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BIOTECH PATENT APPLICATIONS: LACK OF REQUESTS FOR PRIORITY REVIEW

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BIOTECH PATENT APPLICATIONS: LACK OF REQUESTS FOR PRIORITY REVIEW has the Patent & Trademark Office "puzzled," PTO Commissioner Donald Quigg testified at a March 29 hearing before the House Small Business/Regulation Subcommittee. The procedure, "which has the potential to reduce pendency for time-important applications significantly," was requested in only 17 of more than 5,000 biotechnology patent applications, Quigg testified. "We are frankly puzzled over its negligible use." PTO generally examines applications in the order of their filing, but it "has a longstanding procedure to ensure that this examination process does not work to the detriment of applicants that are in need of speedily obtaining patent protection," Quigg said -- "particularly those that are thinly capitalized and may depend on patent ownership to attract additional investment capital." Previously, examination has been "obtained out of turn in circumstances such as the advanced age of the inventor, ongoing infringement of the invention, reliance on the patent for investment decisions, or the nature of the subject matter," he explained. Quigg said he could not explain why more biotech applications have not requested priority review. Subcommittee Chairman Wyden (D-Ore.) noted that the PTO had a backlog of 7,800 pending biotech patent applications in August 1987, nearly double the backlog in early 1985. Other measures taken by PTO to address the increase in applications is the establishment on March 28 of a biotech application review group and a drive to hire and train more reviewers. Quigg said the agency does not need increased appropriations, but noted the difficulty in competing against industry for reviewer talent. Amgen President & CEO George Rathmann, PhD, said his company has requested priority review of Amgen patent applications twice, but would make greater use of the procedure in the future. "In two of our cases, we have requested that they be expedited," Rathmann said. One was filed in "late 1983, and we did not request special treatment until sometime in the summer of 1986, after the application had been going quite some time," he said. "From what I heard today, we should fire in there the day we apply instead of waiting for a year or two of disappointment." Rathmann explained that Amgen had waited before requesting priority review because the company thought "we had to believe that there was a necessity to show some imminent issue with respect to competition. That may have been, as I listen here today, an older interpretation, [but] it was still my impression that it was appropriate to ask for accelerated handling only after there was some clear indication" of imminent competition. "So we [requested] it" in 1986, "and we've done it again in our last molecule [in late 1987] and we do expect it to move more rapidly," Rathmann continued. "It does work. There's no question it changed the priority, and I believe the system should be that way," he added.

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