Should companies be able to patent the genes that cause breast cancer? Anjana Ahuja looks at the issues
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| There are two genes that have been clearly linked with breast cancer — and Myriad Genetics has patented them both |
First, the shares shot up to $36. Then they dropped to $32. The fluctuating
stock price of Myriad Genetics, the American company whose monopoly on
genetic testing for breast cancer was partly dismantled by the US Supreme
Court last month, illustrates the confusion that has greeted the legal
ruling. It has been simultaneously applauded as “a victory for common sense”
and condemned as “insane”. At the time of writing, the share price was
hovering around $26.
It isn’t the share price that matters so much as the ruling itself – that
naturally occurring genes can’t be patented but that modified genes can –
and the symbolism behind it. Myriad Genetics has, for decades, been seen as
the symbol of genomic greed. Ever since the Utah company patented the two
major breast cancer genes, BRCA1 and BRCA2, in the Nineties, and a
diagnostic test for them, it has defended those patents aggressively in a
string of legal showdowns that have scared off companies trying to develop
cheaper tests. When the actress Angelina Jolie revealed her double
mastectomy, she flagged up the cost of genetic testing – around $3,500 – as
a serious public health issue.
But the company also casts a long, potentially litigious shadow closer to
home: it holds European patents on breast-cancer testing that cover the UK,
and which are enforceable under British law. However, Myriad’s patents
didn’t stop the NHS developing its own simpler genetic tests, using publicly
available genetic data. And while the chances of Myriad bringing its lawyers
down on the NHS look slim, they can never be dismissed. A 2011 report by the
now defunct Human Genetics Commission claimed that the NHS and the
Department of Health were ignorant of patent issues, were probably guilty of
multiple infringements, and may soon face lawsuits and the prospect of
paying backdated royalties.
Still, the June 13 outcome of Association for Molecular Pathology v. Myriad
Genetics has delighted Dr Gail Norbury, who oversees genetics laboratories
for the Guy’s and St Thomas’ Hospital Trust, which provides one of the
largest genetic testing operations in the UK. She said: “It provides some
clarity because genes can no longer be patented, although you can patent
complementary DNA [short copies made in the lab that don’t exist in nature].
The ruling won’t make much difference to the NHS, because we didn’t let it
[the threat of litigation] close us down. But companies will now be hard
pressed to rely on patent law to protect themselves. It’s a victory for
common sense.” She points out that the search for breast cancer genes was a
collaboration of thousands of scientists, many publicly funded: “It was
unacceptable for one company to sweep in at the last minute.”
Not everyone, however, finds clarity or comfort in the judgment. One of the
Supreme Court judges admitted in the summing up he barely understood what he
was ruling on. There were two parts to the decision: the Washington court
decided, first, that merely identifying and isolating a gene isn’t enough
for a patent, which demolished five of Myriad’s claims (and should halt the
Wild West mentality that has dogged genetics generally); secondly, that if
genetic material was altered so it was no longer identical to something
occurring in nature, then this new substance could possibly be eligible for
a patent.
It is this second part of the ruling, says Anneke Lucassen, a professor of
clinical genetics at Southampton University, that could curtail the
celebrations of Myriad’s opponents. Many of Myriad’s claims, she notes,
concerned complementary DNA (cDNA). The judges ruled that this is a
substance sufficiently different from “products of nature” to get patent
protection. Myriad’s website says: “Following today’s [Supreme Court]
decision, Myriad has more than 500 valid and enforceable claims in 24
different patents conferring strong patent protection for its BRACAnalysis®
test.”
Note the word “enforceable”. Other diagnostic tests use techniques similar to Myriad’s creation of cDNA, to copy a patient’s DNA sequence and magnify it, making it easier to study. It’s unclear whether Myriad can claim ownership only of its own method of copying DNA, or more broadly.
Prof Lucassen says: “Everything depends on how that second ruling is interpreted. My sense is that we’ll have to wait for the next court case.” In the meantime, she will carry on ignoring patents and ordering about 1,000 BRCA tests a year. Since the ruling, several companies have revealed plans to undercut Myriad.
Dr Penny Gilbert, a patent lawyer at Powell Gilbert, a London practice that specialises in advising biotechnology companies, agrees that the implications of the ruling are still unclear. Her reading is that “if there’s anything other than just chopping out a gene, then it’s patentable”. Another patent lawyer interviewed by the journal Nature called the situation “insane”, as there is no guidance on how much modification is enough for a patent.
Regarding the implications for the NHS, Dr Gilbert said it was rarely in a company’s interest to sue for patent infringement: “I cannot recall a single case where that’s happened in the NHS,” she says. “It doesn’t make sense for companies who value their reputation to do it. That doesn’t stop companies from fighting between themselves. But the NHS should worry about patents if it’s using tests supplied to them by a non-licensed infringer.”
