19. From PhD to Partner: Biotechnology and Patent Law w/ Eldora Ellison

In this episode we’re joined by Eldora Ellison, PhD, director at law firm Sterne Kessler and lead patent strategist for the CVC group in the MIT-Berkeley CRISPR patent litigation. We discuss the long and winding road of filing and defending patents, what it’s like to go from PhD scientist to law firm partner, how biotechnology advances are challenging the world of patents, and more!

Links related to the episode:
Careers at Sterne Kessler
U.S. Biotechnology Patent Law by Jorge Goldstein

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Episode transcripts are the unedited output from Whisper and likely contain errors.

Transcript

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Hello, and welcome back to EBRC in Translation. We are a group of graduate students and postdocs working to bring you conversations with members of the engineering biology community. I'm Heidi Klumpa, a postdoc in Mo Khalil and Mary Dunlops groups at Boston University. And I'm Katherine Brink, a postdoc in Megan Palmer's group at Stanford University. Today we're joined by Eldora Ellison, who is a director at the law firm Stern-Kessler in their biotechnology and chemical and trial and appellate practice groups. She's also a co-chair of the firm's patent office litigation practice, and you might know her as lead patent strategist in the CRISPR patent litigation for the CDC group, which includes the University of California. Thank you so much for joining us today. It's my pleasure to be here. Thank you for inviting me. So to get us started off, before becoming a lawyer, you did your PhD in biochemistry, molecular and cell biology. How did you decide to go to law school after finishing your PhD? And speaking as someone who was very happy to leave homework behind after grad school, was it a tough choice to go back? Thanks for asking. So I started thinking about going into law while I was in graduate school. When I had started in graduate school, I was never interested in having a big research laboratory at a big university. I went to grad school because I was interested in becoming a professor at a small college, something like where I'd gone to school, which was Haverford College in Pennsylvania. And while I was in grad school, I got a little bit of exposure to patent law because my PhD advisor, Fulker Folk, was trying to get a patent on the protein that I was studying for my dissertation. And it made me realize that there was a real need for people who could work across disciplines. It made me realize that there was a need for someone who understood the science and could write about the science, but who also understood the law and could serve as an advocate. And so that really piqued my interest because it would give me exposure to a lot of different areas of technology without me having to do bench work. And I found that attractive. And then as I started looking into patent law and talking to friends, and it turned out that friends had parents who knew something about patent law, I learned things like that law firms would hire me with just a PhD and absolutely no training in the law, and that I could become a technical specialist. And I found that to be interesting. And I learned that I was being practical, that law firms would pay my law school tuition if I went to law school at night and worked during the day, and I thought that was attractive after having been in school for so long. So it actually made it not a tough choice to go into law after finishing my PhD. And then with respect to the idea of sitting through four more years of school, because law schools four years ago at night and three years if you go during the day, I looked around at other people who did it, and then I just thought, okay, well, it won't be a lot of fun, but it's doable. People do it. And I'll wake up four years from then and have something to show for it. And so I thought it was worth making that investment in my career. And I haven't looked back since then. Did you find there to be any interesting differences between being a grad student and a law student in terms of how you had to think, how you had to work? It does require a different way of thinking. And it's kind of hard to explain, at least it's hard for me to explain it. I went into law school thinking, oh, this isn't really going to change how I think about things. And I'd actually already been working in the field as a technical specialist for about a year and a half before I started law school. But then I realized as I was going through law school, and certainly by the time I was finished with it, that it actually does impact how you think, even though studying science requires a lot of critical analytical thinking. Law does, too, but just in a somewhat different way. And I will say one thing that I liked about law school is that in a way, it's psychologically easier than getting your Ph.D., because as you know, when you're getting your Ph.D., you never know, there's no set time period for doing it. And so it could be five years, six years, you just you just don't know. Whereas with law school, it's like, OK, well, if I take these classes and I pass them, I will be done in four years. And just having that definitive nature to it actually, in certain ways, made it easier than getting my Ph.D. My mother used to say, she would always ask me, how long will it take you to get your Ph.D.? And I'd say, you know, Mom, there's no set time period. I don't know. It could be five or six years. And she once said, five or six years, in that amount of time, you could have become a real doctor. It worked out OK. Yeah, I'd say