Patent Law

Aaron F. Barkoff of the Orange Book Blog writes in his March 21, 2008 post:

Amgen holds at least six US patents that relate to erythropoeitin and its derivatives (EPO) and processes for making EPO, protecting the Amgen drugs Aranesp and Epogen.  Sales of Aranesp alone topped $3.6 [b]illion last year.  Roche produces EPO in Europe and has been seeking FDA approval for its own EPO drug, Mircera, in the US.

Roche began importing EPO as part of its effort to generate data for its regulatory submissions to the FDA.  Amgen did not object to these acts of importation.  However, Roche continued importing EPO even after its FDA application was complete (though Roche has not yet sold or contracted to sell any of its EPO in the US).  Amgen responded by filing a Section 337 action with the International Trace Commission (ITC), asking the ITC to enjoin Roches further importation and future sale in the US of its European-produced EPO.

The ITC denied Amgens injunction request...In a decision Wednesday [March 19, 2008], the Federal Circuit affirmed in part, reversed in part, and remanded the case to the ITC.

Read the full analysis of the decision here.