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November 19, 2009


The problem with the patent office examiners is that most of them neither understand the complexities of the written description case law nor the nuances of the scientific differences being claimed by the present day biotech inventions. In part that is because of the Fed. Cir. seemingly higher burden for biotech patents, because it seems, any thing that relates to biotech appears to be unpredictable and any knowledge of the skilled artisan is uncoupled from the analysis.

In 1911, Judge Hand concluded the opinion in Parke-Davis v. H.K. Mulford Co. with the following paragraph:

I cannot stop without calling attention to the extraordinary condition of the law which makes it possible for a man without any knowledge of even the rudiments of chemistry to pass upon such questions as these. The inordinate expense of time is the least of the resulting evils, for only a trained chemist is really capable of passing upon such facts, e.g., in this case the chemical character of Von Furth's so-called "zinc compound," or the presence of inactive organic substances. In Germany, where the national spirit eagerly seeks for all the assistance it can get from the whole range of human knowledge, they do quite differently. The court summons technical judges to whom technical questions are submitted and who can intelligently pass upon the issues without blindly groping among testimony upon matters wholly out of their ken. How long we shall continue to blunder along without the aid of unpartisan and authoritative scientific assistance in the administration of justice, no one knows; but all fair persons not conventionalized by provincial legal habits of mind ought, I should think, unite to effect some such advance.

Sadly, his call for change went unheeded. As Professor Holman has pointed out, the body of biotechnology case law is rife with inconsistencies. Generalist judges cannot be expected to master the field of molecular biology, so what else can we expect as long as the current model endures?

Dear SKD:

Yes and no. I think that one of the problems with PTO examination is that the kinds of bright-line rules that are easy to apply with simple technology get harder to apply as the technology gets more complex. It isn't that the knowledge of the skilled worker is disregarded, but that the skilled worker knows less a priori the more unpredictable the technology becomes.

Thanks for the comment.

Dear AWD:

What I have always found most bracing about Judge Hand's legal analyses is the courage and humility with which he addressed his own lack of knowledge. He did not (as some current members of the Supreme Court have made it a habit of doing) believe that the science needed to bend to the law. His was not a simple "We decide." Your quotation illustrates his commitment to finding the truth, wherever it may lay and using whatever tools he could command, without the arrogance of thinking that finding and using such tools were beneath the court's notice. We live with the great fiction that judges judge and that we must be satisfied with those judgments; Judge Hand points out that there is another way, if we were only smart enough to admit we should take it.

Thanks for the comment.

Well put, Kevin. Thanks for the reply and for a consistently doing a great job with your blog.

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