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ACLU Files Frivolous Lawsuit Challenging Patents


Written by Gene Quinn
President & Founder of IPWatchdog, Inc.
Patent Attorney, Reg. No. 44,294
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Posted: May 14, 2009 @ 11:46 am
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The ACLU should be sanctioned for its frivolous lawsuit challenging gene patents, which was filed Tuesday in the United States Federal District Court for the Southern District of New York.  This lawsuit is nothing more than grandstanding, it presents frivolous arguments and outright lies.  The ACLU would have you believe that the patents cover naturally occurring genes, which is simply not true, and the primary reason they should be sanctioned.  The patents they are challenging relate to altered genes and diagnostic methods, so they are making assertions that are factually false, and challenging the patent system as being unconstitutional, which if successful would only bring an end to the biotechnology industry and perhaps even pharma.  This would mean no new drugs, not diagnostic advances and hundreds of thousands of jobs lost, not to mention a stock market crash.  This is about as dumb as making arguments in court that would seriously undermine national security.

There are only two paragraphs in the entire complaint that can at all be characterized as legal argument or basis to support this frivolous lawsuit filed by the ACLU.  These are:

102. Because human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought, the challenged claims are invalid under Article I, section 8 of the United States Constitution and 35 USC 101.

103. All of the challenged claims represent patents on abstract ideas or basic human knowledge and/or thought and as such are unconstitutional under the First and Fourteenth Amendments to the United States Constitution.



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Perhaps the ACLU is unfamiliar with patent law, which as I write that seems terribly humorous to me.  That is like saying “perhaps water is wet” or “perhaps breathing is good.”  Of course the ACLU knows nothing about patents, and this complaint proves that, and many other things as well.  Patent claims are not invalid for constitutional reasons.  The Supreme Court has time and time again reviewed US patent laws, which have been around since 1790, never once finding the law unconstitutional, and no court has ever ruled a patent claim invalid because the claim violates the US Constitution.  This is grandstanding pure and simple, and it is disgusting that the ACLU is using cancer patients to forward its own political agenda and profile.  If change is what you want ACLU then go to Congress.  You are asking the courts to legislate, and that is not their role.  I feel your pain and understand that getting Congress to do anything with respect to patents has about as much chance as pigs flying, but that is the way it is.  Welcome to the world of patent reform!

Lets take a minute to actually look at some of the claims that the ACLU says are invalid because they cover laws of nature or naturally occuring things.  Before we jump into the text of the claims, which I am sure the ACLU doesn’t want average people to look at because you could tell they are lying if you did, let me state the obvious.  A diagnostic method does not naturally occur, but rather is a process conjured up by humans; and when something is “isolated” and “altered” it is not how God, the creator, spirits or luck (whichever you prefer) caused things to be naturally ordered.  With this basic, factually inarguable understanding, lets proceed.

US Patent No. 5,693,473 is being challenged, specifically claim 1:

1. An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1.

US Patent No. 5,709,999 is being challenged, specifically claim 1:

1. A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.

US Patent No. 5,710,001 is being challenged, specifically claim 1:

1. A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises gene comparing a first sequence selected form the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample.

US Patent No. 5,753,441 is being challenged, specifically claim 1:

1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

US Patent No. 6,033,857 is being challenged, specifically claim 1:

1. A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.

Let me try and put this in terms that even the ACLU can understand… A METHOD IS NOT A GENE!  Also… SOMETHING IN ALTERED STATE DOES NOT OCCUR NATURALLY!


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The complaint also makes the popular, and completely baseless, assertion that patents undermine innovation, which has also worked its way into popular press reports. “Scientific research and testing have been delayed, limited or even shut down as a result of gene patents, stifling the development of new diagnostics and treatments,” said Tania Simoncelli, ACLU science advisor. “The government should be encouraging scientific innovation, not hindering it.”

It seems as if those who hate the patent system think that if they say this a lot it will eventually become true, or be believed to be true.  The trouble with this, however, is that there are absolutely no historical facts to support the claim that patents harm or undermine innovation.  Patents simply do not harm innovation, they spur innovation.  The patent system is set up to encourage engineering around and improving upon protected inventions of others.  The only legitimate argument that patents harm innovation goes like this: “I am soooo lazy and simply have no desire to undertake the hard work necessary to innovate, so I want to copy what others have spent exorbitant amounts of time, money and energy creating, after all, that is the only fair thing!”

