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With regard to the excluded subject matters especially the exploitation ofbiotechnological inventions such as life patenting with regard to human related genemodifications, stem cell research, but also the breeding of plant and animal varietieshas drawn lots of publicity[1].

But what inventions are deemed moral or immoral from apublic ordreperspective inEurope? For subject matters which come under the respective provisions for notgranting a right to inventions of which the commercial exploitation would be contraryto ordre publicor morality, the European Regime provided legislative guidance byissuing the EC Biotechnology Directive[2]which is reflected in the EPC 2000[3]and,despite some slight verbatimdifferences, is enacted in the statutes and schedules ofthe Patent Act 1977[4].At the IPO, the threshold for moral issues goes beyondbiotechnological invention, and thus, is broadly defined by the respectiveexamination guidelines as to prevent the patent grant of an invention that would beexpected to encourage offensive, immoral or antisocial behavior[5].

Nevertheless, the respective schedule focuses on biotechnology and sets out that

processes for cloning human beings and modifying the germ line genetic identity ofhuman beings[6]are clearly excluded on grounds of immorality, whereas the uses ofhuman embryos for industrial or commercial purposes also come under inventionsare currently not patentable[7]on moral grounds. Additionally, processes formodifying the genetic identity of animals which are likely to cause them sufferingwithout any substantial medical benefit to man or animal, and also animals resultingfrom such processes[8]are not patentable due to moral issues.

In case of plant breeding or biotech seeds, besides the fact that EuropeanParliament called the EPO also to exclude from patenting products derived fromconventional breeding and all conventional breeding methods, including SMARTbreeding (precision breeding) and breeding material used for conventional breeding,

and the critics arguments that seed patents impose an abuse of the patent law byusing it as a tool of misappropriation which turns agricultural resources into theintellectual property, the fact that Monsanto already owns 36% of the tomato seedvarieties registered with the Plant Variety Office of the EU, as well as 32% of thepaprika (sweet pepper) varieties and 49% of the cauliflower varieties, it seems to benot sufficient to argue ordre publicor immoral behavior.

In addition, the fact that the second biggest applicant in this field, Syngenta, owns26% of the tomato varieties, 24% of the paprika (sweet pepper) varieties and 22% ofthe cauliflower varieties[9]doesnt bother the EPO to apply Art 53(a) in order tocompel an alteration of the present filing strategies, but illustrates that for these

subject matter the public policy of the EPO relies on the fact that plants and animalsare regulated by EPC Art 53(b).

But where is line draw to invoke such limitation on inventions?

Hereto, the evaluation of Art. 53(a) at the EPO was centered on theOncomouse[10]case. which was ruled prior to and post the introduction of the EPC Rules in2000[11],whereas in terms of animals as shown above, the EPO draws the line ofmorality by the application of the so-called utilitarian balance test in order to exercisebalance between animal suffering, potential risks for the environment and beneficialusefulness to mankind. According to this narrative the necessarily cause ofsuffering[12]to the animals was sufficient to conclude immorality and render the

invention for the process not patentable. However, it has to be highlighted that sharpline is drawn by the black letters of Art. 53(a) and Rule 28, since from an EU and UK

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perspective neither product claims, nor product-by-process claims will be affected bythe non-patentability of biological processes in the above scope[13].

Albeit the established cost-benefit-test with regard to Art. 53(a), in Plant GeneticSystemsthe EPO Opposition Division neglected to employ the test in the opposition

proceedings, because there was no sufficient prove to quantify the reasons for theobjection. Thus, albeit ethnically questionable, the EPOs Technical Board of Appealdenied the opposition motion and upheld the patent grant because of the EPOsfunction to protect the protect the deep rooted norms[14]of the European society butalso to service both, public policy and science, respectively. Hence, the EPO took onthe issues concerning public security, and physical integrity of individuals as part ofsociety[15].

With regard to the above seminal cases, and in line with seminal decision in Regina(in ex parteQuintavalle) v Secretary of State for Health[16]that defined that thetermembryo should not be restricted to a live human embryo produced by the fertilizationof a female egg, but should be interpreted to include an embryo produced without

such fertilization, such as one created by cell nuclear replacement[17],a furthersubject matter that was deemed immoral can be illustrated.Thus, with regard to stem cells to be retrieved with a destruction of a human embryo,the EU view on ethics clearly shows a prudent approach to deny patentability in thisparticular field of research, whereas the impeccable reasoning of the UKs position tothe future of stem cells research that was conveyed to EPO Enlarged Board ofAppeal Judgment in the WARF[18]case, shows an ethnical balance to this issue.

[1]Biotechnology patentability ? the latest from the EPO (Patents in Europe 2013/2014,www.iam-magazine.com)

accessed on 13 September

2013[2]DIRECTIVE 98/44/EC of the European Parliament and of the Council of July 1988 on the legal protection of biotechnological

inventions [1998] OJ L 213/13, especially Art 6(2) which corresponds to EPC 2000 Rule 28 and sch A2 para 3;[3]The European Patent Convention of 2000 Art. 53 (a), Rule 28

[4]Patent Act 1997 s 1(3) and sch A2 para 3,[5]Examination Guidelines for Patent Applications relating to Biotechnological Inventions in the Intellectual Property Office(IPO, July 2012 ) accessed on 13 September 2013 para 103[6]EPC 200 Rule 28; PA 1977 sch A2 para 3(a)-(b)

[7]ibidsch A2 para 3(c)

[8]ibid sch A2 para 3(c)[9]Christoph Then & Ruth Tippe, 'President of the European Patent Office gives green light for patents on plants and animals'

(Green light for patents on plants and animals, March 2013,www.no-patents-on-seeds.org)

accessed on 13 September 2013 p10[10]T19/90 Harvard/Onco-Mouse [1990] EPO OJ 12/476

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8/12/2019 Strength, costs and alternatives to the patent system

3/3