Adrian Speck KC, Henry Ward and Michael Conway successfully represented the Claimants, a group of generic pharmaceutical companies, in a patent invalidity action against the Defendant (“Bayer”).
The patent in suit (“EP 961”) claimed a once-daily dosing regimen for rivaroxaban, for the treatment of thromboembolic disorders.
HHJ Hacon, sitting as a High Court Judge, found the patent invalid for obviousness over three in posters which had been produced by Bayer in collaboration with academics and exhibited at the 45th Annual Meeting of the American Society of Hematology in 2003 (referred to in the judgment as “Harder” and the “Kubitza Posters”). The posters included results from pharmacodynamic assays in phase I studies, which suggested doses of rivaroxaban inhibited blood coagulation for up to 24 hours. Harder contained an express statement that the results suggested suitability for once-daily dosing.
These, among other factors, rendered it obvious to include a once-daily dosing arm in phase II studies, with a reasonable expectation that this would be safe and efficacious in treating patients.