Koepsell and Noonan on Gene Patenting

In 2009, the first edition of Dr. David Koepsell's book "Who Owns You: The Corporate Gold Rush to Patent Your Genes" was published.  With the second edition of his text about to be published, Dr. Koepsell allowed Patent Docs to post the Preface for his book as well as the Foreword, which was authored by Dr. Kevin Noonan.

First, Dr. Noonan's Foreword:

David and I have had a friendly disagreement about the subject (and even the title) of this book ever since it was first published, and I am happy that he asked me to write this Foreword to the Second Edition. The issues David raises in the pages to follow continue to be relevant to a discussion of philosophy and patent law, with events that have occurred since the first edition justifying (indeed, demanding) this update.

Without getting into the deep waters of philosophy (David's métier, not mine), as we have discussed the issues in the book David contends that he takes a deontological approach and has characterized mine as a utilitarian one. Accepting that dichotomy I understand the difference to be that David is operating from "first principles" about the rules society should impose on human activity and specifically on what the law permits individuals to "own" with regard to genes and more broadly naturally occurring substances. I disagree with that approach on several levels, perhaps the most germane of which is that if we posit rules we need to impose a rule‐giver and the potential for improvident rules (if not outright abuse of the privilege) makes me wary; in some ways I subscribe to Lani Gruinier's suspicions about the effects of the "tyranny of the majority" in this regard.

Part of that tyranny is also the tyranny of unintended or intentional ignorance. The issue here—"gene" patenting—is one at the intersection of molecular biology and modern genetics, on the one hand, and patent law (an area notorious for its arcane minutiae). I used to joke with my colleagues about the effect of trying to explain my position to a lay audience of any type and how I distrusted those who advocated that all that was needed was to "educate" the public, the press, and policy makers. The problem for proponents of gene patenting has been that opponents have gotten the better part of the debate, not by making a reasoned philosophical argument such as the one you will find in these pages but instead by making an emotional plea to individuals afraid that corporate America was trying to "steal" their genes, which has proven very effective. This process began with an Op‐Ed piece in The New York Times by Michael Crichton, wherein he posited a scenario where a patent holder knocks on your door one day and demands payment for the use of "her" patented gene that resides in your liver. (Not coincidentally, Dr. Crichton had just published a novel on the perils of genetic engineering and corporate ownership of human genes, complete with an essay as an addendum containing his arguments against the practice. And it should be noted that a constant theme in his novels was a mistrust of technology and particularly the ability of humans to use it without dire consequences). Academics like my friend Lori Andrews at Illinois Institute of Technology (IIT)‐Kent School of Law joined in this theme, which was picked up eventually by most popular press outlets and became, regrettably, the canonical narrative on gene patenting, culminating in the American Civil Liberties Union's (ACLU's) "Keep Your Hands Off My Genes" slogan and logo. I hope that this essay provides some antidote to this argument, which is founded on the literal fear that someone can "own" you. (David assures me that his title is allegorical and that he acknowledges that in all countries that have banned slavery no one can "own" another human being or a part of them. See the 13th Amendment. I assure you that the ACLU has no such illusions about the intended consequences of their ownership rhetoric).

My philosophy is that the principle we should follow is the greatest good to the greatest number, while not infringing on individual rights without (at least) compensation. As regards patent law, this principle is translated into rules that foster the broadest disclosure of technology possible in return for exclusive patent rights and robust‐enough enforcement rights for patents that they provide sufficient certainty to promote investment so his technology is commercialized to benefit the greatest number. In my role as a biotechnology patent attorney, I have seen how risky investment in biotechnology can be (indeed, the evidence is overwhelming that for all its successes, biotech's history is littered with the remains of companies that have failed) and how important it is to have a sound patent system of predictable rights go support that investment.

The evidence in support of "gene patenting" and more broadly natural products patenting is strong: the biotechnology industry has promoted innovation in the form of new drugs and diagnostics assays for a generation. This may continue despite the recent restrictions on patent protection for genes and natural products (including patent‐restricting decisions in Mayo Collaborative Labs. v. Prometheus Labs and Assoc. of Molecular Pathologists v. Myriad Genetics and recently promulgated U.S. Patent and Trademark Office Guidances on Subject Matter Eligibility). In fact, these very restrictions suggest that we would benefit from an appreciation of the facts surrounding the past thirty years of gene patenting to understand why these restrictions are not only wrongheaded but dangerous for future innovation.

