I previously wrote a column opposing the claim of Myriad Genetics over patenting human genes in the case of Pathology v. Myriad Genetics, No. 12-398. The Supreme Court appears to have the same concerns. The Court unanimously ruled this afternoon against the Utah company and by extension of the Federal Circuit in claiming such property rights.
At issue is the patent by Myriad Genetics to genes (BRCA1 and BRCA2) that it found correlate with increased risk of hereditary breast and ovarian cancer. This test was recently made famous by Angelina Jolie who had a preventive double mastectomy after taking the Myriad test (which costs more than $3000). The company has been trying to stop other companies from offering the test at a lower cost.
Thomas drew a bright line that “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” Despite the ruling of the Federal Circuit (which has been in a series of sharp disagreement with the Supreme Court over the scope of patents, Thomas saw the question in simple terms: “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.”
Notably, the Court acknowledged that the company “found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the [patent law] inquiry.” There was interest in how the Court would define the applicability of patent law to synthesized DNA, or “complementary DNA,” or cDNA. Yet in a footnote the Court expressly stated that it was not ruling or indicating that even cDNA is specifically entitled to a composition patent.
We have been following the increasingly draconian copyright and trademark laws used against citizens and companies — laws secured by an army of lobbyists, lawyers, and an obedient Congress and White House.
This specific patent issue is different but raises many of overall issues. The Court has been pushing back on the expansion of patent law into areas considered part of the “law of nature.” What is key about this decision is that it is based on 35 U. S. C. §101. This has been in the past treated as a highly generalized provision that does not seriously narrow the scope of patents. It was the later section that has been used to narrow the scope until now. This creates a threshold determination on patents that a wide array of academic and public interest groups have long advocated.
Here is the decision: Myriad Decision
Most definitely not about money and “no skin in the game” with Myriad at all, except in an ideological sense. (I’m a big supporter of the rights of intellectual and creative property, and have been ever since I learned about how Peter Roberts invented the socket wrench and Sears Roebuck made millions and millions of dollars from his invention, which they stole from him for about $10,000.)
However, if I had known that the SCOTUS was about to render a decision on the Myriad case, I might have shorted Myriad’s stock. To me, the decision was predictable and for the reasons I’ve explained already many times, so there was no surprise here, once you know the principle at work. The only surprise was when the decision actually came.
Interestingly, when the SCOTUS was about render its decision on Obamacare, and everyone knew when that decision was coming, I had been asked on my views on what the impact would be on healthcare stocks, especially given that several of the leading healthcare insurers helped to WRITE Obamacare. I had predicated that despite the so-called “conservative” wing of the SCOTUS, they would find a way to give Obamacare the thumbs-up. I would not have guessed that Roberts would have been the necessary “turncoat” for that decision, nor that a “tax” scheme would be used to alibi its passage, but, as I’ve said many times, I KNOW the principle that the SCOTUS operates under, and the SCOTUS’ decisions–particularly on business matters–are relatively easy to predict when you follow that principle. But even though I knew that the SCOTUS would approve Obamacare and that the healthcare insurers helped to write the plan, the initial knee-jerk reaction would be that the plan would be harmful to the insurers.. So I advised those investors to stay clear from healthcare stocks until after the stocks dropped–but then to buy in when the dust settled at the discount price. Healthcare stocks have since done very, very well because THEY are among the biggest beneficiaries of Obamacare.
Bron,
And I stipulated as much earlier. However, if genes are not patentable (and I agree that – unless they are artificially constructed – they are not), then Myriad’s attempt to do so simply because they isolated a set of naturally occurring genes fails on its face.
Gene H:
I dont think it is about money for Ralph. Adam Mossoff, whom I respect, says no one thinks genes can be patented. But the process which Myriad developed should be patentable.
Bron,
The lady doth protest too much, methinks, to have sold short. 😉
Ralph:
I hope you sold short. 🙂
So how much money did you lose on your Myriad stock, Ralph?
http://www.marketwatch.com/investing/stock/MYGN
Please don’t try to justify the SCOTUS ruling. Those who do sound so foolish after having read some of the views of real scientists and patent lawyers who truly understand Myriad’s invention.
