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Abstract

Biotechnology has become one of the driving forces of science and technology and an important pillar of contemporary economy. This entry examines the role which patents play in this context and the challenges they are confronted with as regards concerns of ethics and morals.

Introduction

Patents are exclusive private rights in inventions, i.e., intangible or incorporeal objects, granted to inventors and their successors in title by competent state authorities, such as the United States Patent and Trademark Ofﬁce (US PTO), the Japan Patent Ofﬁce (JPO), or the State Intellectual Property Ofﬁce of the PR China (SIPO) or international organizations such as the European Patent Ofﬁce (EPO). Patents are territorially limited rights, which confer on the proprietor the right to prohibit third-party commercial exploitation of the patented invention without her consent. This is true even in the case that the third party created the invention independently. Thus, patents are blocking rights because they, unlike copyrights, do not offer protection only against copying. However, a patent is not a license to use the patented invention. This fundamental, however, often overlooked or ignored principle of patent law is best restated in the Directive 98/44/EC of the European Parliament and of the Council on the Legal Protection of Biotechnological Inventions (OJ 1998 No. L212 at p. 13), which reads as follows:

…a patent for invention does not authorize the holder to implement that invention, but merely entitles him to prohibit third parties from exploiting it for industrial and commercial purposes.. . consequently, substantive patent law cannot serve to replace or render superﬂuous national, European or international law which may impose restrictions or prohibitions or which concerns the monitoring of research and of the use or commercialization of its results, notably from the point of view of the requirements of public health, safety, environmental protection, animal welfare, the preservation of genetic diversity and compliance with certain ethical standards

The use of a patented invention may also not infringe the rights of third parties. Patents are limited in time: According to binding international standards, the term of a patent is at least twenty years counted from the date of ﬁling of the patent application. In order to be patented, an invention must be new, i.e., must not be comprised in the state of the art; it must involve an inventive step, which means it must not be obvious to an expert; and it must be industrially applicable and useful.

History And Development

Patents owe their name to medieval documents issued by a sovereign in the form of “open letters” (in Latin “litterae patentes”) granting a title, monopoly, and the like. Unlike the “letters close” (in Latin “litterae clausae”), which could be opened only by the recipient, open letters’ seal was loosely attached to the document, so that it did not have to be broken in order to be read. Since its beginnings in the privileges granted in the early fourteenth century, the patent system has been used as an instrument to generate and acquire more new knowledge and information in order to improve the economic situation of the country. In comparison to continental Europe, England at that time was a developing country. Therefore, her kings attracted foreign craftsmen from Belgium, Holland, France, and Italy to England and granted them privileges limited in time, to perform their business for the express purpose of introducing fellow countrymen to their skills, “instruendi et informandi causa,” (i.e. to instruct and inform), as expressed in a privilege issued by Edward III in 1331. Industrial and inventors’ privileges granted in the course of the ﬁfteenth and sixteenth centuries in Italy, Holland, and Germany were based with similar motives in mind. Also the ﬁrst statutory regulation, the Venetian Statute of Inventors of 1474, with its limited prohibition of imitating inventions, was intended to stimulate “deep thinkers and ingenious inventors from other regions” to exercise their activity for the beneﬁt and advantage of Venice. Thus, the main aim of privileges, the forerunners of today’s patent system, was to promote domestic crafts and industry and especially to introduce to their own country the production of goods which had theretofore been imported from abroad. Even the “real and ﬁrst inventor,” to whom the English Statute of Monopolies of 1623/1624 restricted grant of patent monopolies, did not necessarily have to make the invention himself. Sufﬁcient and decisive was the introduction of new manufacture into the country, and it was totally irrelevant whether he had acquired his knowledge “through travel or research” (Adams 2008).

