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tv   QA Jorge Contreras The Genome Defense  CSPAN  January 9, 2022 8:00pm-8:59pm EST

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>> sparklight supports c-span as a public service. ♪ susan: your new book is the back story of a landmark supreme court decision in amp v. myriad genetics. tell me what was at stake in this case? jorge: this case was about a lot of different things.
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it was about whether companies and universities can patent human genes. susan: what made it landmark? jorge: the case was revolutionary in that the u.s. patent office had been issuing patents on genes for about 25 years. it was considered well-established practice and recognize law this could be done. the case overturned some strongly held expectations in the industry. susan: you write that you also see this as a story about how the law struggles to keep pace with scientific advances, and it's a story about how washington works, specifically people who seize the opportunity to impact outcome. jorge: there was a lot going on in this case. there was a very strong washington, d.c. connection. we can get into that later if you want. the administration was strongly
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involved in the case because of some of the issues it raised around public health and women's health. in the face of a very long-standing government policy to issue patents on genes, it took a group of outsiders from the american civil liberties union to look at this practice and decide they wanted to challenge it. in the united states, our legal system allows challenges. susan: your own story behind the story is a pretty interesting one. jorge: i am a law professor, but i spent most of my career in legal practice. i was an electrical engineer by training, but got into the world of genetics through representing a consortium of pharmaceutical companies back in the late
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1990's, which was involved in funding projects to create a map of markers along the human genome, while the public human genome project was moving along. this project so was to release information to the public free of charge so it could be used as a resource for all researchers. that got me interested in genomics and the idea that the basic science and scientific discoveries could be made available for everyone, which does run counter to the idea of patenting human genes. susan: how did you get from that experience as a lawyer interested in patents to reading this book -- writing this book? jorge: it was a circuitous path, i have to admit. the genes issue in this book, which are two genes related to
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breast and ovarian cancer. those genes were discovered in 1994 and patents issued on them in 1997 and subsequent years. people who knew about genetics and patents new about these genes and the company myriad genetics that was offering diagnostic testing relating to the gene. for a number of years, there was criticism and academic circles and genetic circles of practices. it was a surprise to most people in the industry when the aclu and public patent foundation brought a lawsuit challenging those patents in 2009. i was fascinated as soon as that happened, i knew it was important -- i did not think the case had a huge chance of success, but as it rolled on year after year through
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different appeals and machinations, it became increasingly clear there was something important going on here. other thymic out to the supreme -- by the time it got to the supreme court, i knew this would be an important landmark case and one i wanted to tell the story of. susan: you teach law at the university of utah. the research came out of the university of utah. is that a coincidence? jorge: it is a coincidence. when i began this project in 2013, i was at american university in washington, d.c., and moved to the university of utah with my family subsequently. i am very happy here. i think being here in utah did help me get access to documents and people that i might not have
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been able to access had i not been here locally. susan: how many years a jew work on the book? jorge: i started in 2013. susan: you write that you interviewed 100 people for this. at what point did you as a writer tell a book that is a bit of a page turner. jorge: that was definitely the goal. i knew from the beginning this was a story about people. the story about patents has been written already, many have written articles analyzing the case and issues and patents. there are books that already deal with the technical legal issues. i thought this was an important enough story and development in
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the evolution of the law that general readers should care about and get some understanding about what was going on. to me, the individuals were fascinating. i thought the press coverage at the time was one-sided. susan: we will try to get into the important characters as well as significant legal steps. before we get there, i wanted to ask about the public interest in the larger sense. the researchers was done at the university of utah with grants,
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and spun off into an enormously successful company. i am imagining this happens with federal grants, and the successful ones become for-profit companies. how is the public interest served? jorge: this is an interesting and important question. certainly in the area of genetics, much of the basic research that was done at research institutions, universities and other institutions, and a lot of it is funded by the federal government. nih funds $40 billion in applied research every year. a lot of this comes out of public research institutions.
