Roche Loses Big Patent Case Brought By Amgen

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judge2A federal judge in Boston ruled the drugmaker infringed on Amgen’s patents with its Mircera anemia med, essentially upholding a preliminary decision issued in February. The order by US District Court Judge William Young deals a big setback to Roche, which already cut costs after its plans to market Mircera flopped and further underscores its need to takeover Genentech.

The ruling caps more than a year of intense legal wrangling in which Roche lost a jury trial that found Mircera infringed on Amgen patents for its Aranesp and Epogen meds. That came shortly before Roche won FDA approval to market Mircera. Young subsequently issued a preliminary injunction barring Roche from selling Mircera.

At one point, though, Young declined to issue a permanent injunction, noting it may not be in the public interest to ban Mircera sales, and instead indicated he might impose a licensing deal allowing Roche to launch Mircera if certain conditions were met, such as royalty payments to Amgen, a promise not to eventually raise prices, and the funding of an independent body to monitor the situation.

However, in his 150-page order, Young ultimately decided such a view was untenable. “The uncertainties inherent in the available clinical evidence and the highly speculative economic projections are simply not enough to override the public’s interest in robust patent rights that protect incentives for innovation,” he wrote on page 149. Here is the order.

A federal appeals court in Washington was already scheduled next week to hear Roche challenge the preliminary injunction. In a statement sent us, Roche says it “is assessing how this opinion impacts the current appeal. Roche believes strongly that there should be treatment options for patients with chronic kidney disease and as well as choice for health-care providers.”

The ruling “recognizes that Amgen is entitled to a permanent injunction against Roche and reaffirms the infringement and validity of our patents,” David Scott, Amgen’s senior vice president and general counsel, says in a statement.

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