Biotechnological Innovations and Patent Law

The issue of biotechnological innovations in many respects represents a substantial challenge to law.[1] The provisions in the European Patent Convention 2000(EPC) and the Biotech Directive are lacking in managing this challenge, in light of the fact that they are vague and can't be utilized to reject indecent advancements. Opinions on patents in the field of biotechnology are divided, with support for unfettered scientific progress at one end of the spectrum and a commitment to uphold the basic values of society at the other. Where many see an important contribution to social progress, others are concerned about potential risks and ethical questions.[2] This note will critically analyse the statement by looking deep into patent laws and their interpretation by European Patent Office (EPO). First, this text will define “Biotechnology” and label the provisions of EPC and the Biotech Directive dealing with biotechnology. Moreover the text will discuss briefly how morality influences the patent rights that are granted to biotech inventions. Furthermore some cases showing the uncertainties and controversies (arouses out while interpreting and imposing provisions of EPC and The directive) will also be highlight, proving the provisions of EPC and bio directive are unclear and not even able to identify weather an inventions is immoral. “Biotechnology” means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.[3] According to the European Patent Convention (EPC), "biotechnological inventions" are inventions which concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.[4] To be patentable, biotechnological inventions have to meet the same criteria as those in any other field of technology. Patents can only be granted for inventions that are new, involve an inventive step and are susceptible of industrial application[TM1]. A specific legal definition of novelty has developed over the years, with "new" meaning "made available to the public[TM2]". This means, for example, that a human gene, which existed before but was "hidden" from the public in the sense of having no recognised existence, can be patented when it is isolated from its environment or when it is produced by means of a technical process and as long as its industrial application is disclosed in the patent application[TM3]. All other requirements of patentability must also be fulfilled[TM4]. While biotechnological inventions are in principle patentable, due to the nature of biotechnology and its ethical implications there are specific rules which apply when considering the patentability of an invention in this field.[5] Articles 52 and 53 of EPC say what can and can't be patented. Biotechnological developments are essentially patentable. Nonetheless, no European patent can be allowed for any of the accompanying:

1. Any invention whose commercial exploitation would be contrary to “ordre public or morality”.[6]
2. Plant and animal varieties.[7]
3. Essentially biological processes for the production of plants and animals,[8] i.e. classical breeding comprising crossing and selection.
4. Methods for treatment of the human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body.[9]
5. Discoveries (e.g. the mere discovery of natural substances, such as the sequence or partial sequence of a gene) are not patentable. However, if an inventor provides a description of the technical problem they are intended to solve and a technical teaching they move from being a discovery to being a patentable invention.[10]

Here, Article 52 of the EPC defines patentability in the European Community.'[11] Specifically, Article52(1) states that "European patents shall be granted for any inventions which are susceptible of industrial application, which are new, and which involve an inventive step."[12] Subsequent provisions of the EPC narrow the broad language of potential patentability declared in Article 52(1). First, the EPC details with some clarity matter which does not have a sufficient "inventive step" to be patentable. Such materials include mathematical models, aesthetic creations, and presentations of information.[13]' Next, categorical exclusions from the general rule of patentability are listed under Article 53.[14] Particularly relevant to this discussion, Article 53(b) excludes "plant or animal varieties" and "essentially biological processes" from patentability.[15] However, in contrast to the foregoing explanation of matter not rising to the level of an invention under Article 52, the terms "varieties" or "essentially biological" are not defined under Article 53 or elsewhere in the EPC.[16] While the Guidelines for Examination of Patents (Guidelines) issued by the EPO attempt to define these terms,[17] However the Guidelines are not binding on the member states.[18] Thus, a lack of uniformity in patent protection among member states is distinctly possible under the existing definitional system.[19] In addition to the ambiguities surrounding the key definitions discussed above, the Article 53 exclusions from patentability are problematic with regard to biotechnological patents for several reasons. First, as noted by the European Parliament (Parliament), "the patent system, when applied to living matter, must be adapted to the problems linked to the special nature of such matter.”[20] In light of changing technology, the EC's international competitors have explicitly declared living matter and even animals to be patentable and have enacted special rules to deal with problems unique to patenting living matter.[21] However, under Article 53 of the EPC, only microbiological inventions[22] can be patented.[23] Some member states have responded to the inadequacies of the outdated EPC provisions in this area by enacting national laws to deal specifically with biotechnology.