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IEET > Rights > Economic > Life > Innovation > Vision > Technoprogressivism

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Why I Believe Gene Patenting is Wrong, Although it is Currently Legal


David Koepsell
By David Koepsell
Ethical Technology

Posted: Aug 16, 2009

Before I left for an Alpine vacation of high altitude hiking, fresh air, and peace, I was pondering my response to Randall Mayes puzzlingly entitled: “In Defense of Patenting DNA: A Pragmatic Libertarian Perspective” published in Ethical Technology on July 26.  In the meantime, a much more scathing and less meaty attack on my book Who Owns You? The Corporate Gold Rush to Patent Your Genes was published as a “book review” (more on this in a moment) which stoops to the same level as numerous recent bloggers who, so moved by the danger of my arguments to their cause, have attempted to attack me, and thus misses the point of most of my argument.  I am glad I waited to respond to Mr. Mayes, who at least raises his own policy arguments and responds to a number of my policy arguments.

Before I respond to my disagreements with Mr. Mayes, however, and they are significant, I would like to first address the Holman “review,” which ignores the policy and ethical arguments I raise in both my book and my lengthy online commentaries since.

I can forgive Holman, who teaches at the University of Missouri, Kansas City School of Law, because he is only doing what any good attorney advocating for a position would do.  Unfortunately, he is doing so under the guise of a book review, but actually writing the summary of argument section of a legal brief.  He should also have disclosed any conflicts of interest he might have, such as stock options or other future benefits he might still maintain from his previous positions as a corporate lawyer for several biotechnology firms, including stints at: PhyNexus, Inc., Vice-President, Intellectual Property 2003 – 2005, Maxygen, Inc., Patent Counsel 2001 – 2002 Transgenomic, Inc., Associate Patent Counsel 2000 – 2001. 

Of course, it is possible that he has divested himself of all conflicts of interest, and has nothing to gain or lose by this argument (as I have nothing to gain or lose) and so is merely arguing a true belief, rather than carrying water for an industry which benefits him.  Unfortunately, he uses a number of devices that my former students might have used, and which I used at one time or another in the numerous appeals I have written and argued.  Because not all readers of book reviews have a legal background, however, let me point out just a few of the most egregious techniques before coming to the point: he failed to address the central, ethical argument.

“When the facts are against you, pound the law.  When the law is against you, pound the facts.  When both are against you, pound the table.”  All law students have heard and, at some time during their careers, used it to some success.  Strangely, Mr. Holman begins pounding the table early on, even though, given he is really arguing a legal case, he might have more successfully pounded the law.  This is because he makes the early decision to do what lawyers are trained to do when arguing an appellate case: convince the judge the law can go no other way.  Judges don’t like to have to set precedent, and so we are trained to convince the judge that, all along, the law bends clearly in our favor. 

Of course, looking at the briefs of most cases, you’ll easily see that despite the confidence of both sides in their legal conclusions, the law often leaves plenty of room for interpretation.  This is the case with the law of patenting genes, as the Supreme Court has not yet decided on this matter.  It may yet do so if the current lawsuit brought by the ACLU against Myriad for its BRCA1 and BRCA2 patents (patents on the tests for breast cancer genes) ever gets up to SCOTUS.  Meanwhile, there are clearly good faith arguments to be made on either side of the issue, as indeed the ACLU and other organizations, representing both cancer patients and thousands of researchers, have argued in their papers.  My legal arguments are not much more than theirs. 

So Holman does a good job of arguing his legal case, but in so doing misses the bulk of my argument.  Mine is not a legal argument, because I’ll leave that to the lawyers who are doing their expert jobs in the Myriad suit.  Rather, it is a public policy argument.  I want the law changed.  While Holman can pound the table and claim I am wrong about the law (as he erroneously does when he claims I rest my legal argument on the Moore case – I don’t, but the attorneys at Celera used it when convincing themselves to begin patenting genes), he loses the day when he sidesteps (though applauds my attempt) my ethical and philosophical arguments.  I am not writing to convince judges.  I am writing to convince everyone else, and especially policy-makers, and I am arguing that the current state of affairs should change. 

Of course, this sort of proposed change upsets those who have billed tens of thousands of hours drafting and filing patents on genes, even though there is scant evidence that those patents have encouraged much research, or promoted any great innovation.  In fact, in an article in Forbes, Craig Venter recently said he generally opposes gene patents except in rare cases, stating: “There were a couple of gene patents that were worth a lot of money, so all of a sudden every university and every biotech company spent a fortune on patenting genes, I think only the patent lawyers got rich.”  Perhaps this is why most of my detractors are patent attorneys, and I have received emails from supporters within the industry, including some large biotech firms, stating their support for my arguments while understandably asking for their anonymity.

Holman and Mayes also rightly correct my errors in terminology, I had thought I had caught them all in proofing the text as they caused my biologist wife to wince when she read them too.  These minor errors will be corrected in subsequent editions.  But it is another tactic, taken by Holman and some bloggers to raise these errors as sufficient reason to ignore the rest of my argument.  Holman, for his part, rests on that to his detriment, for he has missed the critical, central, ethical arguments.  Fortunately for Mayes, he responds in depth to my policy arguments, but naturally, I differ with his conclusions.  Let’s examine some of those differences.

Firstly, I am baffled as to how Mayes’s argument is in any way a libertarian one, although it might be pragmatic.  I am consistently confused by “libertarians” who support a government-sponsored monopoly of any kind.  I make a libertarian argument of my own in my book, arguing that there is no free market given the existence of patents, which are the grant by a government of an artificial monopoly of the practice or sale of a useful art or product.  I have been making this argument since my first book, The Ontology of Cyberspace (Open Court 2000). 

The present book elaborates upon my economic/libertarian arguments, explaining that as many software developers who are experimenting with disseminating their goods outside of IP law have found, there are ways to form private contracts and licensing agreements with users that enable the functioning of free markets, and encourage rational product pricing to function without the influence of governmental backing. 

Of course, I have made in both books the rather lengthy and detailed argument that Intellectual Property “rights” are completely unlike rights to other forms of property.  I believe that real and personal property is “grounded” in “brute facts” whereas IP rights are utterly creations of the “positive” law, created for a pragmatic purpose, and alterable at will.  IP laws only conflict with notions of justice when they impinge on some other, grounded right, as I argue they do with the genetic commons. 

This critical argument remains un-assailed by either of the two detractors discussed here, which seems like an admission that they have no particular response.  There are counter-arguments, and given the critical nature of this argument to my ultimate conclusions in both books, I am dumbstruck about why no one goes after that linchpin argument.  I would welcome that kind of discussion. 

Instead, we get Holman’s complete disregard for this underlying policy argument, and Mayes who skims past it even while claiming he will address “why the moral case against patenting DNA fails.”  I seem to have missed his reasoning, as he merely claims that the title of my book is an ad hominem argument, and talks about John Sulston’s argument regarding DNA’s role as part of the “common heritage of mankind” while completely bypassing my argument about types of things that cannot be claimed at all – commons – and why DNA is part of the commons. 

Mayes also reiterates, in addressing my and others’ arguments that DNA is a discovery and not an invention, the same legal arguments that Holman relies on, essentially claiming that because other courts have upheld it in the past, then gene patents are, like courts ruled in the case of synthetic adrenaline, inventions rather than discoveries.  Of course, I have some detailed analogies in my book showing the logical problem with this chain of reasoning, and I conclude that these court cases were wrongly decided. 

Nowhere do I claim that patenting living things is per se immoral, but Mayes feels he needs to address the argument, and I support his arguments in that regard.  I have never argued otherwise.

We disagree starkly on the remaining parts of our discussions of the topic, including the economic and scientific arguments.  I claim that it is inefficient to grant government-sponsored monopolies (which are valuable to the share prices of biotech companies, but often prove less than valuable in the actual process of drug discovery), and that we ought to make biotech companies and other corporations compete with the actual values of their products, and speed to market.  Even setting this radical argument aside, I argue, as Venter and others confirm, that gene patents are not the most economically efficient way to exploit publicly-funded science, nor necessary to spur useful innovation in drugs. 

