Yesterday, when I heard the news about the Supreme Court’s ruling on the Myriad gene patenting case (read yesterday’s post for details), I was frustrated for two reasons. First, my newsfeed was full of headlines saying that genes could no longer be patented, which only sort of partially reflects the true implications of the Supreme Court’s ruling. Second, I was frustrated by the fact that the Supreme Court’s decision only sort of partially dealt with the fundamental issue in the whole case.
To be fair, the split ruling, which invalidated Myriad’s patents on isolated human DNA, did effectively address the immediate concern over patient access to genetic testing services relying on the naturally-occuring BRCA1 and BRCA2 sequences. Myriad no longer has a complete monopoly over the BRCA tests. This may provide some relief to other labs wishing to offer the test (and patients hoping to receive it at a competitive cost), but the immediate benefits are likely going to be short-lived: Myriad’s patents were due to expire by 2015 anyway, and such single-gene testing methods are rapidly losing steam as it’s becoming feasible to sequence whole genomes at a lower cost than the individual tests. So yes, it’s a win, but beyond the ideological victory, it seems too little, too late.
In its compromise — overturning patents on isolated DNA while upholding patents on synthetic cDNA — the Court failed to recognize that the central problem with gene patents is that our genetic information, in whatever chemical form it is expressed, is inherent to nature. It’s not a human invention. And as I argued yesterday, the process of creating cDNA from a naturally-occuring sequence is completely obvious to anyone working in the field. It’s a standard procedure — and indeed cDNA often forms the basis for many applications of genetic engineering.
Take plant biotechnology, for example. Let’s say I find a plant that tolerates stress extraordinarily well, and I can attribute that tolerance to a specific gene. If I wanted to isolate that gene, I probably wouldn’t go digging through the chromosomes looking for the sequence — there’s a lot of extra “junk” in the chromosomal DNA sequences, stuff that isn’t functionally relevant for my purposes. Instead, I’d go looking for the active version of the gene, its “transcript” — the mRNA molecule that has already had all the junk taken out and only contains the information that’s relevant to me. The end product, when I copy that mRNA transcript, is cDNA. According to the Supreme Court’s ruling, that sequence I’ve just copied is no longer a product of nature, and I could patent it, as is, even before I’ve done anything useful with it. Of course, the next step might be to take that cDNA and introduce it into a crop plant, thereby conferring stress tolerance to that crop. I could also patent that. But unlike the first step of merely arriving at cDNA, in applying it, I’ve done something inventive.
But I could have just as easily stopped at the cDNA step, taken my patent on the cDNA, and effectively blocked anyone else from doing anything useful with it. If anyone wanted to use my gene, they could certainly (thanks to yesterday’s ruling) go back to the original source and re-isolate it, but the process would result in the creation of a cDNA identical to the one I have a patent on. To make matters worse, many patents don’t just cover a single unique sequence; they cover that sequence and anything closely related to it. This is intended to stop people from taking my patented sequence, making a minimal number of changes that have no functional relevance, and calling it a different sequence. However, the nature of genetic information is such that genes with similar functions tend to have similar sequences. Nature does not often completely reinvent the wheel. And since cDNA represents the essential functional part of a gene — the instructions that actually produce something — it also tends to reflect the least variable regions of the original DNA sequence. So one patent on a cDNA can, intentionally or not, create widespread barriers to the application of similar genes.
So yes, the ruling against patents of isolated naturally-occuring DNA is a win, but I don’t think it will have a lot of meaningful impact on the biotech industry. The industry will go on operating in an ever-increasing tangle of gene patents (pardon me, cDNA patents), and the outcome is essentially the same: companies will still have the right to own the basic genetic building blocks, regardless of whether or not they’ve done anything inventive with them.
Here’s what I would have preferred to see happen, and what I think would have been far more consistent with the legal precedent cited in the ruling. Throughout the Myriad case, all of the decisions have cited Diamond v. Chakrabarty as the relevant precedent for determining whether isolated DNA or cDNA have “markedly different characteristics from any found in nature.” The case surrounded the patent eligibility of a genetically-modified bacterium that could clean up oil spills. Was the bacterium a product of nature, or had the modifications resulted in something entirely new? The Court ruled that the genetically-modified organism was patent-eligible, because of its markedly different characteristics arising from human intervention.
While I thought Diamond v. Chakrabarty was kind of an apples-to-oranges comparison with Myriad — looking at a whole organism with obvious human invention vs. isolated pieces of DNA, the case does present a compelling standard for biotechnology-related patents. The oil-eating bacterium became patentable at the point where its character, as a result of human invention, became unlike anything found in nature. Makes sense.
Rather than allowing patents on every individual building block, why not regard the building blocks as open technology, and provide patent protection on the unique products that arise from combining different building blocks in different ways for different purposes? Isn’t that the essence of innovation — taking the pieces that are available and assembling them in creative ways to solve problems? It’s kind of hard to foster this kind of innovation when one person owns all the blocks, or each block is owned by somebody different and you have to come to some agreement about how the blocks can be used.
We now live in a world of big data and synthetic biology. We have so much information about different genes from different species, and the technology to combine them in infinitely diverse ways. Yet, today, the first step in any biotechnology project is to establish freedom-to-operate — navigating the potential patent land mines that litter the landscape.
With Myriad, the Supreme Court sought to strike a balance between the established expectations from 30 years of gene patenting practice, and supporting ongoing innovation. I get that. But I wish they could have looked farther ahead than the implications of Myriad and seized the opportunity to clear a path for future innovation that isn’t based on who has access to which building blocks.