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Foaming at the Mouth II: My Alternative to the New But Inane Becerra Bill


Written by Eric W. Guttag
Eric W. Guttag IP Law Office
Posted: April 15, 2010 @ 3:11 pm
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As you may know, I’m already worked up over the inane 152-page ruling by Judge Sweet in Association for Molecular Pathology v. USPTO (aka “the gene patent case”).  See Foaming at the Mouth: The Inane Ruling in the Gene Patents Case .  In AMP, Judge Sweet declared 15 claims in Myriad’s patents relating to the BRCA1 and BRCA2 gene sequences invalid under 35 U.S.C. § 101 as not being patent-eligible subject matter.  This ruling was soon followed by a biased and factually distorted 60 Minutes segment which has generated a popular media “tsunami” that has unfairly vilified Myriad (and the patenting of gene technology) as the new “Evil Empire.”  Never mind that Judge Sweet’s ruling will likely be trounced on appeal by the Federal Circuit as it is factually and legally flawed.

But it gets worse.  Enter Congressman Xavier Becerra (D-California) who has proposed his new but equally inane proposal that would make Judge Sweet’s ruling law by banning gene patenting.  Some may recall that Congressman Becerra (aka  “The Gene Patent Terminator) previously proposed a similar bill (at the prompting of the late Michael Crichton) which, according to its misrepresentative title, would have banned the patenting of human gene sequences.  In fact, by its language, the “old” Becerra bill would have also banned the patenting of all gene sequences, human or otherwise.  Fortunately, the “old” Becerra bill never made it out of committee.

As others have noted, the new Becerra bill goes even further than the “old” bill to ban the patenting of not only “isolated” gene sequences (human or otherwise) but also:  (1) complements of such sequences (e.g., cDNA); (2) any “function or correlation” of such sequences or their complements (e.g., patented medical diagnostics based on such correlations); and (3) “naturally-occurring products” (whatever they might be) that such sequences or their complements “specifies” (whatever that means).  As already hinted at, the language in this proposed bill is poorly written and unclear, and could potentially ban patents on “synthetic” gene sequences which don’t even exist in nature, and are structurally so dissimilar that nature couldn’t possibly make them.

In my opinion, Congressman Becerra should be focusing his attention on more important matters, like how we’re going to pay for the mind-boggling health care package that he and his Democratic cronies just passed without imposing on America a tax-burden which will simply stifle all economic growth, including in the biotech sector.  Also, what about encouraging business and job growth in America, e.g., a growing and healthy biotech sector?  But once Congressman Becerra has destroyed the American biotech industry with this misguided bill, how does he plan retrain all those unemployed biotech folks? Frankly, Congressman Becerra, “The Gene Patent Terminator,” needs to get a life.

But for those who feel I’m simply a “naysayer,” I do have a suggested alternative on the patenting of gene sequences that is far more sensible (and won’t kill our biotech sector) than the “all or nothing” approach of the new Becerra bill.  Instead of banning the patenting of gene sequences, why not provide the U.S. government with something similar to the “march-in-rights” provision that currently exists in Bayh-Dole for patented technology developed through federally-sponsored research that is underutilized?  Admittedly, this “march-in-rights” provision would have to be carefully structured so it isn’t abused by the federal government, as well as those who would push for its too frequent use because they feel “entitled.”

In conjunction with this “march-in-rights” provision, you would also need to provide the patent owner with the ability to secure “reasonable compensation” for what would likely amount to a “compulsory license” in the Court of Claims, similar to an action under 28 USC 1498 for patent infringement by the federal government.  There is precedent for this approach in certain provisions of the Clean Air Act enacted in the ‘70s which provided for the compulsory licensing of air pollution prevention and control technologies.  At least the patent owner wouldn’t be completely deprived of any ROI just because some take the extreme view that patenting gene technology is “immoral.”

One of the “scare tactics” in the AMP case is that Myriad has imposed a “chilling effect” on basic academic research on the BRCA1 and BRCA2 gene sequences.  First, let’s clarify that Myriad has not tried to directly prevent academia from carrying out basic BRCA1 and BRCA2 gene research, only those who want to offer competitive commercial alternatives to Myriad’s diagnostic tests.  In fact, one of the parties being sued in AMP is the University of Utah Research Foundation, a research arm of the University of Utah.  But if it would help negate this alleged (and so far unproven) “chilling effect,” why not enact an “academic research exemption” (as was suggested after Madey v. Duke University) that would allow academia and other non-profits to do basic gene research without fear of a patent infringement suit?

The alternative I propose for responding to the unfortunate media “hysteria” regarding Myriad’s alleged “gene patenting” would certainly require some refining, as well as buy-in from the many special interests involved in this controversy.  But what I propose has the prospect of removing the emotion (as well as the morality) from this controversy, as well as creating a potential “win-win” for all other than the most extreme views on either side of this controversy.  Anything would better than this new oxymoronic Becerra bill which will simply stifle, as well as unnecessarily gut, the American biotech industry.

© 2010 Eric W. Guttag.


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75 comments
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  1. Wouldn’t compulsory licensing for specific technologies be somewhat more in tune with our capitalistic ideals?

  2. Morton,

    I’m not sure I undestand what you mean by your question. Please elaborate.

  3. This is a really interesting solution: would largely abrogate mishaps like the whole COX2 debacle while still protecting discovery rights.

  4. Well, I would be very uncomfortable leaving it to bureaucrats to decide when to exercise march-in rights and then manage the IP. It might make more sense to implement some sort of compulsory licensing scheme, perhaps requiring an initial arbitration and rate-setting committee to establish reasonable royalties. For example, if a company wants to provide BRCA testing, and it is able to show some real and substantial special public interest such as there being no easy or cost-effective way to get a second opinion on a test that can affect millions of patients (and ultimately reduce the cost to society of the cancers that can be prophylactically addressed), or because certain insurance won’t cover it even the first time around (which is despicable IMHO), then it could be granted a compulsory license at a reasonable royalty rate. If the patentee wants to avoid having such licenses issuing, it’ll be a lot more flexible with terms to potential sub-licensees.

    I could go on and on about details on how to balance the rights, how to administer, who to administer, etc. but I’m sure you get the point.

  5. Morton,

    OK, I now understand where you’re coming from. I too am somewhat “uneasy” about a “march-in-rights” provision that proves to be too easy to “politically” manipulate. But the “march-in-rights” provision in Bayh-Dole has so far never been invoked by the federal government in its 30 year history. In fact, I know of only one instance where then Congressman, now Senator Sherrod Brown threw a “hissy-fit”over the NIH not exercising this provision (and rightly so) for two different drugs (Novicir and Xalatan, please excuse me if I get these drug names wrong). The NIH realized that if they gave into popular pressure and exercised the “march-in-provisions” too easily, Bayh-Dole would be dead letter. The same would be true for what I’m suggesting.

    Again, what I’m suggesting with my alternative is to remove the emotion and morality out this gene patent controversy, provide a vehicle for the government to step in if “extraordinary” circumstances truly demand it, and still make sure the patent owner is completely denied at least “reasonable compensation” for the money and time they’ve spent. If I’m put to the choice, I would rather we have at least a “sane”and sensible procedure for doing this, rather than the “inane” and completely draconian proposal made by Congressman Becerra.

    And thanks for your comment.

  6. Sure thing. Incidentally, I’ve long believed that another good reason for compulsory licensing is to prevent patent trolling (now a moot subject) and somewhat reduce the abuse of patent portfolios we see by patent consolidators that create huge collections of rights solely to “sit” on the rights while others do all the hard work.
    Thanks for the opportunity to vent a little.

  7. -Gene

    I can’t say I am amused by the superfluous political insert. Probably because I lean left, but I suppose it is your blog so you can say whatever you want, and when it comes down to it, patents are a political issue.

    wheather is is produced in nature or not, I think there needs to be a provision that no organic matter, DNA or otherwise, cannot be infringing simply for existing, anywhere, at anytime, and for any reason. If they want to go after the people who are illegally producing, modifying, testing, etc, then go ahead, but don’t punish the people on the bottom just because they are in some kind of contact with it.

    If somebody is illegally producing a patented gene sequence for say, grass, and it winds up in my yard, either by me buying it, knowingly or unknowingly that it was illegal; because the breeze brought it in; or for whatever other reason, we can’t assume that I have done anything wrong unless I intentionally bought knowingly infringing goods. How do you track that? It is analogous to the copyright issues with music. Does it make sense to go into homes and check people’s computers, or to go after the people spreading it around? Actually, it is much easier to assume that somebody who is infringing a gene patent wouldn’t know it rather than somebody infringing music copyright.

    The documentary “The future of food”, which obviously has an agenda that I won’t deny, points out some of the tradgedies that have befallen farmers, especially in Canada, who happen to have seeds patented by Monsanto corporation blow into their fields. They were sued for infringement and lost, even though they never wanted or willfully brought the seeds into their farm, but because they were there, it was still decided to be infringing. One of the ugly sides of “it doesn’t matter if you came up with it on your own.” In the end it all but destroyed their farms. Things like that shouldn’t happen.

    Also, in the case of organic matter, or life saving methods, or other such patents, I see no conflict in letting non-profits and government have free licenses or some other kind of agreement to use it for free. If a method is patented for finding some disease, and poor people can’t afford it, then they wouldn’t have likely gotten it anyway, licensed or not, so what is the harm in letting a non-profit, free clinic, or government program administer it to people who really need it? We have other social welfare programs, why not one to help people who need patented technology?

