By Kim Coghill
WASHINGTON - The U.S. Patent and Trademark Office Friday released gene-based patent guidelines that differ little from the interim rules published a year ago, and are considered acceptable by the Biotechnology Industry Organization.
The guidelines were effective upon publication Friday and have "raised the bar" over previous guidelines by requiring more specific, credible and substantial information before issuing a patent, according to Brigit Quinn, PTO spokeswoman.
The guidelines are related to the "utility" section of the patent approval process, which in the past 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."
And, according to the PTO, the invention must have a well-established utility, meaning "a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention."
Lila Feisee, Washington-based BIO's director of federal government relations and intellectual property, said BIO 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 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 genes are discoveries, not inventions and therefore not patentable. But citing standards enacted by Congress, the PTO 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 PTO, 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 PTO 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 PTO.
Regarding whether patents should be withheld pending complete sequence of the gene, the PTO 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 a claimed DNA does not necessarily depend on the function of the encoded gene product."
Several other comments suggested that DNA should be considered unpatentable because a DNA sequence by itself has little utility. The PTO 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 all the statutory requirements are met. 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.
The entire report can be viewed on the Federal Register or PTO web sites.