Lurking in the background is the question of morality: should companies be able to profit from their mastery of DNA, the book of life, and if so, how much profit is acceptable? Conversely, in the absence of patents, what is the incentive for investors to pour millions into medical research?
These are important, difficult questions often overlooked in the debate over gene patenting, according to Dr Michael Hopkins, an expert in science policy at Sussex University, and a co-author of the 2011 report that highlighted the NHS’s ignorance of patent infringements. Biotech companies like Myriad are often unfairly demonised, he says, and should be praised for putting money into developing high-quality therapies and products: “Patents are a bargain between the state and the inventor, done for the public good; the state grants the patent and the inventor is granted a temporary monopoly. The short-term monopolies are a pay-off for having the invention in the first place.” Take away patents, he says, and investment dries up.
Dr Hopkins continues: “I would be very concerned if the NHS carries on as it is, not engaging with intellectual property issues. If it’s going to infringe, then some innovators may choose not to develop their products in the UK, or foreign companies may choose not to launch their products here.” He estimates that in fact 25 to 50 per cent of patents are owned by public sector organisations or charities. Dr Hopkins says it is not the patents per se that are the problem, but the way they are licensed – or not. Myriad does not grant licences that permit other organisations to use its tests for a fee; all tests are done in Myriad labs. The result is a huge private database that helps it maintain its status as a world leader.
Dr Norbury points out that people working in public health are probably motivated by different forces than those who opt to commercialise research. She says amazing advances are achieved in the NHS and shared freely; she questions whether patents really are a necessary price for progress. “When organisations spend a lot of time patenting and prosecuting others for infringement, the only people who benefit are the lawyers.”
Note the word “enforceable”. Other diagnostic tests use techniques similar to Myriad’s creation of cDNA, to copy a patient’s DNA sequence and magnify it, making it easier to study. It’s unclear whether Myriad can claim ownership only of its own method of copying DNA, or more broadly.
Prof Lucassen says: “Everything depends on how that second ruling is interpreted. My sense is that we’ll have to wait for the next court case.” In the meantime, she will carry on ignoring patents and ordering about 1,000 BRCA tests a year. Since the ruling, several companies have revealed plans to undercut Myriad.
Dr Penny Gilbert, a patent lawyer at Powell Gilbert, a London practice that specialises in advising biotechnology companies, agrees that the implications of the ruling are still unclear. Her reading is that “if there’s anything other than just chopping out a gene, then it’s patentable”. Another patent lawyer interviewed by the journal Nature called the situation “insane”, as there is no guidance on how much modification is enough for a patent.
Regarding the implications for the NHS, Dr Gilbert said it was rarely in a company’s interest to sue for patent infringement: “I cannot recall a single case where that’s happened in the NHS,” she says. “It doesn’t make sense for companies who value their reputation to do it. That doesn’t stop companies from fighting between themselves. But the NHS should worry about patents if it’s using tests supplied to them by a non-licensed infringer.”
Lurking in the background is the question of morality: should companies be able to profit from their mastery of DNA, the book of life, and if so, how much profit is acceptable? Conversely, in the absence of patents, what is the incentive for investors to pour millions into medical research?
These are important, difficult questions often overlooked in the debate over gene patenting, according to Dr Michael Hopkins, an expert in science policy at Sussex University, and a co-author of the 2011 report that highlighted the NHS’s ignorance of patent infringements. Biotech companies like Myriad are often unfairly demonised, he says, and should be praised for putting money into developing high-quality therapies and products: “Patents are a bargain between the state and the inventor, done for the public good; the state grants the patent and the inventor is granted a temporary monopoly. The short-term monopolies are a pay-off for having the invention in the first place.” Take away patents, he says, and investment dries up.
Dr Hopkins continues: “I would be very concerned if the NHS carries on as it is, not engaging with intellectual property issues. If it’s going to infringe, then some innovators may choose not to develop their products in the UK, or foreign companies may choose not to launch their products here.” He estimates that in fact 25 to 50 per cent of patents are owned by public sector organisations or charities. Dr Hopkins says it is not the patents per se that are the problem, but the way they are licensed – or not. Myriad does not grant licences that permit other organisations to use its tests for a fee; all tests are done in Myriad labs. The result is a huge private database that helps it maintain its status as a world leader.
Dr Norbury points out that people working in public health are probably motivated by different forces than those who opt to commercialise research. She says amazing advances are achieved in the NHS and shared freely; she questions whether patents really are a necessary price for progress. “When organisations spend a lot of time patenting and prosecuting others for infringement, the only people who benefit are the lawyers.”
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