Explainer Episode 55 – 10 Years On: The Impact and Effects of AMP vs. Myriad

On June 13, 2013, the Supreme Court issued its unanimous decision in Association for Molecular Pathology v. Myriad Genetics Inc. a case that would ban attempts to patent naturally occurring DNA sequences.

Now, ten years down the line with a decade of hindsight, Dr. Roger Klein, who played a central role as an expert, advisor, and spokesperson for the Association for Molecular Pathology in AMP v. Myriad, joins us to discuss this important case. In this Explainer we discuss the context surrounding this case, the debates that arose, and the impact this rule had across the past 10 years.


Although this transcript is largely accurate, in some cases it could be incomplete or inaccurate due to inaudible passages or transcription errors.



Intro:  Welcome to The Regulatory Transparency Project’s Fourth Branch podcast series. All expressions of opinion are those of the speaker.


Chayila Kleist:  Hello and welcome to The Regulatory Transparency Project’s podcast. My name is Chayila Kleist, and I’m an assistant director of The Regulatory Transparency Project here at The Federalist Society. Today, we are delighted to host Dr. Roger Klein for a discussion on the impact and effects of the Association for Molecular Pathology v. Myriad, a retrospective look at this case 10 years on. Dr. Klein, thank you so much for being with us today. We appreciate you taking the time. 


Dr. Roger D. Klein:  Yeah. Thank you, Chayila. 


Chayila Kleist:  For our audience, Dr. Klein played a central role as an expert, advisor, and spokesperson for the Association of Molecular Pathology in AMP v. Myriad. He’s currently a faculty fellow at the Center for Law, Science, and Innovation at the Sandra Day O’Connor College of Law at the Arizona State University. Dr. Klein was formerly chief medical officer at OmniSeq, an oncology focused genomic profiling company that was recently acquired by LabCorp. Additionally, Dr. Klein’s previously medical director of molecular pathology at the Cleveland Clinic, where he oversaw clinical DNA- and RNA-based testing for oncologic and heritable disorders. 


Dr. Klein’s been an advisor to a variety of administrative agencies, including the Department of Health and Human Services, Food and Drug Administration, the Centers for Medicare and Medicaid Services, and the Centers for Disease Control and Prevention. He participated in and assumed leadership roles in a variety of professional society committees and corporate advisory boards. And he’s a policy advisor to the Heartland Institute. He was formerly chair of the Association for Medicare Pathologies Professional Relations Committee. Dr. Klein’s licensed to practice medicine in Ohio, Florida, and New York. Additionally, he’s licensed to practice law in the District of Columbia and Ohio and is admitted to the U.S. Supreme Court bar. 


Now, while there’s more to say, in the interest of time with that summation of Dr. Klein’s impressive resume, I will leave my introduction there and let us get to the meat of today’s topic. That said, if our audience would like to know more about Dr. Klein, please feel free to visit regproject.org and read his impressive full bio. With that, however, we’ll turn to our discussion. 


Before we dive into the details of this case and its impacts over the past decade, I’d love to start out by laying out some of the background of this historic case in validated patents on genes. You, Dr. Klein, played an important role in initiating AMP v. Myriad. Could you provide listeners with some background for the case? What were the parties? How did your organization end up taking the lead in the case, and then what problem or issue were you seeing that you were trying to fix?


Dr. Roger D. Klein:  Thank you, Chayila. This is really a great opportunity to revisit an exciting time and an important time in the history of molecular pathology, genetic testing, and the history of the Association for Molecular Pathology. So what happened and the way this got going is we had had a lot of problems in this nascent area of molecular pathology with patents on genes. Many of them involved cancer, testing for diagnosis, or drug relationship and then a lot of patents on inherited disease genes. It’s interesting the way the evolution occurred because a lot of the testing started out in germ line genetics or inherited disease but then moved to cancer first in the hematopoietic malignancy or blood cancer space, leukemias, lymphomas, that sort of thing, and then moved on to solid tumors. We’re really just getting into solid tumors at the time. 


So there had been a number of our members in addition to me who had been pretty vocal in opposing this gene patenting regime under which we were living. I put out a number of papers, and there were some other folks as well. And so what had happened was we had a clear position on the issue, as did other medical — a number of other medical and scientific organizations. And we were approached through one of our former presidents by the American Civil Liberties Union which was also interested in this area. The person who initiated at ACLU was a woman named Tania Simoncelli, a very smart lady who worked in the women’s rights area. 


