Intellectual Property Concerns

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Introduction In line with the advancement of technology in the field of medicine, there has been a great deal of discovery of human genome related genes and diagnostic methods. Patent law has encouraged inventors to patent their invention so as to avoid exploitation and promote innovation. However, these patents appear to be controversial and have been a hotly debated issue in many countries, such as the BRCA1 gene patents and its diagnostic methods patents. This essay will address the merits and demerits of patent by looking into the relevant legal framework and analyzing it in terms of US, UK and EU case laws. The main focus would be on patentability of genetic diagnostic in vitro test and human genome related genes. Patent Law European Union The general requirements for patent law in Europe is governed by Art 52(1) of the European Patent Convention(EPC) 2000.[1] It provides that any inventions that fulfill the requirement of novelty and inventive step can be patented if they are capable of industrial application.[2] However, the exact concept of invention has not been explicitly defined by the EPC. Nevertheless, it is stated that the invention must possess technical features[3] that relates to a technical field[4], and which involves a technical problem.[5] Thus, it can be seen that ‘technicality’ is a prerequisite in order to be patent eligible. Besides, exclusions that must not be treated as inventions are provided in Art 52(2)[6] and 52(3)[7]. United Kingdom In UK, the governing statute for patent law is the Patents Act 1977.[8] It is passed to implement the EPC. The essence of patent law is in s1 to s3 of the act, where the criteria for patentability are provided. This act also provides a list of exclusions from patentability that will only be applicable when relevant. According to s 4A(1)(b), diagnostic methods themselves are unable to be patented.[9] This provision is very similar to Art 53(c) of the EPC. United States Patent law in the United States is governed by S 101 of Title 35 United States Code(USC).[10] It provides that for a subject matter to be patentable, it must fall within either of these categories, namely process, machine, manufacture and composition of matter.[11] If one discovers or invents any new and useful abovementioned subject matters, or any new and useful improvement, they might be eligible to acquire a patent subject to the requirements and conditions.[12] The prerequisite that an invention be ‘technical’ is not explicitly present in US law. Also, there is no statutory provision equivalent to Art 52 EPC that provides exclusions from patentability. Nevertheless, the courts have devised some exceptions from patentability, such as law of nature, abstract ideas and basic human knowledge.[13] Patentability of Genes European Union and United Kingdom In order for a gene to be patentable, there must be an invention and it must satisfy the requirements of novelty, inventive step and industrial application. In Netherlands v DIR 98/44/EC, it was confirmed that Art 5(1) of the Directive which states that human body is not patent eligible was valid.[14] Therefore,

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