Michele Gauger practices in the area of patent litigation, with a focus on the biotechnology and life sciences. She holds a PhD in biochemistry and has practiced on both the defendant and plaintiff side in cases related to noninvasive fetal diagnostics. Cosmologics sat down with Gauger to talk about her experience working on the legalities of this new technology, and the tensions she’s observed between scientific progress and the sometimes conservative perspective of the law.
—Myrna Perez Sheldon for Cosmologics
Cosmologics: You have a doctorate in biochemistry and a law degree. At what point did you develop an interest in moving your scientific training into the legal realm? And is it typical for lawyers in your field to have a PhD in a science; was your route a common one for the kind of law that you practice?
Michele Gauger: It’s actually unusual to have a PhD: there are more people in my field who have master’s degrees, but I don’t see very many with PhDs. It’s nice, because I enjoy a decent niche of work and value, but it’s not common. This is partly because in the litigation work that we do, we’re working with legal principles, and you don’t necessarily need the technical knowledge that a PhD represents.
Cosmologics: Was there a point while you were doing your PhD that you decided to transition to the law, or did you go into your doctorate thinking you might want to practice biotechnology law?
Michele Gauguer: I definitely did not go into my doctorate thinking that I would like to end up in the law. I started my doctorate thinking that I wanted to go into academia, but I found out a few things over the course of my PhD that led to the decision to go into law. I think if you are going to do research and have a lab, you really need to have a question or a field of questions that you are passionate about answering, and I didn’t really have that. I have a real interest in biotechnology and in this field, but there isn’t one area about which I’m so passionate that it could be my whole career. Another thing was that my interest in academia was in teaching, while in the biosciences teaching is such a small component of what academics do. It turned out that the academic route wasn’t going to be the right path for me.
I started looking into other things that I could do. There were a lot of other people who were going in this direction who I was able to talk to, and I realized that biotechnology law was a field where I could add a lot of value. I just decided to take a leap and try it.
Cosmologics: Could you sketch out for us the scope of the things you do, both in terms of the legal and technological fields that you’ve worked in since beginning your career?
Michele Gauger: I’m viewed at as a specialist in biotech—about 70 percent of my work has been in biotech or in pharma-related matters—but in the past year I’ve been doing a lot of work in semi-conductor electrical engineering. That field has some chemistry in it, which is how I connected with it, but it has been a big switch and interesting for me to learn a new field. My work has tended to cycle: for the first three years I was here, I worked almost exclusively on a suite of cases that dealt with prenatal diagnostic technologies; after that, I switched and started doing a lot of work on pharma and corporate diligence.
Cosmologics: What’s interesting to me about your work is the flexibility of topic in terms of technological and legal issues, and the wide range you’ve covered on both sides.
Michele Gauger: I’ve been very lucky to get a wider range of experience. There are certainly lawyers at my firm who primarily enjoy doing litigation, and they do that with almost all of their time. But I like doing a range of things, from patent office proceedings, to district court litigation, to publishing and teaching. Recently, I assisted a partner with a course she teaches at NYU on biotech patent law. I’m fortunate in that I like having a diversity in the things that I do, and I’ve been able to have that in my work.
Now we’re in the position of using a law that didn’t contemplate this technology, and probably doesn’t fit it, but that’s all we have.
Cosmologics: Do you find yourself in the position of working with legal structures that were put into place long before these emerging technologies and are, in a sense, not equipped to handle the questions and issues that arise from these technologies?
Michele Gauger: The law can move really slowly. As questions come up about the legalities of these new technologies, it becomes clear that the law was written at a time when no one could have imagined these kind of fetal imaging techniques, for instance. Now we’re in the position of using a law that didn’t contemplate this technology, but that’s all we have. Since lawmaking takes so long, it will take some time for it to “catch up.”
Cosmologics: So you have to imagine where these technologies might lead in terms of legal implications, without having the ability to actually predict what their future holds?
Michele Gauger: Absolutely. In this context, a lot of questions have come up, as to whether we should do the things that we are now technologically able to do. The law serves as our gatekeeper at these times, and often suggests that we shouldn’t do certain things.
Cosmologics: Can you talk more about the specifics of the cases that involved fetal diagnostics, and your thoughts on the tensions that arise between a technology of this nature and the structure and practice of the law?
Michele Gauger: When I started working on these cases, there were only a few companies coming out with these less invasive diagnostic techniques, but since then they’ve become enormously popular and the field has truly exploded. It was very interesting to see the field from the ground up—working in Silicon Valley, I’m right in the midst of these developments. Basically, these are techniques that allow us to determine whether a fetus has any chromosomal abnormalities based on sequencing of fetal DNA that is found in maternal blood. Importantly, it can be done a little earlier than traditional techniques such as amniocentesis or chorionic villi sampling, and it is also much less invasive.
We were working with the legal implications of the techniques, not the moral impacts, but of course we were aware of the discussions that many people were having when these tests came out. A lot of that discussion centered on the question: what are people going to use these tests for? If you can find out that a fetus has Down Syndrome at ten weeks, what do you do with that information? This moves into the realm of personal decision, and what impact the generation of all this new biological information has on the kinds of decisions that open up for people.
Cosmologics: In other words, when these diagnostic tools give more information, choices are presented to people earlier on in a pregnancy than they would have been a decade ago.
Michele Gauger: Exactly. And even if people don’t take any particular action, just the increase of information can be devastating. If people learn that a fetus has an issue that isn’t fixable, then they can struggle with that information for a much longer period of time.
The law can serve as a forum in which we think through the implications of a new technology.
Cosmologics: In this context, do you ever think about the law as a check on, or a conservative force for science? What do you see as the ethical ramifications of that?
Michele Gauger: We’re taught that laws reflect our morals, and that what we feel are our moral obligations to each other. The law is a reflection of what we think is right and wrong, and where we draw lines between what we can and cannot do. We say that we have freedom of speech, but we draw a line somewhere. The law in its idealized form reflects where we draw those lines, and because the law moves quite cautiously, it has to be conservative. But I think that this can be a good thing: there’s such a rush to see the possibilities of scientific progress, but I think that the law can serve as a forum in which we think through the implications of a new technology. Even if we decide to go forward, at least we’ve attempted a collective process of review. I think that’s very important.
A lot of scientists feel—and I don’t blame them for feeling this—that if we can do this, then we should do it. I don’t think that is necessarily true. Many technologies are developed on a research scale at a university. That process is very different from commercializing a technique and making it widely available. It’s important to remember that these technologies are geared toward commercialization from the beginning, because that’s how you get money to do the research in the first place.
Cosmologics: How would you respond to critics who are concerned that these fetal diagnostic techniques are eugenic in nature—or at the very least, have the potential to be used in a eugenic manner?
Michele Gauger: It’s all about information and what we do with it. Over the history of eugenics, a lot of what it came down to was what people’s definition of “better” was. Some people thought that making everyone one way was better and more desirable. But I think there is a school of thought now that is much louder, that insists that allowing people to be more diverse and different is a better way. We’ll have to see how these techniques play into that tension. It’s very hard to see into the future!
Michele Gauger received her law degree in 2010 from Harvard Law School, where she concentrated her studies on intellectual property and the impact of technology on the law. Prior to attending law school, she earned her PhD in Biochemistry and Biophysics at the University of North Carolina-Chapel Hill, where she was awarded a Department of Defense Breast Cancer Research Program Fellowship. Her dissertation focused on the effect of circadian rhythm disruption on tumorigenesis and cancer susceptibility.
Myrna Perez Sheldon is co-editor of Cosmologics.
Image via wikipedia.