Myriad Genetics, Inc. it has been awarded patent numbers 6,124,104 and 6,140,473 by the United States
Patent and Trademark Office. The patents cover antibodies to the BRCA2 breast cancer gene and the p15
tumor suppressor gene.
Myriad has now been awarded a total of nine patents covering the BRCA1 and BRCA2 genes, and two
patents covering the p15 gene. The patents announced are of particular interest because they cover
antibodies to the BRCA2 and p15 genes. Antibody research is an important field of therapeutic
development that has experienced a number of recent successes. The continued issuance of Myriad patents
underscores the company's strategy emphasizing composition of matter and method of use gene patents
on full-length DNA sequence. These DNA patents, applied for and awarded to Myriad, have known
function as well as practical real-world utility.
The United States Patent and Trademark Office is preparing to issue its final revised set of guidelines for
the award of DNA patents. The guidelines are to be based upon a set of interim working guidelines that
was published for public comment in December 1999, known as the Revised Interim Guidelines for
Examination of Patent Applications Under the 35 U.S.C. Sec. 101 and 112, para. 1 "Utility Requirement",
(Revised Interim Guidelines).
The company expects that the final guidelines, to be newly issued, will reflect the basic premise of the
Revised Interim Guidelines, with some minor modifications. The Revised Interim Guidelines set a stricter
standard for patent allowance than was previously applied, requiring "specific and substantial utility
that is credible". Myriad's patent strategy is focused on patenting genes that are associated with human
disease, have commercial therapeutic or diagnostic utility, and cover the full-length DNA sequence.
Therefore, Myriad strongly supports the revisions and believes that the final revised guidelines will
strengthen Myriad's intellectual property position and reduce potential future conflicts. Moreover, the
company believes the requirements for real-world utility will favor product-oriented companies like
Myriad that focus on understanding what genes do and how they contribute to human disease.
"We are very pleased with the broad proprietary foundation, both for our therapeutic development
programs and our predictive medicine business, that the award of patents for the company's discoveries
provides," said Peter Meldrum, president and chief executive officer of Myriad Genetics Inc. "Myriad has
now received over 60 patents, has filed patent applications on over 1,000 proteins and protein
interactions, and should benefit in the future from the new guidelines on DNA patents."
The BRCA1 and BRCA2 genes are the basis of Myriad's BRACAnalysis predictive medicine test for
determination of hereditary predisposition to breast and ovarian cancer. The therapeutic development
rights for BRCA1 are licensed to Eli Lilly & Co. while the rights to BRCA2 have been fully retained by
Myriad.
The p15 gene is one of a family of three important tumor suppressor genes that share the same
chromosomal region. The others are the p16 tumor suppressor gene and the p19-arf tumor suppressor
gene, each considered highly important cancer genes and potential targets for development of
anti-cancer therapeutics. Myriad has fully retained its rights to therapeutic and diagnostic development
of the p15 gene.