Finally, I am moved by Fiona Murray’s in-depth examination of the actual chilling effect of gene patents on scientific research.  Her empirical evidence seems to indicate that basic research is being hindered by the existence of patents on genes, and this should concern us all.  Perhaps this is why so many scientists have come out against the practice, and are being represented in their fight against it in the Myriad case.

Listen to a Changesurfer Radio discussion of David Koepsell’s book Who Owns You?

As with any argument, there are counter-arguments and it would be hubris to pretend mine is the only tenable position.  I am glad for Mayes’s honest contribution to the debate, although we differ in the end.  I am dismayed by Holman’s given it seems a less than honest attempt to review a book, and more of a brief in opposition to my legal arguments (which do not form the central part of my many arguments in the long run).  But you are the judge, and to do justice to these arguments such as they are on both sides, you should read them yourselves.  You may agree, and you might not. 

It gratifies me that there is some public support for my position, as well as significant support among the community of scientists.  I leave it to you, ultimately, to come to your own conclusions, and I can only hope that when read in the depth I afford the topic in my book, you’ll find you agree that the human genomes is a commons and cannot be claimed by any person, institution, or corporation.


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COMMENTS


Who owns me?  I do.  Every gene and epigene contained by this rather petite body is mine.  Memory, 85 years of it, is a plentitude of memories despite a myriad of cell deaths in the normal passage of time—all of that is mine too. 
I read Venter’s “A Life Decoded” and understand why the sharks (rich risk takers, independent investors) can argue that they “are owed” for having put up cash to speed the genome ID project.  To the tune of patents for individually identified genes?  That’s ridiculous.  It’s like claiming copyrights to the Chemical Table of Elements. 
A patent on Oxygen?  On Hydrogen?  Nitrogen?  Well, no, not until it makes itself into something—like a molecule of water!  Yeh, patent that!  Add a few light weights and keep it in the gaseous state and patent hot air!  Join hands with the guys who hold the water patent and claim a separate patent for cold air.
I’m disgusted that this patent debate ever was, is needed. 
It’s like hot air being patented.





Thanks, Margaret, for saying it so eloquently.  Obviously, I completely agree.





Welcome back David. I envy your vacation ; unfortunately I am stuck in the North Carolina August heat and humidity while attending cognitive dissonance group therapy sessions (at your suggestion).

In response to your cathartic essay, I will attempt to address your questions. First, my IEET article wasn’t addressed specifically at your book or you, rather towards the movement to criticize patenting DNA from a meta-perspective. Your message fails to provide a better option. Looking at the criticisms and apparent weaknesses in your message, not with you the messenger should be the purpose of this exchange of ideas.

For example, in response to Maragaret’s statement I wrote and you wrote we do not own genes, rather patents. This is not an issue of values, but an ignorance of patent laws.
 
As part of the meta-analysis, maybe not you but others have criticized patenting organisms. Even the USPTO has and their decision was reversed. Also, the reason the moral arguments fail is from a legal perspective i.e. to convince the courts and Congress. I pointed out why I think they fail. I’m not sure logically how these arguments would differ to those of your audience of citizens and policymakers. This raises the question in the event you did have a strong legal argument, would your approach have been different?

It’s unclear if my libertarian views on DNA patenting are a criticism or an enigma. If a criticism, it is uninformed. If an enigma, one runs the risk of appearing lazy with resources such as the internet.

Your confusion related to libertarianism and what libertarians think is probably due to several reasons. What libertarians think is not universal. Libertarians at the Ludwig von Mises Institute are ideologues. They do not want the state involved period, so this provides an argument against patenting DNA for them. Civil libertarians are complaining about freedom of speech restrictions from patenting DNA, which is a week argument.

Pragmatic or mainstream libertarians housed at the Cato Institute and CEI are interested in IP as an extension of individual rights. Ayn Rand regarded IP as the base of all property rights: a man’s right to the product of his mind. In the process, freedom of speech issues arise as well as the monopoly issue which create the confusion. Since the right to own property is the most fundamental right for mainstream libertarians, this overrides the speech and monopoly issues.

website links to Cato’s IP positions
http://www.cato.org/tech/tk/010604-tk.html
http://www.cato.org/pubs/handbook/hb108/hb108-40.pdf

I will provide another example to further illustrate this point which is war. Obama is not for killing people although he has redirected the war efforts to Afghanistan using unmanned aircraft where innocent people and soldiers are dying. Churchill taught other leaders a valuable lesson when he explained we have to choose from the alternatives provided of which none may be perfect. I’m not aware of liberals accusing Obama of being a killer presumably because the ends justify the means.

I am equally baffled with your praise for Fiona Murray. With our previous discussion of the anticommons argument her paper was raised. Now that you agree that genetic engineering and the injection of genes are different processes of attacking the same problem, someone perhaps should notify Fiona. She provides a demonstrative example of why understanding the science you are discussing is important.

I’m not sure if your side of the patenting DNA issue fully appreciates the irony she presents. She unknowingly starts an article with a case where scientists found innovative ways to do science when the whole purpose of her article was an attempt to do otherwise.





I erred earlier and clicked a link that took me off receiving follow-up comments; please put me back on.  I assure you that anytime I am called “eloquent” I am tickled in every cell and would thrive on more—even if chiding, gently rendered, of course.  I miss confabulation with colleagues; let that be a lesson to you, a youngster still surrounded with disputative fellows.

I have Google send me news of what the Nobel Laureates are up to these days—and along came an article by Randall Mayes, that treats a “my ass” end-of-science title—which includes a reference to Einstein (a notable Laureate, hence sent to me).  New to IEET—I’m glad there is such an institution, as Professor Tolman would be—I went exploring and found your earlier article title, clicked on it and found you out of sorts about a book review by Mayes; same guy, but a different topic, I learning you have a book out—which I’ll look up later.  Actually I had earlier in the day read the ACLU review of their efforts to undo the gene patent laws, and was ready to add my voice to their plea—leapt at the chance after reading your focus on changing the law. 

Thanks for telling me of your ethics professorship.  I reread your final sentence and see again the English Commons with sheep happily nibbling away, making valuable wool—and the law about to be called upon because someone wants to fence in that Commons!  Trouble in the glen!  All hands on alert!  I chuckle and say it’s a good thing we humans die off, so as to keep periods overlapping, the tales renewed and modified,  perspective changed, knowledge gained. 

Thanks also for the page references in “Consilience.”  I own the book but it was put in storage while my apartment was refurbished, it not yet retrieved and shelved—a task to list!  As a scientist, chemistry major, I usually visualize Wilson’s leaf-cutter ants, admire them and the man—shrug and shift from his practical occupations to his abstract elevations. 

I’m glad to have run across IEET.  I worry that you youngsters don’t understand the prohibition against using nuclear bombs.  Do you?  Your colleagues?





Dear Randall,

You’re a prickly sort (tossing the word “ignorance” around at people) but now it makes sense.  The reference to Rand makes me feel better.  Like many who never studied philosophy in depth, you are simply infatuated.  Hasn’t the current recession taught you not to listen to her and her followers? 

IP as a natural right?  Needs a hell of a lot more philosophical and historical support.  By not addressing this critical, basic argument of mine, and referring instead to Rand, you again cede the central point.  Come back when you have an actual argument of your own about it.  Cato’s position is uninformed by ontology, history, or legal precedent.

Anyway, as I said, you have at least some sort of policy basis for your position, though I quite disagree with your conclusions.  Murray has at least conducted some empirical study of the “chilling” claims, and it’s hard to dispute her numbers, even while you trash her personally.

best,
-d





...as to Margaret’s statement, since I conclude that the human genome is a natural commons, then she is right.  She owns her genome, I own my genome, we all own the genome.  The commons cannot be taken by any individual, we own it in common.  No one may claim it for themselves adverse to our common claim.  This is all quite explicit in my book.

And Margaret, yes, here’s a recent article of mine regarding nuclear tech., among other dangerous tech: http://www.springerlink.com/content/t0330863q1p5813k/





Its ironic that you mention the current recession since my next article for IEET is on this topic. I’m sure we would disagree on that topic as well.