so. We understand that there are many different aspects to practicing patent law, so we're wondering if to sort of introduce us to that, could you give us a summary of the life cycle of a patent and then explain what's the part that you work on or have worked on? Sure. And I'll answer the latter part first, which is almost everything that I'm going to tell you about. It's something that I have worked on or do work on. So very typically, an inventor is doing research and they come up with some idea. And hopefully, the inventor is asking him or herself, might this be an invention that perhaps could be protected by a patent or some other form of intellectual property? Let's say they're at a university. Hopefully, they have a good rapport with their university's tech transfer office or if they're at a company with their companies, lawyers and can talk to them about the possibility of, let's say, patenting their invention. And then very often the tech transfer office or in-house counsel will conduct some kind of patentability analysis. And that can include, at a minimum, things like considering whether the invention is something that's new or novel, considering whether that invention would have been obvious or not obvious in view of other things that came before it. These are part of the legal requirements. And then as a practical matter, thinking about, well, might there be commercial value to it? Because as I always point out to people, patents are guaranteed to cost money. They are not guaranteed to make you any money. So some tech transfer office or in-house counsel will make some determination as to whether it makes sense to move forward with filing a patent application on the invention. And then a lawyer or a patent agent, and I can explain what a patent agent is in a minute, a lawyer or a patent agent will draft a patent application. And patent applications look a lot like scientific papers in certain respects in that hopefully there's some data that the inventor can include in the patent application. But then there's also a lot of kind of legalese and legal jargon and legal requirements that are also included in patents. And once that patent application is prepared, and it could be many, many pages long, or it can be relatively short, but usually long in the life sciences, that's filed at the US Patent and Trademark Office. And it may ultimately be filed internationally to pursue patents around the world. And in almost every instance, there's more to the process than just that. So then the patent office, certainly in the US, almost always initially rejects the application for patent and they say you haven't adequately described your invention or you're claiming too much or your invention would have been obvious in view of what came before it. And so there's some back and forth arguing that can go on for years between the lawyers and the patent office as to whether the invention is patentable. Maybe some aspects of the patent need to change, maybe instead of trying to seek patent protection on a very broad scope of things, maybe the inventors will pursue more narrow patent protection. And then hopefully the application will issue as a patent. Sometimes in that process, you actually have to appeal the patent examiner's decision to a panel of administrative patent judges, basically to overrule the examiner, or hopefully eventually a patent will issue. And then that's not usually the end of the story either. Under the law these days, the patents can be challenged by pretty much anyone who wants to challenge a patent. And so there are proceedings known as IPRs, which stands for Interpartes Review Proceeding or Post-Grant Review Proceedings, where someone may challenge a patent in a proceeding at the patent office. Or there could be lawsuits in, I say or, but it's really and or, there could be lawsuits in United States federal district courts, you know, you may sue someone for infringing your patent, or they may sue the patent owner and say things like, oh, I should be named as a co-inventor on this patent and you left me off. Those cases can last from a year and a half to several years or even longer. And those decisions can be appealed to a higher court called the Court of Appeals for the Federal Circuit. And if you don't like that decision, you can try to get the Supreme Court to take the case, but they take very, very few cases, I think, as we all know. So if I could interject, this seems to be a very long process. And if I'm an inventor, I might want to make some money off of my patent. Is that possible to do at other points in this in this process? Or do you need to go through the whole thing in order to be able to license it? Yeah, actually, I was just going to mention licensing. And so the licensing can occur early on and actually very often in the kind of academic setting, the university tries to find a licensee even before going through this whole long process of getting the patents. And so there can be diligence analyses on the strength of the patent portfolio as part of that as well. And so I've actually been involved in, I think, every single one of those things I've just mentioned to you. Do you have a favorite part? I spent a lot of my time doing handling these challenges once a patent's been issued, either defending or challenging someone else's patent. And I like that quite a lot. So you just mentioned all of these many different stages, all of which you've worked on at one point or another. A large part of our audience is graduate students or postdocs who work primarily in an academic environment, might not have much exposure to the legal or business side of things. What do you wish