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Monday, 17 June 2013

What one hand gives, the other takes away? A deeper look at Myriad

Catering for all tastes, this weblog has provided (i) the breaking news announcement by Jeremy that the US Supreme Court had given its ruling in Myriad Genetics and (ii) a mouth-watering hors d'oeuvres from guest Kat Matthias together with Roberto Romandini in the form of some succinct comments on that decision. Now's the time for (iii) the main course -- elegantly prepared and eloquently presented by IP master chef and former guest Kat Norman Siebrasse.  This is Norman's take on the decision, flavoured with some delicious thoughts of his own:

Association for Molecular Pathology v Myriad Genetics, Inc 12–398, 569 U. S. ____ (2013)

But what exactly is a law of nature anyway ...?
In Myriad Genetics the USSC has held, in a unanimous decision, that claims to isolated DNA are not patentable subject matter, but that claims to cDNA are patentable. The Myriad Genetics decision is better than I had anticipated after the disappointing Prometheus decision -- and not only because of the holding regarding cDNA. The Court’s reasoning turned primarily on its misguided rule against patenting “laws of nature,” and to that extent it is seriously flawed, but there are hints of a better analysis. Moreover, the Court expressly noted that “this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. . . .  Many of its unchallenged claims are limited to such applications” (original emphasis). There is also an important negative point: the Court did not reaffirm its traditional “preemption” rationale for its rule against patenting laws of nature. This suggests that by claiming applications of knowledge relating to newly discovered genes, an inventor may be able to gain the same practical protection as would be possible by a claim to the gene itself.

The patent systems I am familiar with, including the US, the EPC, and the UK pre-EPC, all have a rule against patenting abstract ideas. (For the origin of the rule, see here.) In UK and Canadian law, this is understood as an objection to patenting abstract ideas: “A disembodied idea is not per se patentable. But it will be patentable if it has a method of practical application.” (Shell Oil [1982] 2 SCR 536 at 554, summarizing UK case law.) Laws of nature are often assimilated to abstract ideas, and often, as with “F = ma” stated as such, this is sound. But starting with Funk Brothers , 333 US 127 (1948), the USSC has interpreted this as a rule against patenting inventions based on laws of nature. This is very different. As Frankfurter J pointed out in Funk Bros “[e]verything that happens may be deemed ‘the work of nature,’ and any patentable composite exemplifies in its properties ‘the laws of nature.’ Arguments drawn from such terms for ascertaining patentability could fairly be employed to challenge almost every patent.” Unfortunately, Frankfurter J was in the dissent on this point, and the result has been that the USSC has tended to strike down claims where it is intuitively clear that the invention rests on a discovery of nature, while upholding claims where the invention is, on the surface, a thing. (For a detailed review and critique of the US law on this point, see here.)

This same fallacious reasoning continues in Myriad Genetics when the Court noted (slip op 11-11) that
It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. The question is whether this renders the genes patentable.
Conversely, “the lab technician unquestionably creates something new when cDNA is made” (slip op 17), and it is therefore patentable. This seems to conceive of the invention as a thing, namely the gene itself, which Myriad admittedly did not create, or the cDNA, which it is did create. But in either case, Myriad’s real contribution was knowledge about the function of the gene. And, as Sir Hugh Laddie, has explained, “The invention is a novel mental concept which is embodied in, or exploited through, new products or processes. The patent's function is to enable that concept to be protected in exchange for publishing it to the world so that, after expiry, the public can use it” (American Home Products v Novartis [2000] RPC 547 (Pat) [18], my emphasis). More pithily, Lord Hoffmann noted in Merrell Dow [1996] RPR 76 noted that “An invention is a piece of information.”

With that said, that an invention is information does not imply that the information may be claimed as such. The rule against abstract claims places limits on how information may be claimed. The Myriad Genetics decision hints at this in its response to the argument that isolated DNA is just as unnatural as cDNA:

Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad’s patent claims on entire genes (such as claims 1 and 2 of the ’282 patent) by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule “invented” by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.

