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Today's Oral Argument in the Myriad Genetics case
Monday, April 04 2011 @ 06:55 PM EDT

Here's the MP3 [some are having trouble with that url, so try this one] of today's oral argument in the appeal before the Court of Appeals for the Federal Circuit of Association for Molecular Pathology et al v. USPTO , Appeal No. 2010-1406. This is the case about whether human genes should be patentable, specifically genes for identifying the risk of breast and ovarian cancer. Arguing against such patents were the Obama Administration (thank you!), ACLU, and PubPat, defending the decision at the lower court in the Southern District of New York that such patents should not have issued, DNA being part of nature.

Here's the ACLU's press release today:
ACLU, PUBPAT And U.S. Solicitor General In Federal Appeals Court Today Challenging Patents On Human Genes Linked To Breast Cancer

Groups Urge Court To Uphold Ruling That Patents On Genes Are Illegal

The American Civil Liberties Union, Public Patent Foundation (PUBPAT) and U.S. Solicitor General Neal Katyal were in the U.S. Court of Appeals for the Federal Circuit in Washington, D.C. today urging the court to uphold a lower court ruling that patents on two human genes are illegal.

"The human gene is a product of nature and no more patentable than a human kidney,” said Chris Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project who argued on behalf of the plaintiffs today. “The district court ruling striking down patents on human genes was a victory for the free flow of ideas and information, and could lead to important medical and scientific advances. The appeals court should uphold that ruling.”

The ACLU and PUBPAT brought a lawsuit in May 2009 against the U.S. Patent and Trademark Office (USPTO), Myriad Genetics and the University of Utah Research Foundation, which hold the patents on two human genes related to hereditary breast and ovarian cancer, BRCA1 and BRCA2. The lawsuit charges that the patents restrict both scientific research and patients' access to medical care, and that patents on human genes are illegal because genes are "products of nature." The groups brought the case on behalf of breast cancer and women's health groups, individual women, geneticists and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals.

In March 2010, a New York federal court ruled in favor of the plaintiffs, holding that the patents are illegal. Myriad and the University of Utah have appealed that ruling. The court granted the USPTO’s request that it be released as a defendant in the lawsuit.

The U.S. government later filed a friend-of-the-court brief agreeing with the groups that isolated DNA is not patentable, and presented arguments today in court. Several major organizations, including the American Medical Association, the March of Dimes, AARP and the American Society for Human Genetics, filed friend-of-the-court briefs in support of the lawsuit.

"Since the beginning, this case wasn't about patent law, it was about the right of women to know what genetic mutations they might have in their own bodies and the right of physicians to help them in doing so," said Dan Ravicher, PUBPAT's Executive Director and Lecturer in Law at Benjamin N. Cardozo School of Law. "Today we asked the Court of Appeals to apply patent law's longstanding prohibition on the patenting of nature to protect these rights from patents that the government now agrees should have never been issued in the first place."

Attorneys on the case include Hansen and Aden Fine of the ACLU Speech, Privacy and Technology Project; Sandra Park and Lenora Lapidus of the ACLU Women's Rights Project; and Ravicher and Sabrina Hassan of PUBPAT.

More information about the case is available online at www.aclu.org/brca


  


Today's Oral Argument in the Myriad Genetics case | 131 comments | Create New Account
Comments belong to whoever posts them. Please notify us of inappropriate comments.
After all this time I am shocked!
Authored by: cricketjeff on Monday, April 04 2011 @ 07:07 PM EDT
Sanity in a court about patents in the US!

Where did that come from< but it is wonderful to see!

---
There is nothing in life that doesn't look better after a good cup of tea.

[ Reply to This | # ]

    Corrections Here
    Authored by: YurtGuppy on Monday, April 04 2011 @ 07:23 PM EDT



    ---
    every guppy is a half-full kind of guy

    [ Reply to This | # ]

    [OT] Off Topic
    Authored by: YurtGuppy on Monday, April 04 2011 @ 07:25 PM EDT



    ---
    every guppy is a half-full kind of guy

    [ Reply to This | # ]

    [NP] News Picks
    Authored by: YurtGuppy on Monday, April 04 2011 @ 07:26 PM EDT



    ---
    every guppy is a half-full kind of guy

    [ Reply to This | # ]

    since it's illegal to implement or use a patented technology..
    Authored by: Anonymous on Monday, April 04 2011 @ 07:40 PM EDT
    what happens to people who carry a patented gene?

    what happens when they implement a copy of the patented gene (i.e. have
    children)

    [ Reply to This | # ]

    Thanks PJ
    Authored by: soronlin on Monday, April 04 2011 @ 10:24 PM EDT
    That was absolutely fascinating.

