Rhone-Poulenc Rorer Inc. and The Scripps Research Institutehave filed a motion for a preliminary injunction to preventsales of Hemofil-M Factor VIII:C by Baxter International Inc.and its Baxter HealthCare Corp. unit.

Rhone-Poulenc and Scripps said they filed the motion onThursday, pending resolution of a patent infringement lawsuitfiled in 1987.

The action in U.S. District Court in Delaware seeks to stopBaxter from allegedly infringing Scripps' patent Re. 32,011 forultrapure Factor VIII:C. Rhone-Poulenc is the exclusivelicensee of the patent.

The injunction is intended to establish the "legitimate marketposition" of Monoclate-P Factor VIII:C, Rhone-Poulenc said.Monoclate-P is manufactured and marketed by Rhone-Poulenc'ssubsidiary, Armour Pharmaceutical Co.

Rhone-Poulenc said it was able to ensure that the supply ofFactor VIII:C would not be decreased or interrupted as a resultof an injunction.

Both Hemofil-M and Monoclate-P are non-recombinant,monoclonal-purified Factor VIII. Rhone-Poulenc estimates theU.S. market for Factor VIII, which is used to treat hemophilia,at $250 million. The Fort Washington, Pa., unit had 1990Monoclate-P sales of $65 million.

Both products will be supplanted within three to five years byrecombinant products, said Cowen & Co. analyst David Stone.

On Sept. 3, Chiron Corp. and its partner, Novo Nordisk A/S,received a U.S. process patent applying to the manufacture ofrecombinant Factor VIII:C.

Rhone-Poulenc and Scripps are also involved in litigation withChiron and Genentech Inc., which also has developedrecombinant Factor VIII.

In March, the U.S. Court of Appeals reversed summaryjudgments by the U.S. District Court of Northern Californiathat had effectively invalidated the Scripps patent. Severalissues have been sent back to the lower court, where the caseis pending.

The Delaware case against Baxter had been suspended pendingthe Appeals Court decision on the California case.

Ten years ago, it would have been unusual for the courts togrant such an injunction, said Morgan Chu, a partner at the lawfirm of Inell & Manella in Los Angeles.

"In more recent years, it has become more common for a partyto request a preliminary injunction in a patent case and for thecourts to grant it in certain cases," Chu said. "The strongestlikelihood is where the patent was previously adjudged validand upheld on appeal."

-- Karen Bernstein BioWorld Staff

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