Friday saw the US Court of Appeals for the Federal Circuit (which we’re told by the New York Times told specialises in patent cases) rule that Myriad can patent the isolated BRCA1 and BRCA2 genes, mutations in which are diagnostic for (some) cases of breast and ovarian cancers.
The three judges didn’t rule unanimously, with the ruling based on a majority. Most sources are citing a 2:1 ruling. My reading of it is that all three judges differed in reasoning.
While the ruling has sided with patenting of the genes, the judges ruled against Myriad’s method of diagnosing the patients.
Below I’ve offered a few links for those interested in this decision.
- New York Times (brief but good; includes brief takes on the Judge’s reasoning)
- The CAFC ruling (PDF file; this is the actual legal ruling – while long it is for the most part quite readable; I’d encourage reading Judge Bryson’s dissenting views, some of which I have excerpted below.)
- Genome Web News (or this article; free registration required)
- ArsTechnica (good discussion and more depth; recommended)
My thoughts? I’m not a lawyer, and this will come down to understanding how their actions sit compared to current law in the USA (something I know nothing about), but colour me surprised. Regardless of the details, I would like to think I’m not a long in thinking that the Judges not putting forward a unified front suggests a need for clarity.
The argument that genes are chemically different through being extracted seems at first blush–to paraphrase Judge Sweet’s earlier remark–’a lawyer’s trick’. It reads to me to be a shifting of the target from sequences (which are information and–surely–what is sought) to ‘chemicals’ (the DNA) in order to try win favour in court.
While this ruling clearly touches on many different aspects in a complex way, let’s look at what Judge Bryson offers in the ruling document where he, to use the language of the ruling document, ’concurs in part and dissents in part’ (see also the New York Times piece and my Footnote):
I concur with the portions of this court’s judgment that are directed to standing, the patentability of the cDNA claims, and the patentability of the method claims. I respectfully dissent, however, from the court’s holding that Myriad’s BRCA gene claims and its claims to gene fragments are patent-eligible. In my view, those claims are not directed to patentable subject matter, and if sustained the court’s decision will likely have broad consequences, such as preempting methods for whole- genome sequencing, even though Myriad’s contribution to the field is not remotely consonant with such effects.
In its simplest form, the question in this case is whether an individual can obtain patent rights to a human gene. From a common-sense point of view, most observers would answer, ’Of course not. Patents are for inventions. A human gene is not an invention.’ The essence of Myriad’s argument in this case is to say that it has not patented a human gene, but something quite different–an isolated human gene, which differs from a native gene because the process of extracting it results in changes in its molecular structure (although not in its genetic code). We are therefore required to decide whether the process of isolating genetic material from a human DNA molecule makes the isolated genetic mate- rial a patentable invention. The court concludes that it does; I conclude that it does not. [Italics as in original.]
Judge Bryson then gives a detailed reasoning for this opinion, citing previous cases. This explanation includes the remark the New York Times cited, here in longer form:
[…] Yet some of Myriad’s challenged composition claims effectively preempt any attempt to sequence the BRCA genes, including whole-genome sequencing. In my view, those claims encompass unpatentable subject matter, and a contrary ruling is likely to have substantial adverse effects on research and treatment in this important field.
In each case, merely isolating the products of nature by extracting them from their natural location and making those alterations attendant to their extraction does not give the extractor the right to patent the products themselves.
Bryson also tackles that the sequences for which patents were sought contain variable regions, a much talked-about point in these patents. (Long story short: these claims are very broad and have impact outside of the BRCA genes.)
Opinions are out everywhere, of course. ‘Rochefort’ in the ArsTechnica comments opined (shown here in full):
Wow, the appeals court got it exactly wrong, IMO. Comparing the sequences from a patient with carcinogenic sequences first discovered by Myriad according to a specific protocol is arguably something that should be patentable. The naturally occurring sequences themselves should not. The court missed a golden opportunity to straighten out some of the worst aspects of current patent law.
You’re welcome to chime in with your own thoughts in the comments.
This article is opinion. I am not a lawyer.
More on Judge Bryon’s dissenting opinion.
I’m struck by Judge Bryson’s words, which I take to be a summary of Myriad’s position, that:
Because the native BRCA genes are chemically bonded to other genes and histone proteins, the majority concludes that cleaving those bonds to isolate the BRCA genes turns the isolated genes into ’different materials.’
My reaction was to think that in removing the histone proteins and other other genes, the gene isolated–what the patent seeks protection for–is left substantially unaltered; it’s a removal of stuff that is not part of the gene, in effect, not a modification of the gene itself. (Small alterations needed for isolation not withstanding.) Reading down, Bryson goes on to write:
[…] In order to isolate the BRCA gene, it is necessary to break chemical bonds that hold the gene in its place in the body, but the genetic coding sequence that is the subject of each of the BRCA gene claims remains the same whether the gene is in the body or isolated. The majority, however, does not agree that the cases are analogous, and indeed appears to have adopted the following rule: Isolated atoms are not patent eligible, but isolated molecules are.
Apart from the arbitrariness of such a rule, if we are to apply the conventional nomenclature of any field to determine whether Myriad’s isolated DNA claims are ’new,’ it would seem to make more sense to look to genetics, which provides the language of the claims, than to chemistry. […]
By ‘the majority’, Bryson is referring to the other judges. (Is it just me, or couldn’t the final sentence of the first paragraph cited is that be read as quite the poke at his colleagues’ reasoning?) There’s much more, but much of it centres on the issue of the material for which patent is sought being the same as in the natural gene. For example Bryson offers:
[…] The use to which the genetic material can be put, i.e., determining its sequence in a clinical setting, is not a new use; it is only a consequence of possession. In order to sequence an isolated gene, each gene must function in the same manner in the laboratory as it does in the human body. Indeed, that identity of function in the isolated gene is the key to its value. […]
I’m curious about the ruling of patenting cDNAs, too. I’d have thought that they were ‘merely’ derived products, but then I’m not a lawyer and true novelty may not be an issue.
I’ve haven’t read the full ruling as yet (and may never find time) – it is very long. Bear this in mind, as my excerpts here are from just one portion of the ruling document.
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