High Court ruling against Roche paves way for EU Herceptin biosimilars
Last week’s decision ruled in favour of Hospira meaning Roche will lose its exclusivity on its trastuzumab monoclonal antibody breast cancer drug on July 28 in the UK.
“We can confirm that two patents have been revoked by the English court for Herceptin,” Roche said in a statement sent to Biopharma-Reporter.com. “We are now analyzing the court ruling and are considering our next steps.”
However, the firm continued, “there are currently no approved trastuzumab biosimilars in Europe. Subsequently, we anticipate the impact of this decision will be minimal.”
Hospira spokesman Dan Rosenberg told us Hospira is “very pleased with this decision, which helps pave the way for [its] trastuzumab product” in Europe,but could not comment on submission or launch timing as its biosimilar partner Celltrion is doing the development work.
Hospira has partnered with the South Korean firm for a number of biosimilar products on top of trastuzumab, including a version of J&J’s Remicade which was approved in Europe last summer.
So far Herceptin biosimilars marketed by Biocon and Mylan have been approved in India, and Celltrion’s equivalent version has been approved in South Korea.
Losing One’s Patents
The two patents the judge overturned were European Patent 115, regarding the dosages for treatment with anti-Erb2 antibodies, and European Patent 455, referring to the anti-HER2 antibodies composition of Herceptin.
For the latter, the patent focuses partly on the purification process claiming that the reserve wash step is a “novel approach to ion exchange chromatography [and] is particularly useful in situations where a product molecule must be separated from a very closely related contaminant molecule at full manufacturing scale,” the court document stated.
Dr. Uwe Gottschalk from bioprocessing company Sartorius Stedim Biotech served as Hospira’s expert witness, arguing, however, that the patent lacked novelty and did not involve an inventive manufacturing step.
“He addressed the characteristics of various trastuzumab compositions and expressed the view that trastuzumab could be separated from the relevant acidic variants on an analytical scale and that purifying trastuzumab on a larger scale was obvious,” the document continued.
However, Roche’s witness - Professor Nigel Titchener-Hooker, Head of the UCL department of Biochemical Engineering – argued separating trastuzumab from the acidic variants on a large scale was in fact difficult and not obvious.
