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14 April 2014Europe

UK High Court strikes down Herceptin patents

The UK High Court has invalidated two patents covering Roche’s breast cancer drug Herceptin (trastuzumab) after a challenge by generic drug maker Hospira.

Hospira sought to make a generic version of the blockbuster drug after a supplementary protection certificate covering the product expires on July 28, 2014.

It argued that the ‘115 patent, which covers a dosing regime, is obvious and that the ‘455 patent, covering a composition of trastuzumab, lacks novelty over a previous patent cooperation treaty application by Herceptin co-developer Genentech.

However, it did not challenge the product’s underlying patent EP 0,590,058, also held by Genentech.

In the April 10 ruling, Justice Colin Birss found both of the patents at suit to be invalid.

A spokesperson for Roche told LSIPR that it was analysing the court ruling and considering its next steps.

She added: “There are currently no approved trastuzumab biosimilars in Europe. Subsequently, we anticipate the impact of this decision will be minimal.”

Hospira said in a statement: "We are very pleased with this decision, which helps pave the way for our trastuzumab product."

Between 1999 and 2003, worldwide sales for Herceptin totalled 49 billion Swiss francs ($56 billion). European sales from 2010 to 2013 totalled eight billion Swiss francs ($9 billion).


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