The Directive on the Legal Protection of Biotechnological Inventions and the European Patent Convention - Essay Example

Topic:  Article 6 of the Directive on the Legal Protection of Biotechnological Inventions (98/44/EC) and Article 53(a) of the European Patent Convention exclude from patentability inventions the commercial exploitation of which would be contrary to morality. Introduction Research about stem cell, especially research on embryonic stem cell may offer remedies for the grievous diseases, also poses numerous controversial and difficult moral questions. This is mirrored in many numbers of regulatory regimes and moral perspectives which are already pursued or in the stages of being developed in EU Member nations. Especially, the “moral exclusion” conditions in Article six of the “European Council Directives on the legal safeguard for inventions of biotechnological” has resulted in much ambiguity in this field. This research essay analyses the EU patent system as applicable to biotechnological inventions and especially stem cell research concerning with the overlapping of EU , EPC (European Patent Commission), national and international law regimes on the exclusion of patents in a morally contested and fragmented field. Further, this research also analyses the legal extent of Article 6, which is considered to be crucial for the fostering of investment and research in Europe while making sure that such research is carried over with obvious ethical limits, which try to tackle the apprehensions of society. In case of injection of human somatic cell nucleus into rabbit eggs which is also known as an inter-species somatic cell nuclear transfer and Article 6 specify that this interspecies nuclear and somatic transfer is not patentable. The grant of patents in Europe connected with stem cells has been sluggish due to ethical prohibition introduced into the “European Biotechnology Directive of 1998”. Thus, “Article Six of the European Biotechnology Directive “needs the prohibition on the grant of patents to inventions that were opposing to order of morality or public order. Article 6 specifically denies patents to the following: Practices for cloning human beings. Processes for transformation the germ line identity of human beings. For commercial or industrial purposes, the use of human embryos. Procedure for altering the genetic recognisation of animals, which are possible to cause them suffering without any significant medical advantage to animal or human. (Gunning & Holm 2005: 20). It is desirable to have ethical exclusion where withholding a patent could definitely handicap the EU nations in the development stem cell medication. Human clone exclusion in EU may hamper the usage of the stem cell line to treat patients. This is like banning cameras as it could be employed in the making of obscene pictures. If somebody wants to discover a method for employing embryos to generate a viable merchandise to cure cancer, this may be considered as commercialisation. It is advisable and good to control “human cloning”, gene therapy, embryo investigation, human cloning, etc., either by European or national law obviously mentioning, and, which is non-permissible. It may or may not just to include by the EU Parliament to have this moral banning in its edict, but it does imply that courts and EU member nations’ patent offices have to function within its structure. On the other hand, the directory of exclusion need not necessarily applicable to EPO as patent office which is not an EU organisation. Moreover, the EPO is hampered by the EPC (European Patent Commission), which has analogues segregation if only expressed in wider terms. The Harvard oncomouse is a drug which has an active oncogene so as to give it a genetic character to develop cancerous tumors and Harvard university scientist invented it. Though, patent was given to it in U.S.A, there was over two-decade long legal battle over the validity of the analogues patent in respect of the “Harvard oncomouse”. Patent was refused by the EPC (European Patent Commission) on the footing of Article fifty-three (b) of the “European Patent Conventions 1973” which bars granting of patent for animal or plant. However, on appeal, considering the probable medical advantages of the mouse which overshadowed by any issues of animal risks of escaping into the environment and possible suffering was the basis for grant of patent. Hence, it was decided that the discovery had not infringed the stipulations of “Article fifty-three (a) of the EPC, 1973” and hence a patent was granted on the Harvard oncomouse. (Rimmer 2008: 91). The Edinburg patent No EP 0695351 pertains to the invention in the field of developmental biology and was granted to University of Edinburg in 1999. However, there were severe criticisms against this by Green Peace activists, and they castigated that EPO is selling out the privilege to use plants, animals and humans to the genetic engineering industry. It was contended that Edinburg patent infringed Articles 53 (a) of the European Patent Convention 1973 which excluded the patenting of innovations whose utilisaton would be opposed to the morality or “ordre public.’ Here, standard of a morality question arises. EU Directive 98/44 of 1998 obliges those Member nations to consider inventions that are not patentable where their exploitation on a commercial basis would be opposing to standards of morality or public order. The use of human embryos and the processes for cloning of human beings are in particular prohibited from patentability. The European Patent office (EPO) viewed that only very little inventions jeopardised on the basis that their usage might be opposed to standard of ethics. The oncomouse case itself exposes a formalised handling of the moral condition that had not really dealt with the issues of standards that opposite parties in that case were putting forthwith1 However, the patent owner contended that it never aimed to get the patent to cover creation of genetically modified humans. The Opposition Division contended that the finding of Opinion that process associated with human stem cells should be patentable only under some scenarios, which cannot be followed rationally. Thus, the Opposition Division was of the view that due to its many logical flaws, inconsistencies, and inaptness with the existing EU Directive and the present patent law, the Opinion must be discounted in toto. (Rimmer 2008:268). In the Leland Stanford / Modified Animal case, it was acknowledged by the parties that there are many medical advantages connected with the invention as the chimeric animals offer an animal replica for infection with HIV-I. EPO was of the opinion that argument that the patenting of animals is considered as essentially unethical in Western society and cannot be pursued and if the discovery has a lawful usage, EPO might not be expected to function as a moral expurgate and to bring into play the conditions of Article fifty-three (a) of EPC to decline on moral footing to award a patent on legal investigation, and even if it has an association with medical benefits. (Fredrick et al 2002: 77). Wisconsin Alumni Research Foundation (WARF) There has been much controversy against WARF’s patent as regards to embryonic stem cell research in EU. WARF filed a patent application for “Primate embryonic stem cells” in 1996. The patent application filed by WARF was rejected by EPC under Article 97 (1). The Division opined that WARF’s claims did not adhere with the needs of the Articles 53(a). (Rimmer 2002:269). The ability of the companies to get broad patents in the areas of biotechnology is already a matter of concern. Broad patent granting is already in existence in USA and EC.2 Robert argues that these varieties of patents destabilise to even stop or slow down the establishment of significant and useful technology. Granting of Agrecetus and Harvard non-human onco-mammal patent are breathtaking and by no means exhaustive illustrations of a broader trend in biotechnology. (Roberts 1994:371)The House of Lords in Biogen Inc v Medeva Plc (1997) held that claims which did not fulfill s 14(5) of the Patent Act 1977 would make the specification insufficient and non-enabling and would be revocable under s 72 (1) (c ) of the PA 19773. Whilst extensive patents on inventions relating to biotechnological have been issued by the EPO so as to sustain competitiveness of the “European biotechnology industry” and its competitors like Japan and the U.S, the EU courts approach is somewhat restrictive and different.4 Conclusion Different perception and approaches by EPO and UKIPO to stem cells mirrors that there exists different moral standards within EU on the subject. Due to different approaches and views, the patentability of stem cells is yet to be solved. In such a scenario, there arises a doubt whether the morality clause is being applied aptly? Further, other exclusions are still being applied narrowly thereby resulting in an increase in what can be the subject matter for a patent. This buttresses the convergence of the issue as regards to the patents, plants and PVR’s which the need of the hour is. When the patentability of biotechnological and genetic has never been opposed by experts , it is still prone to public discussion , especially as regard to the issue of patenting DNA sequences differentiated from the human genome. Much in these arguments relates to fallacy as regards to the part played by the EU patent system5. Agro-biotechnology patent6 have to be administered for the community purpose that is entrenched in patent law and for the wider public morality instead of the proprietarianism in IPR, an instrumental approach should exist since there is nothing essentialists about private property. (Drahos, 1999:443). List of References Fredrick Max, Newman Rothschild Scott. (2002). Intellectual Property Rights in Animal Breeding and Genetics. New York: CABI. Gunning Jennifer & Holm Soren. (2005). Ethics, Law and Society. New York: Ashgate Publishing Ltd. Rimmer Matthew. (2008) Intellectual Property and Biotechnology. New York: Edward Elgar Publishing. Read More