that inventors knew about the patenting process that they might not always know? I think sometimes they forget that it's important to talk to the patent attorneys and potentially file a patent application before they disclose their invention at a conference or in a paper. Too often, they don't reach out to the patent attorneys until the 11th hour. And of course, that makes it harder to prepare a quality application in time. Well, hopefully our listeners take note. Yeah, and it's also nice when there's data that the inventors can include in their patent application that makes it easier to prepare a well-written patent application and makes it easier to deal with the examiners who are naturally inclined to reject the patent for some reason or another. Is data a requirement for a patent? It's not a per se requirement that you have data in the application, but it can be very, very helpful and very important. Switching back to maybe like some more practical side of things, what does a day in your working life look like? How do you spend your time? I can imagine that there are a lot of different aspects to what you do. So how often do you have to wear your scientist hat versus your lawyer hat versus your business hat or whatever other hats you probably have? I think I wear all three of those hats probably every day. And very, very often I'm wearing multiple hats at once. I would say my work is kind of broken into two general areas. There's the practice of law and then there's the business of law. And I spend a lot of time doing both of those. So by the practice of law, I mean things like meeting with clients, meeting with my team to strategize, reviewing and revising their legal briefs, preparing for hearings or depositions or arguing those proceedings, maybe reading the law, I spend a good chunk of my time doing that because of my role in the law firm though, and because I'm a, you know, a partner in the firm and I serve on our firm's executive committee and compensation committees, I also spend quite a bit of time in the business of law doing things that are both internally directed and externally directed. So by external it's things like developing business, attending and speaking at conferences, serving on committees for different organizations. For internal sort of business of law practice, it's things like mentoring associates, dealing with recruiting and training, being on our executive committee and I'm part of the group that sets policies and salaries for the entire law firm. So there's a wide range of things that someone has to do as a leader of this business because we are a business to have a functional business and I play a big role in that in our firm. That's very cool. Is that something that has changed over time? Like when you started out, were you, I guess, focusing more on the practice of law? And then by being a partner, it's actually more of an executive role. And so the business of law becomes more important. Definitely. So, you know, as a new person entering the field, you're pretty much just trying to learn the law and learn through getting experience and getting experience and trying to handle all the different types of things that we do. When one becomes a partner or is looking to become a partner, you have to start taking more of an external view of the world and think about how are you going to develop business because that's generally one of the expectations that are placed upon partners. And then as one progresses in their career, depending on the firm you're at and depending on your personal interests, you may take more of a role in terms of chairing a committee within the firm. So for myself, I chaired our firm's diversity committee at one point in time, our firm's professional development committee. And then I became a member of the firm's executive committee. And by virtue of being on their executive committee, I'm on compensation committee, so I'm involved in setting compensation for all of the partners and setting salaries for everyone in the law firm. So yeah, it definitely changes over time. No one would let me do that if I were a first year associate. That's a lot of responsibilities. Yeah, it is. And you know, these things are important for having a great workplace. So pivoting a little bit away from the sort of day-to-day aspects of what you do, what cases in biotechnology have caught your eye in recent years? And are there any cases that you have worked on that you found to be particularly interesting or important to you? So there are cases such as one's called Amgen v. Sanofi, another one's called Juno v. Kite, and these are cases that get at the issue of what does a patent applicant have to disclose in their patent application to be entitled to their patent claims, patent claims are the parts of patents that precisely define the invention, kind of like the property lines on a deed, the patent claims carve out what exactly is the invention that you're protecting with your patent. And so it's been challenging for people, especially in the life sciences where I practice, it's been challenging for people in recent years to convince the courts that they have adequately described the entirety or full scope of what they are seeking to claim in their patent. And this is particularly challenging for technologies like therapeutic antibodies, where maybe the clearest way of describing the invention is to describe it by its function, like an antibody that binds to a certain protein, as opposed to describing all of the relevant antibodies by their structure. It's been challenging. These are cases that the Supreme Court may take up and consider because the innovators often feel