Law for Business 10th Edition by James Barnes,Terry Dworkin,Eric Richards

Exercise 5

Erythropoietin is a hormone which controls the synthesis of red blood cells in bone marrow and which is useful for treating patients suffering from anemia. Scientists from the emerging field of biotechnology have used recombinant DNA technology to produce genetically altered cells (host cells) which produce large amounts of erythropoietin. To simplify the recombinant DNA procedure, the particular DNA sequence responsible for the production of erythropoietin is isolated and removed from human cells. The isolated DNA sequence is then "recombined" with the DNA present in the host cells. As a result, the host cell is genetically altered so as to produce synthetic erythropoietin (rEPO). Amgen owned the U.S. patent for the recombinant DNA sequences, vectors, and host cells used to produce rEPO. This patent gave Amgen no rights over the product rEPO itself and no rights over any process of making rEPO. Chugai Pharmaceutical of Japan made rEPO overseas by a process that used the DNA sequencers, vectors, and host cells protected by Amgen's U.S. patent. It then imported the rEPO into the United States through Chugai Pharm U.S.A. (its U.S. subsidiary). Amgen complained that Chugai violated its U.S. patent rights by importing the rEPO into the United States. Does U.S. patent law protect against the importation of articles made abroad by a process in which a product protected by a U.S. patent is used? Explain.