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BIO Praises Clinton Reassurances Regarding Gene Patents and PTO Leadership

WASHINGTON, D.C. (April 5, 2000) The Biotechnology Industry Organization (BIO) applauded President Clinton for comments today clarifying his March 14 joint statement with British Prime Minister Tony Blair on gene-based patents.

"BIO has been working diligently since March 14 to end the confusion created by the Clinton-Blair statement regarding sharing of raw, fundamental genomic data by genetic researchers," said Chuck Ludlam, BIO's vice president for government relations. "Such raw, fundamental data is not patentable.

"The March 14 statement about sharing raw, fundamental genomic data had nothing to do with patents where the utility standard - identification of a potential commercial application - is met. The Clinton-Blair statement actually included a specific endorsement of patent protection. We appreciate the president's effort to make this point clear and to reassure investors who fund this vital research.

"We also appreciate the president's implicit endorsement of the current process at the U.S. Patent and Trademark Office (PTO) in setting guidelines for issuing patents on gene-based inventions," Ludlam said. "We strongly support the PTO's efforts, which we find to be totally professional and fundamentally on the right track."

BIO filed comments on March 22 on the PTO's proposed new guidelines for gene-based patents. The comments, posted on BIO's website (www.bio.org) in Issues & Policies under Testimony, supported the PTO's basic approach and offered some recommendations for refinements. In addition to the comments to the PTO, a backgrounder on gene-based patents is posted on BIO's website in News under Press Releases.

"We expect the PTO will proceed to finalize its guidelines and provide detailed standards for applicants and the public about what is and is not patentable," Ludlam added.

The PTO's proposal includes thirty-one specific examples and 140 pages of analysis to supplement guidelines regarding the utility and written description standards.

Below is President Clinton's statement today during a White House Conference on the New Economy:

President Clinton: "On the patent thing, you know, Tony Blair and I crashed the market there for a day, and I didn't mean to. (Laughter.) But I think what happened is - when the market has recovered, I think what happened is, people actually read the statement instead of the headlines or whatever.

"I think in the biotech area, our position ought to be clear. General information ought to be in the public domain as much as possible about the sequencing of the human genome. And where public money contributed to massive research on the basic information, we ought to get it out there. If someone discovers something that has a specific commercial application, they ought to be able to get a patent on it. And the question is always going to be, are you drawing the line in the right place? But I believe we've got the people together with the skills and the experience to draw the line in the right place. And I think that's the right policy. I'm quite confident it is. And what we really need now is to make sure it is implemented in the right way."