Abstract as per original application
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This project aims to evaluate the regime regulating intellectual property as it relates to the pharmaceutical industry in Hong Kong (HK). While HK’s Patents Ordinance is consistent with the TRIPS Agreement it does not clearly delineate or define several important issues relevant to pharmaceuticals. The project, therefore, will evaluate whether the Patents Ordinance is capable of responding to the needs of the pharmaceutical industry (taking into account both the branded and generic manufacturers) as well as the interests of users and make recommendations to the government with a view to producing a modern and flexible agreement which balances the interests of all stakeholders.
While interested parties have at times engaged in dialogue with the government on this issue, there is no sustained, holistic research balancing the often competing interests of stakeholders. This is surprising given the importance of access to medicines and health to a relatively wealthy and aging population and HK’s position as a technology hub attractive to foreign direct investment (FDI).
As a result, inconsistencies have emerged between legislators, laws and the courts. For instance, the government, the Secretary for Food and Health and individual legislators has all maintained that HK does not link the registration of a medicine to patent status but the recent decision in Abbott v. Pharmareg (2009/10) indicates otherwise. Other issues, such as the possibility of patent term extensions, evergreening, protection of test data and even limits on compulsory licensing are also unclear and/or unpredictable in certain circumstances.
The lack of predictability in the current law has lead to intense industry lobbying and even resulted in HK’s regime repeatedly being deemed to lack predictability and transparency by the US Trade Representative in its annual report on Foreign Trade Barriers (HKAPI, 2007; USTR, 2011). Clarification of the patent regime as it relates to the pharmaceutical industry is therefore necessary in order to maintain HK’s attractiveness to FDI as well as to maintain its health-related commitment to its residents.
At present the patent regime does not deal with numerous important issues relating to pharmaceuticals, thus providing little predictability to the industry and potentially failing to meet the health-related needs of residents. This project will evaluate the Patents Ordinance it relates to pharmaceuticals in an attempt to understand fully the interests of all relevant stakeholders and to assess how best to balance these interests with a view to producing recommendations to the government for reform.
本研究項目旨在評估有關香港製藥業知識產權的監管制度。香港的《專利條例》雖然符合《與貿易有關的知識產權協定》，但未明確解釋或規定有關製藥業的幾個重要問題。所以，本研究項目將評估《專利條例》能否夠應對製藥業（包括品牌製造商和普通製造商）的需求並滿足使用者的利益。同時，本研究項目將向政府提供建議以制定與時俱進、機動靈活且能平衡各方利益訴求的條例。
儘管利益團體在該問題上與政府偶有對話，但在如何平衡他們的利益衝突方面鮮有持續性、系統性的研究。醫藥衛生對與相對一個富裕並老齡化的社會的重要性不言而喻，研究領域在此方面的空白不僅令人詫異而且不符合香港吸引外商直接投資的技術中心地位。
立法者、法律和法院之間的矛盾日益明顯。例如，政府、食物及衛生局局長和一些立法者均認為香港的醫藥註冊與醫藥的專利情況無關，但最近法院在Abbott v. Pharmareg （2009/10）上的裁判並非如此。其他的問題，諸如專利條款的續展、“常青”、測試數據的保護以及強制許可的限制等，也是不清楚且難以預測的。
目前的法律在可預測性方面的缺失已經導致了激烈的行業遊說，美國貿易代表在《對外貿易壁壘》的年度報告中甚至屢次認為香港缺乏可預測性和透明度（HKAPI, 2007; USTR, 2011）。所以，無論對保持香港的外商直接投資的吸引力還是遵守香港在衛生方面對居民的承諾，厘清製藥業方面的專利制度是不可或缺的。
因為目前的專利制度尚未處理有關製藥的許多重要問題，所以行業缺乏可預測性，居民的健康需求可能也無法得到滿足。本研究項目將評估涉及醫藥方面的專利條例、了解所有利益相關者的訴求、並就平衡這些利益向政府提供改革建議。
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