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usually it's through private companies. in many cases, with myriad genetics, which came out of the university of utah, the exclusive licensing agreement was signed years before the june was actually discovered. this does get money into the r&d cycle. it does to some degree advanced discovery. on the other hand, it puts valuable resources into the hands of for-profit companies as opposed to universities that presumably have a public mission
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that they are supposed to be fulfilling. my colleague has written about this. we feel this is some degree and abdication of public missions when they transfer to a public/private entity that does not have the same public missions. susan: let's get into the story of the case. how did the publisher get interested in patent challenges? jorge: he did indirectly. i had the privilege of interviewing him for his book and he is an impressive guy.
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he took over the reins of the aclu. one of the outcomes of that tragic period in american history is there was a strong focus on civil liberties and civil rights that came out of it. given concerns about surveillance. the aclu received a lot of funding and donations during that period. so much so they were able to double the size of their staff. one thing that romero thought would be beneficial is more expertise on staff related to scientific issues.
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she is the one who brought their attention to these issues. susan: we found a clip from 2007, while it is not directly related to this piece, it is about dna. let's watch. [cideo clip] >> the biological sample being
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permanently retained by the government. there is a lot of information in that sample. unlike a fingerprint, dna can reveal all sorts of information so long as the biological samples are retained, there is no guaranteed the samples will not be accessed for other purposes. susan: as you tell the story, she seems she is in some ways the godmother of this case. i am wondering how she convinced the aclu to pursue aging patent strategy? jorge: as the clip shows, one of her primary interests was dna fingerprinting and the use of dna in law enforcement. she and a colleague wrote an entire book about that topic while she was at the aclu. there were other issues floating around. as i said, this issue of gene patenting was floating around
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and viewed as problematic in academic and policy circles since the late 1990's. she was well aware of it. she had a science policy background, got a degree from cornell which is one of the leading institutions in that area. one day, as she was discussing avenues that the aclu might take including the dna fingerprinting issue, she mentioned gene patenting to a senior aclu lawyer named chris hansen. hansen was a prominent lawyer litigating cases from school desegregation to mental health care to online corn and head a broad agreement. he was a national legal counsel that could address any legal
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issues he thought were relevant to the aclu. he was a sounding board for the scientific issues. in a conversation where she was discussing a bunch of different issues, she mentioned that there is always gene patenting. she was incredulous and did not believe she actually had correctly identified issue. he thought it was impossible to patent the human gene. she was right, convinced him. that led to his increasing interest in the issue, and it was really he who worked with her to convince upper management at the aclu including steve shapiro and anthony romero that this was a cause worth fighting for. susan: how difficult was it to
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convince the board that this with the direction they should go? jorge: it wasn't easy, and it took about four years to do it. this conversation they had a batching patenting occurred in late 2004. the lawsuit was not brought until march of 2009. there was a long period where much of what they had to do was convince the aclu that this was not only a good thing to do, but it was within established policies. because an organization like the aclu does not litigate any case that comes along, it has to observe its own internal policy. in its 100 years of existing, the aclu had never brought a patent case. there was never an issue related to patents that attracted their
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attention. they brought a lot of copyright cases that relate to free speech and freedom of the press, and patents are sort of related to copyright but not really. they had brought online pornography and communication cases, but, not quite there. they had to form a patent committee of the board which included a bunch of people who were very interested, but did not have a huge amount of expertise in that area. they eventually came around. susan: one of the outside experts with someone you said earned the title the gene queen. jorge: the gene queen, this is a title put on her by a magazine, her name is lori andrews.
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she is a law professor at the illinois into suit -- institute of technology. one of the early thinkers in the area of genetics on law. particular, genetics and patents. in a number of years before this, she had brought a case challenging patents held by miami children's hospital on a gene relating to a hereditary pediatric disease. she was unsuccessful in that effort because she was effectively outgunned by a large health care system with lots of legal resources. she was acting as a law professor at a clinic. there was no law firm. she had some battle scars from this issue, and remained
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interested in it, but it wasn't until the aclu was potentially getting involved that she saw that this really could change things. susan: i have a brief clip of her. [video clip] >> i worked in the area of genetics and i chaired the federal advisory on the human genome project. i was warned that this could be targeted. one of the people who was close to me was a target. i take seriously and totally distinguish that sort of concern about technology and where we are going, but with my position, they are great but let's not have them use against us in unexpected ways. susan: that is a discussion of how stakes this work could sometimes be. jorge: absolutely.
