‘Patenting Life’ shares tales from a career on the cutting edge of science and the law

Episode Notes

Transcript

Lee Rawles:

Welcome to the Modern Law Library. I’m your host, Lee Rawles, and today I’m joined by Jorge Goldstein. He’s the author of Patenting Life Tales From the Front Lines of Intellectual Property and The New Biology. Jorge, thank you so much for joining us.

Jorge Goldstein:

Thank you for inviting me. It’s a pleasure.

Lee Rawles:

So you have a very interesting background. Let’s start out with that. Can you please introduce yourself to the listeners and talk about how you got into this field to begin with?

Jorge Goldstein:

Sure. I am an Argentinian by birth. I studied chemistry in Buenos Aires for a while. Came to the United States to complete my studies. I received a bachelor’s degree in chemistry from Ranser Polytechnic, a PhD in chemistry from Harvard in 1976. And I did postdoc work at MIT up until about 78. And at that point I decided not for anything that was happening in the world, but because of my own personal temperament that I would really not be a very good bench scientist. Not withstanding that I love science and I loved reading it and teaching it and discussing it and writing about it. And so I started looking for an alternative career where I could use my background as a molecular biology trained chemist. That’s what my PhD thesis had been, what my postdoc had been, and apply that in some area in which I could sort of do something other than do research.

And I discovered patent law, and this was in 1978. It was a time when very few folks with advanced degrees in biochemistry or molecular biology or so on were going into patent law. Since then, things have changed and many, many more have since then, but of course, more than 40 years have gone by. And so long story short, I got a job as a scientific and technical advisor at a law firm in Washington, DC went to law school and in 1983, graduated from George Washington University Law School with a degree in law and sort of a specialty in intellectual property law because that law school was one of the pioneering schools teaching patents and intellectual property. And in 1983, I decided to form a law firm with a classmate of mine, Robert Stern. Robert was and is today one of the pioneers on the intellectual property of software and electronics.

And he and I joined forces realizing that the world was changing as we were doing this. And it took me a while to recognize that I went to school during the decade from 71 to 81, more or less, that changed biology forever. It was a decade that was marked by major, major discoveries in biology such as recombinant DNA technology, monoclonal antibody technology, the magic bullets of Paul early from the 19th century and cell biology. And that set of developments was coming along with commercialization, and that was an incredible thing to see during that decade. Genentech was founded in 1976. Of course, apple computer went public in 1980. I think Biogen was founded, genetics Institute was founded. And suddenly the world of science, especially biotech and the sort of biological world that had been primarily pure science to figure out how the world work became interested in commercialization.

Lee Rawles:

Yeah, the timing of both your scientific training and your legal training just seems to be tailor made to this industry. I mean, I did not appreciate before coming into this book, patenting Life. I of course was familiar with, oh, the Silicon Valley. I went to school at the University of Illinois in Urbana Champagne where much of the work with supercomputers began, and a lot of the early work with the internet happened. So I knew about that, and I was aware tangentially about a lot of the crop science I did not understand fully until reading this, not just the scientific transformation that happened, but how quickly the law in this area had to change and adapt and answer questions like, how do you legally describe life when it comes to patenting? Can you patent a living thing? And just to give people an idea, maybe we should start out by talking about the 1980 case diamond versus Chakrabarti, because that was happening. You were finishing up law school, I guess, or had finished law school. So let’s talk about that case and how fundamentally it changed things.

Jorge Goldstein:

Yeah. Diamond VI Chakrabarti was a case in which Professor Ananda Chakrabarti working at General Electric had invented a microbe that was able to degrade crude oil. For example, crude oil spills on top of water like ocean bays and so on by metabolizing multiple fractions of the crude oil. Now, there are microbes in nature that will actually metabolize oil, but one fraction at a time. And what Chay Ardi did is he managed to genetically engineer a microbe so that it could degrade oil multiple fractions at a time, which was terrific. Now the thing was clearly artificial because there were no such microbes, but it was alive. And Chuck Ardi through General Electric, filed a patent application, and the patent office in the United States in the late seventies decided that they would not allow patents on living things, notwithstanding that they had allowed at least one patent in the 19th century to Louis pastor on purified Easts. Pastor was a beer brewer in addition to everything else that he was.

Lee Rawles:

Listers might also know him from the rabies, of course,

Jorge Goldstein:

All the

Lee Rawles:

Vaccines discovery and vaccine and yeah,

Jorge Goldstein:

Yeah, and the pasteurization of milk. And Amir, the man was a genius, but he also brewed beer. And he knew American markets for beer would be big. So he patented methods of brewing beer, among which there was a patent to a live yeast that was purified. Now, the patent office granted that it was a bit of sort of controversial patent, but it was not a legal precedent. And they really took issue with patenting living things. In the Chay Robbar case, they denied Chay, Robbar Ardi his patent application. It went after the Court of Appeals who said, of course, give him a patent. And the patent office didn’t take that and applied to the Supreme Court of the United States. And in 1980, the decision was handed down saying that patenting living things was fine. They did not get into whether this was artificial enough, which is a question to this day, but they at least sit down the rule that the fact that something is alive doesn’t mean that it cannot be a manufacturer if it’s been manufactured by humans or a composition of matter.

