventions in any other fields, are entitled to some legal protection. The controversy is only over the ‘hows’. As far as biotechnological inventions are concerned, the legal practice of the various countries is similar but not identical. In Table 1 we attempt, after Vossius (1997), to summarize patentable and nonpatentable inventions, underlining some exceptions in the field of medical treatment, plant and animal varieties. The volume of the review is not sufficient to give a comprehensive picture of the whole range of biotechnological patents and it does not aim at it either. Some shivers of a mirror are presented from which the whole mirror cannot be put together. Therefore, the present review addresses those topics which mainly occupy biotechnological experts and patent attorneys alike. Ethical issues of patenting biotechnological inventions are in the foreground and constitute the subject of debates with green movements. It will be long before perfect peace can be made among the representatives of research, industry and green movements. The basic principles of the patent system would be violated by decisions which would deprive an invention of patent protection merely on the ground that the results attainable by the invention may possibly be harmful to mankind. Patent rights must be open to all inventions which may bring about new developments, even if their advantages or disadvantages cannot be judged in the given moment. The patent system may be instrumental in safeguarding biodiversity; however, the relevant Convention signed at Rio de Janeiro could not find an appropriate solution to all questions. In spite of this the Convention may be regarded as a milestone in this field. The review gives some pieces of practical advice to biotechnological researchers on how to make their patent applications incontestable or on what grounds can they attack other persons’ patent
applications and patents which were not formulated with due care. It describes the requirements of the deposit of microorganisms which is necessary for reproducibility and draws attention to the importance of deadlines relating to communications, applications and publications, non-observance of which entails the loss of patentability of the invention. References Aharonian, G., 1997. Biotechnology patents, the news from Minneapolis. Biotechnol. Law Rep. 16, 9 – 16. Anonymous, 1996. Opinion of the enlarged board of appeal dated 27 November 1995. Off. J. EPO 4, 169 – 180. Byrne, N., 1997. Patents for human cells and genes. In: Book of Abstracts, 8th European Congress on Biotechnology, Hungarian Biochemical Society, Budapest, Abstract MO168, p. 25. Crespi, R.S., 1997. Biotechnology patents and morality. Trends Biotechnol. 15, 123 – 129. Crespi, R.S., Straus, J., 1996. Intellectual Property Technology Transfer and Genetic Resources. An OECD Survey of Current Practises and Policies. OECD, Paris. Gugerell, C., 1997. Patent and other legal issues concerning genomics; the EPO approach. IBC Conference, 25 September 1997. Ilardi, A., 1997. The deposit of micro-organisms under the Budapest Treaty. In Book of Abstracts, 8th European Congress of Biotechnology, Hungarian Biochemical Society, Budapest, Abstract MO-166, p. 24. Jaenichen, H.-R., 1996. Rules that regulate deposits under the European Patent Convention (EPC) amended effective October 1, 1996. Biotechnol. Law Rep. 15 (6), 883 – 890. Moufang, R., 1995. Deposit of Biological Material for Patent Purposes. Max Planck Institute, Germany. ´ ., Molna´r, I., 1997. Recombinant erythropoietin— lesPetho¨, A sons from a worldwide patent litigation. In: Book of Abstracts, 8th European Congress on Biotechnology, Hungarian Biochemical Society, Budapest, Abstract MO-169, p. 25. Schatz, U., 1996. Patents, ‘Ordre public’ and Morality, Speech in Gent, 1996. Schatz, U., 1997. Ethical issues of patenting biotechnological inventions at the European Patent Office. In: Book of Abstracts, 8th European Congress on Biotechnology, Hungarian Biochemical Society, Budapest, Abstract MO-165, p. 24. Schatz, U., 1997. Patentability of genetic engineering inventions in European Patent Office practice. Talk in Munich Law Society, 25 March 1997. Sedjo, 1992. Property rights, genetic resources and biological change. J. Law Econom. 1, 199. Straus, J., 1993. The Rio Biodiversity Convention and intellectual property. IIC 24, 602.
E. Szarka / Journal of Biotechnology 67 (1999) 1–11 Straus, J., 1997. Intellectual Property in Support of Biodiversity. Book of Abstracts, 8th European Congress on Biotechnology, Hungarian Biochemical Society, Budapest, Abstract MO-167, p. 24. Szarka, E., Posteiner-Toldi, M., 1996. Biological inventions, plant varieties and animal breeds in the patent act of 1995. Proc. Hung. Group AIPPI 23, 29–41. Szarka E., Petz-Stifter, M., 1997. Patenting possibilities of biological, especially biotechnological inventions in Hungary. In: Book of Abstracts, 8th European Congress on Biotechnology, Hungarian Biochemical Society, Budapest, Abstract MO-164, p. 23.
