Monday, December 8, 2003

The House will vote today on a provision that would prohibit the U.S. Patent and Trademark Office from issuing patents on human organisms, including cloned human embryos.

The biotechnology industry has fought for months against the provision but now says it is supporting the language because its concerns have been addressed.

The provision — which was authored by Rep. Dave Weldon, Florida Republican and a physician — is included in the spending measure. The Senate could vote on the spending bill this week as well, although that might be delayed until January.

The Biotechnology Industry Organization (BIO) and the Coalition for the Advancement of Medical Research initially fought the patent provision, telling lawmakers it was too vague and could prohibit patents on a wide range of research, such as stem cells, genes and methods for making replacement tissues and organs.

“We were concerned that it is overly broad,” said Michael Werner, vice president of bioethics at BIO.

Supporters of the language spent weeks disputing these claims.

“My amendment codifies existing patent office practice, ensuring that patents cannot be granted on human organisms, including human embryos and human fetuses. It does not prohibit patents on stem cells; it simply says we should not allow patents on human embryos,” Mr. Weldon reiterated in a statement on Friday.

Mr. Werner said BIO is going along with the provision, because they are satisfied that it simply reiterates the current Patent and Trademark Office (PTO) policy, which is not to issue patents on human beings at any stage. He did add that BIO ideally would like no such language in the spending bill.

The Weldon amendment would prevent the PTO from issuing patents on claims “directed to or encompassing a human organism.” Negotiators recently added report language clarifying that the Weldon provision reaffirms the PTO position and won’t affect existing patents on stem cells, and Mr. Werner says this satisfies BIO.

But supporters of the Weldon amendment say they offered BIO and its allies much more specific clarifying language to address BIO’s concerns and BIO rejected it. That language would have clarified specifically that things such as tissues, genes and stem cells would not be affected by the provision.

Republicans “put out language to clarify everything, but the BIO lobby rejected that,” said one Senate Republican staffer.

Douglas Johnson, legislative director of the National Right to Life Committee, said BIO and its allies rejected that language because their argument that the Weldon provision was “overly broad” was not the true reason for their opposition.

“My conclusion is that these were manufactured arguments,” Mr. Johnson said. “They didn’t want to have to argue out in the open the real issue, which is that they want to be able to patent human embryos and fetuses that are cloned or genetically altered.”

Mr. Werner disputed that.

“Our companies are not interested in getting patents on embryos or human beings,” he said. He also said attempts by senators to modify the Weldon language were rejected by House negotiators, not BIO.

Mr. Johnson said the Weldon amendment will back up the PTO position in law because a scientist inevitably will apply for a patent on a cloned or genetically modified human embryo, be rejected by the PTO, and take the matter to court.

In a Nov. 20 letter to lawmakers in charge of the spending bill, PTO director James E. Rogan supports the Weldon language because it “does not alter the USPTO policy on the non-patentability of human life forms at any stage of development and is fully consistent with our policy.”

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