I apoligize, I do not think you are ignorant, but I do believe that it is a misleading statement especially to people who make think that you actually own genes.

I reread your book yesterday and would like to discuss a point that you made regarding in the 1980s the topic of patenting genes was not held in a public forum. Maybe you could tie this into the more ontological discussions idea.

How does this idea of yours fit into the Constitution? This topic is difficult for you and I who have put many hours into it intricacies. I’m not sure how people who have not studied the topic or have particular values would inform the rule of law on such discussions. I think public education on the topic is a great idea; however, isn’t this issue ultimately a legal decision based on the Constitution?

I do not think you are saying that people that do not understand the topic or people with an emotional investment in certain values should make policy decisions, but it is unclear to me what you are saying.





The Constitution has very little to do with patents at all, except to authorize Congress to create a scheme to “promote the useful sciences and arts,” which they did through the Patent Act and the Copyright Act. 

The PTO promulgates rules and regs regarding patents, including the “restrictions” I mention in the book, allegedly making it harder to patent genes in 2001.  Rules and regulations are generally required a period of public comment under the sunshine laws, and I assume there was such a period for the 2001 rules, but they merely slipped into the practice of granting unaltered gene patents (patent lawyers insist they are “altered” but the analogies I provide I think demonstrate this is disingenuous at best) without input from the legislature or public.

I think, given the relation of the human genome to all of us, there ought to have been greater input by the public over this practice, and a government bureaucracy did a poor job of applying the law and principles embodied in the law.

best,
David





Holman responds to Mr. Koepsell:

Your criticism of my review of your book consists primarily of an allegation of possible conflict of interest owing to my past employment in the biotechnology industry and my focus on the legal arguments presented in the book.  Regarding conflict of interest, I do not knowingly own any stock in a company that owns any patent that could reasonably be characterized as a gene patent (although I cannot be sure with respect to stocks which might be held by mutual funds in which I have invested for retirement). 

Since my expertise is in biotechnology and patent law, not philosophy or ethics, and because the book’s repeated mischaracterizations of patent law were so glaring, my book review focused on those errors.  Although the thrust of your book was an ethical argument against gene patenting, you repeatedly relied on mischaracterizations of the nature of gene patents and patent law to support your ethical conclusions, and I felt compelled to point these errors out for the benefit of readers who might otherwise be seriously misled.

Notably, your criticism does not challenge any of my statements of the law, except where you allege that I erroneously claimed that you rested your legal arguments on the Moore case.  In fact, on page 121 of the book, for example, you state that “the Moore decision, as interpreted by the actions of the Patent and Trademark Office, has established” that “wild-type human genes, unmodified by human intention, are somehow patentable.”  On page 89, you state that Moore “argues essentially that natural products can be patented if synthesizing them is sufficiently ‘difficult.’”  But as I explain in my review, Moore is a state law case having nothing to do with the patentability of genes.  Patent law is solely a product of federal law, not state law, so in fact Moore cannot establish any precedent with respect to patentability.





hi Chris!

Great to hear from you.  Glad you have no known conflicts, but you still mischaracterize the nature of legal disputes when you claim that I am wrong about the law.  Lots of lawyers have written their legal arguments opposing yours, and I agree with their interpretations.  We shall see how the courts decide.  I’ll be curious to see how the Prometheus/Mayo case comes down, won’t you?

I didn’t intend to write another boring legal brief like yours, nor to make the claim that you are wrong about the law either.  I can write that brief, though, and point out in lengthy detail why my interpretation of the law is better, more true to the spirit of the Patent Act, etc., Would that be better?  My point is, in doing so, I’d simply point out further that yours is not a book review, but a legal argument, which still misses the essential point of my book.  I suppose you really just don’t get my ethical and ontological arguments, though, which is a shame since they break new ground in this debate. 

I left the practice of law partly because of sharp practice by lawyers (a term denoting lawyers who like to play dirty) even though I was quite successful as an appellate lawyer (I was batting well over .750)

Anyway, I think you were out of your league in reviewing a work on philosophy, just as you no doubt want others to think I was out of my league in discussing (though not relying on) the law in my book.

All my best,
David





also…

... Moore was one of the cases relied upon by Celera’s lawyers (if one reads the histories) when deciding to attempt to patent sequences.  I am aware of its lack of precedential effect in Federal courts.  The PTO acted on Celera’s lawyers claims, granting them, so Moore was influential, if not precedent.  It has also been relied upon as persuasive precedent by lawyers seeking to patent genes, so it seems fair for me to cite to it as well.

Anyway, no hard feelings on this side, Chris.  Thanks for coming clean about your industry ties and apparent lack of conflict now.  You wrote an advocacy piece which would be persuasive in an appellate court (though not a bona fide book review), and I don’t feel like writing a reply brief since other lawyers have done this many times.  There’s scores of arguments by lawyers on my side of the debate too (who you will no doubt claim are also “wrong” on the law).

I look forward to the legislature or the courts deciding this issue soon. 

best,
David





Here is a nice legal brief addressing many of the same arguments my book addresses, written by amici in a case in which Holman writes an amici in opposition…. this merely demonstrates that other attorneys make good-faith legal arguments in favor of my position regarding nature and natural rpoducts (though this case isn’t explicitly about a gene patent) and with similar policy reasoning (though mine is not a legal argument).  Holman’s word on the law is not final.  His position has failed at this point in the district court, and the appellate court is now considering the matter (I have included only the “argument"section of the brief).  I’ll look forward to the briefs in the ACLU v. Myriad case if and when it goes forward.  I believe it won’t be dismissed on standing, although Holman and defendants in that case are betting the bank on it.  “***” indicate expurgated sections:

***

United States Court of Appeals, Federal Circuit.
PROMETHEUS LABORATORIES, INC., Plaintiff-Appellant,
v.
MAYO COLLABORATIVE SERVICES (doing business as Mayo Medical Laboratories) and Mayo Clinic Rochester, Defendants-Appellees.
No. 2008-1403.
April 6, 2009.

Appeal from the United States District Court for the Southern District of California in case no. 04-CV-1200, Judge John A. Houston

Corrected Brief for Amici Curiae The American College of Medical Genetics, The American Medical Association, The American Society of Human Genetics, The Association of American Medical Colleges, The Association of Professors of Human and Medical Genetics, The Association for Molecular Pathology, and The College of American Pathologists in Support of Defendants-Appellees

Katherine J. Strandburg, DePaul University College of Law, 25 East Jackson Blvd., Chicago, IL 60604, Telephone: (312) 362-8536, Facsimile: (312) 362-5448, Attorney for Amici Curiae: The American College of Medical Genetics, The American Medical Association, The American Society of Human Genetics, The Association of American Medical Colleges, The Association of Professors of Human and Medical Genetics, The Association for Molecular Pathology, and The College of American Pathologists.


TABLE OF CONTENTS


INTRODUCTION AND INTEREST OF AMICI CURIAE ... 1

MEDICAL CONCERNS OF AMICI ... 8

SUMMARY OF THE ARGUMENT ... 13

ARGUMENT ... 14

A. The Claims Asserted in this Case Impermissibly Preempt Natural Phenomena ... 14

1. Correlations Between Metabolite Levels and Therapeutic Efficacy and Toxicity are Unpatentable Natural Phenomena ... 15

B. The Patent Claims Asserted in this Case Fail the “Machine or Transformation of Matter” Test ... 22

1. The Claims Do Not “Transform a Particular Article into a Different State or Thing” Except Perhaps as Part of a Routine Data-Gathering Step ... 23

2. The Claims Do Not Require Any Action after a Physician Takes Note of the Natural Correlations Between Metabolite Level and Toxicity and Efficacy ... 24

3. The Claims are Directed to Unpatentable Abstract Mental Processes ... 27

C. Public Policy is Well Served by Current Limits on Patentable Subject Matter, Which Preclude Patenting Scientific Data ... 28

1. Patents on Scientific Principles Raise Ethical Concerns for Physicians ... 29

2. Patents Solely on Scientific Facts Threaten to Stifle Innovation, Including the Development of Personalized Medicine, and to Increase Health Care Costs ... 31

