New Patent Guidelines Suit Biotech Innovators

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BIOWORLD TODAY 22jan01

WASHINGTON -- The Gene-based patent patent guidelines released recently the U$,. Patent and Trademark Office, which differ little from the interim rules published a year ago, have a backer in the Biotechnology Industry Organization.

The guidelines, effective upon publication in the Federal Register earlier this month, have raised the bar over previous guidelines by requiring more specific, credible and substantial information before issuing a patent, patent office spokeswoman Brigit Quinn said.

In the past, the utility section of the patent approval process was a two-part test requiring the invention to be specific and credible, Quinn said. "But today the invention or utility has to be specific, credible and substantial.'"

What's more, says the patent office, . the invention must have a well-established utility. That means "a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention."

Rules Provide Framework

Lila Feisee, BIO's director of federal government relations and intellectual property, said the trade association welcomes the guidelines because they give companies a framework in which to work.

"We think the patent office has done a professional job and the rules are not inconsistent with how the industry has been practicing."

Quinn said that upon initial publication of the proposed guidelines, "We received a lot of public comments, which required some tweaking.

Among concerns raised by the public were several stating that gees are discoveries, not inventions and therefore not patentable.

But citing standards enacted by Congress, the patent office said that an inventor's discovery of a gene can be the basis for a patent on the genetic composition isolated from its natural state and processed through purifying steps that separate the gene from other molecules naturally associated with it.

According to the patent office, if an applicant discloses a specific, substantial and credible utility for the claimed isolated and purified gene, the isolated and purified gene composition may be patentable.

The guidelines also clarify concerns that anyone who discovers a gene will be allowed a broad patent, covering any number of possible applications.

The patent office said that when a patent claiming a new chemical compound is issued, the patentee has the right to exclude others from using the compound for a limited time and the patentee is required only to teach others how to use the invention in at least one way.

Other inventors who develop new and nonobvious methods of using the patented compound have the opportunity to patent those methods, according to the patent office.

Regarding whether patents should be withheld pending complete sequence of the gene, the patent office said "describing the complete chemical structure, the DNA sequence, is one method of describing a DNA molecule, but it is not the only method. The utility of aclaimed DNA does not necessarily depend on the function of the encoded gene product."

DNA Sequence Non-Patentable

Several other comments suggested that DNA should be considered unpatentable because a DNA sequence by itself has little utility.

The patent office said like any descriptive property, a DNA sequence itself is not patentable.

A purified DNA molecule isolated from its natural environment is a chemical compound and is patentable if it meets all the statutory requirements, the patent office said.

An isolated and purified DNA molecule may meet the statutory 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.

Therefore, a DNA molecule is not per se unpatentable for lack of utility, and each application claim must be examined on its own facts.

This report was prepared by BioWorld

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