12 Biotechnology Law Report 9 (Number 1, January-February 1993) The PTO asked for comments on the proper relation between the Board and the Commissioner and scheduled a meeting for November to consider the responses (see <BLR 1388>, vol. 11, no. 6, November-December 1992). # # # PATENT LITIGATION {BLR 1408} Xoma - Centocor - Mabs. ANTISEPSIS ANTIBODY FIGHT CEASES —Xoma Entitled to Payment from Centocor The long-running litigation between Xoma Corp. of Berkeley, Cal., and Centocor (Malvern, Penn.) ended in December 1992 with an order by the District Court for the Northern District of California granting Xoma payments and sales and use reports from Centocor concerning that company's monoclonal antibody Centoxin. In a jury trial, Centocor had been found to be infringing Xoma's patent for a monoclonal antibody directed against lipopolysaccharide from gram-negative bacteria (see <BLR 1239>, vol. 10, no. 6, 1991). The Xoma product consists of murine light and heavy chains; the Centocor product has a murine light chain and a human heavy chain (for technical information on the products, see <BLR 1034>, vol. 9, no. 2, 1990). Xoma said that it intends to ask the court to set the amount of the payment. It may also ask for an injunction prohibiting U.S. sales of Centotoxin, which is marketed in Europe (see <BLR 1211>, vol. 10, no. 5, 1991). Centocor has asked for a reconsideration of the verdict or a new trial. Neither firm has received marketing approval from the U.S. Food and Drug Administration, although such approval had been recommended for Centoxin by an advisory panel. The alternating press reports of favorable trial results, criticisms of trial design, andfailure of the companies to gain marketing approval has made holding either stock ill advised for the faint of heart. The Centocor product is an example of a trend in Mab development known as "humanization. " It is hoped that reduction of the amount of nonhuman protein in a Mab will reduce the incidence of adverse effects and failure when a product is used clinically. Approximately 40% of the patients who receive murine Mabs form antibodies against them. An example of the problems that can result is shown by reports of cases in which a Mab that was effective initially - such as in preventing the rejection of a transplanted organ - was of no value in repeat treatment because the patient had formed neutralizing antibodies against it. A clinical trial of Centoxin was halted in January when it was suspected that the product had played a part in the deaths of some patients.

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Page 1: {BLR 1408} Xoma - Centocor - Mabs

12 Biotechnology Law Report 9 (Number 1, January-February 1993)

The PTO asked for comments on the proper relation between the Board and theCommissioner and scheduled a meeting for November to consider the responses (see <BLR1388>, vol. 11, no. 6, November-December 1992).

# # #

PATENT LITIGATION

{BLR 1408} Xoma-

Centocor-

Mabs.

ANTISEPSIS ANTIBODY FIGHT CEASES—Xoma Entitled to Payment from Centocor

The long-running litigation between Xoma Corp. of Berkeley, Cal., and Centocor(Malvern, Penn.) ended in December 1992 with an order by the District Court for the NorthernDistrict of California granting Xoma payments and sales and use reports from Centocor concerningthat company's monoclonal antibody Centoxin.

In a jury trial, Centocor had been found to be infringing Xoma's patent for a monoclonalantibody directed against lipopolysaccharide from gram-negative bacteria (see <BLR 1239>, vol.10, no. 6, 1991). The Xoma product consists of murine light and heavy chains; the Centocorproduct has a murine light chain and a human heavy chain (for technical information on theproducts, see <BLR 1034>, vol. 9, no. 2, 1990). Xoma said that it intends to ask the court to setthe amount of the payment. It may also ask for an injunction prohibiting U.S. sales of Centotoxin,which is marketed in Europe (see <BLR 1211>, vol. 10, no. 5, 1991). Centocor has asked for areconsideration of the verdict or a new trial.

Neither firm has received marketing approval from the U.S. Food and DrugAdministration, although such approval had been recommended for Centoxin by an advisorypanel. The alternating press reports of favorable trial results, criticisms of trial design, andfailureof the companies to gain marketing approval has made holding either stock ill advised for the faintof heart.

The Centocor product is an example of a trend in Mab development known as"humanization. " It is hoped that reduction of the amount of nonhuman protein in a Mab willreduce the incidence of adverse effects and failure when a product is used clinically.Approximately 40% of the patients who receive murine Mabs form antibodies against them. Anexample of the problems that can result is shown by reports of cases in which a Mab that waseffective initially

such as in preventing the rejection of a transplanted organ-

was of no value inrepeat treatment because the patient had formed neutralizing antibodies against it.

A clinical trial of Centoxin was halted in January when it was suspected that the producthad played a part in the deaths of some patients.