IP Insights

Revision of Examination Guideline for Medical Method Inventions

Under the old Examination Guideline, methods of preventing, treating, or diagnosing human diseases were exempted from patentability on the grounds that they are considered as being not industrially applicable. However, the new Examination Guideline, which is effective as of January 1, 2008 and is applied to all the patent applications pending in the Korean Intellectual Property Office (KIPO), partly abolishes the previous exemption for methods of diagnosing human diseases.

Under the old Examination Guideline, methods which are regarded as substantial diagnostic methods were not patentable in addition to diagnostic methods which are directly applied to or practiced on the human body, in which substantial diagnostic methods are methods of analysis, measurement, or determination in direct association with the diagnosis or methods of collecting or processing data for the purpose of the diagnosis.

However, according to the new Examination Guideline, the only diagnostic methods to be excluded from patent protection are those that include steps which affect directly and non-temporarily on the human body, and therefore, the diagnostic methods that do not include steps of clinical determination are now patentable. Clinical determination is defined as a mental activity for determining conditions of a disease or health state on the basis of medical knowledge or experience.

Examples of claims which were not patentable prior to the revision, but are now patentable are as follows:

- A method of detecting a cancer marker A from a patients sample by an antigen-antibody reaction for providing information necessary for diagnosis of colon cancer
- A method of detecting albumin from urine for diagnosis of renal diseases
- A method of arranging electrodes for measuring electrocardiograph.

In light of the revision of the Examination Guideline, we recommend amending a claim directed to a diagnostic method to delete a step of diagnosis if any, and rewriting its preamble to recite an appropriate method other than diagnostic method, such as a method of analysis, a method of detection, a method of determination, etc.

Should you have any questions regarding the revised Examination Guideline, please feel free to contact us.