Less Is More, But Still Not Enough, For Genentech’s Dosing Schedule Patent

The High Court has decided, in a single judgment, that Genentech's patents relating to a dosage regimen for Herceptin and a purified composition of non-acidic variants of Herceptin are invalid. This article focuses on the dosage regimen patent.

Background

Herceptin is the world's tenth best-selling drug, with sales of US$ 6.9 billion. Genentech held a (recently expired) patent protecting the monoclonal antibody trastuzumab, the active ingredient in Herceptin. The supplementary protection certificate (Europe's mechanism for patent term extension for pharmaceutical products) based on this patent and protecting trastuzumab expires on 28th July 2014.

Hospira aims to sell a generic of Herceptin in Europe after this date (it has already obtained approval for the generic in South Korea, so Hospira appears well prepared to roll it out in Europe). Genentech, however, also owns two further Herceptin patents with later expiry dates, which were at suit in this action.