3. Patents on Scientific Facts Erode Doctors’ Ability to Provide Quality Patient Care ... 34

CONCLUSION ... 38

TABLE OF AUTHORITIES


CASES

In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) ... passim

In re Comiskey, 499 F.3d 1365 (Fed. Cir. 2007) ... 25

Diamond v. Chakrabarty, 447 U.S. 303 (1980) ... 16

Diamond v. Diehr, 450 U.S. 175 (1981) ... 14

Funk Bros. Seed Co. v. Kalo Inocluant Co., 331 U.S. 127 (1948) ... passim

Gottschalk v. Benson, 409 U.S. 63 (1972) ... 14, 25

In re Grams, 888 F.2d 835 (Fed. Cir. 1989) ... 22

Lab. Corp. of Am, Holdings v. Metabolite Labs., Inc., 548 U.S. 124 (2006) ... 25

Metabolite Labs. Inc. v. Lab. Corp of Am. Holdings, 370 F.3d 1354 (Fed. Cir. 2004) ... 31

Morton v. New York Eye Infirmary, 17 F.Cas. 879 (C.C.S.D.N.Y. 1862) ... 18

Nippon Electric Glass Co. v. Sheldon, 539 F.Supp. 542 ... 18

O’Reilly v. Morse, 56 U.S. 62 (1853) ... 17, 28

Parker v. Flook, 437 U.S. 584 (1978) ... 14, 16, 21, 22

STATUTES

35 U.S.C. § 101 ... 2, 3, 13, 16

OTHER AUTHORITIES

Principle V of the AMA Code of Medical Ethics ... 26

Opinion 9.08 of the AMA Council on Ethical and Judicial Affairs ... 26

***

ARGUMENT

A. The Claims Asserted in this Case Impermissibly Preempt Natural Phenomena

Essentially, the claims at issue here seek to patent the statistical observation that some doses of thiopurine drugs tend to be too high for some patients and some tend to be too low. The patent claims at issue in this case “have three steps: (1) administer the drug to a subject; (2) determine metabolite levels; and (3) be warned that an adjustment in dosage may be required.” Dist. Ct. Op. at *9. These claims run afoul of time-honored prohibitions on patenting “laws of nature, natural phenomena, [or] abstract ideas,” Diamond v. Diehr, 450 U.S. 175, 185 (1981) (citing Parker v. Flook, 437 U.S. 584, 593 (1978) and Gottschalk v. Benson, 409 U.S. 63, 67 (1972)), because they “wholly preempt” the natural relationship between the level of the metabolites 6-TG and 6-MMP in the human body and the likelihood of therapeutic efficacy and toxicity of thiopurine drugs. Dist. Ct. Op. at *10, citing Benson, 409 U.S. at 71-72. While the recognition of this correlation may be new, “a product [or process] must be more than new and useful to be patented; it must also satisfy the requirements of invention or discovery.” Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).
1. Correlations between Metabolite Levels and Therapeutic Efficacy and Toxicity are Unpatentable Natural Phenomena

As the Supreme Court has repeatedly emphasized and this Court has recently reiterated, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Bilski, 545 F.3d at 952, citing Benson, 409 U.S. at 67. Rather, “f there is to be invention from such a discovery, it must come from the application of the law of nature to a new and useful end.” Funk Bros., 333 U.S. at 130. The ban on patenting natural phenomena must apply over and above the “machine-or-transformation-of-matter” test employed in analyzing the abstract ideas issue. Bilski, 545 F.3d at 955. Even if a natural process, such as photosynthesis or digestion, involves the transformation of matter, it remains “the handiwork of nature” and is not patentable. Funk Bros., 333 U.S. at 131.[FN12]

  FN12. In this respect we agree with amici Interested Patent Law Professors, Br. at 2-5, though we disagree with them as to whether the claims asserted here constitute natural phenomena.

Despite this well-established prohibition, the patent here provides exclusive rights to the discovery of a statistical correlation between the levels of certain metabolites produced by the body in response to the administration of certain drugs and the efficacy and toxicity of those drugs. Just as the Supreme Court held in Funk Brothers, which involved “inoculants for leguminous plants” that were effective because of natural interactions of bacterial strains, such a scientific discovery is not an “invention or discovery within the meaning of the patent statutes.” Id. at 132.

The argument that the observed correlation is patentable subject matter simply because it stems from the administration of a synthetic drug is inconsistent with precedent and would lead to absurd results. In patent law, “natural” means “nature’s handiwork” as generally juxtaposed with the products of human agency and ingenuity. Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980); Flook, 437 U.S. at 591-594. Thiopurine drugs are man-made compositions of matter, undeniably patentable under Section 101. Providing incentives to invent such drugs, which work with the body’s natural processes, is a well-accepted purpose of the patent system. Prometheus does not seek to enforce patents on synthetic drugs, however. The drugs involved in the claims are well known. Instead, the patents in suit lay claim to observations about the body’s natural responses to such drugs.

A natural response to a man-made invention has never been patentable. In Funk Brothers, for example, the patentee combined laboratory cultures of selected bacteria to form an “inoculant” that assisted nitrogen fixation in plants. Funk Bros., 333 U.S. at 129. Despite the human effort required to select, culture, and combine the bacteria, the mixture was unpatentable because the mutual non-inhibition of nitrogen fixing properties was a natural response to being combined. Though the combination was artificial, the bacteria “serve [d] the ends nature originally provided and act[ed] quite independently of any effort of the patentee.” Id. at 131.

This distinction between a man-made product and its natural behavior has long been recognized. In O’Reilly v. Morse, 56 U.S. 62 (1853), for example, the Supreme Court discussed the English case, Neilson v. Harford, 151 E.R. 1266 (1841), and distinguished between the unpatentable “principle that hot air will promote the ignition of fuel better than cold” and the patentable invention of a mechanical apparatus for supplying hot air. O’Reilly, 56 U.S. at 115-16. Any invention involving igniting fuel in a furnace is in some sense synthetic, yet that fact would not have rendered patentable a claim to the principle of using hot air to aid ignition. Nor did the fact that printing characters at a distance is a human endeavor save a claim to the basic scientific concept of using “the motive power of the electric or galvanic current” to make such characters. Id. at 119.

Similarly, the important discovery that ether (synthetically produced by distilling alcohol) could be used to produce a state of “total insensibility to pain” was not patentable because it was “only a new or more perfect effect of a well-known chemical agent, operating through one of the ordinary functions of animal life.” Morton v. New York Eye Infirmary, 17 F.Cas. 879, 882-83 (C.C.S.D.N.Y. 1862). As explained by the court:

A discovery may be brilliant and useful, and not patentable. No matter through what long, solitary vigils, or by what importunate efforts, the secret may have been wrung from the bosom of Nature, or to what useful purpose it may be applied…. The new force or principle ... can be patented only in connection or combination with the means by which, or the medium through which, it operates.

More recently, in Nippon Electric Glass Co. v. Sheldon, 539 F.Supp. 542 (S.D.N.Y. 1982), the court invalidated claims to a television tube intended to reduce a viewer’s exposure to X-radiation. Sheldon’s claims centered on constructing the tube so that X-rays emitted through the front did not exceed a limit that he had discovered. In invalidating the patent, the court noted that “[Sheldon] claimed to have discovered a phenomenon of nature, that X-radiation in excess of 0.04 mr/hr from televisions is harmful to human health.” Sheldon, 539 F. Supp. at 546. The health effect of radiation from television sets is a natural phenomenon, despite the fact that the television is a product of human ingenuity. Id. The unpatentable interaction between synthetically produced X-rays and the body proceeds without human intervention.

The crabbed understanding of “natural phenomenon” advocated by Prometheus would lead to absurd results: the process of digestion would be non-natural when digesting synthetic foods and natural when digesting wild berries, the process of sun burning would be non-natural when it occurred in tanning booths and natural when it happened on a beach, and so forth. To comport with longstanding case law, a phenomenon must be deemed natural when it proceeds without human agency even if it responds to a synthetic stimulus. Prometheus’s own expert employed this interpretation of the term, testifying that “the key therapeutic aspect of such thiopurine drugs is that they are converted naturally by enzymes within the patient’s body to form an agent that is therapeutically active.[FN13] Dist. Ct. Op. at *7 (emphasis added.)