These include debunking several myths. First, the concern that patents on specific human genes in some way inhibit innovation in basic genetic research is entirely unfounded. One reason is that the genetic information itself is not patented; while isolated DNA is encompassed by gene patent claims and described in those claims by its sequence, the sequence itself is unpatented information that can be used freely for any purpose (e.g., interrogating genetic databases from other species or even human DNA, inter alia, to find related genes in those databases). Indeed, the innovative benefits to gene patenting are evident in at least two ways. First, scientific publication databases reveal that there have been more than 11 000 scientific papers published on the BRCA1 and BRCA2 genes since the patents claiming them were granted. This outcome refutes the prediction that gene patenting would create a "tragedy of the anticommons" where scientific research would be stifled by patenting (see, Heller & Eisenberg, 1998, "Can Patents Deter Innovation? The Anticommons in Biomedical Research," Science 280: 698–701)), a conclusion supported by the overwhelming majority of studies done on this subject (see, for example, Walsh et al. 2003, "Science and the Law: Working Through the Patent Problem," Science 299: 1020; Walsh et al. 2005, "Science and Law: View from the Bench: Patents and Material Transfers," Science 309: 2002–03).

In addition, policies that the U.S. Patent and Trademark Office adopted in 2001 required applicants to disclose a practical utility for the product of a gene claimed in a patent. These requirements were imposed at a time when the standards for scientific journal publication were much less stringent, so that identifying a gene by the extent of genetic similarity between the "new" gene and previously discovered genes was enough for publication. But it was not enough for a patent, which has been held to be "not a hunting license. It is not a reward for the search, but compensation for its successful conclusion." Thus, genes encoding proteins having no known use or biological activity cannot be patented, because to do so would allow the gene to be within the exclusive patent right undeservedly; the public would not have received its quid pro quo of a useful invention in return for patent exclusivity. All such genes not having patent protection are in the public domain (from which they cannot be retrieved for future patenting), and for humans these constitute the vast majority of genes identified, inter alia, by the Human Genome Project.

The role for patenting genes, and the related genetic diagnostic methods using this genetic information, in the successes of the biotechnology era are evident: The industry has produced hundreds of biologic drugs (at an ever-increasing rate) that have provided effective treatment for a variety of illnesses, and decoding the human genome has enabled researchers to identify genes, like the BRCA1 and BRCA2 genes, that can be used in predictive genetic diagnostic tests. Even the much‐maligned Myriad Genetics has played a positive role in the development and prevalence of genetic diagnostic testing. It must be remembered that in 1997 (when Myriad's BRCA gene patents were granted), genetic testing was in its infancy, and companies like Myriad were under the burden of convincing payers that the tests did the one thing that all insurers, public or private, require of such tests: save them money in the long run, by identifying patients with a high probability of becoming ill and costing the insurers much more for treatment than the costs of prophylaxis. Moreover, Myriad and like companies needed to convince doctors that the testing was worthwhile and to establish a network of genetic counselors who could explain to healthy women that they were at much greater risk of developing breast or ovarian cancer than normal, under circumstances that resulted in empowerment from the information and not abject fear. And in 1997, genetic sequencing technology was not as developed as it is now, and the mechanisms and techniques needed to minimize or eliminate the occurrence of false positives or negatives had not been conclusively established. All these burdens were ones borne by Myriad, and these activities produced the world we have today.

