* Two patents relating to dosage and composition revoked
* Hospira says move paves way for its biosimilar version
* Roche considering its next steps
(Adds Roche and Hospira comment, patent details)
By Ben Hirschler
LONDON, April 10 Hospira has
successfully overturned two patents on Roche's
blockbuster breast cancer drug Herceptin in Britain, clearing
the way for it to launch a cheaper copycat version in the
A ruling handed down by the High Court in London on Thursday
determined that both the 115 and 455 patents on the drug, which
relate to the drug's dosage and its composition, were invalid.
The basic underlying patent held by Roche on its medicine
was not challenged by Hospira. This patent expires on July 28
and Hospira told the court it wanted to sell its version of the
product, known generically as trastuzumab, after that date.
Such a move would ramp up competition for a costly cancer
treatment and could drive down prices. The potential to use
copycat forms of biotech drugs like Herceptin is gaining
increased attention from cost-conscious health authorities
"We are very pleased with this decision, which helps pave
the way for our trastuzumab product," U.S.-based Hospira said in
A spokeswoman for Roche said the Swiss drugmaker was
analysing the court ruling revoking its patents and considering
its next steps.
Herceptin, an injectable antibody-based biotech drug, had
worldwide sales of 6.08 billion Swiss francs ($6.90 billion)
last year, making it the company's third biggest-selling
medicine after two other cancer drugs, MabThera and Avastin.
British sales are a small proportion of that total.
Herceptin is designed to fight cancers that have too much of
a protein called human epidermal growth factor receptor 2, or
HER2, on the surface of their cells. That means it is only
helpful for a minority of women with breast cancer but for this
group it has proved to be an important treatment.
Hospira has pioneered the development of so-called
biosimilar versions of biotech drugs. Unlike conventional
chemical medicines, these biological drugs are complex to make
and copies can only ever be similar to the original product
rather than exact replicas.
Hospira recently launched the first antibody biosimilar in
Europe, called Inflectra, which is a copy of Johnson & Johnson's
and Merck & Co's Remicade drug for rheumatoid
($1 = 0.8807 Swiss Francs)
(Additional reporting by Kate Holton, Editing by Jane Merriman)