Should a biotech company own a piece of me?

Angelina Jolie recently went public with her decision to undergo a prophylactic mastectomy to reduce her odds of developing breast cancer. Her surgery has been widely celebrated as a courageous act. Jolie watched her mother die painfully of ovarian cancer and later discovered she had a mutation of the BRCA gene, which greatly increased the likelihood of her developing breast cancer.  She had the necessary data to make an informed decision.

BRCAkitWhat Jolie did not reveal, however, was that the cost of her genetic test was a staggering $3,340. Her announcement  spurred a surge in the stock price of Myriad Genetics, the company that owns exclusive rights to 24 U.S. patents used in genetic screening for breast and ovarian cancer, including the BRCA1 and BRCA2 mutation tests.[1]

Recently, Genomic Health, another biotech company, announced the imminent availability of a genetic test to distinguish between aggressive and indolent forms of prostate cancer. This test could be instrumental in helping men decide to forego surgery or radiation in the cases where a slow-growing cancer does not need immediate treatment. Jonathon Simons, Chief Medical Officer of the Prostate Cancer Foundation, suggested that this test “represented a watershed, akin to going from pulse rate measurements to electrocardiograms in cardiology.”[2]  The test has a list price of $3,820.

These tests are costly, and not every insurance plan will cover the cost of testing for everyone who wants it. So, why are these genetic tests so expensive?  One major reason is that the biotech companies involved have patented the actual human gene sequence, mutations of which identify the probability cancer in question. A patent gives the company the exclusive right to test for genetic mutations of that particular gene.  The patent also prevents other research institutions from developing competitive diagnostic tools for as long as the companies’ patents are in force—currently 20 years.  In fact, scientists wanting to do further research involving the BRCA1 and BRCA2 genes must seek a license from Myriad, even for investigations that may have nothing to do with breast cancer.

Unlike pharmaceuticals, in which the drug is patented, these companies actually own the patent to the isolated genetic sequence.  Whose genetic sequence, you ask?  Why yours, of course.  Every human being–male and female–has the BRCA gene.

The question of whether a naturally-occurring gene sequence can be patented—a practice that has been going on for 30 years—is now before the Supreme Court, which will be deciding the legality of gene sequence patents within the next few months.

The American Civil Liberties Union, the Association for Molecular Pathology (AMP), and other professional organizations of physicians and scientists argue that the gene sequences whose mutations indicate whether breast cancer is likely to occur or that can distinguish whether prostate cancer is aggressive or indolent are “products of nature,” not patentable “inventions.”  In essence, as one blogger argues, “the patent on the BRCA1 and BRCA2 genes, [have] essentially allowed Myriad Genetics to claim ownership of, and exclusive rights to, my genetic material – and Angelina Jolie’s.”[3]  Somewhat less emotionally, a representative of the Association for Molecular Pathology writes, “Myriad’s patents have eliminated competition among test providers, raising the costs of testing while reducing patient access and inhibiting or delaying the introduction of improved test methods.”[4]

Myriad Genetics responds to these criticisms by arguing, “No one ‘owns’ a part of you. At issue are mutations of the BRCA1 and BRCA2 genes.”[5]  This distinction seems subtle at best. Editorializing in the Wall Street Journal, Kevin Kimberlin, one of the venture capitalists that funded Myriad Genetics, states, “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.”

Kimberlin is engaging in a bit of legal sophistry here.  There’s no economic gain in “further research and competition,” if another company is prevented from commercializing a product based on a gene covered by Myriad’s patent.  Moreover, what does not seem to be widely known is that prior to being commercialized, the BRCA1 and BRCA2 tests–as well as the new prostate cancer test–began with basic research performed by scientists funded by the National Institutes of Health and/or other taxpayer- or contributor-funded institutions. Myriad Genetics may not have been able to achieve its current profitable state without having built its proprietary research on the foundation of original research funded by us taxpayers.

The genetic patent battle will be decided later this year. But the core dilemma will not. Like new cancer-fighting pharmaceuticals, the costs of developing effective genetic tests and putting them through trials are immense—and borne solely by the biotech company, not the government.  As long as private enterprise is willing to take the risk to carry basic research to operational fruition, its investors will logically expect a return on their investment—leading to high prices for patients. But should we really buy the pessimistic scenarios offered by companies like Myriad that tell us that no patent means no research, therefore no benefit to patients?

So how should those of us with cancer—or those at high risk for it—feel about gene patenting?  Does it matter if a company “owns” a piece of us, genetically speaking, if we can reap the benefit of tests that might save our lives or at least avoid the burdens brought on by cancer and its treatment?  Or, as some suggest, do these hardhearted companies care more about maximizing investor return than about the cancer patients they claim to benefit?  Will Myriad Genetics, Genomic Health, and others ever compensate taxpayers for our early investment in basic research that helped launch the tests?  Perhaps losing patent rights to these naturally occurring genes might be that compensation. What do you think?

Comments

  1. Geoff says

    It’s a fascinating issue; the Supreme Court ruling will be very interesting. I think the “ownership” thing is a red herring for a couple of reasons. First, it’s not as if Myriad has the right to take the BRCA gene out of my body; it doesn’t literally own any part of me. Second, the actual BRCA1 sequence is not a secret known only to Myriad, anybody can go look up the scientific paper where it was published. My understanding — which might be wrong, so feel free to correct me — is that it would be more accurate to say that Myriad “owns” the right to use the BRCA sequence in its business. So basically nobody else can develop a test for mutations to the sequence, and anybody who tests a patient for mutations to the sequence has to use Myriad’s test. I also think that the “hardhearted companies” issue is irrelevant. It doesn’t matter whether Myriad cares more about profits or about cancer patients. Obviously, its BRCA1 patent directly serves the interests of its investors, and not the public good. But the patent system as a whole arguably does serve the public good by incentivizing costly and risky innovations, and it seems plausible that if the sequence hadn’t been patentable the relevant diagnostics may not have been developed, leaving some cancer patients worse off. Moreover, the high cost of the test (which is *not* in the public interest) seems not just attributable to the patent. Obviously, competition would bring the cost down, but there are deeper pathologies behind the insanely high costs of medical goods and services in the US.

  2. Craig Pynn says

    Your argument is exactly the one that Myriad makes, and it’s not without merit. Absent the economic incentive created by the patent it’s unlikely companies would develop genetic tests and pharmaceuticals and then take them through costly clinical trials, especially for diseases that do not have high populations. In your opinion, what other factors beyond patent exclusivity and development costs drive the price of diagnostic tests based on genetics?

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>