By CRG staff - Interview with Sandra Park, ACLU

Sandra Park, JD, is an attorney at the ACLU Women's Rights Project.

Was the gene patents suit something that has been in the works for quite a while, or was it Myriad's more recent behavior that really spurred it?

The case was developed over a significant period of time, but by the time it was taking shape, Myriad had already owned its patents for a long time, so we knew how they were enforcing their patents. When they obtained their patents, they immediately sent out cease and desist letters to labs, including a lab right by two of our clients. They immediately took action to enforce their patents in such a way as to prevent other labs from conducting clinical testing.


Have you seen differences in the way that people are viewing gene patents since beginning work on this case?

When patents on genes were first being issued back in the 1990s, there was advocacy organized to try to oppose those patents at the time, and it came largely from the scientific community and allied groups. At the time, though, I don't think that there were legal arguments for why these sorts of patents were invalid, and I think the case has really brought those legal issues-that these patents are for products of nature and therefore should not have been granted in the first place-to the fore. With the lawsuit and the accompanying media attention, there certainly has been greater awareness about the fact that genes are being patented. I think that the scientists who have been concerned about gene patents were on some level not sure how to do any further advocacy on the issue, and I'd say that there wasn't really that much advocacy being done on the issue until the lawsuit came around. There has been a lot of renewed interest in trying to stop these patents from interfering with clinical practice and research.


Do you see that activism still gaining momentum, even after the initial explosion of media coverage around the District Court's ruling?

Well, media coverage tends to focus on specific events, so when the court decision came out, there was a lot of attention-partially because those in the patent world and in biotech were very surprised by the decision. But I wouldn't say the advocacy has died down, and I think that as the case continues through the appellate process, the media will be following it closely. The education that needs to be done on this issue should not just focus on the case. Whatever happens with the case-and I totally expect it to be successful-there are other fronts where people should continue to confront this issue.

You know, media ebbs and flows, and the case has been a galvanizing force for media attention thus far, but other advocacy efforts are being organized. There was the SACGHS report which did get some media attention when it came out in February, making recommendations as to why gene patents should not be enforced, and in Australia there has been a lot of attention on the issue more generally and there have been ongoing advocacy efforts, both through a governmental investigation and a lawsuit that was brought there. So aside from this case, it's an issue that continues to receive a lot of attention.


What kind of patterns do you see, if any, in terms of who lines up for and against gene patents?

The plaintiffs in the case are scientific organizations, physicians, geneticists, researchers, patients, and breast cancer and women's health advocacy organizations; and I think that the amici and our side have really represented the entire medical and scientific community. We have also had some expert declarations, most notably from Joseph Stiglitz, on the economics of patents and why a patent incentive is not necessary and in fact impedes both economic progress and scientific progress on these issues.

On the other side it has been, for the most part, biotech-but a particular segment of biotech. I think part of the reason is that these patents have been issued by the Patent Office for a period of time, and so, from an industry perspective, there's a level of comfort with the status quo, regardless of the merits of the issue. Our position has always been that we actually think these patents impede the kind of research that I think a lot of biotech companies want to do in terms of development of products, and there are new technologies that are being developed that will actually be impeded if you need to go out and get licenses and permissions from patent holders on genes. My take on it is really that those who have come out against the suit are either patent holders themselves or part of the industry, and are just more comfortable with the status quo; but that in fact, if these patents were lifted, it would actually help their industry because there would no longer be impediments to the kind of research and product development that they want to do.


If the plaintiffs win this case, how close does it come to closing the book on the issue? Will there still be a need to draw attention to gene patents?

If the case is successful, it will be setting precedent for many, many gene patents; so while the case is being brought against particular patents, a ruling finding that isolated DNA cannot be patented will affect the other gene patents that are out there. I don't think public education on this issue should be focused on the case so much as on the fact that the Patent Office has been issuing these sorts of patents, and really looking, policy-wise, at why these patents don't serve our health and science policy. I think the case has been a galvanizing point in terms of how to bring this issue to the public and to the media, but I'd like the discussion to be much broader than simply the legal arguments that are being made.


Are there any specific misconceptions you hear repeated a lot, other than just legal arguments, that you would like to clear up?

One argument we've heard is that this case will be the downfall of the biotech industry, and I just don't think that's at all the case. Our goal here is really to lift the monopoly on genes, the central thing needed for research and development to occur, so that's one of the spins on the case I think is wrong.

In terms of public perception, when people first hear about it, I think their immediate assumption is that we're talking about patents on genetic tests, so we've really tried to make clear to people that the patents here are on DNA itself and not on particular tests. The way I think that is made especially clear is the fact that when Myriad obtained its patents on the DNA, they were able to send cease and desist letters to labs that were using different tests than the ones that Myriad uses. It is because their patents are on the actual DNA that they were able to stop labs from using different testing methods to analyze those particular genes.

The other thing is just letting people know that this isn't a new issue-the scientific community has been concerned about it for a long time. It's new in the sense that this is the first lawsuit that has been brought to challenge it, but it's been an ongoing problem. We have learned what the problems are from years of these patents being put in place and being enforced. Because we have had those bad experiences, seeing how these patents affect clinical practice and patient care, it has become even more clear to us that these patents should be challenged.


While working on this issue, I've noticed that certain people on either side of the debate seem to think that no reasonable person could agree with their opponents. So: is there any argument in favor of gene patents where you think reasonable people could disagree?

I understand why patent holders want to protect these patents, but I really haven't seen the arguments to back it up. The thing that I've heard most, and that Myriad has said most in their papers, is that they had to have the patent protection in order to commercialize the patents and spend many millions of dollars advertising the product and educating doctors about the test. I do think it's important for that kind of education to happen, so I certainly agree that it's an important function they have played; but I don't think at all that a patent is necessary for that to happen. Really, that has been the main argument that I have heard, and a lot of the research that has been done on that issue show that patents are not at all necessary in terms of creating genetic tests.

Other than that, the legal arguments have really not been compelling at all to me. It is true that each side sees it in their own way, but what I have found most striking is that the other side really does not want to acknowledge that the Supreme Court has recognized limits on what is patentable subject matter, regardless of whether it is new or useful. There are still limits to what can be patented, even if you are identifying something for the first time or even if you are identifying something useful. When Einstein gave us E=mc2, it was new and useful, but it could not be patented. That's what has been most striking to me, the rejection of that legal principle.

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