I’m pleased the Supreme Court has decided to reject the idea of patenting genes, as such case law would be restrictive to scientific discovery and also just feels fundamentally icky. From a legal perspective, as far as I understand patent law (not a lawyer here), it also seemed to fail on the more basic level of novelty and obviousness. The methods used to discover such genes were not what was invented. And one could conceive of “gene trolls” that would seek out gene aberrations and sit on them, just like other patent trolls, waiting for a payout and hindering scientific and medical progress.
Unfortunately, the second half of the SCOTUS decision makes little sense to me from a scientific perspective, or my unsophisticated understanding of the law. From the NYT coverage:
The price of the test, often more than $3,000, was partly a product of Myriad’s patent, putting it out of reach for some women. The company filed patent infringement suits against others who conducted testing based on the gene. The price of the test “should come down significantly,” said Dr. Harry Ostrer, one of the plaintiffs in the case decided Thursday. The ruling, he said, “will have an immediate impact on people’s health.”
The court’s ruling will also shape the course of scientific research and medical testing in other fields, and it may alter the willingness of businesses to invest in the expensive work of isolating and understanding genetic material.
The decision hewed closely to the position of the Obama administration, which had argued that isolated DNA could not be patented, but that complementary DNA, or cDNA, which is an artificial construct, could. The patentability of cDNA could limit some of the impact on industry from the decision.
This strikes me as completely undermining the nature of the first part of the decision, and scientifically and legally unsound. Now, most of us understand the basics of molecular biology, but all you need to know to understand the significance of this is that DNA is transcribed into RNA, which is then translated into protein. In the process of transcription of DNA to RNA, large sections of the RNA are spliced out (the introns) and the remaining pieces (exons – which are expressed) are what get translated into the final protein sequence by little machines called ribosomes. Scientists are usually more interested in the final, mature RNA sequence after splicing, since that’s what results in function (for now ignoring regulatory elements in introns etc.). To study these sequences, they harvest RNA from cells, and reverse transcribe that information using an enzyme called a “reverse transcriptase” to turn that sequence into cDNA, which is more stable, can then be made double stranded, variously manipulated, cloned into plasmids or amplified by techniques like the polymerase chain reaction.
The Supreme Court has decided that since cDNA is artificial (is it really? We make it with enzymes stolen from viruses so viruses make cDNA too right?), cDNAs can be patented. But the exact same information from the mature RNA is in the cDNA! What’s the damn difference? This is like saying you couldn’t patent a recipe on paper, but if you transfer it word for word onto sheepskin, it becomes patentable. Does this make sense to anyone? Am I taking crazy pills or is this basically saying you can’t patent genes, unless you copy the information into a new format? Unless the cDNA is truly novel, and not isolated or cloned from a human or other organism, this strikes me as simply sleight-of-hand.
This decision is terrible and not the victory science advocates would like to believe, at least to my understanding of what has been done. I’ll read the actual decision once I’m home from work, but just from the news coverage, I’m disturbed.
**Update** As I read the decision it appears that our esteemed Justices don’t really understand biology, and as a result, have made a frankly stupid decision. Sentences that make me cringe include, “cDNA is not a “product of nature
,” so it is patent eligible under §101.” Umm, no, cDNA is found in nature. We use natural enzymes to make it! Viruses make their reverse-transcribed genes all the time. Also, check out this boneheaded statement, “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. Its creation results in an exons-only molecule, which is not naturally occurring.” Agggh! What about the mRNA that is was copied from? Are they saying cDNAs are the only form of “exons” only molecule? This is either bad biology, or poor sentence construction. Or maybe they think cDNA comes from stitching together sections of genomic DNA by some other process?
Then they appear to reject the idea you should be able to patent the only type of DNA that arguably should be patentable:
This case, it is important to note, does not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.
So, copy the information from mRNA to a cDNA and you’ve created something “new” (bullshit) but change that DNA sequence yourself for potentially novel and interesting results and that won’t necessarily be patentable? Idiots!
Check out this nonsense:
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.
The mere fact that they describe this as a mere technical process should be a hint. The human adds nothing. The justices seem to suggest that by taking advantage of the cell’s splicing apparatus, you have created something new, but you have not! You have merely copied the information from the mRNA onto a new media.
Add to this the bizarre rejection of the first section of the decision by Scalia, which only describes facts about biology (he rejects basic science that’s been established for 50 years!) , and I have to ask, why do we let these 9 non-experts decide anything related to technology? How was their extensive education so flawed with regards to biology? Who is educating them on biology now in preparation for a case such as this? Whoever it is needs to be fired. They have written law based on such a flawed conception of basic biology (and one actually abstains from acknowledging the existence of molecular biology!), that we now have this stupid idea that mere transcription of genetic information to a new media should be protected under patent! The source of this idea seems to come from the opinions of the lower court judges who seemed to think that any cutting or synthesizing of DNA to make a “new” molecule should be patentable. That would suggest using any restriction enzyme that cuts genomic DNA creates millions of new patentable molecules. It is equivalent to suggesting that by cutting a wire made up of 4 recurring metals fused together in some order, one is creating new patentable wires because their chemical composition is different from the original wire, but that’s nonsense, because what makes DNA a molecule of any patentable interest is not it’s simple chemical composition or the changes in chemical composition when subjected to enzyme treatments or synthesis reactions, it’s the information contained within the order of the chemicals in the chain. The chemical composition, in terms of the absolute quantity of each of the base-pairs is unlikely even change by such a process. The only thing that matters is the information contained in the code.
The Supremes, and I guess whichever clerk wrote this for Clarence Thomas (not that I esteem his intellect, but that’s how these things work right?) have failed Bio 101. As a result this decision is stupid, unscientific, and worse, bad law. This should not have been reported as any kind of victory for science, but rather is a muddled, ignorant, and unhelpful decision that awards patent protection to the mere transcription of information from one media to another using methods in existence for the last 30 years.