Prometheus Unbound – Are Methods Of Medical Treatment The Next “Targets”?

In my March post “Unnatural Acts – Patenting Diagnostic Tests Post-Prometheus” I wrote:

“I have been trying to formulate diagnostic claims that would pass muster post-Prometheus and I am having trouble. If a researcher discovers the marker, the researcher should be able to patent it and ANY utility it has, including its use for the diagnosis/prediction of disease. Likewise if the researcher discovers a completely new utility for a known marker – e.g., as an  indicator of Alz Disease, this should meet the patent eligibility requirements of s. 101. However, the correlations that the researcher bases the assay claims on are still ‘natural phenomena’ according to Prometheus. So we patent attorneys are completely cycled back into the loop of [divining] what further steps are necessary to yield a patent-eligible claim for the new diagnostic correlation.”

Last night, a new monster crawled out from under the legal bed we have to lie in after Prometheus. It is not simply that diagnostic claims based on “If ‘a’ then ‘b’” naturally-occurring correlations are of doubtful patent-eligibility; we already know that Justice Breyer will exclude such diagnostic claims, such as the one involved in the “Metabolite Dissent,” the first chance he gets – so long as he can hold the Court together. The new monster is a modern Frankenstein stitched together from the language in Prometheus:

“Unlike, say a typical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws…these patents tie up too much future use of laws of nature…”

and the fact that the claims at issue in Prometheus were method of medical treatment claims, although awkwardly drafted. The claims were not diagnostic method claims. The presence or absence of an immune-mediated g.i. disorder was not being “determined.” The Federal Circuit recognized this, or at least that there was a drug administration step in some of the claims, but that analysis did not convince the Supreme Court, which called all the steps surrounding the “natural laws” as adding “nothing of significance to the natural laws themselves.” Slip op. at 18. But what if Claim 1 had been drafted:

“A method of treating an immune-mediated g.i. disorder comprising administering to a subject afflicted with said disorder an amount of a drug providing 6-thioguanine effective to provide a level of 6-thioguanine in said patient between about 230-400 pmol per 8×108 red blood cells.”

Putting commercial value and 102/103 issues aside for a moment, would a claim written like this even have been subjected to a s. 101 challenge? Before Prometheus, I certainly would have said, “No way!” See Bristol-Myers Squibb Co.v. Ben-Venue Labs., Inc., 246 F.3d 1371 (Fed. Cir. 2001), in which the claim in suit was directed to a dosing regimen to minimize side effects. Now, how can we predict where a Supreme Court that has earned the label “anti-patent” will draw the line? Note that Justice Breyer does not include “the use of the new drug” in his short list of “typical patents.” And you “youngsters” should be aware that methods of medical treatment, either surgically or with chemical agents were not considered to be patentable until the 1950’s –See, e.g., Ex parte Scherer, 103 USPQ 107 (Bd .App. 1954). Chisum, in s. 103[3], “Eligible Subject Matter” gets this far in his analysis and then just stops:

“Scherer is only a decision within the Patent Office, and the opinion concerned an injection technique found not to be ‘dependent…upon the…physiological reactions of the human body.’ Hence, it cannot be taken as strong authority for the patentability of medical and surgical methods generally.”

Then what does? Congress added Section 287(c) to the patent statutes in 1996 to immunize doctors and their employers from liability for infringing patents claiming “medical activities” such as surgical procedures and its language expressly excluded from “medical activities,” “the practice of a patented use of a composition of matter in violation of such patent.” So let’s hope that after claims to simple but useful applications of natural correlations, like the correlation of elevated PSA levels with prostate cancer, are ruled patent-ineligible, Justice Breyer will be content to have brought his Metabolite dissent into the majority and stop dismantling a patent system that has done so many of us so much good – and I don’t mean just those skilled in the “draftman’s art.”

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