ARIAD Pharmaceuticals, Inc, of Cambridge, Massachusetts, announced that a jury in the US District Court for the District of Massachusetts has found in favor of ARIAD and its co-plaintiffs (the president and fellows of Harvard College, Massachusetts Institute of Technology, and Whitehead Institute for Biomedical Research, all of Cambridge, Massachusetts) in their lawsuit against Eli Lilly and Company, claiming that Lilly's osteoporosis drug, Evista®, and septic shock drug, Xigris®, infringe on the claims of the plaintiff's NF-kB US patent. The jury found that the claims of the patent (US Patent No. 6,410,516, issued June 25, 2002) are valid and infringed, and awarded damages (back royalties) to the plaintiffs of approximately $65.2 million, based on the determination of a reasonable royalty rate of 2.3% on US sales of Evista and Xigris from the date of filing of the lawsuit (June 25, 2002) through February 28, 2006, and ongoing damages through 2019, when the patent expires.

The patent in question claims methods of treating human disease by regulating NF-kB cell-signaling activity, and will likely have an impact on the many dozens of companies with drugs affecting NF-kB activity that are either on the market or in development for diseases including autoimmune disorders, cancer, and cardiovascular disease. These companies will be closely watching Lilly's countermoves as it seeks to recover from the loss of round one in the legal courts. Lilly has already announced that it will seek to have the trial court judge set the jury's verdict aside as a matter of law, and if unsuccessful, will appeal the decision to the Court of Appeals for the Federal Circuit. In addition, a separate bench trial with the US District Court of Massachusetts will be held on Lilly's contention that the patent is unenforceable and will also consider the patent's improper coverage of natural processes. Lilly also reported that in June 2005, the US Patent and Trademark Office commenced an ongoing reexamination of the patent in order to consider certain issues raised by Lilly relating to the validity of the patent.

—A. Techman