Tuesday, April 18, 2006

Further discussion of Harvard, MIT v. Lilly

Further to an IPBiz post on April 10 about Harvard and MIT suing Eli Lilly, one notes that Harvard, MIT and Ariad stake their patent infringement claim against Lilly on their discovery of the working of "nuclear factor-kappa B" (or NF-kB) by former Whitehead director David Baltimore (now president of the California Institute of Technology, and a Nobel Laureate), MIT scientist Phillip Sharp and Harvard scientist Thomas Maniatis. The issue of patenting basic scientific discoveries came up recently in the Metabolite case, and Michael Crichton's op-ed in the New York Times.

The patent application(s) were at the U.S. Patent and Trademark Office for 16 years before the USPTO decided the discovery warranted a patent. As soon as the USPTO granted it, Ariad and the three research institutions sued Lilly, contending that Evista and Xigris inhibit NF-kB. One recalls that the University of Rochester sued Searle the day that its patent on COX-2 inhibitors issued, but that Rochester lost the case on summary judgment. Ariad said Lilly rebuffed its requests to license use of the pathway.

Of Lilly's position-->

Lilly said in a legal brief that the patent is invalid because it is "simply a discovery of a natural principle that has occurred in nature for 200 million years. The United States patent laws are designed to protect man-made innovations."

Lilly points out that the U.S. patent office, at the company's request, is now re-examining its granting of the patent. [One notes Lilly initiating its re-exam BEFORE the litigation was completed, unlike eBay, who filed a re-exam request ONLY AFTER IT HAD LOST THE LITIGATION.]

Lilly also says it invented the active ingredient of Evista in the 1970s and the active ingredient of Xigris in the early 1980s, and has its own patents on those compounds. The first patent applications by the research scientists were filed in 1986.

"The commercial development of both of these products was essentially complete long before any possible connection of these products to NF-kB was made," Lilly said in a court filing.

Some companies licensed-->

Ariad has said that it approached 50 other companies that had products on the market or in development that use the NF-kB pathway, demanding licensing fees on future sales. Two companies -- Bristol-Myers Squibb Co. and DiscoveRx Corp. -- have entered into agreements, according to Ariad's Web site.

General interest-->

The jury trial in D. Mass. in Boston before U.S. District Court Judge Rya Zobel is expected to last until the end of April 2006. Intellectual property attorneys and pharmaceutical companies are very interested in the outcome, because a victory for the plaintiffs could lead to future claims on biological processes that are "upstream" of drugs -- a potentially significant disincentive to future research by companies.


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