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
Ralph: The proper interpretation of what Thomas is saying is that an invention requires an intellectual component. Yes, the cotton gin was invented with pre-existing materials and tools, but it wasn’t “discovered” as a natural product of evolution or nature in a field somewhere by clearing away some brush. The cotton gin was intellectually conceived and then brought to realization.
The BRCA genes were not, and cDNA genes are not. Obviously anything that exists is a “product of nature” if brought about by natural processes, but the key question is whether the particular combination of bolts, levers, and machinery that is the cotton gin ever existed in their configuration before.
Genes are made of the four base nucleotides, but those are equivalent to the bolts or sheet metal of the cotton gin. The arrangement of parts is what can be patented if it is an original arrangement, and the fact that the BRCA genes exist in humans proves they are not an original arrangement. There was no intellectual input into that arrangement, it was a discovery, like finding a fossil. The fact that Myriad dug for the fossil does not mean they invented it, and they can’t patent it and prevent other people from looking for fossils of the same organism.
*************
For the rest of your thesis, it is incoherent. The companies best able to sue for patent violation and best able to withstand lawsuits against them for patent violation are clearly the richest corporations on the planet. This ruling does not cover just the BRCA genes, it covers ALL human genes, and that is very damaging to the fortunes of the richest corporations. If they are happy about this outcome they are run by idiots because it is a Pyrrhic victory; being allowed to develop one new product while losing patent protection on their own gene discoveries is a very bad trade indeed, they would have much preferred to just buy up Myriad and retain all gene patent protections.
To create the motive for your thesis you have to pretend this ruling applies only to the BRCA genes, and that is a false premise, it applies to all naturally occurring human genes. I believe it can be used as a hammer even in cDNA cases, if the critical sequences can be shown to occur naturally, this case and Thomas’ reasoning will relegate them to the realm of discovery instead of invention, and strip such naturally occurring sequences of patent protection too.
Incorrect, Mike. It is the big pharmaceutical companies that are making unconscionable profits. And the FDA actually helps them to do this And will punish those who interfere with this process. Because the reality is that big government and big business work together to ultimately protect both of our interests. The realities of science have nothing to do with this decision whatsoever.
That was made clear by an expert in the field that I referred to and another Bron referred to.
And the public interest is the last thing on the minds of the justices on the Scotus. Again, they are simply an extension of the interests of big government and big business.
When you understand the real principle at work you will never be Surprised by a Scotus decision again. I certainly wasn’t surprised. And some here who were surprised thought that they should doublethink their original position to see if it was wrong. That was in fact a sound instinct. But here there seems to be a sort of cognitive dissonance principle playing out.
“Incorrect, Mike. It is the big pharmaceutical companies that are making unconscionable profits. And the FDA actually helps them to do this And will punish those who interfere with this process. Because the reality is that big government and big business work together to ultimately protect both of our interests.”
Ralph,
I absolutely agree with your statement, but in this instance it is irrelevant and besides the point. On THIS particular issue, in THIS particular case, SCOTUS made the correct decision. You are letting your political viewpoint dictate your assessment of this case. That Myriad is not Pfizer in size, doesn’t mean that Myriad is being discriminated against by SCOTUS. That Pfizer might have gotten away with what Myriad can’t is speculation that detracts from the verity of this case. I dislike all pharmaceutical companies that gouge the public unfairly for life saving medications and I don’t care whether they are the industry leaders in wealth, or the “little guy” trying to make it. To call Myriad Pharmaceuticals a “small” company is a matter of perspective anyway since they were capitalized by the parent company with $190 million.
Oops. I said “If Myriad wanted to patent…” when what I meant to write was “If Myriad wanted to protect…”.
I agree with the decision, and Gene.
If Myriad wanted to patent their discovery, they should have kept their knowledge of the effect of the variant BRCA1 / BRCA2 as a trade secret, and marketed their test instead as a “black box” that, in double blind clinical trials, separated those at high risk of breast cancer from those at lower risk of breast cancer with a high probability of success.
That is a more difficult route, but with money it can be done. Trade secrets (like the formula for Coca Cola or the spices in KFC) last forever; but because they have no legal protection, are at risk of reverse-engineering.
