Poland has challenged the European Directive on Copyright in the Digital Single Market at the EU's Court of Justice, on the grounds that the snippet tax required by Article 15 amounts to censorship.
The leaders of the Senate Health, Education, Labor and Pensions have released draft healthcare legislation for comment. The Lower Health Care Costs Act of 2019 contains five titles, one of which is titled Lowering the Costs of Prescription Drugs. This title contains sections meant to speed the introduction of biosimilars to the the market; to reduce abuses of citizen petitions to block generic entry; to enhance the transparency of IP for biologics through changes to the Purple Book; and to "modernize" the Orange Book.
The trade ministers from Chile, New Zealand and Singapore have announced a new set of trade negotiations at this month's APEC meeting - the Digital Economy Partnership Agreement (“DEPA”). Their statement says "The DEPA seeks to deepen and strengthen cooperation in digital areas, establish new international approaches for digital trade issues, and explore new frontiers in the digital economy, such as digital identities, e-payments, cross-border data flows and artificial intelligence."
How will the recently-concluded United States-Mexico-Canada Agreement (USMCA) impact access to affordable medicines? The USMCA – the renegotiated North American Free Trade Agreement (also commonly referred to as NAFTA 2.0) – incorporates many of the harmful provisions from the Trans Pacific Partnership (TPP), including patent provisions that were suspended by the remaining Parties following the withdrawal of the US. It goes even further than the TPP in extending the exclusivities for biologics to ten years, an unprecedented TRIPS-plus measure. Beyond the intellectual property chapter, multiple other chapters and provisions of the USMCA also have implications for access to affordable, safe and effective medicines.
Last week, the Indian government released its second Draft National e-Commerce Policy, which is open for stakeholder comments. The document…
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.
[MSF Press Release] Médecins Sans Frontières (MSF) is supporting a patent challenge filed in India this week by two tuberculosis survivors, to prevent pharmaceutical corporation Johnson & Johnson (J&J) from extending its monopoly on the tuberculosis drug bedaquiline. Nandita Venkatesan from Mumbai, India and Phumeza Tisile from Khayelitsha, South Africa, who filed the patent challenge at the Mumbai Patent Office, both survived drug-resistant TB (DR-TB) but lost their hearing because of the toxicity of the treatment. They are now fighting to ensure that newer drugs like bedaquiline – which are safer and more effective – are made affordable and accessible to everybody with DR-TB, to replace painful and toxic drugs that need to be injected.
...PIJIP’s research indicates that American firms in industries that rely on copyright limitations enjoy better outcomes when our trading partners’ limitations are more like fair use. Specifically, US firms in technology and related sectors do better in countries where copyright exceptions permit fair uses and practices of any type of work, by any user, and for any purpose – as long as the use itself is fair to the owner.
[Comments to the International Trade Commission on the economic impact of the USMCA] Last year, we submitted comments to USTR regarding negotiating objectives for US-Mexico-Canada Agreement in which we recommended that U.S. negotiators seek a copyright provision that balances the interest of rightholders and users of copyrighted works... Unfortunately, the U.S.-Mexico-Canada Agreement does not include a copyright balancing provision. By excluding the provision, the United States loses an opportunity to promote the interests of firms in some of its most innovative sectors.
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.
[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.
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.