    I’m glad you opened this up for debate and offered reasonable solutions to appease people in the other camp. We aren’t going to get anywhere without reasonable dialogue and empathy for each other.

  8. -Eirc

    I have got to start looking that the author of these blog posts… sorry for the address to Gene, lol.

  9. Morton,

    It appears that you would benefit from understanding some fundamental concepts concerning patents, from what they allow a person to do (keep out) to what they do not allow a person to do (positive activity) to the essence of the patent (exclusivity) to the basic property aspect (the perfectly legal right to buy and sell, to aggregate – it also appears that you want something “extra” after -grant to be done with the focus of the patent). It is such rampant misunderstanding of the Quid Pro Quo that exacerbates the dialogue. The promoting aspect of impetus and drive to design around the road block of a patent right is much too easily ignored.

    Your comment “prevent patent trolling (now a moot subject) and somewhat reduce the abuse of patent portfolios we see by patent consolidators” seems to both conflate what “trolling” is and what “trolling” can do, at the same time mistakenly puts forth that “trolling is a moot issue. Are you aware that “trolls” bust patent thickets (your patent consolidators)? Are you aware that “trolling” isn’t always done by “trolls” but also by patent holders of a variety of sizes and shapes (universities and large corporations)? Are you aware that the demonizing “troll” campaign seeks to attack perfectly legal (and ethical) behavior for the profit gain of established companies?

    I respectfully urge you to approach patents with an open mind in an attempt to understand what they actually are. Once you have a baseline understanding, then engage the discussion. You might also choose to follow my comments at http://www.ipwatchdog.com/2010/04/01/a-conversation-with-gary-michelson-about-patent-reform/id=9917/

  10. pop,

    That’s OK. As for the “superfluous political insert,” yes I’m what you might call a poltical conservative, although labeling me one on certain issues could be dangerous. I’m just trying to point out we’ve got much bigger problems to deal with than what this Becerra bill addresses. Since you appear to be a liberal, you might argue what about the money spending on the wars in Iraq and now Afghanistan. I might not agree with your view, but I certainly will support your right to express it. That’s what our 1st Amendment is all about, the right to express yourself, whether or not others agree with you. And believe me, I’ve been “demonized” for daring to express my “conservative” views and beliefs, but as I tell those who do so, I’ve got the “intellectual skin” of an alligator, so intimidation isn’t going to persuade me.

    The situation you bring up about Monsanto’s seed program is very strange and one I hadn’t heard of. I agree that if your receive the alleged infringing item totally by accident (e.g.,, it is blown into your field), that shouldn’t be considered an infringing “use.” Can you provide with a case name or other materials? I’m very curious about this.

    As far as the “free license” thought, which expresses what I refer to as an “entitlement” mentality, I’m afraid we’re going to part company on that one. You can’t simply expect that costly and time consuming research is going to be available without someone paying for it. As I suggest, that could be the federal government, which means we’ll all chip in. Also, contrary to how the media portrays them, drug companies are not completely “cold hearted.” In fact, you’ll see many, many drug ads which mention that if you can’t afford the drug, there’s a way to get help. Even drug companies are smart enough to know that making expensive drugs unavailable to those with less money to spend is bad PR.

    Anyway, thanks for your comments.

  11. POP-

    “I think there needs to be a provision that no organic matter, DNA or otherwise, cannot be infringing simply for existing…”

    No need really for that because it already exists. That is part of the terrible misleading going on by the press on this issue. The Myriad claims all require some form of isolation or other human manipulation. The DNA is extracted from the cell and into a state that could never exist in nature. Human intervention and activity is the hallmark of patentability, so if there is no alteration from natural state there can be no patent. So I guess what I am saying is that your point is well taken, but already handled despite what the ACLU and Judge Sweet think.

    “If somebody is illegally producing a patented gene sequence for say, grass, and it winds up in my yard, either by me buying it, knowingly or unknowingly that it was illegal; because the breeze brought it in….”

    Here I think you are referring to the seed case where Monsanto sued the farmer. The facts were that the farmer knew that the seeds blew in and he intentionally killed his own crop so that only the genetically modified crop remained. He then harvested the seeds and planted them. That was infringing. Had he not intentionally killed his own crops and intentionally harvested the genetically modified crops the case would have been very different. The farmer and his supporters flat out lied to the press and no one who wanted to believe them ever really checked out the facts of the case.

    Gotta run for now.

    -Gene

  12. There may be many “alternative” approaches for designer laws and regulations. The biggest problem with them is the “details” and setting new precedents. A few notes: (1) The march-in proceedings for Xalatan were complex, time consuming, costly, and highly contentious. (2) The USA has held a hard line against using the TRIPS flexibilities to require compulsory licensing and has been and remains highly critical of those member states that have invoked these provisions of the DOHA accord. Were we to invoke government “march-in” or “compulsory licensing” (or whatever it might be called), the USG would need to become aware of every patent that might fall within this umbrella (or have a general procedure similar to the FDA’s orange book listings.) Then proceedings would follow and the courts would need to get involved to set “reasonable” royalties. A highly complex process that is filled with political, legal,financial and procedural land mines. (3) Designer legislation caused 103(b) and (c). The USPTO has difficulty finding consistency when every technology is under a singular set of laws; technology specific exceptions would/could mean that claims within a single application would be subject to different standards.

    Thus, while the suggestion is worth considering, history tells us that the best system is one where all technologies have the same standards and USG involvement is kept to the minimum possible. Whether a gene is “human” or not is an absurd question. When the nucleic acid (NA)is in the tube it is virtually impossible to distinguish it from any other nucleic acid. In fact, once the hand of man gets involved and the NA is cloned, it is impossible to distinguish. Thus, your point about this legislative proposal being inclusive of any NA and heading down the slippery slope of anti-biotechism (?is that a word?) is both valid and on point. These types of legal proposals by Congress only serve to highlight the technological ignorance of many of our elected officials.

    Finally, does anyone know what Sen. Orem Hatch thinks? His opinion is highly relevant given his district and his long standing knowledge of this particular debate.

  13. Any time you make ‘special’ rules to carve out specific technologies you end up with detrimental and unforseen effects. If you carve out special rules for Biotech, software, business methods, etc. you will end up worse. The system fluctuates a little bit left to right and right to left, but it fluctuates around a reasonable solution. The “gene” patents they are worried about are now dated. With the published genome, more is required to get a patent than just a sequence. Early in biotech development, a protein coding sequence was unique, thus the gene patents were issued. The technology has progressed, now a function or activity is required. Thus the attempts to BAN gene patents are too late and are ‘correcting’ a problem that doesn’t exist.

  14. Noise above Law,

    I view these exchanges as opportunities to throw ideas up against the wall to see what sticks, not because I fervently believe one way or another. I do not assert that any of my comments are fully or even well formulated plans, just good points for consideration and discussion by people interested in looking at things from various angles.

    As to your insinuation that I know not of where I speak, I have been a practicing registered US patent attorney since 1990 and have prosecuted and litigated patents (biotech and pharma included) since then. I am also admitted and practiced in Israel which does have a compulsory licensing scheme.

    I worked for a number of years as in-house patent counsel for one of the ten largest pharma houses in the world – on both their innovative and generic lines.

    I now am working in the business development and licensing arm of a major research university.

    Patent trolling is a dead issue because of the 20 year life from first claimed priority. Any applications that are based on applications filed before June 1995 are most likely dead or issued long ago and near the end of their life.

    My reference to trollers and patent consolidators was more directed to anyone that gets a patent for the sole purpose of sitting on it and waiting, sometimes for years, for someone else to do the real work of development and creating a market for for an invention. I do not count in that category any patent holder who actively develops and markets their invention and then uses patents to protect that investment in creating that well-earned space.

    Drug manufacturers do by and large go out of their way to get expensive life-critical drugs to those who cannot afford them otherwise and obviously that is a good thing, but it is also clearly a business decision to avoid the kind of backlash that Myriad is facing from patients who have no way to make sure that the Myriad test was accurate.

    Personally I think that DNA patents are generally not an awful thing, especially since most are not enforced at all and since they do not in any way impede research or the development of competing therapies, which is where the real money is. What makes diagnostics such as Myriad’s a bit different is that their test often forms the basis of a decision to take a drastic prophylactic action. I think a person facing such a life-altering decision deserves to have alternatives to be sure the test is available and, more importantly that the results can be confirmed by an independent source…and that is precisely where the actions Myriad took are perhaps correctly deplorable.

    In an ideal world, Myriad would have been smart enough to voluntarily give out some sublicenses if only to serve as a second independent testing authority that patients could turn to for confirmation of the Myriad test result. In fact, Myriad could stipulated that these sublicensees only perform the analysis after being provided proof that Myriad had already performed one for the patient. The sublicensees could independently develop cheaper more reliable methods or at least adopt different/better quality control than Myriad’s, still make plenty of money to recoup the investment, and serve as impetus to improve the technology while providing patients with the second opinion option they now lack.

    Just my $.02

  15. Brian and Mike,

    You’re points are very well taken. I’m just tring to suggest a possible alternative to what is truly an awful proposal in the new Becerra bill. The gene patenting debate has turned into a media circus bearin no relationship to what is factually, scientifically, or legally correct with only essentially one side being applauded (the ACLU’s plaintiffs) and the other side being essentially vilified and demonized (Myriad’s). It also packed with emotion, and unfortunate allegations relating to the “morality” of gene patenting and medical diagnostics based on gene research. I’m trying to suggest a way to remove the unnecessary emotion and morality nonsense. But as you point out, there isn’t an easy way to do it that doesn’t have significant reprecussions in other technology areas which may be patented. Thanks much for your comments and insights.

