A US judge has backed Amgen's court motion, ruling that Roche's Mircera infringes one of its composition patents. Roche is standing firm against the allegations.
The biotech titan has been fighting for two years to prevent Swiss drug maker Roche from launching its peg-EPO (pegylated recombinant human erythropoietin) product on the US market, claiming it infringes five of its patents.
In a separate decision, the court also granted summary judgement in favour of Amgen on certain Roche defenses against the patents-in-suit, Amgen said.
But a Roche spokesperson told Biopharma-Reporter.com that the company was "confident" about the outcome of the trial which starts next week and is expected to last for about six weeks.
"This only one step along the way and the ruling does not determine the ultimate validity of any Amgen patents," she said.
She added that Roche sticks to its belief that all of the Amgen patents and invalid and therefore not infringed.
Amgen had anticipated September would be a busy month when it announced its financial results last month.
"The company is working to win the peg-EPO trial and to keep Roche's product off the market until EPO patents in the United States expire some years from now," said Kevin Sharer, chairman & CEO during a conference call in July.
Roche has filed a biologic licence application (BLA) with the US regulators for Mircera (continuous erythropoietin receptor activator) and has announced plans to launch it in the nephrology segment this year, despite the ongoing lawsuit with Amgen.
Roche already received the thumbs up from the European Commission to market Mircera for use in chronic kidney disease (CKD) in all EU countries.
Mircera has been cleared as a single once-a-fortnight injection for the initial correction of anaemia in patients not currently treated with an erythropoiesis-stimulating agent (ESA) and as a monthly injection for patients currently being treated with an ESA, such as epoetin alpha, epoetin beta and darbepoetin alpha.
The drug is now the first ESA to have such a dosing schedule in the EU, Roche said last month. Currently used epoetin therapies (epoetin alfa or beta) are administered one to three times weekly.
The drug is already available in Austria, the Roche spokesperson said.
If approved in the US, it will compete not only with Amgen's blockbusters Epogen (epoetin alfa) and Aranesp (darbepoetin alfa), but also with Johnson & Johnson's Procrit (epoetin alfa).
The Roche spokesperson said the company expects to get the green light from the Food and Drug Administration (FDA) after the regulatory review on ESAs, scheduled on 11 September, which is aimed as assessing the safety of these drugs in dialysis patients with kidney diseases.
However, Amgen said it has "compelling proof" that the drug violates six of its patents and does not provide any clinical or patient benefit over Epogen and Aranesp.
And so the battle continues.