If patents stand in the way of innovation that is a YOU problem, not a patent system problem!

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Posted in: Biotechnology, Gene Patents, Gene Quinn, IP News, IPWatchdog.com Articles, Patent Litigation, Patents, Pharmaceutical

About the Author

is a Patent Attorney and the founder of the popular blog IPWatchdog.com, which has for three of the last four years (i.e., 2010, 2012 and 2103) been recognized as the top intellectual property blog by the American Bar Association. He is also a principal lecturer in the PLI Patent Bar Review Course. As an electrical engineer with a computer engineering focus his specialty is electronic and computer devices, Internet applications, software and business methods.

 

 


31 comments
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  1. Agreed. There is so much dis-information about patents and what they cover. I often see blog articles criticizing patents based on their titles (they don’t understand its the claims that describe the patented information). The ACLU should be ashamed for being on the wrong side of an issue and twisting facts, again.

  2. Gene,

    I agree with you that the case is bogus; however, I think you may be interpreting the term “altered” incorrectly to imply that there has been some type of manipulation. While the term isn’t explicitly defined in the specification, it looks to be used synonymously with the term “mutated”.

    “It has been discovered that individuals with the wild-type BRCA1 gene do not have cancer which results from the BRCA1 allele. However, mutations which interfere with the function of the BRCA1 protein are involved in the pathogenesis of cancer. Thus, the presence of an altered (or a mutant) BRCA1 gene which produces a protein having a loss of function, or altered function, directly correlates to an increased risk of cancer.” – US Patent No. 5,693,473, Column 16, Lines 57-64

    Mutation of a gene is a potentially naturally occuring processes. In other words, “altered”, as used in the specification, is a result of a natural occurance rather than a manipulation. Therefore, the test for the ’473 patent will most likely hinge on whether the term “isolated” defines a manipulation of the underlying subject matter that couldn’t naturally occur. I seriously doubt that the method claims are in any danger, and I believe that “isolated” should be a sufficient man-made manipulation to affirm the claims, simply because there isn’t a natural pathway for isolation of such a gene. That said, the same test probably wouldn’t work for a claim to “an isolated tumor having altered BRCA1 DNA” or “an isolated body part”, simply because such an isolations may occur naturally without intentional manipulation. (For explanatory purposes and to answer the question of how a body part or tumor could be naturally isolated, one need only think of leprosy.)

  3. For me, when I follow the efforts of the unknowing in my space (patents), I am almost struck dumb by the ignorance revealed. Aside from eroding any credibility of the entity with respect to patents and patent related issues, it seriously calls to question their efforts in areas of which I have no separate knowledge. Are they as mis-led and mis-informed there as they are here? One can only wonder. Their efforts here are without a shred of support. None. Yet, because of the brand name and awareness they have, this will actually be taken seriously in some quarters. Hopefully those who may take it seriously have no ability whatever to affect patent policy one way or the other.

    If patents are not a good thing, then ownership of real property likewise is a bad thing because, after all, someone may have to walk around it if a “no trepassing” sign is erected thereon. Just cede all property to the “people” and be done with it. Jefferson and Madison already had this argument (which Madison won), detailed to some extent in Graham v. John Deere, to wit:

    “Jefferson, like other Americans, had an instinctive aversion to monopolies. It was a monopoly on tea that sparked the Revolution, and Jefferson certainly did not favor an equivalent form of monopoly under the new government. His abhorrence of monopoly extended initially to patents as well. From France, he wrote to Madison (July, 1788) urging a Bill of Rights provision restricting monopoly, and as against the argument that limited monopoly might serve to incite “ingenuity,” he argued forcefully that “the benefit even of limited monopolies is too doubtful to be opposed to that of their general suppression,” V Writings of Thomas Jefferson at 47 (Ford ed., 1895).

