Pharmaceutical Patent meaning

In this issue: Intellectual property Medical devices Pharmaceuticals—regulatory framework Borderline products Commercialisation Advertising of medicines LexTalk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Useful information Intellectual property Chris Weekes, Technical Assistant at D Young & Co, reviews a landmark ruling on infringement of a second medical use patent, indicating how the Unified Patent Court (UPC) may handle such claims. See News Analysis: First UPC infringement decision for second medical use claims. Medical devices MLex reports that the European Commission is weighing a delay to the EU AI Act entering into application amid disputes over a code of practice for AI models, mounting industry resistance, and slippage in drafting technical standards. The move, still unconfirmed, could pause enforcement timelines to allow targeted amendments aimed at simplifying specific elements. See News Analysis: EU Commission eyes pausing AI Act’s entry into application...

In this issue: Medical devices Intellectual property Data protection and life sciences Pharmaceuticals—regulatory framework Research and development Competition in life sciences Daily and weekly news alerts New and updated content Trackers Useful information Medical devices Government supports new UK medical device rules following consultation The Medicines and Healthcare products Regulatory Agency (MHRA) has issued the government’s concluding response to its consultation on planned updates to medical device legislation, setting out future pathways to market for medical devices. The government will advance three principal changes: adopting an international reliance framework, removing the UKCA marking requirement once devices carry unique device identification (UDI), and revising the classification of in vitro diagnostic (IVD) devices. Collectively, these measures are intended to modernise oversight while promoting innovation and protecting patient safety. See: LNB News 23/07/2025 14. AI developers, users see EU’s guidelines on general-purpose AI models MLex: On 18 July 2025, the European Commission released guidance...

In this issue: Intellectual property Pharmaceutical—regulatory framework Research and development Competition in life sciences Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Intellectual property Haemophilia gene therapy patent valid and infringed (Pfizer v uniQure) The Patents Court rejected Pfizer’s attempt to revoke uniQure’s EP(UK) 3,581,650 (EP 650), which claims a “Factor IX polypeptide mutant and a method for its production” and underpins uniQure’s haemophilia therapy, Hemgenix. As a consequence, Pfizer cannot, for now, introduce its gene therapy Beqvez—approved by the EMA on 24 July 2024—in the UK, although it has indicated it will appeal. Pfizer accepted that, if EP 650 stood, it would infringe, but maintained the patent was invalid, alleging the particular amino acid substitution was obvious and devoid of inventive step in light of a single prior art reference. The court placed considerable reliance on secondary evidence reflecting what research groups were actually doing...

For many companies, intellectual property rights (IPRs) constitute an increasingly important and significant asset class. Although contemporary technology firms, pharmaceutical businesses and industrial players are most closely and very commonly linked with holding portfolios rich in IPRs, even the least likely organisations may own rights that are fundamental to them and, without which, they simply could not operate (or do so as effectively or profitably) or would suffer significant loss of value. As a broad category, IPRs are wide-ranging and inherently diverse indeed. According to context, there are, in particular, rights beyond the best known (patents, trade marks and copyright) that may—or may not—be generally regarded strictly as IPRs, such as database rights, websites with their associated domain names, goodwill and contractual rights allied to IPRs. For further detail on the principal types of intellectual property rights an insolvency practitioner as office holder may encounter, see Practice Note: IP right comparison table. Patents, design rights and trade marks depend for their existence and protection on registration (at the...

This Practice Note sets out what are termed ‘biosimilars’, meaning comparable biological medicinal products. It outlines the commercial significance of biosimilars and highlights key challenges encountered by biosimilar manufacturers and biologic originator companies. It reviews the UK and EU regulatory regimes for these medicines and covers matters relating to biosimilar marketing authorisations (MAs), pharmacovigilance monitoring, and the manufacture and market access of biosimilars, eg pricing and reimbursement considerations. It also briefly addresses the position in the US and sets out the US Food and Drug Administration (FDA) procedures for biosimilars. In addition, it examines certain patent issues connected with biosimilars, including application of the Bolar-type exemption, considerations around the ‘clearing the way’ principle, and the Unified Patent Court (UPC), together with the scope for development of its jurisprudence concerning biosimilars. What is a biosimilar? A biosimilar is a biological medicinal product that is similar to a biological medicinal product—the originator, also referred to as the reference medicinal product—which has already been granted a MA on the basis of...

The life sciences industry Comprises a broad constellation of stakeholders, spanning small university spin‑out biotechs built around a single discovery and research team through to vast, global ‘Big Pharma’ firms commercialising and promoting blockbuster medicines across multiple markets. Across that continuum sit, among others, contract research organisations, contract manufacturing organisations, specialist logistics and distribution providers, wholesale and retail pharmacies, and, increasingly, technology and AI businesses offering support and capability. Countless enterprises contribute to the life cycle of a pharmaceutical product—a journey frequently laden with hazards and uncertainty, and one that is operationally complex for most organisations at every step for participants overall. Bringing a medicinal product to market is thought to take 12 to 15 years, with a significant likelihood of failure; only a minute fraction of candidates entering pre‑clinical studies will secure regulatory clearance for use in people over that path over time. Beyond the extraordinarily high costs of launch, the sector faces mounting price pressures from industry ‘payers’, who require evidence not only of safety and efficacy...