And so Chuck Kabati got his patent to these genetically engineered microbes, and then the floodgates opened legally, and I think politically and publicly, I mean legally after the allowability of patents on microbes came, patents on plans on plant cells and on animals. And so the floodgates legally opened, the patent office started receiving thousands of patent applications because the biotech industry was growing. And one of the workhorses for research in the biotech industry are microbes that have been transformed with genes that have been obtained from another organism. So the genetics of the world started manufacturing microbes that contained human genes for insulin or human genes for growth hormone or whatever. And so those things could not be patented.

Lee Rawles:

I think there probably are many people who don’t know that some of the very common medications that they take fall into this category at all. Someone may take insulin and not know precisely where that comes from, or

Jorge Goldstein:

That’s exactly right.

Lee Rawles:

And so that was another fun thing in reading the book was I just had so many moments where I was like, oh, that counts. Oh, that does that too. Oh yeah. I guess I never thought about where precisely X, Y, Z came from. So I want

My listeners to know one of the cool things about patenting life. It obviously talks about Jorge’s experiences and some of his cases, which he writes about in very entertaining ways. But you start the book with a very quick explanation of the beginning of patent law. It has to do with the fall of Constantinople and the Doge of Venice. So anyone who, maybe you’re not a hardcore scientist, but you love little historical facts and learning the stories behind things. You weave these tales about the people behind the science. This is not a sterile book. You talk about the humans involved in these discoveries, and they’re fallible, fallible people. They’re strange and quirky sometimes. So I just want to reassure anyone who’s thinking about picking up patenting life tales from the front lines of intellectual property and the new biology, this is not a dry book in any way. So I just want to say kudos to you in the writing of it.

Jorge Goldstein:

Thank you. Thank you, Leah. That’s what I wanted to do. I wanted to write a book that would humanize what are otherwise pretty dry topics, molecular biology full of jargon full of long third person sentences, law, right full of jargon and legalese and the passive voice. I wanted to write a book that humanized both, not use a great deal of jargon. I also wanted to make it interesting because behind every case, behind every legal battle, there is a human being. There’s usually two. And the story of the folks who get involved in these is as interesting and a general interest that goes way beyond the science and the law. It just happens to be that they are involved in science and law, but they’re humans like all of us. And all of us have made mistakes. I mean, I contemplate with some irony, the fact that for many, many years I filed patent applications on isolated genes.

And Judge Lurie of the court of appeals kept saying, you could patent isolated genes, you could patent isolated genes until the myriad genetics case came around in 2012. And the Supreme Court of the United States said, no, you can’t patent isolated genes. They’re just genetic information and there’s no difference between whether they are sitting in the genome of your cells or they’re isolated. It’s the information. The information is always the same regardless. And so all those patents that I wrote and obtained and enforced and so on suddenly disappeared like a woo of smoke. And they were gone. And nobody has filed patents and isolated genes then. So all of us have gone down roads that led to some trouble in this field because we were all case by case. We were exploring what was possible, what was not possible with the courts tolerate, what would they not tolerate? And all I can say it was fun and I made my share of mistakes, as did some of the judges. What can I say?

Lee Rawles:

Well, and when you talk about morality, I think some of the decisions that scientists made could be questionable. As you were talking about just now, the people behind some of these discoveries. I thought about the case of John Moore. Some of our listeners may have heard about Henrietta Lacks,

Jorge Goldstein:

And

Lee Rawles:

I had never heard of John Moore, who also has a very interesting story that is kind of reminiscent, which you share in the book. Would you mind talking a little bit about John Moore and his experience and then the court case that followed?

Jorge Goldstein:

Yes. John Moore came several years before Henrietta Lacks, but they’re very similar cases. John Moore was a patient in Seattle who went to UCLA medical center to get a diagnosis for a type of a cancer that he had. And the doctor, Dr. Goldie, UCLA medical recommended that he have a spleen removed. So more underwent the operation. The spleen was removed more, lived another 25 years, happily after. But for a few years after the operation, Goldie and the UCLA medical center was calling more back to come down to LA to provide more blood samples for testing. Now, in a post-cancer recovery, patients are yearly tested to make sure the thing hadn’t come back. The unique thing about what was going on here is that they kept asking him to come down to Los Angeles instead of being able to do it in Seattle. I mean, Seattle is not the backwater, right?

