Genentech Inc.'s human growth hormone franchise in theU.S. was strengthened late Thursday when a federal judgegranted a preliminary injunction prohibiting Bio-Technology General Corp. (BTG) from selling its growthhormone, Bio-Tropin.

Genentech thwarted the advances of another potentialcompetitor in June when Denmark-based Novo NordiskA/S was prohibited from selling its recombinant humangrowth hormone, Norditropin. Genentech _ whichcontrols 75 percent of the approximately $350 millionU.S. market _ claims that Novo and BTG would beinfringing its human growth hormone process patents ifthey sold similarly manufactured product.

BTG, of Iselin, N.J., said it will appeal and seek a stay ofthe decision. But success there seems unlikely becauseNovo's similar request, in front of the same federal judge,already has been denied. Both Novo and BTG got FDAapproval of their human growth hormone (hGH) productsin May. Genentech immediately sought injunctionsagainst product launches until the patent issue wasresolved. (See 1995 issues of BioWorld Today, Jan. 10,Jan. 19, May 10, May 26, June 16, June 29, June 30, all p.1.)

The decision "is not a surprise to me because Genentechhas shown itself to be successful in its patent dealings,"Joyce Lonergan, an analyst in Cowen & Co.'s Bostonoffice, told BioWorld Today. "They told us they would beable to do this in spite of the fact that they had litigationdifficulties with Biotech General earlier this year."

Lonergan said the ruling means that sales of South SanFrancisco-based Genentech's hGH products _ Protropinand Nutropin _ will be solid through this year. "But wehave to see how it shakes out in the long term," she said.

Sim Fass, BTG's president and CEO, said, "This case ispart of Genentech's ongoing attempt to preventcompetitors with FDA-approved hGH products fromcoming to market. We continue to maintain that we donot infringe any valid Genentech patent and will defendthis position which we believe will be upheld."

Leah Berkovits, BTG's director, corporatecommunications, told BioWorld Today that Genentechneeded to show it would suffer irreparable harm if BTGwas allowed to enter the market, and the refusal to letBTG sell its product serves the public interest. "So howcould such a claim be upheld?" she asked.

"We were planning to launch in 1995," Berkovits said."If there's a stay we may just do that."

Matthew Geller, an analyst with new York-basedOppenheimer & Co., Inc., said getting a stay of theinjunction doesn't look likely for BTG.

"The moral here," Geller said, "is that the courts takepatents very seriously. Patents are public interest," hesaid. "The courts want people to come up with novelproducts and unless you have a patent they're notprotected.

"It's a mistake to view the bigger company as Goliathbullying David," Geller said. "[Genentech] has the patentfair and square and that means they have certain financialrights."

Eli Lilly & Co., of Indianapolis, currently is the onlyother company selling human growth hormone in the U.S.(BTG and Novo sell their products in other markets).Genentech, which brought its hGH product on the marketin 1985, and Lilly, which launched Humatrope in 1987,were in a patent dispute until Lilly in January agreed topay Genentech $145 million to settle the matter out ofcourt.

Laura Leber, Genentech's director, corporatecommunications, told BioWorld Today that it would beone to two years before the patent battle is taken to a fullcourt hearing. "It's up to BTG and Novo to see if theywant it to go to court," she said. "We will pursueprotection of patents to the extent possible."

Earlier in the litigation the judge dismissed, withprejudice, BTG claims against Genentech that didn'tconcern patent validity and infringement. Those claimsincluded malicious prosecution, abuse of process, unfaircompetition and antitrust violations.

Genentech's stock (NYSE:GNE) was unchanged Fridayat $47 per share. Bio-Technology General(NASDAQ:BTGC) was down 44 cents, closing at $3.06.n

-- Jim Shrine

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

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