Cabilly patent invalidated
Genentech's stronghold on monoclonal antibody production techniques may slip if a recent US Patent and Trademark Office's (USPTO) initial ruling is upheld. In late September, the USPTO rejected the company's ubiquitous Cabilly 2 patent on the grounds that it extends the life of another patent called Cabilly 1, which would have expired next year. Genentech plans to appeal the decision. Cabilly 2, scheduled to expire in 2018, covers principle processes in manufacturing antibody drugs such as Johnson & Johnson's Remicade, Abbot's Humira, ImClone's Erbitux, and MedImmune's Synergis. Each of these companies pays significant royalties to Genentech, and without a patent, Genentech would miss out on between $220 and $300 million dollars a year in license revenue, according to analyst's estimates. Some analysts question the enforceability of the patent beyond the 2006 expiration date of Cabilly 1. “March 2006 is like a stop sign at three in the morning and no cop around,” says Thomas Kowalski, a partner in the law firm Frommer Lawrence & Haug in New York City. At that point, companies paying license fees may make their own rules, he says. Some may pay a portion of their fees and some may not pay at all, he adds, “and Genentech will have to go chasing down all the people who ignored the patent.” EW
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