By Lisa Seachrist
Novo Nordisk A/S has won, temporarily, the right to market its recombinant human growth hormone product in the U.S. The Dutch company received a stay of a preliminary injunction preventing it from selling Norditropin in the U.S. by the U.S. District Court of Appeals.
This most recent installment of the drawn out patent infringement battle between South San Francisco’s Genentech Inc. and Novo Nordisk, of Bagsvaerd, Denmark, came Dec. 20 after the court had reviewed written briefs and heard oral arguments.
“The real world impact of this decision is that we now no longer have any legal obstacles to marketing Norditropin in the U.S.,“ said Steve Zelson, vice president and director of corporate patents, for Novo Nordisk. “We plan to proceed with plans to market Norditropin in the U.S., however, we have yet to establish a time frame.“
Novo Nordisk had not requested the stay and the court took its action sua sponte — of its own volition — in response to filed briefs and oral arguments. Zelson said that while he has no way to predict how the court will rule, the action augurs well for Novo Nordisk’s case.
Genentech began patent infringement litigation with Novo Nordisk as well as Bio-Technology General, of Iselin, N.J., with a case in front of the International Trade Commission (ITC). The ITC ultimately decided to dismiss the case because Genentech failed to provide certain documents in a timely fashion. (See BioWorld Today, Jan. 19, 1995, p. 1.) Both companies filed suits in federal district court in New York seeking declarations that their products didn’t infringe Genentech’s patents.
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 as soon as the FDA approved the drug. (See BioWorld Today, May 10, 1995, p. 1.) However, on June 14, 1995, five days before the company was set for the U.S. launch of Norditropin, the U.S. District Court for the Southern District of New York issued a temporary restraining order preventing the company from marketing the drug.
That restraining order became permanent in the form of a preliminary injunction against the company on June 28, 1995. (See BioWorld Today, June 29, 1995, p. 1.)
Novo Nordisk appealed the decision to the U.S. Appeals Court which threw out the injunction on Feb. 27, 1996. However, the district court once again issued a preliminary injunction against Novo Nordisk on June 27, 1996, based on another patent. Novo Nordisk appealed once again, but the U.S. Court of Appeals denied their motion on Aug. 1, 1996.
The most recent action that permits Novo Nordisk to enter the $400 million per year growth hormone market came after the court heard oral arguments on Dec. 5, 1996. The court decided on Dec. 17, to stay the injunction without a motion from the company.
Kathleen Rinehart, corporate communications manager at Genentech points out that the stay only address the preliminary injunction designed to stop Novo Nordisk from entering the market until the patent infringement case is decided.
“We fully expect this case to continue to a full patent infringement case,“ said Rinehart. “And, even with the stay, we are still awaiting the court’s final decision on the preliminary injunction.“