By Lisa Seachrist

Washington Editor

WASHINGTON — A five-year patent battle between Novo Nordisk A/S and Genentech Inc. over human growth hormone and human insulin has ended with a cease-fire.

The two companies essentially dropped the dispute over human growth hormone by agreeing to grant each other worldwide cross licenses for patents relating to the human growth hormone product and the process by which the hormone is made.

In addition, Bagsvaerd, Denmark-based Novo Nordisk will pay an undisclosed amount to South San Francisco-based Genentech to obtain a license for technology related to the production of human insulin.

"They get a license and we get a license," said Jim Shehan, general counsel for Novo Nordisk North America. "It's like we both had guns pointed at each other, and we agreed to put them down."

Perhaps the most litigated pharmaceutical product ever, human growth hormone became an issue between Genentech and Novo Nordisk in 1993, when Genentech alleged that Novo Nordisk's Norditropin recombinant human growth hormone (rHGH) infringed upon process patents Genentech had established for its rHGH products, Protropin and Nutropin.

However, that original action was dismissed by the International Trade Commission (ITC) because Genentech failed to provide certain documents in a timely fashion (See BioWorld Today, Jan. 19, 1995, p. 1.)

Novo Nordisk won FDA approval for Norditropin in May 1995 for use in children with growth hormone insufficiency. The ITC decision cleared the way for Novo Nordisk to market Norditropin in the U.S.

On June 14, 1995, five days before the company was set for the launch of Norditropin, the U.S. District Court for the Southern District of New York issued a temporary restraining order preventing Novo Nordisk from marketing its drug. On June 28, the injunction became permanent.

In December 1996, the Dutch company received a stay of the injunction, allowing it to market Norditropin in the U.S. Sales of Norditropin began on Feb. 20, 1997.

In October 1997, Novo Nordisk sued Genentech, charging its Nutropin and Nutropin AQ (aqueous), a liquid form of Nutropin, infringed on the product patent granted for Norditropin May 27, 1997.

The agreement disclosed by the two companies Monday takes the issue of rHGH and recombinant human insulin out of the court system.

"We were very pleased with the settlement of this dispute," said Paul Laland, associate director of corporate communications at Genentech, who noted that the competition between the companies will be limited to the marketplace now.

Genentech has the largest share of the rHGH market in the U.S., with 1997 sales of $223.6 million.

Novo Nordisk claims 20.4 percent of the market outside the U.S., with revenues of $238 million in 1997. The company describes its sales in the U.S. as very limited.

"Our sales figures in the United States reflect the fact that we were excluded from the market until last February," Shehan said. "Instead of being third to the market, we were fifth."

At the same time it filed suit against Novo Nordisk, Genentech sued Bio-Technology General Corp., of Iselin, N.J., for patent infringement over Bio-Tropin. Genentech has successfully blocked Bio-Tropin from the U.S. market. Bio-Tropin is sold outside the U.S.

As for Novo Nordisk, this is the second settlement it has reached with a company over its product patent. Novo Nordisk previously settled with Ares Serono Group, of Geneva, but still has suits against Pharmacia & Upjohn, of London, and Eli Lilly and Co., of Indianapolis.

Novo Nordisk's stock (NYSE:NVO) closed at $63.375 down $1.125 while Genentech's stock (NYSE:GNE) closed at $68.125 up $0.75. *