My Review of Luigi Palombi's book, Gene Cartels

It appears in this month's Script-ed, and since it's a creative commons license, I am posting it here as well:

"Book Review

Gene Cartels: Biotech patents in the age of free trade

Luigi Palombi

Cheltenham, UK; Northampton, MA (USA): Edward Elgar, 2009, 416 pp, £85, ISBN 978 1 84720 836 1 (hbk).

DOI: 10.2966/scrip.070110.230


It is a shame that there are so few existing copies of Luigi Palombi’s Gene Cartels. The initial press run for this remarkable book was apparently less than 1000, yet this is a book that every policy maker even remotely connected to issues of patents, economics, and biotech should read.

Palombi’s background is in law. He worked for years as a patent lawyer, writing and arguing for biotech patents. Over time, he grew disenchanted with the scope and reach of patents being granted on biotechnology “innovations”, especially as more and more patents began to be granted further “upstream”, over things that were not inventions, but rather discoveries. He is now a researcher with the Regulatory Institutions Network at the Australian National University. He devotes his research and activism to eliminating “gene patents” and his magnum opus on the legal case against gene patents works methodically through not just recent law on the subject but the history of patent law itself.

Palombi traces the history of patent from its historical roots as a mode of privilege granted by sovereigns and places current debates about both the effectiveness and justice of such monopolies into much needed context. Some modern defenders of patents fail to discern that intellectual property is an artificial device which skews free markets, tending instead to ignore the unnatural, state-sponsored nature of the patent monopoly. Palombi deftly shows us otherwise and comes out strongly, backed both by history and legal theory, against patents as either a necessary or efficient economic tool for innovation. He moves deliberately through a useful discussion of modern day patent regimes and the effects of globalisation and harmonisation of IP regimes, primarily with those of the US and western democracies. He then moves on, just about 200 pages in, to grapple with the subject of biotech patents, and specifically those on genes.

Taking a clear stand against the modern trend in US patent law and extending this to other patent regimes, Palombi rejects the central notion that mere “isolation” or an element of nature is sufficiently inventive to warrant a patent. In a pivotal chapter, the “isolation contrivance” is traced through the cases that gave it credence, and destroyed piece by piece as based upon flawed legal reasoning. It is the lynchpin of the argument favouring patents on “isolated” gene sequences and Palombi shows how this now accepted dicta has resulted in legal nonsense that can no longer stand scrutiny – especially the type of methodical scrutiny Palombi provides.

Simply put, Palombi shows, through careful examination of the evolution of the law regarding “isolated and purified” natural products that patents extended to them defy reason as well as the purposes of intellectual property law itself. The remaining hundred and some pages provide the most explicit, detailed, and definitive arguments against the legality of gene patents so far. He takes us through patents on EPO, adrenaline, genetically-engineered, recombinant bacteria, and then finally through modern-day diagnostic patents on naturally-occurring mutations to naturally-occurring genes, such as Myriad’s patents on the BRCA1 and 2 gene mutations whose presence indicates a propensity for breast and ovarian cancers. In each case, he shows through the legal cases how the law has been perverted from its original intention to reward invention to become a prize doled out now for mere discoveries – the age-old territories of the sciences rather than industry.

Critical to Palombi’s work is his detailed discussion of both the legal and practical consequences of the current situation. The cartels afforded by gene patents, he argues, are unprecedented in the law, gaining monopolies over much more than the mere sequences but also to any and all protein products of those sequences. These cartels then control every facet of a particular gene’s expression, including any treatments that might be developed for genetic diseases, as well as all diagnostic tools. Moreover, as is made clear in the case of the BRCA 1 and 2 patents, research is legally, and sometimes practically, road blocked by such patents.

Palombi’s analysis is deep and broad, providing technical, legal details of the gene patent situation around the world. Influenced as it has been by US laws and corporations, gene patents have now spread throughout Europe and other industrialised nations, despite the proclamation of the various partners in the Human Genome Project that the human genome was our “common heritage”. He concludes his discussion, having demolished the notion that isolation of genes is inventive in any sense previously necessary for patents, by discussing in depth the history of the BRCA1 and 2 patents, and pondering what the current situation means for research in synthetic biology. His prognosis is bleak and his conclusions are justified by his elaborate recounting of not just the errors but ultimate effects of gene patents for both basic science and clinical practice.

This book is essential ammunition for those who oppose gene patenting, and lays out the legal case expertly. My own book, Who Owns You? (Wiley-Blackwell, 2009), was motivated by similar concerns, and makes an ethical case against gene patents from a philosophical perspective but I wish I had had Palombi’s book at my disposal when I was writing, because his legal case is iron-clad and unassailable. Not only will the reader be left wondering how we got to the point where unaltered genetic sequences are afforded patents, but he or she will be moved to confront the policy-makers and jurists who now stand poised to be able to finally stop this practice, to follow the dictate of law, logic, and justice, and to liberate the genome as the common heritage that it is once again.


David Koepsell
Professor, Delft University of Technology, Netherlands



© David Koepsell 2010"

60 Minutes

60 Minutes did a great job with their segment, "Patented". It really is worth watching. Kudos to all involved, including Kevin Noonan, with whom I have sparred on the subject, who did a good job standing up for his side. I hope he'll take part in the documentary we are making as well. It is worth noting that the "lies" Noonan accused me of were the same statements made by Morley Safer on the 60 Minutes segment, though he seems a bit more politic in his references to the TV show than to my book (which he hadn't read, by his own admission, at the time).