  FN13. Amici Interested Patent Law Professors suggest, Br. at 13-15, that a definition of natural phenomena that encompasses the claimed correlations would also sweep in drug product claims and claims to drug methods of treatment. This is nonsense. The claims of a patent determine whether it preempts a natural phenomenon. A patent claiming a pharmaceutical chemical will not attempt to claim the natural bodily responses themselves any more than a patent on a new food product would attempt to claim the natural processes of digestion.

The district court correctly concluded that “the relevant inquiry is whether the correlations are ‘man-made,’ not whether a man-made drug was used to produce the correlation.” Dist. Ct. Op. at *9. It is particularly clear that the correlations between drug metabolite levels and drug toxicity and efficacy claimed here are natural phenomena. Nothing in the claims purports to affect the way in which a patient’s body responds to the administration of the medications: the phenomena are merely observed.

Metabolite production proceeds without human intervention once the drugs are ingested. Indeed the resulting metabolite levels are unpredictable. The unpredictability of the body’s natural response to the drugs is precisely the reason there is a need to measure metabolite levels in a given patient and to use statistics about prior patients’ responses to understand the implications of those measurements for the efficacy and toxicity of the drug.

Having established that the claimed statistical correlations are natural phenomena, it is easy to see that these claims are unpatentable, since they wholly preempt every substantial use of those correlations. The claims cover every instance in which anyone considers whether to adjust thiopurine drug dosage in light of the metabolite level measurements. Dist. Ct. Op. at *10.
B. The Patent Claims Asserted in this Case Fail the “Machine or Transformation of Matter” Test

Even if they were not void for attempting to patent natural phenomena, the claims at issue here would be invalid. This Court recently delineated the test for determining whether a sequence of steps is a patentable “process” or an unpatentable abstract idea. A process is patentable if “(1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.” Bilski, 545 F.3d at 954. These requirements ensure that the claim is “tailored narrowly enough to encompass only a particular application of a fundamental principle rather than to pre-empt the principle itself.” Id. To serve this purpose, the machine or transformation of matter test requires a corollary: “insignificant extra-solution activity” cannot turn an unpatentable claim to an abstract idea into a patentable process. Id. at 962, citing Flook, 437 U.S. at 590.
1. The Claims Do Not “Transform a Particular Article into a Different State or Thing” Except Perhaps as Part of a Routine Data-Gathering Step

Setting aside routine data-gathering steps, the claims here reduce to a doctor being “warned or notified that a dosage adjustment may be required” when he or she sees the results of routine and long-standing diagnostic tests. Dist. Ct. Op. at *9. The claims focus on the statistical correlations between metabolite level and drug efficacy or toxicity. Analyzing those statistical correlations is the sum total of what the patentees contributed to the art. As the Supreme Court held in Flook, 437 U.S. at 590, “[t]he notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance.” The same reasoning applies to routine data-gathering steps. Bilski, 545 F.3d at 957; see also, In re Grams, 888 F.2d 835, 839-40 (Fed. Cir. 1989). Measuring metabolite levels for comparison to a particular number is precisely the type of routine data-gathering step that is insufficient to confer patentability on these highly abstract claims.
2. The Claims Do Not Require Any Action after a Physician Takes Note of Natural Correlations between Metabolite Level and Toxicity and Efficacy

The claims at issue here do not require any action whatsoever by a physician who has perused the test results and been “notified” to consider adjusting the dosage in response. Though their preambles denote them “method[s] of optimizing therapeutic efficacy” or of “reducing toxicity,” the claims at issue in this case are remarkable for their complete failure to set out any specific actions to be followed after a physician is “warned” that an adjustment of dosage might be necessary. The “post-solution activity” here is not merely “insignificant”-it is non-existent. See generally, Flook, 437 U.S. at 590. This is no accident. Interpreting diagnostic tests is not a mechanical exercise. Here, the specification makes clear that the appropriate treatment regimen cannot be dictated by metabolite measurements alone.

Table I of the asserted patents shows that in one test, for example, patients who responded positively to the medication had median metabolite levels of 295, while non-responders had median levels of 184: positive response was correlated with higher metabolite levels. Nonetheless, while 78% of responders had levels over 225 (close to the efficacy level of “about 230” called out in the claims), the other 22% responded despite lower metabolite levels. Moreover, 26% of non-responders also had metabolite levels over 225. Similarly, in the study reflected in Figure 3 of the asserted patents, 78% of patients with metabolite levels above 230 responded positively to the medication. Nonetheless, the figure shows that 42% of those with lower metabolite levels also responded.

It is not surprising, in light of this natural variation in patient response to the drugs, that the specification notes that:

f the level of a 6-MP metabolite such as 6-TG or 6-MMP is higher than a predetermined toxic level, one skilled in the art can monitor for toxic side effects by measuring one or more of the toxicities associated with 6-MP drug treatment, as disclosed herein .... If such a patient exhibits signs of leucopenia or bone marrow suppression, the 6-MP drug dose can be reduced. However, if it is determined that a patient has levels of a 6-MP metabolite higher than a predetermined toxic level but does not exhibit signs of leucopenia or other 6-MP drug toxicities, one skilled in the art can determine that the current 6-MP drug dose can be maintained. Based on measuring 6-MP metabolite levels and determining signs or symptoms of toxicities associated with 6-MP drug treatment, one skilled in the art can determine whether a 6-MP drug dose should be maintained or decreased. 6,355,623 col. 12, 11. 16-37; 6,680,302, col. 12,11. 23-44. (emphasis added)

In other words, depending on a patient’s symptoms or other test results, a physician might decide to adjust the dosage of a patient with more than the claimed toxicity level - or might not! Similarly, depending on a patient’s symptoms, a physician might decide to raise the dosage of a patient with less than the claimed efficacy level - or might not! (6,355,623, col. 11, 11. 12-26; 6,680,302, col. 11, 11. 19-33).

The hedging of therapeutic recommendations in the patent specification, and the corresponding lack of a particular prescription for action in the claims, is not surprising. The statistical correlation between metabolite level and efficacy and toxicity is only one piece of data used by a physician to determine a course of treatment based on further tests, observations of the patient’s symptoms, and so forth. There is no “method of optimizing treatment efficacy” reflected in these claims, but only a suggestion to consider certain test results as part of formulating a treatment plan.
3. The Claims are Directed to Unpatentable Abstract Mental Processes

Observations of statistical correlations such as those reported in the patent specification are “basic tools of scientific and technological work.” Bilski, 545 F.3d at 952, citing Benson, 409 U.S. at 67. They are important inputs to the mental process of medical diagnosis, but determining whether to adjust dosages requires professional judgment that is entirely dependent on the exercise of human intelligence. See Bilski, 545 F.3d at 952, citing In re Comiskey, 499 F.3d 1365 (Fed. Cir. 2007). These claims are, as Justice Breyer remarked about the claims in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124, 135 (2006), “not at the boundary” under this Court’s test for patentability of abstract ideas.
C. Public Policy is Well Served by Current Limits on Patentable Subject Matter, Which Preclude Patenting Scientific Data

Amici medical associations recognize that healthcare-related patents can enhance the provision of high-quality and cost-effective medical care. The financial incentive that patents offer supports the expensive and uncertain research required to identify, test, and gain approval for new pharmaceutical products, medical devices, diagnostic testing kits, and so forth. In this respect, the patent system has served patients and the medical profession well.

Patents on basic scientific principles underlying medical care, however, do not have these salutary effects. Such patents raise ethical concerns for physicians, threaten to stifle innovation and raise the costs of medical treatment, and erode the quality of patient care by limiting the knowledge physicians may use to diagnose and treat their patients.
1. Patents on Scientific Principles Raise Ethical Concerns for Physicians

Physicians have longstanding ethical obligations to advance and share useful medical knowledge with patients and physicians. Principle V of the AMA’s Principles of Medical Ethics states that a “physician shall continue to study, apply and advance scientific knowledge,” and “make relevant information available to patients, colleagues, and the public.”[FN14] Opinion 9.08 of the Code of Medical Ethics of the AMA elaborates upon this basic principle:

  FN14. Available at www.ama-assn.org/ama/pub/category/2512.html (last visited April 5, 2009).

