|The current composition of the US Supreme Court|
The Association for Molecular Pathology (and other plaintiffs) sued Myriad, seeking invalidation of the contested claims. AMP asserted that the claims covered products of nature, laws of nature, natural phenomena, abstract ideas or basic human knowledge, disputing the subject matter's patentability, in light of 35 U.S.C. §101. Further, it argued that the patents hindered scientific research and innovation, prevented competition and threatened patients' rights. Myriad relied on the USPTO's practice, which expressly recognised the patentability of isolated DNA sequences, and claimed that the isolation process resulted in a transformation which rendered the matter patentable. On March 29, 2010, the District Court for the Southern District of New York declared the contested claims invalid, observing that, 'because the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter under 35 U.S.C. § 101', reaching the same result with regard to the method of comparison of DNA sequences, deemed to be an non-patentable abstract mental process.
On appeal (as reported by the IPKat here), the US Court of Appeals for the Federal Circuit overturned the District Court's decision in part, ruling that both isolated DNA sequences and cDNA, as well as the claimed screening method (which implied assessing potential cancer therapeutics via changes in cell growth rates) were patentable subject-matter (only the method of comparison of DNA sequences was deemed invalid). The Court of Appeals also observed that the patentability of DNA sequences comported with the long-standing practice of the USPTO, adding that:
Because isolated DNAs, not just cDNAs, have a markedly different chemical structure compared to native DNAs, we reject the government’s proposed “magic microscope” test, as it misunderstands the difference between science and invention and fails to take into account the existence of molecules as separate chemical entities. The ability to visualize a DNA molecule through a microscope, or by any other means, when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable. It is the difference between knowledge of nature and reducing a portion of nature to concrete form, the latter activity being what the patent laws seek to encourage and protect. The government’s microscope could focus in on a claimed portion of any complex molecule, rendering that claimed portion patent ineligible, even though that portion never exists as a separate molecule in the body or anywhere else in nature, and may have an entirely different utility. That would discourage innovation. ... Visualization does not cleave and isolate the particular DNA; that is the act of human invention.
|What happened to my DNA?|
- Is the isolation or extraction of natural products patentable?
Suppose there is a substance, a chemical, a molecule in the leaves of a plant that grows in the Amazon, and it's discovered that this has tremendous medicinal purposes. Let's say it treats breast cancer. A new discovery, a new way is found, previously unknown, to extract that. You make a drug out of that. Your answer is that cannot be patented; it's not eligible for patenting, because the chemical composition of the drug is the same as the chemical that exists in the leaves of the plant.
Justice Sotomayor posed a tricky question to Mr. Castanias:
I have a sort of analytical problem. I find it very, very difficult to conceive how you can patent a sequential numbering system by nature, in the same way that I have a problem in thinking that someone could get a patent on the computer binary code merely because they throw a certain number of things on a piece of paper in a certain order. I always thought that to have a patent you had to take something and add to what nature does. So how do you add to nature when all you are doing is copying its sequences?Mr. Castanias answered that 'there was invention in the decision of where to begin the gene and where to end' it. He also recited 35 U.S.C. §103, which states that '[p]atentability shall not be negated by the manner in which the invention was made' and made ample reference to the USPTO practice and guidelines (in particular, §2107). The respondent focused on the fact that inventive human intervention is needed to identify, extract and use genes, even though they are a naturally occurring substance. 'The goal of medicine', Mr. Castanias added, 'is to get closer to nature, rather than farther away'. Thus, 'anything that takes the product of nature doctrine beyond the simple truism that the product of nature is something that is not a human invention, then that's very dangerous...'.
Justice Kagan asked Mr. Castanias whether he considered chromosomes to be patentable. The cunning trap was set and Justices Kagan and Sotomayor got to a much more dangerous question (and Justice Breyer showed similar concerns, in relation to the requirements set by §101):
So, you know, if not the more smaller unit in the chromosome, you know, we could just go up from there and talk about all kinds of parts of the human body, couldn't we? Couldn't we get to, you know, the first person who found a liver? (Justice Kagan)Mr. Castanias cited the Chakrabarty case to argue that §101 should be interpreted broadly. Justice Breyer noted that such a broad understanding would lead to the eligibility of 'anything under the sun'.
So what's the difference? I mean, if you cut off a piece of the whole in the kidney or liver, you're saying that's not patentable, but you take a gene and snip off a piece, that is? (Justice Sotomayor)
- Are there sufficient incentives for genetic research, if genes are non-patentable?
If you assume that it takes a lot of work and takes a lot of investment to identify this gene, but the gene is not changed in composition, and what you just said is that discovering uses for that gene would not be patentable even if those uses are new, what does Myriad get out of this deal? Why shouldn't we worry that Myriad or companies like it will just say, well, you know, we're not going to do this work anymore?Mr. Hansen's elusive answers (which pointed to public financing, curiosity, enormous recognition, Nobel prizes) appeared not to please the Court. But Justice Sotomayor accepted the idea that the prospect of obtaining a process or development patent may still fuel research in this field.
Chief Justice Roberts discussed with General Verrilli about the distinction between eligibility requirements and issues of obviousness: the Solicitor General made references to Mayo Collaborative Services and Diamond v Chakrabarty. Justice Alito wondered if focusing on the eligibility stage would be the best solution:
Why should we [focus on §101]? We have claims that if patent eligibility is denied here it will prevent investments that are necessary for the development of new drugs or it will lead those who develop the new drugs, new diagnostic techniques, to keep those secret, not disclose them to the public. Why should we jump in and decide the broadest possible question?General Verrilli observed that in Germany and France it is possible to obtain patents on isolated genomic DNA only for a particular use. He suggested that a similar solution would yield an optimal result, preserving research on non-patentable genes, but allowing use patents, which secure the recoupment of research investments.
Justice Kennedy asked Mr. Castanias if a decision accepting the patentability of cDNA, and rejecting that of DNA sequences, would 'give the industry sufficient protection for innovation and research'. The respondent somehow evaded the answer, focusing instead on the utility guidelines and on the manipulation that occurs when isolating DNA: this is similar, according to Mr. Castanias, to what happens in relation to other molecules which are peacefully considered patentable.
- Differences between DNA and cDNA
Mr. Hansen focused on the process through which cDNA is made, noting that, although manipulation does occur, 'it's letting nature manipulate, not the scientists'. He pointed to the differences between the processes that allow the production of cDNA and aspirin: only the latter results in an alteration of the function of the natural substance, as cDNA and DNA, instead, have exactly the same function.
General Verrilli provided an overview of the distinction between DNA and cDNA and the possible consequences of their patentability:
The claim that isolated DNA is a human invention rests entirely on the fact that it is no longer connected at the molecular level to what surrounded it in the body. But allowing a patent on that basis would effectively preempt anyone else from using the gene itself for any medical or scientific purpose. That is not true about a patent on cDNA. A patent on cDNA leaves the isolated DNA available for other scientists and others in the medical profession to try to generate new uses.The oral arguments offered an occasion to perceive the general orientation of the Supreme Court. It appears that judges were not particularly persuaded by arguments pointing to the patentability of isolated DNA sequences, whereas they exhibited higher sensitivity towards the patentability of cDNA, as suggested by the US Government. The decision is expected by the end of June, but a reasonable guess is that focusing on patents that protect methods, processes and uses, as suggested by Justice Sotomayor, might be the key to guarantee equal protection to all the interests at stake.