Biotechnological innovations and Patent Law

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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).

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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.

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