Myriad Genetics will defend its gene patents Monday in the U.S. Supreme Court, and part of its public relations defense is that by isolating genes, it has created a synthetic piece of DNA worthy of the exclusivity that a patent brings.
A link to Sunday's Inquirer story is here.
The case is Association for Molecular Pathology v. Myriad Genetics, Inc., 12-398.
The U.S. government has changed its position in the last couple years on this topic. The government now says truly synthetic genes that are new inventions should be patented, but it says some of Myriad's patents are protecting natural things, not synthetic ones. The U.S. Solicitor General Donald B. Verrilli filed a friend of the court brief (link here) and will be given 10 minutes to speak during Monday's session.
University of Pennsylvania genetics researcher Arupa Ganguly is an expert on genes and molecules, not handicapping decisions of the Supreme Court. She said she was forced to stop research and testing of an alternate, lower-cost testing procedure because of cease-and-desist letters from Myriad.
"I am very optimistic about the eventual decision," she said via email last week. "I hope the patent is overturned."
One of the oddities in this situation is that among the several patents tangled up in this case are ones originally owned by Penn and the U.S. government. Myriad controlled the use through licensing.
A decision is likely before the term ends in June.
Myriad also said that it helps plenty of patients get reduced prices on its patent-protected test for predicting the possibility of cancer, though it can run to $3,000 without insurance or subsidies.
"This case has potentially broad implications for the biotech, animal health and agricultural industries and the development of products and services of enormous benefit to society,'' Peter D. Meldrum, president and CEO of Myriad, said in a statement. "Countless companies and investors have risked billions of dollars to research and develop scientific advances under the promise of strong patent protection."
Myriad's Supreme Court brief is here.
Myriad's patents on two genes, BRCA1 and BRCA2, expire in two years, but the precedent could go far beyond that in time and reach.
The New York Times reported (link here) Saturday that beside being able to block some other forms of testing, Myriad is also able to use the results of its tests to establish a database of information of gene mutations, which are the indicators for cancer. Even if it excludes identifying patient information, the data might be highly useful in further research. The Times reported that Myriad no longer shares such information. To counter that and build their own database, researches have contacted individual doctors, hoping they would share the information from Myriad tests that those doctors deliver to patients.
The Sharing Clinical Reports Project (SCRP) is led by Dr. Robert L. Nussbaum, chief of the division of genomic medicine at the University of California, San Francisco. Nussbaum told the Times that because of the cumbersome nature of the data collection, the database has only about 1.5 percent of what Myriad has. A link to SCRP is here.