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´ ., 1997. Legal problems and traps of patenting Szentpe´teri, A inventions arising from diversity of different patent systems and legislation. In: Book of Abstracts, 8th European Congress on Biotechnology, Hungarian Biochemical Society, Budapest, Abstract MO-170, p. 25. Vogel, F., Grunwald, R. (Eds.), 1994. Patenting of Genes and Living Organisms. Springer, Berlin. Vossius, V., 1997. Patenting inventions in the field of biology and chemistry: German and European case law. Naturwissenschaften 84, 433. Weitz, 1993. The biological deposit requirement: a means of assuring adequate disclosure. High Technol. L. J. 8,275.
Review article
Patenting in biotechnology: a review of the 20th Symposium of ECB81 Erno¨ Szarka * Hungarian Patent Office, Garibaldi u. 2., H-1370 Budapest, Hungary Received 23 December 1997; received in revised form 6 April 1998; accepted 9 April 1998
Abstract The patenting of biotechnological inventions is practically in harmony with the general requirements of patent protection. It stands still in the foreground of interests since this is the only technical field where the living material itself may be the subject matter of patents. In consequence ethical problems have arisen first of all in the patenting of human cells and genes in which there is no agreement between R&D firms, patent offices and green movements. This has called for the elaboration of special Directives. On the other hand, patent systems are instrumental in safeguarding biodiversity. This review gives a picture of the patenting situation in biotechnology in the European Patent Office and in Hungary, the host country of the Congress. It also gives practical advice to biotechnological researchers on how to draft the applications and to observe the time limits, as well as on the necessity and possibilities of the deposit of microorganisms. © 1999 Elsevier Science B.V. All rights reserved. Keywords: Patentability in biotechnology; Ethics; Biodiversity; Human genes; Deposit of microorganisms
1. Introduction When the Organizing Committee of the 8th European Congress on Biotechnology 1997 began its activity and defined the subject matter of the * Corresponding author. Fax: +36 1 3311383. 1 Based on the symposium, ‘Patenting in biotechnology’, held at the 8th European Congress on Biotechnology (ECB8) in Budapest, Hungary, August 1997.
symposia to be held, it felt it necessary to give an overview of patenting possibilities in biotechnology to those skilled in that art. Therefore the Committee decided to draw up a plan for a symposium dealing with this topic. In selecting the themes, the following considerations had to be taken into account: (1) The symposium should advise first of all researchers in biotechnology on the possibilities of
0168-1656/99/$ - see front matter © 1999 Elsevier Science B.V. All rights reserved. PII S0168-1656(98)00137-0
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protecting their results of research, as well as on special problems of patenting in biotechnology in the host country, in Europe and all over the world. To patent experts it should provide an opportunity to learn how researchers react to the issues arisen during the symposium, and biotechnological experts should be acquainted with the practical issues and pitfalls of the patenting possibilities. (2) Furthermore, ethical issues that may arise in connection with patenting biotechnological inventions should also be addressed. (3) Biotechnological experts should get an overview of how the intellectual property protection system, first of all the patent system, may serve the maintenance of biodiversity in the world. The speakers were asked to base their lectures on international agreements and rules of law which govern, in particular in Europe, the patenting of the results of biotechnological research. These are the following: European Patent Convention; Budapest Treaty on the recognition of the deposit of microorganisms for the purposes of patent procedure; Convention on biological diversity; Agreement on trade-related aspects of intellectual property rights (TRIPS); Directive on legal protection for biotechnological inventions (not yet in force)2; International Convention for the protection of new varieties of plants (UPOV).
2. Patenting possibilities of biological, especially biotechnological inventions in Hungary The legal practice of the host country, Hungary, could be a good example of a patent system 2 As far as the said Directive is concerned, a political agreement on a Common Position—i.e. the first step to final adoption — concerning the proposed Directive on the legal protection for biotechnological inventions has been reached on 27 November 1997. The Common Position was formally adopted by the Council on 26 February 1998. After, it will be forwarded to the European Parliament for its second reading under the co-decision procedure. It is expected that the second reading would take place in June 1998. Therefore, the final adoption of the Directive would be finalised at the latest in autumn.