These technological and economic policy reasons remained decisive also for the further development of the patent system, when the system of privileges became more and more consolidated and ﬁnally led, during the late eighteenth and nineteenth centuries, the age of the industrial revolution, to a legally secured institution for the protection of the inventor. Although the ﬁrst modern patent laws, adopted in 1790 in the USA, where the constitution of the Federation of 1787 stipulated in Article 1 (8).8 that “the Congress shall have the power… To promote the progress of science and useful arts, by securing to… inventors the exclusive right to their … discoveries,” and in 1791 in France, under the inﬂuence of ideas of natural law and as a reaction to the misuse of the system of privileges, strengthened the position of the inventor and awarded him a property right to his ideas, the economic policy aim of patent legislation remained unchanged: to improve the industrial development of one’s own country and close the economic gap between it and England, the leading industrial nation of the time. The appropriate measure for this purpose was – as George Washington stated before Congress on January 3, 1790 – “[t]o efﬁciently initiate the introduction of new and useful inventions from abroad as well as the skill and genius at home for the production of these inventions.” Similar arguments were presented by the Marquis de Boufﬂers, the author of the French Patent Act, before the French Parliament on December 30, 1790 (Beier and Straus 1977; Adams 2008). In order to achieve these aims, the patent system since its early days has required a complete disclosure of invention in patent speciﬁcation. This has best been expressed in 1785 by Judge Buller in the famous case King v. Arkwright, where he stated, inter alia:

It is clearly stated at law that a man, to entitle himself to the beneﬁt of a patent for a monopoly, must disclose his secret and specify his invention in such a way that others may be taught by it to do the thing for which the patent is granted, for the end and meaning of the speciﬁcation is to teach the public after the term for which the patent is granted, what the art is, and it must put the public in possession of the secret in as ample and beneﬁcial a way as the patentee himself uses it.. . for the patent is the reward which, under the Act of Parliament, is held out for a discovery; and, therefore, unless the discovery be true and fair, the patent is void. (Wallace and Williamson 1900, p. 187)

In today’s patent system, its “informational” function is even much more pronounced because patent applications are published already 18 months after the ﬁling date, i.e., as a rule even before the patent is granted (in fact it may not be granted at all) and any effective protection attained.

The ubiquitous character of an invention, which allows its use at the same time at any place anywhere, made it clear relatively early that instruments were needed to provide for their protection internationally. The ﬁrst international legal instrument was created in 1883 in Paris, when the Paris Convention (PC) for the Protection of Industrial Property was adopted and the Union for the Protection of Industrial Property established. The main and lasting achievements of the PC for the area of patents have been the principle of “national treatment” or “nondiscrimination,” which made patent protection of contracting states accessible to the nationals of other contracting states under same conditions, and the so-called Union priority right, which enables applicants to use the ﬁling date of their ﬁrst patent application in a Union member state as the effective ﬁling date in other Union member states for applications ﬁled for the same invention within twelve months from the ﬁrst ﬁling date. The PC which has undergone several revisions, the last in 1967 in Stockholm, thanks to its rule that countries of the Union are allowed to conclude special agreements between themselves for the protection of industrial property, if they do not contravene its provisions, has become an umbrella for all subsequent international treaties dealing with patent protection. This is not only true for the Patent Cooperation Treaty (PCT) of 1970 and the European Patent Convention (EPC) of 1973 but also for the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) adopted in 1994 in the framework of the then established World Trade Organization (WTO). In the area of patents, the TRIPS Agreement for the very ﬁrst time in the history set forth internationally binding standards as regards the subject matter eligible for patent protection, content, and scope of the patent right as well as the term of its protection. Central to the TRIPS protection standards is the obligation of all 160 WTO members (June 2014) to make patents available for any inventions, whether products or processes, in all ﬁelds of technology (Article 27.1) and exclusions from patentability allowed only under strict conditions as set forth in Articles 27.2 and 27.3. Because under these TRIPS standards also developing and least developed countries, after certain transitional periods, had to, or as in the case of the least developed countries, will have to (as of July 2021), provide patent protection, inter alia, also for pharmaceuticals, access to patented drugs in those countries is often viewed as an ethical problem and patents causing this barrier as ethically not justiﬁed (Sterckx 2004).