    His views ripened, however, and, in another letter to Madison (Aug., 1789) after the drafting of the Bill of Rights, Jefferson stated that he would have been pleased by an express provision in this form:

    “Art. 9. Monopolies may be allowed to persons for their own productions in literature, & their own inventions in the arts, for a term not exceeding ___ years, but for no longer term & no other purpose.”

    Id. at 113. And he later wrote:

    “Certainly an inventor ought to be allowed a right to the benefit of his invention for some certain time. . . . Nobody wishes more than I do that ingenuity should receive a liberal encouragement.”

    Letter to Oliver Evans (May, 1807), V Writings of Thomas Jefferson at 75-76 (Washington ed.).

    Jefferson’s philosophy on the nature and purpose of the patent monopoly is expressed in a letter to Isaac McPherson (Aug., 1813), a portion of which we set out in the margin. [Footnote 2] He rejected a natural rights theory in intellectual property rights and clearly recognized the social and economic rationale of the patent system. The patent monopoly was not designed to secure to the inventor his natural right in his discoveries. Rather, it was a reward, an inducement, to bring forth new knowledge. The grant of an exclusive right to an invention was the creation of society — at odds with the inherent free nature of disclosed ideas — and was not to be freely given. Only inventions and discoveries which furthered human knowledge, and were new and useful, justified the special inducement of a limited private monopoly. Jefferson did not believe in granting patents for small details, obvious improvements, or frivolous devices. His writings evidence his insistence upon a high level of patentability.” 383 US 1, 8-9. (1966).

    What the ACLU proposes to undo is 200+ years of thoughtful patent jurisprudence started by Jefferson. I think not.

  4. Gene,

    Agree with you whole heartedly that the ACLU is in over its head, in this suit, is wasting everyone’s time (including the SDNY), and frankly should incur sanctions under FRCP 11. The Complaint counts based on unconstitutionality, especially under the First and Fourteenth Amendments, don’t meet the “smell test.” We can only hope that whatever judge in the SDNY that gets this case has the courage and willingness to put the ACLU in its place (and out of the IP realm where it has no business).

  5. Gene:
    You are revealing your ignorance of the ACLU when you charge the organization with filing a frivolous lawsuit. They pick their cases very carefully.
    Yvonne Cripps, an Indiana University law professor who specializes in IP law and biotechnology characterizes it as a landmark case. After describing the patents as vultnerable, and explaining how the Canadian government has ignored the patents she said” In my opinion they may ultimately be thought to be relevant to the 14th Amendment’s protection for life and liberty” In short, the kinds of issues that the ACLU raises( with a remarkable batting average) all the time.
    Note also that the American Society for Clinical Pathology has joined with the ACLU in the lawsuit. Because they believe the patents stifle reasearch.

  6. John-

    You are entitled to your opinion certainly, but there is simply no other way to characterize this case than as frivolous. If the ACLU prevails the patent system will fall. If claims can be invalidated under Article I, Section 8, the First Amendment and Fourteenth Amendment then all patent claims will be invalid.

    In terms of patents stifling research, that just doesn’t happen. There is no credible evidence to suggest that. Just because you say it doesn’t make it true. Throwing hands up and saying I can’t research in this area without discussion of the claims is proof of ignorance and laziness.

    Doesn’t the ACLU lies in the complaint bother you at all?

    -Gene

  7. Claim 1 of 5837492 recites: 1. An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2.

    Myriad should be rewarded for finding this gene. But, if a researcher can’t work with this gene in their research, doesn’t that stifle research? I’m not saying that a patent isn’t worth the trade-off for creating the incentive for finding the gene in the first place, but perhaps this policy debate is better had in Congress rather than in the context of a lawsuit.

  8. Mike-

    I agree. This is a debate that should be had in Congress. I am not sure whether any legitimate argument can be made regarding research. This is something I am going to have to dig into a little deeper. I know over the past 5 or so years there has been a developing law relating to experimental use, not related to 102(b) but related to what research is allowable. I think I need to dig into those cases.

    I also think in this and in many other areas we are starting to see why a one-size-fits-all patent system makes little or no sense moving forward. In some areas, like pharma, the research and regulatory hurdles are so great that patent term is not enough. In other areas, particularly with computers and software, 20 years is simply not necessary.

    More to come.