And so they’re viewing this as a women’s rights issue. We were looking at it as really a freedom to perform medical services on genes. But when they came to us, they approached us and other organizations. And we were nimble, and we were very concerned in part due to the inspiration of Dr. Jeffrey Kant who was my mentor and a close friend and other folks at AMP and our professional relations committee which I joined in part because of this lawsuit I was asked to join the committee. We decided to move ahead. So we were first. 


And once we joined, other organizations then subsequently joined as well: College of American Pathologists, American College of Medical Genetics, now American College of Genetics and Genomics. And then there were a number of physician or scientist plaintiffs who performed clinical diagnostic testing, some of whom had been approached or threatened by Myriad Genetics. There was also I think some genetic counselors, one or more genetic counselors involved in the case, so a range of health care professionals and organizations. AMP is first. 


And what we were really trying to prevent is what we saw as an error in the patent system, a mistake that didn’t allow doctors or others trained to do molecular genetic testing to perform this testing for our patients because the raw material that we were testing, what we were looking at, the part of the human body that we needed to look at was patented. So we couldn’t move ahead. So it was really a freedom to operate issue for us. It wasn’t so much economics. 


The Association for Molecular Pathology is an organization that’s grown considerably but had maybe 1,500 members at the time. I think we’re over a couple thousand. And these are professionals of physicians and PhDs. Most of the physicians are pathologists with molecular specialization and doctoral folks who work primarily in academic medical centers. And so the plurality of our constituency and focus really are people who are working at major academic centers and other academic centers, hospitals in order to provide testing as a service to patients. And again, we’re just getting started in the field, so this was extremely important to us and to our members. 


Chayila Kleist:  Got it. Thanks for that background, so the personal and institutional history of the case. Turning to the case itself, can you tell us some of the procedural history of the case? How did the case end up before the Supreme Court, and what was the legal issue at stake? 


Dr. Roger D. Klein:  Yeah. So what had happened was — so we filed in a district court. I believe it was Southern District of New York. And we won. Amazingly, we won. 


Now, I’m going to tell you that this case was perceived to be a heavy lift at the time. The entire patent community thought it was not — didn’t even take it seriously and thought we had no chance at all. In fact, I was at a meeting with a group of folks, and it was more of an industry type meeting. I was representing AMP. And somebody asked the question — they raised the hand when a patent lawyer said how many people think that AMP has a chance in this case. And I was the only one who raised his hand. And I really raised it out of loyalty more than out of believing because everybody said we had no chance. 


But we went to the district court, and we won. And we won clearly, handily. What happened was — and there were a number of other issues. And we sued FDA and some other groups. But the bottom line was was a patent on human DNA a patent on a natural phenomenon? And the Supreme Court has crafted a judicial rule in the patent sphere. It’s very, very longstanding that natural products, natural phenomena, natural laws are excluded from patentability. They’re not what’s called patent eligible. To obtain a utility patent in the United States you have to be novel, nonobvious, and useful. And then you have to describe the invention. But there is this carve out or exclusion for natural phenomena that’s judicially created. It’s not in the statute. 


And what happened was the judge went with us. I submitted a declaration. A number of other people in the field submitted declarations, and we won. So of course we were thrilled. And then we went up to the Court of Appeal for the Federal Circuit. 


Now, that’s a dedicated patent appeals court in the United States, which was at the time regarded as very pro patent. There was perceived to be a heavy bias towards patent eligibility, and it was thought we probably wouldn’t do very well. So we went there, and we lost. 


So we lost two to one, and one of the judges, a guy named Bryson, was quite perceptive because his statement really was we’re in the process of doing large scale sequencing. We haven’t really gotten started, but we’re going to get going with this. And allowing this patent would give Myriad Genetics, who was the owner of the patent that we sued — we didn’t have any particular gripe with Myriad per se as a company. It was really a question of gene patents, and they were the logical target. But anyway, he said this would award Myriad greater benefits that would be consonant with what they’d actually discovered so that while they did a lot of work and they discovered something, this would kind of give them control over this large scale sequencing. 


