I’m a little slow getting around to this, but just got back from vacation and while catching up on news saw there were two court rulings last week in cases I’ve been interested in. First, last Wednesday in a district court Judge Royce Lamberth ruled against two scientists who had filed a lawsuit to prevent federal funding of embryonic stem cell research. Then on Friday an appeals court reversed an earlier ruling and upheld a patent Myriad Genetics had involving the BRCA gene sequence as a test for breast cancer risk. Despite some of the headlines I’ve been seeing there’s a bit a nuance in this ruling that will be interesting to see how it is followed up.
The first case centered around the question of whether a law, know as Dickey-Wicker Amendment, which prevents research on embryos also applied to stem cells that were derived from embryos, even if the actual production of the stem cell line wasn’t funded. Since 2000 the NIH has interpreted the act of creating the cell line and further research involving the line as separate activities. Therefore it was legal to fund stem cell research without violating this law. However last fall Lamberth caused a lot of buzz when he issued a preliminary injunction that would have prevented research from continuing while the case was ongoing. This injuction was later overturned by an appeals court which decided the law was ambiguous enough that research should be allowed to continue; this most recent ruling was on the actual merits of the case. In the ruling Lamberth pointed out that he was obligated to follow logic used by the higher court and view this law as ambiguous, though he also seemed to make it clear that he personally disagreed and was “ a grudging partner in a bout of ‘linguistic jujitsu,’ [but] such is life for an antepenultimate court.” Given this ambiguity, he referred to another precedent, Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc. which says that if a law is ambiguous then the court should “defer to the agency’s interpretation of the statute if it is reasonable and consistent with the statute’s purpose”.
The second ruling was a bit more complicated, and I’ll admit I only have had time to read through the the main opinion and concurring opinion, but not the dissent. I might update to include some discussion of the dissent later if I get a chance.
First, despite news articles seeming to focus on the part of the patent that was upheld, the ruling actually held most of Myriad’s claims as invalid. It kept the patents on the actual DNA sequence and a test that was based on cell culture growth as a screen for possible cancer treatments, but invalidated the five patents that relied on comparing the sequence from from a patient with a reference sequence. The court argued this process was simply an abstract mental process, and not something that could be patented. As for the patent on the sequence itself, the two opinions upholding it used similar logic, though with slightly different standards that they felt needed to be met. In both cases the judges focused on whether the DNA sequence that was being patented was significantly different from the natural DNA in our bodies. One way it differs is by being only a fragment of a larger chromosome, though it has also been through further changes. In our bodies DNA is copied into RNA which is further processed to remove chunks called introns, leaving only the sequence that actually codes for a protein. This RNA can be copied back into a DNA molecule which is missing those introns, and known as cDNA. The majority opinion held that these fragments of cDNA are different enough from chromosomal DNA to no longer be considered a “natural product”
It seems to me this leaves open a couple different ways that genetic testing can still go forward despite this patent. First, I’m unsure about how broadly written the Myriad patent is, but if there were alternative ways to produce a cDNA, or if someone were to use alternative fragments that still contained the mutation sites of interest, the logic of the ruling suggests these might be considered different products and not subject to the patent. Even if they were, it seems to call into question the originality of this patent compared to other products which may come up in further appeals. In addition ,as pointed out in this article, sequencing technology is advancing enough that it won’t be long before it’s feasible to do testing on full sequences, which wouldn’t require the shorter sequences that are needed for this to no longer be a “natural product”
Last week was a busy one for science in the courts. One case kept open a field of research, while the other seemed to have closed off some things, but still left some interesting questions. I wouldn’t be surprised to see both cases continuing to be appealed though.