IPR & Legal

A biotechnology company in Scotland, backed by Archangel Investors Ltd, made its first public appearance on 8 June as a potential player in the rapidly expanding field of antibody-drug conjugates (ADCs). Emerging from stealth mode, Bead BioPharma Ltd disclosed its leadership and technology for the first time. The company’s interim chief executive is Dan Ozanne a serial entrepreneur, and its chair is Mike Sun. Mr Sun formerly worked for Seattle Genetics Inc (now Seagen), a pioneer in ADC field. Bead BioPharma has reportedly raised $1.14 million since its founding in 2023.

Following a European Commission announcement in March of a proposed new legal framework for start-up companies, Germany has reportedly lifted its opposition to giving more powers to an EU financial regulator – an important step towards creating a capital markets union. According to The Financial Times, the German finance minister Lars Klingbeil signalled his support for the centralised supervision of a unified capital market, which would effectively mean ceding powers from the German regulator to the European Securities and Markets Authority (ESMA), based in Paris.

Immunic Inc, a US-based biotech with a research arm in Germany, announced the awarding of a key patent by the European Patent Office on 10 March, strengthening its position ahead of the anticipated commercialisation of its lead product vidofludimus calcium (IMU-838) for multiple sclerosis. Vidofludimus is currently in Phase 3 with top line data expected at the end of 2026. If the data are positive, a regulatory review would follow.

AbbVie Inc has joined the competition amongst large pharma companies for leadership of the market for antibody-drug conjugates (ADCs) with the proposed acquisition of ImmunoGen Inc of Waltham, Massachusetts for $31.26 per share in cash or an enterprise value of $10.1 billion. The acquisition was announced on 30 November and is expected to complete in the middle of 2024.

The European Commission has imposed a €432 million fine on Illumina Inc – its largest fine ever –for proceeding with the acquisition of the diagnostic group GRAIL Inc before the deal had been approved by the EU regulator. The fine was announced on 12 July alongside a symbolic fine of €1,000 on GRAIL for enabling the transaction to complete. 

A panel of three arbitrators in the US has ruled against Genmab A/S in a royalty dispute with Janssen Biotech Inc effectively reducing royalty payments due to Genmab from a licensing agreement for the multiple myeloma treatment Darzalex (daratumumab). In an announcement on 8 April, Genmab said it is considering whether or not to appeal against the decision.

The Court of First Instance of Brussels has granted interim measures in a case brought by the European Commission and the 27 EU member states against AstraZeneca Plc, giving deadlines for the delivery of specific quantities of the company’s Covid-19 vaccine to the EU. The Commission brought the lawsuit, claiming that AstraZeneca had not made its “best reasonable effort” to deliver supplies covered by an advance purchase agreement entered into by the parties in 2020.

The Japan Patent Office (JPO) has upheld a patent awarded to Dr Emmanuelle Charpentier and colleagues while giving intellectual property protection for a third discovery. As a result, the inventors have three Japanese patents for their discovery of the Crispr/Cas9 genome editing technology. The legal victories were announced on 1 June by ERS Genomics Ltd which licenses access to the technology.

Kymab Ltd has beaten back a challenge by Regeneron Pharmaceuticals Inc to its transgenic mouse technology for creating antibodies following a decision by the Supreme Court of the United Kingdom. The decision is important for Kymab, the smaller of the two companies, which has a pipeline of preclinical and early clinical antibody therapeutics to treat cancer and immune diseases. Regeneron had challenged Kymab’s foundational technology. But in an opinion delivered on 24 June, the UK court declared that claims made by Regeneron were not valid.

The European Medicines Agency has won a case in the Court of Justice of the European Union upholding its right to publicly disclose information from a pharmaceutical company’s application for marketing, once that product has been approved. The case concerns a decision by the EMA to grant a third party access to a regulatory dossier of PTC Therapeutics International Ltd in 2015 for a product for Duchenne muscular dystrophy.