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Department of Justice Seeks to Cripple Biotech Industry and Fundamentally Change Patent Laws

On Friday, October 29, 2010, practically on the eve of a national election that will in all certainty be an enormous rebuke of the Obama Administration and the Democrats’ agenda in general, the Department of Justice filed an amicus brief at the United States Court of Appeals for the Federal Circuit that would destroy the U.S. biotechnology sector.  In an astonishing and irresponsible policy shift that directly contradicts the long-standing policy of the United States federal government and a variety of agencies, the Department of Justice is promoting the dialing back of what is considered patentable subject matter and is urging the Federal Circuit to rule that “isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter under 35 U.S.C. § 101.”

Mr. President, with all due respect, the anti-business policies of your Administration are not only preventing a recovery, but they are costing Americans jobs.  Uncertainty is what is causing between $1 trillion to $3 trillion to be sitting on the sidelines doing nothing to facilitate a recovery.  Businesses are afraid of what their taxes will be, of the cost of health care, whether there will be some kind of cap and trade regulation through the Environmental Protection Agency and whether there will be slow-down or double-dip recession.  The economy wants to charge forward, but that won’t happen until businesses and individuals feel the future offers some sense of stability.

The fear of the unknown is causing a crippling paralysis, and now your Department of Justice is trying to persuade the Federal Circuit to follow its recommendation, which will cost tens of thousands of jobs and hundreds of billions of dollars of corporate value to be erased.  Pensions invested in the stock market will be destroyed and a double dip recession will be virtually assured. This is irresponsible and has to be demoralizing to the United States Patent and Trademark Office and other agencies throughout the federal government that have disagreed with this interpretation under BOTH Republican and Democratic Administrations.

[Bio-Pharma]

In commenting on the troubling decision of the Obama Administration to throw the biotechnology industry under the bus, the Biotechnology Industry Organization (BIO) explained in its press release:

Unfortunately, the Department of Justice’s brief — to the extent it fails to fully support the patentability of such DNA-based inventions — is inconsistent with the position that agencies of the U.S. government, through both Democratic and Republican Administrations, have taken domestically and internationally for more than two decades. If adopted, the Department of Justice’s position would undermine U.S. global leadership and investment in the life sciences, harm U.S. economic growth and competitiveness at home and abroad, and be counterproductive to the Administration’s own initiatives to fight cancer, develop renewable sources of energy, and clean the environment by reducing dependence on fossil fuels such as petroleum.

So the Department of Justice is potentially going to cripple an entire industry, cause the valuation of some companies to asymptotically approach zero, make it more difficult to fight diseases such as cancer and act as a road block to exciting research into alternative fuels.  The DOJ position also throws the Patent Office under the bus, as well as NIH and other agencies.  Talk about one hand not knowing what the other hand is doing!  It is as if there is no one actually in charge, or at the very least there are no controls in place to ensure that agencies within the federal government are pointed in the same direction and aiming to achieve the same goals.  Its seems as if the Department of Justice is effectively working against the Department of Commerce, the Department of Health and Human Services and the Department of Energy.  Amazing!

In terms of substance, if you actually read the Department of Justice amicus brief it will become clear they know very little about patent law, innovation or the importance of a stable set of laws in general.  The DOJ position can best be summarized by the following, taken from its amicus brief:

Methods of identifying, isolating, and using such DNA molecules may be patented, as may any new and useful alteration of those molecules through human intervention. Genomic DNA itself, however, is a product of nature that is ineligible for patent protection, whether or not claimed in “isolated” form.

We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA. The district court’s judgment in this case, however, prompted the United States to reevaluate the relationship between such patents and the settled principle under Supreme Court precedent that the patent laws do not extend to products of nature. For the reasons below, the United States has concluded that isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter under 35 U.S.C. § 101.

First, let’s clear up one thing right out of the box.  Not only is this position urged by the Department of Justice in direct contradiction to the policies of the Department of Commerce (by and through the United States Patent and Trademark Office), but it would also be in direct contradiction to the well settled law of the United States Supreme Court.  So the DOJ can talk about their position being “reevaluated” in light of Supreme Court precedent, but that is utterly false and horribly misleading.

In Diamond v. Chakrabarty the United States Supreme Court explained:

The Committee Reports accompanying the 1952 Act inform us that Congress intended statutory subject matter to “include anything under the sun that is made by man.”

The Supreme Court went on to explain:

[Chakrabarty’s] claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter – a product of human ingenuity having a distinctive name, character and use.  The point is underscored dramatically by comparison of the invention here with that in Funk. There, the patentee had discovered that there existed in nature certain species of root-nodule bacteria which did not exert a mutually inhibitive effect on each other. He used that discovery to produce a mixed culture capable of inoculating the seeds of leguminous plants. Concluding that the patentee had discovered “only some of the handiwork of nature,” the Court ruled the product nonpatentable… 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.

Thus, the well established law announced by the Supreme Court clearly and unambiguously states that when there is human intervention to bring about a useful innovation that is different from what naturally occurs, there is patentable subject matter.  And that is exactly what we have in the case of isolated genes because despite what the DOJ says, it is a scientific fact that an isolated gene does not occur naturally in nature.  It needs to be extracted.

Unfortunately, the lunacy of the Department of Justice position does not stop with re-writing patent laws and infusing tremendous uncertainty to a question as fundamental as patentable subject matter.  The DOJ brief actually says: “the isolated DNA segment itself remains, in structure and function, what it was in the human body.”  This logical construct is actually rather brilliant because it allows the DOJ to skirt the real issue and ignore the direct and controlling Supreme Court precedent.  Notice that the DOJ wants to really say that the isolated DNA segment is the same as what is in the human body, but that is not what they are saying.  In order to attempt to make a statement that is not scientifically incorrect they merely say that the structure and function of the isolated DNA is the same as that segment within the human body that is not isolated.

Of course, the great minds at the Department of Justice have no support and provide no citation for the conclusion that the structure and function of isolated DNA that has been extracted is the same as un-isolated DNA still within the human body. (see page 21 of their brief).    This creative, but tortured, logical construct completely and totally ignores the fact that in no human body does extracted and isolated segments of DNA exist. You see, this innovation is patentable precisely because the extracted and isolated segment does not exist in the human body.

To support its logically tortured and misleading view that isolated DNA should not be patentable subject matter, the DOJ makes the follow analogy to coal:

Many natural products — coal beneath the earth, cotton fibers mixed with cotton seeds, the stigmas of the saffron flower — must be physically separated, i.e., “isolated,” from their natural environments before becoming useful to mankind, but few would doubt that coal, cotton, and saffron are products of nature and not patent-eligible.

The trouble with this analogy is that coal actually does exist in isolated forms in nature. Coal could be extracted from the ground in isolated form, so the isolation of coal from the ground in a form that requires physical separation does not mean that the isolated form of coal is patentable, although certainly the process for isolating coal, if new and nonobvious, would be patentable.

