超《TRIPS协定》条款对药品专利强制许可的变异及应对策略

签署双边自由贸易协定是后《TRIPS协定》时代美国、欧盟等发达国家提高知识产权保护标准的又一举措,由此所产生的超《TRIPS协定》条款使得药品专利强制许可制度被变异,难以实施.当药品试验数据专有权或药品专利链接制度对药品专利强制许可造成障碍时,立法上应明确其冲突解决方式,有利于避免今后我国的药品专利强制许可受到不利影响.     

重大突发公共卫生危机下的药品专利强制许可——现实需要、伦理因应与法律安排

新型冠状病毒肺炎于2019年底在我国爆发并迅速扩散,引发了全国性的重大突发公共卫生危机。为实现特效专利药品的充分供给,实施药品专利强制许可是最为高效的选择,不仅可以消解药品专利市场运营中所固有的“反公有地”悲剧,同时也可以有效规避药品专利国际合作中技术劫持与贸易倾轧。对于以人为本的主体性原则和与人为善的有益性原则两项伦理准则的遵循,保证了药品专利强制许可实施的伦理正义;而对于药品专利强制许可申请主体扩展和药品专利强制许可补偿标准细化两项法律完善举措的采取,则使我国药品专利强制许可机制克服了自身缺陷,能够在实践中有序运行,为重大突发公共卫生危机的化解提供制度支撑。     

我国专利强制许可零实施的原因分析

专利强制许可制度是对专利枳人的重要限制,它通过强制的方式平衡专利权人和公众或国家的利益.我国专利法对专利强制许可制度设置由来已久,但至今我国专利强制许可的实施记录仍为零,很多人认为该制度没有实际意义.甚至没有必要继续存在.而我国新专利法却对专利强制许可制度的修改作为重点进行关注.本文在介绍新专利法的同时试分析我国专利强制许可零实施记录的原因.     

国外简讯

WTO 允许专利药品实施强制许可制度世界贸易组织(WTO)2005年12 月6日发表公报说,该组织当天通过协议,把实施专利药品强制许可制度文件以永久修正形式纳入《与贸易有关的知识产权协议》(Trips),允许发展中成员和最不发达成员在因烈性传染病而发生公共危机时,在未经专利权人许可的情况下,在国内实施强制许可制度,生产、使用、销售或从其他实施强制许可制度的成员国进口有关治疗上述疾病的专利药品。这是世贸组织首次对其核心协议进行修正。知识产权与公共健康是2001年开始的多哈回合谈判的重要议题之一。这一谈判的核心是既要让发展中国家能以低廉的价格买到治疗艾滋病、疟疾、肺结核等疾病的救命药品, 又要维护发达国家在新药制造等方面拥有的知识产权。WTO 总干事拉米表示：协议的通过再次表明世贸组织成员努力使多边贸易体系服务于人道主义和发展目的的决心。□(解放)     

论我国现行药品专利强制许可立法的不足与完善

面对艾滋病、SARS、禽流感等大规模传染性疾病对公共健康安全的威胁,世界贸易组织以及各国纷纷加强药品专利强制许可立法,当然,我国也不例外。但是,我国现行药品专利强制许可制度,仍然存在立法层次过多、颁发事由不明确、申请主体过窄等不足,在今后进一步完善相关立法时,应考虑在专利法中对药品专利强制许可做出专门的、完整的规定,并明确将公共健康利益需要作为颁发专利强制许可的事由,以及允许任何单位和个人成为药品专利强制许可的申请主体。     

专利强制许可制度初探

专利强制许可制度设置的目的在于防止专利垄断权的滥用和平衡专利权人的利益与社会公共利益。我们应当以专利强制许可制度的合理性为基础,转变专利强制许可的实施思维,对专利强制许可制度进行完善,从而使专利强制许可制度能够与我国的经济发展水平和社会公共利益需要相适应。     

Inadequacy of China＇s Legislation on Compulsory Licensing of Pharmaceutics Patent and Its Improvement

面对艾滋病、SARS、禽流感等大规模传染性疾病对公共健康安全的威胁,世界贸易组织以及各国纷纷加强药品专利强制许可立法,当然,我国也不例外。但是,我国现行药品专利强制许可制度,仍然存在立法层次过多、颁发事由不明确、申请主体过窄等不足,在今后进一步完善相关立法时,应考虑在专利法中对药品专利强制许可做出专门的、完整的规定,并明确将公共健康利益需要作为颁发专利强制许可的事由,以及允许任何单位和个人成为药品专利强制许可的申请主体。     

药品专利强制许可制度与我国应对公共健康危机的政策导向

近年来,面对频频爆发的公共卫生、公共健康危机,如何在使患者获得有效的廉价的治疗药品的同时,又充分保护药品专利权人、制造商的利益,并发挥知识产权的激励创新机制？这个问题是摆在世界卫生组织、各国卫生部门和专利权管理部门面前亟待有效解决的急迫问题。上述问题可以归结为如何平衡专利权人和公众健康之间的利益关系。本文从药品专利强制许可制度人手,指出该制度作为一项得到国际社会认可的救济途径,在TRIPS及相关国际公约已经明文确定了实施药品强制许可的大背景下,一些发展中国家是如何通过采取药品专利强制许可降低药价、解决突发公共健康危机的,以及我国政府在采取药品专利,强制许可措施时所应当注意的问题。     

谈药品专利的强制许可制度——以公共健康为视角

本文简单概述了专利制度,介绍了专利以及药品强制许可制度的发展历程,分析了各国对强制许可的态度。文章力图从公共健康的角度论述专利制度中是药品的强制许可的合理性、必要性,并结合我国的国情,论述了药品强制许可制度在我国的现状以及如何改善的问题。     