conforming to the European laws and regulations, including the possibilities of the protection of biotechnological inventions (Szarka and PetzStifter, 1997). The Hungarian patent system was 100 years old in 1996. The Hungarian Patent Law has been continuously developed according to the Paris Convention for the Protection of Industrial Property. The latest Patent Law (no. XXXIII, 1995) entered into force on 1 January 1996. In 1991, Hungary and the European Union concluded a Provisional Association Agreement according to which Hungary undertook to ask for her accession to the European Patent Organisation. The relevant request was submitted at the end of 1996. Due to Hungary’s resolute intention of accession, the new Hungarian Patent Law was created in such a way as to be in full conformity with the European Patent Convention. The most important change was the appearance of product protection with respect to pharmaceuticals, foodstuffs and chemically produced products. The same relates to products produced biotechnologically and to microorganisms per se. Applications relating to biotechnological inventions are examined in line with the practice of the European Patent Office, not only because the relevant laws comply with each other, but also because most examiners of the Hungarian Patent Office had an opportunity to study personally the methods of the European Patent Office. Therefore it is highly probable that the examination of a biotechnological application will lead to the same result in both Offices, except for certain differences of opinion of the individual examiners. Protectability of new plant varieties and animal breeds is a peculiarity of the Hungarian patent system. Under the European Patent Convention these are excluded from patent protection, therefore plant breeders may usually enforce their rights within the framework of a special plant variety protection system. These rights may be obtained in conformity with the provisions of the UPOV Convention. In Hungary the protection of plant varieties is regulated in a special chapter of the Patent Law. This chapter fully conforms to the UPOV Convention.
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No international agreement provides for the protection of animal breeds, each country tries to afford some form of protection on its own. Hungary also grants patent protection for animal breeds, which is regulated in another special chapter of the Patent Law. The criteria of patentability of biotechnological inventions, plant varieties and animal breeds may be distinguished as follows: inventions (including those relating to biotechnology): novelty, inventive activity and industrial application; plant varieties: distinctness, uniformity, stability, novelty, denomination suitable for registration; animal breeds: distinctness, novelty, reproducibility; denomination suitable for registration. The article of Szarka and Posteiner-Toldi (1996) also gives an overview of the protectability of biotechnological inventions.
3. The deposit of micro-organisms under the Budapest Treaty Another set of topics encompasses the necessity and possibilities of the deposit of microorganisms (Ilardi, 1997). Disclosure of an invention is a necessary requirement which enables an invention to be eligible for patent protection. Where an invention relates to the application of a microorganism which is not available to the public, the disclosure of the invention is insufficient. Some decades ago, this problem was solved by prescribing the deposit of microorganisms not available to the public in a culture collection. This meant that the deposit had to be repeated in each country concerned, and only some countries recognized deposit in the culture collection of another country. The Budapest Treaty was brought about on 28 April 1977 in order to solve this issue. Forty States were party to this Treaty in the middle of 1997. Under the Treaty, a deposit made in a duly accredited culture collection of any of the contracting States is valid in each contracting State. The Treaty provides for the accreditation conditions of culture collections, technical requirements of deposits, the obligatory period of storage and the furnishing of samples of the deposited mi-
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croorganisms to third parties. The purpose of deposit is to make the microorganism concerned available to the public, however, without any opportunity to use it unlawfully. The World Intellectual Property Organization keeps a record of the accredited depositary authorities, which themselves define the range of microorganisms which they accept for deposit and establish the fees for deposit and for storage. Further details of the legal and technical issues of deposits may be read in Weitz (1993), Moufang (1995), and Jaenichen (1996). 4. Intellectual property in support of biodiversity It is the responsibility of scientists to hand down the Earth to the descendants in the same biological condition as it was inherited from their parents. The patent systems have to support this idea (Straus, 1997). It is in the interest of mankind to safeguard the biodiversity of the Earth. At the same time it is also important for it to exploit in a sustainable manner and to its own benefit the natural resources, including genetic resources of the world. The ensuing technological progress offers considerable advantages to humanity. In order to meet this double objective, the Convention on Biological Diversity was signed on 5 June 1992, at Rio de Janeiro by the representatives of 150 countries. However, the hopes that by this the controversy on the access, exploitation and preservation of the world genetic resources would end, have not come true. Nobody questions the necessity of providing effective means and instruments for preserving biodiversity, which is concentrated first of all in the tropics, but there is no agreement as to the means to be employed. The basic principle of the Convention accepted by all contracting parties, according to which each State has the sovereign right to dispose of its own genetic resources, is by all means a step forward. Thus, the former doctrine that genetic resources, irrespective of their geographical location, belong to the common heritage of mankind, that is they may be freely exploited, vanished definitely. Characteristic of this doctrine was free-of-charge use and the so-called ‘biopiracy’.