The rapid progress of globalization which followed the establishment of WTO in the mid-1990s has also generated steady exponential growth of worldwide patenting activities: The number of patent applications ﬁled worldwide grew from some 1 million in 1995 to over 2.5 million in 2013, after passing the two million mark in 2011 (WIPO 2014).

Conceptual Clarification: Legal Basis

Despite its prevailing economic rationale, according to which patents are granted to recognize the intellectual property of the inventor; to reward the inventor for his useful services; to encourage inventors and industry to invent, invest, and innovate; and to incentivize the early disclosure and wide dissemination of technological knowledge (Machlup 1958; Beier 1980), the roots of, the justiﬁcation for, and some limitations of exploitation of patents are reasoned ethically. Traditionally, ethical aspects in intellectual property rights, of which patents form an integral part, have been discussed in the broad justiﬁcation of these rights. Lockean theory of natural rights to the fruits of own’s labor and Hegel’s personality justiﬁcation suggesting that the best way of progressing science and arts is to protect scientists and artists from theft, so as to become the basis for learning by others, are such examples.

Consequently, patent law, as other laws, is subject to barriers inherent in the legal system, set by the constitution, by public policy, and by morals. These barriers exist in most countries, in legal orders of regional organization of states, such as the European Union, and international regional multilateral treaties, such as the EPC. As an example, Article 53 (a) EPC excludes from patentability inventions the commercial exploitation of which would be contrary to ordre public or morality. This general clause was understood to constitute the necessary gates of entry for overriding social and ethical considerations into the patent law system, which is otherwise neutral in its judgment and entirely devoted to the technical appreciation of invention (Beier und Straus 1986).

At the global level, Article 27.2 TRIPS sets forth that:

Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law

It follows from this, on the one hand, that TRIPS itself does not impose the exclusion from patentability of inventions the commercial exploitation of which would contradict ordre public or morality but only allows WTO member states to provide for such exclusions in their national or regional legal instruments under conditions set forth in TRIPS and, on the other hand, that inventions the commercial exploitation of which is allowed cannot be excluded from patent protection under aspects of ethics or morals.

By adopting the notion of ordre public instead of “public order” or “public interest,” TRIPS adopted a more narrow standard. Thereunder, the notion of ordre public comprises only the “major principles of the legal order,” such as the inviolability of human dignity and the right to life, physical integrity, and personal freedom, as, for instance, laid down in Article 2 (2) of the Basic Law (Constitution) of the Federal Republic of Germany. Such principles are not necessarily infringed solely because exploitation of the invention is prohibited by law or administrative regulations. The European patent law founders decided in favor of this narrow standard because it was not necessarily in the general interest to deny patentability in all cases where the exploitation of the invention concerned was prohibited, for instance, under a foodstuff law allowing only certain additives. The inventor of a new additive with possibly less harmful effects should indeed have the possibility of obtaining a patent since it is possible that the prohibition of exploitation may subsequently be removed. Or, in more modern terms, even if the somatic cell gene therapy, or the use of human embryonic stem cells for curing Parkinson’s disease, may be prohibited for safety considerations today, which could be cleared by further scientiﬁc achievements and developments related to transfer vectors, in say two or three or possibly only in ﬁve years, resulting in subsequent removal of those prohibitions, why should an inventor of suitable stem cells or gene constructs, respectively, not be granted a patent, but left empty-handed and others allowed to use his/her invention for free after the removal of the ban? This would not only be unfair but also counterproductive in terms of providing incentives for the necessary investment into innovation. In the chosen construct, account is taken of the fundamental consideration that a patent does not afford its owner a positive right to use, but solely a right to prohibit (Straus 2013).

The phrase “necessary to protect ordre public or morality” in Article 27.2 TRIPS further requires that a causal connection exists between the measure taken (exclusion from patentability) and the effect sought (protection of ordre public or morality) for which sufﬁcient scientiﬁc evidence is necessary. Moreover, if the objective of excluding commercial exploitation of inventions in a certain ﬁeld of technology can be achieved in a way that does not require excluding inventions from patentability, then that way should always be preferred (de Carvalho 2010). Finally, the last part of Article 27.2 TRIPS, which reads “.. .provided that such exclusion [from patentability] is not made merely because the exploitation is prohibited by domestic law,” requires that a WTO member may not base the exclusion from patentability on legal prohibitions unrelated to ordre public or morality. In other words, whereas the prohibition of commercial exploitation is a basic precondition for the exclusion, it in itself is not sufﬁcient, if it is not based on reasons routed in ordre public or morality (Gervais 2012).

