MIT benefits from new Prozac use

By Jeff Swiatek

July 13, 2000 Web posted at: 3:54 PM EDT (1954 GMT)

INDIANAPOLIS, Indiana (Indianapolis Star) -- When renamed Prozac goes on sale next month to treat severe PMS, a share of the revenue will flow to Massachusetts Institute of Technology and two of its scientists. The MIT scientists grabbed a piece of the action on Eli Lilly and Co.'s best-selling drug by getting a method-of-use patent on Prozac for treating severe PMS.

Anyone can get a "use patent" on a drug, even if they don't hold the patent on the compound itself or the manufacturing process, by proving an application that is new, unobvious and useful.

MIT stands to collect millions of dollars from Prozac sales for its scientists' foresight.

"We will be happy" to receive the money, though the amount is modest by MIT standards, said Lita L. Nelsen, director of MIT's technology licensing office.

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"This license is not going to change the price of tuition to MIT," she said.

Lilly, which holds patents on the Prozac molecule and the way it's made, plans to start selling Prozac under the name Sarafem for severe PMS next month. The company received marketing go-ahead from the U.S. Food and Drug Administration last week.

Sarafem will be the first drug marketed to women suffering from severe PMS, or premenstrual dysphoric disorder. About 4 percent of U.S. women suffer from debilitating emotional and physical symptoms linked to their monthly menstrual period.

Technically, Lilly hasn't licensed the rights to sell Sarafem from MIT, but from Interneuron Pharmaceuticals, a Massachusetts company that received the rights from MIT.

Lilly already has paid Interneuron $2 million under the deal, according to Interneuron's filings with the Securities and Exchange Commission.

Lilly will make another payment to Interneuron for the U.S. regulatory approval. Plus, Lilly will pay Interneuron an undisclosed percentage of Sarafem's sales.

A portion of the royalties will flow back to MIT and Drs. Richard and Judith Wurtman.

The two scientists, who are husband and wife, did the research starting in the 1970s that eventually showed Prozac was effective in treating severe PMS.

The Wurtmans, who also patented the use of the ill-fated diet drug Redux for obesity, received a method-of-use patent on their Prozac work.

Richard Wurtman, who is director of MIT's Clinical Research Center, said MIT tried to license the rights to market Prozac for severe PMS to Lilly directly, but the Indianapolis drugmaker wasn't interested in dealing with the university.

"So MIT licensed it to Interneuron just so that Interneuron could approach Lilly company-to-company," Wurtman said. "It worked, and Lilly sublicensed our invention."

Wurtman co-founded Interneuron. He resigned from its board last year.

Lilly's licensing deal on its No. 1 drug is not something the company trumpets.

Lilly didn't mention the licensing in its news release last week about the federal approval for Sarafem.

Lilly general patent counsel Bob Armitage insisted that Lilly was glad to ink the 1997 deal with Interneuron.

"You're constantly on the lookout for these kinds of opportunities," he said. "If we tried to develop everything in-house, we probably would be a less-efficient research organization."

Such method-of-use patents are "getting to be more and more prominent" in the drug industry, as companies and independent researchers seek ways to profit from established drugs, said Arthur R. Whale, a drug patent specialist who is of counsel to the Indianapolis law firm of Baker & Daniels.

Pharmacia & Upjohn's hair restorative Rogaine is a well-known case of a drug use that wasn't discovered by the drug's owner, said Armitage, who worked for Upjohn.

When some doctors in Colorado found an Upjohn blood pressure medicine was causing hair growth in men, they patented the use, and Upjohn licensed it.

No projections were available for Sarafem sales, but they could be large. Prozac generated $2.6 billion in sales last year, so if Sarafem bumps up sales by only 2 percent, that would be $52 million.

The Sarafem revenue will start to flow in August and could prove a boon to Interneuron, a small biotechnology company that lost $37.7 million last year on revenue of only $1.6 million.

"Lilly felt like there is an attractive opportunity to treat (severe PMS), but they needed our patent to do it," said Interneuron spokesman William R. Boni.

Interneuron expects "significant" revenue from the deal, he said.

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