The Patent Review Standards Of Human Gene Sequence

As the 21 st century in the field of biological and life science and technology, one of the most active technologies, human genes related technologies on the issue of patent protection bring out a lot of controversial because of its particularity.The human gene sequence patent review mainly face the following problems: patentability questions are not clearly defined, the practicability of patent examination standard is fuzzy, usability review standard is without a stable and consistent height; The current human genome sequence patent examination standard couldn’t satisfy the interests balance, because of its’ characteristics of material invention, biological medicine invention and chemical invention are not considered comprehensively, so as to the current human genome sequence patent examination standard has caused a lot of controversial. At the same time, it has the characteristics of special ethics significance object so whether it against morality is controversial.Each country has its different legislations about the patentability and review standards of human gene sequence patent according to its different condition. On the patentability of the human genome sequence, the United States assorts it as an industrial product, material composition in patent theme, Japan is invented it as a chemical invention into the patent object, while the European Union classifies it as a biological materials incorporated into the scope of patent protection. At the same time, Japanese and European legislation said that the pure gene sequence which didn’t explain the function is non-patentability. The European Union(the EU) prescribe that its ethical issues should be organized by certain evaluate, also propose gene provider’s right of informed consent. On the issue of human gene sequence patent examination standards, the United States have established a certain height and the complexity of the examination standard through a series of case. While the EU particularly emphasize on the technical characteristics, Japan specially stress on the written patterns of claims in order to control the scope.For our countrie’s current situation of the human gene sequence patent examination standards, namely the patentability of human gene sequence is fuzzy, the standards of usability review is in a low degree and the ethics significance is without a full consideration. So we should improve our examination standards in the following aspects: clearing the human genome sequence protection object with the industrial applied height by telling the difference between "invention" and "discovery", appropriate increasing practical standard. And the introduction of genetic material provider of informed consent right as well as creating a database of genetic material provider is necessary, also to standardize the legal rights of the human genetic sequence source and balance the huge economic benefits which the human gene sequence patent brought.