A short-lived feud over inventorship of the BRCA1 breast cancergene was resolved Wednesday with the parties involved agreeing tobe named joint inventors in patent applications relating to discoveryof the gene.

In a separate matter, researchers reported their analysis of mutationsfound on the BRCA1 gene that appear to cause increasedsusceptibility to breast and ovarian cancer. The findings werereported in Wednesday's issue of the Journal of the AmericanMedical Association.

Researchers from Myriad Genetics Inc., of Salt Lake City, and theUniversity of Utah figure prominently in both actions. Myriad andthe university originally excluded collaborators from the NationalInstitutes of Health (NIH) in their patent application, followingdiscovery of the gene in September. On Oct. 6, the NIH filed its ownpatent application, which included scientists from all three entities.(See BioWorld Today, Oct. 31, 1994, p. 1.)

On Wednesday the three organizations agreed that all would benamed as inventors. The agreement also ensures that Myriad retainsworldwide exclusive rights to the discovery. Myriad already haslicensed commercial rights for therapeutic applications of theBRCA1 gene to Eli Lilly & Co., of Indianapolis, and rights todiagnostic kits to Lilly subsidiary Hybritech Inc. Myriad retainedrights to the diagnostic service.

Peter Meldrum, president of Myriad, told BioWorld that the patentapplication has been amended to include two NIH scientists _Roger Wiseman and Andrew Futreal. NIH spokesman DonRalbovsky said the agency is abandoning its separate patent filing.

"The inventorship issue is a very complex legal issue," Meldrumsaid. "After careful review of the facts surrounding the discovery,patent attorneys from the NIH and the University of Utah reachedthe determination that the two NIH scientists qualified as inventors.

"The end result from the Myriad perspective," Meldrum said, "is thatwe and our licensees have worldwide exclusive rights to alltherapeutic and diagnostic products resulting from the BRCA1discovery. That was our goal from the start."

The parties to the patent said the NIH scientists identified twofragments of the BRCA1 gene that were claimed in the initial patentfiled by Myriad and the university.

Ralbovsky said the agreement was suitable to the NIH because itsscientists now "are going to be recognized for their importantcontribution. The people listed from the NIH will also be able tobenefit financially," in the form of royalties on sales, he said.

The agreement, however, won't satisfy Rep. Ron Wyden (Ore.), theranking Democrat on the House Oversight and Investigationssubcommittee, which has jurisdiction over the management oftechnology developed by government laboratories. Wyden wrote aletter to NIH Director Harold Varmus in October expressingdispleasure at the institute's lack of rights to the technology.

"Let's not mince words," Wyden staffer Steve Jenning toldBioWorld. "The NIH is running a slipshod operation with regard toprotecting these rights. Our feeling is the NIH should be a partner inthe development of these things.

"The NIH should cut itself in as a player," Jenning said. "That's theonly way the taxpayers' investment is going to be protected. Untilthey do, they'll continue to hear from Wyden."

Mark Skolnick, vice president of research at Myriad and a professorof medical informatics at the University of Utah Health ScienceCenter, had a hand in both the discovery of the BRCA1 gene and theanalysis of the gene's mutations.

He said the finding related to the mutations suggest that a test will beneither as difficult to devise as some thought, and more difficult thanothers surmised.

"If we had found just a few mutations responsible for the geneticsusceptibility, then a simple test would have been possible," he toldBioWorld. "If we found a complete dispersion of mutations, it wouldmean a very difficult diagnostic. What we found is between thosetwo.

"We found three mutations that occur frequently, a number that arerepeated and others that are, to date, isolated. This is an intermediatepicture between a good and bad scenario."

Researchers tested for BRCA1 mutations in DNA samples from 372patients with breast or ovarian cancer, who were from high-riskfamilies. They also tested for two recurrent mutations (found in thefamilial sample) from another 714 cancer patients, including 557who were not selected because of family histories of cancer. Of the1,086 patients tested, BRCA1 mutations were found in 80 patients,or 7.3 percent. Thirty-eight different mutations were found. n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.

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