But his view lost in the appeals court. One of the other judges said, well, you know, if it were a de novo issue, I might say that it was not patent eligible, but there’s all this reliance interest. And there’s so many of these patents. And then there was another judge who was very convinced that — who had a chemistry background His name was Lourie, and he was very convinced that any chemicals that were isolated and purified should be patented. And DNA’s a chemical, so it should be patent eligible. 


Anyway, we went up to the Supreme Court. Well, first, what had happened was the Supreme Court decided Mayo v. Prometheus that we’ll talk about later and then sent — we appealed to the Supreme Court. And they sent our case back for rehearing in light of the decision in Mayo v. Prometheus. The Court of Appeal for the Federal Circuit once again did exactly the same thing. And so it went back to the Supreme Court really with the issue as being are human genes patentable. That was really the issue. 


Now, from a legal standpoint, what we’re really talking about is, again, patent eligibility under Section 101 of the Patent Act. Are human gene sequences, which is what they are, and to some extent associations between sequences and physical properties — are these the type of processes — are these the type of things that are actually eligible for patenting? And so that was really the debate at issue. 


Chayila Kleist:  Got it. And what was the eventual decision? 


Dr. Roger D. Klein:  Yeah. So we were thrilled, and the eventual decision authored by Justice Thomas was a nine to nothing victory that human DNA sequences were not patent eligible. And I got to tell you we understood this — there’s this long running debate, for example, with Judge Lourie in the court of appeals who kind of viewed DNA as a chemical. So to him he’s a chemist. It’s a chemical. It’s not like any other Taxol. That’s a drug. You find an aspirin. You find the drug. You purify and isolate it, and you can patent it. And that was how he was looking at DNA. 


But of course, the key to DNA is its informational content. DNA isn’t just a physical item. DNA is software. It’s a store of information. It’s memory and software. It’s a code that really provides the blueprint for the human body. And the whole key is in the sequence. It’s not in — as long as the sequence is maintained, the information is there. And so you have fundamentally the same item whether you take it out of the body or you don’t take it out of the body, whatever you do with it. But anyway, Justice Thomas and the other justices got it. And they focused and honed in on this and gave some very cogent arguments as to why it shouldn’t be patent eligible. And again, we were just thrilled with our 9-0 victory in the case. 


Chayila Kleist:  Fair enough. Well, you mentioned there was an ongoing conversation at the time. To many people in the present day, it might not seem surprising that the Supreme Court would find that human genes can’t be patented. Yet, the case when it was decided as you noted caused considerable opposition and controversy. What stakeholders weren’t happy with the Court’s decision and why? 


Dr. Roger D. Klein:  I will list as — this is a really important point, and I think there’s even some history to it, which I think we’ll get into. But one of the obvious and essential parts of drug development, biologic development, etc., is very, very strong intellectual property protection because you’re investing perhaps even billions into bringing a drug to market. So the biotechnology industry, which wasn’t really using genes per se as patents or as drugs but did have a lot of interest in patent eligibility of biological processes in not only pharmaceuticals but also in, for example, agriculture and vaccines — they’re always looking for the broadest range, the strongest intellectual property that can be possibly awarded. And so bio in general, they were in opposition. 


Now look, testing’s part of biotechnology, too. And in fact, we had some small biotech testing companies on our side. But the organization BIO, it’s very influential and important and actually I think an excellent organization — has been in opposition to it. So that was one of the major ones. 


There’s some other people in the field or in the area who had themselves been able to obtain patents on genes which they could have monopolized. Of course, they had an economic interest in trying to preserve the system. But I think the primary opposition that we had focused on did come from the biotechnology industry. And if you talk to scientists, even folks who work in biotech companies and in the area, it really never made sense to anybody that these things were — who’s in the field who was looking at it objectively, it really didn’t make sense. We had wide support across the scientific community for the proposition that these were fundamental materials of life and shouldn’t be patent eligible. 


But there was a strong economic interest and also I think a legitimate interest in the biotech industry and particularly in those areas about which I’m speaking, pharmaceutical type products which are called biologics and agriculture, to be able to firmly protect what are real inventions. They’re genetically modifying things, or they’re doing things that create — that are innovative and that are inventions and that require intellectual property protection to bring to market. 


