Washington Editor

WASHINGTON - Industry officials here plan to carefully monitor the implementation of an amendment attached to the appropriations bill that has the potential to create roadblocks for researchers.

Introduced by Rep. David Weldon (R-Fla.), the amendment prevents the U.S. Patent and Trademark Office (USPTO) from issuing patents on "human organisms." Since it is part of the larger omnibus appropriations spending bill, it would have to be approved (or rejected) by Congress annually.

At issue here is the interpretation or definition of "human organisms."

"When you say organism, everyone says, Gee, what does that mean? Does that mean cells, does that mean tissue, does that mean a gene?'" said Michael Werner, chief of policy at the Washington-based Biotechnology Industry Organization.

Current USPTO policy prevents patents on human beings, a regulation BIO supports.

"No biotech company wants to get a patent on a human being," Werner told BioWorld Today. "Our companies want patents on nuclear transfer processes - things that may involve embryos in their process, but you don't get a patent on embryos themselves. You want a patent on the product derived from it, so we've always supported the USPTO policy."

The concern, though, is that the Weldon amendment could be interpreted more broadly.

Nevertheless, Werner said: "We have every reason to believe that all it does is reaffirm the USPTO policy. But because the language is a bit imprecise, in theory, someone could read it more broadly and say well, we are not going to allow you to get a patent on some stem cell process or something like that. We don't think that is the case, but we will be watching to make sure."

Indeed, Michael Shuster, a patent attorney with Fenwick & West in San Francisco, told BioWorld Today:"We'll see how it plays out in practice in the first year. We'll see if patents are not being obtained. But Weldon's position is that it changes nothing, that basically it codifies existing USPTO policy."

Weldon, a medical doctor, in the past has made no secret about his views on touchy research subjects.

In fact, Weldon and Rep. Bart Stupak (D-Mich.), earlier this year convinced the House in a 241-155 vote to pass the Human Cloning Prohibition Act of 2003 (HR 534), legislation that not only bans therapeutic and reproductive cloning, but also would prohibit the U.S. from importing medical therapies created from cloned human embryos. (See BioWorld Today, March 3, 2003.)

While the controversial cloning legislation has yet to become law, the patent issue is a little different because it is stuck to the appropriations bill. That means Weldon can stop the USPTO from issuing certain patents by saying it is unlawful to spend money reviewing, researching or approving them.

The appropriations bill passed the House in November and is expected to pass the Senate in early 2004.

Weldon's amendment slipped into the spending bill without much notice. Werner said the process was highly objectionable because there were no hearings or meetings to give the scientific, legal or patient communities an opportunity to have input or to understand the wording of the amendment.

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