It is possible, as some have argued, that BRCA tests may have been developed independently by individual researchers in the absence of patent protection. However, it is almost certain that such researchers would have been located in medical centers in urban environments. Under these circumstances, women living in or near cities such as New York, Boston, Philadelphia, Cleveland, Chicago, Houston, Denver, Los Angeles, San Francisco, Portland, and Seattle might have had access to these tests. But what of women in Appalachia, or the Four Corners region in the Southwest, or more generally in rural or other relatively remote locations? Would Yale University, for example, have had any incentive to provide access to the BRCA tests to these women in these far‐off locations? Or to provide genetic counseling where the women lived? Or to lobby state Medicare administrators or private insurance commissioners to cover the test? I think that unlikely. Myriad Genetics did all of this, as well as perform outreach to the obstetrics and gynecology doctors throughout the United States so that these primary care doctors were aware of the tests. Myriad did not ace from altruism but as part of their business plan in order to expand the number of patients who received the test and thus maximize the company's revenue. While it may be counterintuitive to some, these circumstances may have been the most effective way not only to promulgate the BRCA tests but also to facilitate acceptance of genetic diagnostic testing for other diseases, showing that in this instance Adam Smith rather than Karl Marx provided the most practical solution to the problem of establishing genetic diagnostic testing as a recognized component of a physician's diagnostic armamentarium.

Fortunately, the significance and impact of recent US court decisions (specifically, the Myriad case) is much less than it would have been ten to thirty years ago. Due to patent term rules, most patents (and applications) on isolated DNA filed in the heyday of the Human Genome Project (approximately 1998–2001) are near the end of their actual or potential term; indeed, a recent study shows that the number of granted patents having at least one claim reciting an isolate DNA comprising a gene peaked in 1999 and has been dropping since 2005 (Graff et al. 2013, "Not quite a myriad of gene patents," Nature Biotechnology 31: 404–410)). These recent decisions in the United States have not harmed the biotechnology industry because they retained patent eligibility for species of DNA that show evidence of the "hand of man" and do not occur in nature. These include enzymatically produced copies (cDNA) of cellular messenger RNA and should also encompass the tools of the recombinant geneticist (e.g., including recombinant vectors for cloning and expressing genes in heterologous cells). Most importantly, the U.S. Supreme Court did not overturn its Diamond v. Chakrabarty decision wherein recombinant cells were determined to be patent eligible.

Thus, in many ways the question of patent eligibility for human genes is a philosophical one. However, that does not mean that how we think about patent eligibility for isolated DNA is irrelevant to important questions regarding the usefulness of patents for promoting progress and innovation. Indeed, the most pernicious effects of the current trend in the zeitgeist against patenting has been not that genes have become harder to patent but rather that the ability to patent other natural products has been called into question. It is the extension of these recent decisions on isolated DNA to all natural products that poses the greatest threat to innovation. This threat can be illustrated by a thought experiment: for which of these substances should patent protection be withheld?

• A petrochemical with excellent lubrication qualities isolated in pure form and used as improved motor oil.
• Vitamin B12 isolated from beef muscle, formulated into a medicament used to cure anemia in children.
• The drug penicillin, isolated from a mixture of naturally produced chemicals made by a mold and formulated as a drug to cure syphilis (which is otherwise eventually fatal).
• Human urinary erythropoietin, formulated to treat anemia in kidney dialysis patients.
• The gene responsible for Gaucher's disease, a lipid storage disease, wherein the gene is used to make the missing protein that is administered to children and that cures an otherwise incurable and fatal disease.

The current answer is that none of them are patent‐eligible per se (although there may be ways to claim them that could pass eligibility muster; that remains to be seen). Judge Sweet, the U.S. District Court judge who first ruled that isolated DNA was not patent‐eligible, did so using language carefully crafted to avoid encompassing all natural products into his decision. Specifically, Judge Sweet distinguished isolated DNA as the "physical embodiments of genetic information," a property limited to DNA and not shared by other natural products. (While an enzymatic protein could be characterized as the physical embodiment of catalysis of a particular chemical reaction, that formulation has much less appeal and inherent rationale than Judge Sweet's regarding DNA.) Instead of this careful formulation, the broader language employed by the Supreme Court, as well as the broader rationale the Court used in finding genomic DNA unpatentable, has made it easier to employ that fractured logic to render patent‐ineligible naturally occurring molecules other than DNA.

