Abstract

In this short presentation I will attempt to accomplish a couple of different goals. First, I will discuss a series of recent cases that set Out the doctrine for biotechnology patenting. Judge Lourie of the Federal Circuit has written most of the opinions, and recently one or two other judges have joined in. Looking at these cases is much like looking at a wonderful machine, as the cases progress in a very deterministic and Euclidean manner. Judge Lourie and, to some extent, his colleagues started out with some axiomatic propositions about patent law and biotechnology. They then worked in a syllogistic manner to reach a number of conclusions. Consequently, the case law forms a very intellectually beautiful, very internally consistent, very precise framework for thinking about biotechnology patents in the Federal Circuit.

These cases fit together doctrinally like a beautiful precision instrument, which explains the "clockwork" metaphor in the title of my presentation. But, of course, when looking at a beautiful piece of machinery that functions like a clock or like clockwork, the next question might be whether this wonderful precision instrument bears any relation to reality. And it very well may be that the clock actually does not tell time particularly well, or was set to tell the time in some other time zone. It might work some part of the time; as the saying goes, even a broken clock is right twice a day. But most of the time such a clock would not be especially helpful in keeping people on schedule.

That is where the "lemon" part of the title emerges. The case law developed by the Federal Circuit may constitute a wonderfully intricate and very precise axiomatic framework, but it may not be useful if it bears no relationship to the actual needs of the biotechnology industry. I am going to suggest that it does not. Although it is internally consistent and intellectually fascinating and quite intellectually compelling, the legal framework does not fit very well with what innovation theory tells us society would want to construct for the biotechnology industry. The framework does not work with the innovation profile of the biotechnology industry, and probably does not provide the necessary incentives for innovation in the biotechnology industry. Finally, I am going to suggest some ways society might fix the clock or think about fixing the axiomatic system that the Federal Circuit has developed.

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