  16. Morton,

    With the credentials you list I am even more aghast at what you say.

    You confuse “trolling” with “submarine practice”. The two are very distinct from each other.

    Your view of compulsory licensing is an affront to the Constitutional basis for patents in the US. Perhaps your Israeli experience jades your viewpoint.

    If your posting style is to “throw ideas up against the wall to see what sticks” and “just good points for consideration and discussion” without regard for fundamentals, then I tend to doubt you are who you say you are. At the least, such carelessness on a blog populated with conversations from anti-patent proponents is extremely reckless.

    Aside from your confusion regarding submarine versus troll issue, you should know that patents are public knowledge that anyone interested can search and the notion that someone can sit and wait in prey is a fallacy. Since you have years of experience as in house counsel, would you not take advantage of the publicly available patent database prior to launching any substantial in-house efforts? Or did your experience there also follow the “throw it against the wall and see what sticks” methodology?

    If you indeed have been “a practicing registered US patent attorney since 1990”, you would recognize the basis of the negative right that a patent is and would likewise be aghast for demanding more – demanding anything post-grant, when the Quid Pro Quo has been satisfied. There is simply no basis – legal, moral, ethical or otherwise to demand more Quo. But please, feel free to discuss the basis you see in patent law for this, as I too am willing to see “what sticks”.

    As To “The sublicensees could independently develop cheaper more reliable methods or at least adopt different/better quality control than Myriad’s, still make plenty of money to recoup the investment”, there is NOTHING stopping anyone NOW from developing a cheaper more reliable method outside the duly earned “keep-out” zone developed by the inventor of the patent now correctly held (licensed?) by Myraid. That’s precisely the benefit of having a hurdle – so people WILL try to work around it.

    I think theft and violation of the patent Quid Pro Quo is deplorable. Dressing such theft up in righteous clothes is even worse. I have said before (and been misunderstood) that the ideal world is a beautiful place. Communism in its purest form would work there, and everyone would be happy. The thing is, such a place does not exist. We have the laws that we have precisely because the ideal world does not exist. Closing your eyes and “hoping” that idealism sticks is a dreadful way to live in this world, this non-ideal world – especially as an attorney. This world is the real world where the patent law is looked at from various angles that can be implemented. Let’s face it, in your ideal world, patents would not be needed. Neither would money. “What sticks” in conversations so out of touch with reality is better off not thrown in the first place.

  17. Yeah, how dare you, Morton! Don’t you know that every patent attorney is supposed to fall in line and agree that pretty much everything is properly patentable? Geez, you remind me of patent attorneys like Luigi Palombi, Dan Ravicher, and Stephan Kinsella, all of whom have dissenting opinions and thus are to be shunned. Beware, these guys on IPWatchdog might just kick you outta their elite club!

  18. David,

    “Shunned’ is an interesting choice of words, from one who has shunned,/i> substantive argument, and who would prefer to dabble in semantics and cheap lawyer tricks (loaded questions with circularly presumed answers anyone?).

    Let’s hear your take of the Constitution, the Quid Pro Quo and the legal basis for post-grant requirements.

  19. italics off (I know i should stick to all caps).

  20. Noise above Law,

    Personally, I concede on all the points that you make. Yes I confused the terms submarining and trolling. No excuse for that but aging.
    Of course patent rights are the right to exclude and not a right to practice, basic patent law.
    I agree Quid Pro Quo must be preserved…although post-grant modification happens all the time through reissue, re-exam and litigation.
    And, of course J. Sweet’s ruling is awful, for many reasons.

    Here’s the one comment I wonder about… you say “there is NOTHING stopping anyone NOW from developing a cheaper more reliable method outside the duly earned “keep-out” zone developed by the inventor of the patent now correctly held (licensed?) by Myraid”. All a competitor need do is somehow develop a way to detect the presence or absence in a patient’s genome of BRCA , without isolating the DNA. That’s going to be one hell of a trick and I hope it happens soon.

  21. Morton,

    Your response is more gracious than my reply. The decency to admit mistakes readily places a welcome distinction about you.

    As to post-grant modifications of reissue, re-exam and litigation – none of these are substantive requirements related to the Quid Pro Quo (such fixing is not related to the normative notion of receiving a patent grant). So just like post-grant annuity payments, these are non-sequiturs to the grant itself and what it means.

    As to the “one hell of a trick”, no one said invention was necessarily easy (I don’t know how much effort and money went into the subject patent itself), but perhaps a quicker, easier and more assured correlation exists – one that may not need such extensive isolation or other man-made alteration of a patient’s genome (since the genome itself is not patented – efforts along this track are not part of the “keep-out”, no matter what spin the anti-patent people put out there).

    Some see roadblocks as stop signs. Others see them as inspirations to be even more creative. I know that I would rather have creativity than a “nanny-state” forcing a contract in violation of the Constitutional exclusivity.

  22. Morton – I, too, can’t wait to see how someone manages to determine a genetic mutation without being able to isolate the DNA, as this exceeds patents and would be a feat worthy of a Nobel Prize. It’s the kind of change in scientific methodology that would renovate biological science planet-wide, the kind of change that occurs once every 50-100 years in science. In other words, this kind of technological change is not likely to occur in our lifetimes.

    As a biologist, I find it preposterous that any entity can specify what fragment of my own DNA I can purify, amplify, or probe using off-the-shelf components and the publicly available and commonly accessed human genome sequence. Even 15-20 years ago, any first year molecular biology student could make PCR primers to amplify the BRCA gene using the government-funded human genome source. Myriad’s original PCR and mass-spec patents were akin to saying everyone is legally prohibited from observing themselves in a mirror.

    I completely support strong patent rights and believe we cannot prosper as a nation unless we have strong intellectual property protection. Eric and Gene have presented superb legal analyses of why the patent rights should be protected, to which I cannot contest. Notwithstanding, I’m completely stymied, however, as to how these patents were granted in the first place.

  23. Eric,

    Ben Goldacre wrote a column on the case in the Guardian online a couple of weeks ago. The link is:

    http://www.guardian.co.uk/commentisfree/2010/apr/03/ben-goldacre-gene-patents

    You will see that he did not let the facts stand in the way of a good story.

    One of the critics of his comments did a search on the PubMed site using the search term “BRCA1″ and found 7,200 + papers have been published with this term in them. Next time someone talks about the chilling effect of the BRCA gene patents on research ask them how many more papere would have been published without the chill.

  24. “Even 15-20 years ago, any first year molecular biology student could make PCR primers to amplify the BRCA gene using the government-funded human genome source.”

    Then the proper challenge is under 102 and/or 103 of Title 35, not section 101, and that is the crux of the problem. Rather than doing the heavy lifting required Judge Sweet merely ignored Supreme Court precedent and the legislative history of the 1952 Patent Act. In many other courts the ACLU would have faced sanctions for having filed a defective complaint full of lies.

    Whether we like it or not, the USPTO is incapable of issuing only valid patents. The best they can do is a good faith review, so pretending that patents are or ought to be presumed valid is increasingly illogical, assuming it ever was logical.

    The rational and appropriate thing to do would be to reexamine these and any other patents where there is reason to believe the patent was issued in error. Alas, given the political and social climate of the day I don’t know whether logic is capable of prevailing any more.

    -Gene

  25. David-

    Normally you are a rational guy. I don’t know what is happening to you. Yes, I disagree with you vehemently on pretty much everything of substance, but you know as well as I do why Kinsella was banned from commenting on IPWatchdog. He is a liar. I proved that he lied about communications we had in private to forward his own agenda and try and paint me as the liar. So you know as well as I do that dissent is fine, but lying, manipulating and intentionally casting others in a false light is unacceptable.

    Please do try and keep up!

    -Gene

  26. the best disinfectant is sunlight, Gene, so “bans” are just outright un-American.
    As for Morton, he’s right, there’s no work-around since the patent overs the bare sequence.

    As for Noise,
    My take on the Constitution? There’s no takings issue here, and the SCOTUS created the “product of nature” exception. It’s within their power of judicial review since, well, Marbury vs. Madison. We’ll see what they do with the Myriad case (and Bilski, before that). I’m optimistic.

    good day, folks, I’ll be gone for a while… have to take my father to the hospital, but feel free to go nuts in my absence.

  27. Dave,

    Gene poured “sunlight” on the Stephan Kinsella exchange – that’s why the ban. What you propose is covering a wound with more of the crap that started the infection. That’s not “un-American“, that’s pragmatic.

    Just like the ban of 6 for downright stupidity.

    Let me correct you: “the patent covers the bare man-altered sequence. You should be clear about that. I have previously posted the link to the story at Patent Docs that explicitly covered that.

    As I posted above, some view the patent roadblock as a stop sign while others view it as a challenge to innovate. How many thousands of research papers have been published since the patent? Obviously, there are many who do not see the patent roadblock as a stop sign. You can shoose to stop if you want, but you are gravely mistaken to believe that your choice means everyone must stop.