    -Gene

  9. You need to go through the whole patent. One of the claims includes the full sequence of the gene, which is of course the product of millions of years of evolution rather than human ingenuity. The claims for the methods will be intact, but the claims for gene sequences should not be. Even though they claim they have “isolated and purified” these genes, striking out a couple exons doesn’t count as a useful alteration. It’s just a gimick. The PTO has really dropped the ball in allowing claims on non-engineered genes. I hope that at least that part of the lawsuit works, though I am reticent about the 1st Amendment claims.

    It’s not frivolous either, and there will be no rule 11 sanctions.

  10. David-

    You can think I need to read the whole patent, but it is really you who needs to do research on patent law and understand the matter more fully. You even admit in your answer that there is no possibility the ACLU will win, but you probably don’t even realize that you have done that.

    Whether you think it is a “useful alteration” or not is immaterial. The Supreme Court has long held that any change to the natural state evidences human intervention and that human intervention is all that is required in order to have patentable subject matter. Whether you like it or not, the law is exceptionally clear, it has repeatedly been upheld by the Supreme Court and there is absolutely no basis for the ACLU challenge. If they don’t like the patent laws, and they think the Supreme Court is wrong, the solution is to seek legislative reform. Seeking to get a district court judge to legislate from the bench, ignore the patent laws and ignore the clear teachings of the Supreme Court is reckless at best, and is better characterized as frivolous.

    The district court should sanction the ACLU. There is simply no justifiable legal theory under which the ACLU can prevail, and it is intellectually dishonest to suggest that the Constitution provides a basis for declaring patent claims invalid. That is pure nonsense.

    -Gene

  11. - Gene (ironic name given the case)

    We shall see. There will certainly be no sanctions, there’s a good faith basis for the complaint’s claims, and I believe they may win on some of them (just not necessarily the 1st Amendment claims). Identifying something (like the gene sequence) is not an alteration at all, and the bare sequences ought not to be viable claims in the patent (as they are currently).

    There is a law stalled in Congress (of course) which would, if passed, strike these claims down as unpatentable subject matter (Congressmen Xavier Becerra (D-Calif.) and David Weldon (R-Fla.) introduced a bill (H.R.977) ) It’s a shame that the people at the PTO can’t see the fact of this themselves. The purposes of the Patent Act must satisfy Article 1, Section 8 of the Constitution, which are to “Promote the Progress of Science and the Useful Arts.” Part of the claim in the lawsuit is that when, as Myriad has done, scientists are stifled from doing basic research (which the folks at Yale have been) then that Constitutional mandate is being thwarted, and the Patent Act is being applied contrary to its Constitutional purposes. Seems like a cognizable claim to me, which makes it non-frivolous.

    It’ll be interesting to watch this case unfold.

    best,
    -David

  12. David-

    I am not one to throw around the word “frivolous” because everyone knows that Rule 11 has no teeth. District courts simply do not issue sanctions. What makes this case very different is that the ACLU has lied in the complaint. They are characterizing the patents as covering genes, which the clear majority of the claims they are challenging do no such thing. That is not a stretch, it is an outright lie.

    Your understanding of Article I, Section 8 is also flawed, although a popular misconception by many. This clause gives Congress the power to allow for the issuance of patents. The purpose is to advance science, no doubt. So as long as Congress sets up a process that will promote progress that is all that could be required. It is undeniable that the patent laws do promote progress. Each patent does not need to promote progress, and in fact does not. They system and protection regime is the focus of this clause, and the clause cannot be used to judge any particular patent.

    Likewise, the First Amendment arguments are ridiculous as well. The First Amendment would have to be viewed as amending Article I, Section 8 in order for the ACLU to be correct, which obviously is absurd. The same people who created the Bill of Rights agreed to the Constitution, and never thought that to be the case.

    If the ACLU wins there will be no patent system because if patent laws violate the First Amendment with respect to genes then they would violate the First Amendment with respect to everything. If patent laws are viewed as a law the infringes upon free speech that ends proprietary protections for all inventions. Talk about being irresponsible. It is not enough for the ACLU to want to destroy our national security, they want to destroy our economy as well.

