Welcome to the Spring edition of Inside Life Sciences.
It has certainly not been a quiet time in the life sciences space. It is not simply the extraordinary efforts of the industry in responding to the pandemic, although the rapid developments in the treatment of sufferers and the astonishing pace of the development of the vaccines and the deployment of the vaccination programmes is a testament to the industry and the effective management and flexibility of the regulators.
Behind the pandemic headlines, much has been happening, and this is a full edition. Of particular interest is the activity of the competition authorities, such as the announcement of a European Commission probe into Teva and its alleged patent filing and disparagement practices to protect one of its products from generic competition. Also notable is the CJEU's decision in the Lundbeck case where (to no-one's surprise) the pay-for-delay findings (and the fines) against Lundbeck and several generic companies were upheld. Finally, there has been the announcement that the European Commission's investigation into the excessive pricing practices of Aspen has concluded with a deal being reached over future pricing commitments from Aspen (although it remains to be seen whether healthcare providers in various countries may now seek a refund from Aspen in respect of its pricing activities stretching back over several years).
Elsewhere, in the United Kingdom the struggle to find a workable "modus vivendi" between the regulators (the MHRA, the Food Standards Agency and the Home Office) and the providers of CBD and other cannabinoid based treatments continues. As expected, the FSA has announced that only a very limited number of CBD products can stay on the market (for the time being while their novel food applications are being assessed) following the novel foods application cut-off date of 31 March this year. It will now be interesting to see whether this is effectively enforced and if the unsuccessful products are removed from the market.
And of course the patent courts never take a break. We refer to a number of cases in this newsletter and in particular the Illumina V Latvia MGI Tech case and application of the new principles relating to sufficiency of the patent. Although wider than just life sciences, I also refer to our recent round up of patent cases A Year in Review.
I hope you enjoy the newsletter!