There’s plenty of hospitals in Seattle. But they kept saying to him, only in la, only in a, and so he did. And he did, and he did. And about the sixth or seventh year, they asked him to sign and informed consent form. And he said, well, I’ve already signed one. And they said, well, this is a new one. And he looks at it and he shows it to, and there’s something funny about the informed consent form. The informed consent form says that he consents to all the procedures plus all the blood that he’s been given and allows the University of California to own all of his spleen cells that were removed years ago. And of course, the blood and to do whatever they wish to do with them both research and commercial development.

Lee Rawles:

Well, yeah, that threw up some questions

Jorge Goldstein:

For him that threw up some red flags, right? So he goes to a lawyer, lawyer reads it, investigates it, and lo and behold, discovers that UCLA medical has obtained a patent on a cell line that was derived from the spleen cells of more. And the cell line is essentially cancer cells that have been immortalized to live and reproduce forever, and they can live in a test tube and all kinds of good things can come from this as an experimental thing. You could do testing on them, you can extract growth factors, lymph kines, which are types of growth factors, perhaps even help figure out a cure for certain cancers. So he was not happy and he and his lawyers filed litigation against UCLA medical against a company that had taken a license, I forget what the name was, but doesn’t matter. And the doctors themselves, Goldie and his assistant, and they argued all kinds of theories, but there were two of them.

One of them stuck and the other one didn’t. The one that did not stock is called conversion, which is an old me concept in law that is sort of the parallel personal lawsuit that somebody could file when something has been taken from them. If somebody steals trees from my backyard, cuts them down and walks away with them, I can certainly call the sheriff and have him arrested and criminally tried for a burglary, right? But there’s also a civil cause, which is called conversion. Conversion, allows me as a plaintiff to sue the guy who walked away with the trees to get the trees back, or at least get lumber back that he may have produced, or if he already sold the whole thing to get my money back. In other words, the law of conversion says that that person has converted to his own use something that belonged to me, and I’m entitled to get it back.

And that is in addition to whatever criminal violation he may have committed. So Moore and his clever lawyer argued, well, you have taken my spleen cells and my blood and converted them to your own use, and they are mine, just like the trees were still mine after somebody stole them. They never changed ownership. The title to the trees in medieval England remained with the original landowner. It never changed hands. The trees did, but not the ownership. And so that was his theory that his spleen cells and his blood and everything else taken from his body had been converted, but he still owned them. They didn’t own them anymore. Long story short, the Supreme California said, no, no, no. This ancient cause of conversion doesn’t quite apply. It doesn’t fit. And therefore no, once the blood and the spleen cells left your body, they now belong to the hospital.

Lee Rawles:

Yeah, you said you’re like, well, it was medical waste, so isn’t it just like trash? You threw this away. Yeah,

Jorge Goldstein:

Exactly. That’s what the, that’s exactly right. The court sort of said, well, yeah, that’s how we treat things like medical waste, like other things that come from your body. Once you let them go, you let them go, they’re not yours anymore. And they also had a public policy argument saying if every time a cell like that, by the way that cell is now known, has been known forever as the mo mo line because of more, right? So the mo line could be given to another university, could be given to a company to do more research to discover new things. And the court said, look, every time this thing changes hands, everybody’s going to be worried. Well, who owns it? Who is the real title holder? Do you have the right to give this to me? Am I going to be worried forever that there’s an encumbrance on this cell line that I didn’t know about? It’s much better for general public interest and research ability of all institutions that Title B settled once and for all. And once these cells left Moore’s body, they belong to the hospital. End of report. The court was offended by what had been done to him, really, because from an equitable point of view, this was not right.

Lee Rawles:

Yeah. They didn’t inform him we’re having me return again and again to Los Angeles for more blood draws because we’re using your cells.

Jorge Goldstein:

Yeah. It sounded like they were actually misleading him. And the court said, look, doctors have a fiduciary obligation to their patients because if a patient knows that a doctor might be commercially interested in getting your spleen cell, because he may make a lot of money with a patent license, you might want to say, look, I don’t want you to operate on me. Maybe I need a second opinion. Maybe I need a third opinion. That’s the point. The point is, there was not a fully informed consent, and that’s what stuck, and they send it back, and then the case settled. And as always, we dunno how it settled, but all informed consent forms in the United States today, you get rolled into an operating room, you’ve probably already signed away the ownership of whatever they’re going to take from you and have given informed consent for the hospital or the university or whoever it is to do commercial research with it.

Lee Rawles:

Yes. The language that you said really piqued John Moore’s interest. I thought to myself, well, I have routinely gone to a research hospital and that looks just like what they have mise now.

