OncorMed Inc. said Wednesday it received a license to a patent that=20claims certain mutations for the BRCA1 breast cancer gene.

The Gaithersburg, Md., company said it received the license from the=20University of California, which recently received notice of allowance=20on its patent application. The company believes the application is the=20first to be allowed regarding BRCA1, which when defective,=20predisposes women to breast and ovarian cancers. The license was=20not exclusive.

If the application claims BRCA1 mutations, as university and=20OncorMed officials said, it could set precedents about the=20patentability of gene mutations.

University of California researchers used genetic markers to link the=20BRCA1 gene to chromosome 17, starting a race to find the specific=20gene in the five-million-base-pair area. Myriad Genetics Inc., of Salt=20Lake City, and collaborators are credited with locating the gene and=20was first to file patent applications on the complete gene sequence, a=20filing many expect will give Myriad broad protection.

Doug Dolginow, president and chief operating officer of OncorMed,=20told BioWorld Today the license from the University of California=20contains specific mutations, which OncorMed already is using in its=20genetic testing service. He said the allowance of the patent also could=20have implications for OncorMed, since it has filed for patents on=20specific mutations.

Adrienne Rutledge, an associate for the university's office of=20technology licensing, said the license provided to OncorMed=20"includes the sequences for a series of alleles of the BRCA1 gene,"=20including "mutations or different forms of that gene."

Myriad's patent application basically covers composition of matter.=20Some would argue that gene mutations couldn't be patented because=20they would fall under the obviousness clause.

Peter Meldrum, president and CEO of Myriad, said, "Without seeing=20the patent it is very difficult for Myriad to comment. That patent=20hasn't issued yet so we can't see what those claims are."

Dolginow said, "This is a very gray area of law. It's hard to=20determine what type of patent applications will be allowed. It furthers=20the speculation that there may be a lot of cross licensing in this =area."=20n

-- Jim Shrine

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