Article 27.2 TRIPS enumerates ordre public or morality as two seemingly independent standards for values, the protection of which allows, under the conditions discussed above, WTO members to exclude from patentability inventions the commercial exploitation of which would violate either or both of them. The leading commentaries on TRIPS are quite short as regards the notion of morality. Gervais (2012) observes that morality is a different concept as compared with ordre public and that “it seems to correspond to the French concept of ‘bonnes mœurs,’” further that “it naturally depends to a certain degree on particular culture of a country or region.” In the German legal doctrine, it is understood that the reference to the notion of morality was necessary to directionally regulate speciﬁcally not foreseeable variety of factual constellations. It has also been pointed out that a danger exists that such provisions are applied in a very subjective, eventually discretionary manner resulting in a disproportional loss of legal certainty. Therefore, it was necessary to narrow down this provision according to its purpose and context. The notion of morality, which in the German translation reads as “gute Sitten,” refers, on the one hand, to extralegal principles, but, on the other hand, forms part of the legal order. Consequently, what is at hand is to put in effect in a speciﬁc case the value standards, which are anchored in the general legal order. A potential violation of the morality standard must be of such weight that it would justify an exception of the fundamentally existing claim or right to a patent. Prohibitions which are not anchored in statutory provisions, therefore, have to be essentially generally recognized as obligatory and have to be limited to elementary rules (Rogge 1998).

Ethical Dimensions

Although the general ethical aspects of the patent system have been discussed in legal as well as economic literature and have, as reported, also been to a certain speciﬁc extent reﬂected in statutory provisions, they have not been a major issue either for the legislature or for patent-granting authorities. That has changed radically following the advent of modern biotechnology in the late 1970s and early 1980s of the twentieth century. Recombinant DNA technology, cell fusion, embryonic stem cells, and many other techniques developed in the area of molecular biology and genetics generated within a relatively short period of time not only genetically modiﬁed microorganisms and tissue cultures producing, for instance, human insulin, erythropoietin, and granulocyte colony-stimulating factors, or hepatitis C, HIV, or breast cancer diagnostics but also genetically modiﬁed plants and animals. Moreover, human somatic gene therapy and even human germ line gene therapy came within the reach of possible or at least prospectively doable.

The perspective of having patents issued on genes, i.e., the fundamental units of heredity, or on animals and plants has sparked controversial debates at least partly based on ethical concerns, which even after some 40 years of successful biotechnology have not come to an end. Some religious leaders, for instance, have characterized the granting of patents on genes or organisms as representing “the usurpation of the ownership rights of the Sovereign of the universe” (Stone 1995). The slogan “No Patents on Life!” has gained lasting popularity, irrespective of the fact that it entirely misses relevant and fundamental aspects of patent law, namely, that of which constitutes the subject matter of a patent and which rights a patent confers on its owner. For example, the subject matter of a patent which relates to an animal is the invention, i.e., the teaching, for instance, how to improve the content of a valuable substance in the bovine milk. Thus, as explained from the very outset, it is an intangible or incorporeal object. Unlike an owner of a cow, which can milk, sell, or even slaughter it, the owner of a patent which relates to the said invention has no direct power over an animal covered by his patent, if he does not at the same time own the animal. The patentee can only prohibit third parties to produce, sell, etc., such an animal. Whether or not such animals may be produced, sold, etc., is not a matter of patent law but of regulatory provisions dealing with public health, animal welfare, or, for instance, environmental protection.

