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According to the Korean Patent Examination Guidelines, the inventions concerning medical practice, that is, surgical procedures, methods of treating, or methods of diagnosing a human being, in principle lack industrial applicability and are not patentable. Such patentability rejection is based on the grounds that medical practice is deeply concerned with the dignity and survival of human beings, everyone should be afforded the rights of choosing and accessing medical procedures that can diagnose, treat, mitigate and prevent illnesses, and if inventions relating to a medical practice are patented, open access to the medical practice becomes difficult as the physicians may be liable for patent infringement in performing certain medical acts.
However, recently, a variety of IT technologies, including artificial intelligence technology, have merged with medical technology in the development of new medical technologies. In order to clarify the patent examination criteria related to such development of novel medical technologies, the Korean Intellectual Property Office has recently revised the examination criteria for the biohealth field which took effect as of March 18, 2019.
According to the revised Patent Examination Guidelines, already known inventions of pharmaceutical composition for treatment of a disease comprising a pharmaceutically active ingredient1 are now considered patentable, if such pharmaceutical composition exhibits remarkable therapeutic effect on a certain patient group. For example, the invention of a pharmaceutical composition comprising a known pharmaceutical active ingredient exhibiting a remarkable therapeutic effect only in patients with a particular gene is patentable. For such inventions, a clear definition of a particular patient population and empirical verification of the remarkability of its therapeutic effect should be described in the specification.
In addition, as mentioned above, prior to the subject revision of the Patent Examination Guidelines, inventions related to diagnosis methods of diseases were classified as medicals acts and therefore, not patentable. But according to the revised Patent Examination Guidelines, diagnostic technology concerning methods of information processing on computers such as bio-big data processing methods are not classified as medical acts and therefore, are acknowledged as having industrial applicability. For example, because inventions such as a method of diagnosing a retinal disorder through analysis of retinal scan data by a computer, a method of predicting or diagnosing cancer by analyzing a patient's data through an artificial intelligence algorithm of a computer are not necessarily performed by physicians, such inventions are not classified as medical acts and therefore, are acknowledged as having industrial applicability.
In particular, the revised examination guidelines refer to inventions related to innovative technologies such as intelligent drug development that combine bio-big data and artificial intelligence technologies. In that regard, the revised examination guidelines stipulates that criteria for examining computer related inventions should apply to inventions of methods of searching a candidate for a new drug utilizing technology combining artificial intelligence and big data while, the candidate for a new drug are classified as medical inventions and therefore, the method of manufacture and the pharmacological effect thereof should be described in the specification.
As such, the Korean Intellectual Property Office has broadened the extent of the industrial applicability for medical inventions than before, and has clarified the examination criteria for medical inventions that are fused with new IT technologies. It is expected that the revision will expand the opportunity for patent protection of new technologies in the biohealth field.
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1 According to the Korean Patent Examination Guidelines, inventions related to medicinal use should generally be claimed in the form of “a pharmaceutical composition for treatment or prevention of a disease, comprising a pharmaceutically active ingredient.”
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