This summer, Taylor and I should be able to edit something together in time, hopefully, for a couple festivals, perhaps the Rotterdam Film Festival here in Europe would be a good start. Overall, the timing on this subject really has been amazing. Little did I know when writing my book that the ACLU would bring this suit, nor especially that the time-table on the suit would coincide so well with the launch of the book. I'm been privileged to meet so many activists and academics involved in this debate at this critical time, and really am in awe of their commitment. Glad to see such momentum and media attention finally for this critical issue.

Two brief media hits

An op-ed co-authored with Ken Alfano in the Washington Times today, and a radio interview this morning on The Takeaway, out of WNYC, syndicated nationally in the US. A couple more, potentially big, are in the works. I did a lengthy pre-interview yesterday with a US national network. The good news is that this decision got the media to finally pay some attention to this issue, and the momentum is now with our side of the story. I cannot praise enough those with both the ACLU and Public Patent Foundation for bringing this lawsuit, and calling much needed attention to the problem of gene patents. More to come...

**UPDATE** Here's an excellent piece from Forbes explaining why the technology of cheap sequencing, and the potentially profitable and beneficial services that could be offered, demand that gene patents cease.

**UPDATE 2** so, apparently Joseph Priestley could have (or could not have) patented O2. Read through all the comments to see a truly Alice in Wonderland chain of reasoning.

Win!

I must remember to take more holidays. Everything truly interesting seems to happen when I'm far from my computer. Of course, the ACLU's suit against Myriad is the big news, with proponents of gene patenting scrambling to find fault, or predicting armageddon as the result of Judge Sweet's well-crafted decision. Essentially, the judge held, as I have argued here and in my book, that the patents granted on gene sequences cover products of nature, which are otherwise not eligible for patent protection. He saw past the cute, lawyerly tricks that have been used to try to argue that "isolation and purification" of a gene result in something, somehow unique, and he found as reason and logic dictate: nature made the patented sequences at issue in the case, not man, and the patents are invalid under Section 101. See also my post "It's the novelty."

Expect a long, hard slog as this case moves up to the Federal Circuit Court of Appeals, and then, obviously, to the Supreme Court. Meanwhile, we may get a clue as to SCOTUS's leanings when they issue a decision in Bilski.

WOW

...on holiday at the moment, and this keyboard is too odd to do a detailed post, but suffice it to say for the moment that I am stunned and thrilled that the District Court ruled against Myriad! Much more soon!

Commons Sense

One of my recurring frustrations in making my case against gene patents is the failure by some to grasp the argument I am trying to make regarding the nature of "the commons". Perhaps I have been unclear, or maybe the approach I am taking to property law and justice is too far afield from those more frequently made to be immediately understood. Yesterday, however, I gave a guest lecture in an ethics course for ICT students (software programmers, mostly), and gained a lot from the experience. These students not only grasped the argument, but embraced it, and helped to clarify a subtlety that I need to elaborate upon in defining the "commons by necessity" that I believe genes and other parts of the universe belong to.

Briefly, to summarize, I argue that the justice of property rights derives from the logical and practical ability of people to enclose a space, and the need for a rival to use violence to dispossess a possessor of the space. Thus, property rights in land and movables are grounded in these brute facts. There is no such grounding for intellectual property rights. Moreover, there are parts of the universe that cannot be justly owned, and IP claims over these "commons by necessity" are unjust. These are parts of the universe which cannot be held exclusively by anyone, as a matter of brute fact. Examples include: the laws of nature, radio spectra, and genes which are de facto unencloseable. My thanks to Stephan Kinsella who helped me to realize that this applies, actually, to all ideas, and thus makes all IP law a similar incursion on an unencloseable commons by necessity.

My thanks go to some of the students yesterday who pointed out a fine distinction in the realm of objects belonging to the commons by necessity (as opposed to the commons by choice, which includes encloseable spaces over which we make choices to maintain no private ownership). They pointed out that there are commons not just by logical necessity like radio spectra and laws of nature, but also those that might be called commons by practical necessity which includes sunlight. So one could, given enough time and technical capabilities, enclose the sun and harness its power monopolistically, but this is a very remote technical possibility.

Genes, I argue, are logically unencloseable, and thus clearly belong to the commons by necessity, and attempts to give monopolistic control over them are per se unethical. If there's only one point I hope readers take away from my book, this is it.

**update: I just learned Who Owns You? is being translated into Portuguese! My first book came out in Japanese and Portuguese, so maybe Japan will soon follow suit. I'll keep you updated.

Brief update

The blog is in a holding pattern these days, waiting for courts to do their thing, and trying not to hold my breath. There are still some promising developments to report in the fight against gene patents, including the fact that soon, The Australian Senate inquiry into gene patents should conclude with some form of decision. My friend Luigi Palombi has been heavily involved in that fight, and my fingers are crossed. A good decision there will give us momentum here, and, of course, vice versa.

Also, Congressman Becerra's bill, The Genomic Research and Accessibility Act is once again (or still) on the horizon. I hear that they are looking for a Senate sponsor, and then hopefully, that effort will move forward. The timing is right, with Sebelius confronted with making a decision on the recommendations of the panel regarding limiting gene patents, the ACLU case under deliberation, and continued and growing public attention to the issue, something has to break soon.