    -Gene

  13. Gene,

    You’re engaging in a bit of hyperbole as well. Patent claims are severable, and only those covering the genes themselves are likely to be struck down. So, in fact, the majority of Myriad’s claims will remain intact, since as you point out, most of the claims are on inventive and unique methods.

    Patents won’t collapse as an institution, just those on unaltered laws of nature, or its unaltered products. Since Parker v. Flook and Gottschalk v. Benson, the law on this has been clear.

    relax! The world as we know it won’t end.

    -d

  14. David-

    Can you please point to my hyperbole?

    It seems you agree with me in the end. None of Myriads claims will be invalidated because none of them cover “unaltered laws of nature, or its unaltered products.” All of the claims are either methods or require isolation or alteration. This is exactly why the ACLU should be and will be sanctioned. They are making allegations that simply are not supported by the facts they allege. A motion to dismiss should be granted, and if I were the judge sanctions would be issued. At the very least attorneys fees for Myriad should be awarded.

    -Gene

  15. Gene,

    I disagree. Among the claims is the sequence itself, just as with thousands of existing gene patents. Those are the claims that should be struck down

    Your hyperboles are many and diverse, so far. For instance, I am certain the ACLU doesn’t want to destroy our national security. Nor do they wish to destroy our economy. They (like many outspoken scientists) want to invalidate patent claims that never should have been granted in the first place, to unaltered elements of nature. Nor is this a sanctionable complaint, it doesn’t meet the standard. It states a cognizable claim, as I have pointed out. These are but a few of your alarmist hyperboles.

    I believe in free markets rather than monopolies supported by governments. Let’s keep the basic science in the public domain, and let any and all who find new and innovative ways to use that knowledge to create new and useful products do so, bring them to market, and see which thrives.

    Some people like government to interfere with markets, not me.

    best,
    David

  16. David-

    We are going to have to agree to disagree here, although I have really enjoyed the jousting with you (I hope you have as well).

    I agree we need to keep basic science in the public domain, so our disagreement is not philosophical, just based in different views of the facts. I will say that one thing that does set me off are scientists who opine about what patents do to their research when what they say is not accurate. They are no doubt great scientists, but these folks sway opinions and they frequently pontificate as if they understand patent laws when in fact they do not. A lot of times they allow themselves to be blocked without valid reason. If they want to be honest and say they fear being sued because of the enormous potential liability that is one thing. Perception is important, deterring behavior is a real consideration. Saying that patents harm innovation is a terrible overstatement and without historical precedent. Patents force inventors to invent around. They are intended to be an impediment and cause creative alternative solutions and advances. So the patent system as a whole does not block innovation, it operates to specifically and directly encourage it. Of course, you have to innovate yourself and not copy others, which is what many (not all) want to do.

    In terms of national security, I am admittedly weaving in my disapproval with the ACLU wanting pictures taken in criminal investigations to be divulged through FOIA. The pictures are inflammatory and unnecessary, and would only do damage, as Bush, Obama and all top military officials now agree. An accounting of what was uncovered and description of the actions taken to punish those at fault are enough. No need to give our enemies propaganda to encourage more jihad.

    Cheers.

    -Gene

  17. Gene,

    I have enjoyed it, and on philosophical points we tend to agree. On the specifics, we’ll just have to see what happens in this case.

    Thanks for a good discussion, and best to you and yours.

    -dk

  18. The ACLU joins in on a lawsuit when there are constitutional questions involved. Certainly, since patents are mandated in the US Constitution, it is not “frivolous” to have the legal system determine if certain types of patents were issued in violation of the intent of the founders. In this case, as a result of the PTO granting patents on two NATURALLY MUTATED GENES that cause breast cancer in women to Myriad Genetics, Myriad’s lab is the only place in the country where diagnostic testing can be performed. Because only Myriad can work with “their” gene mutations, others are prevented from testing these genes or developing alternative tests or cancer treatments. Cancer researchers cannot develop treatments without paying a license fee to Myriad simply to study this naturally occuring muted gene! The lawsuit was filed on behalf of four scientific organizations representing more than 150,000 geneticists, pathologists, and laboratory professionals, as well as individual researchers, breast cancer and women’s health groups and genetic counselors.