  28. Noise:

    The “isolated” issue is where I really cannot grasp the logic you and others offer. If merely isolating something that is found in nature as part of some larger whole is enough to meet the patent-eligibility threshold, then I can imagine all sorts of acts that suddenly qualify (isolating an antelope from a herd, isolating a chip of rock from a mountain, isolating eyes from faces, isolated raven, etc. all of these are human-alterations) and the O2 debate on another thread (Hakuna Matata) led to contradictory conclusions (some eventually said that O2 did not qualify because photosynthesis has been isolating O2 for a few billion years and so is a product of nature – Yet Another Examiner said this, and I agree) still others claimed that Priestley’s isolation of O2 by heating mercuric oxide would give him a claim to all isolated O2, even where isolation is done by other means such as electrolytic separation of O2 and H from water, or natural, photosynthetic separation of C from O2 by plants. This latter chain of reasoning really escapes me, and seems to defy reason. O2 is a naturally-occurring substance, even where it occurs most prevalently in a mixture with other elements, and it has helped make life possible here on Earth for quite some time. I can see the logic of allowing a patent on a new process for isolating it, but cannot see how that extends to the product, no matter the source. The isolation of O2 from C occurs molecularly in the photosynthetic process, creating “pure” O2 that then mixes with other gases in the atmosphere. Moreover, the isolation and separation of individual genes from the whole genome occurs at the molecular level too, as mRNA is created, copying the active gene sequence (excluding the “junk” naturally) and then taking that sequence to the ribosomes to manufacture proteins. Again, molecularly, the isolation and purification is occurring by natural processes, just as with the production of O2 by plants. I suppose, if you still think that the fact that photosynthesis has been producing isolated O2 for billions of years somehow does not foreclose a claim on the product O2, and that you think the product O2 is really not a product of nature, and that anyone who first discovers a way to isolate O2 (like Priestley did) should not only get a patent on the process, if it is new, but also on the product, then we’ll never be able to agree on the claim you make that somehow isolated genes are truly man-altered as you claim. To me, it seems to stretch not only the doctrine but the purposes of patent law to the breaking point.

  29. DK,

    With due respect, you are continuously demonstrating mis-appreciation of science in general and chemistry in particular.

    Essentially all atoms (Hydrogen, Helium, … Nitrogen, Oxygen, … Carbon, Silicon …) are found in nature.

    But Mother Nature is not so kind as to provide these atoms (or molecules thereof) in isolated, purified and concentrated forms.

    It is only by the industrious efforts of men that many of these purified, isolated and concentrated substances come into being.

    You keep insisting that all these things are “products of nature”.
    But you happen to be plainly and simply wrong.

    Mother Nature is not here for you, DK (personally or generically) with a beneficent intent of producing for you products (of nature) that are useful to you at each moment in your life.

    I gave you the example of a nurse at the hospital trying to put an oxygen feed line into your nose and you never responded. (Doctor, come quickly. Patient is nonresponsive!)

    Mother Nature does not produce for you, a concentration of oxygen that is measurably correct for you in the case where you are suffering from some respiratory disorder. Each specific flow of oxygen, be it 6% above normal or 10% above normal, or whatever, is unique and is NOT a product of nature. The fact that you, DK cannot comprehend this does not make it un-so. It moves nonetheless.

    (BTW, do you know why the nurse, or RT, will generally not want to administer 100% oxygen to you? Hint: it will cause you to stop breathing and may end up killing you.)

  30. Dear Step Back,

    Regarding chemistry/scientific knowledge: actually, people can live in pure oxygen environments, step back, as the first astronauts knew (and some expired, but due to explosion, not suffocation) as long as the pressure of the 100% oxygen environment is sufficiently low (note the link from my name explaining that the Mercury flights had 100% pure oxygen at 1/3 the pressure of sea-level). But now, pursuing your logic: any new mix of gasses not already present in the environment would be a man-made mix that would be patent-eligible? You’re just digging yourself in deeper. By this reasoning, If I am the first to mix say, 72% oxygen with 28% helium…. WHOOPEEE!! I have a patent-eiigible, new, useful, non-product-of-nature composition for which I can get a patent! I’m a-gonna be rich!

    madness, Step Back, pure madness.

  31. …and just to be clear, since you seemed to be using “oxygen” to mean O2 gas (since that’s what Priestley isolated, and what I have consistently used as my example of scientific discovery of products of nature), I did the same.

  32. Dear David,

    Respectfully sir, it is you who needs to step back from the mirror and realize the image reflecting back at you is that of a scientifically too certain of himself, mad man.

    I myself am not an expert in these things. But I do know that breathing pure oxygen for prolonged times is dangerous.

    But rather than me spouting from my not so strong knowledge base about the gas (O2) that rusts iron bridges and makes them fall down, I will let the following entry at the mad science web site speak to you (or at least try to). Scan down to the part where they explain why you cannot be kept on 100% O2 flow in a hospital:

    http://www.madsci.org/posts/archives/2005-03/1110848716.Me.r.html

  33. @30 David,

    It seems we have opened up a new Pandora’s box of debate regarding oxygen and oxygen.

    Apparently, there is something known as Oxygen Toxicity:
    http://en.wikipedia.org/wiki/Oxygen_toxicity

    If you breathe pure isolated oxygen for too long of a time, you start “foaming at the mouth” –see opening title of this thread.

  34. David says: “If merely isolating something that is found in nature as part of some larger whole is enough to meet the patent-eligibility threshold, then I can imagine all sorts of acts that suddenly qualify (isolating an antelope from a herd, isolating a chip of rock from a mountain…”

    What is so hard for you to understand about meeting the threshold inquiry? Do you know what “threshold” means? Really David. I would expect more from you. What you want to do is cut off all forms of early stage technology without ever reaching the question of whether it is new, useful, non-obvious and adequately described. You and your arguments are no different than the ignorant persecutors all throughout history who stood in the way of scientific advancement.

    The problem is an acute lack of understanding of patent law that at the very least borders on willful ignorance. Isolating an antelope from a hear and isolating a chip of rock from a mountain would indeed be PATENTABLE SUBJECT MATTER. That does not mean that they would be patentable. The fact that an otherwise intelligent philosopher cannot grasp this simple distinction leads me to the inescapable conclusion that there is willful manipulation and misrepresentation for the purpose of attempting to change hearts and minds based on misrepresentation.

    Please David, if you are going to continue down this line do yourself (and the rest of us) a favor and learn and understand the distinction between patentable subject matter, which is a threshold inquiry under 35 USC 101, and a patentable invention, which requires no less than 5 separate requirements under 101, 102, 103 and 112 to be satisfied prior to the issuance of a patent. So if you want to lie and try and sway the unknowing masses who don’t care about the truth, go for it. All you are doing here is demonstrating you are either incapable of understanding or nothing more than a snake oil salesman.

    I also find it more than mildly amusing that a philosopher thinks he knows more about science than patent attorneys who are scientists themselves.

    -Gene

  35. Noise-

    Just to re-explain for those unfamiliar with 6… I would have let him say whatever incorrect and ridiculous things he wanted if his comments were limited to articles aimed at the attorney and professional market. What got him banned was when he started giving incorrect advice on articles aimed at inventors. He would write that I didn’t know what I was talking about, explain as an examiner he is much more knowledgeable, and then proceed to give advice that if followed would result in the forfeiture of rights.

    The right to be ignorant is observed and respected, the right to counsel others to do things that would destroy their ability to protect their inventions is where I draw the line.

    Simple rules really. Don’t lie, don’t suggest courses of action that destroy rights and contribute substantively. If you don’t contribute substantively you better not engage in flaming or name calling. If you are contributing substantively you get a lot more leeway and I realize our debates get hot and hyperbole and exaggeration can be tolerated.

    While I disagree with Koepsell on pretty much everything, he is an example of someone who pretty much always contributes substantively, just offering a different perspective.

    Cheers.

    -Gene

  36. Step Back: you should read the whole article, it confirms that oxygen toxicity occurs with pure oxygen environments at greater pressures, which is why NASA kept the Mercury capsules at 1/3 the pressure experienced at sea level. The astronauts successfully lived through their space flights, and NASA only switched to an oxygen/nitrogen mix after the Apollo 1 disaster. Even now, astronauts breath pure oxygen in their spacesuits during spacewalks. Helium is mixed with oxygen for scuba divers, because they experience greater pressures and would indeed suffer oxygen toxicity.

    Gene: I do understand what a threshold is, and know that the Supreme Court has developed some threshold analysi of section 101 reflected in the Chakrabarthy decision and other cases, including the important criterion that the thing for which the patent is sought not be a “product of nature, natural law, or abstract idea.” The fact that you now embrace the notion that not only isolated O@ is patent-eligible, and is somehow not a product of nature, or that a chip of rock from a mountain is eligible under 101, and is not also a product of nature proves you cannot effectively read the case law. To wit:

    “This is not to suggest that §101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable. See Parker v. Flook,437 U.S. 584, 198 USPQ 193 (1978);Gottschalk v. Benson, 409 U.S. 63, 67, 175 USPQ 673, 674-675 (1973); Funk Seed Co. v. Kalo Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948);O’Reilly v. Morse, 15 How. 61, 112-121 (1853);Le Roy v. Tatham,14 How. 155, 175 (1852). Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2;nor could Newton have patented the law of gravity. Such discoveries are “manifestations of * * * nature, free to all men and reserved exclusively to none.” Funk, supra,at 130, 76 USPQ at 281 .” [emphasis added]

    So, the chipped rock from a mountain, even if it were a newly discovered mineral would not be patent eligible under sec. 101 according to the US Supreme Court. Please, Gene, if you’re going to discuss patent doctrine, don’t forget the controlling nature of Supreme Court rulings.

    And I too find my discussions of science with the engineers on this board amusing, Gene… but for different reasons.

