Aventis/TKT Dynepo
Executive Summary
BLA for gene-activated erythropoietin will be resubmitted in about six months, firms estimate. The BLA submitted Aug. 2 has been withdrawn while the companies collect additional process validation data following an increase in manufacturing scale from 2,000 liter to 5,000 liter bioreactors
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Amgen Epogen
Erythropoietin exclusivity may extend until 2015 following a Jan. 19 Boston federal court ruling. Aventis/Transkaryotic Therapies' gene-activated erythropoietin Dynepo was found to infringe three patents covering the Amgen product. Claims in Amgen's pharmaceutical composition patent No. 5,955,422 are "valid, enforceable and literally infringed," Judge William Young ruled. Amgen's host-cell patent No. 5,756,349 was also found to be literally infringed, while Amgen's patent No. 5,621,080, claiming certain EPO glycoproteins, was found to be infringed under the doctrine of equivalents. The Dynepo BLA, filed Aug. 2, was withdrawn from FDA in November (1"The Pink Sheet" Nov. 27, 2000, In Brief)
Amgen Epogen
Erythropoietin exclusivity may extend until 2015 following a Jan. 19 Boston federal court ruling. Aventis/Transkaryotic Therapies' gene-activated erythropoietin Dynepo was found to infringe three patents covering the Amgen product. Claims in Amgen's pharmaceutical composition patent No. 5,955,422 are "valid, enforceable and literally infringed," Judge William Young ruled. Amgen's host-cell patent No. 5,756,349 was also found to be literally infringed, while Amgen's patent No. 5,621,080, claiming certain EPO glycoproteins, was found to be infringed under the doctrine of equivalents. The Dynepo BLA, filed Aug. 2, was withdrawn from FDA in November (1"The Pink Sheet" Nov. 27, 2000, In Brief)
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