EU Action Plan on IP – the challenge ahead

Herbert Smith Freehills' European IP team have had a feature article on the EU's IP Action Plan published in the April edition of PLC Magazine – see EU Action Plan on IP – the challenge ahead here. The article looks at the current challenges for the EU in relation to IP, its key focus areas and plans for future regulation and legislation, including: • The Unified Patent Court (UPC) • Supplementary Protection Certificates (SPCs) • Compulsory licensing • Standard Essential Patents (SEPs) • AI and emerging technologies • Counterfeiting • Designs • Geographical Indications • Data • The Pharmaceutical Strategy for Europe Read more

Judicial review – another weapon in Big Pharma’s disputes arsenal?

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

A ‘new normal’ when it comes to the TGA regulation of medical devices?

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

Patent pending: the law on AI inventorship

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

Patent and Pharma Update, February 2021

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

Challenges to German ratification of the UPC Agreement trigger delay but possibly not for long

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 Trade and Cooperation Agreement and its impact on IP, Pharma and Medical Devices

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