Of immediate concern following the Task Force’s launch was the Trump Administration’s proposed free trade agreement with Kenya because it specifically sought provisions governing intellectual property rights similar to those found in U.S. law, including “undisclosed test and other data”, and it was intended to serve as a model for future accords with other African countries.
The reason trade agreements with developing nations are of heightened concern is because of the asymmetrical negotiating power enjoyed by the U.S. as well as the outsized political influence of U.S. pharmaceutical industry lobbyists. In the past, this situation has resulted in trade agreements that extend the monopoly granted to pharmaceutical patent holders beyond the 20-year maximum established by the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). These WTO TRIPS plus provisions include additional years to compensate for bureaucratic delays in granting the underlying patent and/or the authorization to market the product by the relevant health authorities (i.e., patent restoration time). These measures may also restrict access to the laboratory and clinical trial data proving a medication’s safety, quality, and efficacy that should otherwise become public records once the patent expires (i.e., data exclusivity). The practical effect of such provisions is to delay cheaper generic medications from coming to market.
The inclusion of intellectual property rights within the ambit of the WTO at its creation in the mid-1990’s was controversial given the existence for decades of a World Intellectual Property Organization based in Geneva. Equally as controversial was the decision requiring WTO member states to protect pharmaceutical patents. Many countries such as Germany until 1988, Spain and Portugal until 1992, Finland until 1993, and Ireland as well as Norway until 1997, excluded medications from patent protection. Although U.S. negotiators finally succeeded in securing patent protection for pharmaceuticals through the TRIPS, most developing countries were exempt until 2005. Meanwhile, the least developed nations were given until 2016 (since extended to 2033). Interestingly, protecting patents for up to 20 years from the date of filing was primarily to compensate for regulatory delays in approving the underlying patent application or in the registration/marketing approval of a medicine. Prior to TRIPS, those countries that even provided patent protection for medications did so for considerably less years. Even in the United States, patents were only protected for 17 years pre-TRIPS.
For the Task Force to be effective, it was deemed critical that that it include at least one representative from the Intellectual Property Law (IPL) Section. The IPL Section named its Task Force representative, while at the same time raising concerns about the effort led by India and South Africa at the WTO to temporarily waive TRIPS patent protection for COVID-19 vaccines. In May, the Biden administration announced its support for such a waiver.
The Task Force has, to date, been unable to achieve a consensus on an ABA Presidential Statement in support of the Biden administration’s TRIPS waiver on COVID-19 vaccines or a House of Delegates resolution making it ABA policy not to advocate for the inclusion of WTO TRIPS plus provisions in any trade agreement the U.S. may negotiate with a developing country. It has, however, succeeded in opening a channel of communication with the IPL Section leadership. This has provided an opportunity to inform the IPL Section of future opposition to any letter similar to the one it sent under Blanket Authority to the Office of the U.S. Trade Representative on February 14, 2018 advocating the inclusion of WTO TRIPS plus provisions on pharmaceutical patents in the trade agreement the Trump administration was negotiating to replace the North American Free Trade Agreement (NAFTA).
In the United States-Mexico-Canada Agreement (USMCA) that replaced NAFTA and was signed into law by President Donald Trump on January 29, 2020, the U.S. House of Representatives succeeded in removing text granting “data exclusivity” for so-called biologics for ten years and for new uses of existing pharmaceutical products for up to three years. Also eliminated was a provision that would have locked in the practice of “patent evergreening” by which pharmaceutical companies obtain patents on new uses for known products as a result of minor or insignificant chemical modifications. Furthermore, the USMCA expressly allows generic manufacturers to utilize compounds used to make a patented drug in order to develop a generic version in anticipation of that drug’s patent expiration. These modifications to the USMCA removed “provisions that contribute to high prescription drug prices” in order to “improve access to affordable medicines”.
The Task Force has also provided a way to provide information to the IPL Section on how the United Nations Guiding Principles on Business and Human Rights (UNGP) imposes an obligation on business enterprises to respect human rights. Law firms, as business enterprises, have a responsibility to avoid infringing on the human rights of others and should address adverse human rights impacts with which they are involved. Although the UNGP are voluntary in nature, there are efforts at the UN to make these principles legally binding through a Business and Human Rights Treaty. The European Union is also engaged in efforts to make these principles legally binding on companies that are based in member states or that do business with them.