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The Convention imposes certain rights and obligations both on the developing country and the industrialized country members. The countries, in the territory of which the genetic resources may be found, have to create conditions, e.g. legislation, to facilitate access to these genetic resources by other contracting parties. At the same time access to, and transfer of, advanced technology must be made easier for the developing countries. Whether access to genetic forms or to advanced technologies is concerned, mutual agreement and respect for the eventual intellectual property rights are important prerequisites. One of the basic principles of the system is that the countries disposing of genetic resources must be adequately compensated for the use thereof, that is they must have a share in the profit gained. The Convention contains a number of financial and administrative provisions serving the purposes of the Convention. These are instrumental in the in situ and ex situ conservation of genetic resources, in the maintenance of agricultural research centres keeping the plant genetic resources, in the establishment of a permanent Secretariat, etc. The Biodiversity Convention came in for a great deal of criticism. The main points of criticism were the following: (1) The Convention does not take due account of the interest of the private sector. The obligation to transfer and provide access to advanced technologies coerces, rather than encourage the transfer of technology from the private sector of industrialized countries to developing countries, leaving a free market system out of consideration. (2) The Governments of developing countries were given the power to restrict the whole system of intellectual property protection, to obtain and distribute privately owned technology possibly without due countervalue. The unjustified use of compulsory licenses may also be feared. (3) The products of biotechnology are regulated differently than other products. (4) The Convention is poorly drafted, its terms are not clear enough. (5) Most of the countries possessing genetic resources are not party to the Paris Convention,
thus the protection of intellectual property is not adequately ensured. As to the future of the Biodiversity Convention, the industrialized countries—both the USA and the European countries—are of the view that the Convention may only be viable if the following conditions are met: (1) The rights and obligations imposed by the Convention on the contracting parties may not be contrary to intellectual property rights ensured either by patents or by plant variety rights. (2) Access to genetic resources (mainly by developing countries) transfer of technology (on the part of developed countries) must be provided on the basis of mutual agreement in which the conditions of free competition prevail. (3) The contracting parties have to provide a similar level of protection of intellectual property rights in their respective countries, the enforcement of which may not be restricted. In spite of its many defects, the Convention is the first serious step to safeguard the biodiversity of the world. This is very important as far as the future of the Earth is concerned, not only because we want to preserve the varieties, but also because of the advantages they may offer to industry and research institutes whose researches bring about new products, new drugs and create new working places. Once the Convention complies with the patent and plant variety provisions, it could serve the purpose for which it was designed. The following articles provide detailed information on the preservation of biodiversity with the aid of patent systems: Sedjo (1992), Straus (1993), and Crespi and Straus (1996).
5. Patents for human cells and genes Since scientists can intervene in biological systems and the genes, the means of inheritance cannot only be determined but also manipulated, more and more ethical problems arise in connection with the patent protection of biotechnological inventions and there are more and more disputes between scientists, patent offices and the ‘green’ movements which have become political organizations. Lately the debate about the
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patentability of human cells and genes has become acute and it does not weaken on other fields of biotechnological inventions either (Byrne, 1997: Patents for Human Cells and Genes). The European patent system provides legal protection for inventions in all fields of technology, including biotechnology, if this invention is new, involves an inventive step and is susceptible to industrial application. The disclosure of the invention must enable a person skilled in the art to carry out the invention without undue difficulty. Since the end of the 1940s, patents have been granted routinely for inventions involving the use of microorganisms, first of all in the production of antibiotics or in the food fermentation industry. In the following decades patenting of these procedures has not caused any public concern, and opposition on ethical basis to biotechnological inventions has not been characteristic. Opposition to patents relating to biotechnological inventions, or rather certain types of such inventions, became more frequent at the beginning of the 1980s when the green movements, just because of the possible manipulation of materials transmitting life, have strengthened and have become a political force. The patenting of new plants and animals produced by means of genetic engineering has also evoked protests in the form of either demonstrations or opposition and revocation procedures within legal frameworks. This was, however, only a mild opening compared with the protests that emerged when patent applications involved biological material derived from humans, first of all human cells and genes, or the use thereof. In the opposition and revocation procedures before the European Patent Office, biotechnological patents were attacked on three legal grounds. The first was prohibition of patenting plant varieties under Article 53(b) of the EPC. It was partly on this ground that in the Plant Genetic System case the grant of a patent for herbicide-resistant plants could be opposed reasoning that these were actually plant varieties. This legal ground is, however, not applicable when products comprising or processes using human cells or genes are concerned. Article 53(a) excludes the grant of European patents in respect of inventions which are con-
