The life sciences and healthcare sector is subject to complex regulation and decisions of Government bodies can have a significant impact on the availability and production of pharmaceutical products.  Where Government bodies take decisions of this nature, and there is no other recourse available, judicial review provides an avenue to healthcare companies and others to challenge Government decisions. Herbert Smith Freehills has had a practice note published in Practical Law which considers the various grounds of judicial review, the application of these grounds to specific cases in the healthcare sector and some particular considerations to be taken into account when making a judicial review application. Read more

Key points: In Australia responding to the urgent need for COVID-related medical devices the TGA implemented a number of emergency measures to bring medical devices to market faster. The emergency regulatory measures have proven agile, flexible and successful with the potential risks to the public well managed. The regulatory measures have potential utility beyond the … Read more

Last year the UK High Court decided that an AI system cannot be named as inventor on a patent application within the meaning of the Patents Act 1977, simply because an AI is not a person – but with the UKIPO recently calling for views on AI inventorship, could a change in law be on … Read more

On 4 March 2021 the EU Commission announced it has launched a formal investigation into possible anti-competitive conduct by pharmaceutical company Teva in relation to its blockbuster drug Copaxone, which is used in the treatment of multiple sclerosis. Read more

Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector In this edition we cover an important decision on sufficiency in England & Wales. We also cover several significant updates from the French courts, including two important decisions on SPC law. We also report on interim decisions of the Court of … Read more

After the German Parliament's upper house, the Bundesrat, passed the legislation to allow Germany to ratify the UPC Agreement (UPCA), there have been two challenges filed before the German Constitutional Court.  As a result, according to information from the Federal President’s office, he has been asked to delay his signature, which is required in order for the legislation to enter into force. This time the challenges include interim injunction applications, but we expect that if these are rejected, Germany will deposit its ratification of the Protocol on Provisional Application of the UPCA and not await the full decision. Read more

The final Brexit agreement, the Trade and Cooperation Agreement was agreed between the UK and the EU on 24 December 2020. Within this agreement are provisions that set out the standards expected to be recognised (mutually) between the EU and the UK in relation to intellectual property (including SPCs and trade secrets). There are some provisions concerning pharmaceutical regulation and product standards, but overall there is a lack of mutual recognition, with the consequence that, for both pharmaceuticals and medical devices, there are now effectively two separate regimes for the EU and the UK. Read more

We have previously discussed the changes to the regulation of medical devices both in the UK and the European Union in our May 2020 blog post here.  This post provides an update on the UK Medicines and Medical Devices Bill (the UK Bill), post-Brexit transition period guidance in the UK on the regulation of medical … Read more