Michael Crichton has an oped in the March 19 New York Times, "This Essay Breaks the Law" on the issues in the Metabolite case--orally argued this week. Can one patent a law of nature?

An excerpt:

• Elevated blood sugar is linked to diabetes.

• Elevated uric acid is linked to gout.

• Elevated homocysteine is linked to heart disease.

• 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.

Is the patent in Metabolite really that broad? My review of the briefs--and I am *not* a patent lawyer--was that Crichton's characterization is not that much of a stretch. (I'd be delighted to heard from someone who thinks it is not). I read the briefs with a vague sense of disbelief. The legal system does some very silly things. But as a general matter it is nudged back onto the path of common sense by judges.

For some reason, in the patent context, this does not seem to be happening consistently. Today I am wondering, what is the role in all this of judicial philosophy? Caution: What follows is speculation, albeit fairly well-informed speculation.

Patent appeals have been (to a large extent) centralized in the Federal Circuit, and the Federal Circuit is home to a significant number of relatively conservative judges, including a number of Reagan appointees. And this generation of appointees is associated with a fairly distinct judicial philosophy--an old-fashioned commitment to the textualism, to plain meaning, to legal certainty, and a distaste for judicial "law-making" as such. Nothing wrong with all that in my book.

But I wonder, can it be overdone? Several scholars, (Dan Burk and Mark Lemley for starters) have noted the reluctance of the Federal Circuit to cite or refer to economic papers or other scholarly work in the patent field. And then there are a whole set of "presumptions" that have been set out in Federal Circuit patent cases, including that at issue in KSR v. Teleflex--the presumption that an "obvious" advance in technology must be explicity taught or suggested by the prior art. And the peculiarly wooden reasoning of Metabolite, which where the rules of thumb at work in the Federal Circuit seem to have as an end result the upholding of a patent claim that in the end strikes an ordinary lawyer, me, as just too much.

I gently suggest that it is indeed possible to carry a judicial philosophy too far. One can search in the patent statutes--or the constitution--endlessly for explicit textual instructions that are simply not there. The gaps have to be filled somehow. But surely there is a better way to do it than by these wooden presumptions. Even if one must bind patent examiners to a set of rules of thumb, as they stand in need of some guidance, the Federal Circuit surely need not constrain itself in this manner. That is why they call them "judges." They are supposed to judge.

posted by Solveig Singleton @ 8:31 AM | Big Tent, Patents, Pharma

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