Jorge Goldstein:

That’s correct. And they did something similar to Henrietta LA on Hopkins,

Lee Rawles:

Although she never later. Yeah, she never learned of it because she passed away.

Jorge Goldstein:

That’s right. And her cells, which are even more famous than the Molan, are known as Hila cells, Henrietta lax, HELA cells. And those cells were taken without her knowledge, they were immortalized. That’s why the name of Slug’s book is The Immortal Life of Henrietta lax. The hela line is very, very famous. There are companies today like Thermo Fisher that sell products derived from the healer line. And so when all of this broke open, the estate of Henrietta Lacks filed a lawsuit against Thermo Fisher saying that they wanted to have a financial return on the commercial exploitation of their ancestors cells. And this was an echo of the Moore v California case of many years earlier, and it settled. It never went to court. And I’ve looked in vain to see what the amount of settlement was and how it settled, but it settled. So the estate of Henrietta Lacks got obviously some financial compensation and Chance Hopkins was shamed into creating all kinds of annual memorial ceremonies and lectures and so on in honor of Henrietta Lacks. And so the idea of what happens when somebody takes something from your body and exploits it commercially without telling you, is now pretty clearly in everybody’s mind. And hospital administrators know that they need to be extremely careful.

Lee Rawles:

Well, we’re going to take a quick break to hear from our advertisers when we return. I’ll still be speaking to Jorge Goldstein about patenting life tales from the front lines of intellectual property and the new biology. Welcome back to the Modern Law Library. I’m your host, Lee Rawles here with Jorge Goldstein. So Jorge, you mentioned this briefly at the beginning of the episode, but there really was a sea change in the idea that biologists themselves perhaps thought about pure versus commercial biology. And I think we should talk about that because I think you must have had in your career some interesting moments talking to some of your scientist clients as a lawyer about, no, no, this is why patenting is appropriate and why we need to consider it. So what was this shift? And when we say pure biology, that seems to be kind of a moral or loaded word, but what are we talking about when we talk about pure versus commercial biology?

Jorge Goldstein:

Yeah, the idea that somehow folks could commercialize basic discoveries that were being made in biology was very foreign to the biologists of the 1940s, fifties, sixties, all the way up to the 1970s biologists in laboratories around the world, and whether it was the Pastore Institute in France or the plank in Germany or Stanford and California were basically explorers and they were exploring nature, and they were trying to figure out how do cells work? How does DNA work? What is DNA? How do proteins fold and on and on and on, and then suddenly, and they did not think that there was much that could be commercialized that was of interest to anybody. The classic example was Paul Berg, who in 1971 did the first recombinant DNA experiments the world had ever seen, and he recombined the DNAs of two different viruses and made a hybrid, a chimeric virus. He didn’t know what he had done, but he published it and he said, look what I’ve done. He was like, gee, whi.

Lee Rawles:

And then he spooked himself and he stopped. He’s like, oh, maybe I’ve gone too far.

Jorge Goldstein:

Yes, exactly. Exactly. He said, oh my, what have I done? This could cause serious trouble. This could lead to runaway viruses, it could cause cancer. It would be horrible. So he kind of called for a major conference in California, the Asmar Conference with ethicists and lawyers and politicals and scientists, and on and on, and they issued the Asilomar guidelines that were basically a set of guidelines to said to people, look, this is a brand new science. It could be dangerous. You’ve got to be careful. You cannot do this out of control. It’s got to be verified. There’s got to be committees that approve it. The experiments need to be done under containment procedures and on and on. And all NIH grants were then, granted, federal money was granted subject to the SMAR guidelines. Now we now know that it was a little overcautious, but you would know at the time,

Lee Rawles:

No, not at the beginning. And this was so close to the Manhattan project, and we know that there were scientists who worked on that who had regrets about what their discovery. So I guess it makes sense for the people of the 1970s to be leery.

Jorge Goldstein:

Yeah. And it was a very ethical, very honest, straightforward thing to do. And my hat goes off to Paul Berg and all of them for having done this, and he did not, however, think that any of this stuff could be patented. In fact, the folks who then took the next step in recombinant DNA were two scientists, one from Stanford, one from California Coen and Boyer Boyer in California, and Coen in Stanford. So they were working with DNA from a frog, and they clipped out a little piece of DNA that essentially was a little section of the whole genome of the frog, and they separated it from the frog cells, and they put it into a bacterial cell called e coli, the workhorse of the genetic engineering industry and e coli started producing this frog protein, and they published a paper again.

Lee Rawles:

They were just like, neat, okay. They were like,

Jorge Goldstein:

Oh, look what I’ve done. Look what I’ve done. It’s like children playing. Look what I’ve done, man.