    Frank Provasek

    Board Member, ACLU of Fort Worth

  19. Frank-

    You and the ACLU will find out soon enough exactly why your lawsuit is frivolous. The complaint is full of inaccuracies, and there is simply no justifiable basis for your claims. You are attacking a patent with an enabling clause giving Congress the right to issue patents. In this case the patent was issued and Article I, Section 8 provides no legal basis to challenge the validity of a claim. I am also troubled by the fact that the ACLU did not read the patents before filing the lawsuit. If you did you certainly would have realized that your claim that a gene has been patented is completely erroneous. The ACLU is simply using this in an effort to confuse the public and turn sentiment against the patent system with claims that are objectively baseless and false. To me, that is the definition of frivolous.

    Be prepared to open your wallet on this one. The ACLU is going to be sanctioned.

    -Gene

  20. I agree with you Gene, that the ACLU has tried to use buzzwords and shocking statements to get the public sentiment on their side. After all, how can anyone “patent” something so fundamental as your genes? Claim 1 that I posted above, I believe, without judicial interpretation otherwise, preclude research with the gene until the term of the patent is over. Has your research produced any statutory exceptions? I’ve never heard of any for this.

    Perhaps we would not have the sequence for this gene had there not been a patent incentive in the first place? Perhaps not this quickly at least.

    You’re right Gene, as lawyer myself, I do not see any basis for the lawsuit in the US constitution. I think you put it well, above, by saying congress has a right to promote science, and it has done so. And if you say that a patent on a product violates a person’s free speech, then they all do. Absurd. I find it ironic that the ACLU, who’s usually a champion for the little guys, would want to weaken a system designed to protect them. A weakened patent system, means that companies with the biggest market share will rule.

  21. Mike-

    I couldn’t agree with you more! Bravo and well said! I know of no statutory exceptions, and without patents there would be no research and development, so there would be no arguing whether patients are entitled to so-called second opinions. What they really want is for someone else to do the test, which is not a second opinion. But without the patent right we wouldn’t have the test so folks would just not be able to know whether they had the disease or were predisposed, which is so much better, right? Better that no one can have benefit and then everyone have benefit when the invention goes off patent. Absurd!

    -Gene

  22. Hi Gene. You seem to misunderstand what Myriad Genetics has patented. In your article, you mentioned that patented genes are “teased” by the inventors to not resemble the natural counterpart. Myriad Genetics/University of Utah did NOT “tease” BRCA1/2. They simply identified the mutant forms of these genes that are also naturally ocurring. They claim ownership on a natural substance.

    Additionally, patents are supposed to drive innovation, not provide a single company the means to monopolize a genetic test. Myriad charges $3000 for simple sequencing of a gene that costs no more than a few dollars. I know this, because I do this every day in my lab.

    I agree that misinformation can lead to bad decisions. Unfortunately, your article misinforms your readers about what these “gene” patents are really about.

  23. Gary-

    I notice that you didn’t say anything about the 5 patents that claim diagnostic methods, because if you did you and anyone who is intellectually honest would have to completely agree with me that the ACLU lied in the complaint.

    I am afraid we are going to have to agree to disagree regarding what you call mutant forms of genes. The claims clearly identify isolation (which does NOT occur in nature) and other things that require human intervention. The fact that you do not like genetic engineering that requires human action (which again, by the way, does NOT occur in nature) does not mean that I am wrong. What it actually means is that you are wrong.

    Patents do drive innovation, they do not get in the way of innovation.

    As for your admission that you are infringing the Myriad Genetics patent every day in your lab, that was really stupid of you. Substantively, however, you ignore the cost of figuring out the science involved and are focusing only on the costs after millions have been spent and many dead ends pursued. Even assuming it only does cost a few dollars, I suppose Myriad and others should donate the millions, or in some cases billions, and then only charge what it costs after all sunk costs are removed from the equation. That is simply absurd, and I am sure you realize it.

    At least we agree that misinformation is bad. Of course, everything I wrote was 100% true, despite your attempts to challenge my indisputable factual assertions.

    -Gene

  24. Gene,

    I never said that I was sequencing BRCA1/2 in my lab. What I said was I know how much sequencing reactions costs and they are nowhere near the amount Myriad charges for this simple task.

