[James Damian Hakert] Abstract: ... NAFTA allowing pharmaceutical companies to successfully dispute national patent laws could have significant future consequences. This note outlines the circumstances surrounding Lilly’s dispute, analyzes the dispute’s viability, and explores various potential implications of the dispute going forward.
Democratic lawmakers are again warning that USMCA intellectual property chapter's rules on test data protection for biologics could scuttle the deal. The text grants developers of new biologic drugs a ten year period of exclusivity during which biosimilar competitors cannot win marketing approval based on the innovator's test data.
The undersigned organizations representing healthcare providers, patients, public health experts, workers, people of faith, and consumers are committed to advancing public health and promoting access to affordable medicines. Access to affordable healthcare and medicines is one of few demands that now unites the American public. We write to you today with concern that provisions currently included in the proposed NAFTA 2.0 (referred to by the Trump administration as the United States-Mexico-Canada Agreement) would entrench and expand prescription drug monopoly protections, thwart competition and thus undermine efforts to expand access to affordable medicines.
This post will demonstrate that prices of pharmaceutical imports have grown more quickly after countries adopted data exclusivity in their laws. It is also intended to show that trade data can be a useful source of information for studies of drug pricing. The post is based on my presentation given at pre-Global Congress workshop on empirical research into the effect of TRIPS-Plus trade agreements on access to medicines.
[Ping-Hsun Chen] Abstract: The Trans-Pacific Partnership (“TPP”) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan’s proposal includes both measures.
[Sean Flynn and Mike Palmedo] Comments to USTR - re: Negotiating Objectives for a U.S.-European Union Trade Agreement: PIJIP is managing a multidisciplinary research project on the impact of copyright user rights in the digital environment. One issue that the United States and the European Union face in their upcoming negotiations is the degree to which they should seek to include language promoting copyright balance through limitations and exceptions in the agreement. We make this statement to share information from our research indicating that the promotion of balanced copyright systems promotes U.S. trade interests. ... We also provide the results of research on existing language in trade and international law that promote balance in copyright laws and include some analysis of how such provisions could better meet U.S. interests.
[Jeremy De Beer, Jeremiah Baarbé, and Caroline Ncube] Abstract: Intellectual property (IP) policy is an important contributor to economic growth and human development. However, international commitments harmonised in IP treaties often exist in tension with local needs for flexibility. This article tracks the adoption of IP treaties in Africa over a 131-year span, from 1884 to 2015, through breaking it down into four periods demarcated by points in time coinciding with key events in African and international IP law: the periods 1884–1935, 1936–1965, 1966–1995, and 1996–2015. The article explores relevant historical and legal aspects of each of these four periods, in order to assess and contextualise the evolutions of the IP treaty landscape on the continent. The findings show that treaties now saturate the IP policy space throughout the continent, limiting the ability to locally tailor approaches to knowledge governance.
This is the second in a series of blogs comparing copyright and technology provisions in eight trade agreements: TPP, CPTPP, USMCA, CETA, RCEP, EU-Mercosur FTA, EU-Japan FTA and the China-Korea FTA. The previous post discussed provisions calling for copyright ‘balance’ and addressing the circumvention of technological protection measures. This one looks at the provisions requiring secondary liability for internet service providers (ISPs) and allowing-or-requiring safe harbors from such liability.
The revised North American Free trade Agreement (NAFTA 2.0), rebranded by the Trump Administration as the U.S.-Mexico-Canada Agreement or USMCA, was signed last Friday during the G20 summit in Argentina. NAFTA 2.0 is an updated version of the nearly 25-year-old NAFTA, with significant and harmful changes to the intellectual property (IP) provisions, which build on the harmful TRIPS-plus standards in other U.S. free trade agreements since NAFTA 1.0.
[Prabhash Ranjan] Abstract: Given the increasing interface between intellectual property rights and international investment law, the aim of this chapter is to examine whether issuance of compulsory patent licenses could be challenged as indirect expropriation under investor state dispute settlement of investment treaties/free trade agreements of India, China, Malaysia and Thailand.
...According to Inside U.S. Trade (paywalled) President Trump told reporters “I don't expect to have very much of a problem” with Congressional implementation of the deal. However, some Democrats in Congress and some civil society groups oppose key provisions and plan to block ratification unless certain provisions are changed. Among the issues are intellectual property concerns.
Dear Mr. Prabhu: We are writing to you as concerned people living with HIV and civil society organizations working on the issues of intellectual property (IP), trade, and access to medicines to express our serious discontent over the IP provisions in the ongoing negotiations of the Regional Comprehensive Economic Partnership (RCEP). These provisions in RCEP are referred to as TRIPS-plus, and go way beyond India’s obligations under the World Trade Organization’s Agreement on Trade Related Aspect of Intellectual Property Rights (TRIPS). We call on the Government of India to protect the flexibilities available under TRIPS agreement in larger public interest.