关于强制许可制度的完善

为更好地施行《专利法》中有关强制许可的新规定,《实施细则》也进行了相应的修改,具体包括:明确界定了强制许可相关规定中涉及的"未充分实施其专利"、"取得专利权的药品"等重要概念;对我国具体实施出口专利药品强制许可提出了符合国际条约的基本要求;进一步完善有关强制许可的程序性规定等。     

公共健康和强制许可制度

TRIPS协定将传统的专利保护客体扩大到所有技术领域的任何发明,将医药产品及方法纳入了专利保护的范围,以致受专利保护的药品价格大幅上扬,在一些国家尤其是发展中国家和不发达国家产生健康危机。本文试图在分析《多哈宣言》及其《执行决议》中关于强制许可制度规定的基础上,提出我国可将其作为解决公共健康危机的基本途径。     

An Economic Justification for Open Access to Essential Medicine Patents in Developing Countries

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the "deadweight losses" caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which can be corrected through compulsory licensing. Open licenses that permit any qualified firm to supply the market on the same terms, such as may be available under licenses of right or essential facility legal standards, can be used to mitigate the negative effects of government-granted patents, thereby increasing overall social welfare.     

Comment: Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options

In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS Agreement of 1994 to the 2003 waiver to, and later proposed amendment of, article 31, which enables poor countries to obtain needed medicines from other countries that possess manufacturing capacity. The Comment then evaluates recent, controversial uses of the relevant legislative machinery as viewed from different critical perspectives. The Comment shows how developing countries seeking access to essential medicines can collaborate in ways that would avoid undermining incentives to innovation and other social costs attributed to compulsory licensing. It ends by defending the legality of recent measures taken to promote public health in developing countries, and by reminding developed countries that unilateral retaliation against such measures is demonstratably illegal under WTO foundational law and jurisprudence.     

中国专利强制许可制度的完善

专利强制许可制度是保护社会公众利益和防止滥用专利垄断权的重要手段。TRIPS协议允许WTO的成员在一定情况下使用专利强制许可制度。我国社会保障制度不健全,现行立法对专利强制许可制度的使用限制亦过严,没有充分利用WTO规则所赋予的灵活性,许多规定甚至超过TRIPS协议的要求。这种状况与我国的经济发展水平和社会公共利益需要不相适应,有必要通过修订法律加以完善。     

The status of WTO non-members: A review in light of the 6 December 2005 proposed amendment to the TRIPs Agreement

Legal context: After almost four years of debate, the World Trade Organization(WTO) has finally proposed to amend Article 31 of the TRIPsAgreement as part of the international endeavour to tackle theconflict between drug patent rights and the right of victimsof public health crises to have access to affordable drugs.The proposed amendment, Article 31bis introduces a special compulsorylicence regime for the purpose of manufacture and export ofcheaper pharmaceutical products from some Members of the WTOto those which have no or insufficient capacity to manufacturethese products. Key points: This article discusses the status, in light of the proposedamendment, of non-members of the WTO that are otherwise membersof other health-related international organizations (like theWorld Health Organization), which have been striving to finda solution to this conflict alongside the WTO. The article providesbackground information on the drug patent-public health debate,and discussion of Article 31bis and compulsory licensing. Practical significance: The discussion on the status of non-members of the WTO in lightof the proposed system will help the reader to understand thatlimiting the benefits of the system to Members of the WTO might,contrary to the spirit and the history of the proposal, leavenon-members behind in the global fight against public healthcrises. The article will show that without directly violatingthe TRIPs Agreement and the proposed amendment, non-memberscan also participate in the global fight against public healthcrises and thus benefit as many victims of these crises as possible.     

非法实施发明专利入罪的认识误区及克服

加强专利权保护是形势使然。专利权具有无形性、公开性和非竞争性,容易受到侵害。专利民事司法保护存在刚性不足、赔偿数额认定难等局限。专利行政执法对效率的追求造成程序监督弱化。刑法具有制裁手段的严厉性和“二次保障性”特征,遏制专利侵权优势明显。以专利权系私权、专利权具有不确定性、专利案件审理存在技术性难题为由反对非法实施发明专利侵权入罪的主张并不成立。专利刑事立法应当从“权利救济”转向“法益救济”,重构有关专利犯罪客体,增设非法实施发明专利罪,把故意侵犯发明专利且情节严重的行为规定为犯罪。     

论精神障碍患者强制住院异议机制的完善

以维护精神障碍患者的合法权益为立法宗旨、经过27年反复斟酌的《精神卫生法》终于出台，填补了精神卫生领域立法的空白，也将人权保障写入法律。精神障碍患者以自愿住院为原则，强制住院为补充，减少了“被精神病”的发生，但是对于强制住院的异议机制规定甚少且可操作性不强，不利于维护精神障碍患者的权利。在借鉴国外精神障碍强制住院异议制度的基础上，从提出异议的主体、异议机构以及异议程序方面，结合我国国情，对强制住院异议机制进行完善。     

WTO成员方认可《TRIPs协议修正案》的法经济学分析

与一般强制许可相比,《TRIPs协议修正案》下的强制许可,其生产成本更高。由于受到竞争、竞售药品、生产成本、风险、市场大小、药品捐赠等经济因素的影响,许多通用药品制造公司不愿意援引《修正案》及其所涉强制许可制度生产并且出口药品。多个经济因素的存在,都会影响到WTO成员方对《修正案》的认可。