GENE PATENTS DRIVE MEDICAL INNOVATION: KEVIN KIMBERLIN
Gene Patents Drive Medical Innovation
The BRACAnalysis test has warned one million woman of their risk of breast and ovarian cancer.
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The biotech industry began in 1978 when the University of California applied for a patent on the gene for the human growth hormone. Since that filing nearly 20% of the 20,000-plus genes in our DNA have been patented.
The current Supreme Court case challenging the patent on the breast cancer gene (Association for Molecular Pathology v. Myriad Genetics) could invalidate thousands of these patents, affecting hundreds of diagnostic and therapeutic products. The biotech industry saves tens of thousands of lives and creates as many jobs. However, a ruling against the patent will deep-six future life-saving technologies as investor support for such discoveries disappears.
I know this because I wrote the check to start Myriad Genetics MYGN +0.39% —the firm that holds the patent on the breast cancer gene—and talked some 200 investors into its first venture funding.
These investors hoped to make a difference as well as a financial return. To us, the promise of a patent was crucial. The first page of Myriad’s initial offering in 1993 made this connection clear: “The Company has filed a patent application claiming the BRCA1 gene and methods for its detection.”
BRACAnalysis, Myriad’s breast cancer test, has warned one million women about potential genetic breast and ovarian cancer risk. Angelina Jolie’s discovery that she carried the mutated BRCA1 gene led her to choose a preventive double mastectomy.
A lab technician for Myriad Genetics in Salt Lake City starts a robot that will prepare DNA.
Although not all women carrying the gene make this choice, they should know their predispositions in order to weigh their options. Early detection is always better. The same BRCA1 and BRCA2 anomalies may also signal a genetic predisposition to ovarian cancer, which is extremely difficult to diagnose in its early stages. Women like Angelina Jolie who receive and act on this genetic warning can significantly reduce their ovarian cancer risk.
Understandably, some people are uncomfortable with the concept of awarding patents based on human DNA. But let’s keep four points in mind:
• No one “owns” a part of you. At issue are mutations of the BRCA1 and BRCA2 genes.
Some argue that these sequences are obvious products of nature and not patentable. The reality is it took more than 17 years of intense research, involving sophisticated genetic mapping and sequencing skills to discover and isolate the molecules at the heart of the breast-cancer test. The complexity required to purify these molecules makes them anything but obvious.
• Patents promote research and competition. Patent-holders do get the exclusive right to commercialize their discoveries, but they must disclose all the details. In that way, a patent actually provides the information for further research and competition. Since the BRCA1 patent was granted, more than 9,600 studies have been published based on this gene. Several other ways to detect breast cancer have been developed—but there is still no better predisposition test.
• Scientific acclaim is not enough; innovation requires money. Before forming Myriad, one of the co-founders, Walter Gilbert of Harvard, won the Nobel Prize in chemistry for co-developing DNA sequencing. Co-founder Mark Skolnick of the University of Utah, and some of his colleagues created the gene-mapping technique that catalyzed the Human Genome Project. Ultimately, neither researcher could translate his scientific innovations into a viable test.
“I’d helped uncover the best resource on the planet for getting at the underlying genetic cause of cancer,” Mr. Skolnick later observed. “I just didn’t have the resources to take advantage of it.” It took an investment of $500 million to commercialize the BRACAnalysis test.
• Patents lure investors: Medical innovations require investors willing to take great risks over long periods. Two decades passed before Myriad recouped its enormous investment—an investment that would not have happened without patent protection.
We have entered the golden age of the genome. Consider recent cutting-edge discoveries such as the studies on prenatal heart defects due to genetic mutation, and inherited heart disease risks. Without patents, who will take the financial risk to bring such medical findings to market?
A patent system that protects medical innovation encourages investors to make these types of long-shot bets. Ruling against patents on isolated DNA will drive this risk capital elsewhere.
An adverse decision would also silence researchers. Findings with commercial potential will disappear into trade secrets, much as Coca-Cola KO -1.37% has kept its formula under wraps for 100 years. Brilliant insight and scientific discovery, now available to all through patent disclosures, will be kept confidential.
At stake is a system that shares the life-science miracles that propel humanity forward. The Supreme Court must uphold the ability to patent isolated DNA to keep this innovation engine going at full speed.
Mr. Kimberlin is a co-founder of Myriad Genetics Inc. and chairman of Spencer Trask & Co., an advanced-technology venture firm.
A version of this article appeared May 21, 2013, on page A15 in the U.S. edition of The Wall Street Journal, with the headline: Gene Patents Drive Medical Innovation.
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