WASHINGTON -- Xoma Corp. will seek an injunction to blockmarketing of Centocor Inc.'s drug Centoxin in the UnitedStates, according to Gerald Sobel, lead counsel for Xoma.
"We are going to apply to the judge for an injunction shortly,"Sobel told BioWorld on Tuesday.
The decision to seek an injunction comes in the wake ofMonday's finding by a federal court jury that Centocorinfringed the patent covering Xoma's rival E5 antibody againstgram-negative sepsis.
Although the prospects for marketing approval of E5 remainhazy, the verdict puts Centocor on the defensive as it preparesto bring Centoxin to market. A Food and Drug Administrationadvisory panel on Sept. 4 recommended marketing approval forCentoxin, but agency spokeswoman Faye Peterson on Tuesdaywould not estimate timing for final approval.
Centocor officials remained optimistic. "FDA approval usuallycomes anywhere from three to eight months after the panelmeeting," said Centocor spokesman Charles Cabot III.
Xoma's stock (NASDAQ:XOMA), which had been pummeled by itsfailure to get a marketing recommendation in September,climbed $1.50 to $19.50 on Tuesday. Centocor (NASDAQ:CNTO)fell $2 to $48.25.
According to James Johnson, patent attorney for the JonesAkew & Lunsford law firm in Atlanta, Xoma could win aninjunction if it demonstrates all of the following: that FDAapproval of Centoxin is imminent; introduction of Centoxinwill cause irreparable harm to Xoma; the public interest willbe served by an injunction; and that Centocor is not likely towin if it appeals the infringement suit.
Johnson predicted Centocor will "fight tooth and nail" for courtpermission to market Centoxin during the appeals process,under the condition that Centocor will provide relief to Xomaif the verdict is upheld.
Centocor probably will argue that an injunction will not servethe public interest because Centoxin is a life-saving drug,Cabot told BioWorld.
In response, Sobel said Xoma will repeat trial testimonydisputing the assumption that Centoxin is a life-saving drugbecause "clinical data (on Centoxin) does not support theclaims made by Centocor."
Cabot would not confirm that Centocor will appeal the trialverdict, but analysts and attorneys said an appeal, as well ascross-litigation in support of Centocor's own patent, could beexpected because the stakes are so high.
Although E5's marketing approval has been stalled, the verdicthas established its patent as dominant.
If Centocor loses on appeal and is permanently enjoined frommarketing Centoxin, then "Xoma wins the whole game in theUnited States" if it gets FDA marketing approval, Johnson said.
He added that Centocor probably will lose an appeal becausethe company would have to present "clear and convincingevidence" that the Patent Office erred in issuing the patent onE5.
Failing this, Centocor could file a patent suit of its own,alleging that Xoma is infringing on its Centoxin patent. Ifsuccessful, the companies would be in stalemate, and thesolution would be a cross-licensing agreement.
Such a suit might pressure Xoma into accepting a cross-licensing offer from Centocor, said Albert Halluin, director ofbiotechnology for the Fliesler Dubb Meyer & Lovejoy law firmof San Francisco,
"Cross-licensing would be a way to resolve this dispute,"Halluin said.
-- Kris Herbst BioWorld Washington Bureau
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