A lot of the commentary in the conventional news media has been to the effect that the Supreme Court has banned the patenting of human genes. That's not necessarily so. The Court specifically held:
“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.”Myriad Genetics, as is clear from the statement about the case on their website, see the decision largely as a victory in two respects -
- Firstly although the Court struck down the company's claimed ownership of the naturally occurring DNA segments that are the BRCA1 and BRCA1 genes, they upheld Myriad's patent claims relating to complementary DNA, cDNA. (Note cDNA is called complementary DNA by experts, not 'composite' DNA, the term used by Justice Thomas in the decision). So Myriad has the exclusive right to synthetically create BRCA1&2 cDNA.
- Secondly, though the case was not reviewing Myriad's method patents – patents relating to the way the company does genetic testing, biotech research and other processes – the company are interpreting some of the remarks of Justice Thomas in Part III of the ruling as re-inforcing all of their method patent claims.
"The decision helps to lay the foundation for continued research and application of diagnosis and treatment of diseases at the molecular level. "AMP applauds the U.S. Supreme Court on their ground breaking, unanimous decision. There is no question that this is a critical and right decision for the future of medicine and science. Biomedical researchers, clinicians, and most importantly patients will see great benefit from this development," said Jennifer L. Hunt, MD, MEd, AMP President."
Which of the two parties has the most right to claim victory only time will tell. What does appear clear is that the reasoning of the Court in striking down the DNA claims and upholding the cDNA claims was effectively unanimous but confused.
Justice Scalia wrote a separate short concurring opinion disassociating himself from Justice Thomas's efforts to explain the science, and implying that doing science was not the business of the Court. He would not put his name to what he did not understand.
"I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature."The fact that the Court has decided that a naturally occurring DNA segment is not patentable is clear. The attempted logic they use to get from there to the patentability of cDNA is flawed. Justice Thomas goes to great pains to emphasise that the Myriad patents under review are information patents not chemistry patents (see p14):
...extensive effort alone is insufficient to satisfy the demands of §101. Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 andBRCA2 genes"Merely doing chemistry and breaking a chunk of gene out of a DNA chain is not enough to grab ownership of that gene. That makes sense. We shouldn't be allowed to cut up products of nature and say we now own the offcuts.
DNA chains have useful functional sequences of crossbars called exons and less useful sequences called introns.
On the route from DNA -
- to RNA where the DNA unwinds into single strands from the original double helix
- to the removal of the useless introns
- to mRNA where the exons spliced back together in their original sequence
- then on to the production amino acids and proteins in cells
Let's put it another way. The collections of genes inside living cells are a bit like the cells' recipe books. When a cell needs to do something like manufacture a protein it consults the gene recipe book and follows the instructions there. BRCA1&2 DNA and cDNA have the same information content, in the same order, the same recipes. The BRCA1&2 cDNA recipe book might be shorter and neater, stripped of the waste intron pages, but it contains the same instructions, methods, recipes.
Not only has the Supreme Court not banned patenting human genes, in this case it has granted Myriad Genetics control of the most functionally useful naturally occurring information in BRCA1 and BRCA2 genes.
So as I understand the reasoning, it goes something like this -
- BRCA1 & BRCA2 genes are naturally occurring DNA segments
- As naturally occurring DNA segments (with their naturally occurring exon recipe books) they are not patentable just by cutting them out of the DNA chain they form part of
- Chemistry doesn't cut it - excuse the pun - to earn patent control
- BRCA1&2 cDNA, however, (with their naturally occurring exon recipe books with the same natural recipes) are patentable because they are different without the introns and there's more chemistry (you have to cut out the genes, cut out the introns, put the exons back together in the same order)
"Myriad did not create or alter either the genetic information encoded in the BCRA1 (sic)and BCRA2 (sic) genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry."Neither has Myriad created or altered the functional genetic information encoded in the BRCA 1 and BRCA2 cDNA. It makes little sense, therefore, that the DNA is not patentable but the cDNA is. Justice Scalia may have been honest in noting he could not sign up to the fine details of molecular biology in the opinion. All nine justices may have had a variable grasp of the science but it seems none of the nine had a proper handle on the information science.
Casual readers should probably call a halt there. I look at some extracts from the decision below.
Justice Thomas in Part I, Section A, pp1-4, attempts to explain the science in the case. I can't help feeling the inclusion of pictures/illustrations could have helped his task enormously here. I wonder when courts looking at science and technology are going to embrace science and technology beyond text to help deliver their reasoning. In section B he describes Myriad's discovery.
