[2] Whether the disclosure of test data or test result in a pharmaceutical invention is an essential requirement for the application specification (negative)

[2] In the specification of an application for patent, if a person with ordinary knowledge in the relevant technical field can clearly understand, recognize and reproduce the contents, even though there is no experimental data sufficient to establish the effect, the description is legitimate, and it is sufficient to state the pharmacological effect in the invention, and it is not an essential requirement in the specification.

원심심결 이유에 의하면, 원심은, 이 사건 출원발명(이하 본원발명이라고 한다)은 포유동물에 있어서 호중구(호중구)에 의한 엘라스타제(elastase)의 방출을 저해하기 위한 테니댑(Tenidap) 및 그의 약학적으로 허용되는 염기염에 관한 것인바, 발명의 상세한 설명에 테니댑 및 그의 염은 포유동물에 있어서 호중구에 의한 엘라스타제의 방출 그 자체를 저해하고, 엘라스타제-매개질환 및 기능부전을 치료하는 데 유용하며, 엘라스타제-매개질환 및 기능부전이 동맥염, 단백뇨, 폐기종 등으로 약리효과를 기재하면서 투여량, 투여방법 및 시험방법도 상세한 설명에 기재되어 있음을 알 수 있으나, 본원발명의 약리효과에 대한 시험방법의 기재는 그 과정만이 기재되어 있을 뿐 그에 따라 달성되는 시험 결과 내지 구체적인 데이터 등의 기재가 없음을 알 수 있어(항고심판 계속 중에 제출한 진술서는 명세서의 기재가 아님) 본원발명은 그 약리효과를 확인 내지 인정할 수 있을 정도로 명확하게 기재한 것으로 인정되지 아니하므로 본원발명은 그 명세서의 상세한 설명에 당해 기술분야에서 통상의 지식을 가진 자가 용이하게 실시할 수 있을 정도로 본원발명의 목적, 구성 및 효과를 명료하게 기재한 것으로 인정되지 아니하므로, 결국 본원발명은 명세서의 기재불비라 할 것이어서 특허법 제42조 제3항 에 의하여 그 등록을 거절한 원사정은 정당하다고 하였다.

Therefore, according to Article 42 (3) of the Patent Act, the detailed description of the invention in the patent application shall state the purpose, composition, function, and effect of the invention to the extent that the person with ordinary knowledge in the art to which the invention pertains can easily conduct it. The purport of the above provision is to publish the contents of the invention in the patent application to a third party and clarify its technical scope. Thus, it is to say that a person with average skill in the art to which the invention pertains, without adding special knowledge to the invention at the time of the application based on the description itself, shall clearly understand the contents of the invention without adding special knowledge to the technical level at the time of the application (see, e.g., Supreme Court Decision 94Hu654, Jul. 14, 195). Thus, if a person with ordinary knowledge in the art can clearly understand and reproduce the contents of the invention, it shall be legitimate even if there is no sufficient data to prove its effect.

Therefore, it is sufficient that there is a statement on the pharmacological effect in the invention of a drug, and the statement on the experimental data or test result is not an essential requirement of the specification. However, the examiner of the Korean Intellectual Property Office may request the submission of a separate test score or test data only when it is doubtful that a person with ordinary knowledge in the technical field at the time of the application, who is considered as the technical level at the time of the application, shows the use (effective) stated in the specification. According to the record, the applicant can be found to have submitted a test score in the name of the written statement during the appellate trial in this case (the first instance court recognizes it), and there is no omission in the written application for the invention in this case.

Nevertheless, the judgment of the court below that the effect of the pharmaceutical invention of this case is not stated in the patent application specification of this case on the grounds that there is no examination result that can confirm or recognize the pharmacological effect or specific data, etc., is an error of law that affected the conclusion of the trial decision by misunderstanding the legal principles as to the entries in the patent application specification. Thus, the issue of this point is with merit.

Therefore, the decision of the court below is reversed and the case is remanded to the Korean Intellectual Property Office Appeal Trial Office for a new trial and determination. It is so decided as per Disposition by the assent of all participating Justices on the bench.

Justices Cho Chang-tae (Presiding Justice)