Chayila Kleist:  Got it. And for our audience, if anybody’s interested in biologics, I’ll quickly plug another podcast Dr. Klein did with us on biologics, biosimilars, and their impacts. But back to the topic at hand, you’ve mentioned some of the private parties that had incentives to keep human genes patentable. But this is a court case interpreting the law, so I’d also love to know was there any feedback on this decision from the other branches of government. 


Dr. Roger D. Klein:  Well, at the time, no. What I would say is — and I think we can get to that a little maybe later in the discussion. I think there are currently — actually, maybe I’ll talk about it now. At the time, the Solicitor General was a guy named Neil Katyal, who actually I went to law school with at Yale who was a couple years ahead of me. I didn’t really know him. I met him during that case. But he was part of the Obama Administration, and they were supportive of our position. So we had the White House mostly on our side, not 100 percent in all the ways we were seeing it. But by and large, they were on our side. And we didn’t hear much elsewhere. 


Now, people didn’t think we were going to win. So after the decision came out, subsequently there was of course a lot of complaints. And I participated in a number of sessions. Hans Sauer from BIO who was in charge of their intellectual property in this area and I used to occasionally have pleasant debates about the subject and even one recently at AMP. 


But what’s happened in the transpiring years is there have been bills introduced in Congress that would change Section 101, which would give courts less leeway in terms of using, for example, natural product, natural phenomenon, natural law exceptions and more clearly define the statute. For one thing, it would overturn AMP v. Myriad. It would also overturn Mayo v. Prometheus, which we’ll get into, which in my view would be really just a very damaging thing for the field of genomics. We’re just getting started with trying to sort out all the information, understand it, learn about it. And the last thing we need is effective patents on basic raw materials that would completely obstruct and inhibit the freedom to operate, to learn, and for people to provide testing to patients.


 So my hope is that if something ever does come through—this legislation hasn’t gone anywhere—that it would be narrowly crafted and carefully written so as to provide the distinct type of protection that after analysis is determined to be required rather than coming in with some sort of broad sweep and taking the whole biotechnology area, the whole much larger than even biotechnology software, etc. Rather than sweeping all of that into a rework of the entire statute, rather they would define what if any problem exists. I think there may be one. I do hear from biotechnology that there are specific areas in which they could use protection. It would be best if they would target any future legislation toward where there’s perceived to be a problem rather than trying to recreate the environment that existed prior to the AMP v. Myriad and Mayo v. Prometheus decisions. 


Chayila Kleist:  Got it. I appreciate sort of the laying out of some of the private parties as well as the actions that have happened since then. Continuing on on the conversation around the case — and we’ll get to the impacts in sort of the last decade. But around the time of this decision, some argued that the Court was departing from decades of precedent. How does AMP v. Myriad fit with the previous Supreme Court rulings about patent eligibility in biotechnology?


Dr. Roger D. Klein:  Yeah. So in my view, that’s a misreading of the law. I mean, if you look at — first of all, let’s start off by saying that the Supreme Court in the United States doesn’t take a lot of patent cases. It’s pretty infrequent. It’s rare. We didn’t know that we — we were looking toward it when we filed the case. We didn’t know that we’d get there. It was a long shot. 


And the Court goes through periods where they seem to be relatively stronger for patent eligibility. They appear to favor patents more. And sometimes they appear less. It’s sort of hard to make strong generalizations because they take so few cases. 


But that being said, they’ve never taken a case on DNA patenting, and a lot of the current regime, the regime that existed at the time stemmed from a case called Diamond v. Chakrabarty, which was a 1980 case in which essentially I think it was with General Electrics was trying to develop a biological solution to oil spills and genetically engineered a bacterium to eat up oil, to eat up hydrocarbons. And when they went to patent it, the patent was rejected because the Patent Office said you can’t patent a living organism. 


And so that went up through appeals and got to the Supreme Court, and the Supreme Court ruled that, yes, you can patent manmade things where human intervention changed the living product to create essentially a new one. That would be patent eligible. And they used this — they have the same misquote, anything under — that I think came from a — it may have come from the legislative history. But it was popularized for the Court was “Anything under the sun that’s made by man can be patented.” And this set off really a strengthening of the intellectual property regime. 


