By Sherri Oslick --
In a recent press release, ARIAD Pharmaceuticals, Inc. announced that it has filed suit against Amgen Inc., certain Amgen affiliates, and Wyeth for infringement of U.S. Patent No. 6,410,516 ("Nuclear Factors Associated with Transcriptional Regulation," issued June 25, 2002). The '516 patent is directed to certain aspects of the NF-kB transcription factor pathway. ARIAD's complaint alleges that Amgen's products Enbrel® (etanercept, a TNF blocker) and Kineret® (anakinra, an IL-1 receptor antagonist), both 
used to treat arthritis, infringe the '516 patent. Both drugs were developed by Amgen and are marketed by Amgen and Wyeth.
The suit, filed in the District Court of Delaware, is directly related to an earlier suit filed in the same court. In April 2006, Amgen filed an action for declaratory judgment of invalidity and non-infringement (based on the manufacture and sale of Enbrel® and Kineret®) of the '516 patent. The complaint was later amended to include a count of declaratory judgment of unenforceability. In its answer to the original complaint, ARIAD denied Amgen's claims, but did not file any counterclaims. As set forth in a scheduling order in that case, the parties had until April 13, 2007 to join parties and amend or supplement the pleadings.
As noted in letter authored by ARIAD's counsel to the Court in the declaratory judgment action, out of concern for the possibility of waiving its right to pursue an affirmative claim of infringement in view of Amgen's indication that it would oppose ARIAD's efforts to add an infringement counterclaim, ARIAD filed the separate infringement action on April 13th as a precautionary measure. Shortly after ARIAD's filing, Amgen filed an amended complaint, immediately after which ARIAD answered, adding counterclaims of patent infringement. ARIAD has asked the court to either consolidate the actions or to dismiss the infringement action without prejudice in view of ARIAD's filing of an infringement counterclaim in the declaratory judgment action.
ARIAD's claim for infringement is case number 1:07-cv-00202, pending in the District Court of Delaware. Amgen's original declaratory judgment suit is 1:06-cv-00259, also pending in the District Court of Delaware.
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