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PTO Issues Broad Guidelines for Gene Patents, Allows Patenting of ESTs

NEW YORK, Jan 5 - The U.S. Patent and Trade Office reaffirmed its broad policy of patenting genes Friday, issuing a set of guidelines that respond to a variety of concerns about the patentability of genetic information.

“DNA compounds having naturally occurring sequences are eligible for patenting when isolated from their natural state and purified and when the application meets the statutory criteria for patentability,” the guidelines said.

“While descriptive sequence information alone is not patentable subject matter, a new and useful purified and isolated DNA compound described by the sequence is eligible for patenting, subject to satisfying the other criteria for patentability.”

Celera, which has filed applications for 6,500 genes and for numerous ESTs, stands to benefit from such broad-ranging guidelines, as do the thousands of other sequence patent applications now pending at the U.S. PTO.

The patent application for a sequence must describe a single “specific, substantial, and credible” utility for the gene. But this utility does not have to be marketable, according to the new guidelines. The utility can also be based on showing that the gene is homologous to nucleic acids or proteins that have a previously-established use. Under the new guidelines, the burden is on the patent examiner to refute this assumption once the applicant asserts it.

The guidelines further specify that a DNA molecule can satisfy this utility requirement if “it can be used to produce a useful protein or it hybridizes near and serves as a marker for a disease gene.”

This clarification would seem to allow the patenting of expressed sequence tags. Indeed, the new guidelines say that ESTs “are eligible for patenting when the application teaches those of skill in the art how to make and use the invention .”

Within the guidelines, the PTO also refuted a number of arguments that have been made against gene patenting. For example, the PTO said that objections to patenting based on the argument that a person’s body would actually infringe on a patented gene were invalid since patents would only be granted for the purified chemical, not the gene as it exists in nature.

The PTO also said that claims that patenting ESTs would interfere with gene research and the beneficial application of genetic information ran contrary to a statute that binds the PTO to allow patenting of “anything under the sun” as long as the patent applicant can show that the substance or process is new, useful, and non-obvious.