Day November 25, 2019

Five Reasons the U.S. Should Not Review Its Dealings With South Africa

[Sean Flynn and Jonathan Band] On November 13, 2019, BusinessTech published an article listing the International Intellectual Property Alliance’s five primary concerns with the Copyright Amendment Bill awaiting President Ramaphosa’s signature. These concerns have led the U.S. Trade Representative to review the eligibility of South Africa for trade preferences. An examination of these five concerns reveals that they have no merit.

Access to Knowledge? WIPO Not Ready to Decide

[Electronic Information for Libraries] ...During the SCCR/39 session, and at the International Conference, three core issues emerged from the discussions: 1) there was clear recognition that L&Es are intrinsic to a balanced copyright system; 2) there was wide acknowledgement that copyright laws in many countries are falling behind in the digital age, and 3) there was emerging consensus on the urgent need to support preservation and access to cultural heritage, a core public interest activity of libraries, archives and museums.

The Biosimilar Action Plan: An Effective Mechanism for Balancing Biologic Innovation and Competition in the United States?

[Simone A. Rose and Tracea Rice] Abstract: The strain between balancing pharmaceutical innovation and competition in the United States (U.S.) is centered around the need to ensure that the U.S. continues to encourage medical innovation while simultaneously providing patients with access to affordable and innovative drug treatments. This tension exists whether the drugs at issue are chemically-synthesized or complex large molecule drugs, such as biologics. In 2010, Congress passed the Biologic Price Competition and Innovation Act (BPCIA). The statute created a statutory approval pathway for biological products shown to be biologically similar (biosimilar) to the originator or “brand” biologic, while retaining the same safety, purity, and potency as the brand. Unfortunately, the BPCIA’s provisions failed to accelerate biosimilar product development in the United States and we continue to lag behind Europe in providing patient access to affordable biosimilars.