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« Scientist-Law Professor Files Amicus Brief in Myriad Case | Main | Webinar on Reverse Payment Settlements »

July 12, 2012


If the primary concern of Watson and Sulston is that information should be disseminated as fully and as early as possible, they should be in favour of the patent system. As to scope of protection commensurate with the contribution to the art, the patent system has always been well able to regulate that. All that is needed is competent patents judges.

Dear Max:

Your argument is logical. Unfortunately, we are far past logic at this point.

Thanks for the comment.

I gave a lecture on patent law basics back in 1983 or so to a group of scientists employed by a biotech start-up in Boston. Watson, a consultant to the organization, attended. He didn't get it then, and still doesn't judging from his brief. If only I had tried harder....!

Watson's arguments are consistent with the analysis in Mayo and Bilski, and are not "wrong". I never cease to be amazed about how members of the patent bar treat with disdain decisions of the Supreme Court that conflict with the economic interests of their clients. KSR is perhaps the best example of this---members of the patent bar and the Federal Circuit, itself, proceed as if neither KSR, Mayo or Bilski changed anything. How many times will the Supreme Court have to whack the Federal Circuit (and patent bar) over the head until they get it.

Maurice has an excellent point, which is exemplified by Noonan's posts here. Noonan's blatant bias is evident in all of his posts. Surprising that he doesn't even explain his conflict of interest.

Well, Maurice and Patent, one man's opinion is another man's bias. I will say that, rather than launching an ad hominem attack on Professor Watson I merely mentioned where I thought he was wrong. There are many places in his brief where he could have qualified his statements but he didn't: he made affirmative statements of fact that were, in fact, not facts. And when he raised an issue with some support I acknowledged it - I just disagree with his proposed solution (compulsory licenses). It is ironic that the US led an effort to discourage compulsory licenses in other countries by sponsoring GATT/TRIPS and now we have domestic pundits recommending this as a solution.

And as to a conflict of interest, as I have said elsewhere on the blog the patentability vel non of human genes will not affect my retirement savings one whit - these patents will expire naturally in less than 10 years, and should the Supreme Court or Congress vanish down the rabbit hole of a "products of nature" exception, I will be able to counsel clients on ways to provide diagnostic inventions without disclosing their genetic bases. And my clients will be able to charge whatever they want forever, or at least until someone else independently discovers the basis for the tests.

I don't think this is good for the country, as policy or economics, but it isn't up to me.

And, finally, if you think the Supreme Court is so omniscient, may I remind of of Dred Scott, Plessy, Buck and Korematsu?

Thanks for the comments.

Maurice: As far as SCOTUS "wacking" the Federal Circuit or the patent bar over the head, it might help if SCOTUS would bother to use correct patent claim terminology (in Mayo, Breyer called a "wherein" clause a "step" which won't get you many brownie points with the patent bar or the Federal Circuit), as well as use reasoning that relies upon the patent statutes (where does "common sense" as articulated in KSR International appear in 35 USC 103?). Even worse, while Breyer says in Mayo that they are following prior precedent, that prior precedent includes Diamond v. Diehr which Mayo cannot be squared with. So if SCOTUS wants to earn respect from the patent bar and the Federal Circuit, they need to act like a responsible reviewing court and not simply hurl illogical and ambiguous thunderbolts at us "mere mortals" which do little more than create chaos.

Patent: as far as "bias," let me point out that the anti-patent bias of SCOTUS is manifest. In the past 60 years, SCOTUS has upheld the validity of patents in only 5 cases (U.S. v. Adams, Diamond v. Diehr, Diamond v. Chakrabarty, JEM Ag Supply v. Pioneer Hi-Bred International, and Microsoft v. i4i). Even more striking is that in each of these 5 cases SCOTUS simply affirmed the validity determination of the lower court. If there was any "balance" (and the Federal Circuit has far more "balance" on validity/invalidity than SCOTUS) you would have expected SCOTUS to at least reverse some invalidity rulings from the lower courts.

Kevin: you should also add Kelo v. City of New London where the SCOTUS majority turned the "takings clause" in the 5th Amendment on its head.

