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As Amgen’s patent infringement trial against Transkaryotic Therapies Inc. drags into its third month, central arguments are emerging in the landmark intellectual property trial. A verdict could be issued by the end of September. In an industry based on complex intellectual property claims, the case could clarify existing standards or rewrite the legal standard for process patents. A lawsuit filed by Amgen, a biotechnology pioneer based in Thousand Oaks, Calif., alleges GA-Epo, an enzyme-fighting drug developed by Boston-based Transkaryotic Therapies, violates patents for Epogen, Amgen’s $2 billion-in-sales treatment for anemia. Both medications are erythropoietins, compounds stimulating production of red blood cells in patients suffering from kidney failure. Amgen’s erythropoietin is produced by injecting human genes into hamster cells while Transkaryotic Therapies’ process promotes production of erythropoietin from human cells. After three years of pretrial motions, on May 15, testimony began in U.S. District Court Judge William Young’s Boston courtroom. To win, Transkaryotic Therapies must convince Judge Young that GA-Epo doesn’t infringe on Amgen’s erythropoietin patents or that the patents are invalid based on flaws in the application process. To bolster one of its charges that the patent is invalid, the charge of inequitable conduct, defense lawyers plan to call several Amgen patent lawyers. Since Dr. Michael Borun, Amgen’s lead patent prosecutor in 1984, is seriously ill, Judge Young has postponed testimony until the first week of September. Assuming Dr. Borun is able to testify, Judge Young’s verdict could be issued the end of September. Once a verdict is issued, the case is expected to be appealed. Judge Young can halt the trial at any time if he concludes a patent was infringed. Lead defense attorney Herbert Schwartz of Fish & Neave has presented arguments for non-infringement based in the legal concept of enablement. If defense attorneys demonstrate that human synthesis of erythropoietin required creation of a new process, Transkaryotic Therapies may not have infringed on Amgen’s patents. Judge Young suggested the case hinged on two of those arguments during instructions to Amgen’s lead attorney, Lloyd Day of Day Casebeer Madrid & Batchelder. In the first enablement argument, Transkaryotic must prove that a competent professional could not synthesize erythropoietin from human cells based on information in Amgen’s patent applications. Defense attorneys claim discrepancies in Amgen’s 1984 patent applications excluded production of erythropoietin from human cells. In its first patent application, Amgen referred to production of erythropoietin by human cells, but the word “human” was dropped in subsequent filings. In a third filing, Amgen included specific instructions to avoid using erythropoietin synthesized from human cells. Defense lawyers argued that the distinctions demonstrate Amgen’s patents were not intended to cover Transkaryotic Therapies’ process of synthesizing erythropoietin from human cells. In addition to testimony on the subtle distinction between the proteins, defense attorneys have suggested the definition of urinary erythropoietin in Amgen’s patents is too ambiguous. The defense argued that without clarification professionals could not be expected to recreate the product described in Amgen’s patent. In June, Judge Young ruled GA-Epo did not “literally” fall within the scope of a second Amgen patent because the protein contained one less amino acid, but deferred his decision on the broader question of equivalence — whether the two proteins have equivalent characteristics although slightly different chemical structure — until his final ruling. Ambiguity on which isomer must be equivalent could be grounds for non-infringement. Copyright �2000 TDD, LLC. All rights reserved.

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