I would be remiss not to mention the rather comical (but persistent) efforts of former Acting Solicitor General Neal Katyal, who included in the U.S. Government's amicus brief to the Federal Circuit the distinction engine he called a "magic microscope," embodying the concept that if you are able to visualize a natural product (like a genomic DNA molecule) using this mythical microscope then the natural product would not be patent‐eligible, whereas if you could not (e.g., a cDNA molecule) then the natural product could be eligible for patenting. Fortunately, the disdain with which the Federal Circuit greeted this fantasy (particularly from Judge Moore) prompted its quick abandonment as are argumentative distinction as the case moved forward. Nonetheless, both the courts and the U.S. Patent and Trademark Office have adopted this standard de facto even as it becomes the theory that dare not speak its name in legal circles. The philosophical point here is that these substances, and natural products generally, have been deemed patent‐ineligible categorically, which while consistent with (and perhaps even mandated by) the deontological approach imposes a distinction that cannot be flexibly applied to the individual circumstances. Without such flexibility, the law is constrained to use one criterion, that the substance can be found in some form in nature, to decide patent eligibility, instead of making the determination of whether permitting patenting exclusivity satisfies the criteria that the invention "promotes progress" as the U.S. Constitution requires and has a benefit to the public that outweighs any categorical disabilities.

The potential that using this standard for determining patent eligibility will result in negative practical outcomes that no one in this debate desires is illustrated by a 2012 Report from the National Institutes of Health, Natural Product Branch, regarding statistics relating to the number of FDA approvals (a total of 1355) for new drugs falling into the following categories:

Drug type/source                                  Number
Biological (B)                                           203
Natural product (N)                                   55
Natural product (botanical) (NB)              149
Derived from a natural product (ND)        298
Totally synthetic (S)                                393
Total synthesis/natural product (S*)         176
Vaccine (S)                                               81

These statistics illustrate the consequences of a general ban on patenting naturally derived products; of the 1355 drugs approved between 1981 and 2010,

• Fifty percent of all small‐molecule drugs approved between 2000 and 2010 are natural products.
• About 75% of antibacterial drugs are natural products or derived from natural products.
• Almost 80% of small‐molecule anticancer drugs were natural products or derivatives.

In addition, only 15% of drugs approved during this time frame were socalled biologic drugs, which are also putatively patent‐ineligible. This, the problems caused by the current interpretation of the law excluding natural product drugs from patent eligibility will be exacerbated in view of reports from every study showing that the percentage of drugs that are biologic drugs has been growing and will be the predominant type of drug developed in the 2011–2030 time period.

Another "thought experiment" illustrating the practical illogic (David can provide his philosophical justifications in the body of the text) of broad natural products patent ineligibility is as follows. Suppose a researcher finds a molecule produced by the human body that causes blood pressure homeostasis, that is, lack of this molecule causes or contributes to the disease of high blood pressure. The logical consequence of the current natural product patent ineligibility standards would be that the closer a drug molecule is to the structure of the molecule as it occurs in the body the less patent‐eligible it would be. Practically speaking, there would be no incentive to modify the molecule to confer patent eligibility on the altered molecule because of the unpredictability of such changes on the molecule, such as its biological activity, half‐life, stability, antigenicity or other biological properties. And there would be even less incentive to develop the molecule as a drug because without patent protection the available regulatory exclusivities would not pass economic muster to sufficiently defray the large development costs (some of which prevent drugs neither safe nor efficacious from being sold and thus provide their own justification).

There is one further pernicious outcome that can be predicted to arise from a ban on natural products patents (including patents on isolated DNA and genetic diagnostic methods based on such isolated DNA). Natural products are almost by nature complex, and an "active principle" isolated from nature is beneficial because it is isolated; Kodak ran an advertisement in the journal Nature in the 1970s showing a scientist in a lab coat holding a 250‐ml flask and standing next to several bushels of green peppers, wherein the content of the flask was the purified "essence of green pepper" equivalent to that substance contained in all the peppers in all the bushels and bushels that the scientist was standing beside. But this very complexity makes it possible for the "active principle" (either as a chemical compound or as a diagnostic genetic sequence) to be "hidden in plain sight" in ways that may be particularly refractory to reverse engineering.

