Recently proposed legislation designed to add another layer of protection for U.S. patent holders could become a question of the government's ability -- or right -- to control information.
Dubbed the "Informatics Act of 2005," lawmakers seek to make information gained from the practice of a U.S. patent process overseas subject to infringement in the United States. Current law prohibits only the importation of "physical objects" derived from patented manufacturing processes.
A stated goal of the Informatics Act is to "promote research among universities, the public sector and private enterprise in the informatics realm."
"I would call it interesting," said biotech attorney Thomas Jurgensen, the managing shareholder of San Diego's Catalyst Law Group. "There are some kernels of good ideas there, but it's not ready for prime time. It needs to be more carefully thought out and drafted."
The proposal, introduced by Rep. James Gerlack, R-Pa., on Nov. 2, admittedly is still in its infancy.
Some of the questions surrounding the proposal include enforcement and exactly how far its reach extends.
In the era of the information superhighway, documenting the origin of an idea is not simple.
"You can track products coming into the U.S. through customs," Jurgensen said. "I'd like to see how you track data flying over the Internet, and how are you going to catch that?"
Some legal analysts wonder if it covers scientific papers published in Europe or results posted to a Web site.
"It's intended to be good if it were more carefully crafted," said San Diego's Ned Israelsen, managing partner of intellectual property firm Knobbe Martens Olson & Bear LLP, "but the current bill is drafted way too broadly.
"You have to make sure it doesn't cover scientific publications, public documents and general scientific knowledge. People who try to control knowledge have always failed."
The debate has been sparked, in part, by the Federal Circuit's recent decision in Bayer AG v. Housey Pharmaceuticals Inc. In that case, the Federal Circuit held that patent statute 271(g) applies only to the importation into the United States of "physical objects" derived from manufacturing processes. In so doing, it ruled that the importation of "information" derived from a patented process does not constitute infringement under 271(g).
"When the Federal Circuit issued that opinion where it said this statute only applies to physical products, it raised everyone's fear that someone would import information," said patent attorney Scott Harris, a principal with San Diego's Fish & Richardson PC. "People keep talking about it, saying there could be a chilling effect on research and development."
It's a loophole that Harris doesn't think has been abused, or even used, but the threat has caused panic in some circles.
"We don't really know how many companies were being very, very careful to be secret because they were afraid this loophole would allow someone overseas to use their information," Harris said.
The bill could be very beneficial to biotech and drug discovery companies that want to prevent others from using their discovery technologies aboard to develop and eventually sell drugs in the United States.
"It's a way to prevent the erosion of the value of those patents," said intellectual property attorney John Wetherell of Pillsbury Winthrop Shaw Pittman LLP. "It puts some teeth into the U.S. claims.
"I think it will add value to companies that have patents that relate to tool patents and universities that have tool patents. Someone can't avoid an infringement claim by running screening methodology somewhere there is no patent protection."
Small biotech companies, which can't obtain patents in every country around the world, would benefit as well.
"It will increase tremendously the value of the research tool or drug-screening patent," said Peng Chen of San Diego's Morrison & Foerster.