Even so, if we are talking about a pharmaceutical, then even if reverse-engineered, Myriad would have no obligation to acknowledge the success of that effort, so a competitor would have to build their own justification from scratch, re-executing the double-blind clinical trials, marketing, and so on. That is a steep hill to climb, and in the lore of marketing, those that have tried that feat in the past almost always find the first to market remains king of the hill forever, even if the competitor’s product is better. (e.g. the QWERTY keyboard vs many superior layouts).
Even though willow bark was used by many cultures for thousands of years as an analgesic, that is NOT how it was introduced to Western Medicine; it was independently rediscovered in England while searching for an alternative to (very expensive) quinine as a treatment for Malaria, and mistakenly thought to be an inexpensive and more available cure because it relieved the fever and aching symptoms of Malaria. Which it is not.
What made powdered willow bark popular and widespread was this independent beginning, not as a general analgesic but as a medicine, and its other properties were then rediscovered. The use by non-Englanders was discovered later, it was not the impetus in any way for the English usage of willow bark.
In fact the impetus for the English usage of willow bark was a belief in sympathetic magic; because Malaria was thought to be caused by smelling the fumes of stagnant water, and quinine bark was known to be bitter and grow near stagnant water, a magical thinking pastor decided to look (in England) for trees with bitter tasting bark, growing near stagnant water, and bumbled into the willow. Forming a tea of the dried, ground bark, he found it seemed to relieve malaria. Success! (well, not really.)
No, Ralph. The analogy was perfect. The manufacture of aspirin on a mass scale was enable by scientists figuring out how to synthesize acetylsalicylic acid (containing aspirin’s active ingredient salicin) – a patentable process. The compound itself is naturally occurring and is not what Bayer patented. Charles Frederic Gerhardt was the first to prepare acetylsalicylic acid in 1853 as an isolate but the properties of willow bark as an analgesic were known to the ancients (including Hippocrates). In 1897, chemists working for Bayer created a synthetically altered version of salicin that was easier on the digestive system than the naturally occurring compound. A technical innovation based on a novel manufacturing process like synthesizing acetysalicylic acid is patentable. A naturally occurring compound like salicin isn’t. Bayer was making something not found in nature.
This is a horrible decision. The patent did not try to claim naturally-occurring DNA. The media campaign has spun this case all out of proportion. It tried to claim isolated, purified, concentrated forms of DNA. If someone claims that these are naturally occurring, well I say:
Can you show me where I can get some of this stuff for free, ’cause I have some experiments to run asap. Thx.
Also, an effect of this decision will be that artificially created hearts and lungs will no longer be eligible for a patent, because they mimic a naturally occurring heart. !!!
Who would spend the R&D $ to make artificial organs now, after this travesty?
Darren,
Gene quipped:
“I’m sure it has something to do with the “Leftists”.
~+~
Perhaps, but maybe on the molecular level it might be levorotatory
Wrong analogy. Bron referred to the correct analogy. This case is like aspirin. Aspirin was patented on February 27, 1900. Aspirin was derived from willow bark, And general use of that product had been in effect for centuries before the patent. However, for this patent, Scientists synthesized The compound that we call aspirin today as acetylsalicytic acid. As a result of this new decision, the big pharmaceutical companies Effectively steal the patent without having to pay any royalties. But you can rest assured that if any of the major big pharmaceutical companies develop their own invention That would match exactly the circumstances of this case, The Congress or the Scotus Would come to their rescue to make their invention patentable. I understand, you do not want to accept the principle that I have made clear to you. Your mind is not trained to see things as they are but only as you have been programmed to see them.
“But you can rest assured that if any of the major big pharmaceutical companies develop their own invention That would match exactly the circumstances of this case, The Congress or the Scotus Would come to their rescue to make their invention patentable.”
Ralph,
I’ll grant you that would have been a possible, perhaps probable outcome and then assert to you that your argument still fails logically. This question devolves on whether the BRCCA-1 gene is patentable, since it occurs normally in nature and indeed whether any genes should be patented. That SCOTUS has a history of siding with big business is incontrovertible given its overall history, yet that is irrelevant to this discussion, because occasionally SCOTUS rules correctly as in this case. Myriad was in effect trying to stifle competition, was charging unconscionable amounts for its cancer tests and this was what their “patent” was all about. From a capitalist perspective it was stifling research and competition,since no doubt other companies could have developed a test, yielding equal results, through different techniques. By “patenting” the end result Myriad was trying to preclude that, closing the market, eliminating competition and keeping the cost of their test unconscionably high.