[24] Second, the interpretation of the plant and animal varieties exclusion may be problematic. The basis of this exclusion was that,under the International Convention for the Protection of New Varieties of Plants (UPOV), another method exists besides patenting through which to obtain legal protection for plant varieties. The Convention declared that plant varieties were entitled either to a special title of protection or to a patent, but not both.[25] Unlike plants, however, animals do not have protection outside the scope of the EC patent system, under the UPOV or any other convention. Nonetheless, this exclusionary provision was invoked in the HARVARD/Onco-mouse decision by the Examining Division, which considered the Onco-mouse to be a type of animal variety.[26] The member states of the EC also have inadequate guidance on patenting biotechnological inventions because of inconsistent EPO decisions. Two prior decisions by the EPO Technical Board of Appeal indicate a proatent protection attitude[27] and seem initially to forecast fundamental change to the patent system.[28] In the Hybrid Plants/LUBRIZOL decision, the Technical Board of Appeal narrowly construed one of the stated exceptions to the general rule of patentability.[29] Also, in the CIBAIn the Article 53(b) exclusion clause and held that "no general exclusion of inventions in the sphere of animate nature could be inferred from the EPC.[30] In HARVARD/Onco-mouse, however, the Examining Division initially refused to construe Article 53(b) narrowly and thus broke with the preceding opinions on the basis that there was different legislative intent behind the provision for plant and animal varieties.[31] The Appeals Board disagreed and noted that "any such exception must, as repeatedly pointed out by the Boards of Appeal, be narrowly construed."[32] Because of HARVARD/Onco-mouse, the interpretation of Article 53(b) is unsettled.[33] In addition, by introducing Article 53(a) as a consideration in its patentability decision, the Examining Division thus set forth another consideration for member states to apply when determining patentability without any guidance other than the dicta from the HARVARD/Onco-mouse decision itself.This environment of inconsistent EPO case law may have a chilling effect on commercial biotechnology-a field where the economic incentive of the patent system is necessary to stimulate biotechnology research and development. This is true because biotechnology research is very expensive.[34] On the other hand, beside all these circumstances , in Europe, a debate on biotechnology patents started in the late 1980s with the aim of clarifying the distinction between what is patentable and what is not, and harmonising EU member states' laws in this area. This led to the adoption on 6 July 1998 of EU Directive 98/44/EC on the legal protection of biotechnological inventions. The directive has been implemented by all EU member states. As early as 1999, the EPC contracting states decided to incorporate the directive as secondary legislation into the Implementing Regulations to the EPC. Together with the EPC articles on substantive patent law, these rules now provide the basis for deciding on the patentability of biotechnology applications at the EPO. The incorporation of the EU directive into the EPC strengthened the practice of the EPO in biotechnology, whilst putting greater focus on ethical considerations. [35] Though the Directive only lists four specific types of invention as being unpatentable on moral grounds ((i) processes for cloning human beings,[36](ii) processes for modifying the germ line genetic identity of human beings,[37] (iii) uses of human embryos for industrial or commercial purposes,[38] (iv)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.[39])It also confirms that elements of the human body, such as genes, can be patentable when isolated from the human body.[40]The Directive basically settled a lot of the ethical debates about patentability of biotech inventions in Europe.[41] On the other hand discussing about immoral inventions it can be taken into consideration that the moral concerns currently raised in conjunction with biotechnology patents are misplaced because they stem from a lack of understanding of the patent system. A patent system is not a means of safeguarding the public interest. It is primarily a commercial and industrial tool that encourages innovation, divorced from social and moral concerns.[42] Because a patent grant affords a limited commercial monopoly to use only what is already in existence, the grant of a patent is not an ethical event.[43] Instead, it is the regulatory system of a given nation that monitors social concerns as it implements general legislation-concerns which frequently encompass ethics and morality.[44]Thus, a patent makes the existing research on genetic engineering open and available to the public, which, in turn, permits public monitoring of genetic engineering.[45] In the context of the FDA decision on genetically engineered foods,[46] it was noted that "genetic technology is too promising, to dismiss it out of a free-floating mistrust. If the public understood the technology, they would understand that part of their emotional reaction is irrational.”[47] It is evident, then, that ethical concerns raised about the patent system reflect concerns about biotechnology itself rather than the grant of the patent for that biotechnology. Ethical issues associated with patents are inappropriately channeled fears of insufficient regulation.[48] Nevertheless, the patent system has become another arena for the campaigns of the Green Party, environmental groups, and animal rights activists to try to regulate science and technology.