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12:00 AM
Jan 13, 2003
 |  BioCentury  |  Politics, Policy & Law

EPO case turned upside-down

Last week's ruling by a federal appeals court in Amgen Inc. v. Transkaryotic Therapies Inc. and Aventis S.A. puts TKTX in a better position than it held at the end of the District Court trial, as the U.S. Court of Appeals for the Federal Circuit ruled that an AMGN patent covering the erythropoietin molecule itself is invalid. But that hardly solves TKTX's problem, as AMGN still has process claims in two patents that TKTX could be found to infringe.

That question will be left to the lower court to reconsider. And indeed, the CAFC ruling raises questions that could lead to a decision almost the polar opposite of the 2001 ruling by Judge William Young of the U.S. District Court for the District of Massachusetts (see BioCentury, Jan. 22, 2001).

In his decision, Young carefully separated product and process, determining that TKTX's process for producing its Dynepo EPO by activating endogenous EPO genes in cultured human cells did not infringe AMGN's patents covering processes for producing EPO. However, he did find that TKTX's resulting EPO product was the same as AMGN's and therefore infringed AMGN's product patent claims.

Finally, Judge Young rejected almost all of TKTX's arguments that AMGN's numerous EPO patents are invalid.

Thus, following the District Court ruling, it appeared that TKTX's gene activation process was free and clear of AMGN's patents, but that the resulting EPO still infringed AMGN's composition patent claims.

Last week, however, the CAFC returned a decision on the appeals - made by both sides - that reopened the question of process infringement even while it called into question the validity of AMGN's product patents.

According to the CAFC, when considering...

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