Vines Tim
J Law Med. 2014 Jun;21(4):797-809.
The method of treatment of suffering in patients, including through surgery and the administration of therapeutic drugs, are essential features of medical professionalism. Few, if any practitioners committed to developing the core professional virtue of loyalty to relief of patient suffering through consistently implementing the basic principles of medical ethics, would consider that such beneficial methods of practice are, or should be, the subject of a patent--requiring the practitioner utilising them to pay a royalty or risk infringement proceedings. Indeed a formal opinion of the American Medical Association declares "the use of patents, trade secrets, confidentiality agreements, or other means to limit the availability of medical procedures places significant limitation on the dissemination of medical knowledge, and is therefore unethical". Yet this could be the direction in which Australian patent law is heading. The decision of the High Court of Australia in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50, upholding a patent over a method of using a known drug to prevent or treat psoriasis, may ultimately force practitioners to re-consider whether their basic ethical obligations to patients are secondary to a requirement to maximise profit for shareholders in companies holding medical patents. This column reviews this decision and its possible implications for health practitioners. It places it in context of other recent court decisions that have expanded the intrusion of corporate-owned intellectual property monopolies into Australian medical practices, and how legislative restrictions upon them in the Patents Act 1990 (Cth) places practitioners and patients at risk of more costly, ineffective or restricted health care. This column concludes by cautioning that Australia's scope to address policy problems caused by this case may be limited should it sign up to the Trans-Pacific Partnership Agreement, particularly if that preferential trade and investment deal includes an Investor-State Dispute Settlement clause that creates a mechanism for multinational corporations to challenge offshore, Australian federal and state policy decisions they perceive undercut their investments.
治疗患者痛苦的方法，包括通过手术和施用治疗药物，是医学专业精神的基本特征。很少有（如果有的话）致力于通过始终如一地践行医学伦理基本原则来培养对减轻患者痛苦忠诚这一核心职业美德的从业者，会认为这样有益的执业方法是或应该是专利的主题——要求使用这些方法的从业者支付专利使用费或面临侵权诉讼风险。事实上，美国医学协会的一份正式意见宣称：“使用专利、商业秘密、保密协议或其他手段来限制医疗程序的可用性，会对医学知识的传播造成重大限制，因此是不道德的”。然而，这可能正是澳大利亚专利法正在发展的方向。澳大利亚高等法院在Apotex Pty Ltd诉Sanofi-Aventis Australia Pty Ltd [2013] HCA 50案中的判决，维持了一项关于使用已知药物预防或治疗牛皮癣方法的专利，这最终可能迫使从业者重新考虑，他们对患者的基本道德义务是否要服从于为持有医疗专利的公司股东实现利润最大化的要求。本专栏回顾了这一判决及其对医疗从业者可能产生的影响。将其置于近期其他法院判决的背景下，这些判决扩大了企业拥有的知识产权垄断对澳大利亚医疗执业的侵扰，以及1990年《联邦专利法》（Cth）对它们的立法限制如何使从业者和患者面临医疗保健成本更高、效果不佳或受到限制的风险。本专栏最后警告称，如果澳大利亚签署《跨太平洋伙伴关系协定》，尤其是如果该优惠贸易和投资协定包含投资者-国家争端解决条款，为跨国公司建立了一个机制，使其能够挑战它们认为会削弱其投资的境外、澳大利亚联邦和州的政策决定，那么澳大利亚解决此案所引发政策问题的空间可能会受到限制。
