Law360, London: Regulators in the US and EU delivered some welcome news to the pharmaceutical industry last week by jointly releasing a set of agreed-upon principles intended to guide the use of artificial intelligence (AI) in drug development.

A medicinal product that is similar to a biological medicinal product (the originator or ‘reference’ product) that has already been granted a authorisation'>marketing authorisation in the EEA, but which does not meet the definition of a generic medicinal product owing, in particular, to differences in raw materials or manufacturing processes.

This Practice Note explains what so-called ‘biosimilars’—that is similar biological medicinal products—are. It summarises the commercial importance of biosimilars and describes some of the issues faced by biosimilar manufacturers and biologic originator companies. It describes the UK and EU regulatory framework for these products and discusses biosimilar marketing authorisations (MAs), pharmacovigilance monitoring and the manufacture and market access of biosimilars, eg pricing and reimbursement considerations. It also briefly considers the position in the US and sets out the US Food and Drug Administration (FDA) procedures for biosimilars. It also considers some of the patent issues regarding biosimilars, including the application of the Bolar-type exemption, considerations on the ‘clearing the way’ principle and the Unified Patent Court (UPC) and scope for development of its jurisprudence relating to biosimilars. What is a biosimilar? A biosimilar is a biological medicinal product that is similar to a biological medicinal product (the originator product, also known as the reference medicinal product) that has already been granted a MA

This Practice Note sets out which biotechnological inventions can and cannot be patented. It refers to Directive 98/44/EC (often known as the Biotechnology Directive) and Schedule A2 to the Patents Act 1977 (PA 1977), which permit biotechnological inventions to be patented but provide some important exceptions. These exceptions have been subject to interpretation by the Court of Justice in cases such as Oliver Brüstle v Greenpeace and Monsanto v Cefetra. This Practice Note also considers the exclusions to patentability under Article 52(b) of the European Patent Convention (EPC) and the relevant European Patent Office (EPO) case law, Tomatoes I, Tomatoes II and Broccoli II. Finally, it considers the 2017 European Commission Notice on biotechnological inventions. Patenting biotechnological inventions Biotechnological inventions are, in principle, patentable. While there is no general exclusion against them in PA 1977 or the EPC, there are specific rules governing the patentability of such inventions (see: The regulatory framework for biotechnology patents below). Further, in practice, certain biotechnological inventions, while not necessarily specifically

Law360: A flight attendant with bipolar disorder revived her claims of disability discrimination against CAE Crewing Services after the Employment Appeal Tribunal (EAT) concluded that the tribunal hearing the claims misinterpreted a vicarious liability law.

Leansale Limited, trading as Roopyal Laham Halaal Butchers, has been fined £10,000 for breaching the law around the treatment of animals, on 18 November 2021, 13 January 2022 and 23 January 2022. The offences included the overcrowding of animals in holding pens, failure to provide drinking water to animals, keeping some areas unsafe for animals, failure to respond appropriately to the unloading of a lame animal, and grabbing and dragging a sheep by its fleece and horns. The offences were discovered when officers from the Food Standards Agency (FSA) investigated the company on behalf of the Department for Environment, Food and Rural Affairs (Defra) and examined CCTV footage of the premises which identified several offences around the handling of cattle and sheep. The FSA gathered the evidence and passed it to the Crown Prosecution Service (CPS), who authorised a number of charges against the company under the Welfare of Animals at the Time of Killing (England) Regulations 2015, SI 2015/1782. At Birmingham magistrates' court on 22 May 2023, the company was ordered to pay a fine of £10,000 as well as costs of £500 and a surcharge of £190.

An extra parochial ministry licence (allowing a priest to perform services as a minister outside of his parish or in an institution) is a relevant qualification for the purposes of discrimination by a qualifications body under the Equality Act 2010 and so the Church of England bishop granting such a licence is a qualifications body for these purposes. The refusal to grant such a licence because the priest has entered into a same sex marriage amounts to direct discrimination because of sexual orientation but an exception applies where the purpose of the employment is for an organised religion and the action taken by the body was to comply with the doctrines of that religion. EAT: Pemberton v Inwood.

Electronic data can be measured in bits, which is basically the space it takes up.

Law360: Lawyers for the man who failed to prove he invented bitcoin told a London court on 14 June 2024 that he has dropped a case brought by his company against software developers as it also turned on his claim to be the pseudonymous inventor of the virtual currency.

IP analysis: Craig Wright claims to have founded Bitcoin, the well-known cryptocurrency. He is involved in several sets of legal proceedings. In the present claim, he was seeking permission to serve a claim outside of the jurisdiction, and so had to demonstrate that there was a serious issue to be tried. In this judgment, the High Court ruled that no copyright subsists in the Bitcoin file format. The judgment provides an in-depth analysis of whether copyright is capable of subsisting in the format of data files used in a computer program. For a literary, dramatic or musical work to be protected by copyright it must be recorded or fixed. To get copyright protection in a file format, files in that format must have content indicating the structure, rather than just reflecting it. Written by Connor Griffith, associate, and Giles Parsons, partner at Browne Jacobson LLP.

A wholesale product which consists of an access link to the customer premises (over copper, coax or fibre) and a transmission service (eg Ethernet) to a defined set of handover points (the access point). It enables alternative communications providers to differentiate their services by altering a number of technical parameters and/or the use of their own network.

Fischer Black and Myron Scholes invented formulae which showed how investments, especially in a hedge fund and especially options, should be priced. They won the Nobel Prize for their work, but it fell into disfavour after they were involved in the largest investment failure ever at the time (Long Term Capital Management lost $4.6bn in four months, thought to be a virtual impossibility)