that once they've made the key connection in biology as to what is the key protein, a target to treat your cancer, if they can only claim one single antibody as opposed to a class of antibodies, for example, they feel like they are not going to get adequate patent protection. And so there's real dispute in the law these days about what's necessary in this regard. That's really interesting, the focus on function. One way that I think about biological molecules being similar or different from one another is with their sequences or their structures, like you said, and that seems like it could be a really difficult way to define an invention, because if you make one small change, is it still the same or is it different, right? Exactly. While a lot of times these patent claims may include some structure in them, often there's the question of, did you describe enough of the structure and correlate that well enough with the function of the antibodies or whatever you're claiming to be entitled to broad patent claims on it, or did you not? I think the other part of your question was cases that have been particularly important to me, you know, of course they're all important to me and I wouldn't, I would hesitate to make Sophie's choice as we say about that. But as an example of a case that I was involved in, that I'm rather proud of is our firm handles the patent work for Bristol Myers Squibb on its key cancer drug known as Opdivo. You probably see commercials for that every time you turn on the TV. Those patents were involved in one of these proceedings where another party, Merck in that instance, challenged those patents at the patent office and we defended them and there was also related district court litigation on them involving Merck's drug, Keytruda. Ultimately those cases turned out very well for Bristol Myers Squibb. I think as a result of it, Bristol Myers Squibb received a settlement, an upfront payment from Merck to the tune of $625 million, that's public information, as well as ongoing royalties. And, but the best thing about it is, you know, both drugs are on the market for patients to receive the benefits of them. And while one may think, geez, it's crazy that there should be so much money associated with these patent cases that may be someone, you know, a typical person's initial reaction. I think you have to bear in mind the cost of bringing drugs to market. You know, if you look at estimates of what is the cost to bring a biological drug to the market, you're looking at a billion dollars and up. And so, you know, these companies need to be able to recoup their investments so that they can develop more life-saving drugs. And now, you know, these drugs, both of them are used for many, many different indications. And I think patients are better off. And I'm glad you've played my tiny little part in that. Maybe transitioning to one of the cases that you're most well known for, perhaps to our audience who followed the case closely, is the CRISPR patent case where you represented the CDC group, which includes the University of California in Berkeley. How did you decide to take that case? And can you maybe summarize for us what your main arguments and strategies were? Sure. So first, let me say that cases like that, and frankly, most cases are ones that we actually have to actively pitch for. So I wish it could just be a matter of us deciding whether to take it or not. But to the contrary, it's one where we do a lot of work to prepare and, you know, and to meet with our potential clients, to showcase our technical and legal skills. We were very pleased to have been selected because, as you can imagine, there are many law firms that would have liked to have handled that work. You know, that type of case involved a number of different proceedings. Mostly, people think about fights over who was first to invent the technology. And ultimately, the University of California has some very broad patents in this area. In terms of the legal arguments and legal strategies, a lot of the dispute relates to who was first to invent the use of CRISPR technology in eukaryotes. And we tried to showcase to the judges that the CDC inventors, Dr. Doudna and Dr. Chappentier and our colleagues, Martin Genick and Christoph Chalinski, really were first to have described in both their patent applications and in their laboratory notebooks and other records that they had invented the key aspects of this technology. I think the scientific community certainly recognized it by awarding them the Nobel Prize, which they most certainly deserved. And I think most people in the field recognize that once the Doudna and Chappentier team announced their invention, everyone else rushed in to try to just do these experiments in eukaryotes. And obviously, it's changed the world. Yeah, something that I was curious about when you talked about patent law, you did describe this sort of like long process of even though the inventor thinks they know what they've invented, they might have to explain it to USPTO several times and then other people might have a different idea about what they've invented. And it seems like the CRISPR case also went on for a long time. Was it hard to find a new angle in like it seems like that's what's like a big part of what lawyers have to be good at doing, like thinking about it from multiple angles. I don't know. Is that a challenge and how do you approach it? Yeah, you certainly want to take a 360 view of any set of facts that you're handed, because, you know, the key activities that relate to that case occurred literally 10 years ago, 2011, 2012. And so, you know, you have to take a close look at things like