In nature there is no such thing as an isolated segment of DNA. The segment of DNA is inextricably intertwined with the rest of the DNA, and only though human intervention is the segment of DNA capable of being extracted, thereby resulting in something that affirmatively does not exist in nature; namely an isolated segment of DNA.  Thus, pursuant to the controlling precedent in Diamond v. Chakrabarty, isolated segments of DNA are patentable.  So while the Department of Justice is undoubtedly proud of themselves for the aforementioned coal analogy, comparing something that exists in nature to something that does not exist in nature shows either a complete failure to understand the fundamental issues or a level of deception in order to achieve an agenda driven goal that is unbecoming of the Department of Justice.

The vast majority of the cases relied upon by the Department of Justice are from the 1920s and the 1930s, except for those that are from the 1880s and a concurring opinion here and there. So the DOJ is acknowledging that they are promoting a view that would require the overturning of well settled law and a return to our un-enlightened view of patentability prior to World War II, a time when genetic innovations like the ones being made today could never have been imagined.

The same liberals responsible for this anti-patent position are also so quick to chide Supreme Court Justice Antonin Scalia for his rather radical desire to interpret the United States Constitution as if we are living in 1790. I have to agree with the chiding of Justice Scalia on this point. I think we need to understand the principles and what the Framers of the Constitution were attempting to accomplish and why, but pretending that it is 1790 and there are no planes, trains and automobiles is silly. Scalia was the only Justice who didn’t sign on to an opinion or dissent in Bilski v. Kappos that acknowledged that at least some software is patentable subject matter. Nevertheless, excuse me for noticing the hypocrisy here. If it is fair game to chide Justice Scalia for how he views the Constitution it is appropriate to point out that those same people want patent laws for the 21st century that harken back to the 19th century and early 20th century? This is ridiculous!

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58 comments so far.

  • [Avatar for Gary]
    Gary
    November 1, 2010 02:13 pm

    Vindication!

    “Department of Justice Seeks to Cripple Biotech Industry and Fundamentally Change Patent Laws” should actually read “Department of Justice Seeks to Cripple Biotech Industry’s Lawyers”.

    I’m in the biotech industry and the unnecessarily granted “gene patents” are what’s crippling the industry, not the other way around, Gene. The diagnostic industry doesn’t need protection from gene patents to advance. The protection for the new devices that we develop (and not for something that is naturally occurring) is more than enough for progress.

    By the way, we’ve seen more positive action from this administration (more research funding/grants, tax credits, etc) than all previous republican ones combined. I would write so much more, but I’m just too excited from having a letter in front of me this morning that says the government is paying for half of the investment that my investors put into this company. And this is all thanks to the health care reform that was passed this year. How is that anti-business, Gene?

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 1, 2010 02:32 pm

    Gary-

    You are sadly mistaken, but given that you are benefiting from tax-payer dollars I suppose you cannot be faulted for believing that the government picking winners and losers isn’t a problem.

    I refuse to believe you are at all involved in the biotech industry if you can’t understand what the invalidating of 20,000+ gene patents will do. The position urged by the Department of Justice would result in many thousands of patents having no enforceable claims. The only thing that most biotech companies have in terms of assets is their patent portfolio. As Jim Greenwood (President of BIO) explained to me, most biotech start-ups own a microscope and maybe a folder to keep their patents, and that is the sum total of their assets. If you strip their assets then investors will leave.

    Surely, if you are really in the biotech industry, which I doubt, you know that biotech start-ups need to rely on investors for at least a decade, sometimes far longer, in order to have any realistic chance of becoming a going concern. Without exclusivity for their innovations investors won’t provide the hundreds of millions of dollars, or billions of dollars, required for a biotech company to exist. So if the DOJ position is adopted biotech companies will go under, large numbers of them. That will cost jobs, erase shareholder value and lead to FEWER innovations because companies will no longer be able to invest in the development of innovation. Why would anyone invest in creating innovation when it can’t be protected? Generics simply come in and copy without having to have funded the research and development. That is a free rider problem.

    Look at the Orphan Drug Act. Once Congress provided exclusive rights for those who come forward with drugs and treatments for rare diseases we have seen a 1300% increase in the number of drugs and treatments for rare diseases. The facts are irrefutable. See:

    http://ipwatchdog.com/2010/07/22/senate-hearing-rare-neglected-diseases/id=11734/

    Sorry Gary. You are wrong, and you are obviously not at all acquainted with the biotech industry if I have to explain this to you. You are just an imposter who is posing as someone knowledgeable so your ridiculous assertions will be taken seriously by those who don’t know any better.

    -Gene

  • [Avatar for Mike]
    Mike
    November 1, 2010 02:57 pm

    Gene – I think your hyperbole is unnecessary. The biotech industry is not going anywhere even if the DOJ’s line is adopted (assuming it even survives the standing issue). I have some serious doubts that those 20k patents simply claim a gene in an isolated form that is the same as found in the human body and used for the same purpose. If that’s the only protection they sought, well, I have no problem seeing those patents go away. But more to Gary’s point, identifying the gene is not what brings the funding. If you think it is, then it is you that is seriously mistaken. The real funding occurs once you have identified targets or assays.

    And your citation to the ODA is a red herring. The ODA is going after treatments for rare diseases, and in exchange for it promises seven years of market exclusivity FOR DRUGS that treat those diseases. No one here is going to dispute that the treatments associated with those genes are unpatentable or perhaps that such treatments are undeserving of longer protections. This is a completely different issue.

  • [Avatar for Gary]
    Gary
    November 1, 2010 03:32 pm

    First of all, I’m a CSO of a biotech start-up and am very involved in the field. It’s obvious from your reply that you either don’t understand the industry, or are ignorant and don’t understand my comment. I never for a second would suggest that all patents be stripped in the biotech industry. Gene patents are a fraction of what the biotech industry relies on for protection of their inventions. Your suggestion that the viability of the biotech industry relies solely on gene patents just shows your ignorance for the subject matter.

    I’m against gene patents because they hinder innovation (I know this because I have to fight this every time I’m trying to develop a new diagnostic test). I’m NOT against patenting methodologies, devices, or anything else that is NOT NATURALLY OCCURRING. I’ve had this argument with you before and you are still suggesting that DNA, in isolated form, is somehow not naturally occurring. You are absolutely wrong. The process of isolating and/or detecting a mutation/polymorphism can and should be patented (if it’s novel), but to say that the DNA molecule in a test tube is not natural and can be patented is ridiculous.

  • [Avatar for Gary]
    Gary
    November 1, 2010 03:34 pm

    Mike, I did not see your comment, but you nailed it. Thank you!

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 1, 2010 03:38 pm

    Mike-

    You are the one who is mistaken, and there is absolutely no hyperbole here at all. If you want to ignore the fact that there are hundreds of biotech companies with these types of gene patents that is up to you. You can also choose to ignore the fact that those companies will have their valuations erased. It is also up to you if you choose to ignore the fact that without providing basic protections on the foundational innovation these companies won’t be around to do more innovation. Discovery is the first part of creating a cure or treatment, even if you choose to ignore that as well.