For example, even using somewhat dated "gene chip" technology, genetically diagnostic markers could be encrypted onto a microchip comprising 10000 unique sequences, wherein a computer‐readable bar code would be used to identify the positions of diagnostically relevant sequences on the chip. This form of encryption, which can be random and confounded by the presence of positive and negative control sequences as well as variable numbers and lengths of sequences specific for the gene (or more likely genes) of interest, would be very difficult if not impossible to reverse‐engineer. Even if reverse engineering could be done, it would be difficult and expensive to undertake and thus make it more likely that the innovator would be able to avoid competition (i.e., it would provide unlimited exclusivity to its purveyor not constrained by patent term or burdened by the requirement that the invention be disclosed with the specificity required by the Patent Act). While the possibility that this type of chip could be made exists with or without patents, the absence of patent protection could tip the scales in favor of the extra effort needed and risk entailed in nondisclosure, if the reward of extended "monopoly" is great enough. But particularly for genetic diagnostic inventions the benefits of developing a proprietary database, for which a corporation could provide the economic and marketing wherewithal to expeditiously produce, would result in a "worst of both worlds" outcome: unlimited exclusivity based on undisclosed proprietary information that not only is difficult to replicate but whose existence would inhibit competition. After all, if a company had such a database, its outcome for any particular patient's test would be more accurate (and might identify disease risk–associated genetic variants not available elsewhere) and this would provide little incentive for a physician to choose an alternative provider to perform the test (and even more malevolently, could create a system where the wealthy could afford the best diagnostic testing while the less affluent would be restricted to the more limited assays offered by companies without access to the "innovator's" proprietary database information).

The other aspect of foreclosing patents for certain substances or technology areas categorically is that it upsets a carefully crafted dynamic that has worked extremely well during the biotech era, between "true" innovators (typically university professors or small start‐up biotechnology companies) and more established companies capable of commercializing innovation. Pundits who worry that permitting patenting will harm innovation miss an important point: innovation will happen, particularly in universities, research institutes, and like places, because human nature demands it and regardless of whether patent protection is available. The intelligent ape in us wants to know, and the disparity between how university professors and patent lawyers are paid should establish how powerful the need to know can be. Patenting, and the impetus for patenting provided, for example, by the Bayh–Dole Act in the United States, prevents the fruits of these inventive efforts from mere predation by commercial concerns. The benefits that can be had from a system where private commercialization is encouraged are tempered by the types of corporate shenanigans that raise cogent criticisms of the system. But perhaps it is mere human nature that people (in the corporate as well as individual sense) will want to expropriate technology rather than pay for it, and patenting prohibits (or at least retards) this outcome (if not these tendencies). Thus, paradoxically, limiting patent rights does not free innovation but rather makes it more likely to be kept captive by the entities capable of using such innovation to make a commercial product, that is, not from the power of building a better mousetrap but by being able to outcompete smaller innovators merely by their greater economic prowess and resources. Conversely, patents provide a way for the innovators to protect their innovations and compel corporations to license their inventions, producing revenue that can be used to fund future research endeavors. This useful cycle has resulted in the successes of the biotechnology era and is something that we abandon at our peril.

Thus, in my view patents are a useful tool for achieving these societally beneficial goals, promoting innovation and commercialization, and protecting and supporting individuals who use the patent system to protect the products of their labors from being expropriated by others. David provides a cogent and honest counterpoint to these thoughts. Enjoy reading them.

Kevin E. Noonan
Chicago, Illinois 2014

And now Dr. Koepsell's Preface:

A lot has happened in nearly every respect since I first decided to try to delve into philosophical issues of gene patenting nearly a decade ago. I have learned much, the world has changed, and I have changed. I would very much like to think I have played a role in that change, though chances are things would have changed in almost exactly the same way without my small contribution. When the first edition came out, patenting genes was still a regular part of biotech, and only months after the first edition appeared did a surprising and now‐landmark lawsuit alter that significantly. Little did I realize the nature of the forces that would be involved in what I had originally assumed was no more than an academic exercise, but which became a matter of weighty and heated public debate and finally judicial action.