laboratory notebooks and emails and think about not only how do you want to view that set of facts, but how will a judge view it, how will opposing counsel view it? And so cases like that tend to have really large teams of lawyers. And when I say large, I mean, dozens and dozens of lawyers who are working on the case and, you know, just bringing every potential angle to the analysis. And by the way, it's still going on. It's not. How large is your team? And I guess you're still working on it or? Yes, those cases are still going on. The teams, I won't say the exact number, and actually, I probably couldn't tell you the exact number, but it's dozens and dozens because there are many different stakeholders who have interests and there are many different law firms who are involved and there are lots of lots of brain cells working on those cases. Sounds like a very complicated, complicated situation to be in. And my understanding is that the way that patents are aborted has also changed in those 10 years away from being a first to invent or a first to file, is that right? Could you explain the difference? Yeah, that is that's absolutely correct. And so up until 2013, patents that were newly filed were intended to be awarded to the party that was first to have invented the invention, irrespective of when their patent application was filed. But in 2013, the laws changed such that now the patents are intended to go to the party that was first to file. The US had been really different from the rest of the world in this regard with the first to invent system. And so when the laws changed roughly 10 years ago, it brought the US more into harmony with the rest of the world, with the emphasis being on who's first to file. You could debate whether that's a good thing or not, particularly if you're a university or a smaller company that has fewer resources than some large entities that may be able to get their patent application on file faster. But it is what it is with the laws now. You mentioned that there are also international patents. Is that a part that you also work on or mostly in the US patent in space? Most of the applications that we are involved in do have an international component. Like most of the US attorneys, I'm not licensed outside the US, so we work with lawyers who are licensed in their various jurisdictions. Very cool. Well, we already talked about one evolution in the patent system from the first to invent to first to file. And engineering biology is also changing all the time as new inventions are coming out, new discoveries are being made. What do you think the biggest challenges to patent law will be as biotechnology continues to advance and do you foresee a particular type of technology on the horizon that might really shake things up? So in addition to the legal challenge that I was mentioning earlier about adequately describing the invention to get adequate patent protection, another area where that's challenging is I think we all see that big data, computers, artificial intelligence, machine learning are becoming increasingly important in the life sciences as well as in every other area. And without going into excruciating detail, it can be very difficult under the current set of laws to be able to get patents on developments that at their foundation are really based in, let's say, machine learning and these kind of intangible technologies and developments. And that's because the patent laws, as they're often applied these days, deem that kind of subject matter not to be eligible for a patent. And so that's frustrating. If you talk to people in the field, they're trying to get the laws to be changed or clarified or at least brought in to encompass these types of important innovations, but I think that's a challenge that we're going to continue to see for a while. Are there specific ways that you would change the laws to be able to address that challenge better? Yeah, I don't know if I can articulate at this moment what that would be, but I personally find it unfortunate that the law precludes some really cool innovations like that. So like, as one example, years ago, I worked with an inventor who had discovered that instead of necessarily having to do amniocentesis and having a large needle stuck into the belly of a pregnant woman, you could take a small DNA sample and look at the fetus's DNA because the fetus's DNA was found in the mother's bloodstream and that fact and that invention and discovery was found not to be eligible for a patent. I think that's a shame. I think it's, you know, life changing, but under the same kind of legal principle, at least the way those patent claims were drafted, it was deemed not to be patent eligible. So I would try to find a way that makes it easier to get diagnostic patents for companies because entities, because it really is an innovation that I think the Constitution really should try to protect or it was meant to protect when the Constitution said, you know, secure for inventors exclusive rights to help promote innovation. So along those lines, what are some things that scientists might think they would be able to patent, but that in reality, they probably can't? So I'm thinking along the lines of what you were just talking about with this type of discovery or, you know, maybe like a naturally occurring organism that you would isolate. What are, what are some other examples of that? People can run into trouble with computer software and you may need some very sophisticated software as part of a diagnostic method or you may discover some correlation that exists in biology and try to claim it as a diagnostic. And you may have real difficulty doing