Ok, keeping with the gene-theme this summer, I’ll now be briefly turning my attention to gene patents. Jorge Goldstein’s Patenting Life: Tales from the Front Lines of Intellectual Property and the New Biology is a great introduction to biological patents in the US (and beyond). It’s also a rather personal narrative; Goldstein entered the field of patent law at a time when biotechnology was experiencing some rapid advances (many of them mentioned in the previous book I reviewed), and he describes his career as like riding a wave. Indeed, the more you read into the book, the clearer it is that he made his entrance at the exact right time.
Thankfully, before he gets too deep into describing the different cases (and sometimes his personal involvement in them), Goldstein does give us a quick primer on patent law, starting as far back as the fall of Constantinople. Goldstein’s explanations here are very clear and anything but boring and dry. His explanations are quite accessible; I personally was not familiar with the legal concept of conversion, which played a big role in one of the cases. But with Goldstein, it was well-laid out—I think I have it now.
While many of the foundations of these systems are quite old, the idea that people could commercialize basic discoveries, especially in the field of biology, is much more recent—in fact, for most academic biologists up until the early seventies, the idea seems quite foreign. The change seems to go back to the very first recombination DNA experiments performed by Paul Berg in 1971. Berg’s work involved recombining the genetic material of two different viruses, making a chimera. And then he sort of spooked himself—what he had just pulled off was really unprecedented. Berg’s work kicked off the Asilomar I conference, which focused on the safety and future guidelines of genetic engineering research. But the issues of property and of the ownership of the products of said research? They were not given the same level of attention. And perhaps they should have been.*
It was Niels Reimers, the head of what is now Stanford University’s Office of Technology Licensing, who realized there was potentially money to be made in the field. He contacted two other pioneers in biotechnology, Herbert Boyer and Stanley Cohen, to argue the merits of a patent application for their work. What really stood out to me was that it was a non-biologist who first saw the value of chasing a patent. The date this patent was filed—1974—could be argued as the moment the ball really got rolling for biotechnology commercialization.
This development led to a double-edged outcome. On one hand, we soon saw some fantastic breakthroughs: by the 1980s, we had our first recombinant insulin, Humulin, which would prove to be a godsend for diabetics. On the other hand, there was now a new framework—or minefield—that had to be navigated regarding ownership. What can be owned? Who can own what? And who owns you?
One of other important points Goldstein mentions over and over is that people make mistakes and that not everyone acts in the most moral fashion. Just because a certain scientist has performed a certain action, or a judge has made a particular ruling, that doesn’t make them right. Balance is extremely important; not everything is set in stone. Which is relieving, because there have been some decisions made in past cases that don’t really stand the test of time.
One of the more notable examples of course correction involves the decision in Association for Molecular Pathology v. Myriad Genetics—better known in popular consciousness as the ‘breast cancer gene’ case**. What struck me both as a PhD student when I first encountered this case and again now while rereading it was the odd hyper-focus many people placed on the breaking of covalent bonds when cutting or excising DNA. Cut the DNA sequence out of the genome? You’ve isolated it now. It is now artificial. This emphasis on certain principles of organic chemistry felt completely out of place to me as someone with a genetics background. So you cut it out? Great. Does it code for anything new? Does it have a new function?
I’m not alone though; the judge also found this viewpoint to be out of place in the light of patent law. Chemical novelty is not the same as patent eligibility, and cutting DNA doesn’t always result in a distinct biological function. A case where perhaps a few individuals couldn’t see the forest for the trees? But the key thing here is that the original decision on gene patentability, based on this fixation, was not upheld by the Supreme Court. And all those patents on isolated genes that Goldstein had defended in the past? Void!
There are some other great examples here as well. Without giving away too much (because I want you to read it for yourself), there are examples of dealing with cows and IP laws across countries, discussions on GMO soybeans and the economies of developing nations and a lengthy section on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). I was also delighted to find that Peter Hotez’s efforts to make a more simplified, patent-free covid vaccine also got a shout out! Finally, in the final section of the book, Goldstein describes some pro bono work he’s done for Indigenous communities, a section which did a fantastic job bringing in some new perspectives on how patent law could be utilized to assist different communities.
This was a great read that helped with my understanding of the kind of case law dealing with patents a little better, alongside introducing me to some new perspectives. A book like this is an especially important read if you have an interest in biotechnology. However, I did ‘read’ the audio version of the book, and while the narrator does point out where certain figures are in the hardcopy and ebook version of the book, there is no supplemental PDF provided—at least with the version I purchased. That would have been helpful.
No cute pics of GMO cows for me I’m afraid.
For cbr17bingo, this is Green. For the cover.