The case between Ariad Pharmaceuticals and Eli Lilly over rights to develop drugs that modulate the nuclear factor-κB (NF-κB) pathway has finally reached a federal court in Boston. If the court upholds Ariad's patent and decides that Lilly infringed it, many other companies might have to pay royalties for drugs that affect NF-κB. Such a ruling would set a precedent for the patenting and exclusive licensing of other biological pathways and could seriously hinder the capacity of companies to develop new drugs.
In 2002, the US Patent and Trademark Office awarded USP6,410,516 to inventors from Harvard University, the Whitehead Institute and the Massachusetts Institute of Technology after a lengthy patent examination period of 16 years. The patent contains 203 claims relating to methods of treating disease by regulating the NF-κB family of molecules and is exclusively licensed to biotechnology company Ariad. As soon as the patent was awarded Ariad sued Lilly, claiming that its osteoporosis drug Evista and its sepsis drug Xigris both infringe the patent because they work by affecting NF-κB. It also sent letters to 50 other companies, of an estimated 200, that have products either in development or on the market that modulate NF-κB.
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