Rather, just say, “It was a good decision. . . . a mighty good decision . . . a REAL good decision.” Be sure to repeat this often on the telephone and on your emails, and also take the time to commend the US Government on its wiretapping too. This will help you build up a good record on your file. “It’s a good thing they done, a REAL god thing.”
So keep drinking the Cool Aid. After all, you don’t want to get whisked out into the cornfield, now, do you?
P.S. by “new thing” I mean a legal standing somewhere between a copyright and the exclusivity of a patent; something that does not prevent other people from relying on the research but does, for some number of years, demand a royalty of some percentage of revenue derived from the research.
lottakatz: There is no ‘clean’ DNA, it does not have to be ‘filtered’ to leave a ‘clean expression.’ DNA is essentially digital information, base 4 (allowable numerals are 0,1,2,3 corresponding to nucleotides A, T, C, G in some order, which themselves are molecules of fixed shape without variation).
If you unzip the double-helix of DNA, you end up with two chemical strings, and a segment of one of these strings is a gene that gets processed by a ribosome pretty much digitally, like computer code; literally like a punch-tape being fed into a reader. The ribosome machinery recognizes three-letter sequences (64 of them are possible; since each letter can be any of the four letters, so 4x4x4) which we call “codons” as corresponding to specific amino acids that pervade the cellular fluid. There are 20 amino acids, so in some cases several codons correspond to the same amino acid. One of the 64 codons is almost always used as a signpost to start the Gene, and 3 are almost always used as the sign post to terminate the gene, the are called Start and Stop codons.
The ribosome feeds in the string of codons, and each selects for a particular amino acid, which gets bound to an output chemical string. Basically a translation of digital selections to make a product. The “STOP” codon, when encountered, causes the ribosome to bind a cap on the end of the chemical string and eject it. The string itself will fold up into a protein, the shape of which can attach to receptors on cells, to block functions, initiate functions, moderate functions or themselves to be used as raw material to be harvested and used or consumed by cells.
How the chemical string folds up into a protein depends upon the amino acids it contains. So a “mutation” consists of changing one of the letters in the sequence, from whatever it is to some other letter, any of which is legal. but remember there are 64 codons and only 22 functions (20 amino acids plus start/stop), so if that changed letter means the three-letter codon still selects the same function, then no-harm, no foul. But if it does not, then we do not code exactly the same protein, and therefore not exactly the same shape.
Some substitutions of amino acids will produce nearly the same shape, so the protein can still partially function, but perhaps it binds to cells much more strongly, or much more weakly, and that creates problems analogous to a vitamin deficiency or toxicity. Also, some slightly altered shapes can present binding sites to other proteins, and such bindings can reduce the level of those other proteins in the blood, causing a more indirect deficiency.
If we look at cancer (as I recommend) as a cellular respiration malfunction, then some slightly altered variant like BRCA1 is presumably, by its binding or failure to bind, increasing the odds of such a respiration malfunction in breast cells due to some particular expression of binding sites unique to breast cells.
So IMO all Myriad found is that a variant of the BRCA gene, a slightly altered protein shape that still seems to be functional, in the long run produces a side-effect, induced cell respiration failure, that is not produced by the most common version of BRCA. Because it is a long run effect, it is difficult for natural selection to weed it out, because it does not typically kill its victims before they mate and reproduce.
I’ve gotta run, but I do not believe they invented any new process, once a gene’s digital sequence is known, many standard methods can determine if it is present in a particular person’s DNA.
What they did was select a sub-population of women with breast cancer and compare their DNA to the general population, and found a relative spike in the expression of this gene. Perhaps that detective work deserves some reward to be protected by the government (like a patent) and therefore incentivized, but I do not think patenting the gene is the way to do that; as you point out, that is not in the best interest of the public.
Perhaps some new thing like a royalty payment or something would be appropriate.
Not one of those schmucks on the Court will wear jeans.