Lee Rawles:

Just as an aside. Yeah. We talked in a different episode about corporate espionage, and the author said, I’ve talked to many corporate espionage experts, and they say the hardest thing is that scientists want to talk to each other. Scientists get so excited, and they go to conferences and they want to share their findings. And that is sometimes very against the commercial interests of whoever they’re working for.

Jorge Goldstein:

That’s correct. That’s correct. But these people were all brilliant academic scientists. They weren’t working for anybody. They were just working for themselves and for the greater good. And so a coin and Boyer published a paper in the proceedings of the National Academy, and an industry guy called Neils ERs. Neils ERs had been hired at Stanford to create an office of licensing and technology transfer, not necessarily because of biology, but because the chemists had been making drugs and pharmaceuticals for a long time. And Stanford, which is one of the classical American universities that translates basic research into applied research quite well, as we all know, right? Google and the Stanford Research Institute. It’s also true in the world. So Ramers was charged with finding inventions that could be commercialized. So lo and behold, he’s sitting in his office and he is reading the New York Times article by a journalist called McKelvy McKelvy, I think it was his name.

And he reads a story about Stanford. Well, something very important had just happened in the bio labs across the quad. It turns out this New York Times reporter had read the proceedings in the National Academy Journal and had understood the impact that this could have on medicine and on agriculture, on health, on industrial production. This Little Frog protein produced in e coli was not really the end of anything. It was the beginning. And so the New York Times wrote this article about how this little thing that these two scientists had done could be applied, and that there was an enormous future for recombinant DNA and genetic engineering. He runs over to Coin and he says, what’s this? He goes, yeah, well, we’ve published it. It’s neat, isn’t it? We made a frog protein in E Co. And he goes, yeah, but I mean this New York Times guy says that this could have enormous implications and there could gold.

And coin says, nah, nah, I don’t want to patent this. This is for everybody to use. So what does Reamers do? He tells me, when I interviewed him, he says, look, the SR guidelines and every federal grant that comes from the NIH is subject to them, and people need to be very careful with their federal money. If we got a patent, there’s two things that will happen. Number one, you’ll get millions and millions of dollars for your lab to do research and to continue this research. And that opened his eyes. And number two, we could license this to industry, private industry that doesn’t take N NI H grants subject to the CIN guidelines. And that was a brilliant argument and agreed. And the patent application was filed. It came to be known as very famous two patents that issued owned by Stanford and California, the so-called Coin Boyer.

Patents are the basic patents on genetic engineering, how to take genes from one organism, move them to another one, and produce whatever protein that gene encoded in large quantities. And this is the stuff that was actually never done by the frog protein, which was envisioned by a very good patent lawyer, Burt Roland, California, who realized he could write a pretty prophetic patent application that predicted all of the things that could be done with genetic engineering. Long story short, at the end of the patent life, Stanford had about 250 million in the bank from industrial licensing. Genentech was founded by Boyer of the Cohen Boyer payer, a company, the very first company that could be counted to a commercialized genetic engineering. So started making human growth hormone in bacteria, insulin in bacteria, somatostatin in bacteria, and they started making a lot of money, and money started flowing into the world of biology and the world of biology started becoming interested in patents.

Lee Rawles:

And you really expand on this in the book. We’re not trying to cover literally everything because it has so much in it. But I do encourage listeners, if this has intrigued you, there’s so much more in patenting life about this specifically. But one thing as a reader that it explained to me is there’s of course always the balance with patenting where you want to reward the person who has made a discovery, but you do not want to do so in a way that’s going to hinder forever further exploration or stunt growth. And there’s that balance you have to hit. I didn’t appreciate really the licensing structure from a patent and how, oh, well, no, this isn’t blocking anyone from continuing to follow this down. Its biochemical lines and processes. You need to license certain of these techniques or products to then continue to study them.

So that’s not something that I understood as a lay person before reading your book. But you have a whole chapter where you talk about the pitfalls of the patent system and anyone who wants to can pick up the book and really get into it. But is there something you’d like to communicate to just the lay reader rather quickly about where you think this balance is and what are maybe some questions that we’re now asking or we’re going to have to answer in the future about that balance between patenting life and allowing freedom of research and discovery?

Jorge Goldstein:

It is a careful balance. You’re right. And everybody that has looked into patent systems and they’ve been around for hundreds of years, as you pointed out, started in Venice and we’ve had it since the beginning of our republic. The patent system is a very careful balancing act. It wishes to incentivize researchers to disclose their inventions, which in academia is not a big problem. People disclose all the time, but it is a problem in industry. And so as an incentive to industry to disclose some of the things that they would otherwise keep as a secret, they give them 20 years of exclusivity from the filing date of a patent application. So it’s a quid pro quo. It’s also a way to allow investments to flow into risky inventions and technologies, especially in the life sciences, especially in pharmaceuticals, in biopharmaceuticals, in therapies and so on. And the balancing act is, look, I will give you 20 years exclusivity.

