IPR & Legal

The European Medicines Agency has appealed against a court order preventing it from releasing documents relating to two marketed medicines, arguing that the disclosures are consistent with its policy on transparency.

In a decision on 8 September, the General Court of the European Union has upheld €150 million of fines imposed by the European Commission on H. Lundbeck A/S and four generic companies for what it says were infringements of competition law.

Merus BV of the Netherlands has secured another legal victory over Regeneron Pharmaceuticals Inc in a battle over intellectual property rights to transgenic mouse technology for the production of therapeutic antibodies.

Merus BV has successfully fought off a patent infringement lawsuit brought against it in the US by Regeneron Pharmaceuticals Inc, thus securing freedom to operate in the space for transgenic-mouse based antibody therapeutics. The Dutch company announced the decision on 5 January 2015.

The Court of Justice of the European Union has issued a decision in a patent case brought by a US corporation which gives a fresh interpretation to restrictions laid down in 2011 on the patentability of human embryos for industrial or commercial purposes.

Regeneron Pharmaceuticals Inc is to appeal against a decision of the European Patent Office (EPO) to revoke its patent for transgenic mouse technology, a patent that was successfully challenged by Kymab Ltd of the UK.

Kymab Ltd has successfully challenged a European patent issued to its competitor, Regeneron Pharmaceuticals Inc, for transgenic mouse technology that is a foundation for developing therapeutic antibodies. The patent was said to lack an inventive step as required by European patent law.

The Advocate General of the Court of Justice of the European Union has given a fresh interpretation to restrictions laid down by the court in 2011 on the patentability of human embryos for industrial or commercial purposes. 

The European Commission has been overruled in a dispute over the authorisation of an orphan medicine, in a case that further clarifies the ‘well-established medical use’ criteria for approving new drugs for marketing in Europe.

A lawsuit has been filed in the US by a patient with Type 2 diabetes who was prescribed Byetta and Janumet and later developed pancreatic cancer. The suit was announced by Rheingold, Valet, Rheingold, McCartney & Giuffra LLP in New York.