IPR & Legal

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.

Patent litigation involving two of Europe’s most important antibody companies plus Janssen Biotech formally ended on 31 January after the parties agreed to drop their mutual claims. The lawsuit was brought by MorphoSys AG against Genmab A/S and its partner Janssen relating to Darzalex (daratumumab), the latter companies’ marketed drug for multiple myeloma.

A US district court has ruled against MorphoSys AG in a patent infringement suit that the Germany company brought against Genmab A/S and its partner Janssen Biotech Inc relating to Darzalex (daratumumab), their marketed drug for multiple myeloma.

The decision, by the District Court of Delaware, means that MorphoSys’ claims for damage have been rejected and its three US patents for a similar drug have been declared invalid.

The UK, on the basis of a democratic decision, can unilaterally revoke a decision to withdraw from the EU as long as the withdrawal agreement has not entered into force, the Court of Justice of the European Union, announced on 10 December.

ViiV Healthcare Ltd, the specialist HIV company majority-owned by GlaxoSmithKline Plc, has filed a patent infringement suit against Gilead Sciences Inc over bictegravir, an integrase inhibitor that is part of a combination therapy approved in the US on 7 February.