A federal judge in Boston ruled last week that Roche violated an Amgen patent in the production of Mircera, a pegylated version of the red-blood-cell-stimulating protein erythropoietin, which Amgen sells as Epogen and Aranesp.
The decision marks a legal triumph in what has otherwise been a dismal year of setbacks for Amgen, culminating in a first-ever downsizing, including the slashing of its 20,000-person workforce by up to 14 percent. Aranesp is the struggling California biotech's top-selling drug, with sales last year of $4.1 billion; Epogen, an older product, raked in $2.5 billion.
In the property-rights face-off, Amgen charges that the Swiss-based drug giant's anti-anemia agent, which nabbed an approvable letter from the FDA in May and is already on sale in Europe for patients with kidney failure, infringes on a pile of patents.
A trial opened on Tuesday in Boston to determine the fate of the remaining six alleged infringements. If Amgen wins in court, Roche will be blocked from marketing Mircera in the United States until 2013, when the epo-exclusivity protections expire.
But Roche isn't likely to admit defeat without further legal assaults. In a statement, the drug giant said it disagreed with the judge's decision and will begin selling Mircera as soon as the FDA waves it through review--patent issues be damned. Analysts were also predicting that Roche is likely to sue to have Amgen's key patent declared invalid. Such aggressive action would raise the stakes considerably, since if the judge's ruling is upheld, Roche would have to pony up damages to Amgen three times over.
That prospect may lift the biotech's current black mood a bit. Its two red-blood-cell-boosting blockbusters, along with Johnson & Johnson's Procrit, have been sagging in sales since last spring, when the FDA slapped a black-box warning on the pricey products after recent studies indicated that commonly administered high doses may not only cause cardio problems but also encourage tumor growth in cancer patients. Medicare responded in July by pushing down the newly approved lower dose even further--and refusing to reimburse docs who fail to get with the program. The new policies took a 20 percent bite out of Aransep sales in Amgen's second quarter.
Next week, the FDA will review use of the anemia antagonist for kidney failure, clearing the way for Mircera's expected final OK. And given the safety scares, Roche's pegylated version of the protein may yield a big commercial advantage in this major market, since the process generally improves a drug's solubility, allowing for fewer--and perhaps lower--doses and possibly less toxicity.