Now, some other dynamic occurred at the time. We were really — this is 1980. We’re coming off the horrible 1970s, terrible economic time, particularly in the late 70s. And there was a decision to try to do — I think people recognized some changes needed to be made in a whole bunch of areas. But intellectual property was one of them, and in particular, biotechnology was coming on. So they had some other areas that stimulated it. They passed Bayh-Dole, which allowed universities to patent. They created the Court of Appeals for the Federal Circuit in 1982, which was a patent specific court which ended up to be a court very knowledgeable and specialized but then very pro-patent. And really what the Supreme Court does is they sort of step in now when they feel that it requires a generalist look when they feel that the specialist court has sort of gone maybe away from what the law really is. 


So anyway, so this statement that it reduced or was contrary to years of precedent really isn’t true in the sense that what we did have were a few lower court decisions that had historically allowed patenting of isolated purified chemicals. They never ruled on DNA or anything approaching it, and in fact, you can’t patent mathematical algorithms. You can’t patent pure software, and it has elements of that. 


So I would argue especially going to — if you go to the Prometheus case which was decided — it’s very consistent with Prometheus. And I think if you read Justice Breyer’s opinion that was also 9-0 authored by Justice Breyer — if you read his opinion, I think it gives a very good history of how the determination is made between what’s a natural law. It set up sort of a two part factor. Is it a natural law/natural phenomenon? And then what do you need to do to transform it into something that would be patent eligible? Because everything — natural laws underlie everything. The question is are you patenting the law, or are you patenting something new that was really a human invention? And the idea was what do you need to do to make it one. 


I thought Justice Breyer fit it really in beautifully that decision with past precedent. Nothing was overruled. Nothing was reversed. And AMP was really right in keeping with that decision a year later. That was in March, I think, of 2012. AMP was on June 13 of 2013. 


Chayila Kleist:  Got it. And just to clarify, Justice Breyer was the one who wrote the opinion in Mayo Collaborative Services v. Prometheus Laboratories which is the one decided a year prior, yes? 


Dr. Roger D. Klein:  Correct. Justice Breyer wrote the Prometheus, and Justice Thomas authored AMP v. Myriad, which ought to say something. These are two justices not a political case but from opposite ends of the judicial philosophy spectrum. And both saw it the same way. And actually, every justice voted 9-0 on both of these cases. 


Chayila Kleist:  Wonderful. With that helpful breakdown of the context of the case, of the case itself, part of the reasons we’re talking about this today is that we now have 10 years of hindsight. We’re approaching the sort of decade mark on this case, and it seems like a good time to look back at the aftermath and impacts of this case. During AMP v. Myriad and after, I believe there was considerable discussion on the potential effects of this case on innovation, particularly in clinical diagnostics and personalized medicine, also referred to as precision medicine. Before we go into some of that, for listeners who may not be familiar with these terms as well as myself, what do people mean when they talk about personalized or precision medicine? 


Dr. Roger D. Klein:  Yeah. So what you’re really — the contemporary term, it’s really jargon, personalized or precision medicine. But what we’re really talking about in today’s world is looking at and guiding treatment, looking at diagnosis, looking at the prognosis but through the use of genetic biomarkers, so looking at genetic change and giving a drug to treat a cancer based on the genetics of the cancer rather than the type of cancer it is. It’s not just breast cancer; it may be HER2 positive breast cancer, this kind of thing where you’re really trying to use genetics or genomics, biomarkers, to individually tailor treatment or therapy. 


Ultimately, it’s going in the clinicals space will be broader and involve proteomics, which is proteins in combinations. But that’s what it is. It’s trying to craft — make diagnoses and craft therapies and estimate the course of disease based — and actually I should even add who will have side effects or respond to medicines based upon the individual profile. So that’s what personalized or precision medicine. Precision tends to be more directly related to therapeutics. 


Chayila Kleist:  Got it. Thank you. I appreciate that context and background. Moving to the impacts of this case, especially given the events of the past couple of years, it seems it’s hard to be a consumer of news from whatever news source without regularly hearing something new about genetics or genomics. You mentioned in an article published in the Journal of Molecular Diagnostics around the time of this decision and I think you actually mentioned earlier in this podcast that we were standing then at the cusp of the clinical adoption of large scale gene sequencing. In the intervening 10 years, what has happened in gene sequencing and other genomic testing? How did the result in Myriad enhance or detract from these developments?


