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Application of the Reverse Doctrine of Equivalents to Amgen v. Hoechst Marion, Inc.
In the previous issue, we discussed the principle of the Reverse Doctrine of Equivalents and provided several illustrations of cases that have addressed the same. In this issue, we apply the principle to the Amgen, Inc. v. Hoechst Marion, Inc. case, wherein the defendants Hoecht Marion and Transkarayotic Therapies (collectively 'TKT') were found liable for infringing several of Amgen's patents. Amgen, Inc. v. Hoechst Marion, Inc., 126 F. Supp. 2d 69 (D. Mass. 2001). Although the Reverse Doctrine of Equivalents defense was not raised, this article discusses how this doctrine might have relieved TKT of liability.
Although Amgen asserted a number of patents against TKT, this article focuses on claim 1 of U.S. Patent No. 5,756,349 (the '349 patent), the text of which is as follows:
1. Vertebrate cells which can be propagated in vitro and which are capable upon growth in culture of producing erythropoietin in the medium of their growth in excess of 100 U of erythropoietin per 106 cells in 48 hours as determined by radioimmunoassay, said cells comprising non-human DNA sequences that control transcription of DNA encoding human erythropoietin.
(Erythropoietin is a protein that stimulates the production of red blood cells.)
Amgen's Technology: By taking advantage of recombinant DNA techniques, Amgen developed a method for producing human erythropoietin (EPO) in quantities previously unattainable by purification from bodily fluids. In short, Amgen removes the gene that encodes EPO from a cell naturally containing the gene and then introduces (transfects) it with non-human control sequences (SV40 viral promoter) into a Chinese Hamster Ovary (CHO) cell. Relative to the CHO cells, the promoter DNA and the human EPO gene are exogenous because the promoter and the EPO gene do not naturally reside in the CHO cells. Amgen, 126 F. Supp. 2d at 55.
TKT's Technology: TKT also developed a method of producing human EPO. However, rather than transfecting a cell with an exogenous EPO gene, TKT manipulates the endogenous human EPO gene where it naturally resides in a human cell. The EPO gene is endogenous relative to the cells used by TKT because the EPO gene naturally resides in those cells. To facilitate the manipulation, TKT inserts a control element (a cytomegalovirus (CMV) promoter) upstream from the EPO gene. Additionally, TKT homologously recombines its CMV promoter into the cells, as opposed to the heterologous recombination used by Amgen, and TKT inserts its CMV promoter at a position farther upstream than the position at which Amgen inserts the SV40 promoter.
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