Ariad v Lilly, a "a drug pathway" patent dispute

In May 2006, a jury in the U.S. District Court of Massachusetts in Boston issued an initial decision in the case of Ariad Pharmaceuticals et al v. Eli Lilly and Company. The federal jury's verdict is that U.S. Patent No. 6,410,516, owned by Harvard, the Massachusetts Institute of Technology, and the Whitehead Institute and licensed to Ariad Pharmaceuticals, is valid and infringed by Lilly's sale of Evista(R) and Xigris(R). Ariad, based near Boston, sued Indianapolis-based Lilly, accusing the larger company's drugs Evista and Xigris of infringing the patent on its experimental drug pathway, NFkB. The patent covers a method of treating disease by regulating a certain type of cell activity. The patent is on a an experimental drug, AP23573, covering a method of treating soft-tissue and bone cancers. Critics question the validity of the drug’s patent because it attempts to protect the process in which the drug works, not the drug’s chemical composition.

However, jurors in U.S. District Court in Boston agreed with Ariad, slapping Lilly with $65 million in damages in May.

"In my more than thirty years of experience in patent law, which includes involvement in dozens of patent lawsuits, I've never seen a jury verdict with which I so strongly disagree; the finding of infringement stands at odds with the most basic premise of the patent system. If practicing technology that's already known, and therefore is old, infringes a patent, the inventor hasn't properly limited the patent to technology that is new," said Robert A. Armitage, senior vice president and general counsel for Lilly.

This decision appears to go against long-standing patent practice in that one cannot get a patent that would remove known materials from the public. In addition, it has always been the case that one may patent a drug without knowing how it works. If this decision were allowed to stand, many drugs could eventually be found to infringe patents that were issued long after the
drugs themselves were discovered. This also begs the question of if a researcher discovers a drug without ever knowing the drug acts on a patented pathway or before the pathway is
understood, does that constitute infringement? If the drug was acting on the pathway before the pathway was discovered, does the existence of the drug invalidate the patent on the pathway by rendering it not "new"? This could also give rise to an ever-increasing number of conflicting patents. Because NF-kB can activate so many genes, more than 150, it is implicated in many diseases. A separate bench trial with the U.S. District Court of Massachusetts has been held last week (August 7) on Lilly's contention that the patent is unenforceable and will also consider the patent's improper coverage of natural processes. In June 2005, the U.S. Patent and Trademark Office commenced a reexamination of the patent (Reexam. C.N. 90/007,828). The reexamination is currently in progress.

From: Patent Baristas (blog by Stephen, May 4, 2006), CNN Money, August 4, 2006,