    In claim 1 you underlined “isolated”. Myriad/University of Utah did NOT invent the methodology of isolation of this gene or any other gene. You also underlined the word “altered” and you keep saying this means it’s not naturally ocurring. Maybe this is because you simply don’t understand molecular biology. The word “altered” in this claim means other than wild-type (non-mutant) form of the gene. This is something that occurs naturally. It’s not something Myriad scientists do after they isolate the gene. So your argument is completely flawed.

    For all the claims you underlined “method of detection”. Once again, Myriad/University of Utah did NOT invent the methodology they use to identify the NATURALLY ocurring mutant forms of BRCA1/2.

    Myriad would not be the most hated diagnostic company if they had favorable licensing terms for these genes. Actually any licensing would have been better than the complete monopoly they have over this diagnostic test.

    You may think that everything you write is 100% true, but it’s probably because you don’t have a clear understanding of the science behind all of this. The claims I read in these gene patents are simply ridiculous, and so are your attempts to defend them.

  25. Just to clarify something. I am in no way against patenting inventions. I’m a scientist myself and would love nothing more than to have a dozen patents for some of the hard work that I’ve done for the past 20 years. I just don’t agree with granting patents on genes or the methods of identifying mutations UNLESS the invention is the methodology. Again and again, I will say that Myriad’s methodology or even isolation of the genes is NOT unique or and invention of Myriad.

  26. Gary-

    I personally think you don’t understand patent law. If you want to talk micro biology that is fine, but if you refuse to acknowledge that all that is required for patentability is alteration then there is not much to talk about. I think you would do very well to brush up on patent law before you make broad statements and jump to conclusions that my arguments are flawed.

    What kind of arrogance does it take to believe that you know patent law because you are a scientist and then chastise me. If you choose to believe I am wrong, fine. Everyone is allowed to live with their own ignorance if that is what they prefer.

    -Gene

  27. Gary-

    Whether you agree with it or not isn’t the issue. The fact that you don’t approve doesn’t mean that others who do approve and do understand the patent laws shouldn’t receive patents.

    -Gene

  28. I agree, if there is alteration then it’s patentable. Now tell me which claim states that Myriad alters the BRCA1 gene.

    Your statement above: “Also… SOMETHING IN ALTERED STATE DOES NOT OCCUR NATURALLY!”

    The alteration they state in their claims ARE NATURALLY OCURRING. They are not something Myriad does to the DNA. – Again, your argument that there is any kind of alteration produced by Myriad is flawed.

  29. The Myth that Patents are a Monopoly

    A patent gives the holder the right to exclude others from making, using or selling their invention. 35 USC 154. It does not give the holder the right to make, use or sell their invention. A monopoly is an exclusive right to a market, such as an electric utility company. An electric utility company has the exclusive right to sell electricity in a certain territory. Since a patent does not even given the holder the right to sell their invention, let alone an exclusive right to a market, it is clearly not a monopoly.

    When a person describes a patent as a monopoly to be consistent they should also state that they have a monopoly over their car or over their house. In fact, they have more rights in their car and house than a patent gives the inventor over their invention, since you have a right to use and sell your car or house. A patent does not give these rights to an inventor over his invention. All invention are built upon existing elements (conservation of matter) and if the elements that the invention uses are patented, then the inventor will not have the right to sell their invention without a license.

    Some economists argue that a patent is designed to give the holder monopoly power. Those economists who are consistent also state that all property rights give some monopoly power. The property rights are monopolies thesis shows how confused economic thought is on this subject. The only logically consistent definition of a monopoly is an exclusive right to a market.

    People who suggest a patent is a monopoly are not being intellectually honest and perpetuating a myth to advance a political agenda.

    For more information on patents and innovation see http://www.hallingblog.com.

  30. Looks like you were pretty WRONG!

  31. Anon-

    Why would you say that I was wrong? You do realize that there is complete unanimity in the field that the Federal Circuit will reverse Judge Sweet. His decision is intellectually dishonest, wrong on the law, wrong on the facts and shows a complete bias toward scientific advancement and lack of respect for precedent.

    Other than that he was spot on though.

    Please do try and educate yourself.

    -Gene

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