[49] In fact, biological patents have been granted routinely since the 1800s,[50] but ethical concerns did not enter the realm of the patent system until genetic engineering blossomed. Public concern over patenting biotechnology may reflect a public reaction to the scope and sophistication of genetic engineering involved in biotechnology due to misperceptions and unfounded fearof genetic engineering. This is illustrated by a series of decisions in the Europe. In 1970, the German Supreme Court allowed a living organism to be patented in the Red Dove case.[51] That case preceded the development of genetic engineering and was not followed by any significant public controversy. [52]However, following the advent of genetic engineering the 1980 United States Supreme Court holding in Chakrabarty, which paralleled the Red Dove decision in principle by holding genetically engineered bacteria to be patentable, was followed by a public debate over the morality of patenting living matter.[53] Then, in 1987 the United States Board of Patent Appeals and Interferences determined in Ex Parte Allen that higher life forms, such as oysters, were patentable.[54] That decision triggered significantly more controversy [55]than a typical Board decision."[56] Finally, the 1987 PTO decision to allow genetically engineered animals such as the Onco-mouse to be patented stimulated tremendous controversy.[57] This litany indicates that debate over patenting biotechnology has sharpened with the sophistication and use of biotechnology despite the fact that the underlying scientific principles and patent procedures remain the same. There is a distinct paucity of case law that discusses ethical issues as a preclusion to patentability. This is the case even in the EPO decisions despite the existence of Article 53(a), which explicitly allows a consideration of ethics for patentability. The EPO Guidelines indicate that Article 53(a) is to be invoked only in "rare and extreme cases"[58] and is aimed at preventing extreme situations such as riots and criminal behavior[59]The lack of discussion prior to HARVARD/Onco-mouse may indicate that ethics were generally not considered in patenting decisions. In fact, the Examining Division initially stated in HARVARD/Onco-mouse that it does not consider patent law an appropriate legislative tool and therefore declined to rule under Article 53(a)."[60] To a limited extent, the EPO Guidelines on Article 53(a) and the cases are illuminating on the role ethics should play in the area of patentability. Ethics have been considered regarding the usefulness requirement that all patentable inventions must meet in both the EC and the United States. The issue is whether ethical issues render an invention "useless" according to statutory requirements for patentability.[61] In the United States, courts historically have been reluctant to deny patents based solely on ethical concerns[62] and consider an invention patentable so long as it has some moral use.[63] The drafters of the EPO Guidelines seem to concur in this result. The Guidelines state that a patent may be granted if an invention has both an offensive and non-offensive use.[64] The Guidelines set forth as an example a process for breaking open safes; that is a process that may be offensive if used by burglars, but which is potentially non-offensive and very useful if used by a locksmith in an emergency. [65] Imposing barriers to biotechnological patents will not prevent the advance of genetic engineering or address the ethical issues raised by scientific advancement. These issues will persist regardless of whether patents are granted.[66] Furthermore, even if the EC ignores the field of biotechnology, its international competitors will not.[67] As the United States Supreme Court stated, "The grant or denial of patents on micro-organisms is not likely to put an end to genetic research however whether claims are patentable may determine whether research efforts are accelerated by the hope of reward or slowed by want of incentives."[68] In Germany a special Commission of Inquiry on the Opportunities and Risks of Genetic Technology echoed these insights and stated that the types of "criticism of genetic engineering are often simultaneously or primarily criticisms of over-arching strategies which have developed independently of genetic engineering involving basic problems of industrialization." [69] The Directive enacted by the EC because it recognizes the potential ethical concerns and the reality of scientific progress.[70] The international competitors of the EC are capitalizing on biotechnology and encouraging scientific innovation by allowing biotechnological patents to issue under systems more lenient than the EPC. The Directive begins to address the EC gap in protection for biotechnological inventions, which are crucial to the commercial and international competitiveness of the EC, by mandating uniform legal protection. Although the scope of protection for biotechnological inventions under the EPC and the directive is limited, passage of the Directive was still a necessary step to take in narrowing the gap between the EC and its international competitors. Whether the Directive will achieve its goals remains to be seen. However, the history of the European Onco-mouse has shown that the current outlook for biotechnological innovations will remain bleak if no action is taken.The Onco-mouse currently stands alone in an area of inadequate and murky protection for biotechnology innovations. Without immediate action on the part of the Commission and member states, the EC will stand alone in its ethical debate as other nations simultaneously commercialize biotechnology and manage ethical concerns associated with biotechnological inventions.

