A landmark case challenging the practice of patenting genes is working its way through U.S. courts.
The American Civil Liberties Union and Public Patent Foundation filed a lawsuit on behalf of more than 20 plaintiffs in May 2009 against Myriad Genetics, the U.S. Patent and Trademark Office, and officers of the University of Utah. The suit challenges 15 claims in seven patents to which Myriad Genetics holds exclusive rights, including two patents involving the breast cancer gene. On March 29, 2010, Judge Robert Sweet of the United States District Court for the Southern District of New York struck down all of the patents held by Myriad. In April of this year, the U.S. Court of Appeals for the Federal Circuit began hearing an appeal of the case, which has the potential to shape gene-patenting law for decades to come.
THE MARK: What’s the situation with gene patenting at present?
ROBERT COOK-DEEGAN: The possibility of getting patents on genes really dates back to the early 1980s and recombinant DNA technology. The first generation of gene patents were basically patents on the DNA that could produce a protein; the first few proteins included, for instance, insulin. It wasn’t terribly controversial and almost every court system has dealt with this and they’ve all reached more or less the same conclusion: no big deal to patent a gene. But in these cases the gene … has actually been modified before it’s applied.
So let’s step forward now. Today there’s a different use of gene patents, and that’s when you identify a gene has been changed, or there’s an error in it, and it gives rise to a disease. One of the most important and prevalent diseases that was identified as a really important target was the inherited risk of breast and ovarian cancer. The discovery that there were certain families that had a broken gene was made in 1990 by Mary Claire-King at Berkeley. And that set off a really intense race that lasted four years to find out what was the gene that mutated. And the genes discovered in 1994-1995 were called BRCA1 and BRCA2, for breast cancer one and breast cancer two.
The winner of the first race – there were six or seven groups that were competing intensely all over the world – was a combination of the University of Utah and Myriad Genetics. So they got patents on the BRCA1 gene, and there was kind of a tie for finding BRCA2, and the patent status there was kind of complicated.
But as soon as you know where the mutations are and what they are, you have a way of detecting who in those high-risk families has the mutation and who doesn’t. So that gives you a diagnostic test, and that became something that was also subject to patents. Myriad started getting the patents in 1997 and 1998, and then they sent out letters to labs in the United States that were offering BRCA testing, and they sued the University of Pennsylvania and they sued a competitor company that was offering BRCA testing. Those lawsuits never went to court; they were settled out of court.
The other company basically sold its rights to BRCA1 and BRCA2, and all of their patents have now been assigned to Myriad as part of an out-of-court settlement. And the suit against the University of Pennsylvania was dropped when the University of Pennsylvania agreed to stop doing the testing. So from that point, from 1998 until now, Myriad is the only commercial tester for BRCA1 and 2 in the United States.
THE MARK: So what’s the legal issue?
COOK-DEEGAN: What happened in May of 2009 is that 20-some plaintiffs filed suit against Myriad. It was a group of different kinds of people. Some of them are women who wanted to get tested and, for one reason or another, they believed the policies of Myriad were getting in their way. And that’s the case that’s before the courts right now. Some of the other plaintiffs are people who are health professionals – doctors, or the people who run labs – and they want to be able to do this testing either themselves or send it to the places that they want to send it to rather than having to send it to Myriad.
So they brought suit against Myriad, the judge agreed to hear the case, and Judge Robert Sweet handed down his decision on March 29, 2010, and said, basically, you can’t patent a gene. All the claims being challenged in these lawsuits are invalid, because your method claims are too broad and they don’t comply with patent law, and you can’t patent the molecule of DNA because it’s the embodiment of genetic information.
So he overturned the patents, and that is what has been appealed. There’s one court in the United States that hears all appeals for all patent cases from all of the 94 district courts, the U.S. Court of Appeals for the Federal Circuit. And that is the court that has this case in front of it now. And it heard oral arguments in this case on April 4.
The Court of Appeals will make its decision fairly soon, and it’s almost certain that either one or both parties will appeal whatever the Court of Appeals for the Federal Circuit decides. That’s where we are right now, in the case.
It’s gotten a lot of attention partly because it’s really high profile and people care about it, but partly because this is not your usual patent suit. This isn’t Ford suing GM, or Pfizer suing Eli Lilly, over who’s going to make the money off of selling a drug; this is two civic organizations suing a company over access to diagnostic testing. And it is the first case that’s ever gone before a judge that’s not about DNA patenting in this context of engineering, and using the DNA for producing something that you put in a bottle and sell for high prices; rather it’s about using DNA to tell somebody what the DNA sequence is from their body.
THE MARK: What will be the consequences of this lawsuit?
COOK-DEEGAN: There are three or four scenarios. One scenario is that Myriad wins decisively, and the Court of Appeals says, “Judge Sweet, you got it completely wrong.” And then we’re back to status quo ante – that is, as though this case never really happened, and they’re saying this is now the precedent: You can patent DNA and moreover you can patent DNA for diagnostic purposes. Then we’re back to where we were. Myriad’s broadest patents begin to expire in 2014-2015, so in three years some people might be able to begin offering BRCA testing in the United States.
If Myriad loses decisively, it will certainly appeal, but the decision will set a precedent, saying you can’t get patents toward this purpose. It’s possible that the Court of Appeals would split the difference just like the Department of Justice did in saying, yes, you can have DNA patents of this kind but not of that kind.
The final thing I should say about the consequences is, depending on how the court decides, one of the other things that’s going on in the world is that the cost of getting your whole genome sequenced and interpreted is getting cheap enough that probably within a few years, we’re going to be able to do your whole genome for the same cost as Myriad charges to do these two genes. And there’s a lingering question out there: Is that an infringement of their patent or isn’t it?
THE MARK: What do you think the court’s decision should be?
COOK-DEEGAN: Well, I don’t think that the courts are going to say that you can’t patent DNA at all. My personal view is that that’s right, and I think that in fact there are things that have been done with DNA that are pretty inventive and are pretty close to … an invention and something that’s been discovered that’s very useful. My personal opinion is it’s a bad idea to have these very broad patents that allow monopolies on particular kinds of testing to be established. So in my perfect world we would have gene patents, we would even have diagnostic gene patents, but they would be pretty narrow, and they would be narrow enough that nobody could set up a monopoly.
There would still be competition for testing for this thing or for that thing, and it wouldn’t block full genome sequence analysis. What it might lead to is there are lots and lots of people who are going to have ownership rights. We have to have a way of getting money back to the people who have done something valuable by discovering something that’s really important, but we can’t give them so much money that they get to block somebody else from doing it, or that they get to get in everybody else’s way.
So my solution to this is yes, patents, but they have to be pretty narrow.
Photo courtesy of Reuters.