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醫療方法之專利保護向來是一個充滿爭論且棘手的問題。歐洲專利公約於2000 年修法時，將不予醫療方法專利的立法架構，從擬制不具產業利用性變更法定不予專利事項。限制的項目維持不變，仍為人體或動物之「手術方法」、「治療方法」及在人體或動物上實施之「診斷方法」。而歐洲專利局擴大上訴委員會於2005 年關於診斷方法的G 1/04 （ Diagnostic methods/CYGNUS）案，及2010 年關於手術方法的G 1/07（Treatment by surgery/MEDI-PHYSIC）案之決定，更是進一步嘗試替爭議許久的醫療方法判斷標準及解釋方法，找出一最符合法安定性的平衡觀點。特別是在G 1/07 案中，擴大上訴委員會明確指出歐洲專利公約中之法定不予專利事項，應和其他可專利性要件採同樣之解釋方法，而非逕自認為宜採從嚴解釋。我國專利法及審查基準對醫療方法之看法，不管是定義或構成要件，都與歐洲形成之判斷標準十分接近。本文藉由對歐洲專利局最新醫療方法相關決定的詳細分析，期能提供我國法制在醫療專利和公共健康議題上，參考借鏡之處。 Under article 53(c) of the European Patent Convention (the “EPC”) 2000, methods for medical or veterinary treatment, namely therapeutic, surgical and diagnostic methods, are excluded from patent protection. Considering the difficulty to find a balance between the interests of public health and of patients, specially freeing the medical profession from constraints which would be imposed on them by patents granted on method of medical treatment, and the proper patent protection for these medical related inventions, the Enlarged Board of Appeal of the European Patent Office has delineated the boundaries of the exclusion to insure the necessary legal certainty by two recent decisions G 1/04 and G 1/07. This article attempts to analyze these recent decisions by considering the definition and the scope of the exclusion of surgical methods in the light of the ratio legis of Article 53(c) EPC. By doing so, some suggestions could be given to TIPO, in hope of more consistent in their interpretation of the exclusion of methods of medical treatment. |
