Amgen v. Hoffmann-LaRoche: Back to the District Court

    By Kevin E. Noonan --

The Federal Circuit today issued an Order, pursuant to Federal Circuit Rule 36, affirming the District Court's grant of a preliminary injunction in Amgen Inc. v. F. Hoffmann-La Roche Ltd., Amgen's patent infringement suit over Roche's Mircera® drug product.  The District Court granted the preliminary injunction on February 28, 2008, after a jury verdict that Amgen's patents-in-suit (U.S. Patent Nos. 5,547,933; 5,441,868; 5,618,698; 5,955,422; and 5,756,349) were not invalid and Mircera® infringed the claims of the '933, '868, and '698 patents (see "Amgen Survives Another EPO Challenge").  Massachusetts District Court Judge William Young entered the injunction to prevent Roche from putting Mircera® on the market while the Court prepared its opinion.  The Court issued that opinion, 150 pages in length, last Thursday (see "Victory for Amgen in District Court Decision" - Part I, Part II), which presented procedural and other problems for the parties and the Federal Circuit during oral argument just this Wednesday (Part III).

By ruling as it did, without an opinion, the Federal Circuit did the only thing both parties agreed would help move the case to resolution:  get the case back within Judge Young's jurisdiction so he can enter a final judgment.  Lacking a final judgment precluded the Federal Circuit panel hearing oral argument on Wednesday from considering the merits of any of the parties' contentions, a circumstance all agreed was "unusual."

Upon questioning from the panel at oral argument on Wednesday, Amgen's counsel Rusty Day suggested that Amgen might file post-judgment motions, and indicated that Amgen expected to file a notice of appeal on some issues.  Roche filed its notice of appeal last Friday; that notice will not become effective until Judge Young enters his opinion as a final judgment.  The parties and the panel expected entry of judgment to happen rapidly; as Judge Plager asked, "don't you think Judge Young is waiting by his telephone [for their opinion]?"

It is unlikely that the Federal Circuit will hold oral arguments on the merits much before next summer, even if Roche moves to expedite the briefing schedule as their counsel, Leora Ben-Ami, told the panel Roche intended to do.  This just delays even further Mircera®'s entry into the marketplace, to Roche's detriment.  They may have to be satisfied for the foreseeable future by selling Mircera® in Europe, a circumstance mentioned by Judge Young in his opinion:

European companies such as Roche can profit from building upon American discoveries by producing and selling infringing products in Europe and throughout the rest of the world.  Nevertheless, the fact that Roche "built up its manufacturing facility in [Europe] and prepared to market its product was simply a risk it took with eyes open to the" possibility that it would not be permitted to market MIRCERA in the United States.