Patent Law for Biopharmaceuticals

Abstract

The patenting of all technological innovations has to be accommodated within one and the same patent law. This is true for engineering, physics, chemistry, and biotechnology in all their many sub-categories. To be patentable, biopharmaceuticals and their processes of manufacture have to meet the same three legal tests of novelty, inventiveness, and practical utility as do the simpler compounds and preparative methods of synthetic chemistry. As for all such other inventions biopharmaceuticals must also be capable of adequate description and defmition in the patent specification, the all-important document upon which rest all questions of patent scope (how much the patent covers) and patent validity (whether it is enforceable).

It is in this last of these legal requirements that biopharmaceuticals present a special case, because of their exceptionally complex structure and the complexity of the methods by which they are prepared.

For the first generation of biopharmaceuticals the requirement of novelty had the important consequence that the recombinant forms of the blood proteins and other valuable naturally-occurring proteins could not be patented as products. This will be explained in some of the case studies to be outlined below, but first it may be helpful to summarise some basic distinctions between product and process patents. These distinctions are concerned entirely with the ‘claims’ of the patent i.e. the legal clauses which come after the technical description and form the last and most important section of the specification.