"[M]arkedly different characteristics from a product of nature"
So I've finally had the time to read through last week's 156-page ruling in "Association for Molecular Pathology v. US PTO", the case which challenged the patents held my Myriad Genetics on the BRCA1 and BRCA2 breast cancer genes. It's a delight to read, in that Judge Sweet clearly took great pains to understand the molecular biology involved.
There are two basic types of claims in the patents under discussion: some on the "composition of matter" that is the actual, physical molecules encoding the BRCA genes, in purified form, and some "method" claims on the way to use the BRCA sequences to diagnose cancer questions. The method claims were ruled invalid mostly under the precedent from in re Bilski, a Federal Circuit decision which is in the middle of being appealed to the Supreme Court, which pretty much sets the standard for what method claims can cover.
But the really interesting part is the invalidation of the "composition" claims, in which Judge Sweet lays out a clear case for the idea that, as a matter of law, human genes are inherently not patentable.
Everyone agrees that you can't patent a "product of nature" — if there is some naturally-occurring bacterium that has useful properties, for example, you can't discover that this is the case and patent it. Things are a little trickier when you purify some substance found in nature; in that case, it may be possible to patent the resulting purified substance if it has "markedly different characteristics" from the naturally-occurring material. Myriad wants to prevent any other company from diagnosing breast cancer tendencies based on mutations of the BRCA genes, so it needed to argue that its molecules of pure BRCA-sequence DNA has markedly different characteristics from DNA found in your body.
And Judge Sweet found that it did not. His argument (pp. 121–135) comes in three parts, and I like every one of them:
There are two basic types of claims in the patents under discussion: some on the "composition of matter" that is the actual, physical molecules encoding the BRCA genes, in purified form, and some "method" claims on the way to use the BRCA sequences to diagnose cancer questions. The method claims were ruled invalid mostly under the precedent from in re Bilski, a Federal Circuit decision which is in the middle of being appealed to the Supreme Court, which pretty much sets the standard for what method claims can cover.
But the really interesting part is the invalidation of the "composition" claims, in which Judge Sweet lays out a clear case for the idea that, as a matter of law, human genes are inherently not patentable.
Everyone agrees that you can't patent a "product of nature" — if there is some naturally-occurring bacterium that has useful properties, for example, you can't discover that this is the case and patent it. Things are a little trickier when you purify some substance found in nature; in that case, it may be possible to patent the resulting purified substance if it has "markedly different characteristics" from the naturally-occurring material. Myriad wants to prevent any other company from diagnosing breast cancer tendencies based on mutations of the BRCA genes, so it needed to argue that its molecules of pure BRCA-sequence DNA has markedly different characteristics from DNA found in your body.
And Judge Sweet found that it did not. His argument (pp. 121–135) comes in three parts, and I like every one of them:
- The primary characteristic of DNA — as distinct from just about every other molecule that occurs in nature! — is the information carried in the sequence of Cs, Gs, As, and Ts that make it up. The isolated DNA has just the same information content as the naturally-occurring molecules inside your cells, so this can't possibly be the marked difference. (The ruling nicely addresses splicing and intron issues here too.)
- Aside from information content, purified DNA can also be used chemically — as a probe, or as a primer for PCR, for example. This works because of single-stranded DNA's vital chemical property of binding with another strand that is a perfect base-for-base complement. But in that case, Judge Sweet keenly observed, the purified DNA that Myriad uses must be acting identically to DNA already inside your body: the DNA in your cells does the base-pairing trick, and Myriad's purified DNA would be useless if it weren't acting identically to the naturally-occurring stuff.
- Finally, there's a very on-point precedent: Funk Brothers v. Kalo, in which the Supreme Court invalidated a patent on a certain combination of strains of bacteria that fixed nitrogen without inhibiting each other. In Funk Brothers, the patent attempted to cover (a) the discovery that these particular strains didn't inhibit each other, and (b) the innovation of aggregating these specific strains together. Part (a) was rejected on the grounds that you can't patent the discovery of some fact of nature; part (b) created a new composition of matter by applying that discovery, but only using "techniques well-known to those skilled in the art" once you know (a). The parallel is that Myriad's case included (a) figuring out which segments of DNA were the genes now called BRCA1 and BRCA2, and (b) isolating those sequence fragments outside the cell. Yep.
