Genentech Inc., the Appellant and Defendant, were represented by Michael Tappin QC and Mark Chacksfield in this appeal regarding a dosing regimen patent for the anti-cancer drug trastuzumab (Herceptin). Hospira UK Ltd. instructed Richard Meade QC as lead counsel.
At first instance, Birss J found the Patent invalid for obviousness on the basis of a figure produced by Hospira’s expert, “Figure 1”. Figure 1 used information from an FDA label for Herceptin and discoverable knowledge of the drug’s target trough concentration to create a graph which would allow the skilled person to estimate serum levels over time depending on dosage.
Genentech appealed on the basis that Figure 1 alone was not enough to establish obviousness. Giving the leading judgment, Floyd LJ found that there was ample material before Birss J for him to conclude, on the basis of Figure 1 and the evidence given in relation to it, that the FDA label would render the Patent obvious. Floyd LJ said that Birss J was not reversing the burden of proof when he referenced an absence of positive evidence of inventiveness. The appeal was dismissed.
Michael Tappin QC and Mark Chacksfield were instructed by Marks & Clerk Solicitors LLP and Richard Meade QCwas instructed by Taylor Wessing LLP.