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professor andrews dealt with a lot of controversial genetic issues including human cloning, embryo screening, so forth. definitely a lot of stuff to attract the ire of certain people. susan: i wanted to follow-up. no law firm or patent bar would join her in the case. that is a theme that comes up throughout the story. why is it that patent attorneys are not interested in joining challenges? it might seem like an obvious question. jorge: it is a recurring theme. we have to remember, there were lots of companies at this point who held patents covering different dna sequences and chains. those companies did litigate,
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litigation was ongoing in many cases as companies fought it out over who's patents took priorities. they challenged each other's patents as being invalid. there are lots of ways to challenge patents, someone invented it before, it was obvious, so forth. patent lawyers were heavily involved in fighting over gene patents. and every one of those cases, -- in every one of those cases, they accepted the premise that gene patents were ok. it was just mine are better than yours. or there is something wrong with yours. the fundamental principle that these patents should exist was generally accepted by the industry. nobody in the industry would take a position against getting these patents. there was such a strong
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commercial interest that the entire bar and most of the industry were aligned in favor of those. she had a law firm that was working but pulled out on the eve of the filing. they thought this could damage the biotech patent practice if we had a reputation of being anti-patent. susan: what is your estimate of the size of the marketplace? jorge: it depends on how you define the market. it is huge. the broader market covering pharmaceuticals and all sorts of other testing is a trillion
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dollar market. susan: once the legal team was assembled, how did they focus on myriad genetics as the object of their pursuit? jorge: this was an interesting analysis. in 2005, a couple of researchers estimated a full 20% of human genes were covered by patents. that is thousands of different genes. hansen's idea was not to attack the individual patent of an individual company, but to attack the whole principal of patenting human genes. to do that, you can't attack an entire industry in litigation, you have to pick a defendant. that is what you always do in civil rights cases.
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you have to pick a gene. there were many likely candidates. there had to be a patent that injured somebody, because you can't have a lawsuit without an injury. michigan made a patent available to anyone who wanted to run a diagnostic test. that was not really injuring anybody. there was a patent causing injury. one of the front runners was a patent covering a gene that related to pediatric cardiac arrhythmia called long qt syndrome.
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the really sad thing about the disease is it affects children and creates a cardiac arrhythmia that is often fatal, but can be treated with beta blockers. prescribed beta-blockers to a child is going to give them arrhythmia. the diagnostic tests to see if you have this defect is really important. that gene was discovered, also by researchers at the university of utah, but the university licensed the patents to a company that planned to run a diagnostic testing business. it did at first, but then it went bankrupt. it stops doing the testing. the bankruptcy trustee who oversees the estate refused to allow anyone else to operate under the patent.
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that took years. not surprisingly, children were dying because they were not able to be diagnosed. that was a leading candidate. when you are a civil rights organization, you're trying to identify plaintiffs were sympathetic and defendants who seem worthy. this company certainly did. the problem was that they realized it's a fairly rare disease, a rare disorder, and even though it was extremely tragic for those families affected by it, not many people had heard about it. one of the goals is to marshal public sentiment to the cause. long qt syndrome did not qualify.
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but, a gene related to the disease that everyone knew related to breast and ovarian cancer. these diseases are very well known. breast cancer is probably the most heavily supported advocacy disease in the united states. tons of research relating to it. most importantly, though tragic also, almost everybody in the united states is affected by breast cancer either because they had it, or a close family member, mother, sibling has headed or friend has headed. it is just so well-known and so embedded in the public eye that the brca genes were the genes that were picked. susan: it has the built-in
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public constituency as you explained, but they also needed to put together a group of plaintiffs before they pursued the case. i am wondering what is amp? jorge: it is the association for molecular pathology. it's constituents are people who perform diagnostic testing. laboratories, geneticists, so forth. the amp was directly affected because one of the things myriad did with these patents is unlike the university of michigan, which allowed everyone to operate under the cystic fibrosis gene patent, myriad reserve the market to itself. it shut down other researchers
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and clinics that were performing proper testing. -- brca testing. amp suffered an injury as a result of the patent. susan: the case was centered on the fact that they were enforcing their patent and the idea was people's health was in danger because they could not get access to these tests. you also write that the company was charging a great deal of money for the patents at the time which put it out of reach. what was the cost? jorge: that's right. this is a diagnostic test. it's given to people who are not sick. most tests like that, cholesterol, wellness visits, they are and expected. $50, $100.