    You are also free to choose to ignore the chilling that will take place if the courts ignore Congressional intent, if they choose to ignore the direct and binding precedent of the Supreme Court and elect out a class of innovation from patent protection. If they do it here they can do it anywhere, and lets not kid ourselves — that is exactly what the ACLU wants and many of the other anti-patent groups.

    As for you calling the Orphan Drug Act a red herring, what you are really saying is that you choose to ignore those irrefutable facts because they don’t support your position. It is not a red herring, but by all means keep your head in the sand if you like.

    -Gene

  • [Avatar for Gary]
    Gary
    November 1, 2010 03:49 pm

    Just to clarify my last comment, I’m not suggesting that DNA in the test tube occurs naturally. I meant the actual molecule, whether in the cell or a test tube, is still the same molecule.

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 1, 2010 03:50 pm

    Gary-

    I couldn’t care whether you want to call yourself the Grand Poobah of a biotech start-up. Your comment suggest you are not at all sophisticated in the biotech industry, not familiar with the role of patents and unfamiliar with investors and how they think and react to a radical, fundamental shift in law and policy. In fact, the DOJ taking this position, even if the CAFC doesn’t adopt it, will hurt the industry.

    In your first comment, and then again here, you claim that an extracted and isolated segment of DNA is naturally occurring. That is absurd and if you are in the industry you know it. So answer me this: does an isolated segment of DNA exist in nature without humans isolating it? If you are honest you know that isolated DNA does NOT exist in nature.

    You say: “to say that the DNA molecule in a test tube is not natural and can be patented is ridiculous.” You do understand that is a conclusion, correct? You do understand that it is impossible to win arguments with conclusions, correct? Why not answer the one critical question? You know that isolated DNA does NOT exist in nature, but you don’t want to admit that because that TRUTH undermines your entire argument.

    You say: “Your suggestion that the viability of the biotech industry relies solely on gene patents just shows your ignorance for the subject matter.” Answer me this: does the valuation of certain biotech companies rest on these types of gene patents? If you are honest, you know the answer is YES. If you are honest and know anything about the funding of biotech companies you know that investors will retreat from the ENTIRE industry because they will see uncertainty, which investors hate. For 30 years the law and regulatory climate has been settled, ALL government bodies, courts and agencies have been on the same page. Now the DOJ wants to significantly alter the landscape. If you are at all serious, knowledgeable and engaged in the industry you know what that means.

    In your first comment you wrote:

    “By the way, we’ve seen more positive action from this administration (more research funding/grants, tax credits, etc) than all previous republican ones combined. I would write so much more, but I’m just too excited from having a letter in front of me this morning that says the government is paying for half of the investment that my investors put into this company.”

    That smacks of someone who is not seriously engaged and an imposter. Everyone in business knows that the Obama Administration has pursued anti-business policies. The fact that you are getting taxpayer funds means your business has gotten assistance, but what about the rest of us? What about the fact that policies have continued to create an uncertain business climate because of increased paperwork, increased cost of doing business, increased taxes and threats of unilateral regulation given that they can’t get their agenda through even a Democratically controlled Congress.

    You being too excited to write more is laughable. You only offer conclusions and argument. You never refute the facts I present, but merely call me arrogant and incorrect. Facts combined with analysis win arguments, and everyone who is objective knows you have lost because all you can do is pretend.

    -Gene

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 1, 2010 03:54 pm

    Gary-

    You say: “Just to clarify my last comment, I’m not suggesting that DNA in the test tube occurs naturally. I meant the actual molecule, whether in the cell or a test tube, is still the same molecule.”

    Thanks for conceding the argument. With this concession it is clear I am correct, and I appreciate you admitting that.

    Since the isolated DNA does not occur naturally then it is clearly patentable under Diamond v. Chakrabarty. The fact that the segment is the same in the cell (integrated with the entirety of the DNA) as in a test tube (extracted and no longer intertwined with the entirety of the DNA due to human manipulation) is of no importance to the patentability inquiry. The fact is the isolated DNA exists ONLY because of human intervention and that is what makes it non-naturally occurring and patentable subject matter.

    -Gene

  • [Avatar for Jeanne]
    Jeanne
    November 1, 2010 04:23 pm

    Could you be MORE biased. Your writing is shamefully biased. It is overblown and most of your statements are untrue. Do some homework and practice balanced writing. I won’t be coming back here for any of my research.

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 1, 2010 04:29 pm

    Jeanne-

    I’m sorry you don’t like the truth, but please do feel free to find outlets that are dishonest so that you can complete your research in a manner that you have already determined is appropriate.

    By the way, just to help educate you, research is supposed to be conducted without any preconceived notions. Nevertheless, I’m sure you will find plenty of liberal, pro-DOJ articles that don’t understand the science or the law that will satisfy your need to conclude your preconceived notions are accurate.

    Before you do go on about your life, it would be interesting to know what you think I got wrong. Given so much of the article is directly quoted from the DOJ brief, from Diamond v. Chakrabarty and from a BIO press release I wonder what I could have gotten wrong in your mind. Clearly it isn’t that the election tomorrow will be a rebuke, or that if the DOJ policy is adopted it would cripple the biotech industry. It certainly also isn’t that enormous shareholder value would vanish or that this would be bad for pensions invested in the market. It also isn’t that curtailing what is patentable will result in less innovation. So I guess I am perplexed as to why you think everything I wrote, which is correct and verifiable, is wrong. I also wonder why you think your incorrect conclusions are correct.

    As for balanced writing— obviously you are new here. I largely do OPINION writing, which is NOT balanced by definition. It is my opinion, just like an Op Ed page or Opinion section of any number of widely read magazines. So if you are offended by my opinion and are comfortable chastising me for having an opinion contrary to yours I suggest that is a YOU problem.

    -Gene

  • [Avatar for step back]
    step back
    November 1, 2010 04:50 pm

    Gene,

    It is a shame that you threw your right wing political biases into the post because such are merely red herrings leaping out of the water in salmon-ill-ah style to obscure the real issues.

    The real issue is that of scientifically illiterate pundits jumping into the water with sound bite logic in place of science and rational logic.

    Mother Nature does not on her own produce money-bearing trees or bushes having DNA-filled test tubes hanging from branches with the DNA being in “isolated” form. In simpler terms, isolated DNA is not a phenomenon of nature.

    Sadly, the ill informed folk at Justice hear some horrible sounding sound nibbles about “patents”, “genes”, tigers and bears and they run out from behind the Oz curtain screaming, Oh my, Oh my!

    Hopefully, when Dorothy, Toto and the rest re-gather their senses, pick up their post-Halloween broom sticks, and the dust settles, people will come to understand what “any new and useful … composition of matter” means as written in black and white in 35 USC 101.

    Until then, we have only histrionics gushing forth from these polemic web pages.