Nobody else can come in and copy you. And that gives an investor the ability to put in risk money and hope that he or she has a beachhead that will allow her to start making some money before others can come in. At the end of the 20 years, judge Rader or the Court of Appeals calls this a generational gift. We allow 20 years of exclusivity to the inventors of something, and then after 20 years, it becomes available for the public to commercialize the next generation. So it’s a gift from one generation to the next. That’s a very nice way of thinking about it. Now, of course, during those 20 years, nobody else can come in. There are people who try to come into the field, and in order to do so, they have to litigate. It costs a lot of money to litigate. They have to not only avoid the patent by inventing their own things around them or they need to invalidate the patent.

The first would be non-infringement. The second one would be invalidity. It is a barrier to entry, and it allows the owner of a patent to set a price. And sometimes the price is seen by the public and by society at large as too high. And we all know that the price of patented drugs is high, and it’s not necessarily only because they’re patented. The patent is there because that’s the compromise we have. Many times industry has discovered through clever lawyering that the 20 years can be extended. The 20 years could be extended by creating, let’s say, new formulations or long lived slow delivery products that contain the active ingredient, and yet extend in a way the patent life to go beyond 20 years. This used to happen pretty dramatically before the United States patent law changed. We used to have patent applications that were filed and prosecuted in secret.

Nobody knew that they were pending. And the life of the patent in those years used to be 17 years from issuance. So you can imagine filing a patent application, keeping it secret for maybe 5, 6, 7, 10 years, and then getting another 17 years on top of that. So suddenly you would have 27 years of patent exclusivity. Now that’s gone. That’s gone. We don’t have that system anymore. Thank God I welcome the change to make it open. Anybody could see what’s going on in the patent office. Now, there are no longer secret patent application spending, although every now and then there are. And I mentioned in my book The Case of Enbrel, a very famous drug that is used against rheumatoid arthritis that was invented and was originally filed almost 40 years ago. The patent on that one expired 17 years from issuance, and it should have been the end of it.

And yet there was an under the water submarine patent, as we called it, pending on a very similar invention to Enbrel. And that thing issued much of the surprise of everybody. And the patent on Enbrel will now not expire. The exclusivity on Enbrel will not expire until I think 6, 7, 8 years from now. So that is way beyond the careful balancing act, and that’s one of the situations that I think we are not likely to see happen again because we’ve removed old semblances of so-called submarine patents, and yet the companies involved were able by clever lawyering to get this extension. So there are many, many different ways of extending patent life and preventing the entry of competitors for as long as possible. And that’s where I critique the sort of gaming of the system. And I think it’s a difficult proposition to get it right. But we have seen, for example, in the previous administration, the attempts through the inflation reduction act, the IRA, to try to start dealing with excessive drug prices, for example, by looking even at patented drugs and forcing companies that own the patents on these drugs to come to the table and negotiate for more accessible prices.

Lee Rawles:

And there’s also an interesting discussion in the book about vaccine production, which everyone who has made it through a COVID-19 pandemic, it’s top of mind. The speed at which vaccines were able to be produced really was kind of unprecedented. And I think that a lot more people may be talking about those questions when it regards, okay, patents and vaccines. Jonas Salk famously said he wanted the polio vaccine to belong to the people.

Jorge Goldstein:

Well, yeah, yeah, yeah. Jonas Salk had some strange ideas.

Lee Rawles:

Yes, he did. And there was

Jorge Goldstein:

Another, when they asked him, he said, you cannot patent the moon. Well, of course you cannot patent the moon, right? But vaccines for polio are not quite like the moon anyway. The issue of vaccines and patents on vaccines is treated in detail in the book because it’s an interesting social issue. And I think the companies who own patents on the message RNA, the mRNA vaccines like Moderna and BioNTech and others, Pfizer, they are already litigating. We have seen a number of litigations start in the United States and Europe dealing with a technology for making these vaccines. But there’s also an understanding, and I think it’s increasingly so that we need to treat patents on vaccines differently in the United States and in Europe than in Africa or Asia or in India. And this is what I discuss as humanitarian licensing in the book. But the point being that you could carve the world into two, and you could say, look, I’m going to enforce my patent against other companies that are trying to copy my technology in the us, but I will not enforce it in Africa, in Sub-Saharan Africa, in Asia, in India, wherever it is, because I want vaccines to be made available to the developing world.

I will charge top price in the developed world, and to some extent that’ll finance my ability to distribute vaccine to the poor of the world. And this is being done more and more in a voluntary way. Or as we saw during Covid, the government would just buy the vaccines and then distribute them. And so there is a recognition that different parts of the world have different needs and different abilities, and that there are the wealthy who can pay for the higher prices of enforcing patents. And then there’s the developing world that cannot.

