By Randall Osborne

The latest salvo in the battle over growth hormone products was fired by Novo Nordisk A/S, which has filed a patent-infringement lawsuit against four competitors, including a familiar rival.

Bagsvaerd, Denmark-based Nordisk is suing Genentech Inc., of South San Francisco, Eli Lilly and Co., of Indianapolis, Pharmacia & Upjohn Co., of Kalamazoo, Mich., and Serono Laboratories Inc., of Norwell, Mass.

The lawsuit relates to Nordisk's drug, Norditropin, which was approved by the FDA in May 1995 for use in children with growth hormone insufficiency, although the drug was not sold in the U.S. until Feb. 20 of this year. On that date, a court vacated a temporary injunction, won by Genentech, against marketing Norditropin. (See BioWorld Today, Dec. 27, 1996, p. 1.)

Genentech had sued Nordisk, charging that Norditropin infringed on Genentech's patents for its growth hormones, Protropin and Nutropin.

Now, Nordisk is suing back. The company's complaint is that Genentech and others are infringing Nordisk's U.S. Patent No. 5,633,352, granted May 27.

Nordisk's complaint, filed in the U.S. District Court of New Jersey, says the offending products by Genentech are Nutropin and Nutropin AQ (aqueous), a liquid form of Nutropin. Three other companies also are accused of infringing the patent, and Lilly is accused of infringing two additional patents from the same family.

The lawsuit asks for damages "adequate to compensate" Nordisk, plus interest.

Steve Zelson, director of corporate patents for Nordisk, said the new lawsuit is different in one major respect: The patents in dispute belong to Nordisk. Earlier fights with Genentech have been over Genentech patents. Also, those skirmishes — unlike the one begun most recently — had to do with processes of growth hormone manufacture, rather than with the products themselves, Zelson noted.

"It's not some esoteric way of constructing DNA [at issue in the Nordisk lawsuit]," Zelson said. "In this case, the claim is pretty clear."

Patent Fights Part Of Landscape

Genentech's first growth hormone product was Protropin, approved in 1985. Nutropin, a similar product, was approved in 1993. The U.S. competition is beginning to heat up as products come to market from Nordisk, Lilly, Bio-Technology General Corp., of New York, and Serono Laboratories Inc., an affiliate of the Geneva, Switzerland-based Ares-Serono Group.

Zelson estimated the human growth market at $300 million or more in the U.S.

Growth hormone is "one of the few biotech pharmaceuticals out there, and it's one of the first," Zelson said. As growth hormone products mature into products that canbe patented, they have almost inevitably become the subjects of disputes, he added.

Betsy Rosenberg, spokesperson for Genentech, said the company had not yet seen the lawsuit and had no comment.

Joyce Lonergan, an analyst with Cowen & Co., of Boston, said investors ought to take in stride the lawsuit against Genentech over human growth hormone. "I don't find it very stressful," she said. "It's not like this product is lagging in a portfolio that's gorgeous."

Growth hormone accounts for about $200 million in revenues per year for Genentech, out of about $1 billion total, she said.

A more important fact about the company, Lonergan said, is that its products are old, and the alternatives to its drugs are getting stronger in the marketplace. Activase, for example, for acute ischemic stroke, faces "heavy, heavy competition," she said. Activase, or tPA (alteplase recombinant), was approved in June 1996 for stroke victims.

Lonergan predicted Genentech's customer service will keep the company in the black — with or without lawsuits.

"Genentech has clearly done a good job of keeping patients on [human growth hormone]," Lonergan said. "They feel they'll be able to differentiate themselves, and I'd give them a fair shot. They've been able to hold their own."

The Nordisk lawsuit will not drag on as long as other patent litigation, Lonergan predicted. "Our expectation is that they will have some sort of answer from the court by the end of this year," she said. "I expect a trial will be likely." *

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