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One of the most closely watched intellectual property trials in recent memory concluded Friday evening as William G. Young, Chief Judge for U.S. District Court in Boston, ruled Transkaryotic Therapies Inc. infringed on three of five patents protecting the best-selling anemia drug, Epogen, sold by Amgen Inc. The four-month trial attracted attention from the media and trial lawyers, but the verdict sent mixed signals and is certain to be appealed to the U.S. Court of Appeals for the Federal Circuit. “We look forward to competing with them [Amgen] to provide patients with the best possible product after a successful appeal,” Richard Selden, TKT chief executive said in a statement. Amgen sued TKT, alleging the experimental drug Dynepo infringes on its patents for Epogen. Dynepo, also known as gene-activated Epo, uses a virus to activate secretion of erythropoietin from a human cell while Thousand Oaks, Calif.-based Amgen currently produces the medication in hamster cells. Erythropoietin stimulates proliferation of red blood cells in patients suffering from kidney failure. Most observers expected Amgen to win infringement on at least one patent. During pretrial hearings, lead by the plaintiff’s attorney, Lloyd Day of Day Casebeer Madrid & Batchelder LLP convinced the court to adopt Amgen’s definitions and interpretation of key scientific terms. Using these definitions as a framework for determining infringement, Young granted summary judgment for Amgen on one of five patents before the trial began on May 15. The best arguments for lead defense attorney Herbert Schwartz of Fish & Neave were to invalidate Amgen’s patents under the doctrine of inequitable conduct — intentionally withholding relevant information during the patent application process — or the issue of enablement, which involves the failure to disclose enough information in its patents to teach a researcher in 1984 how to produce erythropoietin. Although the judge wasn’t convinced by TKT’s central arguments, the Cambridge, Mass.-based company did win several smaller victories. On June 9, for example, the court ruled TKT didn’t infringe on patent 698, outlining Amgen’s process for producing Epo. Young said Friday a patent broadly describing recombinant erythropoietin didn’t provide sufficient information about the composition of naturally occurring Epo to be enforced: “How can one prove that a recombinant Epo has glycosylation which differs from that of urinary Epo when the glycosylation of urinary Epo itself varies?” And the court was split on another claim covering the chemical structure of mature erythropoietin’s amino acids. Amgen’s patents refer to a diagram showing erythropoietin with 166 amino acids. Although erythropoietin has 166 amino acids inside a cell, the last amino acid is removed before the protein is secreted from the cell. The distinction is technical, but may affect granting of future patents. Young ruled TKT didn’t literally infringe on the patent, but under the doctrine of equivalents, GA-Epo did infringe on Amgen’s product patent. The judge observed that removing one amino acid wasn’t shown to affect erythropoietin’s efficacy and shouldn’t receive separate protection. “It seems safe to say that never before has one arginine [an amino acid] been so significant in a court of law,” Young said in his 245-page ruling. Copyright (c)2001 TDD, LLC. All rights reserved.

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