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trary to morality or ‘ordre public’. Such attacks give the EPO much trouble. Neither morality nor ‘ordre public’ are precisely definable notions, and it is not the task of a patent office to determine their nature since they are not patent-law notions. Patents in themselves do not mean that a product or process is permitted since they are only tools of competition, and the refusal or revocation of a patent is not a ground for prohibiting a product or a process. It is, then, not in the field of patenting that the restriction of morally contestable processes or products is efficient. The European Patent Office is generally of this opinion, but careful considerations are frequently required, for example in the Harvard Mouse case where the sufferings of the animal had to be compared with the advantages caused to mankind. Much more relevant is the Relaxin case which concerns the patenting of genes and genomic fragments encoding for H2 relaxin. Here the gene is isolated from pregnant women, and the opponent is of the opinion that a human state (pregnancy) is immorally used in a technical process which is aimed at gaining profit. This violates human dignity and in such a case patent protection would mean a modern form of slavery. This argument is based on the principle that patents transmit the proprietary rights of physical objects, in the present case, genes in possession of a person. The object of the patent is, however, immaterial—it is the right to exploit a technical disclosure. Therefore the Opposition Division of the EPO decided that patents relating to DNA encoding for any human gene do not grant any right to the patentee to human beings or their parts. On this ground it did not admit the opposition and upheld the patent. The fact that under the practice of the European Patent Office human genes and their use are patentable does not mean that basic human rights may be violated. It is unlawful to isolate genes or cells from a human body without the consent of the person concerned. This derives from the basic human right that any person may freely dispose of his/her own body. This has nothing to do with the issue whether already isolated cells and genes and their use may be regarded as
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patentable subject matters. Irrespective of the patentability of human cells and genes, there still remain unsettled questions concerning the ownership of biological materials taken from humans by researchers. There is little hope that this issue will be removed from the agenda. The granting of patents for human cells and genes evoked in the public strong emotions that are not easily tempered by the niceties of legal reasoning. Several opponents are of the opinion that since genes occur in nature they may be discovered but not invented, and according to Article 52(2) of the EPC discoveries cannot be regarded as inventions. The redrafted directive on legal protection for biotechnological inventions takes the point of view that the human body and its elements in their natural state are not patentable, but an invention capable of industrial application which relates to an element isolated from the human body or otherwise produced by means of a technical process must be patentable, even if the structure of that element is identical to that of a natural element. Further details on the patentability of human cells and genes may be found in the lecture by Gugerell (1997), and in the book by Vogel and Grunwald (1994).
6. Ethical issues of patenting biotechnological inventions at the European Patent Office Disputes about ethical issues do not facilitate it for patent offices to decide on patenting biotechnological inventions. It is very difficult to keep the balance of the various interests, in particular between the preservation of the freedom of research, the maintenance of the competitiveness of biotechnological industry in the given country or on the given field and moral issues, first of all the question to what extent mankind may intervene in the biological order of the Earth and its living things, including human beings. The European Patent Office is faced with the same problems (Schatz, 1997a: Ethical issues of patenting biotechnological inventions of the European Patent Office).
In biotechnology, as in other fields of technology, patent protection is an indispensable means to promote industrial innovation and economic growth. In order that Europe should not lag behind the USA and Japan, the European patent system has to encourage biotechnological researches. Since 1980, about 15000 European patent applications have been filed for biotechnological inventions, 1000 thereof for transgenic plants, 300 for transgenic animals and more than 2000 DNA sequences isolated from the human body. The objects of biotechnology, including genetic engineering, serve the welfare of humanity. By means of plant breeding, the aesthetic and consumption value of foodstuffs originating from plants may be enhanced. The average yield may be increased under identical conditions. Resistance to parasites and to herbicides may be developed. As to animal husbandry, productivity and quality may be improved in the case of mammals, poultry and fishes alike. By gene transplantation animals (e.g. sheep) may be involved in drug production, while by means of microorganisms modified by human (or mammal) genes, human protein fragments (e.g. relaxin, tissue plasminogenic activator) may be produced in large quantities—and the possibilities are still before us. While the European Patent Office is clearly of the opinion that the subject matters of biotechnology are usually patentable if the requirements of novelty, inventive step and industrial application are met, it is to be admitted that the most ethical and moral issues may arise in this field. Although the European Patent Office applies the general criteria of patentability to biotechnology-related inventions, plenty of special problems arise, which rarely characterize the other fields of technology, and there are also more grounds for refusal. The first problem is the distinction between discoveries and inventions. Under Article 52(2) of the EPC, discoveries cannot be regarded as inventions. Mere sequencing of a genome belongs to the category of discoveries, thus, it is not patentable. The situation is different where a DNA sequence or a gene encoding for a protein is isolated from nature by technical means and is