  37. {sorry, I always try to edit but missed the “O@” which ought to be O2, and to attribute the quote to the Chakrabarthy decision, which is linked to my name here}

  38. David-

    Exactly which part of the scientific truth that isolated things do not naturally appear in nature seems to be presenting the most confusion to you?

    As for the chip of the mountain, again you are being intellectually dishonest and sneaky. You ask whether ” isolating a chip of rock from a mountain” would be patentable. The answer is yes, it would if it is new, non-obvious and adequately described. Then you jump to the conclusion that what I have said is a chip of a mountain would be patentable, which is not true and not what I said.

    Your parlor tricks are growing old David. Your arguments are disingenuous and either you know that or you are not as intelligent as I have given you credit for. You throw around “isolated oxygen” and “isolated DNA” as if mother nature isolates them naturally. You ask if a method would be patentable and then you say… see… see… see… you are saying the product of the method is patentable.

    Please try and keep it real David (if you have that intellectual ability). There are plenty of places on the Internet where you can spew unchecked nonsense, twist words and forward your agenda. But your bait and switch logic is insulting.

    If you want to live in a world without patents then relocate to any third-world country on the planet.

    -Gene

  39. Dear Gene,

    Forgive my causing confusion, honestly, it was sloppy of me to equate “isolating a chip from a mountain” with the product “an isolated chip of a mountain.” I am simply trying to apply the logic of Chakrabarthy to the isolation of a chip of rock from a mountain, and the direct quote from the same case (“Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter”) and reaching the conclusion that neither the isolation of the piece of the mountain, nor the chip of rock itself is patentable subject matter under section 101. But let me extend you some credit as you are right the chip itself is different than the act of isolating a chip from a mountain, so let’s acept that the process of isolating a chip of rock from a mountain is patentable subject matter — isn’t it clear from the quoted language above that the product is not?

    Here’s the scenario: you are climbing around, and find a marvelous new mineral in a vein of rock, you hack it out. Let’s grant that the hacking out of the mineral is patent-eligible subject matter under 101. The mineral itself, and any instance of it anywhere, is clearly ineligible according to the Supreme Court. Now, this is the logic that has led me to continue to conclude that the product claims over the sequences of BRCA1 and 2 are ineligible subject matter under sec 101. Even if the process claims are (we’ll see what happens with Bilski. I’m ignoring all the inuendo about sneakiness, dishonesty, parlor tricks etc., because I know that’s just your style, and I apologize for my sloppiness in phrasing, I really regret equating the process with the product in the mountain-chip example, but now my question for you is, why isn’t the claim to the sequence as invalid under 101 as a claim to the mineral in the mountain? I really see these as equivalent, and thus I think Sweet reasoned correctly in holding that claims to the sequences were invalid under sec. 101 according to the reasoning of the Chakrabarthy court. For the sake of refreshing our memory over the exact claims, here are just a few:

    “1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

    2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

    5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

    6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2.”

    best,
    David

  40. David,

    You have conflated the term “isolated”. In one sense, nature itself “isolates” mountain chips all the time (erosion). In quite a different sense (as I have repeatedly shown you over at Patent Docs), the “isolation” that Myriad claimed was a man-made item.

    Gene is more forgiving than I, as no amount of “sloppiness” excuses the “lawyerly” tricks you play, as soundbyting and running away from substance are your stock.

  41. Dr. Koepsell,

    I have read with some sadness your comments on the the issue of gene patenting. Having spent most of the last 20 years addressing this very issue, I find it incredible that anyone is able to find distinctions once the hand of man changes something in form or function that would or could not occur or have occurred in the absence of that intervention. A mineral, when changed from that found in nature, should be patent eligible; i.e., once the hand of man causes it’s form or function to be distinguishable from that found in nature. True, mineral “veins” exist, but then the mineral is present in substantially pure form in nature. Thus, the Court has concluded that no transformative event occurs by “chipping it out”. However, if the mineral is ground up, admixed with other minerals from other sources, and that mixture then has, e.g., new thermal or conductive properties, it is patent eligible so long as that mixture is not found in nature. That is the so-called “gene’ patenting debate by analogy..

    One must first accept the history of biotech claim language. At one time, I fought long and hard to have a hard line on not using the word “gene” or “sequence” in a claim. Instead, I advocated the use of the more precise term “nucleic acid”. A nucleic acid is a chemical and a polynucleic acid is another chemical. (I lost the battle.) Variations of both chemicals are found in nature and in the test tube. However, the transformative question that evidences man is that the scientist takes the long polymer from a source, purifies it to a form not found in nature, clones it so its origin is lost, chops it up, rearranges it and fuses it to other nucleic acids (sometimes entirely synthetic in origin or whose characteristic sequence of monomers might be found in another species from the first nucleic acid, and then, after exhaustive and expensive experimentation, arrives at a new polymer. Thus, the hand of man is clearly evident and the product patent eligible.

    Now to the hard one: Taking a nucleic acid out of a natural source, cutting it up using molecular tools, and then using the segment for testing, such as in the BRCA situation. If one put the nucleic acid obtained directly from a human source in one tube and the cloned nucleic in another, even though the segment that is known as BRCA would have the same characteristic sequence, the two nucleic acids would be distinguishable at a chemical level. If one were to simply put the entire human genome in a tube, perhaps it could be argued that it is same as that found in nature; so long as the histones, associated proteins scaffolds, etc. were still present. However, once someone takes the material found in nature, separates the proteins and other materials from the nucleic acid, cuts it up and takes only one piece, and then defines functional elements that were not known before; is that not transformative? Has not a patentable invention with new properties and usefulness been developed through the hand of man?

    The USPTO’s Utility examination guidelines coupled with principles found in the computer implemented invention guidelines provides guidance as to how to draw a reproducible line on a case-by-case basis.

    If one wants nucleic acids, in and of themselves, ineligible for patenting, then lawmakers are free to attempt to do so. However, it is my earnest opinion, that this is impossible in the absence of establishing an entirely new system for rewarding inventors for their inventions as required by the US Constitution. Again, if the necessary electorate wishes to change this, mechanisms exist for that as well. However, my caution is that altering a system that has been in place and functioning for at least 500 years is a exercise fraught with danger. We have arrived at where we are through trials by fire over the ages.

    Isolated problems have been found and remedied. Some remedies have been good, some have been like chemotherapy (functioning only at the brink of death), and still others have turned out to be harbingers of economic ruin. I have personally been accused of trying to shut down biotech (as if I had that power) although the opposite more closely characterizes my professional charge. Designer laws that weaken IP in the US have only turned out to weaken our economy and our innovative capacity. Change needs to be wholesale or, minor and iterative- that is the method proven by centuries of experience.

    Law, ethics, and morals are related but not identical. Our decisions now will affect generations to come. Caution is recommended.

  42. Mr. Stanton,

    Thank you for this eloquent explanation, it’s the most civilized posting I’ve read here from anyone for some time, expressing an honest desire to debate a really important topic without the use of insult.

    I guess we differ in the transformative nature of “isolating” the sequence for the sake of a diagnostic test. I agree that engineered genes that acquire new characteristics, functions, forms, and uses ought to be patent eligible under sec. 101. Here, however, the “isolation” is in marking the sequence of the naturally-occurring mutation for the purpose of comparing it with other naturally-occurring mutations of the same type. In your example of the mineral admixture, again, I’d agree that if it takes on new forms, functions, properties, then it is eliigible subject matter under sec. 101. What new properties do the sequences in the claims I listed in comment 39 have? Like the chipped piece of rock, the composition is the same as in nature. No “purification” is even involved since that would defeat the purpose of the diagnostic test, which is to compare the sequence of the mutation with a sequence being tested for the presence of the mutation. If some new method of comparing sequences were involved, then again, that would be eligible subject matter under 101, but that is not the case with the BRCA 1&2 tests. I think, and the Supreme Court seems to say, that some more transformation from a natural product to something new is necessary. Again, from Chakrabarthy the court concludes: “Here, by contrast, the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under §101″ What are the “markedly different” characteristics in the sequences listed in the Myriad claims and the sequences found in those people who possess those genes? I am truly baffled by this question, am trying to get to the root of it, and am happy to hear how these particular sequences differ from products of nature. I still can’t fathom it. To me, it seems like noting that the Grand Canyon has walls, and then claiming that I somehow have isolated the Grand Canyon from the surrounding landscape because of my mental act of noting the borders that are naturally there (as the promoter and stop codons of BRCA1 & 2 define the borders of those genes).

    best,
    David

  43. Here’s some helpful discussion from the Federal Circuit (Ex parte CARL A. LUNDGREN, Appeal No. 2003-2088, Application 08/093,516, April 20, 2004):

    “Laws of nature” and “physical phenomena,” if drafted as such, usually do not fit within a statutory category; e.g., a claim to “E=mc2, where E is energy, m is mass, and c is the speed of light” does not fit the definitions of a “process, machine, manufacture, or composition of matter” because it is neither a series of acts nor a physical thing. Of course, a competent draftsman can always draft “laws of nature” and “physical phenomena” to appear to be in a statutory category, such as a product or process, which is why the exceptions must apply to subject matter that otherwise falls within one of the statutory classes of § 101. See Sarkar, 588 F.2d at 1333, 200 USPQ at 137 (“Sets of steps conducted entirely by nature are not subject to patenting; they are not invented by man.”); Smithkline Beecham Corp. v. Apotex Corp., 365 F.3d 1306, 1331, 70 USPQ2d 1737, 1756 (Fed. Cir. 2004) (Gajarsa, J., concurring) (“SKB’s paroxetine hemihydrate … can be ‘made’ through a natural process of spontaneous conversion” and the claim covers a product of a “natural process”).

    so, since copies of BRCA1 and 2 are made through natural processes (mRNA transcription, for instance), why ought the claims to the product similarly be ineligible as SKB’s claims to a product of a natural process?