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this was priced in the neighborhood of $3000. the price rose every year. that is expensive for most people. unaffordable for many people. not covered by most insurance policies, especially at the beginning. not covered by medicaid. the testing was not available to a large number of individuals who most likely needed it. susan: i have a clip from the ceo of myriad genetics, i want to put that on screen. as you said, the case was filed five years after the aclu first got started in doing research. let's get him into the conversation.
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[video clip] >> we did not win the race. the group that was in that laboratory, working seven days a week, we are doing it to beat the other team. >> the ovarian cancer susceptibility gene. the most controversial patent. >> there is no controversial patent. it's all very easy to understand. susan: that was the ceo and founder, i believe now retired. that was a 2008 documentary. when the case landed, was myriad aware of it? jorge: no, the case took myriad
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completely by surprise. that was not a surprise given the aclu assembled 20 plaintiffs including some of the major medical associations. doctors, patients, genesis. they had not heard about it. they were completely floored when it was filed. susan: what was the first stop in the legal system? jorge: in the united states, patent cases are heard in the work -- federal court, so you have to pick a federal court, and for a number of reasons, the aclu filed in the southern district of new york. susan: why was this significant? jorge: cases are assigned randomly to judges in the federal courts and there were something like 50 sitting judges
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when this case was brought, and it was assigned at random to a judge named robert sweet who is an interesting character. he was a senior judge at the time, 88 years old, had a reputation as a champion of civil rights and free speech, overturned new york's panhandler law that it one time try to abolish panhandlers from the city. he had also been familiar with cases involving science. he is the judge that dismissed the challenge brought against the mcdonald's corporation. he was a matter of fact judge who did not have a science background, but kind of enjoyed science-based cases. susan: we have about 25 minutes
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left. judge sweet seemed to have a secret weapon in a law clerk. jorge: every federal judge has two law clerks who generally recent law graduates who, after they get their law degree, will go and spend a year or two working for a judge. it's great training. that year, judge sweet had two clerks. one of whom who had a phd in molecular virology. he had recently graduated from nyu law school, was working for the judge, and was more than thrilled that the gene patenting case was assigned to his chamber. susan: what was the decision? jorge: judge sweet ruled in favor of the aclu.
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there were 15 claims of seven patents held by myriad and the university of utah that the aclu challenged. he overruled all of them. for a number of reasons. most significantly, a doctrine that says you can't patent something that is created by nature, only things that are created by people. susan: what was the next up? jorge: the next step for patent cases in the united states is an appeals court. there is one appeals court in washington, d.c. that hears all of the patent cases. susan: that court was headed up the time by someone who seems to be well known, a chief judge. what was the significance of him taking the lead on this case?
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jorge: the judge wasn't remains to be very well known. he is retired from the court at this point. he was also known as an outspoken judge. he spoke a lot at conferences. the aclu picked up on comments.
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they made a motion that the judge should be recused because of his comments. that motion is the kind of motion that is likely to get a judge annoyed, and of course, the motion was never actually heard. he did -- susan: we learned mr. hansen was leading the legal team for the aclu. jorge: myriad, like most companies has in-house lawyers. general counsel, internal patent
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group selected jones day to represent them. susan: they are a big firm in washington, d.c. about two blocks away from c-span studios. when the question -- the department of justice. the obama administration had an interest in scientific issues and the like. what was the role of the justice department in deciding what level they would involve themselves in these cases? jorge: this is an interesting and unique aspect of the case.
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the patent office wanted the government to step in and advocate on behalf of the patent office. that happens quite often. in the united states, individual agencies can go to court. all litigation conducted on behalf of the united states is handled by the department of justice. at the highest level, the solicitor general who was a presidential appointee. the solicitor general has a staff and then also oversees all of the different attorneys throughout the country. when an agency like the patent office wants to be heard in court, they have to get the department of justice to represent them and make an appeal to the solicitor general to take up the case.