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made available for the purposes of industrial production. Thus, it amounts to a novel technical teaching that is industrially applicable. The second problem is the issue of therapeutic methods. Article 52(4) excludes from patent protection methods for treatment of the human or animal body and therapeutic and diagnostic methods practised on the human or animal body. This exclusion serves the purpose that the treatment of the human or animal body would be free of any restriction by patent rights. The third problem stems from Article 53(b) of the EPC, according to which plant or animal varieties or essentially biological processes for the production of plants or animals shall not be granted patent protection. However, this provision does not apply to microbiological processes or the products thereof. This exception goes back to the Strasbourg Convention of 1968, and is aimed at excluding non-reproducible, traditional breeding processes (crossing, selection) from patent protection. Genetic engineering has already superseded this argument because its processes are reproducible and not ‘essentially biological’. This also holds true to the production of plant varieties and animal breeds. As regards the exclusion of plant and animal varieties from patent protection, the EPO faces serious legal problems. If this exclusion was initially explained by the need that the end products of the unpatentable, ‘essentially biological’ processes could not be patented either, the explanation is already obsolete since, as was mentioned above, technical processes are also involved in the production of plant varieties and animal breeds. At the time of creating either the Strasbourg Convention or Article 53(b) of the EPC, one could not even imagine the possibilities which are now offered by genetic engineering. This is why heavy controversies had developed even within the EPO until the final decisions were made (Anonymous, 1996). The fourth problem arises in connection with inventions whose publication or exploitation would be contrary to ‘ordre public’ or morality (Article 53(a) EPC). In the 25-year history of the EPO, during which about 400000 patents have been granted, there was no precedent for a refusal
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or revocation on this ground, and the situation is almost the same at the national offices and courts. This may be due to the following reasons. Here, it is not the patentability of the subject matter of the invention, but its exploitation, that is at stake. An invention should not be grasped in a manner that it is not patentable because there is some use which is not permissible. It is patentable if at least one use is allowable. Article 53(a) EPC applies almost exclusively in cases where an invention cannot be patented due to its inherent nature, e.g. a letter bomb. However, patent protection is not sought for such inventions, they are kept secret. The notions of ‘ordre public’ and morality are not precisely defined in Article 53(a) EPC. That which was not specified by the legislator, cannot be specified by the executive body either. ‘Ordre public’ and morality are not notions of the patent law. Their meaning is determined by other legislation or by the moral judgement in the given country. Those who are for ‘no patents on life’ or who oppose the application or patent on other ethical considerations must be aware that it is not the technological potential but its exploitation that is covered by such ethical considerations. A patent per se does not mean that the claimed invention will actually be used. According to the concept of ‘ordre public’ in terms of patent law, the exploitation of an invention is only contrary to ‘ordre public’ if it is prohibited by law. The limits to morality in patent law context are, however, set by ethical norms which are established in the individual professional fields. In 1995 the Technical Board of Appeal of the EPO stated in a decision, that there did not exist any uniform European concept with respect to ‘ordre public’ or morality. Therefore the EPO has to undertake to define the content of these notions and to use them. Thus, the EPO combines to a certain extent the role of the legislator and of the judge. To put it briefly, the notion of ‘ordre public’ includes the safeguarding of public security, the protection of the physical integration of individuals and also encompasses the protection of the environment. As to morality, for the purposes of the EPO, European culture is decisive.
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Inventions whose exploitation does not comply with the presently accepted standards of attitude concerning European culture must be excluded from patent protection since they are contrary to morality. Although the Technical Board of Appeal outlined a certain concept in respect of ‘ordre public’ and morality, it is not probable that the examiners of the EPO will often undertake to decide on such issues since, as was mentioned earlier, it rarely occurs that the subject matter of an invention may be excluded from patent protection with absolute certainty. Decisions may perhaps be expected when the exploitation of the invention would seriously jeopardize the environment. However, no other norm may be used to assess the technological risks of biotechnological inventions than in the case of inventions in other fields of technology. In connection with the said fourth problem certain conclusions may be drawn which may be summarized as follows: (1) The claim ‘no patents on life’ cannot possibly be satisfied by Article 53(a) EPC. (2) Article 53(a) EPC should not be construed as providing a legal basis for the control and prevention of technological hazards. (3) To the extent that the claim ‘no patents on life’ implies that inventions, the exploitation of which would not be contrary to ‘ordre public’ and morality, should nevertheless be excluded from patentability, it is founded on a misconception of patent law, of its function in society and of the nature of the rights conferred by a patent. (4) Excepting the subject matter of biotechnological inventions, such as human genes or transgenic plants or animals or technical processes for their production, from patentability in Europe would not impede their production, trade or use in Europe but would rather destroy the competitiveness of European industry in the field of biotechnology. (5) Those holding the view that the making, the trading and the use of transgenic plants or animals or of medicaments derived from human genes is not morally permissible must campaign for their prohibition, not for their exclusion from patentability.
