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27 May 2014Biotechnology

Genentech refused appeal in Herceptin case

Justice Colin Birss has refused Roche’s biotechnology subsidiary Genentech the permission to appeal against an English High Court decision in which two patents covering its blockbuster breast cancer drug, Herceptin (trastuzumab), were revoked.

One of the patents, which were invalidated last month after a challenge by Hospira, related to a dosage regimen for trastuzumab, while the other covered the drug’s formulation.

Herceptin is one of Roche’s biggest selling drugs, making worldwide sales of $6.7 billion in 2013. Between 2010 and 2013, European sales of the drugs totalled $9 billion.

Genentech sought to appeal against the decision in relation to the dosage patent, but on May 16 Birss refused to grant permission, finding that it was seeking to argue a new point about the dosage regimen.

In his judgment, Birss said that Genentech wanted to argue that its claimed 8 mg/kg loading, or initial, dose followed by three once-weekly maintenance doses of 6 mg/kg was inventive, despite the product’s FDA label recommending 500 mg, or 7.1 mg/kg once every three weeks.

“That is, in my judgment, a new point, or rather includes a series of new points,” he said.

Hospira said in a statement: “Hospira is very pleased with this decision, which helps pave the way for our trastuzumab product.”

A spokesperson for Genentech told LSIPR that it was disappointed with the court’s decision, and that it is in the process of reviewing the decision to determine its next steps.


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