Wednesday, March 21, 2012

The Patent Religion suffers a blow: reading tea leaves on AMP v Myriad in the Mayo v. Prometheus decision by SCOTUS

The Patent Religion's believers think that "anything under the sun made by man" is patent-eligible, even where nature made it first. This is the liturgy to which they appeal when challenged about patenting "isolated" or "synthesized" natural products. They think it means that even scientific discoveries, if properly couched in some "transformative" phrasing, are sometimes man-made. This was the case in the Mayo v. Prometheus case in which the patented claims included the correlations between, on the one hand, thiopurine drug metabolite levels and, on the other hand, efficacy and toxicity. These correlations were discovered through empirical research, they were not created. But the unfortunate wording of the Patent Act in the US, which makes patentable any new invention or "discovery" has enabled the patent lawyers to continue to argue that there is essentially no boundary between science and technology. Fortunately, the Supreme Court just burst their bubble. The Court's decision can be found here and should be read by one and all. Justice Breyer, a long-time skeptic of IP-lawyers' rhetorical tricks, pokes through the claims to look at the underlying subject matter. He does an ontologist proud.

While the unanimous decision makes worthy policy arguments about the negative effects on innovation of granting monopolies too far upstream, it also goes a fair way in describing the distinction between laws of nature, and something inventive and patent-eligible. From the decision's syllabus, the following language says it all:

"Because the laws of nature recited by Prometheus’ patent claims—the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm—are not themselves patentable,the claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations. The three additional steps in the claimed processes here are not themselves natural laws but neither are they sufficient to transform the nature of the claims. The 'administering' step simply identifies a group of people who will be interested in the correlations, namely, doctors who used thiopurine drugs to treat patients suffering from autoimmune disorders. Doctors had been using these drugs for this purpose long before these patents existed ... The 'wherein' clauses simply tell a doctor about the relevant natural laws, adding, at most, a suggestion that they should consider the test results when making their treatment decisions ... The 'determining' step tells a doctor to measure patients’ metabolite levels, through whatever process the doctor wishes to use."

Patenting is not a game. Simply trying to squeeze square pegs into round holes using magical phrases will not do. There is a reality that must be observed, and rhetorical tricks aside, the claimed "inventions" were merely scientific discoveries about facts of nature. In this case, the Supreme Court has made both a logical and ontologically-grounded decision, recognizing that even where a claimed invention might be "man-made" it is not created by humans. Where a claim encompasses something that nature created, it cannot be eligible for patent, and fails under section 101.

Already, the patent lawyers have gone apoplectic, claiming that the Supreme Court is not qualified to make such decisions. The wailing and gnashing of teeth is certain to grow before it fades. Industry will not come to a halt, but science can flourish a little less hesitantly, secure in exploring nature and her truths without impinging upon some governmentally-created monopoly.

So what does this mean for gene patents, and the much anticipated AMP v. Myriad, Supreme Court showdown? Notably, Myriad had submitted an amicus brief in the case for the losing side. They know the implications of this decision for their practices and patents. Of course, I think the writing is on the wall. Breyer's language is sufficiently broad and suggestive in the Mayo v. Prometheus decision to indicate that they will be very skeptical of claims by Myriad that "isolated" sequences, not created by man, but identified as existing in nature, are patent-eligible. Procedurally, the case is interesting because in late February everyone expected SCOTUS to either accept the appeal on certiorari, and reconsider the case, or reject the cert petition and let the CAFC decision stand. But nothing happened. Some speculated that they were booting it over to the Solicitor General, who had put in an amicus brief opposing Myriad, to change his mind. But perhaps there is a clue here as to what's going on from the procedural history of Mayo. After the Bilski decision, SCOTUS kicked Prometheus back to the appellate court to reconsider the case in light of Bilski. They did that, and did so wrongly, upholding their previous decision, only to get overturned by a unanimous Supreme Court. Could SCOTUS now do the same with the Myriad case, and if they do, will the Federal Circuit once again ignore SCOTUS, make the wrong decision, only to get overturned, or will they actually try to apply the law of the land? Time will tell.

** UPDATE **

The Supreme Court has scheduled a meeting on the Myriad case for Friday, Mar 23. It seems likely, based on the Mayo v. Prometheus ruling that they will remand to the appellate court, or take the case up on cert. It seems highly unlikely that they would refuse cert outright. We should know by Monday.

** UPDATE **

The Supreme Court vacated and remanded the appellate court judgment for further consideration in light of their reasoning in Prometheus. This makes the district court's ruling current law of the case (with no precedential effect), and means we must hold our breath until the CAFC makes a ruling (which might, if they apply Prometheus honestly, find the product patents invalid). Let's hope!

1 comment:

Arthur Gershman said...

"Patent-Industrial Complex is a great name, but doesn't go far enough. Bayh-Dole allows the universities to participate in the "gold rush." In my book I call it the "Biotech Industry-Government Patent Complex." Keep up the good work. Oral arguments in Myriad II are scheduled for July 20.