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[1] Roberto Bin, Sara Lorenzon, Nicola Lucchi, Biotech Innovations and Fundamental Rights (1st, Springer Science & Business Media, 2012) 3 [2] European Patent office, 'Patent on Biotechnology' (epo.org 2013) <https://www.epo.org/news-issues/issues/biotechnology.html> accessed 29 January 2015 [3] Convention on biological diversity 1992 Art. 2 [4] European Patent Convention 2000 Art. 26 (2) [5] European Patent office, 'Patent on Biotechnology' (epo.org 2013) <https://www.epo.org/news-issues/issues/biotechnology.html> accessed 29 January 2015 [6] European Patent Convention 2000 Art. 53(a) [7] Ibid. Art. 53 (b) [8] Ibid. [9] European Patent Convention 2000 Art. 53 (c) [10] Ibid. Art. 52 (2) (a) [11] Ibid. Art. 52 [12] Ibid. Art. 52 (1) [13] Ibid. Art. 52 (2) [14] Ibid. Art. 53 [15] Ibid. Art. 53(b) [16] Kevin W. O'Connor, 'Patenting Animals and Other Living Things' [1991] S.CAL. L. REV 65, 597,617 [17] European Patent Office, 'IV', Guidelines for examination in the European Patent Office (1992).p 3,4, [18] Exxon, “Aluminia Spine” [1998] Eur. Pat. Off. Rep. p.389,391 [19] Andrew J A Parkes, “The Significance of the European patent convention and the community patent convention”, (Marry Robinson, 1999) p.51 [20] Proposal for a Council Directive on the Legal Protection of Biotechnological Inventions Approved with the Following Amendments, 1992 (C 125) 183, 183 (Amendment No. 3) [21] See infra notes 62-74, 100 and accompanying text. [22] European Patent Convention 2000 Art. 53 [23] Convention on the Unification of Certain Points of Substantive Law on Patents for Invention 1963, Art. 2(b) [24] John Hodgson, “Dutch Regulations Now in Force biotechnology” (1990) p. 284 [25] International Convention for the Protection of New Varieties of Plants 1978, art. 2(1), [26] See infra note 77 and accompanying text. [27] LUBRIZOL/Hybrid plants [1990] Eur. Pat. Off. Rep. 173 (EPO); CIBAGEIGY/ Propagating material, [1985] C Eur. Pat. Off. Rep. 758 (EPO) [28] Fundamental changes in patent law have been previously sparked by court decisions, at least in the United States. See Exparte Allen, 2 U.S.P.Q.2d 1425 (PTO Bd. Pat. App. & int. 1987) (genetically engineered oysters are potentially patentable, even though they are living matter); In re Bergy, 596 F.2d 952,972,976 (manmade, biologically pure culture of microorganism is patentable because it only occurs in an impure form in nature). These decisions foreshadowed the PTO announcement, although it was most immediately prompted by the ruling in Allen. See Donald 3. Quigg, Animals-Patentability, Statement of April 7, 1989, reprinted in ANIMAL PATENTS, supra note 9, at 159 (outlining the holding of Allen and the rationale behind it, as well as the scope of patentability under 35 U.S.C. 101). For a more detailed discussion of case law preceding and the PTO decision, see Bradford Chaucer, Note, Life, The Patent Office and Everything: Patentability foreshadowing of Lifeforms Created Through Bioengineering Techniques, 9 BRIDGEPORT L. REV. 413 (1988). [29]LUBRIZOJHybrid plants, [1990] Eur. Pat. Off. Rep. 173,177. (EPO) [30] CIBA-GEIGY/Propagating material, [1985] Eur. Pat. Off. Rep. Vol. C. 758, 759 [31] HARVARD/Onco-mouse, [1990] Eur. Pat. Off. Rep.4,7. [32] Ibid. [33] Ibid.; [34] IRA H. CARMEN, CLONING AND THE CONsTITbTON: AN INQUIRY INTO GOVERNMENTAL POLICYMAKING AND GENETIC EXPERIMENTATION 23, 26 (1985) [35] European Patent office, 'Patents on life? European law and practice for patenting biotechnological inventions' (tomkins.com ) <https://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&ved=0CCoQFjAB&url=https://www.tomkins.com/uploads/what-we-do/patenting_biotechnological_inventions.pdf&ei=00_KVJuIJMHR7Qa59IGgDA&usg=AFQjCNGgxAV_9Nyekl73ByDXVZeUXW-6Bw&bvm=bv.84607526,d.ZGU&cad=rja> accessed 29 January 2015 [36] Directive 44/EC 1998, Art 2(a) [37] Ibid. Art 2 (b) [38] Ibid. Art 2 (c) [39] Ibid. Art 2 (d) [40] Ibid. Art 5 (2) [41] Suleman Ali , 'The ethics of biotech patenting: a dialogue about monopolies, human dignity and the cost of medicines' (https://ipkitten.blogspot.co.uk/ 2015) <https://ipkitten.blogspot.co.uk/2015/01/the-ethics-of-biotech-patenting.html> accessed 29 January 2015 [42] Robert P. Merges, Intellectual Property in Higher Life Forms: The Patent System and Controversial Technologies, (1988) 47 MD. L. REV. 1051, 1067-68 [43] See Bent, supra note 69, at 7; Debates, supra note 50, at 18 (right of prohibition only). [44] 148. See BIOTECHNOLOGY GLOBAL, supra note 2, at 203-04; Bent, supra note 69, at 7-8; Merges, supra note 146, at 1067-68. [45] 149. Debates, supra note 50, at 18. Rapporteur Rothley stated that: [46] 'Gene-Altered Food Called Safe, Facts on File World News Digest,' (www.lexisnexis.co.uk/ 1992,) accessed 29 January 2015 [47] Molly O'Neill, Geneticists, ‘’Latest Discovery: Public Fear of 'Frankenfood,' N.Y. TIMES’’ (1992) [48] 152. See generally Cantley, supra note 112, at 14-15 [49] (1991) 59 U. Mo. Kan. City L. Rev. 409,410; (1989) 42 OKLA. L. REV. 131 [50] Alex Barnum, “Biotech Labs Enraged by Bid to Patent Human Genes”, S.F. CHRON. (1991) [51] Rote Taube (Red Dove), 1 Int. Rev. of Indus. Prop. & Copyright. (IIC) 136 (1970) [52] 156. See Straus, supra note 4, at 17-18. [53] 157. See generally id at 17-18 (indicating public concern about patenting higher organisms stems from the novelty of genetic engineering and a general lack of understanding of how the patent system functions). [54] (1987) 2 U.S.P.Q.2d 1425 [55] 159. See Manspeizer, supra note 9, at 418-19; Merges, supra note 146, at 1052. [56] 160. See Merges, supra note 146, at 1052. [57] 161. See supra notes 68-70 and accompanying text (discussing legislative activity following the grant of the Onco-mouse patent). [58] EPO Guidelines, IV, 3.1. [59] Ibid. [60] Harvard/Onco-mouse, (1990) Eur. Pat. Off. Rep. 4, 11. [61] See Merges, supra note 146, at 1062-63 [62] (1977) 200 U.S.P.Q. 801, 802;Fuller v. Berger, 120 F. 274,275-76 (7th Cir. 1903);Lowell v. Lewis 15 F. Cas. 1018,1019 (C.C.D. Mass. 1817) [63] Klein v. Russell, 86 U.S. 433, 467 (1873) [64] EPO Guidelines, IV, 3.3 [65] Ibid. [66] 181.COOK Er. AL, supra note 2,'at 120. [67] 182. See supra notes 51-59 and accompanying text. [68] Chakrabarty, 447 U.S. at 317. [69] BIOTECHNOLOGY IN FUTURE SOCIETY: SCENARIOS AND OPTIONS FOR EUROPE 117, 123 (Edward Yoxen & Vittorio Di Martino eds., 1989). [70]

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