This suggests that the Court’s real objection is not that the patents claimed naturally occurring DNA, but rather that it claimed “presentations of information . . . as such,” to put in the terms of EPC Art 52. The difficulty with the Court’s reasoning here is that a proper analysis of this issue would turn on how the claims are construed. It is no doubt true that the claim is “concerned primarily” with the information, but that alone does not make it a claim to information as such, rather than a claim to a molecule embodying that information. The Court seems to have assumed that because the claim is about information, is therefore a claim to information. This again reflects the basic misunderstanding that has dogged the USSC analysis of patentable subject matter for decades: the USSC cannot seem to grasp that there is a difference between a claim to an idea, and a claim to an application embodying that idea. So, this passage is at most a hint at a better analysis, rather than a sound justification for the decision.

How would a proper analysis proceed? Though that rule against abstract claims is fundamental, it has seldom been applied to strike down a claim, and its precise bounds are not clear. I have argued that the rule against abstract claims is probably best justified by the difficulty of determining the bounds of such claims. For example, Morse’s famous eighth claim at issue in O'Reilly v Morse 56 US 62 (1854), to the use of electromagnetism for communication at a distance, should have been held invalid as being anticipated, not just for overbreadth: the claim would encompass semaphores, as light is a form of electromagnetism. But no one could appreciate this at the time, as it was not known that light and electromagnetism were linked. Put another way, if an invention is claimed as a theory, it is necessary for a defendant to know the theory of how its gizmo works in order to know whether it infringes the claim. When an invention is claimed as an application, all that is necessary is to see whether the practical application is the same. On this rationale, a claim to isolated DNA might be invalid if the claim did not provide adequate notice to other as to what activity would be infringing. I suspect that on a proper construction of the claim, a claim to isolated DNA would not offend the rule against abstract claims; but that conclusion would require a very different analysis from that provided in Myriad Genetics.

While the reasoning in Myriad Genetics is deficient, the Court did indirectly affirm one half of the traditional rule as stated in Shell Oil, namely that applications of knowledge are patentable, when it acknowledged that “this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes” (slip op 17-18). Moreover, it made no reference at all to the rationale for the rule against patenting laws of nature offered in cases such as Prometheus, which is that patents based on laws of nature would monopolize or “preempt” that knowledge. The preemption argument is also fallacious; a patentee should be able to monopolize it inventive contribution, in order to ensure that the reward is commensurate with the contribution. By omitting any mention of the preemption rationale, and by affirming the patentability of applications of this knowledge, it may be that the USSC in Myriad Genetics has taken away with one hand, but given with the other. By claiming all applications of the knowledge of a gene sequence, it may well be possible to get the same practical protection that would be offered by a claim to the isolated gene.

Note that the holding regarding cDNA was strictly obiter. The claims at issue in the USSC were claims 1, 2, 5, 6, and 7 of U. S. Patent 5,747,282, claim 1 of U. S. Patent 5,693,473, and claims 1, 6, and 7 of U. S. Patent 5,837,492, all of which claimed an isolated DNA molecule, and all of which are consequently invalid. In addition to these claims, at issue were claim 20 to ‘282, claim 1 of U.S. Patent 5,709,999, claim 1 of U.S. Patent 5,710,001, claim 1 of U.S. Patent 5,753,441, and claims 1 and 2 of U.S. Patent 6,033,857, all of which were methods for screening by comparing the suspect gene with the specified gene sequence. All of these claims were held to be invalid by the Federal Circuit. Claims that were not challenged include transformed cells, primers and kits.
Thanks so much, Norman. We really appreciate your well-informed analysis and hope that our readers will too.

2 comments:

Roufousse T. Fairfly said...

Many of the links are defective.

I think that these ones should work:

-- Association for Molecular Pathology v Myriad Genetics, Inc 12–398, 569 U. S. ____ (2013)

-- Various Myriad patents (at Espacenet)

I have to study the material more in detail before making comments.


s1 (pronounced easy one) said...

Matthias Lamping & Roberto Romandini: An Unanimous; Jeremy: A Unanimous. So the Kats differ Grammatically too...

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