Amgen (AMGN) holds at least six U.S. 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 million last year. Roche (OTCQX:RHHBY) produces EPO in Europe and has been seeking FDA approval for its own EPO drug, Mircera, in the U.S.
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 U.S.). 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 U.S. of its European-produced EPO.
The ITC denied Amgens injunction request because:
In a decision on Wednesday, the Federal Circuit affirmed in part, reversed in part, and remanded the case to the ITC.
The ITC determined that Roches importation of EPO was protected by the FDA safe harbor provision of Section 271(e)(1), which provides that conduct cannot infringe a patent when it is reasonably related to securing FDA approval. The ITC has no jurisdiction absent a sale or contract for sale of EPO in the U.S.
Amgen made three arguments on appeal:
Section 271(e)(1) provides no exemption for the importation of articles made overseas by patented processes in Section 337 actions before the ITC. Section 271(e)(1) does not provide blanket protection for all pre-FDA-approval. The ITC has jurisdiction whenever sale of the accused article is imminent.
All three Federal Circuit panelists sided with Amgen.