In connection with these topics, further information may be obtained from certain pertinent publications (Schatz, 1996, 1997b; Crespi, 1997; Aharonian, 1997). The symposium ended with two short papers in which practising patent attorneys called the attention of biotechnological researchers to pitfalls that may arise in the course of the patenting procedure (Petho¨ and Molna´r, 1997; Szentpe´teri, 1997). Thus, in addition to general theoretical and ethical issues, the biotechnological researchers could obtain a picture of the practical patenting problems as well. 7. Recombinant erithropoietin: lessons from a worldwide patent litigation In the first case a worldwide patent litigation is concerned, with particular emphasis on the points which may be interesting for biotechnological researchers. The parties ‘A’ and ‘B’ are involved in a lawsuit relating to recombinant erythropoietin. Erythropoietin is an important blood protein stimulating the production of red blood cells, thus, it can effectively be used for the treatment of anaemia. The lecture analysed the stages of the long-lasting litigation in the USA, Europe and Asia. The main reasons of litigation in this case are characteristic of the field of biotechnological inventions: (1) use of patented biotechnological materials; (2) sufficiency of disclosure; (3) importance of depositing microorganisms; (4) appropriate indication of inventive step. These are the issues of which applicants of biotechnological inventions have to take care first of all in order not to be exposed to litigation, and on which opponents may centre their attacks most easily. 8. Legal problems and traps of patenting inventions arising from diversity of different patent systems and legislation In the second case those problems are addressed that may arise from the diversity of legislation and legal practice of different countries.
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Table 1 Nonpatentable and patentable inventions Nonpatentable inventions
Patentable inventions
(a) Not novel, not inventive, not completely disclosed, not feasible for industrial application (b) Discovery (straightforward expansion of knowledge; reference to its occurrence)
(a) Novel, inventive, completely disclosed, feasible for industrial application (b) Discoveries which result in an enabling technical teaching, e.g. plasmids, viruses, microorganisms, products of nature; e.g. insulin or morphine (c) Methods for the medical treatment of humans or animals, (c) Working means for the medical treatment of man or e.g. somatic gene therapy; conventional procedures (‘analogous animals, e.g. pharmaceuticals for somatic gene therapy; methods’) for preparing known compounds. In some countries antisense oligonucleotides; DNA sequences with specified these are also patentable functions; antibodies; vaccines (d) Methods for the treatment of humans or animals by surgery (d) Diagnostic substances (working means) for carrying out or therapy, and diagnostic methods practised on the human or diagnostic methods on man or animals; ESTs, e.g. for animal body. In some countries these are also patentable identification genes, or expression studies of different tissues; inventive methods of preparing known or new compounds (e) Plant varieties. In some countries, as in Hungary, these are (e) Genetically modified plants, plant cells, seeds patentable under a special chapter of the patent law (f) Animal varieties. In some countries, as in Hungary, these are (f) Animals, e.g. molluscs, oysters, genetically modified patentable under a special chapter of the patent law mammals (mice, etc.); mammalian, animal cells, hybridoma cells (g) Essentially biological (nontechnical) processes for the (g) Technical, e.g. genetic engineering, methods (i.e. production of plants or animals processes) of creating modified plants and animals and varieties; cloning procedures (h) Inventions contrary to ‘public order’ or morality when (h) Inventions not contrary to ‘public order’ or morality published or exploited when published or exploited
Once an invention is made, the patenting procedures start at different times in the different countries. National and regional patent laws and legal practices are slightly, or sometimes considerably different. Consequently, the grant of a patent in one country cannot serve as a guarantee that a patent will be granted in the same extent in another country—there may occur limitations, even refusals. Once a patent has been granted, competitors may have, everywhere, an opportunity to invalidate the patent. However, the manner of invalidation varies from country to country — it may take the form of either opposition, or revocation or the combination thereof. Accordingly, biotechnological researchers claiming patent protection for their inventions, as well as their patent attorneys must be very careful to avoid any mistake that may lead to invalidation. In addition to the requirements of disclosure outlined in the previous lecture, the different time
limits in the different patent systems, the date of publication of relevant scientific articles, etc. must be taken into account.
