A New York judge's opinion to toss out the patents on two breast cancer genes paves the way for high-tech gene sequencing to begin having a real impact on medicine.
The ruling by federal judge Robert Sweet earlier this week invalidated long-standing patents on two breast cancer genes held by Myriad Genetics. His basic argument is one that many researchers have been making for years: You can’t patent genes because genes are natural. But thousands of patents on human genes have been granted anyway.
"This is the moment when a lot of issues are crystallizing in the public's mind in a way they have not before," says Daniel Vorhaus, a patent lawyer at Robinson, Bradshaw & Hinson who also blogs at The Genomics Law Report. He says he has been fielding phone calls from people who would normally not be interested in genomics at all, many reflecting a general sentiment that companies that would restrict people's access to their own genes "needs to be put in their place."
The ruling may be overturned on appeal and is unlikely to have immediate financial effects on Myriad, which sells a $3,000 test for genetic breast cancer and ovarian cancer risk. It has a dominant position in testing for the two genes, called BRCA1 and BRCA2, and big insurers cover its tests.
Nonetheless, the court case brought by a coalition of patients, scientists, and the American Civil Liberties Union represents a significant turning point. It is the first battle in which the future of medicine confronted the past--and the future won.
Far from hurting biotech innovation, eliminating pure gene patents will greatly speed innovation in the biotech sector. Instead of tying up basic genetic information with patents, the biotech industry will have to become more like computer industry. It will compete on the quality of its machines and software algorithms, not by making scientific discoveries and locking up the information for decades with a patent. Numerous high-tech gene companies will be able to flourish thanks to superior technology.
The simple fact is that new technology will soon make Myriad’s gene test obsolete. Myriad charges $3,000 for information on two genes out of 25,000 in the human genome. It can do so because its patents have granted it a total monopoly on the testing. In the old days when two breast cancer genes were discovered, genes were hard to identify.
But now new ultra-fast gene sequencing machines will soon be able to sequence the 6 billion letters inside a person's genetic code—all 25,000 genes--for the very same $3,000. Numerous venture-backed companies and publicly traded companies including Illumina and Life Technologies are racing to do this. They are likely to reach the goal in a year or so. Currently, their machines are too complicated to be used in your average hospital or clinical testing lab. But this will eventually change as the technology matures.
Top gene researchers envision a day where patients will have all their genes sequenced early in life to gain information about future disease risk. In the shorter term, gene sequencing will help diagnose rare genetic diseases in people with unexplained symptoms and help oncologists devise personalized cancer treatments.
But this future will never happen if patents on individual genes are allowed to remain.
A $3,000 gene test no longer makes sense in a world of $3,000 gene sequences.
In the new world where machines can sequence every gene for a relatively low cost, researchers believe that figuring out how multiple genes work together is the way forward. Patents on individual genes could mean having to pay royalties on every single one of them. "It's like 1,000 people have to show up to paint your house because each one owns a part of your wall," says Linda Avey, president of the Brainstorm Research Foundation.
Imagine this scenario: You develop lung cancer, so the hospital does a gene scan to identify what genes are mutated in your cancer in order to personalize treatment. In the future it may be important to know all the genes that are mutated in a tumor, not just some of them. Under the current scenario, the hospital cannot look for the patented genes, even if doing so might help save your life and even if it has a machine that can search through all the genes at once.
Judge Robert Sweet's decision doesn’t have precedent value and thus isn't the law of the land or even the Southern District of New York. But it fits with this changing technological landscape. In essence, he ruled that despite Myriad’s protestations to the contrary, it is basically patenting fundamental genetic information about an individual.
Contrary to the protestations from some biotechnology lawyers (who could stand to lose lots of money writing obscure patents), his ruling doesn't affect most patents on diagnostic tests or biotechnology drugs from companies like Amgen. You can always patent a novel testing method. You can always patent a novel genetically engineered organism that doesn’t exist in nature.
Judge Sweet smartly saw through the technical mumbo-jumbo that some lawyers have used to defend patents on raw genes. Pure gene patents rested in part on the logic that performing a gene test involves isolating DNA outside the body that is chemically modified from the DNA inside the body. Therefore, it is patentable.
Slight changes are meaningful (and patentable) when it comes to drug molecules, where altering one tiny atom can change the effectiveness of a medicine drastically. But the value of DNA is the genetic information contained it, and isolating the DNA doesn’t change the information contained in it one iota, despite the chemical modifications, the judge pointed out.
The court battle is hardly over yet. Patent lawyer Vorhaus predicts it could be overturned as it overlooks lots of case law. It could reach the Supreme Court before it is over.
Harvard University's George Church, who is running a project to cheaply sequence thousands of people's DNA, notes that Myriad still has many patents protecting its diagnostic tests, and it can still sue people for sequencing them. (The decision only invalidated 7 of 23 patent claims.) Newer gene diagnostic patents are far more sophisticated. "It seems far too early to gloat" that the gene patent stranglehold has been broken, says Church.
Myriad's tests will probably keep churning out sales of $300 million annually for years--they are useful to women at risk for an inherited form of breast cancer. But the company might want start paying a nice quarterly dividend to give that money directly to investors. The-one-gene-one-disease business model is marked for dead, and nobody knows what is going to replace it.
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