The Boston Globe reported that Genzyme Corp. sued Transkaryotic Therapies Inc. in the District Court of Tel Aviv, claiming that their method of purifying a treatment for Gaucher’s disease infringed on Genzyme’s Israeli patent No. 100,715, which covers certain cell culture processes involved in the manufacture of glucocerebrosidase. TKT is conducting a clinical trial in Israel of its investigational gene-activated glucocerebrosidase (GA-GCB) for the treatment of Gaucher disease. Genzyme believes that TKT infringes Genzyme’s patent by importing into Israel and using in Israel the GA-GCB product manufactured by the processes protected by Genzyme’s patent.
Genzyme’s patent covers novel culture processes that have been critical in the production of Cerezyme(R) (imiglucerase for injection) on a large scale for the treatment of thousands of patients around the world. In 2004, Genzyme sold $839 million of Cerezyme, accounting for 37 percent of Genzyme’s total revenue. TKT is challenging Cerezyme with an investigational drug, and has recruited 12 patients to its trial in Israel.
In an agreement in October 2003, the two companies ended disputes over two key drugs, and agreed to become partners in developing another of TKT’s drug candidates. They remain partners in the development of TKT’s I2S, an experimental treatment for Hunter’s disease, another rare genetic disease in which patients are unable to process certain carbohydrates, leading to disfiguring and fatal complications.