  • [Avatar for Gary]
    Gary
    November 1, 2010 05:01 pm

    does an isolated segment of DNA exist in nature without humans isolating it?

    Of course it doesn’t. I clarified my answer before your response. The method of isolating DNA should be patented (if it’s their own technology). It should not be specific to any gene/sequence, unless the method specifically isolates that part of the sequence, which it currently doesn’t. But the diagnostic power has nothing to do with the fact that the DNA is in its isolated form. It’s in the sequence itself, which is naturally occurring.

    There are new polymerases that can be used to do PCR without isolating DNA from cell lines/blood and maybe some day tumor tissues. If I understand you correctly, these enzymes will pretty much have the same effect as throwing out 20K gene patents that these biotech companies are clinging to for survival.

    Your fear mongering is the same tactic used by the right wing nut jobs that all hell is going to break loose with Obama’s anti-business policies. Relax, the biotech industry is healthy, it will stay healthy with or without gene patents. I predict that it will thrive without them.

  • [Avatar for Jeanne]
    Jeanne
    November 1, 2010 05:11 pm

    Wow. First of all I did not mean to flame you. I want to apologize for being insulting. I mean that. No sarcasm.
    I come to your site for honest opinions of legal decisions and I like that. But you went overboard on this and interjected your politics with no regard for the real issues of this patent decision. Here is a rough draft of my article on the topic:
    BTW: I am a professional journalist and a fiscally conservative Democrat. This is my opinion piece.

    Specific DNA is No Longer Patent-Eligible

    The Department of Justice last Friday filed a brief that claims that simply discovering a gene’s function does not give you the right to patent it, since it is still part of nature.
    “The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth.” (DOJ, 2010)

    Daniel B. Ravicher, executive director of PUBPAT and co-counsel in the case, states, “The impact of the U.S. now taking the position that isolated or purified genetic sequences are indeed not patentable is a substantial boon for society and the biotech industry.” (Genengnews.com, 2010)

    According to news reports and blog posts today, most in the BioTech industry are enraged. Many claim that this undermines their ability to make money on their years of research. This decision calls into question the validity of patents now held on approximately 2,000 human genes, according to the ACLU. The USPTO has issued about 35,000 patents reciting a gene sequence in their claims.

    I personally don’t see why the patents were granted in the first place because DNA does not meet the requirements of being patent-eligible. After all there isn’t anything new about DNA. As a matter of fact isn’t it one of the oldest things on earth. I further don’t get why the Bio Tech companies are so angry. Patent law has always held that once a natural product undergoes man-made manipulations it is no longer a product of nature so then it can be patented. Examples include genetically modified crops or gene therapies. As long as these companies produce something of value from their DNA sequencing they will still be able to make a lucrative income.

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 1, 2010 05:20 pm

    Step-

    I understand what you are saying about throwing politics into the debate, but I just don’t know how you can’t in this debate. Don’t forget, right after President Obama took Office his FTC determined in a report that 0 years of exclusivity was appropriate for biologics. The industry wanted 12-14 years, so he wanted to compromise and got involved personally and said 7 years was appropriate and enough exclusivity. Ultimately the industry got what it wanted. Thus it is fair to observe that the Obama Administration has had anti-bio leanings in a number of areas since the beginning, despite these issues not being political in the past.

    For more on the biologics and Obama’s position see:

    http://ipwatchdog.com/2009/06/27/obama-administration-wants-short-biologic-exclusivity/id=4283/

    http://ipwatchdog.com/2009/07/14/howard-dean-supports-strong-protection-for-biologics/id=4584/

    In terms of the other anti-business stuff I said about the Obama Administration, I do really feel that way. At some point how much is too much? Biotech is one area where the US truly dominates and it is responsible for hundreds of thousands of jobs, if not more when you consider all the indirect jobs that exist because of the industry. I viewed this surprising stance, which throws even the USPTO under the bus, as a last straw.

    -Gene

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 1, 2010 05:25 pm

    Gary-

    I was working on my response before you clarified.

    But your clarification is an admission of defeat. If the isolated DNA does not exist but for human intervention, as you admit, then it is patentable subject matter. It really is that simple.

    What you are saying is “should” and “shouldn’t.” What I am saying is not what should or shouldn’t be, but what is.

    I’d love to hear you address the point that investors hate uncertainty. We both know that is the case, and we both know that many biotech companies will have their value erased and it will be harder to get investors if decades of well established law and regulation, understood and applied the same by both Republicans and Democrats, is erased. That will not, in my opinion, cause a thriving biotechnology industry. Quite the opposite. We will lose this type of innovative company to other countries where the laws are more friendly.

    -Gene

  • [Avatar for Jeanne]
    Jeanne
    November 1, 2010 05:58 pm

    RE: If the isolated DNA does not exist but for human intervention, as you admit, then it is patentable subject matter. WRONG!
    If this is true then why isn’t E=MC2 patented. Humans did not invent the Theory of Relativity. It was just there. It is a fact and not new or the end result of someone’s creation. If Einstein had not discovered e=mc2 someone surely would have. And the same goes for DNA sequencing.

  • [Avatar for step back]
    step back
    November 1, 2010 06:04 pm

    Gene,

    I voted for Obama.
    However I am deeply disappointed in the audacity of his anti-innovation tactics.

    In public he says he is all for “innovation” and progress.
    But the back door antics say he is always against inventors and giving them their just due for their efforts.

    Everything he has done thus far has been talk-left and walk-right.

    He promised he would pull out of Afghanistan, but instead he has escalated the war there.
    He promised he would pull for the little guy, but instead he has given to the rich (TARP) and withheld from the poor (a reverse Robbin Hood).

    Of course I expect no different from the Tea Party once they take over and don their Mad Hatter caps in public after tomorrow’s elections.

  • [Avatar for Gary]
    Gary
    November 1, 2010 06:12 pm

    Yes, we are in an unfortunate situation where things are the way they are and not the way they should be. Just because gene patents were granted over a decade ago, when we really didn’t understand the full extent of what we were doing with this stuff, doesn’t mean we should not correct ourselves, now that we understand things somewhat better. In my opinion, today’s brief indicates a move in the right direction regarding this specific issue.

    It’s true that investors hate uncertainty, but why do you assume that the viability of the biotech industry solely rests on the ability to patent genes?

  • [Avatar for step back]
    step back
    November 1, 2010 06:13 pm

    Jeanne,

    There is a complex subtlety to science and our understanding of the Universe.

    E=m(*)C^2 did not exist in Nature and does not now exist as a physical “thing” in Nature.

    We humans try to “model” the Universe as best we can by inventing mathematical descriptions of how we expect the Universe to behave. History has shown us that we generally get it relatively wrong, although we do seem to have recently been getting better at our “modeling” attempts.

    So E=m(*)C^2 is simply our latest abstract mathematical “model” for how we currently think the Universe works. It is not a something physical that itself exists in Nature.

