“In some areas of research there were also significant time savings. You get to what you are looking for more quickly, which all goes to the value of the product.”
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In this issue: Intellectual property Advertising of medicines Competition in life sciences Commercialisation Post-market Data protection and life sciences Pharmaceuticals—regulatory framework Research and development LexTalk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Useful information Intellectual property Could we…and would we..? UK CoA confirms that it is bound by previous precedent on second medical use SPCs On 28 January 2025, the UK Court of Appeal delivered its long-anticipated ruling in Merck Serono v Comptroller-General of Patents. The panel of three LJs—Lewison, Arnold and Birss—held that existing binding UK authority on second medical use supplementary protection certificates (SPCs) constrained the court, so it could not depart from that line. The judges further observed that, even if a departure from their own case law were available, they would not exercise that option on these facts. Commentary on the decision is provided by Priyanka Madan, senior associate...
In this issue: EU fundamentals Competition and state aid Corporate Data protection and cybersecurity Free movement, immigration and employment Financial services Environment Insurance and reinsurance IP Life sciences Regulatory TMT International trade Daily and weekly news alerts Trackers EU fundamentals Commission issues formal notices to EU Member States for failing to transpose EU directives The European Commission has dispatched letters of formal notice to several EU Member States that have not implemented five directives into national law. These measures span electricity market design (26 Member States), building energy performance (9 Member States), digital operational resilience (13 Member States), road transport social legislation (16 Member States), and food extraction solvents (5 Member States). Member States have two months to reply and finalise transposition of the directives, whose deadlines fell between January and February 2025. Denmark alone has fully transposed the Electricity Market Directive within the required timeframe. See: LNB...
In this issue: Planning policy Heritage and natural environment Judicial review Green belts Nationally significant infrastructure projects Daily and weekly news alerts New and updated content Latest Q&A Related Documents Planning policy Chief Planner’s planning update newsletter for September 2024 published Chief Planner, Joanna Averley, has issued the September 2024 planning update newsletter, prepared for chief planning officers within local planning authorities. It covers: a letter from Minister of State, Matthew Pennycook, to the Planning Inspectorate’s Chief Executive setting out a refreshed approach to ‘pragmatism’ in local plan examinations; the Deputy Prime Minister, Angela Raynor’s, unveiling of the New Homes Accelerator; and a Historic England update offering new advice on adapting historic buildings for energy and carbon efficiency. See: LNB News 16/09/2024 12. Defra launches Floods Resilience Taskforce The Department for Environment, Food and Rural Affairs (Defra) has established the Floods Resilience Taskforce to co-ordinate flood preparedness and resilience measures across central...
What is the impact of Brexit on the UK nuclear sector? As of 31 January 2020 (exit day), the UK ceased to be an EU Member State. From that date, a transition/implementation phase applied, during which the EU continued, for many purposes, to treat the UK as if it remained a Member State. Leaving the EU also entailed withdrawal from the Euratom Community. The transition ended at 11 pm (GMT) on 31 December 2020—known in UK law as ‘IP completion day’. At that point, key transitional measures expired and notable shifts started to apply across the UK’s legal framework. The UK’s exit from the EU likewise meant departure from Euratom. Any changes pertinent to this content are outlined below. Following IP completion day, the European Union (Withdrawal) Act 2018 (EU(W)A 2018) introduced a new category of domestic law—‘retained EU law’ (REUL)—comprising EU-derived rights and legislation preserved in the UK after Brexit. On 29 June 2023, the Retained EU Law (Revocation and Reform) Act 2023 (REUL(RR)A 2023) received Royal Assent...
This Practice Note offers a primer on the agreement. It sets out the scope, the three categories of prohibited subsidies, the notification and transparency obligations, and dispute resolution. It also highlights other provisions relevant to the agreement. Introduction The AFS was agreed at the 12th WTO Ministerial Conference in June 2022 in Geneva. It forms part of a set of key trade initiatives known as the ‘Geneva Package’. Other outcomes include: Ministerial Decision on TRIPS Non-violation and Situation Complaints Ministerial Declaration on Responding to modern Sanitary and Phytosanitary Challenges Ministerial Declaration on the Emergency Response to Food Insecurity Ministerial Decision on the TRIPS Agreement, and Ministerial Declaration on the WTO Response to the COVID-19 Pandemic and Preparedness for Future Pandemics Negotiations on the AFS began in 2001 during the Doha Round. It is only the second multilateral agreement concluded since 2001; the other is the Trade Facilitation Agreement. The AFS talks were launched because a growing portion of...