State of Innovation

Patents and Innovation Economics

ACLU – Gene Patent Non-Sense

In the ACLU v. Myriad case, the ACLU has alleged that the patents involved in the case cover genes found in nature.  This statement is so patently (pun intended) false, that the ACLU either purposely deceived the court or is guilty of gross negligence about the facts plead in the case.  As Gene points out in his post, Fired up: Challenging the Constitutionality of the Patent Act  none of the claims in question cover genes found in nature.  These claims are directed to screening, identifying, and isolating the BRCA1/2 genetic sequences.  This is not a claim to the gene itself, but methods of screening, indentifying and isolating the genes, which are processes not found in nature. There are claims to an isolated gene, but genes are not isolated from human cells in nature.  These claims are similar to claims on vitamin B12.  More than 80 years ago, prior to the isolation and purification of vitamin B12, the only “treatment” for megaloblastic anemia was for patients to consume a pound of raw liver a day.  Since isolated and purified vitamin B12 is not found in nature, a patent issued for isolated B12.  The ACLU purposely deceived the court when they stated, “The patents cover the human genes themselves”, paragraphs 3-4, 55-67, & 102 of the complaint, while ignoring that isolated genes do not occur in nature. 

The ACLU used this purposeful deceit to argue that the Myriad patents violate the First Amendment of the Constitution.  The court’s ruling that the ACLU’s complaint provides sufficient facts to support the allegation that the Myriad patents violate the First Amendment do not stand up to even the most cursory statutory analysis.  The First Amendment states”

Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.

The highlighted portions are the parts of the First Amendment in contention in this case.  The ACLU plead that the patenting of human genes violates the First Amendment of the Constitution.  Even if you believe ACLU’s pleading that the claims of the patents cover human genes, this is insufficient to support a claim that the patents violate the First Amendment.  In order for the ACLU’s pleading to support a First Amendment claim, they must plead that Congress  passed a law abridging freedom of speech or the press.  They cannot argue that the Patent Office (PTO) has passed a law (regulation) that violates the 1st Amendment, since the PTO does not have substantive rule making authority.    Unless the ACLU is claiming that patent law violates the First Amendment, this claim is frivolous.  An individual patent cannot violate the First Amendment, since it is not a law made by Congress.

Even if the ACLU had plead that Congress passed a law abridging speech or the press, such a pleading would not be plausible on its face.  The rights provided with a patent are defined in 35 USC 154 (a)(1), which states:

Every patent shall contain a short title of the invention and a grant to the patentee, his heirs or assigns, of the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States, and, if the invention is a process, of the right to exclude others from using, offering for sale or selling throughout the United States, or importing into the United States, products made by that process, referring to the specification for the particulars thereof.

The key portions of the statute are highlighted.  The right to exclude others from making, using, offering for sale, selling or importing an invention, has nothing to do with speech or the press.  It is clear that Congress did not pass a law abridging the freedom of speech or the press by the enactment of the patent statute.

The ACLU also alleges that the Myriad patents violate the 14th Amendment to the Constitution, which reads:

Section 1.
All persons born or naturalized in the United States, and subject to the jurisdiction thereof, are citizens of the United States and of the State wherein they reside. No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; nor shall any State deprive any person of life, liberty, or property, without due process of law; nor deny to any person within its jurisdiction the equal protection of the laws.

Section 2.
Representatives shall be apportioned among the several States according to their respective numbers, counting the whole number of persons in each State, excluding Indians not taxed. But when the right to vote at any election for the choice of electors for President and Vice-President of the United States, Representatives in Congress, the Executive and Judicial officers of a State, or the members of the Legislature thereof, is denied to any of the male inhabitants of such State, being twenty-one years of age,* and citizens of the United States, or in any way abridged, except for participation in rebellion, or other crime, the basis of representation therein shall be reduced in the proportion which the number of such male citizens shall bear to the whole number of male citizens twenty-one years of age in such State.

Section 3.
No person shall be a Senator or Representative in Congress, or elector of President and Vice-President, or hold any office, civil or military, under the United States, or under any State, who, having previously taken an oath, as a member of Congress, or as an officer of the United States, or as a member of any State legislature, or as an executive or judicial officer of any State, to support the Constitution of the United States, shall have engaged in insurrection or rebellion against the same, or given aid or comfort to the enemies thereof. But Congress may by a vote of two-thirds of each House, remove such disability.