"Myriad discovered the precise location and sequence of what are now known as the BRCA1 and BRCA2 genes. Mutations in these genes can dramatically increase an individual’s risk of developing breast and ovarian cancer... Myriad identified the exact location of the BRCA1 and BRCA2 genes on chromosomes 17 and 13. Chromosome 17 has approximately 80 million nucleotides, and chromosome 13 has approximately 114 million...
Within those chromosomes, the BRCA1 and BRCA2 genes are each about 80,000 nucleotides long. If just exons are counted, the BRCA1 gene is only about 5,500 nucleotides long; for the BRCA2 gene, that number is about 10,200. Knowledge of the location of the BRCA1 and BRCA2 genes allowed Myriad to determine their typical nucleotide sequence. That information, in turn, enabled Myriad to develop medical tests that are useful for detecting mutations in a patient’s BRCA1 and BRCA2 genes and thereby assessing whether the patient has an increased risk of cancer. "Once they found BRCA1&2 they headed for the patent office. Nine claims from 3 of those resultant patents were under consideration here - claims 1, 2, 5, 6 and 7 of US Patent No. 5,747,282; claim 1 of US Patent no. 5,693,473; and claims 1, 6 & 7 of US Patent no. 5,837,492. From Section C, page 6 of the decision:
"Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes (or any strand of 15 or more nucleotides within the genes) by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome. The patents would also give Myriad the exclusive right to synthetically create BRCA cDNA"The italics above are mine. Not only did Myriad want control of the 80,000 nucleotide strings in BRCA1 or BRCA2, they wanted control of any 15 nucleotide strand within the 80,000. Any 15 piece nucleotide string that could be chopped out of BRCA1&2 would belong to Myriad.
Justice Thomas then goes on to explain (p7) that once the patents were granted Myriad sued or threatened to sue "entities that performed BRCA testing" ending up with a monopoly as a result. One of the doctors on the receiving end of the Myriad's legal action along with a number of others returned the compliment several years later declaring Myriad's patents invalid. That case eventually reached the Supreme Court via the District Court which ruled against Myriad and the Federal Circuit appeal court which ruled in favour of Myriad (see pp 9-10 for an outline of the decisions in those courts).
In Part II Section A, Justice Thomas describes the provisions of §101 of the Patent Act.
“Whoever invents or discovers any new and useful . . . composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”He follows up with an important exception:
We have “long held that this provision contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable.” ... Rather, “‘they are the basic tools of scientific and technological work’ ” that lie beyond the domain of patent protection... the Court has explained, without this exception, there would be considerable danger that the grant of patents would “tie up” the use of such tools and thereby “inhibit future innovation premised upon them.” ... The rule against patents on naturally occurring things is not without limits, however, for “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,” ...patent protection strikes a delicate balance between creating “incentives that lead to creation, invention, and discovery” and “imped[ing] the flow of information that might permit, indeed spur, invention.”Part II Section B gets onto the meat of the decision.
"It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. The question is whether this renders the genes patentable."On page 12 Justice Thomas compares Myriad's work to the Chakrabarty case in 1980 where the US Supreme Court held that a modified bacterium used to break down components of crude oil was patentable.
"In this case, by contrast, Myriad did not create anything. To be sure, it 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 §101 inquiry." {My emphasis}
...
Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes “new . . . composition[s] of matter,” §101, that are patent eligible." {My emphasis again}From page 14 onwards Justice Thomas tackles Myriad's patent claims.
Many of Myriad’s patent descriptions simply detail the “iterative process” of discovery by which Myriad narrowed the possible locations for the gene sequences that it sought.6
[Note 6: Myriad first identified groups of relatives with a history of breast cancer (some of whom also had developed ovarian cancer); because these individuals were related, scientists knew that it was more likely that their diseases were the result of genetic predisposition rather than other factors. Myriad compared sections of their chromosomes, looking for shared genetic abnormalities not found in the general population. It was that process which eventually enabled Myriad to determine where in the genetic sequence the BRCA1 and BRCA2 genes reside.]
Myriad seeks to import these extensive research efforts into the §101 patent - eligibility inquiry. Brief for Respondents 8–10, 34. But extensive effort alone is insufficient to satisfy the demands of §101.
Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad’s patent claims on entire genes (such as claims 1 and 2 of the ’282 patent) by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule “invented” by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence , not with the specific chemical composition of a particular molecule."In essence this section of the decision amounts to two things - firstly the sweat of the brow or hard work is not enough to make something patentable; and secondly Myriad's specific patent claims are not about chemistry, they are about information. Myriad's claims are "concerned primarily with the information contained in the genetic sequence , not with the specific chemical composition of a particular molecule." {My emphasis} That key point is crucial when the Court later distinguishes the patentability of naturally occurring DNA from that of cDNA.
