By Christopher Robertson The Federal government has wrested billions of dollars from the drug and device industry in settlements of claims that the companies broke the law by promoting their products “off-label” for uses not approved by the FDA. In response, companies have asserted that promotions are a form of speech, protected by the First Amendment. Speech…
By Shailin Thomas Earlier this month, the FDA announced that it is asking Endo Pharmaceuticals to remove the opioid Opana ER from the market. Opana ER is an extended-release pain reliever often abused by those who take it. While opioid abuse is nothing new, and many opioids leave those who take them addicted to narcotics or…
Join us at yet another webinar with J. Wested at the University of Copenhagen. This time we will debate procedural issues in compulsory licensing with H. Grosse Ruse-Kahn (University of Cambridge) & M. Desai (Eli Lilly). Further information on our webinar series is available at here, here, and below: Procedural Aspects of Compulsory Licensing under Trade-Related Aspects of Intellectual…
By Christopher Robertson Scholars and policymakers have long been concerned that the biomedical science literature — and thus the practice of medicine — is biased by the companies who fund research on their own products. Prior research has shown that industry-funded studies tend to produce results favorable to their company sponsors. One solution is disclosure of industry…
By Timo Minssen I am happy to announce the publication of our new working paper on “Patenting Bioprinting Technologies in the US and Europe – The 5th element in the 3rd dimension.” The paper, which has been co-authored by Marc Mimler, starts out by describing the state of the art and by examining what sorts of bioprinting inventions…
By Timo Minssen I am happy to announce the publication of our collaborative paper with Helen Yu and Jakob Wested on “Innovation and intellectual property policies in European Research Infrastructure Consortia (part I)” in the Journal of Intellectual Property Law and Practice (Oxford University Press). Taking the European Spallation Source ERIC as an example, our paper investigates ERIC Regulations…
By Rachel Sachs Yesterday, a group of 20 Democrats in both the House and Senate introduced the Improving Access to Affordable Prescription Drugs Act, a 129-page bill designed to lower drug costs while increasing innovation and promoting transparency. The bill aims to accomplish a number of different goals, and in this post I’ll go through…
Research Seminar at the University of Copenhagen debating intellectual property and innovation in synthetic biology, systems biology & gene editing. New technologies in biology offer a brave new world of possibilities. Promising solutions to some of the most urgent challenges faced by humanity: climate change, environmental protection, growing population, renewable energy and improved health care. Scientific…
This new post by Claire Laporte appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017. Believe it or not, the Patient Protection and Affordable Care Act (Obamacare, or here, ACA) has intellectual property provisions. In addition to establishing mandates, subsidies and insurance exchanges, the…
By Timo Minssen Dear Colleagues, I am happy to announce that I have just joined the Board of Editors of the new journal “European Pharmaceutical Law Review” (EPLR). One of my first tasks is to spread the news about our “Call for Papers”. Further information is available here. The European Pharmaceutical Law Review (EPLR) reports on key legislative…
