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.
IPR & Legal
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.
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.
Johnson & Johnson Inc became the latest pharmaceutical company on 1 October to settle lawsuits brought by two counties in Ohio over its alleged role in the US opioid epidemic. J&J agreed to a settlement of $20.4 million, thereby avoiding a trial in federal court. The settlement includes no admission of liability.
The European Commission has published proposed rules for electronic commerce that, among other things, would guarantee the validity of e-contracts and e-signatures and introduce measures to combat spam. The proposal has been introduced within the context of ongoing negotiations among World Trade Organization members about making e-commerce more transparent and reliable.
“Despite a fast increase in digital trade, there are currently no multilateral rules in this area,”
the Commission said in a statement issued on 3 May.
The US Patent and Trademark Office has issued a new patent to Emmanuelle Charpentier and colleagues for their work on the gene editing technology CRISPR-Cas9. The patent, granted to Dr Charpentier, the Regents of the University of California and the University of Vienna, focuses on systems and methods for using the CRISPR-Cas9 technology in a single guide format, including uses to target and edit or modulate genes, according to ERS Genomics Ltd, an Ireland-based company created to provide access to the technology.
The European Medicines Agency (EMA) has been told it will have to continue servicing the lease covering its former London headquarters even as it completes plans for a move to Amsterdam. The move to Amsterdam follows the UK’s 2016 vote to leave the EU.
The UK High Court ruled on 20 February that the move “was not required as a matter of law.” Therefore the agency’s rental contract remains in force along with the landlord’s right to collect rent. The case was brought by the property company Canary Wharf Ltd.