我國藥品專利權期間延長制再探討

Abstract

專利制度對於醫藥產業的作用有目共睹，有十分積極地作用。但藥品專利權過度保護產生了諸多弊端，對於藥品專利權的適度平衡成為必然。平衡制度中的藥品專利權期間延長制度，亦為重要的一環。\n藥品專利權延長制度主要為鼓勵專利藥的研發。但由於專利藥的高昂價格和產能制約等原因，學名藥的存在具有重要的意義。無專利藥，則藥廠無研發新藥動力；無學名藥，則公民生命權和健康權無法得到良好的保障。因此藥品專利權延長制度的設計中對雙方權利的平衡至關重要。世界各國對於藥品專利權延長制度大多有詳細之規定。美國規定有「藥價競爭與專利權期間回復法案」（Drug Price Competition and Patent Term Restoration Act）；歐盟規定有歐盟藥品補充保護證書制度(SPC， Supplementary Protection Certificate)；日本和我國亦對於藥品專利權延長制度有詳細規定。\n我國於西元1994年制訂最初版本之藥品專利權制度，並未妥善考慮對於國內產業之保護，在實踐操作過程中，亦為學者和實務界所詬病，現行修正的專利法，仍尚存在著較有利於專利權人之不合宜情形。比較我國制度與他國制度，本文認為，應以我國產業實際出發，對於學名藥廠給予更多的保護和扶植。在「第一次許可證之取得」的定義、專利權延長期間之核定，以及在專利權延長期間之計算上，我國現行制度尚可因應我國產業發展之現實而進行改進。\n因此，依我國的產業發展現況，本文建議，在「第一次許可證之取得」的認定上，不應給予多個許可證的選擇，應限縮第一次許可證之認定範圍，只判斷有效成分，減低第一次許可證選擇機會。在專利權延長期間之核定上，有兩個選擇，如果不分國內或國外之無法實施之臨床試驗期間全部納入計算，應採美國之作法為試驗期間之1/2計算，如果不納入國外試驗期間計算無法實施專利之期間，則可全額納入在國內臨床試驗期間作計算。最後，在專利權延長期間之計算上，如無限制上市後之獨佔期間，恐放寬了獨佔時間，應加註上市後至專利到期日止不可超過14年。

The role of the patent system for the pharmaceutical industry is obvious to all, and it has a very positive effect. However, the excessive protection of drug patent rights has produced many drawbacks, and a proper balance of drug patent rights has become inevitable. The extension of the drug patent right period in the balance system is also an important part.\nThe main purpose of the drug patent extension system is to encourage the research and development of patented drugs. However, due to the high price of patented drugs and production capacity constraints, the existence of generic drugs is of great significance. Without patented drugs, pharmaceutical companies have no incentive to develop new drugs; without generic drugs, citizens’ right to life and health cannot be well protected. Therefore, the design of the drug patent right extension system is very important to the balance of the rights of both parties. Most countries in the world have detailed regulations on the extension of patent rights for medicines. The United States provides for the "Drug Price Competition and Patent Term Restoration Act" the European Union provides for the EU Supplementary Protection Certificate (SPC); Japan and Taiwan also have drug patent rights extension system has detailed regulations.\nTaiwan formulated the initial version of the drug patent system in 1994, and did not properly consider the protection of the domestic industry. In the course of practice, it was also criticized by scholars and practitioners. The current revised patent law still has relatively high unsuitable circumstances that are beneficial to the patentee. Comparing Taiwan`s system with other countries` systems, this article believes that we should start from the reality of Taiwan`s industry and give more protection and support to scientific-name pharmaceutical factories. In terms of the definition of "first license acquisition", the verification of the patent right extension period, and the calculation of the patent right extension period, Taiwan`s current system can still be improved in accordance with the reality of Taiwan`s industrial development.\nTherefore, according to the current state of Taiwan’s industrial development, this article suggests that in determining the "first license acquisition", multiple license options should not be given, and the scope of the first license should be limited and only judged active ingredients, reducing the chance of first license selection. There are two options for the approval of the patent extension period. If all the clinical trial periods that cannot be implemented in domestic or foreign countries are included in the calculation, the US method should be adopted as the half of the trial period. The period during which the patent cannot be implemented during the external trial period can be fully included in the domestic clinical trial period for calculation. Finally, in the calculation of the extension of the patent right period, if the exclusive period after the unrestricted listing, the exclusive period may be relaxed, it should be noted that the period from the listing to the expiration date of the patent should not exceed 14 years.