    __________________
    m(*)= Lorentz value for mass

  • [Avatar for Bobby]
    Bobby
    November 1, 2010 06:15 pm

    First of all, the claim of crippling is not accurate. What would happen is that we would stop actively supporting certain parties in the biotech industry.

    As for isolated genes, I don’t see a good argument for patenting them. The isolated gene isn’t functionally different than the natural occurring gene, as far as I know. The same enzymes, proteins, etc. are produced by both. There are uses to isolating a gene, but the innovative things are the methods for isolating the genes and the products that make use of an isolated gene, and there’s no indication that either of these is threatened.

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 1, 2010 06:53 pm

    Step-

    You say: “Of course I expect no different from the Tea Party once they take over and don their Mad Hatter caps in public after tomorrow’s elections.”

    And that is a depressing thought, borne out by history. We deserve better than our leaders seem capable of delivering from both sides.

    Don’t forget that the Obama Administration has been objectively good… strike that… EXCELLENT… for the administration of the Patent Office. I understand what you mean by anti-innovation, but Kappos and company are trying to turn the ship around, and doing excellent work, even if they are inadequately funded and money is still being siphoned off. So the people in place at Commerce and at the USPTO are good. Let’s not lose sight of that.

    -Gene

  • [Avatar for Steve M]
    Steve M
    November 1, 2010 07:26 pm

    “Your writing is shamefully biased.”

    Jeanne–Truth is often falsely labeled by those who either disagree or do not comprehend as “bias.”

    Gene knows of what he speaks.

  • [Avatar for Gary]
    Gary
    November 1, 2010 07:37 pm

    ‘Jeanne–Truth is often falsely labeled by those who either disagree or do not comprehend as “bias.”’

    And sometimes it’s simply bias.

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 1, 2010 08:09 pm

    Gary-

    What is amusing is you and Jeanne act as if you are NOT biased. You just have a different bias and find it convenient to ignore that and label me as biased. Truth is everything I said is accurate. You just don’t like the truth, so in your mind that means I am biased. How pathetic.

    Sent via iphone

  • [Avatar for David]
    David
    November 2, 2010 08:18 am

    Gene, I thought your expertise and this blog was about patents. I take offence at your partisan rants. We know you are a right wing radical so must you now take an entire post to share your views on economics and politics — which seem quite far afield?

  • [Avatar for Just visiting]
    Just visiting
    November 2, 2010 08:47 am

    “The isolated gene isn’t functionally different than the natural occurring gene, as far as I know.”

    Myriad, in their brief, says otherwise. They say, I quote …. “These isolated molecules are man-made chemical compositions, structurally and functionally distinct from any substance found in the human body—indeed, in all of nature.”

    “They are neither laws of nature, nor abstract ideas, nor mere information, but instead are useful as molecular tools (e.g., primers and probes) because of their ability to target and form stable chemical structures with a BRCA DNA sequence in a tissue sample.”
    Is this true?

    “These isolated molecules can also be sequenced in the laboratory.”
    Is this true? and does it distinguish it from normal DNA strand?

    “The method claims are directed at detecting BRCA mutations and screening for potential cancer therapeutics; none involves merely “looking” at genes. (A3445; A3447-48; A3455-58; A4342-43.) Indeed, one cannot detect mutations or determine the sequence of DNA by mere inspection. Detection of a gene requires molecular tools such as probes or primers; the isolated molecules are these tools, which transform a patient’s sample to allow detection of mutations and sequence variations in the patient’s genes.
    Is this true? Would the method claims survive?

    I ask all of these questions because I don’t know the answers because I’m not a biotech guy. I know 35 USC 101, however.

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 2, 2010 10:47 am

    David-

    My views only seem right wing and radical to a true liberal without a sense of reality. Everything I wrote was true, and if you think the truth is radical then that is a YOU problem.

    If you take offence (I note the English spelling) then you should stop reading.

    As for an entire post to share my view on economics and politics, perhaps you need help with reading comprehension. The article was about a critically important patent issue, which deals with what is patentable subject matter. If the DOJ position is adopted that will cripple the biotech industry in the United States. Perhaps you should re-read the article and try and check your pro-Obama, anti-patent and anti-business bias at the door.

    -Gene

  • [Avatar for Ron Hilton]
    Ron Hilton
    November 2, 2010 10:58 am

    As one whose backgraound is in another hotly-contested field in terms of patentable subject matter (software), I can fully understand the problem with changing the rules of patentability in the middle of the game. But I have also seen how bad patents can cripple rather than promote innovation. If I understand it correctly, methods of isolating DNA would remain patentable, and any novel uses of the DNA would remain patentable, but only the DNA itself in isolation would no longer be patentable? It would be helpful if those on both sides of the issue could give some more specific examples, both of how innovation has been fostered or been thwarted by the existing regime. Also, am I correct in assuming that the DOJ brief has no force of law whatsoever, until the issue fully works its way through the court system? Of course, the uncertainty factor is still huge and could significantly impact investment and company valuations.

  • [Avatar for Chris]
    Chris
    November 2, 2010 11:06 am

    The truly disappointing part in all of this is how people in high judicial positions can completely misunderstand the law and spend my tax dollars to create such a mess.

    The DOJ brief states that the gene would have the same function and effects whether in vivo or in the isolated form, and therefore the subject matter requirement is not met. (Of course they offer no scientific basis or evidence for that statement at all as Gene points out above.) Their logic is that the case law (Funk Bros and American Fruit Growers) set the precedent that unless there is a “marked difference” in the product of nature then the item is not patentable subject matter. However, they fail prima facie since, as they admit, “isolated DNA” is not a naturally-occurring form of DNA.

    Further, an integral part of their argument – is that there is no “new and useful” function of the isolated DNA by itself (i.e., it’s useful only with additional critical features and not by itself). It seems to me that this is a conflation of the subject matter requirement of 101 with the utility requirement of 101 and 112.

    Judge Sweet amazingly argues that DNA coding in vivo is an abstract, like the text of a book. If this were true, then any chemical composition, using the building blocks of the periodic table in an abstract comstruction, would be unpatentable. Sweet is in direct contradiction to 35 USC 101 which clearly states that compositions of matter are patentable subject matter. The fact that DNA conveys genetic information (which *might* be an abstract process) does not change its nature as a composition of matter. I can stamp a word into a new kind of plastic, or add a color to it in order to convey information, but that does not change its nature as a composition.

    Sweet also seems to conflate 101 and 103. He practically says that since anyone can isolate DNA and people have been doing so for years, that it’s not patentable subject matter under 101. If he had attacked the patent claims under 103 alone, he would have had a much stronger basis, in my opinion.
    If Myriad had stuck to arguing obviousness and utility, they could have raised some real issues about the patentability of “isolated DNA.” But as it is, the issue is patentable subject matter in 35 USC 101, which must stand alone from 102, 103, and 112. Sweet or DOJ can’t make an argument against patentable subject matter, so they conflate it with obviousness and utility and waste my tax money for politics. I see almost no chance of the decision not being eventually overturned based solely on Sweet’s convolution of the law. Stranger things have happened though.

