"INFORMATION PLEASE!" – BILSKI TAKES IT TO THE SUPREMES

Reading the transcript of the oral arguments presented yesterday (a copy is attached at the end of this posting) as Bilski was presented to the Supreme Court, I was struck by how quickly certain Justices homed in on one of the last frontiers of patentable subject matter, namely whether or not the simple transmittal of information from one person to another should be patentable subject matter. Particularly, Justice Breyer’s first question was to ask whether or not a method of teaching antitrust law could be patentable subject matter [laughter]. Justice Sotomayor then mentioned “speed dating.” Bilski’s counsel replied that, while the data itself is not patentable, “but if it is a series of steps,” it might be. Breyer demanded that counsel “make that balance in terms of information.” Sotomayor asked “[Doesn't there have] to be something more substantive than the mere exchange of information; that it has to involve…’transformation’? [The Fed. Cir.] hasn’t defined the outer limits of what it means by that.” Counsel Jakes, “Yes.”

Suddenly, I thought of a fairly obscure but interesting decision, In re Ngai, 367 F.3d 1336 (Fed. Cir. 2004). The claims in question were to a “kit” for amplifying RNA comprising certain known reagents and “instructions describing the [amplification] method of claim 1.” In other words, the only “point of novelty” was the instructional material. The court affirmed the rejection below, and distinguished In re Gulack (where a sort of circular slide rule was claimed), stating:

As the Gulack court pointed out,”[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” If we were to adopt Ngai’s position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product. This was not envisioned by Gulack. Ngai is entitled to patent his invention of a new RNA extraction method, and claims covering that invention were properly allowed. He is not, however, entitled to patent a known product by simply attaching a set of instructions to that product.”

“Hold on,” you may say, “this is a section 102 rejection, not a section 101 decision.” But I re-read this decision after being asked to opine about the potential patentability of claim in a published application. I will simplify it as follows: “A method of increasing the safety of drug x by providing instructions to a patient taking drug x to stop taking drug x if side effect y is observed.” One of the other claims recited the further step of providing drug x to the patient and then providing the patient with the warning (label, most likely). But there was no step involving administering the drug or adjusting the dosage.

This is about as pure a claim to a transmittal of information between two people as I can think of, that does not come off as a judicial joke (“speed dating”). It might be categorized broadly as a method of medical treatment. As Justice Sotomayor questioned, “Do you think that there is some benefit to society from patenting a method to cure someone that just involves human activity, as opposed to some machine, substance or other apparatus to help that process?” The answer is “yes.” In fact, there was some discussion before the Supreme Court relevant to the fact that pure surgical methods are patentable, even after Congress acted to limit damages for infringement.

The “warning claim” I summarized would also seem to be an attempt to answer this question affirmatively, and to patent “the mere exchange of information.” Hopefully the Bilski Court will not attempt to resolve this question, as they deal with the “machine or transformation test” that is before them, but a number of the Justices are certainly interested in the broader issue a la the Metabolite Labs, dissent by Justice Breyer et al. Mr. Stewart for the PTO made it clear that he hoped that the S. Ct. would not muck around in “software innovations or medical diagnostic techniques.” We can only hope.

Bilski Transcript.pdf

2 Responses to “"INFORMATION PLEASE!" – BILSKI TAKES IT TO THE SUPREMES”

  1. G.K. Cooper, Ph.D., J.D. says:

    Warren sayeth: "As Justice Sotomayor questioned, "Do you think that there is some benefit to society from patenting a method to cure someone that just involves human activity, as opposed to some machine, substance or other apparatus to help that process?" The answer is "yes." In fact, there was some discussion before the Supreme Court relevant to the fact that pure surgical methods are patentable, even after Congress acted to limit damages for infringement."

    One might wonder just what benefit there is for society to raise the barrier to physicians providing warning information about possible side effects of drugs to patients. Scenario: pharma company patents drug and use thereof. In a separate filing, pharma company claims administering the drug in conjunction with the giving of instructions to discontinue use if hair falls out, etc. Second patent, not claiming the priority of the first patent, expires later. During that interval, a physician prescribing a generic version of the drug would be barred from instructing the patient to discontinue use if the harmful side effect is experienced! Or the physician must obtain a license from the patentee to do so!

    And this is good for society?

    It is not just a restriction of free speech, it is detrimental to the patient, interfering with the giving of honest advice. That would make allowing such claims hard to justify from the perspective of anyone BUT the patentee (and perhaps his attorney). Who else benefits?

    Such a legal limitation reminds of the one-time government restriction on a physician receiving federal funds from discussing abortion with a patient.

    Patents are rightly given for inventions, not for restrictions on free speech and interference with patient care.

  2. Anonymous says:

    "We can only hope."

    Your statement assumes that the absence of patent protection for methods for correlating traits with biological markers will mean less commercially available tests based on the correlations. First, there is no basis in reality for this assumption. We're not talking developing and commercializing a drug here. We're talking about tests. Certainly it takes some amount of time and money to get a test developed and commercialized, but it is trivial relative to a drug. I mean, it costs money to start a coffee shop too. Second, even if the assumption is correct to any degree, is that so bad? Do you know how many crappy tests there are on the market? For every BRCA1/BRCA2 test (which isn't even THAT predictive), there are a hundred that are pure snake oil. Third, do you know where all the correlations are discovered? They're discovered at universities, government agencies, and non-profit research institutes. The discovery underlying the patents at issue in Prometheus v. Mayo was made at CHU Saint-Justine in Montreal. The discovery underlying the patent at issue in LabCorp v. Metabolite was discovered at the University of Colorado and Columbia. The list goes on forever. Do you think that these entities are going to stop discovering these correlations if there is no patent protection available to them? Of course not. Everybody accepts as gospel that Bayh-Dole has been this incredible thing, but where is the evidence? I'm not saying that it's had a negative impact (although some people would), just that it's not had a positive impact. I'd say it's had no impact whatsoever. If you want a guarantee on your investment for bringing a test based on a biomarker correlation to market, the way to handle that is through a regulatory exclusivity scheme. Just as is CURRENTLY done with new chemical entities and orphans. Certainly this would add a cost, namely greater scrutiny as to a test's "efficacy," but again, is that so bad?

    The gravy train is coming to an end.