that given the way that the laws are applied at the moment. Yeah. It seems like we've really had to, or like when I think about maybe the history of biological patents, our understanding of what is patentable, like the idea like, can you, can you patent a gene versus a protein versus like an antibody that you engineered or like something that you discovered that's naturally occurring, it feels like we didn't fully understand biology, which maybe made it hard to write laws about what, what could or could not be patented. I mean, or do you think that's fair? Yeah, I think, I think we haven't gotten it quite right. I can understand that you don't want people to be able to patent things that just purely exist in nature because they shouldn't have the exclusive right to something like that. But on the other hand, again, it's, it can be very challenging to get diagnostic patents as an example, uh, under the way the laws are currently applied. And I just feel like there's, there's room for improvement in this regard to continue to promote innovation. Taking it in a slightly more personal direction, I double majored in English and chemical engineering in college. And so I thought about going into law as a way to use both of my degrees, but wasn't sure if I would enjoy it or if I had the right skills. So I was curious, what would you say to maybe people like me who are trying to figure out like if law would be a good fit or what kind of skills do you think are necessary to do the job well? So I think that's actually a great background for doing this kind of job. Well, again, we spent a lot of our time reading about science, writing about science, combining that with advocacy. A lot of what we do is in writing. Um, so being a good writer is very important. It's a very deadline oriented business. So if you like deadlines, uh, it's great. It certainly can help counteract procrastination. A lot of times we work in teams, uh, depending on the type of work one does, it can be large teams or it could be much smaller teams. Obviously you have to have a tech, the technical aptitude to become a registered U S patent attorney, meaning to be someone licensed to practice before the U S patent and trademark office. You actually have to have a technical degree or the equivalent thereof to even be able to sit for the patent bar, which is a separate exam from state bar exams. And you can actually become a registered patent agent. In other words, you can become registered to practice and represent clients at the patent office to help them get patents and fight over patents at the patent office, even without being a lawyer. So you don't have to go to law school. You can take the same exam and practice just at the patent office. And some people do this and, um, are registered patent agents as their careers and never go to law school. Um, but I think you certainly need to enjoy the writing and the analytical thinking and the technology and the stress, because it's not, you know, it is deadline oriented, which means there is by nature, some stress associated with it, um, but most of us can manage it. Do you have any particular kind of concrete advice for how to acquire the types of skills that you need to be able to do this job? Well, definitely, uh, having good technical skills is important. Now there are a lot of people who go into patent litigation, who may or may not have technical backgrounds. Um, they won't become registered patent attorneys, but that's okay. They're fighting in district court or at the international trade commission. And I would say though, that those people nonetheless need to have good technical aptitude because there's always technology involved in patent law. Yeah. Learn it, learn as much as you can about different areas of technology and take writing classes and perhaps even public speaking classes, but definitely writing, granted legal writing is different from other forms of writing, but, uh, it still helps to be a good writer and you can learn that in a lot of different ways. Wonderful. Well, thank you so much for coming on the podcast. It's been a pleasure talking with you. Uh, before we wrap up, is there anything that you would like to promote? Um, I will say if you actually really want to dig into patent law and understand it, one of my partners, Jorge Goldstein has published a book, many versions of it on U S biotechnology patent law. Um, so I, um, recommend that it's not your normal copy table reading, but it's for someone who's interested in really trying to understand some of the nuanced legal issues that, um, we were talking about before. And then finally, I'll say, um, for people who are interested in this field, you know, reach out to me and our firm because we look for talented folks. We hire technical specialists who, um, don't have legal training, but who have the scientific background and, um, is up here for you. That sounds wonderful. I'll definitely be checking those things out. Great. This has been another episode of EBRC in translation, a production of the engineering biology research consortium's student and postdoc association. For more information about EBRC, visit our website at ebrc.org. If you are a student or postdoc interested in getting involved with the EBRC student and postdoc association, you can find our membership application linked in the episode description. A big thank you to the entire EBRC SPA podcast team, Catherine Brink, Fatima Inam, Andrew Hunt, Kevin Reed, Ross Jones, Kokesy Lee, David Mai, Heidi Klumpa, and Rana Saeed. Thanks also to the EBRC for their support and to you, our listeners, for tuning in. We look forward to sharing our next episode with you soon.