In this article, the authors discuss new updates from the UK’s Medicines and Healthcare products Regulatory Agency on how software and artificial intelligence medical devices will be regulated in the United Kingdom after Brexit. Read and learn more!
Biotech Patent Wars: If at First You Don’t Succeed . . . University of California v. The Broad Institute Abstract This case discussed in this article is about two methods of editing DNA: one that has infinitely more lucrative applications because it can edit human DNA (plus all animals and plants), another that works in cell-free environments. Whether inventions are separate or part of the same innovation is an important factor in patent interference disputes; if there are two patentably distinct inventions there cannot be interference. One party in this case lost its argument that there was only one invention at issue, but returned with a second interference claim, arguing that it was the first inventor to constructively reduce to practice the animal and plant DNA editor. In this article, the author examines the nuances and intricacies of the patent process in the world of biology, and how patent lawyers must possess a level of knowledge in disciplines related to the inventions they seek to protect. This is necessary, for example, in understanding whether an invention is a significant improvement over prior innovations. The author also shares the importance of confidentiality especially when potentially groundbreaking (and lucrative) inventions are in development. Author Adrienne B. Naumann (adriennebnaumann@uchicago.edu) practices intellectual property law at the Law Office of Adrienne B. Naumann in [...]
"The potential to use artificial intelligence methods increasingly for the analysis of the increasing amounts of pharmacovigilance data is well understood and many companies are moving (or planning to move) there, and we can predict that routine tasks in pharmacovigilance will in the future be increasingly automated. It will be crucial, however, for regulatory authorities to very clearly provide a position about the use of AI as well as the acceptable level of quality from AI applications. But in parallel with the shaping of those definitions, given the massive increase in their AE case workloads that most companies are currently experiencing, the industry will out of necessity proceed swiftly with the adoption of AI and cloud technologies to reduce their costs and increase their efficiencies. "Like other industries, the pharmaceutical business and in particular the pharmacovigilance field will see a massive change in their processes in the near future, away from tedious, repetitive manual tasks towards a better utilization of scarce resources, in particular medical and scientific knowledge, for value-adding tasks. It is imperative for all stakeholders – industry, service providers and regulators – to provide an environment in which such a transformation can take place without ever compromising public health or the safety of the individual patient, and ideally providing additional benefit for patients." A quote from Addressing the Data [...]
