新藥監視期、資料專屬及專利連結制度對學名藥上市之影響

Effects of New Drugs Post-Approval Surveillance, Data Exclusivity and Patent Linkage on Marketing of Generic Drugs

陳昭華(Jau-Hwa Chen) ； 鍾鏡湖(Jing-Hu Chung) ； 張乃文(Nai-Wen Chang) ； 鄭耀誠(Yao-Cheng Cheng)

《臺灣科技法律與政策論叢》 4卷4期 (2007/12) Pp. 39-83

https://doi.org/10.7050/TJLTP.200712.0039

摘要

藥品研發是一項技術及資金密集的產業，由專利申請到藥物可以上市販賣，往往即須耗時八至十二年之久，在新藥研發成功後，業者無不期望能獲得專利權保護，藉以回收其過去在研發上所花之資金，並作為進一步研發之基礎。基於此，具有專利權之原廠藥價位自然高。但高價位可能就有需要用藥者負擔不起，也因此在專利藥專利保護期限過後，其他藥廠依原廠藥申請專利時所公開的資訊，產製相同成分、相同療效、相同劑量的學名藥就開始搶進市場。新藥與學名藥在試驗項目、耗費時間及資金上自有天壞之別，學名藥進入市場對原廠藥自是一種衝擊，為同時保護二者，乃須考慮如何權衡專利藥廠商與學名藥廠商間之利益問題。我國製藥產業多以技術門檻低的學名藥為主，但台灣已逐漸邁入已開發國家之林，我國製藥產業也必須逐漸轉型為具有相當開發能力的研發型藥廠。在此轉型階段，可適度地引進先進國家保護新藥廠商的制度，以尋求最適合我國製藥產業發展的規範。本文探討了為調和專利藥廠商與學名藥廠商間的利益衝突，在各國法制上多所運用之制度，包含延長專利期、新藥監視期、資料專屬及專利連結，與台灣現行規定做一比較，以作為我國在檢討相關法規或引進相關制度時之參考，以求在促進藥品產業研發與社會大眾能更容易近用藥品的兩個公共利益中取得適當的平衡點，謀取最大的社會利益。

關鍵字

新藥監視期 ； 資料專屬 ； 專利連結 ； Hatch-Waxman法案

並列摘要

Pharmaceutical research and development is a capital-intensive industry. Development of new drug, from patent pending to marketing drug product, usually takes 8 to 12 years. Investors depend on patent protection to retrieve their investment and collect fund for further developments, thus patented drugs are highly priced. However some patients are unable to afford such expensive drugs, other drug manufacturers may make the same drugs as patented drugs according to disclosed information of related patents after expiration of such drugs, which are so called ＂generic drugs＂. There are significant differences between new drugs and generic drugs on experiments requirements, consumptions of time and fund, marketing of generic drugs is a great impact on new drug manufacturer, and thus we have to balance revenues of manufacturers of new drugs and those of generic drugs. Generic drug manufacturers are majority of pharmaceutical industry in Taiwan, however Taiwan is gradually transform to a developed country, pharmaceutical industry should gain their research and development ability and transform to new drug manufacturers. In this progress, we can import some suitable new systems that protect new drug manufacturers from leading countries, and find out regulations that fit developments of Taiwan most. This article discusses on systems used in leading countries that harmonizes conflicts of profits between new drug manufacturers and generic drug manufacturers, including patent term extension, post-approval surveillance, data exclusivity and patent linkage; and compare these systems with current regulations of Taiwan in order to make a suggestion when importing related system or regulations, and to find the balance and maximize of two public interest, drug development and easier drug access.

並列關鍵字

Post-Approval Surveillance ； Data Exclusivity ； Patent Linkage ； Hatch-Waxman Act