On October 16, 2014, WikiLeaks released a complete draft of the Intellectual Property Chapter of the proposed Trans-Pacific Partnership Agreement (TPP). The TPP is a controversial free trade agreement being negotiated behind closed doors by officials from Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, United States, and Vietnam. The commonly understood objective of the agreement, under negotiation since 2006, is to lift trade tariffs and quotas between the negotiating ￼parties. In reality, this agreement would set new rules for many non-trade issues, ranging from food safety to internet freedom, and rewrite important non-trade policy for all counties involved. In fact, only five of the TPP’s twenty-nine chapters cover traditional trade matters, such as tariffs or quotas.
One such non-trade chapter is the agreement’s text on intellectual property ￼(IP) protection—a section that actually restricts rather than frees competition.
The United States’ most recent proposals for the TPP’s intellectual property chapter would require the majority of the negotiating parties to significantly alter the scope of their intellectual property laws — changes that would raise drug and crop costs, therein restricting access to affordable medicines and foodstuffs. For those nations that have already aligned their domestic laws with the TPP’s intellectual property provisions, this agreement would further ossify detrimental standards. This feature examines only one small—but important—piece of the TPP’s intellectual property chapter: the text’s provisions on patentability requirements. We argue that the patentability requirements set forth in the TPP could seriously harm public health and local farming practices in the negotiating countries. Patentability requirements are the conditions that an invention must meet to qualify for patent protection. These requirements can be separated into two different categories: subject matter requirements and substantive patentability requirements. In a given country, certain types of inventions cannot be protected by patent a priori because they relate to a subject matter that the country has excluded from patentability. For example, in some countries, plants are per se excluded from patentability. Accordingly, a patent application on a breed of cactus would be rejected because such an invention (a plant) is excluded from patentability. If a patent applicant succeeds in showing that her invention meets the threshold subject matter eligibility requirements, she must then show that her application also satisfies certain substantive patentability requirements. For example, under the World Trade Organization’s (WTO) Agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS), an invention must meet the substantive requirements of newness, inventive step, and industrial application.
The negotiating parties to the TPP have vigorously debated the scope of patentability requirements. The most recent draft indicates that the United States has retreated from its position that patents should be available for medical procedures, but might succeed in obtaining patent protection for plant-related inventions. The proposal to provide flexibility to exclude medical procedures from patentability will help ensure that the populations of the negotiating parties have access to all useful diagnostic, therapeutic, and surgical methods. However, if implemented, the new plant patent provisions could seriously disrupt traditional farming practices in the Pacific Rim and threaten food security in poorer farming communities. The text also shows that the parties are still debating how they should define utility—a substantive requirement that all inventions must be useful. Furthermore, a provision relating to the practice of drug-evergreening (when drug manufacturers obtain a second term of patent protection on a new form, use, or method of using a known substance) still remains in the agreement. Accordingly, despite some improvements, we contend that the text of the TPP’s intellectual property chapter remains a bad bargain for participating countries from a public health perspective. As government officials indicate that the agreement is nearing completion, careful consideration of the TPP’s patentability provisions becomes imperative.