My non-legal nor scientific assessment has been this, filtering the dna to leave a clean expression of the gene and then patenting the gene in its clean form was the wrong basis for a claim because the gene was already there. That particular filtering process may be unique and the most efficacious way to filter out the vagrant dna That process is patentable. The clean dna is the first ripple on the water, the filtering process is the pebble that generated the ripple(s). If the filtering process was not already under patent protection that’s where Myriad should have been fighting. Similarly, if the method and technology of testing the clean genes are unique to Myriad’s invention then that is also fair game for a patent.
From my reading on this case the only second opinion a patient could get under the Myriad patent of the gene led back to Myriad. They owned the gene so the labs they licenced to test it were contractually required to use their testing procedures, standards and any attendant Myriad sanctioned equipment. There was no valid second opinion because if any error or lack of ‘sensitivity’ (for lack of a better word) was built into the Myriad process it wouldn’t show up in the second opinion. It was bad science/medicine. They had a monopoly on the money and the science.
Myriad Genetics Not Allowed To Play, “GOD”
Decision! U.S. Supreme Court rules human genes cannot be patented,
And so the ridiculous request of Myriad Genetics shall not be granted,
Whereas the High Court said the company cannot patent human genes,
Now market shares of Myriad fell this thunderous rainy day of June 13.
Can’t fathom any company of humans are attempting to play, “Yahweh,”
They want to decide who can and cannot have the right to testing DNA,
Of who might contract ovarian or breast cancer if you can afford to pay,
Those who cannot find out too late, unable to see another healthy day.
What is with a supposed great country where insurance companies deny?
Life saving testing and or treatments so shareholders profits climb high,
Therefore, causing less fortunate American citizens to hover in despair,
Because all are still not united equally in love, war and, “Obama Care.”
Many industry giants have patents and generic brands are against the law,
Approved by elected government officials who obviously dropped the ball,
Then again, with high campaign contributions flowing in like, “Tsunamis,”
Anybody in politics care if little Tommy or Suzy never again see mommy?
How were HMO’s able to get many drugs off their lists of covered care?
Saving $$$ leaving the insured with one option, go without it if you dare,
Between lights, gas, utilities, mortgage payments or whatever daily need,
Our health care system is nothing more than, “Good Old American Greed.”
Why is it that many U.S. Citizens cross the Canadian Border or go online?
To seek medical attention or order prescriptions, certainly not to save time,
It is for one reason and one reason only, that of affordable, qualified care,
Is there any in Washington embarrassed that constituents have to go there?
Apparently not, since the stream of patients over the years have increased,
For this to be presented before the Supreme Court means it will not cease,
Crooked law firms, collection agencies & mortgage companies are not alone,
Add unscrupulous medical research facilities, they’re all right here at home.
quikwit:
the process with which the organs are made would be patenable.
I judge people and results separately; so I do not judge results by who participated in the making of them. I think Clarence Thomas is a corrupt and bigoted fool. I doubt, with a unanimous decision, there was any lack of clear thinking among the nine Justices for Thomas to draw from, or any ambiguity on why they all agreed upon the same thing.
If anything, I think letting Clarence write the opinion, with other justices providing input and suggesting clarifications, was probably just a favor to Clarence.
I will agree with an idiot if they happen to speak the truth, because doing otherwise would require me to lie, and put something else (my ego or how others perceive me) above the truth. You see, that is called being “principled.” Some do not attach much importance to that, but I do.
You mistake acknowledging that Thomas can hit the legal equivalent of a slow pitch softball as praise.
I must admit there is something very funny in seeing so many on this board falling over one another to sing the praises of Clarence Thomas. Perhaps it has something to do with the disclosures of rampant government wiretapping. The government tracks and records every phone call or email that you make and closely monitors what everyone is saying, doing, and thinking. Perhaps it’s better to have it put on the “record” that we are all being obedient to the State.
Okay, I’ll go along with you on that….. It was a very good decision, a REAL good decision……
Thanks Gene.
There you go, Tony. Spam filter had you.
Gene (or Mike) can you check if my comment is filtered, or just taking forever to post?
Any truth to the rumor that Thomas requested copies of all the mammograms that Myriad use in its research?