What is a time of joy for many women was my darkest hour.
You may have heard of Myriad Genetics: They're a biotechnology company that briefly got famous in 2013 when the Supreme Court stepped in to rule that the company's patents on BRCA-1 and BRCA-2, genes associated with a higher risk of breast cancer, didn't actually hold good. The case was an important moment in biotech and caselaw, ruling that simply discovering something didn't equate to inventing it. (Sorry, Columbus.)
While acknowledging that the discovery was important for science, the Court declined to uphold the patent — though Myriad is free to create and patent synthetic genes, and of course can use BRCA-1 and -2 in the development of tests used to improve breast cancer care and treatment. One example is Oncotype DX, which just performed extremely well in clinical trials — the Genomic Health product can determine whether patients will actually benefit from chemotherapy after surgery on the basis of key DNA markers.
Myriad's business strategy included applying for a range of patents all over the world, including Canada, Japan, New Zealand, several EU nations, and Australia. Which is where Yvonne D'Arcy, 69, comes in, along with Cancer Voices Australia. She's survived breast cancer twice, and she has no time for Myriad's strategy, which she argued was harmful for breast cancer patients and access to health care. So she took them to court.
Five years later, she won a 7-0 High Court victory striking down the patent, setting important precedents for Australia. However, it's not just about Australia. The world of genetic sequencing is still very new, as is the use of specific genes in medical testing and therapy. Thus, new genes are constantly being uncovered, and biotech firms are attempting to leverage them.
One of the most productive ways to leverage them is, of course, by cornering the market: If one company controls a gene, it's the only one that can make diagnostic tests relying on it (and various mutations — Myriad filed for multiple patents to cover variants of BRCA-1 and -2). It's also the only one that can lease rights to other companies interested in developing their own products.
With tests costing thousands of dollars each (many, but not all, covered at least partially by insurance), biotech firms stand to make an extremely large amount of money from the discovery, patenting, and sale of genetic material.
Almost as soon as DNA was discovered and researchers started sequencing it, natural questions started to arise about DNA as intellectual property. It's a naturally occurring substance, after all. In its ruling, the Supreme Court commented that:
The rule against patents on naturally occurring things has limits, however. Patent protection strikes a delicate balance between creating 'incentives that lead to creation, invention, and discovery' and 'imped[ing] the flow of information that might permit, indeed spur, invention'...It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.
No dice, Myriad. The case was important in the United States because it set a clear precedent for biotech when it comes to attempts to patent naturally-occurring genes. (As discussed in the same decision, any synthetic genes are grounds for patenting as they represent innovations, not discoveries.) That meant that anyone could access and use the BRCA-1 and -2 genes in research and product development — but don't cry for Myriad, because they still make substantial profits off their products, and their patents overseas were going just fine.
Until Australia, that is, when the High Court, much to Myriad's dismay, generally agreed with the U.S. Supreme Court. Myriad attempted to argue that it was "manufacturing" the material by isolating it from the patent gene, but the court wasn't impressed with the argument. At the end of the day, the material is still naturally occurring, which means that Myriad isn't entitled to patent it — as in the U.S., Australia doesn't offer patents on products from nature. (Sorry, everyone running out to patent kangaroos.)
It's exciting news for cancer patients who argue that preemptive genetic testing can help people make informed choices about their health care. Patients aware of the presence of variant BRCA-1 and/or BRCA-2 can talk with doctors and genetic counselors about available options — which might be more frequent breast cancer screenings, or even a preventative radical mastectomy, if it appears warranted. (In periodic instances, an oophorectomy might also be appropriate, as the genes are also associated with ovarian cancers for some patients.)
Such rulings also set the stage for similar court decisions in the future, expanding the availability of genetic testing for patients concerned about cancer risks. The more we understand patterns of cancer and genetics, the more people we can support.
However, the industry isn't so certain the ruling will make a significant difference. The Financial Review reports that patenting genes isn't the new hotness any more: Patenting synthetic or altered genetic material is, along with developing new processes and diagnostic tests. The ready availability of information about given genes isn't as much at issue as the ability to do something with it, under this framework, and highly customized testing is definitely the future face of medicine.
Someday, and to some extent already, these kinds of tests will be used in detailed, patient-oriented, custom medicine. While options like screening to make informed decisions about prevention and treatment are already available, medications tailored to individual patients likely aren't far behind. Someday in the not too distant future, the presence of BRCA-1 and/or BRCA-2 will be less important than what people can do with that information, and the biotech industry knows it.
After a vicious and hard-fought battle in this case, Myriad likely isn't going to back down just yet, but the probability of turning its attention to other matters is definitely high. Investing litigation resources in what are ultimately losing battles isn't something any company likes to do, especially when it stands to earn huge profits in other areas.
While Myriad and others are huffing and puffing about how "strong patent protections" are necessary to promote biological innovation, they have plenty of aces in the hole.
For patients, this may be a hollow victory.