  • [Avatar for David]
    David
    November 2, 2010 11:57 am

    Gene, please hang onto your “liberal” insults and explain how the quoted rhetorical material below is patent matter? I’ve been Republican since before you were born, friend. Of course I understand the basic DNA patent question at hand, but your going over the top with firebrand political rhetoric on a forum like this doesn’t help anyone. In fact, it is quite unbecoming. Stick to your profession and permit other intelligent people to hold a different political view without alienating them.

    on the eve of a national election that will in all certainty be an enormous rebuke of the Obama Administration and the Democrats’ agenda in general,

    Mr. President, with all due respect, the anti-business policies of your Administration are not only preventing a recovery, but they are costing Americans jobs.

    The fear of the unknown is causing a crippling paralysis, and now your Department of Justice is trying to persuade the Federal Circuit to follow its recommendation, which will cost tens of thousands of jobs and hundreds of billions of dollars of corporate value to be erased

    In commenting on the troubling decision of the Obama Administration to throw the biotechnology industry under the bus,

    Unfortunately, the lunacy of the Department of Justice

    That smacks of someone who is not seriously engaged and an imposter

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 2, 2010 12:12 pm

    David-

    I am happy to explain, so hopefully you can understand.

    “on the eve of a national election that will in all certainty be an enormous rebuke of the Obama Administration and the Democrats’ agenda in general,”

    The above is a true statement. Everyone who is observing the election cycle knows this. So it is a fact. I’m sorry if that fact offends you. It is to provide context relative to the fact that even on the eve of the Democrats being widely rebuked they continue in their anti-business fashion. The anti-business policies I refer to are the positions taken by the DOJ in the brief, which was filed in a patent case.

    “Mr. President, with all due respect, the anti-business policies of your Administration are not only preventing a recovery, but they are costing Americans jobs.”

    Jobs are a huge issue, perhaps you have missed that, much as the President and Congress has missed that and instead pursued other things. I write about jobs, job creation and the link to innovation all the time. I also write about how the Patent Office can help if it were actually funded properly and money was not siphoned off. Jobs is the critical issue and the part of the federal government most able to help, the Patent Office, is being ignored. By taking more anti-business positions on biotechnology that is a jobs issue.

    “The fear of the unknown is causing a crippling paralysis, and now your Department of Justice is trying to persuade the Federal Circuit to follow its recommendation, which will cost tens of thousands of jobs and hundreds of billions of dollars of corporate value to be erased”

    Now you are just being silly. You really don’t understand what the crippling paralysis relative to the fear of the unknown has to do with this patent story? Wake up, will you? AS I EXPLAINED AND YOU OBVIOUSLY MISSED, the DOJ position will force a 180 degree shift in the patent laws relative to biotechnology. That means UNCERTAINTY. Investors HATE uncertainty. The market in general HATES uncertainty. It will negatively impact those companies operating directly in this biotech space, and all biotech companies because it will become harder to raise money knowing that decades of law can be ignored and a new course charted at a whim. That is an innovation story because if companies go out of business they don’t innovate. The backdrop is a patent story because the ridiculous position of the DOJ that causes this harm to the biotech industry, innovation and jobs is a misguided, ill-conceived and flat incorrect PATENT policy shift.

    “In commenting on the troubling decision of the Obama Administration to throw the biotechnology industry under the bus,”

    The DOJ is throwing the biotech industry under the bus. Which part of this is confusing to you?

    “Unfortunately, the lunacy of the Department of Justice”

    Re-writing 30 years of law, urging the ignoring of binding Supreme Court precedent, citing only cases from the 1880s, 1920s and 1930s and urging an interpretation that would cripple the biotech industry is lunacy, particularly on the eve of a national election where the anti-business, liberal policies of the Administration are going to be squarely rebuked.

    “That smacks of someone who is not seriously engaged and an imposter”

    Just pointing out the facts. The comment was ridiculous, shows no understanding of the industry, how money is raised from private investors and the patent system. He even went on to admit that I was correct, although he didn’t realize he was doing that.

    Please David, try and keep up. You quoted things that were to put my comments about A PATENT STORY into context. If you don’t like the truth that is a YOU problem.

    By the way, I don’t for a minute believe you are a Republican.

    -Gene

  • [Avatar for Kale]
    Kale
    November 2, 2010 12:16 pm

    I fail to see how an isolated, otherwise naturally occurring gene, when used to do what that gene does can possibly satisfy 101. Did the first barber who cut off someone’s hair (isolated) and washed it (purified it) for use in a wig “invent” hair? Note that I don’t think that the wig itself, the method of getting the hair into the wig, or the use hair or something else would necessarily be unpatentable. But the hair-as-hair would not seem to be patentable by that barber. Simply skipping a head a few thousand years, using really high-tech scissors and a chemical “hair” does not change the analysis in any meaningful way.

    Also, Chris, Judge Sweet is hardly the first judge to conflate 101 and 103. The Supreme Court did the same thing in Bilski. The analysis in Bilski reads more like 103 than 101. But I think that this has a lot more to do with the nature of what people (judges and non-patent folks) assume “invention” means. Specifically, that invention does not include those things which are in and available to all mankind for intellectual pursuit. These things would be both “obvious” and not patentable. Obvious, in this sense, is not the 103 definition, but the definition that is closer to “evident,” “open to view,” etc.

  • [Avatar for David]
    David
    November 2, 2010 01:00 pm

    Good Grief, Counselor! I’ll read no further since you don’t seem to understand that your statement below is most certainly NOT a fact! Sir, that is a widely held opinion and expectation but NOT A FACT!

    Ever see the picture of Harry Truman holding up the newspaper annoucing that Thomas Dewey won the 1948 presidential election.

    Every one knows this ..? Huh, where did you go to lawyer school. Don’t bother responding, I’m done reading your “stuff.”
    _____________________________________________________________________________

    I am happy to explain, so hopefully you can understand.

    “on the eve of a national election that will in all certainty be an enormous rebuke of the Obama Administration and the Democrats’ agenda in general,”

    The above is a true statement. Everyone who is observing the election cycle knows this. So it is a fact.

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 2, 2010 01:05 pm

    David-

    We shall see who is correct. Would you care to enter into a friendly wager?

    -Gene

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 2, 2010 01:10 pm

    David-

    One more thing, since I know you are still reading… Awful odd that a Republican such as yourself had such a visceral reaction to the fact that Americans will be rebuking President Obama and the Democratic agenda today. We shall see who is right, but the polls, history and the elections of November 2009, among other things, all suggest that you are ignoring reality and holding onto a hope. Hope is not truth, it is a desire. This is not Truman v. Dewey. You should do your homework on that election anyway. While the Tribune got it wrong, this election looks nothing like that one.