Another small but important point on page 15 related to Myriad's argument that the US PTO's past practice of awarding gene patents was "entitled to deference". Justice Thomas for the Court simply said "We disagree". The notion that decisions of a patent office should not be subject review in the courts is unsustainable. And even the US government had argued in the Federal and Supreme Courts that isolated DNA was not patent-eligible.
That was it on the patentability of isolated DNA. Yet the Court goes on to make the following enormous (il)logical leap in sanctioning cDNA as patent eligible in Part II Section C on page 16-17 of the decision:
"cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. As already explained, creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring. Petitioners concede that cDNA differs from natural DNA in that “the non-coding regions have been removed.” Brief for Petitioners 49. They nevertheless argue that cDNA is not patent eligible because “[t]he nucleotide sequence of cDNA is dictated by nature, not by the lab technician.” Id., at 51. That may be so, but the lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA."Remember that Myriad's claims are "concerned primarily with the information contained in the genetic sequence , not with the specific chemical composition of a particular molecule." Yet the lab technician doing chemistry "unquestionably creates something new when cDNA is made"? The lab technician doing chemistry may well be breaking up gene molecules, clearing out the intron rubbish and rebuilding the molecules with the clean exon components but s/he does not create new genetic information. So are we dealing with information patents or chemistry patents here?
Well in Part III the Court says "It is important to note what is not implicated by this decision" but this short conclusion doesn't help deal with the confused interpretation of the information science. It does, however, explain Myriad's confidence that their methods patents have received some re-enforcement.
"It is important to note what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent.
...
Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson aptly noted that, “[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications.” 689 F. 3d, at 1349.
Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of §101 to such endeavors. We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material."So there is a hint not only that Myriad's method patents may be ok but that the company is in a strong position to claim such patents. Though they approve cDNA patents where the order of the exons is not altered from the DNA from which they are derived, the Court didn't consider the patentability of naturally occurring DNA where the nucloetides have been shuffled.
To conclude, then, let's return to the heart of the decision where the Court has held that:
"A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring."The case is specifically about information encoded in genes not chemistry. Myriad's claims are "concerned primarily with the information contained in the genetic sequence , not with the specific chemical composition of a particular molecule."
The naturally occurring DNA segments that are the BRCA1&2 genes are products of nature and not patent eligible merely because they have been isolated. The isolation and lopping of a gene out of a DNA chain is not sufficient to engender ownership rights over that gene. Fair conclusion.
However, somehow breaking up those genes, throwing away the useless bits (introns) from the cellular recipe book perspective and putting the functional bits (exons) back together in the same order with the same, naturally occurring, information - doing chemistry which is specifically excluded by the Court (pp14-15) as the focus of this decision - such that they provide the same cellular recipes as those naturally occurring in products of nature, does facilitate (patent time limited) ownership rights over BRCA1&2 cDNA. That, in the words of certain fictional Vulcan of Star Trek fame, is illogical.
The upshot is that Myriad can control the useful information in BRCA1 and BRCA2 genes but not the naturally occurring DNA kind. They are "limited" to controlling the same information except in synthetic cDNA form, once some chemical magic has been deployed, to extract the functionally information free introns. (Remember the introns don't make it into the cellular recipe book).
In summary the Court's decision effectively reads:
- The dispute is concerned primarily with the information contained in the genetic sequence
- Myriad cannot control the information in the naturally occurring DNA segments that are the BRCA1 & BRCA2 genes; because these are products of nature and not patent eligible merely because they have been discovered/isolated
- Myriad can control the same information after some chemistry has tidied up the naturally occurring DNA and turned it into synthetic cDNA
It's not about chemistry.
It's about information.
The information cannot be commercially controlled.
If you do some chemistry the same information can be commercially controlled.
QED.
This not the kind of "logic", I suspect, that Paul Otlet, Henri Le Fontaine or Claude Shannon would recognise as such (and Otlet and Le Fontaine were lawyers!).
I'm tempted to launch again into my diatribe on the absence of scientific and technical understanding of the legislature, the executive, and the judiciary but to those who have made it this far, it's probable you have suffered enough.
Update: On the advice of a much more informed scientist friend, the wonderful Jo Davis, I've tweaked the bullet points under the diagram describing the sequence from DNA through RNA to mRNA and onto amino acids and proteins. Apologies for any confusion.
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