By Tony Strattner
Nov. 12, 2002 | Welcome to Bio·IT World's first Strategic Insights report on legal services in the life sciences. Although its theme — "Genes & Liens" — sounds a tad whimsical, the topic couldn't be weightier.
The patenting of genetic information is a prime economic mover in the life science community, from business-model creation, to R&D choices, to company valuation. During the past decade, the number of U.S. patent applications for biotech inventions has doubled, from 15,000 to about 35,000 — more than half gene-related. And, as Andrew Torrance points out in his lead article, "there appears to be no end in sight" to what may be patented from the recently sequenced human genome.
The surge of gene-related patent applications has spurred the U.S. Patent and Trademark Office (PTO) to raise the bar for application approval. In her article, Paula Campbell Evans explains the new standards for showing possession and proving usefulness, as well as their implications for business strategy. (Hint: quality, not quantity.) But as the number of gene patents increases, so does the risk of infringement, and Beth Arnold offers practical advice for how to stay out of court. When that's unavoidable, however, the best defense is a good offense, and Arnold pinpoints areas where gene patents are vulnerable to invalidation.
Indeed, many patents granted prior to the PTO's tougher standards might not hold up in court. Which would be just fine with Sue Mayer, who provides a contrasting European perspective on the concept of gene ownership and its putative economic benefits. She cites recent reports demonstrating that gene patents are still a political hot button — and their continued existence and practical value may be subject to politics.
The patent landscape is continually shifting, and we hope this report proves informative in evaluating your intellectual property strategy. We appreciate the support of the five subject experts who contributed to this section, and look forward to bringing you more special reports on a diversity of bio-IT-related topics in 2003.
Special Projects Editor