Section 4.
The validity of the public debt of the United States, authorized by law, including debts incurred for payment of pensions and bounties for services in suppressing insurrection or rebellion, shall not be questioned. But neither the United States nor any State shall assume or pay any debt or obligation incurred in aid of insurrection or rebellion against the United States, or any claim for the loss or emancipation of any slave; but all such debts, obligations and claims shall be held illegal and void.

Section 5.
The Congress shall have the power to enforce, by appropriate legislation, the provisions of this article.

I assumed that the highlighted portions are the parts of the 14th Amendment the ACLU alleges were violated by the Myriad patents.  No other sections of the Amendment appear to be even remotely related to this case.  The ACLU’s complaint does not specifically allege nor plead facts sufficient to show that a State made or enforced a law that abridges the privileges or immunities of citizens of the United States or deprived any person of life, liberty, or property, without due process of law or denied equal protection to anyone.  Since the actions of one of the States are not involved in this case, it would be impossible for the complaint to plead a cause of action under this clause of the 14th Amendment.  Patent law is federal, it is evident on its face that the 14th Amendment cause of action fails.  The fact that the court did not even explore this issue, shows a complete lack of objectivity.

The ACLU should be hit with rule 11 sanctions for bringing this obviously frivolous lawsuit.  They either purposely lied about the contents of the claims in the Myriad patents or were grossly negligent with regard to the facts in this case.  Their pleading is not sufficient to state a First Amendment case, since they did not plead that Congress passed a law abridging speech.  Even if they had a sufficient pleading, it is a matter of basic statutory analysis to show that rights conferred with a patent do not abridge speech or the press.  The 14th Amendment cause of action also fails, since the only portions that can possibly be relevant to the present case deal with actions of the States.  Patent law is federal law not State law.  The obvious errors by the court calls into question its objectivity in this case.

November 30, 2009 - Posted by | -Law, -Philosophy, Patents | , , , , , ,

7 Comments »

  1. Dale,
    I am certainly no fan of the ACLU but I am still puzzled by this whole thing. And it sounds that they way they are attacking the BRCA1 patent is absured (based on free speech?). I am not saying that it is right or wrong but currently Myriad is the only laboratory in the country that can perform genetic testing for germline BRCA1 mutations with the exception of a few labs that have they have given a license to. One of the concerns of the molecular diagnostic community has been that it has been shown by research labs that Myriad has sometimes missed BRCA1 mutations that were detected by other methodologies that Myriad does not use. These false negative test results by Myriad certainly have negative consequences for patients. So, I think there is a sincere concern about quality. But I also think there is a bit of a sour grapes attititude too because labs want to simply be able to perform this testing for economic reasons. Myriad Genetics certainly invested a lot in the discovery of the gene but a fair amount of money came for taxpayer funded NIH dollars too. I certainly am in favor of Myriad retaining their patent on this but I wonder what you think about moving from exclusive licensing to non-exclusive licensing as relates to gene patents. I am sure I am showing my ignorance about patent law but thought I would bring these questions up. Kevin

    Comment by khalling | December 6, 2009 | Reply

  2. Hey Dale,

    If I were you I would stick to patent law and leave the Constitutional issues to the lawyers who work in that area. The Fourteenth Amendment was included in order to reach the directors of the University of Utah Research Foundation (UURF) who are considered state actors for the purposes of personal jurisdiction (International Shoe and all that 1L fun). You can check it out on page 72 of Judge Sweet’s decision ( http://www.aclu.org/files/assets/MTD_decision.pdf ).

    Also, your First Amendment argument (“Their pleading is not sufficient to state a First Amendment case, since they did not plead that Congress passed a law abridging speech.”) is terribly misguided. Congress does not always have to pass a law in order for a government action to violate the First Amendment. All it takes is an act by a government agent stifling protected speech in order for a plaintiff to allege a violation. For example, when a school prevented a student from wearing a black armband to protest the Vietnam war it was a violation of the First Amendment. This was not because Congress passed a law but, instead, because a government actor (the principal) stifled protected speech. So, in this case, the government actor is the USPTO (and the directors) who are stifling speech by granting the patent. Again, that’s 1L stuff, Dale. You can argue all you want with the merits of the argument but their complaint is solid (see Judge Sweet’s decision if you don’t buy my dribble).