Physicians have an obligation to share their knowledge and skills and to report the results of clinical and laboratory research…. The intentional withholding of new medical knowledge, skills and techniques from colleagues for reasons of personal gain is detrimental to the medical profession and to society and is to be condemned.[FN15]

  FN15. Available at http://www.ama-assn.org/amal/pub/upload/mm/369/ceia_ 3i07.pdf (last visited April 5, 2009).

Discovery of a basic scientific principle that could be useful to others in devising medical applications or to physicians in reaching diagnoses and treating patients is a quintessential example of the kind of medical knowledge that physicians are obliged freely to share. To interpret the patent laws to make scientific principles eligible for patent protection threatens to undermine, rather than promote, the ethical practice of medicine.
2. Patents Solely on Scientific Facts Threaten to Stifle Innovation, Including the Development of Personalized Medicine, and to

Increase Health Care Costs Basic scientific facts “are part of the storehouse of knowledge of all men.” Funk Bros., 333 U.S. at 130. Ensuring wide dissemination and free access to such facts is essential to scientific progress. The discussion above of the history of research into thiopurine drugs and their relationship to metabolites such as 6-MMP and 6-TG illustrates that these patentees are neither the first nor the last to consider the implications of these metabolite levels for human health. Ready access to basic facts, such as a relationship between levels of drug metabolite and the drug’s efficacy and toxicity, are essential to important, ongoing research efforts. Exclusive rights to scientific facts hinder efforts to develop or employ new and superior medical advances that would build on them.

Here, disclosure of the correlations between these metabolites and drug efficacy and toxicity creates incentives for laboratories, such as Mayo, to compete to develop fast and inexpensive ways of testing for the metabolites and for researchers such as Dr. El-Azhary to study similar correlations. Mayo Br. at 10. But a patent that covers a mere “notice” to a physician that he or she might want to adjust the dosage of the associated drug may “shut[] the door” to the development or use of such new tests, and discourage further research and development. O’Reilly v. Morse, 56 U.S. at 113.

Patents on scientific facts, such as the statistical correlations involved here, would stifle rather than incentivize developments in medicine, including those in personalized medicine. At its core, personalized medicine has been central to the practice of medical genetics since its inception.[FN16] As described by the Personalized Medicine Coalition (PMC):

  FN16. See Motulsky AG. Drug reactions, enzymes, and biochemical genetics. 165 J. Am. Med. Ass’n 835-37 (1957).

Personalized medicine ... aims to achieve optimal medical outcomes by helping physicians and patients choose the disease management approaches likely to work best in the context of a patient’s genetic and environmental profile. Such approaches may include genetic screening programs that more precisely diagnose diseases and their sub-types, or help physicians select the type and dose of medication best suited to a certain group of patients.[FN17]

  FN17. http://personalizedmedicinecoalition.org/sciencepolicy/personalmed-101_overview.php (last visited April 5, 2009).

Much of the public’s understanding of personalized medicine relates to pharmacogenetics-the study and clinical testing of genetic variation that gives rise to differing response to drugs, which is central to this case.

Amici agree with the PMC that:

A strong intellectual property system is necessary to stimulate investment in innovation. It is essential that government patent systems offer protection for innovations relating to personalized medicine, as well as high quality patent examination that allows patents of appropriate scope and quality.[FN18]

  FN18. http://personalizedmedicinecoalition.org/sciencepolicy/personalmed-101_overview.php. (Emphasis added.) (last visited April 5, 2009).

The patents at issue in this case far exceed the appropriate scope for patents on diagnostic tools and methods, however. Such patents, which do not cover inventive diagnostic tests but instead seek to preempt the facts underlying proper diagnosis, threaten to slow the development of diagnostic testing. Subjecting physicians to a thicket of patent licensing obligations merely for thinking about how best to treat their patients also would increase the transaction costs of practicing medicine, and lead inevitably to higher-priced medical treatment.

The unpatentability of mere observations about the body’s natural responses to a drug does not threaten the development of personalized medicine. Indeed, a recent report by the Secretary’s Advisory Committee on Genetics, Health, and Society found that patents “do not serve as powerful incentives for either genetics research in the diagnostic arena or the development of genetic tests.”[FN19]

  FN19. Secretary’s Advisory Committee on Genetics, Health, and Society, 110 Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Test (March 9, 2009).

There is no need for patents to incentivize physicians to study the kinds of clinical correlations at issue in this case. On the contrary, when knowledge of such correlations is freely available there is enormous incentive for physicians to make use of them to provide necessary and appropriate care for their patients.
3. Patents on Scientific Facts Erode Doctors’ Ability to Provide Quality Patient Care

Patent claims such as those at issue here conflict with doctors’ ability to provide effective patient care. Here, the patentee argues that a doctor infringes by thinking about the correlation between dosage efficacy and toxicity after receiving results of a metabolite test even if the test was ordered for a reason other than a desire to adjust dosage in light of the limits set out in the patent claims. Mayo Br. at 10-12. There can be no design around a scientific fact. A physician who learns-from the medical literature, colleagues, continuing medical education, or elsewhere-of the statistical correlation between metabolite levels and drug efficacy and toxicity cannot put that knowledge out of mind. Thomas Jefferson aptly described this characteristic of ideas:

If nature has made any one thing less susceptible than all others of exclusive property, it is the action of the thinking power called an idea, which an individual may exclusively possess as long as he keeps it to himself; but the moment it is divulged, it forces itself into the possession of every one, and the receiver cannot dispossess himself of it.[FN20]

  FN20. Letter from Thomas Jefferson to Isaac McPherson (Aug. 13, 1813) reprinted in The Letters of Thomas Jefferson: 1743-1826, available at Electronic Text Center, University of Virginia Library.

Such is the nature of scientific fact; once known, it must be considered. Quality patient care demands that a physician consider test results in light, among other things, of current medical knowledge.

Claims to exclusive rights to simply considering scientific facts concerning medical diagnosis and treatment distort patent law beyond recognition. By discovering a previously unknown correlation between obesity and illness, for example, a researcher could obtain a patent on the process of having a patient step on a scale, measuring a weight above a particular statistically significant value, and then thinking about whether to recommend that the patient diet to lose weight. Any entity that made or sold scales, and that dared to mention that correlation in a brochure, might then be liable for intentionally inducing infringement. Such a result is unthinkable, as recognized by the district court’s sound analysis in this case.

If the claims at issue here were properly patentable, a laboratory might induce infringement simply by informing a doctor of the correlation in conjunction with delivery of test results or perhaps even by publishing articles or brochures discussing the correlation. Indeed, confronting very similar facts in Metabolite Labs. Inc. v. Lab. Corp of Am. Holdings, 370 F.3d 1354 (Fed. Cir. 2004) (where the patentable subject matter issue was not raised) this court found that the defendant laboratory had induced infringement through the publication of medical articles. Id. at 1365. If patent licenses are required for physicians merely to consider newly discovered implications of well-established diagnostic tests, and if laboratories become contributory infringers merely by educating doctors about those implications, it is hard to imagine how the medical diagnostic community will continue to serve the goal of quality patient care.

CONCLUSION

For these reasons, the district court’s grant of summary judgment should be affirmed.
PROMETHEUS LABORATORIES, INC., Plaintiff-Appellant, v. MAYO COLLABORATIVE SERVICES (doing business as Mayo Medical Laboratories) and Mayo Clinic Rochester, Defendants-Appellees.





David,

No hard feeling on my part either.  I do not doubt that you are as sincere in your convictions as am I.  I strongly believe that so-called gene patents have overall had a positive impact on the development of the biotechnology industry, and that the biotechnology industry is providing important products for saving lives and improving life quality.  I was asked to review the book, and did so based on my own expertise which is in biology and law.  Should I ever write a book steeped in philosophical and ethical analysis, I would consider it appropriate for one trained in philosophy and ethics to review my work, and if necessary keep me honest.

