U. sues lab over cancer drug patent infringement

Licensed exclusively to Eli Lilly, the Alimta patent was set to expire in 2011 but was extended to 2015 last year after the U.S. Patent and Trademark Office decided that the U.S. Food and Drug Administration (FDA) had taken an unusually long time to approve the drug. The FDA first approved the drug in 2004, and Alimta went on sale later that year.

According to documents released by Eli Lilly, the company pays the University royalties that amount to a “single-digit percentage of net sales.” Based on last year’s sales, this means the University could have received as much as $103.5 million from the deal. The University’s new 250,000-square-foot chemistry building, located on Washington Road, is being funded in part by royalties from the sale of Alimta.

“The primary issue here is that Alimta is an anti-cancer drug developed based on basic research here at the University,” University spokeswoman Cass Cliatt ’96 said in an e-mail. “We can’t think of a better public benefit than that, and so our primary goal here is to have a public benefit to some of the research done at the University.”

The active chemical in Alimta was discovered in 1989 by chemistry professor emeritus Edward Taylor, who studied enzyme cofactors, which are compounds related to folic acids.

In 1948, research at other institutions revealed a link between these cofactors and the remission of leukemia. Early research showed that these cofactors disrupted cell division.

Over the next 30 years, Taylor and his team looked for a compound that would accomplish that task only in cancerous cells. In the 1980s, when one of his compounds seemed promising, Taylor brought it to Eli Lilly — where he had previously worked as a consultant — and asked workers at the drug manufacturer to test it. Taylor continued to refine the compound, and in 1989, he created the chemical that would become the active ingredient in Alimta. In 1991, the University filed for a patent, and it was approved in 1994.

This is not the first time the University has filed a suit against a drug company, nor is it the first time that this particular patent has been at issue. In 2008, the University and Eli Lilly sued Teva Pharmaceuticals, another generic drug maker, for violating the same patent.

According to the complaint filed in the U.S. District Court in Delaware, Teva had notified the University and Eli Lilly that it believed the patent was “invalid, unenforceable, and/or will not be infringed by the manufacture, use, offer for sale, or sale” of the generic version of the drug. The suit is still pending, but in December 2008, Teva acquired Barr Pharmaceuticals. Soon after, Lilly and the University sued Barr.

A Teva spokeswoman said the company does not comment on ongoing litigation, and multiple calls to Eli Lilly went unanswered.

Teva’s argument for patent invalidity does have some precedence. In 2003, the University of Rochester filed a similar suit against Pfizer and Pharmacia for infringement on a patent covering a chemical in the painkiller Celebrex.

The judge in that case ruled that the patent was invalid because it did not contain a detailed enough description of the invention, according to The New York Times. In 2004, the U.S. Circuit Court of Appeals for the Federal Circuit upheld that decision.

In 1997, Eli Lilly prevailed over the Regents of the University of California in another patent suit, in which the University of California aimed to protect its patent for the manufacture of human insulin. The Regents’ patent was also deemed invalid for failing to provide “an adequate written description” of the patent’s claims, according to the decision issued by the court.

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Nine years later, Lilly was again on the defending end of a patent suit, this time a suit filed by Ariad Pharamaceuticals, which had licensed a patent from MIT, Harvard and the Whitehead Institute for Biomedical Research. The patent covers any drug that works by influencing an important protein complex that regulates the immune system.

Lilly argued that the scope of the patent was too large because it covered a natural phenomenon rather than a particular compound. In 2006, the Federal District Court in Boston ruled that the patent was valid, however, and ordered Lilly to pay $65.2 million in royalties to Ariad.

Just last month, that decision was overturned by the Federal Circuit Court of Appeals, which ruled that the patent did not provide adequate descriptions of the work or sufficiently explain how others could duplicate the work.