Ralph,
It appears that you don’t understand the nature of what patents are used for. There was no innovation involved in isolating these genes. These genes have been active in humans since there have been humans. Could Myriad have a possible patent claim on the methodology of their testing? Sure. But the genes involved are public domain by the very fact that Myriad didn’t build them and insert them into the human genome. They are naturally occurring and once identified there is nothing preventing other companies from detecting the genes using other possibly patentable technologies. To grant a patent on these genes would be like granting Carl Wilhelm Scheele a patent on oxygen. Utter nonsense with possibly horrific legal consequences.
AY,
A little joke about Ralph’s usual bad guys of choice. FWIW, I agree with you and the other posters noting this is an unusually sane decision from a Court that has made some very questionable calls in the recent past. The idea that a company could patent a naturally occurring DNA segment merely because it has been isolated is lunacy. The reductio ad absurdum for that is a company could patent blue eyes and seek licensing fees from every blue eyed devil on the planet. But I’m not shocked that it was unanimous nor that they let Thomas write one for a change. The argument is against the patent is fairly self-evident.
Of course, big business wins here. They are now in a position to make the serious money that Myriad would’ve made otherwise. I think I’ll have to apologize to the slow learners. They should not have been denigrated by comparing them to some of the deeper “thinkers” on this board.
Gene,
Leftist of what…..seems like someone wanted an exclusive on the human already evolving body….
AY,
I’m sure it has something to do with the “Leftists”.
Oh… And since when is pharmacology small business…. What big business won… I’m curious…. Maybe I am slow… You can help educate me…. A fool that suffers from the lack of knowledge you seem to posses…. Impart your pearls of wisdom…
aw, ain’t that special. they let clarence talk. yaaaay (hands clapping).
Anonymously Yours, you appear to be a very slow learner. Yes, SMALL business lost, but BIG BUSINESS won.
I realize that some of my concepts are difficult to comprehend or accept, much as people once had a difficult time understanding or accepting that the Universe doesn’t revolve around the Earth. But perhaps in time, or by repeated examples, hammered over and over and over, some learning, at some remote level, might actually take place.
Yes, Bron, that’s very informative. Although Adam Mossof is not a scientist, he is a highly regarded legal scholar in the area of intellectual property, and his explanations make perfect sense to me.
And just to make my point about the REAL principle behind the SCOTUS– so there can be no mistake about it–if it had been PFIZER, instead of Myriad, that was seeking to obtain patent protection, the SCOTUS would have IGNORED the writ of certiorari altogether, clearing the way for Pfizer to have its way. The SCOTUS would NEVER interfere with the desires or plans of such a major big business force like Pfizer, which engages in fraud, tax evasion, and worse, every single day of the year. But Myriad, a small innovator, with no claim whatsoever to being part of the power-player global “elite”? In their case, of course, the pseudo-intellectual dishonesty of the “high court” dispatched with them, as the SCOTUS follows their real masters with strict obedience.
You mean business did not win this one…. I’m glad… Surprised by Thomas though…very… Thought he could be bought and paid for…. Guess…. Miracles can happen….. Nifty cool….
Ralph Adamo:
from that article:
“However, you can get a patent for identifying, isolating and purifying something that already exists in the world. For example, the inventor of aspirin at the turn of the 20th century isolated and synthesized the active ingredient in willow bark, which people had chewed for thousands of years to relieve pain and fever.
The greatest confusion in the debate about the Myriad case stems from failing to understand this distinction. Unfortunately, the Supreme Court contributed to the confusion when it took the case to answer: “Are human genes patentable?” Patent experts scratched their heads, because the answer is undisputed: No, human genes in their naturally occurring form are not patentable.
But Myriad’s patents don’t cover genes in their naturally occurring, unisolated form, just as the aspirin patent did not cover chewable bark. Rather, the BRCA1 and BRCA2 patents claim the genes as isolated, purified and used in a scientific or medical context.
Thus, Myriad’s patents cover the same “composition of matter” that these patents have always covered, and which built the modern pharmaceutical industry in the early 20th century.”