As in his Prometheus analysis, Mr. Noonan once again exhibits a very good sense of both the law and the science, which is a challenge as expertise in one discipline does not preclude expertise in the other but they are rarely coincident. Curiously, in Mayo v Prometheus, the Supreme Court exhibited expertise in neither.

In this case I believe (as a molecular biology expert) that in most past examples, inventive ingenuity was indeed required to conceive, develop and practice methods of locating sequence properties conveying or linked to particular phenotypes, including pathologies. However, going forward, given the known reference genome sequence and ultrahigh density genpotyping techonlogies, including rapid whole genome resequencing itself, I believe that most variant/phenotype association discovery has now been reduced to routine experimentation.

So appropriately directing the scope of a decision in favor of Myriad may turn out to be tricky, limiting it to what is truly inventive, maybe even to the Myriad BRCA mutations themselves (in which case it probably shouldn't be in the SCOTUS I suppose).

Dear Dr. Noonan,
Please count me among the "motley mischief makers."
You state: "The first argument is that human genes should not be patented because DNA is a unique molecule different from other chemicals and should be treated as such; this is a variant of Judge Sweet's view that DNA is different because it is the 'physical embodiment of genetic information.'"

I believe this omits an essential element of James Watson's argument no 1.
Rather, he states:


Being human is a rather ephemeral concept to grapple with, especially for patent attorneys who are so used to concrete characterizations such as claims, but it is not one which should be lightly dismissed, or in the case of the first quotation above, ignored.
Respectfully submitted,
Arthur P. Gershman
RN 27,035

Dear Arthur:

Thank you for your comment. However, the reason we didn't mention that part of the quote is that it is irrelevant to the question. There are many situations where it is not irrelevant - using genetic information to discriminate, for example, or to deny health coverage, or to clone or manipulate human beings, or the like. These types of uses for genetic information do raise serious ethical concerns

But for the purposes of the discussion at hand they are at best a distraction and at worst a way to focus the debate away from the question and into the land of "it's just wrong." That is where the ACLU wants the debate, because that line of argument blends in all the worries provoked by the concerns above. But because genetic information is not patented these concerns don't apply.

Dr. Watson's argument smacks of vitalism - "this molecule is sacred." Sorry, I just don't see it. And 30 years of biotechnology, and its fruits in terms of positive benefits for human health, are more ethical to me than these potential problems of how DNA is used (which, by the way, don't require patenting).

Thank you for reading.

Dear Kevin,
Thank you for this forum.
While Watson's argument smacks of Vitalism, I find it difficult to get behind a mind set which denies the existence of the soul. It is ironic that while Watson is an atheist, I am coming from the viewpoint of a Reform Jew, whose gaze is fixed on, to cite another scientifically discredited doctrine, Eugenics, culminating in the Holocaust, and yet Watson and I arrive at the same conclusion. What lessons may we draw from this paradox?

Dear Arthur:

I think there is an atavistic, visceral reaction to the concept of someone "owning" a part of you, an aspect of the argument that the ACLU (and Michael Crichton before them) has played up most effectively. And the two subjects I would choose if I wanted to put a cocktail party asleep would be patent law and molecular biology, which explains to me why arguments based on gene "ownership" have been so effective.

I certainly think your reference to Eugenics, from a Jewish perspective or not, is an apt one regarding genetic information, particularly because it was Galton who began the movement - the ideas of a genetic hierarchy fit well within the British class system. That these ideas were so easily permuted (and perverted) into the idea of a "master race" by the Nazis is a good illustration of how politics can twist scientific fact to its purposes. Similarly to the genetic response to eugenics - that the "tree of life" is a shrubbery and what is "fitter" genetically is not fixed virtue but rather whatever works best under prevailing conditions (not to be confused with situational ethics), the correct answer to the ACLU is as has been set forth here many times. No one owns genetic information, and indeed the information in patent applications is many times more detailed than in scientific papers, due to the rigors of Section 112 - even scientists try to hide the ball sometimes in their published work. So ultimately, the fact that patents expire within 20 years of filing does exactly what the patent system is intended to do - promote disclosure. After all, even I can come up with scenaria where genetic information is suppressed in ways that would be difficult to reverse engineer, leading to "monopoly rents" on assays using these sequences that might extend much farther into the future than 20 years.