I first became interested in the subject of gene patents when I began reading up on the topic my future wife was researching: pharmacogenomics. To grasp what she did, I first needed to study the science, and in so doing, I also studied the history of that science. Along the way I read about the Human Genome Project and learned about the practice of gene patenting that it spawned. Having had some experience and interest in general issues of the philosophy of intellectual property (see my 1997 Ph.D. thesis turned 2000 book, The Ontology of Cyberspace), my ears perked up when I first read about the notion of patenting genes. So I dived into the research and thinking, in my ordinary style of philosophical work. Although I sometimes teach ethics, my primary field is ontology, and it is from an ontological approach that I start with everything in philosophy. Thus I began to try to get a grip on the nature of the existence of the underlying objects, some of which are "brute facts" (molecules exist, with or without social institutions or intentionality), and some of which are social objects (like laws, rights, and other parts of "social reality," existing only because of collective intentionality). The book was an attempt to lay all this out and to connect it together into a theory that is somehow connected to notions of "justice," which I argued bridges the worlds of brute facts and social objects.

The conclusions I reached were, I thought, pretty neat. Specifically, I worked out an ontology of "the commons" that I had never heard expressed before, and one that connected nicely with the objects involved to show why artifacts and nature ought to be treated differently, and how to decide what constitutes an artifact and what constitutes nature, and a defense of the viewpoint that unmodified genes were clearly not artifacts. It seemed all the more relevant and interesting, even perhaps somewhat important in light of the then ongoing practice of gene patenting. I was much too focused on the ontological arguments and their seeming relevance to real‐world practices than I was to the scientific and legal terminology with which I was engaging, and this was an error. When the book was released, minor errors I made in using technical terminology from both the science and the law were latched onto by a couple critical reviewers from the Intellectual Property law and teaching worlds and urged as a basis to ignore my substantive arguments. They were right to call out the errors, and I have attempted to correct them in this edition. Regardless, the underlying arguments I had set forth would become, shortly, echoed nearly precisely in the lawsuit that the American Civil Liberties Union (ACLU) spearheaded against Myriad Corp. over the BRCA1&2 gene patents.

For a brief period of time, partly due to lucky timing, I was thrust headlong into the public debates about gene patenting, with the Myriad case leading the headlines. Given numerous opportunities to engage publicly with the issues and ideas I had previously assumed were only academic musings unlikely to alter public policy, and given feedback and counterarguments in those same venues, the general arguments could be more finely honed. This edition attempts to coalesce them.

Perhaps more importantly, in the intervening years since I began my musings about the nature of genes, artifacts, nature, and patents, I came to learn the very personal impact that gene patents have on people's lives. Because the ACLU chose to sue over the patents on BRCA1&2 genes, there was a ready‐made, large, and passionate community (mostly women) whose heredity put them at risk of breast and ovarian cancers but who were basically forced into paying monopolistic prices for the only test available for the gene, which was patented by Myriad Corp. Breast cancer and the threat of inherited tendencies for breast cancer are real. They are not legal sophistry, they are not philosophical musing. They kill people or alter their lives irrevocably.

I began researching and considering the effects of gene patents believing they were potentially a threat to the conduct of science, whose foundational objects I argued were part of a commons‐by‐necessity, but I realized after my book came out that real lives were being harmed by patents on genes. The Myriad case brought together the theoretical with the actual for me, and the dynamics of both the case and the loud and sometimes angry public debate raised my awareness not only about this particular subject but also the power and responsibility of academic research in the sphere of public policy. Suddenly, ideas seemed more important, had relevance outside the academy, and could perhaps make a difference in peoples' lives. I began to interact with the activists who were fighting to liberate genes, to stop companies like Myriad in the courts, and engage not just in the philosophical arguments but in those fights. I joined with authors of amicus (friend of the court) briefs, interviewed and interacted with BRCA1&2 mutation‐positive women who were actively pursuing an end to a practice that I had only previously considered to be an interesting metaphysical conundrum. I also debated Intellectual Property (IP) attorneys and others, primarily with backgrounds in biotech industries, and learning better the nature of their arguments. I came to understand that most of them, including Kevin Noonan who once called me a "liar" on his blog, but who has now drafted the foreword to this edition, that they too generally have the best intentions. Many, like Dr. Noonan, truly expect that without gene patents as they existed until recently, the sort of innovation we need in biomedical technologies would not occur as it should.