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some cases are too unimportant to do that, but something like this was not going to be. the surprise here was there were other agencies within the administration they were advocating against the patents, against myriad's position. primarily, that effort was initiated by nih, the national institute of health led by francis collins. the nih was instrumental in marshaling other agencies within the administration. they lobbied the school so general not to support the patents. in the end, the solicitor general did decide that for the most part, it was not going to support the patent office or
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patents at issue. susan: ultimately, the solicitor general decided to personally argue the government's position before the circuit. we have -- in the end, ruling 2-1, they reversed judge sweet. on to the supreme court. in the interest of time, i will tell people it took the aclu two go rounds to get the case heard at the supreme court. let's fast-forward to oral arguments. what did the court zero in on the central question in this case? jorge: despite all of the issues around pricing and access to health care and competition in the market, the real issue before the court in this case was whether a human gene is a product of nature that can't be
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patented, or whether it's a human creation when it is isolated and taken out of the human body that can be patented. the supreme court oral argument revolved largely around the one issue. susan: when was the case heard? jorge: april 15 2013. susan: did you have an opportunity to be in the supreme court? jorge: i kick myself repeatedly, no, i had attended oral arguments in other cases relating to patents at the court but i had to teach a class that day and did not make it out to the court for that argument. susan: that is where the recordings came in handing. we have a little clip. this is a question between justice stephen breyer and the jones day attorney. let's listen. [audio clip]
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>> anything you isolated? that is what is bothering me. >> let me try to help you out. the distinction is between the liver or kidney which was brought up in the federal circuit opinion. pick an organ. it is the same thing. there is nothing different about that piece. >> that is very interesting. we are reducing the 1012 anything under the sun. that is rejected more often than we follow. it's not just human kidneys and so forth. everything is inside something else. plants, rocks, whatever you want. susan: i am sure you listened to
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that oral argument several times. how did you think about it? what was your reaction to the exchanges? jorge: this was a really fun oral argument to listen to, because it involved so many better for's and there was so much -- metaphors, and there were so much creativity flowing. justices struggled to understand what the arguments were and how to conceptualize whether a human gene when taken out of the body is something different than the human gene in the body. you heard the metaphors. chalk chip cookies, baseball bats.
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susan: there are no scientists this does not having a scientific background matters the outcome? jorge: it should not matter. the justices on the supreme or -- court are generalists. reducing principles down to simple enough concepts that the rules of law can be applied. susan: you described in the book that the questioning of the lawyers was almost a bloodbath. why did you described that as such? jorge: he was in a difficult
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position. justice breyer, who i had as a professor in law school, a very probing question her. there is a high degree of skepticism. that decision came out in favor of the aclu's position in large part. the justices were initially skeptical of myriad's position. it is difficult to be a lawyer facing a bench of nine justices who are skeptical of your position. they are going to ask difficult questions. i think he did as good a job as good be done under the circumstances, but it was very tough. susan: that was april 15 of that year. after these cases, there is always a meeting with the press corps. what was the attitude of both sides after the case was heard? jorge: the aclu side was pretty
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ecstatic. you can see from some photos and news clips. i think everybody who saw and heard the arguments agreed that they came out looking pretty good in the case. the myriad and jones day group did not give up hope, but i think were a little bit less optimistic. susan: for these cases, there are often people on the supreme court plaza. what was the atmosphere like that they? -- that day? jorge: this case attracted a lot of attention. breast cancer action, banners, megaphones, all the things you would expect in a big civil rights case.
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people lined up from 1:00 a.m. the previous night to get a spot in the gallery to view the arguments. i have to say, this is very unlike most patent cases. this was highly unusual. susan: when did the court announced that decision? jorge: it was a couple months later in june. susan: you already told us the case was won by the aclu. what was the vote? jorge: it was a 9-0 decision. that is unusual for the supreme court. it was unanimous, with one concurring three sentence opinion by justice scalia who basically said i don't know anything about molecular biology and neither do the rest of you. what are we doing here? that was his typical aside.