The responses of the lawmakers in the USA and in Europe to the ethical concerns raised against patents on genes and organisms have differed profoundly. The US Patent Law (35 United States Code – USC), which in its § 101 provides for the issuance of a patent to a person who invents or discovers “any” new and useful “manufacture” or “composition of matter,” despite many attempts in the US Congress to introduce amendments, has remained unchanged and does not dispose of any provision which would link the patentability issue to any speciﬁc considerations of ethics and/or morals. In its famous 1980

Diamond v. Chakrabarty decision (447 U.S. 300, 100 S.ct. 2204 (1980)), the US Supreme Court, ﬁrst, emphasized that the Congress intended statutory subject matter to “include anything under the sun that is man-made” and clariﬁed that while laws of nature, physical phenomena, and abstract ideas were not patentable, a claim to a hitherto unknown natural phenomenon, thus to a nonnaturally occurring manufacture or composition of matter – a product of human ingenuity “having a distinct name, character, and use”– was therefore patentable. Consequently, the Court found a genetically modiﬁed bacterium from the genus Pseudomonas, capable of degrading oil spills, patentable. At the same time, however, the Court has refused to deal with objections raised against genetic research and related technological developments, which, as some amicus briefs had asserted, may spread pollution and disease and may result in loss of genetic diversity and in practice could tend to depreciate the value of human life. The Court, in principle, has not put into question the validity of those concerns, but made it clear that such contentions should be addressed to the political branches of the Government, the Congress, and the Executive and not to the courts. As a consequence, the US PTO since the 1980s has issued numerous patents on genomic as well as complementary DNA (cDNA), monoclonal antibodies, human embryonic stem cell lines, plants, plant varieties, as well as animals. The overall impact of this practice on the availability of new drugs has been remarkable: During 2012, the total sales of biologics, i.e., monoclonal antibodies, hormones, growth factors, fusion proteins, cytokines, therapeutic enzymes, blood factors, recombinant vaccines, and anticoagulants, reached US $ 63.6 billion in the USA (Aggarwal 2014). However, in a 2013 decision in Association for Molecular Pathology et al. v. Myriad Genetics Inc. et al. (596 U.S. 12–398 (2013)), the US Supreme Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. Under this holding, only the cDNA is patent eligible because it is not naturally occurring. Patentable are also processes for manipulating and isolating genes, as well as new applications of genes. This approach of the US Supreme Court has not been shared, for instance, by the Federal Court of Australia. Deciding on essentially same facts and claims, the Australian Court in D’Arcy v. Myriad Inc. ([2014] FCAFC 115) held isolated genomic DNA a patent-eligible subject matter and emphasized that the isolated nucleic acid has “markedly different characteristics from any found in nature” and that Myriad did not merely “separate that gene from its surrounding genetic material.” Myriad’s claim, according to the Australian court, properly considered was not, as the US Supreme Court considered, concerned “primarily with the information contained in the genetic sequence [rather than] with the speciﬁc chemical composition of a particular molecule.”

In order to secure a harmonized patent treatment of biotechnological inventions throughout the European Union and bring it in line with the then practice in the USA and Japan, the Community legislator, unlike the US Congress, decided in favor of a statutory regulation and, after some ten years of tense debates in 1998, adopted the aforementioned mentioned Directive 98/44/EC on the Legal Protection of Biotechnological Inventions. Altogether, ten recitals of this Directive directly or indirectly refer to ordre public or morality as the yardstick for patent eligibility of biotechnological inventions. The recitals, inter alia, emphasize that the patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person and the human body at any stage in its formation or development including germ cells cannot be patented (Recital 16). It is further emphasized that ordre public and morality correspond in particular to ethical and moral principles recognized in a member state and that such ethical or moral principles supplement the standard legal examinations under patent law regardless of the technical ﬁeld of invention (Recital 39). Under Article 7 of the Directive, a European Group on Ethics in Science and New Technologies has been established to evaluate all ethical aspects of biotechnology. This Group, however, may only be consulted at the level of basic ethical principles.

