Amgen's EPO Patent Win At The Federal Circuit

Implications: (1) The US Court of Appeals for the Federal Circuit - in a complicated 22-page split Opinion earlier today Wed 19 Mar 2008 - provided Amgen another victory in its long patent battle(s) with Hoffmann-LaRoche. (2) Amgen's Aranesp® and EPOGEN® (each a prescription only product that relates to EPO/erythropoietin) are protected by multiple US patents. (3) As indicated in the Wall Street Journal article, Aranesp® and EPOGEN® are each critical revenue-producers for Amgen with combined sales in excess of $6 billion. (4) Further ITC proceedings may ultimately transform the current intermediate patent victory into a more effective and more valuable ruling in favor of Amgen.

Analysis: (1) As always in Life Science Patent Battles, the details are critical.  The reported Opinion is Amgen/Appellant versus ITC/Appellee and Hoffmann-LaRoche/Intervenor ( Case No. 2007-1014).

(2) The WSJ correctly notes that "... the decision to send the case back to the ITC is the latest step in a long feud between the pharmaceutical companies, as Amgen tries to prevent Roche from bringing its anemia drug onto U.S. turf. Amgen has argued that Roche's Mircera infringes on its patents, and that Roche's application for U.S. Food and Drug Administration approval to sell the drug in the U.S. established an intent to sell."

(3) Using a more detailed viewpoint, the Federal Circuit (a) affirmed-in-part the prior ruling by the US International Trade Commission; (b) reversed-in-part that same ruling; and (c) remanded the case back down to the ITC for further proceedings.  At one-level, the "safe harbor" protection of Title 35 United States Code, Section 271(e)(1) rescues certain aspects of Hoffmann-LaRoche's conduct which relate to regulatory submissions to the FDA/Food and Drug Administration.  But at the next level of more and more details, the Federal Circuit clearly held that this same "safe harbor" protection is not unlimited; beyond the protected activities, other conduct might ultimately be held to be patent infringement.  In essence, the court held that the ITC improperly (due to inadequate evaluation) found virtually all of Hoffmann-LaRoche's conduct to fall within the zone of safety.  Upon the subsequent remand back down to the ITC, Amgen will have the possibility of proving patent infringement by Hoffmann-LaRoche.

BOTTOMLINE CONCLUSIONS At the ITC, Amgen will have an opportunity to secure another patent victory in defense of its EPO products.  The "safe harbor" aspects of the Court Opinion should not be overhyped; although they are important, new on-the-merits proceedings at the ITC might ultimately prove favorable to Amgen.