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he did vote with the unanimous court. susan: unpack the results. what did they do for the plaintiffs involved in larger biotech and patent laws? jorge: there were a lot of effects. the immediate effect on the market was literally the day the decision was announced, competing labs announced they were now offering rocco -- testing. some at half the price. competition was introduced into the marketplace immediately. that gave access to many more people. it broke the monopoly. but, the implications were much broader than just this one company. the aclu was not out to get
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myriad genetics. this was a case about a principal. all of those patents covering human genes, though technically they still remained on the books. they are not enforceable at all. whether it is cystic fibrosis or whatever the case may be, the jeans are not patentable. this had an interesting effect. it has enabled more research to occur. it has taken away some barriers to more advanced forms of testing. there was a lot of hesitation. myriad is still doing fine. they are profitable company.
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they are a leading provider of testing. it is now covered by all major insurers, medicare and medicaid. the price has come down. they have other products. this is not a one product company. they have a panoply of test. susan: readers will find that after you complete the story, there is an addendum. what are your thoughts? did the court make the best decision for the future of the public? jorge: i think the court made a good decision. i think it is logically inconsistent in some ways and i and other academics -- overall,
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i think it is the right decision. it's not a decision that abolishes patents and some sweeping way. i agree that patents are beneficial in a lot of situations. patents on these basic products of nature and natural phenomenon i feel are not appropriate, because they should be available for use and exploitation by all researchers who can build on them to create new technologies and get patents on actual inventions as opposed to things that they found in the natural world. susan: one thing to explain. when one holds a patent, is internationally enforceable? jorge: patents are national. every country issue their own patents. there is an international aspect to the myriad story, which again would triple the length of the
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book if i try to cover that as well. susan: genes cannot be patented by u.s. law, does that put u.s. companies at a disadvantage against international competitors? jorge: no, certainly not. when markets are international, myriad side patents and got patents in other countries, and non-us companies are on the same playing field in the u.s. as u.s. companies. it is one of these common misperceptions that changes in u.s. patent law will affect u.s. companies in some way. more u.s. patents are issued to foreign companies than u.s. companies these days. the real impact is on u.s. consumers. u.s. consumers are the ones who were impacted by the fact that there is only one company who was able to perform these testings.
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this testing in canada and europe was much less expensive because there was competition. susan: as we close out, is the story over? you right there have been efforts in congress to deal with this question legislatively. jorge: that's right. that is the way the u.s. legal system works. the supreme court is the ultimate arbiter of the interpretation of u.s. laws, but the law can be changed. as long as congress -- congress frequently overturns supreme court decisions in the patent area. in 2019, two u.s. senators involved in ip issues did advance a bill that has eliminated all supreme and other
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president relating to patent eligibility. that legislation did not advance in 2019 and then covid came along and lots of other issues were before congress. but, it is back. this summer at the urging of senators, the patent and trademark office made a public call for comments on how these patent eligibility decisions from the supreme court are affecting industry. they got a lot of responses. 140 different responses that they are sorting through now. it will probably form the basis for on the legislative effort in the next session. susan: are the senators bipartisan? jorge: it is bipartisan. interestingly, patent issues don't really fall along party lines. there are lots of divides in the
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world, but republican and democrat is not the big one. you have people on both sides agree. susan: he spent eight years of your life working on this project. looking back at the effort you put into it, how did your view of the system change? jorge: i learned a huge amount doing the research for this book. the personal stories i heard from some of the plaintiffs who were patients were heart wrenching and gave me a huge appreciation for what individuals face out there in the health care market. even more, learning about the intricacies of how the federal government operates behind the scenes, the way that the solicitor general instigated
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intra-agency process to come up with its position in this case. even among academics that study litigation, this is not very well known. i was extremely grateful to people who will remain anonymous who spoke to me and explain how this all works. i hope the book gives a greater appreciation of these issues to the general reader. susan: eight years worth of effort and telling the story of the landmark supreme court case amp v. myriad genetics. thank you so much for spending an hour with us. jorge: thank you so much, it was a pleasure. ♪ >> all q and a programs are
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