    [ Reply to This | # ]

    Just sad
    Authored by: Crocodile_Dundee on Monday, April 04 2011 @ 10:59 PM EDT
    I work for a company that is involved in this field (very closely, but not in a
    way that is conflicting with either side here)

    It is really sad that we have Judges asking scientific questions, and lawyers
    answering them.

    Not so bad (I guess) when the lawyers are fully briefed, but when the Judges ask
    hypothetical questions...

    Much of the arguments seem to end up revolving around whether PCR should be
    patentable, since this is the process used. What they *think* they're arguing
    about is whether the *product* can be patented. And none of them really know
    enough to properly draw the distinction.

    Note that PCR (Polymerase Chain Reaction) is NOT a technique discovered by any
    of these people (nor are the use of primers or probes). At best, I would say
    that primers and probes should be copyrightable, but not patentable -- but
    that's a non-lawyer trying to sound legal.

    The argument about taking out a kidney is good, except that in this process you
    would end up with 1000 tonnes of duplicate kidneys

    ---
    ---
    That's not a law suit. *THIS* is a law suit!

    [ Reply to This | # ]

    A primer on the process involved.
    Authored by: Crocodile_Dundee on Tuesday, April 05 2011 @ 12:26 AM EDT
    It strikes me that for many people here, some description of the processes involved in the extraction of BRCA1, highlighting where those procedures were developed (and potentially first patented) may be useful.

    The process is basically as follows:

    1) extract some material containing DNA. This may be saliva, blood, cells from the skin, or a sample from a biopsy (or any of a myriad of other sources)

    2) Isolate the cells containing the DNA. This varies depending on the sample type. For blood, you spin it and take off the layer (called the "buffy coat") containing lymphocytes.

    3) Release the DNA. In this process the cells are lysed, a process which destroys membranes and causes the contents of the cell to spew forth. The main cell wall, and the wall of the nucleus are the main targets here.

    4) Purificaton of DNA. The DNA is purified and separated from all the other stuff we don't want.

    5) PCR amplification. The DNA, a pair of primers (small pieces of DNA that bracket the area you're interested in), polymerase (an enzyme that replicates DNA) and nucleotides (the individual "letters" making up a DNA sequence ae combined with some other things that are not particularly important here, and a series of repeated heating and cooling is applied which causes the string of DNA between the primers to be replicated over and over again.

    6) Purification. The amplified sequences are separated from the rest of the DNA, polymerase, nucleotides, etc.

    7) Sequencing reaction. The DNA is mixed with another primer, nucleotides, and special terminators. and more polymerase. A similar sequencing reaction occurs as above, but when a terminator gets added to a sequence it can no longer be extended. This happens randomly, generating fragments starting at the "beginning" of the sequence and of every length up to and including the full length of the original fragments.

    8) More purification (all we want are the terminated fragments)

    9) measuring the length of the sequences. A sequencer essentially measures the length of these fragments and identifies the terminator on the end. Thus I can determine that a length of 10 ends with a C, of 11 ends with a G, of 12 ends with a T, and so on, giving me the sequence CGT...

    This is an overly simplistic description, but it will put a few things into sharp focus.

    a) PCR (step 5) was first described in 1968, but was made into a practical method in 1884.

    b) Sangar sequencing (steps 7 to 9) was developed in 1974. Whilst his method is no longer used, similar methods are typically referred to generically as "Sanger sequencing".

    c) the steps 1 through 4 have been known for a long time, I won't even try to find references for who discovered them. The various "purification" steps used in the process are very similar in nature.

    d) An important discovery were high temperature polymerases (found in extremophiles living in near-boiling water) This leads to polymerase often being called "taq", an abbreviation of Thermus Aquaticus, the bacteria from which this polymerase was extracted.

    So what part of this process has Myriad discovered?

    The answer is none. They have identified a small part of the genome that they are interested in, and developed a pair of primers (probably more than just a pair) that bound it. They then claim that anyone using the above process (or one similar to it) and using their primers is infringing on their patent. In fact, they don't even care if you use this process -- just ending up with the same result is enough.