9. Conclusion The patenting of biotechnological inventions is practically in harmony with the general requirements of patent protection. However, there are two reasons for which this field has been the focus of interest for decades. The first is that in the case of biotechnological patents the living material itself may be the subject matter of the patent. The second is the resultant ethical problem: to what extent science may intervene in life and in what respect patent systems may control that process. It was due to the special character of biotechnological patents that the Directive on legal protection for biotechnological inventions was drafted in the European Communities. The fact that this
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directive has a past of 7 years shows that many people deem it superfluous, since patent laws may well be adapted to biotechnological patents; and those who do not regard it as superfluous can hardly agree upon the contents. However, it can never be left out of consideration that inventions brought about in the field of biotechnology, like inventions in any other fields, are entitled to some legal protection. The controversy is only over the ‘hows’. As far as biotechnological inventions are concerned, the legal practice of the various countries is similar but not identical. In Table 1 we attempt, after Vossius (1997), to summarize patentable and nonpatentable inventions, underlining some exceptions in the field of medical treatment, plant and animal varieties. The volume of the review is not sufficient to give a comprehensive picture of the whole range of biotechnological patents and it does not aim at it either. Some shivers of a mirror are presented from which the whole mirror cannot be put together. Therefore, the present review addresses those topics which mainly occupy biotechnological experts and patent attorneys alike. Ethical issues of patenting biotechnological inventions are in the foreground and constitute the subject of debates with green movements. It will be long before perfect peace can be made among the representatives of research, industry and green movements. The basic principles of the patent system would be violated by decisions which would deprive an invention of patent protection merely on the ground that the results attainable by the invention may possibly be harmful to mankind. Patent rights must be open to all inventions which may bring about new developments, even if their advantages or disadvantages cannot be judged in the given moment. The patent system may be instrumental in safeguarding biodiversity; however, the relevant Convention signed at Rio de Janeiro could not find an appropriate solution to all questions. In spite of this the Convention may be regarded as a milestone in this field. The review gives some pieces of practical advice to biotechnological researchers on how to make their patent applications incontestable or on what grounds can they attack other persons’ patent
applications and patents which were not formulated with due care. It describes the requirements of the deposit of microorganisms which is necessary for reproducibility and draws attention to the importance of deadlines relating to communications, applications and publications, non-observance of which entails the loss of patentability of the invention. References Aharonian, G., 1997. Biotechnology patents, the news from Minneapolis. Biotechnol. Law Rep. 16, 9 – 16. Anonymous, 1996. Opinion of the enlarged board of appeal dated 27 November 1995. Off. J. EPO 4, 169 – 180. Byrne, N., 1997. Patents for human cells and genes. In: Book of Abstracts, 8th European Congress on Biotechnology, Hungarian Biochemical Society, Budapest, Abstract MO168, p. 25. Crespi, R.S., 1997. Biotechnology patents and morality. Trends Biotechnol. 15, 123 – 129. Crespi, R.S., Straus, J., 1996. Intellectual Property Technology Transfer and Genetic Resources. An OECD Survey of Current Practises and Policies. OECD, Paris. Gugerell, C., 1997. Patent and other legal issues concerning genomics; the EPO approach. IBC Conference, 25 September 1997. Ilardi, A., 1997. The deposit of micro-organisms under the Budapest Treaty. In Book of Abstracts, 8th European Congress of Biotechnology, Hungarian Biochemical Society, Budapest, Abstract MO-166, p. 24. Jaenichen, H.-R., 1996. Rules that regulate deposits under the European Patent Convention (EPC) amended effective October 1, 1996. Biotechnol. Law Rep. 15 (6), 883 – 890. Moufang, R., 1995. Deposit of Biological Material for Patent Purposes. Max Planck Institute, Germany. ´ ., Molna´r, I., 1997. Recombinant erythropoietin— lesPetho¨, A sons from a worldwide patent litigation. In: Book of Abstracts, 8th European Congress on Biotechnology, Hungarian Biochemical Society, Budapest, Abstract MO-169, p. 25. Schatz, U., 1996. Patents, ‘Ordre public’ and Morality, Speech in Gent, 1996. Schatz, U., 1997. Ethical issues of patenting biotechnological inventions at the European Patent Office. In: Book of Abstracts, 8th European Congress on Biotechnology, Hungarian Biochemical Society, Budapest, Abstract MO-165, p. 24. Schatz, U., 1997. Patentability of genetic engineering inventions in European Patent Office practice. Talk in Munich Law Society, 25 March 1997. Sedjo, 1992. Property rights, genetic resources and biological change. J. Law Econom. 1, 199. Straus, J., 1993. The Rio Biodiversity Convention and intellectual property. IIC 24, 602.
E. Szarka / Journal of Biotechnology 67 (1999) 1–11 Straus, J., 1997. Intellectual Property in Support of Biodiversity. Book of Abstracts, 8th European Congress on Biotechnology, Hungarian Biochemical Society, Budapest, Abstract MO-167, p. 24. Szarka, E., Posteiner-Toldi, M., 1996. Biological inventions, plant varieties and animal breeds in the patent act of 1995. Proc. Hung. Group AIPPI 23, 29–41. Szarka E., Petz-Stifter, M., 1997. Patenting possibilities of biological, especially biotechnological inventions in Hungary. In: Book of Abstracts, 8th European Congress on Biotechnology, Hungarian Biochemical Society, Budapest, Abstract MO-164, p. 23.
.
11
´ ., 1997. Legal problems and traps of patenting Szentpe´teri, A inventions arising from diversity of different patent systems and legislation. In: Book of Abstracts, 8th European Congress on Biotechnology, Hungarian Biochemical Society, Budapest, Abstract MO-170, p. 25. Vogel, F., Grunwald, R. (Eds.), 1994. Patenting of Genes and Living Organisms. Springer, Berlin. Vossius, V., 1997. Patenting inventions in the field of biology and chemistry: German and European case law. Naturwissenschaften 84, 433. Weitz, 1993. The biological deposit requirement: a means of assuring adequate disclosure. High Technol. L. J. 8,275.