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12:00 AM
 | 
Jan 14, 2002
 |  BioCentury  |  Regulation

Biotech on both sides of Festo

The Supreme Court heard oral arguments last week in a case that could determine the characteristics of a critical area of patent law: the applicability of the doctrine of equivalents, which extends protections from the literal claims of a patent to obvious but unstated embodiments.

Although there is broad agreement that the outcome of Festo Corp. versus SMC Pneumatics Inc. is of great importance to biotech, companies have adopted diametrically opposite views of the best outcome. In briefs filed with the Supreme Court, Guilford Pharmaceuticals Inc., Chiron Corp., Xoma Ltd. and Celltech Group plc argue in favor of overturning a federal appeals court ruling against Festo. On the other side, Genentech Inc., MedImmune Inc. and Applera Corp. urge the Supreme Court to let the decision stand.

For more than a century, the Patent and Trademark Office and the courts have wrestled with questions about how literally patent claims should be interpreted. Indeed, in representing Festo in last week's arguments, Robert Bork cited a case from 1853. But the issue has taken on new urgency with the increasing complexity of inventions. Especially in biotechnology, it is difficult to fully describe, or even contemplate, all of the potential applications or embodiments of an invention.

Patent attorneys typically deal with this problem by specifying a degree of sequence identity or homology, the presence of particular sequence motifs, specific binding, nucleic acid hybridization, or other functional terminology in claims.

When these literal claims fail, invoking the doctrine of equivalents is the fallback position. Amgen Inc. (AMGN, Thousand Oaks, Calif.), for example, successfully asserted equivalence in litigation over a patent on erythropoietin with Transkaryotic Therapies Inc. (TKTX, Cambridge, Mass.) (see Biocentury, Jan. 22, 2001), and equivalence is an issue in litigation...

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