The wording of the Directive itself generally speciﬁes that:

The human body, at the various stages of its formation and development, and the speciﬁc discovery of one of its elements, including the sequence of a gene, cannot constitute patentable inventions. (Article 5 (1))

Whereas the exclusion from patentability of “the human body at various stages of its formation and development” is clearly aimed at guaranteeing human dignity and integrity, the exclusion of the “simple discovery” of the elements of human body addresses the delimitation between non-patentable discoveries, as such, and inventions. Due to the accompanying clarifying addition that:

An element isolated from the human body or otherwise produced by means of 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 natural element. (Article 5 (2))

It is clear that unlike in the USA, in Europe, for instance, genomic DNA as well as other “products of nature” are, in principle, patent eligible.

Directly addressed are ordre public and morality in Article 6(1) of the Directive, which by and large corresponds to the aforementioned Article 53 (a) EPC, i.e., excluding from patentability in general inventions the commercial exploitation of which would be contrary to ordre public or morality. Under the settled case law of the Court of Justice of the European Union (CJEU), this provision allows the administrative authorities and courts of the member states a wide discretion in applying the exclusions from patentability of inventions, which are necessary to take account of the particular difﬁculties to which the use of certain patents may give rise to in the social and cultural context of each member state, a context which the national legislative, administrative, and court authorities are better placed to understand than the Community authorities (Case C-377/98 – Kingdom of the Netherlands v. European Commission and Council of European Union [2001] ECR I-7079). However, as also clariﬁed by the CJEU, no such discretion of the member states exists as regards the four speciﬁcally identiﬁed categories of inventions expressly excluded from patent protection for ethical reasons in Article 6 (2) of the Directive, namely, (a) processes for cloning human beings, (b) processes for modifying the germ line genetic identity of human beings, (c) uses of human embryos for industrial or commercial purposes, and (d) processes for modifying the genetic identity of animals, which are likely to cause them suffering without any substantial medical beneﬁt to man or animal, and also animals resulting from such processes (Case C-456/03 – Commission of the European Community v. Italian Republic, [2005] ECR I-5335). In applying Article 6 (2) (c) of the Directive, the CJEU (Grand Chamber) deﬁned the term “embryo” not only as any human ovum, as soon as fertilized, if that fertilization is such as to commence the process of the development of human body, but also a non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted and a non-fertilized human ovum whose division and further development have been stimulated by parthenogenesis. However, the CJEU also explicitly clariﬁed that “a non-fertilized human ovum must necessarily have the inherent capacity of developing into human beings,” in order to be classiﬁed as a “human embryo” (Case C-34/10 – Oliver Brustle v. Greenpeace e.V. [2011] ECR I-09821; Case C-364/13 – International Stem Cell Corporation v. Comptroller General of Patents, Designs and Trade Marks, ECLI:EU:2014:2451). Under this case law of the CJEU, any invention, the implementation of which required a prior destruction of a human embryo, is unpatentable, even if the claims of the patent do not concern the use of human embryos and even if that destruction is

neither described in this speciﬁcation nor necessary for the working of invention. The Court also held that although the aim of scientiﬁc research must be distinguished from industrial or commercial purposes, the use of human embryos for the purpose of research which constitutes the subject matter of a patent application cannot be separated from the patent itself and the rights attached to it. Thus, the exclusion in Article 6 (2) (c) of the Directive covers also the use for purposes of scientiﬁc research. Consequently, the CJEU has declared the (legal) destruction of a human embryo from which, like in the Brustle case, the claimed human pluripotent stem cells were (legally) generated as a part of the technical teaching at hand in the application, although it has neither been claimed nor described nor was it necessary for performing/implementing the invention as claimed. Considering that the human embryonic pluripotent stem cells used in the Brustle invention were legally generated from destroyed supernumerary embryos in Israel and imported into Germany, in line with German regulatory provisions, considering further that the working of the Brustle invention is allowed, and, ﬁnally, considering that the commercial use of the “products” of that invention is allowed in a number of EU member states allow for the only conclusion to be that in the opinion of the Court the act of ﬁling the patent application has been implicitly classiﬁed as the use of the embryo for “commercial or industrial purposes” and constituted a violation of ordre public or morality. Under the pretense to protect human dignity, under the regime established by this case law of the CJEU, the Brustle invention remained unprotected, but at the same time stem cell lines of the type used by Brustle for his invention can in a great number of the EU member states be legally generated from supernumerary human embryos, the products of the Brustle type invention can be commercialized in most of the EU member states, and the Brustle invention can be freely copied EU wide. This does not appear to be in line with ethics and morals, or with the basic mission of the patent system, or with Article 27.2 TRIPS (Straus 2013).

