On March 20, 1979, the Ortho Pharmaceutical Corporation (Ortho) applied for a U.S. patent on its invention entitled “Monoclonal antibody to human T cells, and methods for preparing same.” On March 19, 1980, presumably taking advantage of the 1-year application window allowed in the EPO, Ortho applied for its equivalent European patent, application number EP1980030082, using the U.S. application date as its priority date. On the basis of the application’s March 1979 international priority date, the EPO published the application on October 15, 1980, signaling the existence of the pending patent. Ortho designated its European states of interest on that date as Austria, Belgium, Switzerland, Germany, France, Great Britain, the Netherlands, Italy, and Sweden.

On December 14, 1982, after some 2 years and 9 months pending in the USPTO, the U.S. patent issued (number 4,363,799), with 11 claims. Approximately 2 years later, on September 20, 1984, Ortho filed a complaint alleging patent infringement against Becton Dickinson Monoclonal Center, Inc. in the Federal District Court in Wilmington, Delaware. The complaint also covered 12 other patents owned by Ortho. Within 10 months, the European equivalent patent (No. 17381) issued, on July 10, 1985.

During 1986, legal maneuvering on both sides of the Atlantic tested the validity of the Ortho patent. On June 4, 1986, an EPO opposition was filed by Behringwerke AG and Sandoz AG. Within a week, on June 11, a second opposition was filed by Becton, Dickinson & Company and by Boehringer Mannheim Gmbh. On July 24, 1986, Ortho’s U.S. infringement action against Becton Dickinson, an opponent to Ortho’s EPO patent, was transferred to the U.S. Federal District Court in Northern California. On September 26, Ortho again asserted its patent in an infringement action against Coulter Corporation and Coulter Electronics Corporation in the Southern District of Florida.

By October 3, 1986, Ortho and Becton Dickinson had settled their California litigation. Each party stipulated to a voluntary dismissal of the case and the Court announced that the parties had “resolved their differences.” But the EPO opposition proceedings continued, and after the two pending oppositions were consolidated, the EPO patent was revoked on October 17, 1986. Ortho immediately appealed the adverse decision to the EPO, but the appeal was finally rejected on January 8, 1991, 5 years after settlement of the firm’s infringement suit against one of the EPO patent opponents.

Ortho’s suit against Coulter Corporation and Coulter Electronics Corporation in the Southern District of Florida was finally settled in November 1993, with a consent judgment and a dismissal. Ortho’s U.S. patent remains in force but has not been asserted in court since. The patent number is not withdrawn, although the patent is close to expiration.



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