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Crichton's Comments On Patentable Subject Matter: Imaginary Or Real?

In the face of the Metabolite case impending before the U.S. Supreme Court, Michael Crichton published an op-ed in the New York Times on March 19, 2006.

Important text at the beginning is the following:

• Elevated homocysteine is linked to B-12 deficiency, so doctors should test homocysteine levels to see whether the patient needs vitamins.

ACTUALLY, I can't make that last statement. A corporation has patented that fact, and demands a royalty for its use. Anyone who makes the fact public and encourages doctors to test for the condition and treat it can be sued for royalty fees. Any doctor who reads a patient's test results and even thinks of vitamin deficiency infringes the patent. A federal circuit court held that mere thinking violates the patent.

All this may sound absurd, but it is the heart of a case that will be argued before the Supreme Court on Tuesday. In 1986 researchers filed a patent application for a method of testing the levels of homocysteine, an amino acid, in the blood. They went one step further and asked for a patent on the basic biological relationship between homocysteine and vitamin deficiency. A patent was granted that covered both the test and the scientific fact. Eventually, a company called Metabolite took over the license for the patent.

Right off the top, there is a bit of confusion in need of clarification. A corporation was not involved in the filing of the patent application. Three university professors, two from Colorado and one from Columbia, filed the application, the research funding for which came from the federal government. The patent is a manifestation of the Bayh-Dole Act, passed in 1980, which facilitates the granting of patents based on research funded by the federal government. A company (Metabolite) later obtained rights in the patent.

Crichton's essay concluded:

The Supreme Court should rule against Metabolite, and the Patent Office should begin to reverse its strategy of patenting strategies. Basic truths of nature can't be owned.

Oh, and by the way: I own the patent for "essay or letter criticizing a previous publication." So anyone who criticizes what I have said here had better pay a royalty first, or I'll see you in court.

On March 19, 2006, I emailed a letter to the editor of the New York Times concerning the Crichton op-ed. There was no acknowledgement by the Times, and the letter was not published. The text of the letter follows:

Michael Crichton's article ("This Essay Breaks the Law," March 19) conjures up frightening issues, which like dinosaurs and trolls, may be presently more imaginary than real. The patent at issue, US 4,940,658, derived from university workers operating under a federal grant, and thus comes to us through the Bayh-Dole Act. These people are represented by a professor from the Stanford Law School generally considered an advocate of patent reform. In a different area, one recalls that the Eolas patent, at issue in the Microsoft case, came from a professor at UC/Berkeley and was ably defended in re-examination by professors from Princeton and Michigan. The claim at issue in the Metabolite case is (schematically) a method of measuring a deficiency of X in warm-blooded animals by assaying a body fluid for an elevated level of Y and correlating an elevated level of Y with a deficiency in X. X can be cobalmin or folate and Y is homocysteine. This claim cannot be infringed merely by thinking about the correlation or writing about the correlation. In the current dispute, between two companies, Metabolite and LabCorp, the argument by defendant is that the correlating step is so vague that the claim amounts to patent protection over a basic scientific fact (the observed correlation) and thus is invalid. People can disagree over the patentability of methods employing correlations which were discovered as the result of research, and the Supreme Court may shed some light on this issue. What Crichton ignored is that patents of this type, which are more of a tool to accomplish an end than an end product, have been fostered by the Bayh-Dole Act, and are the logical consequence of basic researchers, such as government-supported academics, entering the patent arena. The COX-2 patent of the University of Rochester is an even more extreme example of the phenomenon. Although there can be legitimate concerns about what is being patented these days, an inquiry into the source of the problem is also helpful.

Based on the oral arguments before the Supreme Court, it is unlikely that the Court will rule on the patentability arguments presented in the Crichton op-ed and within certain amicus briefs. There will not be an immediate resolution of the issues through the Metabolite case.

Five days BEFORE the Crichton op-ed, there was a March 14 meeting on stem cell patent issues in California, at which WARF noted the likelihood that it would seek patent royalty payments from California's stem cell agency, CIRM. Jennifer Washburn's article in the April 12 Los Angeles Times attacking WARF utilized Crichton-esque arguments.

Separately, Harvard, MIT and Ariad stake their patent infringement claim against Lilly on their discovery of the working of "nuclear factor-kappa B." The corporation Lilly defends against the academic onslaught by asserting that the university patent is invalid because it is "simply a discovery of a natural principle that has occurred in nature for 200 million years, a Crichton-esque defense. Lilly also asserts that the university patent application(s) were at the U.S. Patent and Trademark Office for 16 years before the USPTO decided the discovery warranted a patent.

In an article in the Stanford Law Review in November 2005 ("Patenting Nanotechnology"), Professor Mark Lemley favorably discussed patents to Columbia University professor Axel. Lemley did not mention that Axel and Columbia had tried to extend the lifetime of the patents through the use of continuations, a practice that Lemley elsewhere had criticized. In a sublime irony, the district court judge in a case involving the lifetime extension, cited an article by Lemley on abuse of continuations to criticize the same Axel work that Lemley had praised in November 2005:

In the instant case, the '275 patent was issued twenty-two years after the application from which it derives was filed. There were several delays in the prosecution of the application. Columbia [University] has provided no evidence, or even argument, to explain why it took twenty-two years to obtain the '275 patent or to justify the delays in that process. n6 The timing of its issuance strongly suggests that Columbia deliberately delayed obtaining a patent that it always intended to secure in order to make it effective just as the other Axel patents expired and thus increase its commercial value by maximizing the period in which the public would have to pay Columbia royalties for the use of the Axel patents.

n6 "Analyzing the 2,224,379 patents that issued from 1976 through 2000, two commentators found that prosecution of these patents 'took an average of 2.47 years from the earliest claimed filing date to issuance date.'" Pls.' Mem. in Supp. of Mot. for Prelim. Injunction at 29 n.8 (quoting Mark A Lemley & Kimberly A Moore, "Ending Abuse of Patent Continuations," 84 B.U. L. Rev. 63, 71 (2004)).

It's nice to be on both sides of the same question, but real patent policy has to be based on consistent application of neutral principles. Crichton's op-ed needs to be reviewed with thorough attention to the Bayh-Dole Act. A simplistic analysis involving "bad corporations patenting laws of nature" doesn't work as a general matter. To a large degree, the enemy is us. The public funds the universities and instructs them to get patents.

More importantly, the Crichton approach isn't going to work in the coming era of state-funding (and state-patenting) of results in the area of embryonic stem cell research. Labeling patents of Wisconsin as bad (because they are first) is a bit silly, when all the states, including California and New Jersey, are seeking patents, and royalties, in the stem cell area.

[As an aside to an earlier ezine submission on the use of Google, with its PageRank feature, to obtain usefully-prioritized search results, I note the following "first page" hits on the title of Crichton's op-ed:

unixthugs.org/l/6IxK
digg.com/security/
www.drudge.com/news/79433/crichton-essay-breaks-law
reddit.com/info/39zm/comments

If there is anybody who seriously thinks these are the most valuable webpages on Crichton's op-ed, please feel free to comment herein.]

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