This week, the EU General Court partially overturned the EU Commission’s decisions in Perindopril (Servier v Commission and Krka v Commission). The judgment was handed down pretty much on the tenth anniversary of the original dawn raids in November 2008. The raids came as a follow-up from the European Commission’s pharma sector enquiry and led to a number of infringement decisions that have also found their way up to the General Court and…
Arnold & Porter’s Future Pharma Forum invites you to a complimentary regulatory seminar aimed at junior lawyers and new joiners in the UK/EU life sciences industry. We will provide a comprehensive introduction to key EU regulatory law topics from an in-house practitioner’s perspective and touch on the implications of Brexit. Topics Overview of the EU pharmaceutical law framework Clinical trials, unlicensed supply and compassionate use Obtaining marketing authorisations Incentives: regulatory data protection, marketing protection, orphan…
On 28 November 2018, the UK Government published draft secondary legislation changing UK intellectual property law relating to exhaustion of IP rights to deal with Brexit. The aim is to ensure that the doctrine of EEA-wide exhaustion continues to apply in the UK post-Brexit, irrespective of whether there is a deal or a no-deal Brexit. What is exhaustion? As summarised in the explanatory memorandum, the exhaustion rule prevents the holder of an intellectual property right from…
The case arose from the reimbursement by the Italian authorities of medicinal products used for an indication for which they are not authorised, in circumstances where there is an alternative authorised product available. Italian law permits the reimbursement of such products “provided that the [unlicensed] indication is known and is in line with research conducted by the national and international medical-scientific community on the basis of economic and suitability considerations”. In these cases the Italian…
On 12 November 2018 the EU Commission announced that its rapid alert system formerly known as ‘RAPEX’ is being updated and rebranded as ‘Safety Gate’.  Aside from the rebranding, the main new features of the Safety Gate platform are that it is more accessible to consumers, being now available in 25 languages, and it is capable of being shared by consumers via social media. With certain exceptions, this online product safety database covers…
The UK Government (Department of Health and Social Care, DHSC) and the ABPI have announced today that they have agreed the Heads of Agreement for what will now be called a Voluntary Scheme for Branded Medicines Pricing and Access, expected to become effective from 1st January 2019 following the end of the current 2014 Pharmaceutical Pricing Regulation Scheme (PPRS”). The details of the new Voluntary Scheme are still being finalised and, if agreed in full, will…
On 14 November, the Supreme Court handed down its judgment on the validity and infringement of the second medical use patent that protected Pfizer’s Lyrica® (pregabalin) for the treatment of various types of pain. In Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) & Anor [2018] UKSC 56, the Court decided that the patent held by Warner-Lambert (a company in the Pfizer group) was invalid for insufficiency, because it did not render it…
Publication of clinical trial data and results continues to be a hot topic in the EU. A recent BMJ article investigated the level of compliance with the European Commission’s requirement that the results of all trials are published within 12 months of completion. The Commission guidance expands on the obligations in the Clinical Trials Directive, and states that for all trials (paediatric and non-paediatric), result-related information should be supplied and made public within 12…
On 25 October 2018, the Court of Justice of the EU (CJEU) held in Case C-527/17 Boston Scientific that, where a medical device incorporates an ancillary drug substance, that substance will not be entitled to supplementary protection certificate (SPC) protection. That is the case even if the drug substance has been subjected to an evaluation of its safety, quality and efficacy that is analogous to the authorisation procedure for medicinal products, which are entitled to…