Lee Rawles:

And I want to get more into that in just a second. We’re going to take a quick break to hear from our advertisers. One year turn, I’ll still be speaking with Jorge Goldstein about patenting life. Welcome back to the Modern Law Library. I’m your host, Lee Rawles here with Jorge Goldstein. So Jorge, the last section of your book delves into some really interesting areas, and you raise this idea of repairing the world. I hope I’m saying that correctly. And in particular, the work that you have done with indigenous communities. The way before reading the book that I was most acquainted with microbiology, biochemistry, all of these questions I’d heard about Monsanto and crop products I mentioned I grew up near Champaign Urbana in central Illinois around crops and farmers my whole life. And many people heard about genetically modified foods and had concerns. And so that’s what I was coming to this book with was a lot of those debates.

And one thing that I had always thought about was many people, when you say, oh no, we started genetically modifying the corn. Corn doesn’t exist in nature. Corn itself was developed by the mesoamericans brilliant agriculture developments. The closest thing we have to it, they think is a weed called teosinte. So indigenous communities have a long, long history with many of the natural substances that corporations are now finding, refining, et cetera, and you really get into the work that you have done with these communities in the last section. So I’ve talked enough, let’s hear from you. Can you share a little bit with the listeners about those projects?

Jorge Goldstein:

Sure, happy to. There are two projects that I discussed in the book in the last two chapters. One is called Tik Lamb to Heal the World, and the other one is foliar feeding. These are projects that I undertook pro bono in order to heal the world, and they are projects in which I have focused our attention on representing disenfranchised and impoverished indigenous communities. One in Colombia, south America, the other one in the state of Virginia in the Blue Ridge Mountains. And what I have done is I have found at least two groups. One is a group in Colombia, and there was a particular individual in Virginia that have made interesting technological inventions in the field of agriculture. And I have worked with them, filed patent applications on their inventions, and have obtained patents for them. And in one instance, we were successful in licensing the technology to a major multinational company in Denmark called ra.

And RA is going to commercialize this technology worldwide. RA just obtained FDA approval. The technology in Colombia is there is a blue color in a fruit that grows in the rainforest in colo. And this tribe had used this blue for tattoos and cosmetics, but it turns out that it’s edible, and it is a beautiful blue color, cobalt blue color that can be made into a powder. So working with a chemist in Medellin, the blue fruit juice is made into a very stable powder. The blue powder can then be added to foods, to drinks, to liquids, to salads, to powders, whatever

Lee Rawles:

M and ms. You mentioned blue M and Ms. M and

Jorge Goldstein:

Msm. That’s right. Yeah. Yeah. The FDA has approved its use for foods, and because of the great concern there is these days with synthetic dyes that are being used and widespread use in fools as being poisonous or potentially very hazardous, a blue color that comes from a rainforest tree that’s approved by the FDA. And this edible is a terrific invention. It’s a terrific technology. So this Danish company will bring the blue into the United States. The money will then flow back to the Colombian tribe in what I call reverse tech transfer, because the technology comes from the developing world and it results in exploitation by the developed world, which is usually the backward from what things happen, right? Technology is developed in the north and moves south, whereas this is backward. And so this is done under the Biodiversity Treaty of Rio of 1992, and the Nagoya protocol, which requires access to the rainforest, permission to get access from the Colombian government, and then sharing financial benefits with the indigenous groups from once this came, that is now coming into the United States.

The FDA just granted approval for entry in early 24, and you’ll soon see blue things coming up for food, whether you like ’em or not, I dunno. But they’re not poisonous, they’re not hazardous. They’re good and healthy, and you will see more blue foods and more blue candy and water and whatever you want. The other project is for Lucas Tyree. The story of Lucas Tyree is really one of violation of human rights. And it just hit me hard when I heard the story. Lucas is a member of the Monarch and Tribe and the Tyrese. There was a very nasty member of the medical community in Virginia for many, many years in the early 20th century called Ker. David Ker. David Blecher made it his life’s work to classify Native Americans as African-Americans. Now, if you can believe how perverse this concept is, the reason he wanted Native Americans be treated like African-Americans was so that the state of Virginia could discriminate against them under the Jim Crow laws.

So the Tyree family to which Lucas belongs was never allowed to go to public schools, never allowed to mingle with whites, never allowed to go into a public hospital, sit in the back of the bus, you get the picture right. So Lucas was one of the first members of the Stripe ever to go to school in Virginia. He was so good that he ended up at the University of Hawaii, and then he ended up at Yale. And halfway through his PhD, he decided he wanted to go back to his ancestral lands. And Yale wanted him to stay, but he didn’t. He went back and he made an invention. He had studied agriculture and environmental studies at Yale. He made an invention which allows him and you and I eventually hopefully to grow plants in plain water with no nutrients through the roots or in sand or in the Ted soils, eroded soils by feeding them the entire nutrients that they need, all the minerals, all the amino acids, everything through the leaves.