Throughout the course of the litigation in Myriad, I remained engaged, continued to speak, to hone my arguments, adding to my list of criteria for something to be a creation (artifact) capable of patent "design" (as well as intention and being man‐made) and finally rejoicing when the decision of the Supreme Court came out as close to what I believed and argued was right as possible. I had seen an academic idea mature and bloom into public policy, real law, enforceable justice. While I realistically believe that the first edition of this book had only a very minor role in what finally happened, I am proud to have played some part, to have foreseen the issues, to argue them honestly from what I think is a rational and logical standpoint, and see that the world can be changed by ideas.

There remain issues to discuss, and not everything about gene patents has been resolved by Myriad. Some still argue that cDNA ought not to be patent‐eligible (in fact I still think it should be under the criteria I have set forth, though there are also arguments to be made that it is not, somehow, "designed" by man). Moreover, we should expect patent attorneys to do their creative best to continue to pursue patents on as much of the genome as they can within the constraints of Myriad. Finally, Myriad Corp. has not given up. They are still suing potential competitors under theories of infringement of parts of their patents that might have survived the ACLU's case against them. We shall see how they are eventually resolved and what the future holds for companies like theirs who profited mightily from gene patents for decades. I describe as much of this recent legal history as possible in this edition.

This book is meant to be a definitive version, sewing up the past five years since the first edition emerged, and so much changed in the world, summarizing that recent history and refining the arguments I originally made, correcting errors, and describing where we are, where we yet may be, and why gene patents as they once were ought never to be again.

David Koepsell
August 14, 2014
Mexico City, Mexico

Comments

[EG]

Kevin,

A well-stated and factually supported view on why the patenting of genetic materials and other natural products is necessary. I frankly grow weary of philosophical arguments like those proposed by Dave K. which are reminiscent to me of Aristotle's view that the sun revolved around the earth and thus impeded astronomical research for centuries. And before I hear that I'm simply a scientifically trained patent attorney, my degree in chemistry is a BA, not a BS, as I got a traditional liberal arts education at Carleton College, just happened to major in chemistry. (BTW, the ACLU attorney who argued at SCOTUS is a fellow Carleton alum with a degree I believe in political science and I had an interesting discussion one evening with some of his classmates about the Myriad case.) Like you suggest, we need to address issues like the patent eligibility of natural products with some logic and more factual understanding of potential consequences of impeding research and innovation in such materials if deemed patent-ineligible. Unfortunately, this debate is being dominated far too much by philosophy, hype, PR, and agendas that are given far more credence than they deserve. That includes the Royal Nine who seem to proud of being scientifically ignorant, but sure be frankly embarrassed for expressing such an attitude.

[Paul F. Morgan]

A great example of the very apt statement above that "a patent is not a hunting licence" [for an actual, complete, invention with specific utility and enablement] is the University of Rochester v. G.D. Searle & Co., Inc., 375 F.3d 1303 (Fed. Cir. 2004)(denying rehearing en banc).
Also, the Sup. Ct. decision some years ago that everyone likes to forget about that just claiming a compound as an "intermediate" is insufficient.

[David Koepsell]

Dear Kevin,

I appreciate your contribution to the new volume, and your respectful ability to engage with contrary points of view, as well as to take seriously the philosophical investigation of legal topics. You are a mensch, and a gentleman. You have also proven since we began our conversation about this topic that people of good will and contradictory opinions can be civil, logical, and also passionate in defense of their claims without casting aspersions on each other's characters. This is a rare faculty in this day and age, and especially in this medium, and your site and its contributors are a testament to what is best in this field.

best,
David

[Kevin E. Noonan]

Thanks, David. Likewise

[The Memory Motel]

I do so love the back-slapping.

Unfortunately you've got a long way to go, Kevin, before anyone should take you seriously as a critic of "intentional ignorance."

Prometheus v. Mayo is only a few years old, after all. You think everyone has forgotten your endless attempts to divert discussion away from the unrebuttable facts of that case? Nice try, anyway.

That said, your web site operates without major interruptions in service. Congratulations.

[Skeptical]

I see the entity (MM) has morphed with yet another sockpuppet...

Get well soon, PatentDocs.

[EG]

Skeptical,

Most definitely agree that a new incarnation of Malcolm has unfortunately infested Patent Docs