NF-κB is a transcription factor that regulates multiple genes, the expression of which leads to the production of, for example, cytokines, chemokines and adhesion molecules. It was discovered by researchers at the Massachusetts Institute of Technology and is now known to be involved in a wide range of processes, such as cancer, inflammation and bone regulation. Patenting such a pathway is viewed by many as inappropriate, as it imposes licence fees on basic biology. Indeed, various drugs on the market, many of which were discovered before the patent was filed, modulate the NF-κB pathway. The dispute between Lilly and Ariad, which has been running since 2002, relates to one such drug: Lilly's Evista (raloxifene), a selective oestrogen receptor modulator for the treatment of osteoporosis.

The '516 patent contains broad claims that relate to methods of reducing NF-κB activity. Lilly argued that the claims were not supported by 'written description' because the '516 patent fails to adequately disclose how the reduction of NF-κB activity is achieved. Under US patent law, a patent must describe the manner and process of making and using the invention in full, clear, concise and exact terms that would enable a person to make and use it. The '516 patent puts forward three classes of molecules that are potentially capable of reducing NF-κB activity: specific inhibitors, dominantly interfering molecules and decoy molecules.

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