For the sake of completeness and in view of the often expressed ethical concerns as regards patenting of higher organisms, it should be added that under the EU Directive inventions which concern plants or animals are patentable “if the technical feasibility of the invention is not conﬁned to a particular plant or animal variety” (Article 4 (2)). In other words, generic, i.e., generally applicable, inventions concerning plants or animals are patent eligible. The fact that plant or animal varieties are excluded from patent protection in Europe is not based on ethical but rather on legal (existence of a special type of protection for new varieties of plants) and economic considerations. Policy and economic considerations were also responsible for the fact that WTO member states under Article 27.3 (b) TRIPS are allowed to exclude from patent protection plants and animals in general (de Carvalho 2010; Gervais 2012).

Conclusion

The attitude of the contemporary society toward new developments in science and technology, maybe more than in the past, is characterized by a deeply rooted and complex conﬂict between, on the one hand, high hopes in all sorts of beneﬁt, in particular as regards new drugs for curing or at least treating as yet not curable illnesses and, on the other hand, fears and concerns of harm which the new technologies could cause. To the same extent as the hopes may be and are unrealistic, at least in short or medium term, the fears and concerns may be and, as the past has often proven, have been groundless. Patents as legal instruments whose primary economic rationale is to provide incentives for inventors and industry to invent, invest, and innovate and to protect the effected, in particular in the area of biotechnology high-risk investments, therefore, have been and still are exposed to variably motivated attacks. Those who oppose or are skeptic of research and technological developments and/or are against the use of their expected results, for instance, as regards research with human embryonic stem cells or research and development, as well as the use of genetically modiﬁed plants, do not hesitate to attack patenting with contradicting arguments. On the one hand, they may contend that patents are blocking access to the new technology; on the other hand, they may contend that the technology at hand will harm the environment, affect and reduce biodiversity, etc. This is in Europe very often the case in the area of the so-called green biotechnology. In the case of stem cell research, the attacks against patents are primarily motivated with arguments of ethics and morals, because that research is linked to the use of human embryos. Under circumstances, however, in which such research is allowed under stringent regulatory provisions, as is the case in many member states of the European Union, patents actually constitute only a surrogate target, because the real target is the research and development itself. Interestingly, and a possible sign of double moral standards, it has to be observed that nobody has thus far expressed objections against the use of potentially successful drugs for curing diseases such as Parkinson’s or multiple sclerosis, developed with such a technology.

Linking patent eligibility of inventions to ordre public and/or morality implies a complicated and tense relationship. Although to a different degree, both ordre public and morality are subject to unpredictable, or at least difﬁcult to predict, evolutionary changes, as a consequence of scientiﬁc and technological developments as well as changes of public acceptance. Granting of patents, which do not confer on their owners any positive license to exploit the patented invention, but only an exclusive right to use it in compliance with regulatory provisions and rights of third parties, and whose main macroeconomic aim is to provide sufﬁcient incentives for investment into risky research and development, ideally leading to badly needed innovation and, via market success, to reward inventors and innovators, should not be made dependent on rules and principles, which are more or less broadly accepted by the public at large and, by all means, almost without exception, subject to unpredictable evolutionary changes. Developments of science, technology, and industry in the USA and in Europe reveal the higher efﬁciency of the US approach, whose statutes and case law have not established such a link, over that adopted in Europe. If generally accepted ethical concerns in a society exist against speciﬁc research and development or the use of results of such development, it is, as convincingly and correctly stated by the US Supreme Court in the Chakrabarty case, a matter and responsibility of the regulatory legislator to act accordingly and take into account those concerns. It should be generally realized that the grant of a patent does not contain any value judgment other than the patented invention meeting all patentability requirements.

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