    In the future it might be a good idea to check into this kind of stuff before going on a rant. Just saying.

    Ben

    Comment by Ben | December 21, 2009 | Reply

    • Ben,

      1st Amendment
      Even if you expand the 1st amendment to all government actions, it does not prove your or the ACLU’s point. The only rights provided under a patent do not deal with speech or the press. The ACLU’s case is clearly nonsense.

      14th Amendment,
      The University of Utah argument while cleaver is clearly nonsense also. The only relevant portion of the 14th amendment is:

      No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; nor shall any State deprive any person of life, liberty, or property, without due process of law; nor deny to any person within its jurisdiction the equal protection of the laws.

      The state of Utah did not make or enforce the patent laws, at most it sought protection under federal laws. The State of Utah did not deprive any person due process. The ACLU’s 14th amendment argument is clearly nonsense.

      Constitution
      I know that it is unpopular to actually read the text of the Constitution and interpret what it actually says now days. However, the Supreme Court does not have the right to ignore the clear meaning of the Constitution. Perhaps we would get less nonsense out of the Supreme Court if they actually interpreted the Constitution instead of just making it up as they go along. For instance, the Supremes have made a mockery of the 4th and 5th amendments in order to support our drug war, protect of us from terrorists, and to justify a redistributionist tax scheme.

      This by the way is first year logic, something that is often missing in constitutional law arguments.

      Comment by dbhalling | December 22, 2009 | Reply

      • Dale,

        1st Amendment:

        I never said that the First Amendment argument was a winner. In fact, as it relates to the gene patents, its downright dumb. All I was saying is that you misinterpreted what pleadings are necessary to bring an action based on a First Amendment claim.

        14th Amendment:

        This is the same issue you incorrectly raised with regard to the First Amendment. When the Fourteenth Amendment states that “No state shall…” it doesn’t address only the passage of laws by the legislature, but also the actions of state agents. The Directors of the UURF are state agents, and thus, their actions are regulated by the Fourteenth Amendment. Again, I’m not saying that the ACLU’s arguments are meritorious, just that they are solid with respect to the pleadings.

        Constitution:

        I agree that the Supreme Court has consistently used the Constitution as a way to get what they want (see Bush v. Gore) without regard to what the text says, but in this instance, the court is spot on.

        Ben

        Comment by Ben | December 23, 2009

  3. Ben,

    If you agree that the 1st Amendment argument is clearly “just dumb” then it should have been thrown out on summary judgment. As to the congress versus other government actors, that was never the main point of my argument. Nor is it a point that I was unaware of, however I could have made that point more clearly.

    I understand the state actor argument with respect to the 14th amendment – but it is still clearly nonsense. This is not the same argument as the 1st amendment. In the 1st amendment case it is logical extension of people’s rights to suggest that no government entity shall infringe free speech. (However, see the nonsense about commercial speech and the fairness doctrine under the FCC) With respect to the 14th amendment, there is no logical extension to suggest that a state availing itself of federal law should in any way be covered by the 14th amendment. The 14th amendment is a post civil war law, meant to inhibit states from not protecting or actively obstructing a person’s rights in their state. There is just no connection or extension of the words or purpose of the 14th amendment where the 14th amendment applies to this case.

    Comment by dbhalling | December 23, 2009 | Reply

  4. […] is exemplified by Mayo’s involvement in two frivolous patent lawsuits Mayo v. Prometheus and ACLU, Mayo et al. v. Myriad and in their support, though their lobbying organizations, for the America Invents Act (H.R. 1249 […]

    Pingback by Mayo Clinic’s Invention Theft Strategy « State of Innovation | June 25, 2011 | Reply

  5. […] is exemplified by Mayo’s involvement in two frivolous patent lawsuits Mayo v. Prometheus and ACLU, Mayo et al. v. Myriad and in their support, through their lobbying organizations, for the America Invents Act (H.R. 1249 […]

    Pingback by Mayo Clinic’s Invention Theft Strategy | Law Office of Dale B. Halling, LLC - Intellectual Property Law Firm - Patent Attorney - Patents, Trademarks, Copyrights - Blog | June 29, 2011 | Reply


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