Dr. Roger D. Klein:  Yeah. This is such a great question. So at the time of the decision, a lot of our testing was still really looking at a gene at a time, looking at a mutation at a time, and very small scale. And we had had what’s called the Human Genome Project—some people may have heard of it—where it costs a couple billion or more to sequence an entire genome. There was a public effort, private effort. Well, it has progressed to the point in large measure because of this decision and the Mayo decision, these critical decisions that formed the basis for the freedom to move forward — we are now sequencing genomes clinically for real patients, babies in a NICU, in a very short time, within 24 hours very inexpensively. 


And there are new technologies continuing to come out. We’re talking about doing a whole genome, for example, for maybe $250, $300 when we were talking about $3 billion around the year 2000 when the genome came out. And on a regular basis, thousands and thousands of tests in cancer are performed each year, hundreds of thousands — probably millions of tests which are potentially implicated by these patents are performed each year. We regularly sequence tumors for large numbers of mutations all at the same time. You get a very little biopsy specimen. You look at all these different mutations that could potentially result in a drug therapy all at the same time. 


This has exploded. The molecular pathology field, the idea of molecular genetics, we do exomes, which are looking at all the coding regions, all the genes at one time, routinely on a regular basis, thousands performed each year, thousands of genetic tests performed for inherited diseases of all kinds, rare ones, more frequent ones, for cancers, for unusual diseases. In advance tumors where people have the tumors that spread and they’re needing to rely on certain targeted therapies or immunotherapies where you harness the body’s immune system, these are all selected or often selected by tests that are genetic sequencing or other genetic marker tests that would have potentially been not available. We wouldn’t have been able to move ahead had people been able — had individual entities been able to own these genes and to own the relationships between the genes and their impacts on disease. 


Chayila Kleist:  Got it. Thank you. Speaking of the events of the past couple years and of testing, during the COVID era millions of people regularly obtained tests for the responsible virus, SARS-CoV-2 and received vaccines that were widely known to be comprised of mRNA. How have diagnostics and mRNA treatments, including those used during the recent pandemic, developed in a post Myriad world? And how could they have looked different had the decision gone a different way? 


Dr. Roger D. Klein:  So we’re speaking primarily about genetic diseases, inherited diseases, and cancer. But molecular techniques, molecular diagnostics are used in many other places, including infectious diseases. And the argument for example that diagnostics would be impeded or harmed by not having these gene patents is obviously wrong given the explosion that we’ve had. And COVID I think illustrates that really well. COVID’s a virus, and it’s a nucleic acid, a gene sequence. It’s a couple of genes and some proteins. That’s really what a virus is. So when this epidemic hit rapidly in just a matter of days they sequenced — they were able to establish through sequencing a sequence of this virus. 


Now, had the prior patent regime been in place, it’s conceivable that somebody could’ve patented that sequence and completely monopolized testing. We got off to a slow start in the U.S. in testing. I can refer also back to a podcast that we did at the time on COVID testing at FedSoc for anybody who’s interested. But once we got going — and that was more of a regulatory issue. Once we got going, testing exploded. And there’s never been anything like the millions and millions and millions of COVID tests that were performed during this epidemic developed in such a short period of time, so many different tests of high quality. 


Now, the PCR test, the gold standard COVID test for SARS-CoV-2, that used a method called PCR that is legitimately patented. Kary Mullis patented it in the 1980s. He won the Noble Prize for it. That forms a basis for a lot of the molecular tests we do today. But I think the important point is that the method was — the patents have expired, but the method — the original patents have expired. But the method itself was important, that PCR, in allowing us, teaching us how to be able to test for millions of COVID tests accurately and specifically so we were getting the right answer. 


But we weren’t patenting the COVID sequence. If you patented the COVID sequence, whoever owned that could prevent anybody else from testing for it. And really there were lots of different tests, lots of different ways to test people at different regions that they tested. And it was very important to preserve that freedom. 


Now, you can extrapolate that experience across the diagnostics world. And really, as long as the basic materials aren’t patented, as long as they’re not patent eligible, people come up with all sorts of innovative and new methods that continually advance and move forward. But it’s that argument that the raw materials — patenting the raw materials, getting too far upstream, what are really biological phenomena or relationships, that becomes an impediment to going forward because people can’t innovate, and people can’t develop new things. 


