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"Patent claims, limited in scope to a specific novel and non-obvious EST expressed sequence tag , generally should not preclude the future patenting of the corresponding, latter discovered, full length gene of known function or of therapeutic technologies arising therefrom," Lehman states in the letter.
"Under the appropriate and limited circumstances," he adds, "claims of a perceived broad scope that are adequately supported by the disclosure...and the state of the art may be patentable, but such claims do not necessarily preclude future patenting of the full-length gene."
The letter responds to two NIH letters sent to PTO in late March - - one from NIH Director Harold Varmus and the other from Office of Technology Transfer's (OTT) Jack Spiegel.
The NIH letters formally protest PTO's decision to allow patenting of ESTs. Varmus earlier had publicly expressed opposition to the PTO policy in a presentation at a Brookings Institution/American Enterprise Institute/Federation of Societies for Experimental Biology forum in March. PTO Deputy Commissioner Lawrence Goffney announced the policy at an American Association for the Advancement of Science meeting in February ("The Blue Sheet" Feb. 19, p. 3).
"An EST may be patentable in the United States under appropriate circumstances (i.e. an EST which meets all the criteria under applicable patent laws, including utility, enablement, novelty, and unobviousness)," Lehman states in the letter.
"Disclosures of the use of ESTs for forensic identification, tissue type or origin identification, chromosome mapping, chromosome identification, and to tag a gene of known and useful function, may be enabled," he notes, "if supported by a sufficient disclosure."
The PTO commissioner does seek to quell NIH concerns about broad EST patents inhibiting research. "Mere allegation of the utility of an EST as a probe without further disclosure is not sufficient to meet the utility and enablement criteria," he says.
"Examples of potentially non-enabled utilities include location of disease associated genes, wherein the disease has no known genetic origin; use as an anti-sense reagent, wherein the corresponding protein to be suppressed is unknown; use as a triplex probe to inhibit expression of a protein, where the protein and its function are unknown; and, for the location and identification of genes of unknown utility," Lehman states.
NIH filed what it believes are the first patent applications on ESTs in 1991 based on technology developed in Craig Venter's laboratory at the National Institute of Neurological Disorders and Stroke.
NIH Patents On ESTs Meant To Forestall Claims Of Prior Art
In his March 21 letter to PTO, Spiegel explains that "a serious concern, at the time, was that public disclosure of EST sequences could create a prior art effect against subsequent patenting of newly- discovered complete gene sequences possessing important diagnostic or therapeutic utilities."
"EST patent applications were filed, in significant measure," Spiegel states, "to provide short-term insurance against such potential prior art blockage of future gene discoveries."
These applications were abandoned, the OTT official notes, after several rulings in court cases "reduced significantly our prior art concerns."
At least 300 EST patent applications have been filed with PTO, covering 500,000 sequences or more, according to NIH estimates.
In the normal application process, PTO is not obligated to examine more than one invention per application. If the office determines that one application contains more than one invention, the applicant may be asked to choose one for consideration and file separate applications for others.
In the case of ESTs, in which thousands of sequences may be submitted in a single application, PTO has determined it will examine up to 10 ESTs in one application.
F-D-C Reports
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