Ariad V. Lilly - The '516 Patent at Issue

The '516 Patent At Issue

The '516 patent was licensed by Ariad from Massachusetts Institute of Technology (MIT), Harvard, and the Whitehead Institute. Nuclear factor-kappa B (NF-kappaB) is a transcription factor that plays a critical role in many cell functions including embryonic and neuronal development, cell proliferation, apoptosis, and immune responses to infection and inflammation. Defendant Lilly was manufacturing two drugs accused of infringing the '516 patent: Evista(r) for the treatment of osteoporosis and prevention of breast cancer, and Xigirs(r) for the treatment of sepsis.

On May 4, 2006, Lilly was ordered to pay ~$65 million in back royalties, and 2.3% royalties on future sales of the drugs Evista and Xigris which inhibit

The lower court's opinion was controversial because many commentators felt that the scope of Ariad's patent's claims went far beyond what was covered or enabled in the patent itself. As a transcription factor, NF-κB regulates over 300 genes, and NF-κB-controlled pathways are relevant to many human diseases. As many as 200 marketed drugs have mechanisms of action that may affect the NF-κB pathway. Lilly's defense is termed by some as the "Lilly written description" doctrine, as it entails the need for an extremely detailed and precise description of the action embodiment of the invention itself.