So far, Genentech Inc.'s aggressive defense of its patents andprotection of its dominant share of the U.S. growth hormone marketare working with one new competitor barred from the field and asecond likely to remain on the sidelines.
Novo Nordisk A/S Thursday appealed a federal judge's preliminaryinjunction against sales of the Denmark-based pharmaceutical giant'sNorditropin. The court ruling prevents Novo Nordisk from enteringthe U.S. market until its growth hormone patent fight is resolved withGenentech, of South San Francisco.
The U.S. District judge in New York issued the injunctionWednesday at the request of Genentech. Novo Nordisk suedGenentech seeking to invalidate its patent claims and Genentech filedsuit against Novo Nordisk charging patent infringement.
Genentech also is in federal court seeking a preliminary injunctionagainst Bio-Technology General, of Iselin., N.J. to stop sales of itsgrowth hormone drug pending the outcome of patent litigation. Bio-Technology General has contested Genentech's patent claims in alawsuit seeking $100 million in damages. Genentech, in turn, hasfiled court action alleging Bio-Technology General's product, Bio-Tropin, also infringes Genentech's patents.
Leah Berkovits, spokeswoman for Bio-Technology General, said ahearing on the injunction was held this week and will continue intonext month.
The FDA cleared Norditropin and Bio-Tropin for marketing in May.Novo Nordisk already sells its drug in 66 countries. Bio-Technologyhas Bio-Tropin on the market in seven countries.
Novo Nordisk acknowledged its appeal of the injunction will take 18months. If that's unsuccessful, the company could wait years before itfinds out if the district court agrees with its contention thatNorditropin does not infringe Genentech's patents.
While being deprived of U.S. sales may only pinch Novo Nordisk'sbottom line, it would be more damaging to Bio-Technology General,which reported a net income of $400,000 on $5.7 million in revenuesfor the fiscal quarter ending March 31.
"For Novo Nordisk it may be disappointing," said Peter Drake, ananalyst with Vector Securities International in Deerfield, Ill., "but it'snot something that's going to be a strategic disaster. For Bio-Technology General, Bio-Tropin is a more important product. It'scritical. An injunction against Bio-Technology General would be asevere blow."
In its decision on the Novo Nordisk injunction, the court saidGenentech showed "a strong likelihood of success" in arguing thatNorditropin infringed its patent protection.
Berkovits did not make any predictions on the outcome of hercompany's battle to keep an injunction from issuing.
"Obviously, we'd like to have Bio-Tropin on the market in the U.S.,"she said. "But the company has lots of other markets and products."
Genentech commands 75 percent of the U.S. growth hormone marketwith two products, Protropin and Nutropin. Eli Lilly and Co., ofIndianapolis, which makes Humatrope, has the other 25 percent.
Genentech and Lilly ended an eight-year patent fight in January whenLilly agreed to pay Genentech $145 million. Drake had predicted thesettlement signaled Genentech's probable success in keeping a thirdparty off the U.S. market.
He speculated Thursday that even if Novo Nordisk and Bio-Technology General wanted to license patents from Genentech, itprobably would not be interested.
"The U.S. market is extremely important to Genentech," he said,"and [the company] should protect its patents." n
-- Charles Craig Staff Writer
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