  44. …admittedly, that Gajarsa’s concurrence, but I think he’s making the same argument I am making re:101, and that SCOTUS applied in it’s 101 cases… simply put, if we stretch the threshold of 101 to include all products of isolations, then we end up saying that products like chipped rocks, sheep isolated from their herds, etc., all become patent eligible subject matter. That seems to be no threshold at all.

  45. Q: “What are the “markedly different” characteristics in the sequences listed in the Myriad claims and the sequences found in those people who possess those genes? I am truly baffled by this question, am trying to get to the root of it, and am happy to hear how these particular sequences differ from products of nature.”

    A: “Taking a nucleic acid out of a natural source, cutting it up using molecular tools, and then using the segment for testing, such as in the BRCA situation. If one put the nucleic acid obtained directly from a human source in one tube and the cloned nucleic in another, even though the segment that is known as BRCA would have the same characteristic sequence, the two nucleic acids would be distinguishable at a chemical level. If one were to simply put the entire human genome in a tube, perhaps it could be argued that it is same as that found in nature; so long as the histones, associated proteins scaffolds, etc. were still present. However, once someone takes the material found in nature, separates the proteins and other materials from the nucleic acid, cuts it up and takes only one piece, and then defines functional elements that were not known before; is that not transformative?”

  46. All: I give great thanks to Gene for stirring keeping discussion alive. This issue remains as important today as ever has.

    Dr. Koepsell: I truly believe you to be incorrect. At this point, I can only suggest that you search the internet for presentations under my name, John Doll’s, and Stephen Kunin’s (as well as many others). Then take a thorough read of both the USPTO’s utility guidelines and associated exemplars as well as the trilateral studies done among the USPTO, JPO, and EPO on gene patenting, “reach-through” claiming, and other biotechnology related issues.

    Then, review the NIH’s and OECD’s licensing best practices for licensing genetic inventions, and the US National Academy of Science’s review of “reaping the benefits of genomics and proteomics.”

    The bottom line is that the professional/governmental IP communities ALL concur that nucleic acids are patentable and that the standards currently being used by the USPTO are the exemplar. There is also relatively uniform consensus among the OECD countries as to licensing best practices for diagnostics and nucleic acids. Divergence at the national policy level only begins to come in when various signatories to the TRIPS agreement and more specifically the DOHA I, II and Hong Kong flexibility provisions come into play.

    I think that this particular discussion highlights the difficulties of the practical realities involved with IP as a concept; drawing lines is difficult because the system is designed to be broad and enforcement and licensing to address specific situations.

    My; fear is that while one side of the debate believes that non-IP systems and non-exclusive licensing will suffice for the next generation of innovation, this has yet to be substantiated. The SACGHS’ recent report on access to genetic inventions highlights the dogmatic arguments. The opinions fall almost completely in line with the source; academics and non-profits believe that they can provide the innovation and the service/testing whereas business and for-profits believe that the best way to maximize innovation and availability is through the free-market system.

    I have been asked to prove a negative: that IP does not harm public access to medicines. The other side only asserts that they can do it all. What I can document is that funding in the non-public sector is drying up, and becoming more limited in the public sector; lines are forming at testing labs; many scientists are moving to Asia; and formularies are becoming more limited in regard to availability of multi-track medicines and procedures within a given therapeutic class. I can only hope that I am wrong because if I (and so many others) are right, our children’s access to innovation in general and next generation medicines in particular, will be restricted or simply not come into being.

    So, I stand by my public comments to the SACGHS and plead with you to be careful what you ask for because in the current economic and political climate both in the US and internationally, we are heading into waters that are sure to be stormy. The ones that will be most affected will be our children. Choose wisely.

  47. YA: it seems no more transformative to me than extracting the “newly discovered mineral” from a mountain, removing the debris and other minerals from it, and noting its molecular structure. I think we all agree now that the “newly discovered mineral” is not eligible under 101, according to the case law. You state: “If one put the nucleic acid obtained directly from a human source in one tube and the cloned nucleic in another, even though the segment that is known as BRCA would have the same characteristic sequence, the two nucleic acids would be distinguishable at a chemical level.” It is the one-to-one correspondence of the characteristic sequences that matters because this is exactly what the diagnostic test is looking for. Molecular dissimilarities would mean that the two sequences differed, leading to a conclusion of the absence of the mutation. The molecular identity of the sequences is the critical similarity: the extracted human gene, and the cloned BRCA gene are identical. All you are saying really is that the solution containing these sequences is dissimilar, but the claims in the patent cover the nucleotide sequences, not the solution containing the genetic material.

    Mr. Stanton: thanks again for you well-considered and stated opinion. I understand it, but still do not agree. I respect your viewpoint completely, however.

  48. YA: I’d note that you have, in my opinion, done what the court in Lundgren (comment 43) seems to warn about when reading Mr. Stanton’s description, to wit: “Of course, a competent draftsman can always draft ‘laws of nature’ and ‘physical phenomena’ to appear to be in a statutory category, such as a product or process, which is why the exceptions must apply to subject matter that otherwise falls within one of the statutory classes of § 101″ The copying of the gene also occurs, as I have pointed out many times, by natural processes. Comparing two sequences might be patentable subject matter, but that still doesn’t get us to the product claim over the sequences. You agreed that O2 is not eligible under 101 because plants isolate O2 through photosynthesis and we could gather plant-generated O2 from aquatic plants in a simple experiment. So, now, let’s suppose I invent a way to detect the presence of O2 by comparing found O2 with some artificially-extracted sample of O2. The process of comparing, again, would be eligible subject matter, but that doesn’t suddenly make the product O2 itself 101 subject matter, does it? Or have you changed your mind about O2?

  49. @47 DK wrote: “It seems no more transformative to me …

    DK,

    With due respect, there’s the problem: the word “me”.

    I kind of “get it” as to where you are coming from. However, it is a highly unscientific and lay person’s starting point. It cannot be the starting point from which a chemist can approach the real physical world.

    You see, none of us has an atomic scale set of tweezers with which we can seize a single molecule and then call it an “isolated” molecule (and puhleeze do not cite to me some popular science nonsense article).

    Instead, if you are going to have an “isolated” composition of matter, you are going to need millions or billions of such molecules collected together in a highly purified form.

    Mother Nature does not produce “that”.

    (P.S. Mother Nature also does not produce 100% O2 at 0.33 atmospheres in outer space.)

  50. “it seems no more transformative to me than extracting the “newly discovered mineral” from a mountain, removing the debris and other minerals from it….”

    Sounds like there’s some significant human interaction required there. That Stanton fellow pretty much knocked the ball out of the park with his explanation of why the isolated compound is different and transformative.

    “It is the one-to-one correspondence of the characteristic sequehnces that matters because this is exactly what the diagnostic test is looking for… but the claims in the patent cover the nucleotide sequences, not the solution containing the genetic material.”

    What matters is the claimed invention. They aren’t claiming the sequence, they’re claiming the isolated molecule, removed from the other cell components. You could write out the sequence on paper without infringing on the claim.

    “The copying of the gene also occurs, as I have pointed out many times, by natural processes.”

    Copying the gene isn’t what’s claimed. You’ve brought up mRNA several times by the way, but mRNA is not DNA as someone pointed out last thread, nor is the mRNA isolated at any point.

    “So, now, let’s suppose I invent a way to detect the presence of O2 by comparing found O2 with some artificially-extracted sample of O2. The process of comparing, again, would be eligible subject matter, but that doesn’t suddenly make the product O2 itself 101 subject matter, does it? Or have you changed your mind about O2?”

    A patent on detecting molecule X does not affect the patentability of molecule X one way or another.

  51. YA: “…Sounds like there’s some significant human interaction required there. That Stanton fellow pretty much knocked the ball out of the park with his explanation of why the isolated compound is different and transformative.” so do you believe the isolated newly discovered mineral too is sufficiently transformed? Doesn’t that conflict with Chakrabarthy? More than just significant human interaction is needed, it seems from the case law. What must result is something markedly different from the natural product. That simply isn’t the case, again, in my opinion, with “isolated” genes.

    “What matters is the claimed invention. They aren’t claiming the sequence, they’re claiming the isolated molecule, removed from the other cell components. You could write out the sequence on paper without infringing on the claim.” But you cannot replicate that sequence, so it covers any useful interation of the sequence, and as shown recently by Cook-Deegan et al., claims 5 and 6 (see comment 39) cover strings that appear all over the genome, and not just in BRCA.

    “Copying the gene isn’t what’s claimed. You’ve brought up mRNA several times by the way, but mRNA is not DNA as someone pointed out last thread, nor is the mRNA isolated at any point.” Right, it is the sequence itself that is claimed. So no one may replicate that sequence through PCR without infringing the claims. Moreover, RNA replaces one letter (T) with Uricil for the purposes of transcription. This is why Sweet found that DNA is special, as it is both an information storage medium, and part of a mechanism. The gene in the DNA does differ from the RNA, because the RNA is a functional part of the mechanism of transcription, doing the same work that humans do when they transform genes by isolating the gene itself, and purifying it by ignoring the introns.