He had to develop a formula. It has a penetrant in the formula, which allows all these things to go through the leaves. And this is an ideal way of feeding plants in hydroponic systems or in plain river, especially leafy plants like lettuce. And we got him two patents on this thing. We are now talking to hydroponic companies and getting their interest in perhaps taking licenses. And Lucas would like nothing more than to take some money, which he will hopefully receive someday from hydroponic companies or others, and buy back the lands that were stolen from his family because of the Jim Crow laws, because of Virginia’s past history, and also by the Ku Klux Klan who haunted him and his family for decades. And that’s his revenge as it were. And it is one of the most moving cases I’ve ever had in patent law is to help Lucas.

Lee Rawles:

So Jorge, I hope that people have now kind of a taste of everything that is contained in patenting life. There’s so much we didn’t get to if you were listening to this to hear about Monsanto. Jorge actually has fought them in court. There’s some very interesting anecdotes in the book, and we didn’t even talk about your deposition with the Caltech Post-grad, which I thought was hilarious. So that’s a little strike for anyone who goes and picks up the book. But to end our discussion, if there are any law students or young lawyers listening who are like, wow, Jorge jumped into the profession. He spent it sort of the beginning. What are your best pieces of advice for young aspiring patent attorneys who think, you know what, yes, this sounds weird and wonderful. I have a scientific background, I’m so interested. What are some of your pieces of advice for them if they’re listening?

Jorge Goldstein:

Well, I have advice to two communities. One is scientists like I was who are perhaps not quite happy working at the bench anymore. I call them unhappy postdocs. And I always, always go around looking for them and talking to them because coming into biotech law, into biotech patent law is a really good alternative career. And I was just at my alma mater and I gave a lecture there, and several PhD students came over and said, this sounds very interesting. Maybe I will go to law school. And I said, do so, do so. My advice to them is, yes. Think about going into law. My advice to young lawyers, and I have many of them in the law firm, we have about 160 lawyers. Many of them are PhD lawyers, always is look for a niche that you and only you or a few others will be able to develop.

If you see it coming, jump on it. Just like I saw the little cable car of biotechnology coming by in the 1970s when I was studying, and I jumped on it, and I have been on it for 45 years. There are cable cars coming by you all the time. You need to have a sense of, yeah, this is the right one. And then you have to have a sense of risk. You have to be able to jump on it and stick with it. There are so many developments in biotech and in general technology law that all you need to do is just wait for the next one and then become an expert on it. The big thing that’s coming down the pike, obviously Lee, is artificial intelligence. And I say very little about it in the book. I’ve never had a case on ai.

Lee Rawles:

Not yet,

Jorge Goldstein:

Not yet, and I’m not sure I will. But the impact of AI on biology, on molecular biology, the ability to a, create new proteins, to create new biomolecules that will be specifically aimed at particular receptors and particular diseases is coming down the pike really fast. And if I had to give advice to anybody in the biotech patent law area, is that’s the next big thing. And you need to understand ai, and not only technologically, but legally, it’s going to cause all kinds of headaches. AI, for example, cannot be named as an inventor in a patent application. The law is it’s got to be a human being. It cannot be a computer. So if AI invents things and you are working for a company and you use ai, you cannot get a patent. And if you name yourself, you may be committing fraud on the patent office by lying about who invented it. And AI is inventing stuff. There’s no question. I hear stories of AI inventing drugs all the time. Now, that’s the next big thing, both legally and technologically, it’s the mixture of law biology and computer science. And I’m not going to live it now in my retirement phase. I am writing books. I will not be practicing law for much, much longer, but my young lawyers would be well advised to think about the next big thing and jump on it.

Lee Rawles:

And if anyone wanted to reach out and get the book, which by the way is also available as an audiobook, patenting life, or to speak to you about any of these ideas or good advice, is there a website that you would point them to?

Jorge Goldstein:

Yes, I have a writer’s website, and it is www jorge goldstein one word.com. And that’ll take you straight to my writer’s website. And there is a contact link and you can write me an email and I check my emails for the website pretty much every day. And I will be more than happy to get back to you. And we can have a chat if you wish.

Lee Rawles:

Well thank you to Jorge and thank you listeners for joining us for this episode of the Modern Law Library. If you enjoyed this, please rate, review, and subscribe in your favorite podcast listening service. That’s a big help to us. And if you have a book that you’d like me to consider for a future episode, you can always reach me at books at ABA Journal dot com.