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Written Description Requirement For The Medical Use Inventions Characerized By A New Administration And Dosage

For many years, novelty of medicinal use inventions characterized only by an administration method and dose was denied and only inventions for the medicinal use of medicinal substance were allowed in Korea. This was changed when the Supreme Court, on May 21, 2015, rendered a decision that medicinal use inventions characterized only by a new administration method and dosage could be protected by law. However, despite the fact that the patent eligibility was recognized by the Supreme Court’s en banc decision, the substantive judgment of the value of the invention (judgment of inventive step) could not be assessed due to the defect of the formal requirements such as incomplete description and rejecting these inventions because of formal deficiencies is not proper. An inventor selects an appropriate time to apply for a patent at the time when the inventor considers that the invention seems to have matured. If the written description requirement is excessively strict, the inventor cannot obtain a patent for a valuable invention because it is difficult to file an application at an appropriate stage, and the purpose of the patent law cannot be achieved. Therefore, the written description requirement needs to be set so that technological progress through the disclosure of the invention and the protection worthy of the value of the invention is harmonized. In the case of the medicinal use inventions that is characterized only by a new administration and dosage, except in special cases, the use (effect) as a medicine or the pharmacological mechanism by which the substance acts to exert its medicinal effect is already known. Therefore, even if there is no specific description such as pharmacological data, the invention should be regarded as satisfying the description requirements of the description. Except in special cases where the pharmacological mechanism itself changes depending on the dose (the therapeutic effect itself changes), the pharmacological mechanism itself generally does not change depending on the administration route and dose. If the target disease is the same and the goal is to reduce side effects, improve compliance with medication, and increase drug efficacy by changing the dosage regimen, the pharmacological mechanism for the disease is already clear. Therefore, even if it is not described in a test example in which pharmacological data is shown, or is not specifically described to the extent that it can be substituted, the substance should be regarded as satisfying the description requirements of the specification because it can be easily used for its pharmaceutical use.