    I am glad we still agree that isolated O2 is not eligible under 101.

  52. For a real good debate on this same subject at PatentDocs, please click my name above.

    it’s been surreal.

    -d

  53. Dr. Keopsell; Would you do me the honor of searching my name? If you would like to get some insight into the history of this debate, let me know and we can talk directly. In the meantime, please do more homework because the answers are all in the materials that I cited. Otherwise, the only conclusion that can be drawn from your comments is that they represent dogmatism rather than learned legal reasonsing. There is a difference. If you feel that the legal standards that have spurred the greatest revolution in medicine since Pasteur (who, btw has a patent on yeast issued in the 1890′s), are incorrect, please propose a positive solution that includes ALL subject matter and is capable of being administered. Otherwise, it must be concluded that your opinions fall more into the realm of theology, morality and ethics. Propose language for Congress to consider. Propose an actual set of documents and language by which the US and other members of the WTO can function. Otherwise…..well, honestly, I’m tired of trying to convince those that are afraid or simply entrenched. It is easy to “kvetch” but difficult to put that into practice. We need practical solutions. I truly believe the system has functioned and continues to function as designed. If you want a different design, propose one. Otherwise, join the Judge in NY in killing the cow that has provided milk for generations. —I have made the offer…for an open debate…many times. I have worked, done press conferences, written papers…I can only hope it is not for naught.

    Is anyone out there or are my just as wrong as I believe Dr. Koepsell to be?

  54. be drawn from your comments is that they represent dogmatism rather than learned legal reasonsing.

    Ouch.

    Amen.

  55. Brian-

    I agree with you, and so do many others. I wouldn’t worry about Koepsell. Even after we have all demonstrated he is incorrect he clings to the belief that he is right. But then again, he is the author of “Who Owns You,” which pretty much provides all the context you need to know. No amount of argumentation or explanation will convince a zealot like Koepsell, who ignores the obvious and misrepresents what everyone says.

    -Gene

  56. Noise,

    Definitely “ouch!” BTW, on a different subject, one of those commenting on one of the recent Patently-O threads thinks I’m “channeling” your thoughts. I’ve tried my best to disuade that commentor of such nonsense. You and I are perfectly capable of own “crtical thinking” (which I’ve also been wrongly accused of not having).

  57. Gene et al.:

    Well, this “zealot” actually is thankful for this post by Mr. Guttag, and I do think that the idea of mandatory licensing, or a research exception, or march in rights, would be worthy compromises. I have been open to compromises from the start, and I argue as much repeatedly in my book and elsewhere. {Of course, it’s impossible that those who support patents on nearly anything are “zealots” too, right? Nevermind that the courts have narrowed the range of statutory subject matter over the years, they too have been zealots, I’m sure.}

    Nonetheless, I do think there are interesting and fundamental issues that require debate at the core of this issue, including the philosophical and practical distinctions between man-made products and products of nature.

    Mr. Stanton, my arguments are not based upon positive law, as I think the positive law is wrong. You can see elsewhere how I have argued that there are issues of natural law at stake, and I am actually not religious at all (I’m a well-known atheist) but yes, I do make an ethical argument, primarily based upon natural law theory. I am a philosopher, primarily. That’s what I do. But natural law theory is at the heart of our republic’s founding documents, and philosophy can sometimes inform policy. That’s all I’m seeking to do.

    Thank you again for some reasonable dialogue, I always learn quite a bit even while enduring the silly brickbats.

  58. David,

    Your spin knows no bounds. Check again regarding “But natural law theory is at the heart of our republic’s founding documents“. Your athiest leaning definitely clouds your judgment, as the founding fathers did not want separation of church and state for an athiest rationale, but rather, the fathers had a deep and abiding interest in God. Of course I am thrilled that this country allows you to not only be an athiest, but to discuss your belief as well. It is just that that belief is not the focal point here. The founding fathers were very much concerned with the “positive law” you seek to disband, including in section 8 the basis for the system that you despise. I take issue with your “all I’m seeking to do” nonsense – you are pursuing an agenda, and a rather particular philosophy in order to influence policy in a very deliberate way. That way is contrapose to the positive law our founding fathers set in place. Cloaking your agenda like you do is but a silly lawyer trick.

    As for “positive law”, it is clear that your arguments are not based on it. As we have discussed previously, parading around in ignorance of the arena of law that you are in will not win you any argumetns or advance your position very far.

    EG,

    I take the comment about channeling as a compliment – something about certain minds thinking alike perhaps.

    As for the Trainwreck, my time is currently filled with much better things, and taking the amount of time necessary to don my radiation gear and walk through the neutron-bombed playground, where it takes more effort to continuously reset the conversation then to understand different views does not reach a minimum payoff. The site is entertaining, a bit like watching the Three Stooges, but the relation to actual patent law is rather thin. Changing diapers is more rewarding.

  59. Noise,

    The “channeling” comment was definitely a compliment, at least in my opinion.

    I hear you about dodging the “landmines” strewn throughout the threads on the Patently-O site. Too much “Kool-Aid” drinking going on there.

  60. Kool Aid at Patently-O?

    I better scout it out, i hear sales calling…

  61. Koepsell writes: “But natural law theory is at the heart of our republic’s founding documents…”

    Capitalism was far more in play than natural law theory in the founding documents and minds of the founders. The founders were the business class elite who would be most directly impacted by increased taxation. They clearly wanted to separate from England and establish a republic that would allow for individual freedom and business success. Intellectual property rights were so much in the mind of the founders that they included them in the Constitution itself. Not even free speech was included in the Constitution, nor was the cherished right to bear arms included. Both, along with other incredibly important rights such as State Sovereignty, the right to a jury trial and the right not to be subject to unreasonable search and seizure, were left out and added in the Bill of Rights. So it is really impossible to argue that property rights and business rights, which are all over the Constitution itself, were not at the forethought of our founding fathers.

    The founding fathers exhibited great wisdom and Jefferson grew to understand that government should not stand in the way of innovation, but rather allow innovation to move forward, recognizing property rights in successive generations of never before contemplated inventions.

    -Gene

  62. …and yet we have a patent here in question which has held back a great number of universities from innovating due to Myriad’s overtly exclusionary business practices. Without being able to amplify the gene sequence, a mundane laboratory process, there’s little else, scientifically, that can be investigated from BRCA.

  63. Rich Kulesus-

    You say: “we have a patent here in question which has held back a great number of universities from innovating…”

    The trouble you are having is that you are basing your beliefs on a factually flawed premise. The above statement is simply not correct. Even Duke University didn’t say that in their recent study. Patents do not prevent innovation and it doesn’t serve you well to continue to cling to such falsehoods.

    -Gene

  64. Blind Dogma-

    Looking forward to your reporting back! I hope Kool-Aid sales are exceeding expectations!

    -Gene

  65. You’re doing a fine job standing up for those “business class elites,” Gene. The version of the Founders YOU think existed would be proud.

  66. “You’re doing a fine job standing up for those “business class elites,” Gene. The version of the Founders YOU think existed would be proud.”

    Washington, Jefferson, Franklin, Madison, etc. weren’t business class elites? The guys who made land ownership a requirement for voting rights and who decided to scrap the Articles of the Confederation without telling the public? Seriously?

  67. David (@65):

    The FF’s (Founding Fathers) were not gods. They were mortal fallible men!
    They owned slaves and drank tea without biscuits for bloody sake!

    They understood that all men are fallible. That’s why they established a system of checks and balances. (They didn’t intend for later Americans to see that as blank checks and infinitely re-balanced budgets, but that’s a story for another time.)

    The Founding Fathers did understand however, that men are greedy. That description applies both to those who create inventions and those who steal inventions (take without just compensation). That is why the FF’s empowered Congress to create a patent system that grants exclusive and enforceable rights for **limited** times.

    The FF’s had no intention of creating a utopia based on some crazed notion of “natural rights”.

    If you want “natural rights”, move to North Korea. That’s the place where the biggest and baddest war lord takes over as total authoritarian control (unchecked and unbalanced control) over the poor enslaved and malnourished peasants of that country. That is very “natural”, namely, survival of the meanest SOB in the valley of the shadows. Thankfully, in this country, we do not yet walk through that valley of the shadows and we do not yet fear all evils.

  68. David-

    I don’t really understand what you are trying to say. It seems like you are quibbling with my characterization of the founding fathers, which is ridiculous because what I said is true and easily verifiable.

    Really, were you challenging what I said? You do realize that while you may be able to fool some people with your junk science, you really can’t expect anyone to ignore historical truth, do you?

