The International Trade Commission (ITC) has ruled that it willnot grant Genentech Inc.'s request for a temporary exclusionorder barring the import of human growth hormone (hGH) byBio-Technology General and Novo Nordisk A/S. The case willnow proceed to trial, where the ITC will hear arguments on thevalidity of three Genentech patents and decide if they areinfringed by BTG and Novo Nordisk.

Genentech sued BTG and Novo Nordisk in March 1993, claimingthat the companies were violating three Genentech processpatents by importing their hGH products into the U.S. forclinical studies. Neither BTG nor Novo Nordisk have U.S.approved-hGH products; BTG filed a new drug application(NDA) for a product in 1987, about six months after Eli Lilly &Co. filed one for its approved hGH, Humatrope. Novo Nordiskhas also filed an NDA for Norditropin, another hGH product.

Lilly currently enjoys orphan exclusivity on its growthhormone, meaning that neither BTG nor Novo Nordisk can selltheir products in the U.S. short of proving clinical superiority.Since BTG's product is identical to Lilly's, a BTG spokespersonexplained, FDA will not approve it until Lilly's seven-yearorphan period expires this March.

The ITC administrative law judge's decision on Genentech'srequest for a temporary exclusion order has not yet beenpublicly released. According to BTG of Iselin, N.J., however, thecase will be reviewed by the full commission of the ITC. If it isnot reversed there, the decision will become final on February26, 1994.

To have successfully obtained a temporary exclusion orderagainst BTG, Genentech's vice president of Intellectual PropertySteven Raines told BioWorld, Genentech needed to satisfy threecriteria. First, the company needed to convince the judge that itwas likely to succeed in proving the validity of its patentsduring trial. Second, it needed to establish that it was likely tosucceed on the merits of its patent infringement claims. Andthird, Genentech needed to establish that it would beirreparably harmed by the import of BTG's hGH.

The administrative law judge was satisfied that Genentech waslikely to prove its infringement claims regarding one of itspatents (No. 4,601,980, covering microbial expression of thegene for hGH). The South San Francisco, Calif., company wasunable to convince the judge that it was likely to succeed onthe merits of its infringement claims regarding the other twopatents, however.

Raines observed that this does not mean Genentech cannotsucceed in its infringement claim during the trial, but only thatthe judge "couldn't rule at this time" and "needed a morecomplete hearing."JBTG was most successful, he added, inconvincing the judge that it, rather than Genentech, would bemost harmed by a temporary exclusion order banning itsimport of hGH.

The finding that Genentech is likely to succeed on the merits ofone of its infringement claims, he added, indicates that thecompany may "lose the battle, but win the war" in its suitagainst BTG and Novo Nordisk. BTG maintains that it has notinfringed any of Genentech's hGH patents.

A trial is scheduled for March and should be concluded bySeptember, BTG said. Under the ITC, Raines remarked,companies cannot sue for monetary damages but only forexclusion of import. Companies often choose to bring a casebefore the ITC instead of a U.S. District Court, however, becauseturnaround is set in statute and is quicker than court action.

Genentech's Protropin (hGH) brought in $216.8 million in salesduring 1993. Approved in 1985, it was the company's firstproduct to enter the market. Genentech said it maintainsapproximately a 70% share of the U.S. hGH market.

-- Karl A. Thiel Associate Editor

(c) 1997 American Health Consultants. All rights reserved.