For those interested in an alternate view of human gene patents, you might check a couple of my law review articles, available on SSRN at http://ssrn.com/author=537838.  I also wrote a commentary published in Science in 2008 on the topic of human gene patent litigation.  A variety of amicus briefs filed in Prometheus, including the one I drafted, are available on “Holman’s Biotech IP Blog.”

Chris Holman





Thanks, Chris, for the civil reply.  Other attorneys have not been so even tempered, and I hope you’ll forgive my inquiry about conflicts of interest.  I think it was valid given your background, and I respect your right to hold beliefs contrary to mine. 

Now, can you call of the dogs?  Brian Leiter ( http://leiterlawschool.typepad.com/leiter/2009/08/david-koepsell-doesnt-know-how-to-cut-his-losses.html ) decided to use this as an excuse to call me “incompetent”...  I’ve been called worse, and expect more, but would really like to focus on the arguments.

Central to my argument is the notion that DNA is what I call a “commons by necessity” which I make a detailed ontological argument regarding.  Thus, my chapter 7 is critical, and is not at all an anti-commons argument of which you are familiar as an IP lawyer, but a metaphysical/ontological argument about the underlying objects.  Despite any differences we might have on the nature and effect of gene patents, my critical ethical argument, the central thesis of the book, hinges not on the law but on this ontological argument about the nature of certain things in the world that I claim simply cannot be enclosed by any claim whatsoever.

I see the legal arguments you and other attorneys want to raise as being utterly orthogonal then to my argument, which despite our disagreements about the nature and effects of the current patent regime, brings unmodified genes out of the range of any property scheme for ontological reasons.  If you grasp this point, then you’ll understand my frustration that quibblling over the current state of the law doesn’t get around my central thesis.

A friend of mine who does IP and is familiar with my work and methodology, shares my frustration in making these sorts of arguments, he writes:

“I read his review and the comments back and forth. You are spot on, he comes at the argument like a law student. My experience, starting with law schools, is that lawyers are trained to crush the humanitarian considerations and dispose of them like “good Positivists.” After all, how else can our law elite defend the free market? I have ordered your book and want to read it for myself, but after reading the blog and understanding your position in advance, it appears that he has side-stepped or is blind to the fact that the policy is flawed (I think the latter). The policy is flawed because it is informed by forces (mostly corporate in this case) that consider the ethical complaints as ruts in the road to be avoided at all costs. I spoke before the Pennsylvania Bar Association IP Section in Philly in 2007 and introduced them to the ontology of IP and social reality (used computers and software to make my points) and was greeted as a Galileo”

I feel his pain.

best,
David





David

I found your exhange with Chris very useful in understanding what your argument actually is (in general). Specifically, not so much. Would you be willing to lead conversation on the specifics?

I believe it is extremely important that both sides of this debate have a common understanding what a gene actually is and what is actually patented in order to understand your argument.

On rereading your book, I’m impressed that you nailed what is actually patented the molecule, a 3D structure, and not the alphabet letters, or the popular notion of a gene as privileged information, or the code.

To take it step further Wilson’s article discusses casual info
http://muse.jhu.edu/journals/american_journal_of_bioethics/v002/2.3wilson.pdf

On p.5 of you book you accurately say that patenting ls not a possessory right, but “repeatedly” refer to owning genes.

So, if you do not actually own genes and you do own nature’s code will you please clarify to us ontologically challenged in plain terms what you offered new to the academic world, so we can discuss your idea fairly.

Wilson’s article references Alex Rosenberg who teaches phil. of genomics at Duke and S. Sarkar who I consider the top philospher of biology. What I learned from the class that is important for this discussion and also relates to my All Hell Breaks Loose article on IEET is the changing notion of the gene.

Since the 1940s, many people think of a gene simply as a compact unit that makes a protein. We now know the relationship between genes and proteins in much more complex. You discuss developmental biology and its importance in your book. How does this complex relationship and casual information relate to your ontological thesis?





Hi Randall,

Thanks for this question, let me try to walk through it step by step as I have tried to argue it in my book:

1.) I argue property rights over land and moveables are grounded in brute facts of possession

2.) I argue that IP right are not grounded, and so we can generally alter them at will except where they may conflict with grounded rights

3.) I explain that patents protect the [removed]manifesting a type in some way in the world of tokens) of a type, not the type itself, as you note.  They are exclusionary, not possessive rights, giving the patent holder the right to exclude another from reproduction or practice of his or her type

4.) A gene is the arrangement of nucleotides that codes for a protein.  Its action involves the creation of proteins by mRNA, which as it creates the proteins, reads the beginning and end of the gene, and leaves out the introns.  This is the same mechanism employed by humans when we make cDNA. 

5.) A patent on cDNA, I argue, is not different than the patent on the gene itself as there is nothing new about the cDNA.  Nature devised long ago the methods of reading genes and making proteins.  cDNA is thus not novel and not properly patentable.  (ultimately, though, my commons argument trumps all of this).

6.) Newly created genes, not otherwise found in nature but assembled from intentional action by humans is properly patentable.

7.)  The human genome is a constantly evolving object that involves every member of the species, and is, I argue, a commons by necessity, like outer space, the atmosphere, sunlight, and radio spectra.  Discovering its nature, replicating its processes and using them to our benefit cannot ethically be done to the exclusion of others. Granting exclusionary rights to discoverers of gene that are part of that genome interferes with our common rights and beneficiaries and possessors of parts of the human genome.

8.) Myriad, for instance, when it uses its patent on the BRCA1 and 2 genes that are linked to breast cancer, prohibits meanwhile the replication by others of the genes themselves.  It has sent cease and desist letters to scientists who were doing lab work on those genes.  I argue that it is our right in common to explore and investigate our individual genomes, as well as the human genome, unhindered by claims of others.  What Myriad “owns” is a right to stop you from doing that, and they have excersized that right to the our common detriment.

9.) Miami Childrens Hospital has done the same thing with the Canavan’s disease gene, and while their right is not one of standard, possessory ownership, it is the right to exclude others from doing research on that disease.  This is, I claim, an unethical usurpation of the commons of DNA.

10.) my argument differs from what you and other lawyers know as the argument of an “anti-commons,” which I do discuss in my book, but which my argument does not rely upon.  Anti-commons are created where over-patenting has hindered research.  This may well be happening, as the Murray article tends to point that way, but my argument about the commons and DNA is a totally new, totally different argument founded on my ontology of commons by necessity.

I hope this clears up my arguments a bit.  In a bit, I will also point out how I believe Holman and others have distorted my discussions of the law (as I begin to discuss above in justifying my discussion of Moore based on its use by Celera’s attorneys). 

But I see all that discussion as a distraction, and my book spends 15 out of its 200 pages discussing cases, none of which are determinative of the argument or conclusions.

best,
David





(all due apologies for suggesting that Leiter is Holman’s canine… I meant it figuratively, of course, and was just trying to lighten the mood and no offense was meant)





My point-by-point response to Holman’s claims of errors is at my blog:
http://whoownsyou-drkoepsell.blogspot.com/2009/08/methodical-response-to-chris-holmans.html





I know nothing about your book and am willing to assume the correctness of your views, but your reckless attacks on Prof. Holman (frivolously speculating about conflicts of interest, for example) were disturbing.  Were you an equally uncivil advocate?  That is probably why your opponents sometimes acted in ways that you did not like.  That is known as reaping what you sow.  As for your claimed appellate excellence, Westlaw seems to reveal only about ten opinions in which you were counsel.  Why brag about a lifetime .750 batting average for what apparently amounted to a three-game season?





Doug,

You make good points.  I am chastened.  I have apologized to Chris for speculating about his financial interests.  But my references to appellate successes merely show that Leiter’s slurs about my being an JD were not grounded in my record.  I do admit to being a bit defensive, and will attempt to correct this in the future.

more humbly,
David





Mr. Koepsell,

I read with interest your comments above criticizing IP from a self-professed libertarian perspective. I am a libertarian and a practicing patent attorney and I too oppose patent rights (one of the few patent attorneys who dare to)—patents are, as you say, unnatural and artificial privileges granted by the state at the expense of real property rights. My website contains various articles, books, and speeches on this topic, including Against Intellectual Property, and my recent speech “Intellectual Property and Libertarianism.”  I’m also affiliated with the Mises Institute, so I suppose Mr. Mayes has my work in mind when he unfairly, uncharitably, and falsely disparages and dismisses us as “idealogues.”

