What constitutes inventorship?Certainly co-authoring a paper doesn't. Nor does working alongsidethe inventor. Officials at the National Institutes of Health (NIH) andMyriad Genetics Inc. agree on at least those issues. But they aredebating, along with members of Congress, who should be includedin the patent application resulting from last month's long-soughtdiscovery of the BRCA1 breast cancer gene.The gene's co-inventors _ Myriad, of Salt Lake City, and theUniversity of Utah _ filed a patent application that excluded theNIH collaborators. On Oct. 6, the NIH filed its own patent, whichnamed nine people as inventors, including scientists from the NIH,Myriad and the university, according to an Oct. 27 letter from NIHDirector Harold Varmus to Rep. Ron Wyden (D-Ore.)."I've spoken with the patent counsel [for the university]," PeterMeldrum, Myriad's president, told BioWorld Friday. "He advises methat the inventors put on the patent were correct."The Discovery Is `Not Subjective'Meldrum said the Utah and Myriad scientists discovered themutation and sequenced the gene. "It's not subjective," he said."Only those inventors who conceptualize the invention are" includedon the patent application. "I'm confident it was done properly."Steve Jenning, staff director of the Committee on Small Businesssubcommittee chaired by Wyden, told BioWorld that the issue is farfrom resolved."The NIH is saying that we can settle this ourselves or go to court,"Jenning said. "That's certainly implicit. My reading is that the die'sbeen cast."Varmus' letter said the NIH Office of Technology Transfer (OTT)was advised by patent counsel that the NIH scientists are co-inventors, and based on that the counsel and OTT "contacted seniorofficials at the University of Utah and Myriad . . . to begindiscussions about co-inventorship and licensing."Meldrum flatly denies that he has been involved in any discussionsrelated to the patent. The only talk, he said, has been between patentattorneys for both sides. "We haven't heard the NIH position,"Meldrum said.Complicating the matter is that Myriad has licensed commercial useof BRCA1 to Indianapolis-based Eli Lilly & Co. A cooperativeresearch and development agreement (CRADA) proposed earlier wasrejected because of the "objection of Lilly to the NIH's `reasonablepricing' clause," Varmus wrote.Jenning pointed out that the NIH has been working with MarkSkolnick and others at the University of Utah since 1975 and hascontributed $15.5 million, $4.5 million of which was earmarkedspecifically for work on the BRCA1 gene. In addition, he said, NIHcontributed two scientists to the project at a cost of more than$800,000."This was all done without a written collaboration agreement, whichwe consider to be a useful tool in setting the ground rules betweenthe NIH and extramural collaborators," Jenning said. "In the area ofintellectual property, if you don't protect your rights, you lose yourrights. NIH must protect its rights."Wyden, who sits on the Energy and Commerce Committee, whichhas jurisdiction over the NIH, has been concerned for years abouthow the NIH transfers medically important technologies to theprivate sector, Jenning said. "We are protecting a variety of publicrights and interests when taxpayers spend million of dollars in theNIH laboratory system."Wyden, in an Oct. 19 letter to Varmus, wrote that the NIH "mustexercise reasonable responsibility in managing the results ofcollaboration with the private sector . . . We are disturbed that theNIH apparently has provided valuable, indeed seminal assistance tothe BRCA1 project absent a written agreement with the companyapparently trying to commercialize this discovery."Varmus' response said that a "CRADA formalizing thiscollaboration would not have prevented the current ownershipinquiry. Regardless of the applicants name as inventors, the PTO[Patent and Trademark Office] will examine the application forproper inventorship if an interference or question of deceptive intentarises. More importantly, any patent that issues will be subject tochallenge on any grounds, including inventorship, by those seekingto practice the invention without a license." n

-- Jim Shrine

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