    -Gene

  69. Please familiarize yourselves with John Locke, who influenced the Founders in justifying the revolution:

    “John Locke (1632-1704), is among the most influential political philosophers of the modern period. In the Two Treatises of Government, he defended the claim that men are by nature free and equal against claims that God had made all people naturally subject to a monarch. He argued that people have rights, such as the right to life, liberty, and property, that have a foundation independent of the laws of any particular society. Locke used the claim that men are naturally free and equal as part of the justification for understanding legitimate political government as the result of a social contract where people in the state of nature conditionally transfer some of their rights to the government in order to better insure the stable, comfortable enjoyment of their lives, liberty, and property. Since governments exist by the consent of the people in order to protect the rights of the people and promote the public good, governments that fail to do so can be resisted and replaced with new governments. Locke is thus also important for his defense of the right of revolution.” from the Stanford Encyclopedia of Philosophy

    and thus, Jefferson: “”The evidence of [the] natural right [of expatriation], like that of our right to life, liberty, the use of our faculties, the pursuit of happiness, is not left to the feeble and sophistical investigations of reason, but is impressed on the sense of every man.” –Thomas Jefferson to John Manners, 1817. ME 15:124

    “Natural rights [are] the objects for the protection of which society is formed and municipal laws established.” –Thomas Jefferson to James Monroe, 1797. ME 9:422

    “Some other natural rights… [have] not yet entered into any declaration of rights.” –Thomas Jefferson to John W. Eppes, 1813. ME 13:272

    “I shall see with sincere satisfaction the progress of those sentiments which tend to restore to man all his natural rights, convinced he has no natural right in opposition to his social duties.” –Thomas Jefferson: Reply to Danbury Baptists, 1802. ME 16:282

    and then remarking on patents and natural law: “By an universal law, indeed, whatever, whether fixed or movable, belongs to all men equally and in common, is the property for the moment of him who occupies it, but when he relinquishes the occupation, the property goes with it. Stable ownership is the gift of social law, and is given late in the progress of society. It would be curious then, if an idea, the fugitive fermentation of an individual brain, could, of natural right, be claimed in exclusive and stable property. 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. Its peculiar character, too, is that no one possesses the less, because every other possesses the whole of it. He who receives an idea from me, receives instruction himself without lessening mine; as he who lights his taper at mine, receives light without darkening me.” – –Thomas Jefferson, letter to Isaac McPherson, 13 August 1813

    or Abraham Lincoln on natural law, which was his justification for the emancipation, despite the positive law of the Constitution: “I have never said anything to the contrary, but I hold that notwithstanding all this, there is no reason in the world why the negro is not entitled to all the natural rights enumerated in the Declaration of Independence, the right to life, liberty and the pursuit of happiness. I hold that he is as much entitled to these as the white man.” The Collected Works of Abraham Lincoln edited by Roy P. Basler, Volume III, “First Debate with Stephen A. Douglas at Ottawa, Illinois” (August 21, 1858), p. 16

    yes, laws, codes, and other positive laws are fallible, and in this case contrary to natural law, which is exactly what those of us who are trying to correct the error of gene patents recognize.

  70. “Please familiarize yourselves with John Locke, who influenced the Founders in justifying the revolution:.”

    DK,

    If only SCOTUS would do so when it comes to interpreting the Patent & Copyright Clause, as witnessed by a very misguided passage in Graham v. John Deere that suggests this Clause imposes a constitutional standard for patentability that Congress cannot determine. Much of SCOTUS’ view on this Clause comes from Jefferson who not only didn’t attend the Constitutional Convention, but in fact despised the enactment of the Constitution (that’s not opinion but historical fact). I’m not denying that Jefferson was our first Commissioner of Patents, but his views on this Clause should be taken with a huge grain of salt. Instead, there are Founding Fathers who’s views are far more relevant, especially Alexander Hamilton and James Madison who authored the Federalist Papers (more on Madison’s views shortly).

    This overzealous citation to what Jefferson says about the Constitution has unfortnately created the myth espoused by SCOTUS that is rightly called the “Jeffersonian story of patents.” See Adam Mossoff, “WHO CARES WHAT THOMAS JEFFERSON THOUGHT ABOUT PATENTS” who explodes this “myth” by doing his historical homework, including Locke’s views on the “social contract” as applied to patent rights (or more appropriately referred to as patent “privileges” in the 18th and 19th century context of that phrase and not how we currently interprete that phrase). In fact, Mossoff points out a little known fact which is that James Madison wrote the only know interpretation of what this Clause means in Federalist Paper No. 43:

    The utility of this power will scarcely be questioned. The copyright of authors has been solemnly adjudged in Great Britain to be a right of common law. The right to useful inventions seems with equal reason to belong to the inventors. The public good fully coincides in both cases with the claims of individuals. The States cannot separately make effectual provision for either of the cases, and most of them have anticipated the decision of this point by laws passed atthe instance of Congress.

    In debunking the critics of this Paper and their misinterpretation of Lockean philospohy, Mossoff says the following

    These critiques miss the significance of Madison’s defense of the Copyright and Patent Clause and his connection of patents to copyrights, because they fail to account for the intellectual context of the Founding Era—the then-dominant natural rights philosophy and its social contract doctrine. As Jefferson wrote in 1825, the Declaration of Independence “was intended to be an expression of the American
    mind” and “[a]ll its authority rests then on the harmonizing sentiments of the day, whether expressed in conversation, in letters, printed essays, or in the elementary books of public right, as Aristotle, Cicero, Locke, Sidney, etc.” Madison likely presumed that the readers of The Federalist Papers were aware of these basic principles, and thus he need not be pedantic, saving his lengthier explanations for the more novel ideas and institutions in the Constitution.

    In setting this intellectual context, it is clear that the fulcrum of the justification of patents in The Federalist No. 43 is Madison’s claim that patents are justified “with equal reason” as common law copyrights. Madison was not alleging that patents were secured at common law, which he certainly knew to be false; rather, he was arguing that the reason why copyrights were secured at common law was the same reason why patents should be secured by federal statute. In other words, Madison was suggesting a connection between copyrights and patents in their policy justification, not in their technical legal status.

    That “patent privileges” under ths Clause were viewed as significant “civil rights” (under Lockean philosophy) is further emphasized by Mossoff with the following statement which ties in to the “labor theory of property of natural rights philosophy and further elaborates on why Madison ‘s remarks on this Clause have been misinterpreted:

    Madison’s justification for patent rights as privileges (civil rights) becomes even clearer once one recognizes the eighteenth-century justification for securing copyrights at common law: the labor theory of
    property of natural rights philosophy. [For the purposes of breveity, I've omitted Mossoff's detailed description about Challcellor Kent's views ] By invoking the natural rights principle that one should reap the fruits of his labor—“mental as well as bodily labor”—Chancellor Kent also made explicit the policy justification for copyright that Madison invoked in The Federalist No. 43 as applying “with equal reason” to patents. In sum, Madison was not making a legal argument that patent rights were secured at common law—an argument that he surely understood as false—but rather he was justifying these civil rights with
    the same labor-desert policy justifying the common law (natural right) in copyright. Without this context, of course, Madison’s brief remarks in The Federalist No. 43 are easily misinterpreted, or, at the very least, their
    significance is lost on the modern reader who lacks the cultural context of the eighteenth and nineteenth centuries

    Yes, it is important to understand the context of Lockean philosophy. I would strongly suggest you read Mossoff’s article (Cornell Law Review 92:953 (2007)) before you make any more general declarations about Lockean philosophy (as you just did) as it relates to patents. In particular, you should read pages 977-85 of that article (some of which I quoted from above) which discuss the “patent privilege” in Federalist Paper No. 43 and how the “patent privilege” was interpreted in early SCOTUS cases such as Wheaton v. Peters. You might find it “eye-opening.”

  71. David-

    Please familiarize yourself with the Constitution, the Federalist Papers and the biographies of the founding fathers. As it turns out, John Locke was nit a founding father and history clearly indicated what I said is true. If you want to ignore truth in yet another arena be my guest.

    -Gene

  72. EG: if you study carefully what I was quoting Locke for, it was to justify the role of natural law theory in our organic laws, not for guidance on patents in general (I was responding to step back’s crazy claim that North Korea somehow is based upon natural law theory, or whatever he was trying to claim, it’s unclear – he seemed to confuse Natural Law theory with social darwinism). As for Jefferson vs. Mossoff on IP, I’ll stick with Jefferson, I do actually care what Jefferson thought a great deal more. Maybe someday you, or Gene, or some other IP LapDog will be nominated to SCOTUS and can set them all straight. Stranger things have happened.

  73. In the meantime, David and his “philospohical LapDogs” will continune their silly lawyer tricks and misrepresent any and every historical fact to suit their agenda. Truth is a mere inconvience, Gene. It doesn’t stop Judge Sweet. It doesn’t stop the ACLU, why do you think it will stop David?

    Same old dance.

  74. DK,

    I haven’t heard of John Locke locking up (pun, yes intended) a trade mark in the words “natural” and “law”.

    I thought you were referring to some form of laws of nature, which as you readily admit, can include survival of the most ruthless, evil and mean (not necessarily the “fittest” –could be a sadistically sick boy king who is anointed Caesar of Rome). It is man made laws of checks and balances that help us strain against the tidal forces of raw nature.

  75. “As for Jefferson vs. Mossoff on IP, I’ll stick with Jefferson, I do actually care what Jefferson thought a great deal more.”

    DK,

    Have it your way. Just understand that Jefferson was opposed to our Constitution being enacted and what he says about it (includingl what the Patent & Copyright Clause means) I take with a big grain of salt. I also consider Alexander Hamilton and especially James Madison’s views (having been at our Constitutional Convention and having written about it contemporaneously in the Federalist Papers) as far more relevant in interpreting the meaing of our Consitution (including the Patent & Clause) than anything Jefferson had to say who wasn’t there, and frankly despised it. If that bothers you, go pound salt.

    Also, I thought we were addressing patent-eligibility on this thread, so I was addressing what our Founding Fathers would view Locke as having to say about how patent rights (or more appropriately “patent privileges”) fits into the the social contract doctrine. In that regard, what Madison had to say about that in Federalist Paper No. 43 is far more on point then anything Jefferson had to say. If that’s not what you intended by your quote to Locke, you’re way off the subject on this thread.