Thanks for the conversation.

Dear Kevin,
I value your opinion, so I would restate: It is ironic that while Watson is an atheist, I am a Reform Jew, yet Watson and I arrive at the same conclusion. What lessons may we draw from this paradox? Also, your imagination is more vivid than mine. Could you give one or two examples of "scenaria where genetic information is suppressed in ways that would be difficult to reverse engineer, leading to 'monopoly rents' on assays using these sequences that might extend much farther into the future than 20 years."
Art Gershman

Further, your comment about publication versus obtaining a patent is apt. I would champion the cause of obtaining an SIR over a patent. Details may be found in my book "Other Peoples Bodies" (available on LuLu.com) in the section "Roslyn Yalow's Patent."

Dear Arthur:

I see the irony but am not sure there are lessons.

As for the hypothetical, remember that while the prevailing metaphor for genomic DNA is that it is a library, a prior metaphor is that it is a haystack, and finding a particular sequence was like looking for a straw needle. That's because until the past 30 years it was much more difficult to isolate a particular nucleic acid sequence than a particular protein.

As for the scenaria, there are two. First, if I want to produce a protein, particularly a complicated one with a naturally occuring variant that confers beneficial properties, I can just isolate the gene and put it into a cell. Once it is back in the cell the needle is back in the haystack, and if it is a human gene in a human cell it will be very difficult to re-isolate (particularly if the cell contains the "normal" genetic variant).

More powerfully for diagnostics, in most instances for most diseases the genetics involve many changes in both sequence and level of gene expression. If I identify a diagnostically informative pattern of genetic changes (which will typically fall somewhere between six and a dozen), I can put the diagnostically relevant sequences onto a "gene chip" having about 10,000 total sequences, and position the informative ones on the chip in an encrypted way - if you do the math it will be very difficult if not impossible to reverse engineer. In that way my (Particular Cancer) Diagnostic Gene Chip will be able to be sold for whatever the traffic will bear for as long as I like (or until someone else repeats my discovery). But I will never disclose what genes/sequences are relevant.

As for SIRs I think websites are easier - just put something on the web and be done with it. But there will be a lot of chaff for the kernels of wheat disclosed that way, and it will be a much less efficient way of disseminating genetic information than the current system.

Thanks for the comments.

Assuming arguendo, that an "inventor" eschews a patent (such as Benjamin Franklin or Roslyn Yalow), perhaps for ethical reasons, the gentleman from NIH I met at the 7/20/12 FC hearing said they would just publish also, because it is less costly; but I think a website is dodgy - I'm sure you believe everything you read on the internet (sarcasm). I think an SIR has an advantage in that it has the imprimatur of the USPTO, but of course Dr. NIH is right that it is just as expensive as a patent. I am reminded of the RCA "Notes" and IBM "Disclosures" they had when I used to work there. Do you know if NIH has such an outlet? But I suppose any outfit which presumes to obtain a patent has some kind of public organ it can use to create the same kind of shield created by the SIR. Or, would the new (relatively) publication for purposes of opposition rules serve just as well? Oh what a complicated system we have wrought!


The section of Title 35 that provides for Statutory Invention Registrations (§ 157) was repealed by § 3 of the Leahy-Smith America Invents Act. The repeal of § 157, and resulting elimination of SIRs, becomes effective March 16, 2013.

Thanks for your comments.


Dear Don,
Thank you for pointing that out. I suppose that a similar aim could be accomplished, as I said previously, by publication of the patent for purposes of opposition and then disclaiming the claims. This is what happened in U.S. Patent No. US-6,444,872-B1, May 24, 2004, when the International Center for Technology Assessment opposed the University of Texas in its patent on a beagle whose immune system was compromised to facilitate the dog’s use in medical experiments.
See: http://www.icta.org/patent-watch/legal-actions-5/
and reported in my book.

I read the brief and all I saw was a commercial for James Watson. If nothing else, it detracts from his current credibility.

His cite for his Nobel prize? His own book! Was there no better citation available? Perhaps a NY Times article or the Nobel Prize website?
Other publications of James Watson are also thoroughly cited throughout!

The poor arguments notwithstanding - this was just an excuse for James Watson to talk about James Watson.

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