But diagnostics have done wonderfully well, and I think our real shot in the arm came during COVID. If there’s a silver lining to such a horrible event, it is that there was a renewed understanding and emphasis on the importance of diagnostics and how critical it is to be able to have reliable diagnostics produced and inexpensively offered. And so I think it’s kind of rejuvenated the field quite a bit because people are now much more attuned to its importance. 


Chayila Kleist:  Got it. I appreciate sort of the context and tying it to something that is very tangible and practical and in recent memory. You’ve touched on diagnostics, including sequencing and companion diagnostics in subsets. And in our conversation before our recording, you noted that among the areas affected by this decision were big data, bioinformation, bioinformatics—I know I’m butchering that time, apologies—and drug discovery. Could you as we’re wrapping up this segment on the impacts of this case cover a couple of the advancements in these areas that have happened over the past decade that may have been encouraged by the decision in Myriad


Dr. Roger D. Klein:  Yes. I just have to speak for a few minutes broadly about this because it’s so critical. We’re hearing in the news every day about AI, and we’re hearing about big data. Well, one of the things that enabled the sequencing to advance once the barriers, for example, of patents on individual genes were removed was the advancement in computing technologies that allowed these instruments to handle all the data that was generated and converted into what’s more or less an understandable result. 


But we still don’t know most of what, for example, the genome means. Most of the information we get we don’t even know what it is. We don’t know what it means. We don’t know how to use it. We’re just scratching the surface, and there is a whole industry — it’s a whole ecosystem built around this trying to understand what data means and then how to use it to better people’s lives, to improve medical progress. And this goes from drug discovery, drug development all the way to diagnostic testing and combinations of markers and parameters — we’ll get into proteins as I mentioned earlier. And these new techniques, these new computing bioinformatic, artificial intelligence, these new powerful technologies will allow us to make better use of this information. 


And none of this could have happened, again. In this area, we wouldn’t have been able to move forward had all these — 20 percent of the genome was patented at the time we went to — 20 percent of known genes were patented at the time we filed the Myriad case. And it’s impossible to overemphasize how important and significant Myriad and Mayo were. 


We didn’t really talk about it, but Mayo related to the relationship — Mayo was another diagnostics case that related to the relationships between a marker and the medical property. It was in this case a reference range really for a metabolite of a drug. But those two principles were critical in allowing all of this to move forward. Nobody knew how it would evolve. Now we of course have this new area of artificial intelligence which can combine with genetics and genomics to create new things. Many drugs today, for example, are made with artificial intelligence. 


But still if you’re looking for — how should I say it? Instead of screening zillions of compounds, you use AI to kind of select potential compounds and design them because you can chemically construct drugs. And this interaction, for example, with genomics is critical. All of this couldn’t happen. 


I’ve talked about some of the other events. If you have a kid who has developmental delay or autism, there’s a good chance that they’re going to get an exome performed to try to see whether or not they can identify a genetic cause for that child’s disability. Elderly people with neurologic features — there are thousands, maybe four or 5,000 known inherited diseases. Again, in cancer if you have lung cancer, there’s about 14 markers, genetic markers that we test for. And one sequencing test, you can test them all in one sequencing test. That really do a lot — even in a terrible disease like lung cancer to prolong survival, to give patients more time with their families. So I can’t speak enough about how important these decisions were. And I really do thank you for the opportunity to discuss them with our listeners. 


Chayila Kleist:  Well, we’re grateful for you joining us. I’m happy to wrap the podcast there unless there are any last thoughts on this topic. 


Dr. Roger D. Klein:  No, thank you very much. 


Chayila Kleist:  Of course. It’s fascinating what a decade can do and with 10 years of hindsight how this case has impacted development in some of the key areas of health in our lives. Dr. Klein, thank you so much for joining us today. We really appreciate you spending the time and sharing your expertise and insight. 


Conclusion:  On behalf of The Federalist Society’s Regulatory Transparency Project, thanks for tuning in to the Fourth Branch Podcast. To catch every new episode when it’s released, you can subscribe on Apple Podcasts, Google Play, and Spreaker. For the latest from RTP, please visit our website at regproject.org. That’s R-E-G project.org. 

Roger D. Klein

Faculty Fellow, Center for Law, Science & Innovation

Sandra Day O'Connor College of Law

FDA & Health

The Federalist Society and Regulatory Transparency Project take no position on particular legal or public policy matters. All expressions of opinion are those of the speaker(s). To join the debate, please email us at [email protected].

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