    -Gene

  • [Avatar for Moocow]
    Moocow
    November 2, 2010 01:18 pm

    A few simple facts:
    1. Mid-level DOJ lawyers filed an amicus brief purporting to speak for the US Government;
    2. We do not currently have a Solicitor General to keep an eye on things;
    3. Said brief is terrible for the ACLU’s position. It rejects arguments that are absolutely crucial to their case (“… DNA is just an embodiment of information…”);
    4. The brief doesn’t even mention Myriad’s method claims, which are being attacked by the ACLU for allegedly interfering with the thought processes of doctors. No help from DOJ on that theory either.
    5. The brief informs us that none of the following things can be patented: coal mined from the ground; cotton picked off a plant; elemental lithium; the stigmas of saffron flowers; an isolated electron; and the yet-to-be-discovered graviton. Mysteriously, there is no discussion of genetic diagnostic testing, whole genome sequencing, or personalized medicine. Maybe they used all their space to talk about coal?
    6. As government briefs go, this is a strange and unusual brief that explains at no point why it was filed, or why now. What is clear, though, is that political folk inside the administration are openly talking about slamming the door on whole classes of technology.

  • [Avatar for Ron Hilton]
    Ron Hilton
    November 2, 2010 01:19 pm

    Gene,

    As a proud Tea Party Republican I agree with your politics, but I also agree with those who feel that we have veered far off-topic on this forum today. Maybe inevitable, given the potentially historic election now underway. I’d still like to hear some more specific examples regarding the likely bad or good effects of the DNA patent issue.

    Ron Hilton

  • [Avatar for TINLA IANYL]
    TINLA IANYL
    November 2, 2010 01:22 pm

    It’s unfortunate that the criticisms going both ways are fairly well founded. This is one of those points on which reasonable people can disagree, and disagree they do. Bias is inevitable on both sides of the issue.

    But I have to wonder what kind of research would be supressed, kept secret, or slow to emerge if isolated gene patents become invalid. The negative aspects of the patent system are real, but they are necessary to encourage disclosure. I mean, imagine of all privately funded research came with an NDA and non-publication, as the company tries to keep the gene discovery a secret while it tries to develop products first? Scientuific advancement is rapid due to fast global collaboration. The problem is that, however “evil” gene patents may be, they are necessary to encourage disclosure of basic research.

  • [Avatar for Just visiting]
    Just visiting
    November 2, 2010 01:24 pm

    Gene:

    This is why I dislike your politics — not because I dislike many of your political positions (and that I do), it is because when you introduce your politics into this blog it devolves into a “left versus right” fight.

    We had an opportunity to ask people skilled in the art some poignant questions about the technology and that art, which we as patent attorneys, could use to determine whether DOJ or Myriad has the better argument.

    But noooooo … you couldn’t resist your Obama bashing, and now, most of the latest posts fail to discuss the actual merits of the case.

  • [Avatar for Blind Dogma]
    Blind Dogma
    November 2, 2010 02:16 pm

    Another glass?

    Sure.

    Chaa..ching

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 2, 2010 07:08 pm

    JV-

    Sorry you disapprove of how I told the story. The truth is the Obama Administration obviously doesn’t have its act together when Commerce takes one position and Justice takes the exact opposite opinion.

    Excuse me for telling the truth and observing that this is just another example of the Obama Administration infusing needless uncertainty into the economy. Excuse me for also correctly observing that business hates uncertainty and this uncertainty is preventing a recovery, which is doing as a matter of fact.

    -Gene

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 2, 2010 07:15 pm

    Ron-

    Fair point, although I will take issue with veering off topic. It might seem to be veering off, but it is an off-topic or tangential debate that was the intention. I write opinion journalism, and I honestly believe that when important issues are at stake I should write about them. Of course at least a tangential relationship to the core message should exist, and I think it fairly does.

    There will be plenty of time moving forward to explore the full variety of issues, both scientific and legal, presented by this case. I plan on doing that and seeking out experts to tell the story. As I think you and others know that I open up the pages of IPWatchdog.com for anyone to write and tell their side of the story. I did that with the Gene Patent issue earlier, publishing those who are on the opposite side as me.

    So for those who thought I veered off topic I would say that you are entitled to your opinion on that point, but this is exactly where I wanted to go. To engage in debate and let it go where it may, which is something I think we need more of. I am happy to allow any article to provoke a debate in any direction as long as the discourse, although heated, is grounded in substance.

    Cheers everyone.

    -Gene

  • [Avatar for Ron Hilton]
    Ron Hilton
    November 2, 2010 09:52 pm

    As long as we’re talking politics, would we all agree that Republicans tends to favor strong patent rights and weak anti-trust enforcement, and the Democrats vice-versa? Having said that , I actually favor strong anti-trust enforcement even though I am a conservative Republican, because I have seen the monopolistic abuse of patent rights by large corporations to the detriment of competition and innovation. Unchecked, big business exhibits some of the same negative statist attributes as big goverment. My political views are largely dictated by my entreprenuerial, free-market orientation.

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 2, 2010 10:04 pm

    Ron-

    Wow… complicated subjects here, which probably deserve a complete article. I would love to write about this. I have done some writing about antitrust, and like you I see absolutely nothing wrong with antitrust enforcement, at least in the abstract. I hate listening to the anti- Teddy Roosevelt nonsense from Glen Beck; he obviously doesn’t understand Teddy the trust buster. Having said that, I tend to think that there is over enforcement in the antitrust arena when it comes to technology dominance. This may be an over generalization, but in the latest big fight between DOJ and Microsoft, after years of abuse DOJ finally caught up to Microsoft and the order was essentially for them to play fair. I think that really under cut the growth of open source, particularly Linux, which I think would have been the de facto standard by now but for antitrust enforcement. This is because software developers and others had a vested interest to stay engaged with the Microsoft platform once they had to “play fair.”

    I am actually working on an article about what the election means for patents and patent reform, and I think many will be surprised.

    I do think that generally speaking it is accurate to say Democrats tend to favor stronger antitrust enforcement and Republicans weaker, but I am not sure that there is much of a difference, maybe around the margins and with respect to undertaking big cases.

    -Gene

  • [Avatar for MBT]
    MBT
    November 3, 2010 04:56 pm

    I am a Republican and a former biotech patent examiner who is currently a patent practitioner. Perhaps the heat can be turned down somewhat but everyone has touched on an obviously hot topic with both sides feeling strongly about the subject. The subject has been made political by the DOJ entering their brief in opposition to policy elsehwhere in the government. Since Obama is president, and his DOJ filed the brief, then the buck stops in the Oval Office – first year law school Constitutional law, methinks. This is Gene’s blog and he has a right to his opinion just as much as other blogs that call conservatives Neanderthals, uneducated and the like. I haven’t heard Gene calling anyone names, he is calling folks “liberal,” which I assume has not become a dirty word.