    Just to be clear... The result from this process is a small piece of DNA clipped from the genome. In the case of cDNA it's just more than one piece where they are *EXPRESSED* as if they were connected together (but they're not actually connected -- they're separate pieces).

    More clarification... DNA is a bit like computer code with labels an goto's. Typically the labels mark the start and end of the "program" (the gene) and the goto's only jump forward. The pieces through which you would execute are called the EXONS and they get converted to peptides. The pieces that are jumped over are called INTRONS and at this level we can consider them to be like lines of dead code that is never executed. Genomic DNA (gDNA) is what you get when you list the entire program (including all the dead code). cDNA is what you get if you follow the program counter and note down only the lines that are executed.

    Now, to be sure, finding the piece of DNA and determining it's function was non-trivial. Perhaps even the design of the primers was non-trivial. But the end process? It's the bread and butter of sequencing labs all around the world. Almost anyone in those labs could now extract that gene. Once you know where it is, it requires no more than the skills of someone with average knowledge in the field to define the primer, and an even less skilled person to extract it.

    I am not even skilled enough to do PCR, but I have written software to suggest possible binding sites (and hence primer sequences) to extract regions of DNA from larger genomic sequences (human genome project anyone?).

    So why do they want to patent the result and not simply copyright the primers? The answer is that primers are not as critical as you might think. You can change a base here and there, you can lengthen or shorten them, you can move them a bit, and they will still continue to do their work. In addition, you can't make their location secret.

    ---
    ---
    That's not a law suit. *THIS* is a law suit!

    [ Reply to This | # ]

    Intellectual Property: Your Intellect is my Property
    Authored by: Winter on Tuesday, April 05 2011 @ 03:47 AM EDT
    We see now that not only is your intellect my property, but your body and mind
    are mine too.



    ---
    Some say the sun rises in the east, some say it rises in the west; the truth
    lies probably somewhere in between.

    [ Reply to This | # ]

    Both parties agree on the impact
    Authored by: jpvlsmv on Tuesday, April 05 2011 @ 08:06 AM EDT
    I heard about this case last night, and the first thing I thought of was how the
    exact same arguments were being offered on both sides as to what the impact of
    these sorts of patents are-

    The court's decision (either way) will stifle innovation in the biomedical
    field.

    With patents, there is an incentive to do the advanced research that results in
    innovations like this. Researchers have a patent-enforced time window where
    their "invention" can be profitable and make up for the very expensive
    process of creating it for the first time. But future research and
    "inventions" must be careful not to infringe the patent.

    Without patents, the free flow of information from this research to subsequent
    research will allow future scientists to come up with innovations that go beyond
    the original "invention". (Note that this is also the case when the
    patent expires) But there's nothing to stop someone else from taking the
    original research and "commoditizing" it, making it cheaper to
    implement without the up-front work that was so difficult/expensive in the first
    place.

    Honestly, I think that both of these positions have merit. But in the case of
    fundamental medical research, where we are talking about patients' lives, I
    would say the balance of harm weighs against patents. If a medical diagnosis
    can be had for $100, but for a $300 patent license, society benefits from that
    savings in health care cost.

    --Joe

    [ Reply to This | # ]

    USA Taxpayers Pay For The Vast Majority Of Scientific Research
    Authored by: Anonymous on Tuesday, April 05 2011 @ 02:34 PM EDT

    The National Institutes of Health(NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency. USA taxpayers funds the vast majority of scientific research through the NIH!

    The university and commercial enterprise gets a free $300,000 per year for each and every research project. $150,000 goes directly to lead university researcher as salary or goes to enterprise. The other $150,000 goes for equipment and staffing.

    In the case of universities the $150,000 goes to equipment and to pay minimum wage to Teaching Assistants (TAs) who do the research grunt work, as well teaching, marking profs exams and assignments, and making coffee for the prof.!

    So the university and the prof. that have profited several times over; further profits by selling a license for the "discovery", or selling it outright, or by going into partnerships with commercial enterprises!

    Since the public pays for the research; shouldn't the public own the "discovery"? In the same fashion, that if a scientist works for a private commercial outfit (that totally funds itself), and a discovery is made; the company owns the discovery (not the scientist who is on salary.

    [ Reply to This | # ]

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