I heartily agree with you when you write that you are “consistently confused by “libertarians” who support a government-sponsored monopoly of any kind” and that patents “are the grant by a government of an artificial monopoly of the practice or sale of a useful art or product.”

Given that you recognize this, it is not clear why you seem to draw back (at least in this post; I have not yet read your book, which I intend to do) from a more sweeping critique of patents in general. E.g., you write, “IP laws only conflict with notions of justice when they impinge on some other, grounded right, as I argue they do with the genetic commons.” IP laws always impinge on property rights. That is their purpose and nature.

I must say I sympathize with your comments about conflicts of interest on the side of IP advocates—isn’t it striking that almost every patent lawyer or big company that benefits from this state monopoly is in favor of the practice? You are right: the patent industry benefits patent lawyers, so of course they tend to mindlessly repeat the state propaganda that supports their profession’s existence.

As for Mr. Mayes’s comments, he writes:

“Your confusion related to libertarianism and what libertarians think is probably due to several reasons. What libertarians think is not universal. Libertarians at the Ludwig von Mises Institute are ideologues. They do not want the state involved period, so this provides an argument against patenting DNA for them. Civil libertarians are complaining about freedom of speech restrictions from patenting DNA, which is a week argument.

“Pragmatic or mainstream libertarians housed at the Cato Institute and CEI are interested in IP as an extension of individual rights. Ayn Rand regarded IP as the base of all property rights: a man’s right to the product of his mind. In the process, freedom of speech issues arise as well as the monopoly issue which create the confusion. Since the right to own property is the most fundamental right for mainstream libertarians, this overrides the speech and monopoly issues.”

Well, as for free speech, I grant you that it is more endangered by another state-granted pattern-privilege, patent law’s cousin, copyright (see my post Book Banning Courtesy of Copyright Law). Some Cato scholars support IP rights, but not all (see the work of Tom Palmer, for example—are they idealogues too, now?). Ayn Rand’s defense of IP was seriously confused, and she would never have granted that IP so important that it “overrides” “speech and monopoly issues.” IP rights are not an extension of property rights; they quite obviously undercut and invade property rights—a patent gives a right to its holder to legally force someone else not to use their own property as they see fit.

As for the repeated claims by various defenders of IP and critics of Mr. Koepsell to the effect that patent protection is “needed” to “incentivize” various forms of innovation—Mr. Holman in his review refers to “the important role gene patents have played in incentivizing the development of life-saving therapeutics” as if this is obvious and uncontroversial—this is the same old bankrupt utilitarian reasoning that is triply flawed. First, as I point out in Against Intellectual Property, utilitarianism is morally flawed—you could justify all sorts of horrible policies, including legalized theft, this way; and it is methodologically flawed since it is based on the unscientific notion that utility can be cardinally measured and interpersonally compared (the insights of Austrian economics shows that this is not the case).

But even if we ignore the ethical and other problems with the utilitarian or wealth-maximization approach, it is bizarre that utilitarians are in favor of IP when they have not demonstrated that IP does increase overall wealth. They merely assume it does (or say they assume it does) and then base their policy views on this assumption. It is beyond dispute that the IP system imposes significant costs, in money terms alone:not to mention liberty costs. The argument that the incentive provided by IP law stimulates additional innovation and creativity has not even been proven. It is entirely possible:even likely, in my view:that the IP system, in addition to imposing billions of dollars of cost on society, actually reduces or impedes innovation, adding damage to damage (see my post What are the Costs of the Patent System?).

But even if we assume that the IP system does stimulate some additional, valuable innovation, no one has established yet that the value of the purported gains is greater than the costs of the system. If you ask an advocate of IP how they know there is a net gain, you get silence (this is especially true of patent attorneys). They cannot even point to any study to support their utilitarian contention; they usually point to Art I, § 8 of the Constitution, as if the back-room dealings of politicians two centuries ago is some sort of evidence. In fact, as far as I’ve been able to tell, virtually every study that attempts to tally the costs and benefits of copyright or patent law either concludes that these schemes cost more than they are worth; or that they actually reduce innovation; or the study is inconclusive. There are no studies showing a net gain (see my post “Yet Another Study Finds Patents Do Not Encourage Innovation”; and, in this connection, I also highly recommend Boldrin and Levine’s Against Intellectual Monopoly and their blog Against Monopoly, to which I contribute).

Instead, we hear repetitions of propaganda trotted out by the state to justify its artificial legislative schemes. But the truth is that anyone who accepts utilitarianism should, based on the available evidence, be opposed to IP. That they are not is telling—it is like those who claim to be environmentalists or fret about “global warming” but never advocate nuclear power, the obvious solution to the “problems” they pretend to be worried about.





Interesting, I noticed you quoted one of your correspondents as having written “I spoke before the Pennsylvania Bar Association IP Section in Philly in 2007 and introduced them to the ontology of IP and social reality (used computers and software to make my points) and was greeted as a Galileo”—

I lived and worked in Philly in the late 90s and was a member of the IP section of the Pennsylvania Bar Association an indeed Founding editor (1997) of the PBA IP Law Newsletter (and Editor-in-Chief till 1999), I published in that journal an article entitled “Is Intellectual Property Legitimate?” (Winter 1998, later republished in the Federalist Society’s newsletter).





My comment was posted in Are Libertarians for Intellectual Property?.





I have no legal or technical/scientific background w/regard to these arguments.  In fact, I was just reading ‘Next’ by Crichton for the 2nd time, b/c I do find it fascinating (and quite a bit of it is true).  It encouraged me to ‘look up’ topics, which is how I came across this site.  This is just crazy.  I mean profiting off the misery of others-at all costsis that really the only way that medical science can move forward.  Really?!

Late in 2007, I discovered I had a cerebral aneurysmover the past 15 years, I had 2 aunts die from cerebral aneurysms that had burst.  The doc of the 2nd aunt suggested that all of the women on my mother’s side of the family be tested, I did, and voila, it was discovered.  I scheduled surgery for January 2008 and now it’s ‘gone’, for all intensive purposes.  Earlier this year, I was asked to participate in a study w/Yale, which I quickly agreed to do, as most people are unlike me, and don’t have the opportunity to discover a cerebral aneurysm before it is too late. My thinking was that I would be more than happy if my participation could in any way assist someone in the future.  Then I started reading Next againand, well damn : even if I participate and discoveries are madeit’s quite possible, likely even, that the info wouldn’t be available for 1) to help others, 2) for a reasonable cost, 3) for further researchwhat?! Why should I do this then?!  So anyway, all of the materialspapers I need to sign, vials needing filling, etc, are now sitting on my desk.  Of course, I would normally read the documents very carefully before signing, but NOW, I’ll be looking for specific information : and there’s no way I’ll participate, if I feel my participation will do more harm than good. I would rather wait, or look for others doing the same type of research, but where their primary goal is to help others, and not to stifle research or common understanding unless there’s some profit in it for them.  Don’t get me wrong, I totally respect any organizations desire to recoup their investment and turn a profit, but really : at the expense of the health of others who can’t afford testing, or at the expense of further research : come on.  That’s just greedy and I don’t want to be a part of thatand I’ll make sure that everybody I know knows that.  So I ask again, Is it really not in any way possible for medical science to advance in an ethical manner?  And we call ourselves civilized.





And also, isn’t halting research/testing (for reasons of profit, or lack thereof) akin to depraved indifference-should someone die due to those reasons?  If not the legal definition, it certainly is the term that I would use to describe those actions.  Ditto for reckless endangerment.  Either way, just a complete disregard for human lifewhen there’s no profit in it…  Ugh.  Yeah, makes me sick.

know my comments are somewhat off-topic, but they just had to be said.





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