    That being said, controlling patents in any field can be argued to be anticompetitive – the same thing happened in the antibody art, business methods and the Harvard mouse. I don’t hear anyone calling to stop patenting antibodies. Invalidating an entire class of valid patents, in addition to the issues discussed by Gene and other also has a hint of improper taking. If the Obama administration wants to shut down siolated DNA patents (and I presume also the translated proteins), then perhaps Obama should go to Congress and convince them to pass the legislations. This issue is too important to be legislated from the bench.

  • [Avatar for Shaum]
    Shaum
    November 4, 2010 12:01 am

    Gene,
    I could try to “isolate” you by making a pro-Obama remark :), but instead I’ll state two comments that I think are helpful for non-patent people on this board, but are quite obvious for patent practitioners. Then a short quip. Correct me if I’m mistated anything.

    1. Section 101 as raised in the DOJ complaint pertains to patentable subject matter, and has been a relatively broad gateway, but it is still not an end all for patentability. Just because an isolated gene is patentable subject matter doesn’t necessarily mean that an isolated gene will be patented (probably will be though). More steps are needed in the analysis.

    2. Sections 102 Novelty and 103 Nonobviousness are requirements to be met for patentability, not something such as conventional wisdom. One of the comments above raised an analogy to isolating a hair, making a wig, and suggested that such a wig would not be patentable. That is not the case, as evidenced by US 6,691,714. The reality is that the particular wig probably presented something novel at the time of the invention, something that may be difficult to understand in 2010, especially without reading the patent carefully. Without standards in place for evaluating patentability, we can have hindsight and effectively eliminate patentability of everything by simply saying “I could have thought of that” or “but of course.”

    Now to jump into the opinionating….does an isolated gene do exactly what it would have done in its natural state, as expected? If there is clear scientific evidence of this, I would think obviousness may be a better rejection approach, rather than something so drastic as to change 101, thereby upsetting the balance of a basic gateway standard for subject matter and throwing countless patents and R&D into complete disarray. Perhaps it is a harder argument for the DOJ to make, but policy wise, I think it would be a more narrowly focused move that poses less risk and harm to those that rely on the patent system.

    Your political points concerning anti-business policies which you relate to this issue are interesting. I’d argue that there is a pro-business side to the white house initiatives, in that the funding improvement to the patent office, health care reform, credit card reform, student loan reform, are all things that help people in similar situations to mine start their own businesses and take positive risks which can benefit innovation overall. Also, the energy policy and cleantech initiatives may help push innovation forward. Regardless, you raise a great question as to how such a law change would impact the particular industry. Thanks for your valuable blog.

  • [Avatar for IANAE]
    IANAE
    November 4, 2010 10:00 am

    I haven’t heard Gene calling anyone names, he is calling folks “liberal,” which I assume has not become a dirty word.

    Rush Limbaugh had a pretty memorable rant a couple years back, about how proud he was of the conservatives’ efforts to make “liberal” a dirty word.

    If it isn’t in fact one, it’s not for lack of trying. Either way, it would be pretty disingenuous for a conservative (especially an IP lawyer) to re-brand his opponent and then claim he’s not name-calling.

    Getting back to patents, there’s no good reason why any particular molecule in the world (including an isolated DNA) should be unpatentable under 101. This is clearly a 103 issue, if it’s anything at all other than a political issue.

  • [Avatar for Bobby]
    Bobby
    November 4, 2010 11:56 am

    @MBT
    “That being said, controlling patents in any field can be argued to be anticompetitive”
    That seem odd to me, because patents are themselves anticompetitive, which is precisely why they have limited duration.

  • [Avatar for Blind Dogma]
    Blind Dogma
    November 4, 2010 12:03 pm

    there’s no good reason why any particular molecule in the world (including an isolated DNA) should be unpatentable under 101

    So help me out IANAE, which statutory class does the molecule O2 belong to?

  • [Avatar for IANAE]
    IANAE
    November 4, 2010 12:19 pm

    So help me out IANAE, which statutory class does the molecule O2 belong to?

    The exact same statutory class as the acetaminophen molecule.

  • [Avatar for step back]
    step back
    November 4, 2010 12:30 pm

    BD,

    When mixing your Kool Aid, don’t forget to include the dihydride oxygen molecules in there.

    I think it is some sort of “composition of matter”.

    But then again, there are some Had Madders out there who are “strict constructionists” when it suites them and loose lippers when the literate meaning pendulum swings in a way not to their arbitrary and capricious likings.

  • [Avatar for Blind Dogma]
    Blind Dogma
    November 4, 2010 12:39 pm

    The exact same statutory class as the acetaminophen molecule.

    Wrong.

    Try again.

    And yes, this question is asked under the legal meaning of the statutory category, not the literal one. And yes, the term “new” in 101 has a specific legal meaning, although it is often overlooked.

  • [Avatar for ikh]
    ikh
    November 4, 2010 01:51 pm

    Gene,

    What a gorgeous OTT rant. Wow, the sky is falling!!!

    A question ( as IANAL ). What is protected by an isolated gene patent?
    I’m guessing that it is any research on the patented gene. In which case
    I would suggest that such patents are a barrier to innovation and defeat the
    purpose of a patent.

    It is interesting to note that Europe does not allow isolated gene patents and
    it does not stop them having a thriving biotech industry.

    /ikh

  • [Avatar for General Admission]
    General Admission
    November 5, 2010 05:56 pm

    @IKH – Not to quibble, and I may be mistaken as I’m not a European patent attorney, but Europe seems to allow gene patents — or did you mean to say “Gene’s patents” 😉 ?

    EPC Rule 27:Patentable biotechnological inventions

    Biotechnological inventions shall also be patentable if they concern:
    (a) biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature;

    And note EPC Rule 29(2)

    Rule 29: The human body and its elements
    (1) The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.
    (2) An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.
    (3) The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.

    So, it looks like its fair game in EP.

    Also, I suppose “thriving biotech industry” is a relative measure. I don’t know for sure, but I suspect that the US has about 3x as many biotech companies as does the EP.

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 9, 2010 04:28 pm

    Jeanne-

    You ask why isn’t E=MC2 patented. The answer is because the Supreme Court said it cannot be patented. It is a discovery. Mathematical equations and laws of nature cannot be patented. On the other hand, isolated DNA is NOT a mathematical equation or a law of nature.

    By the way, I just saw the flaming rant you tried to post as a comment, which was caught by the spam filter because of the language you chose to use. While I tolerate a lot of heated debate, language like you used in that post attacking individuals personally is inappropriate for IPWatchdog.com. As a result, I have added you to the banned list, which means all comments posted by you will be caught by the spam filter and will only be approved when they exhibit the level of discourse appropriate for IPWatchdog.com.

    -Gene

  • [Avatar for Mike]
    Mike
    November 29, 2010 04:12 pm

    I never knew it was possible for a person to troll in his own blog. I see that it is.

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 29, 2010 09:22 pm

    Mike-

    You say: “I never knew it was possible for a person to troll in his own blog. I see that it is.”

    Would you care to elaborate so that we can all understand what you are talking about? Obviously, this cryptic comment seems to have some specific, ill-defined meaning to you.

    -Gene