The Problem Of Patent Protection

Patents are problematic to the biotechnology industry in a number of ways. While they are decidedly helpful to the patentee, they represent a substantial commitment in cost, there are uncertainties in the types and scopes of claims that may be granted and in the interpretation and enforcement of granted claims, said Kate Murashige, a partner in US firm Morrison & Foerster, presenting at the Financial Times conference Biotechnology - A Revolution In The Making, held in London last month.

These uncertainties are pervasive in the patent system and are not limited to biotechnology, she continued. First of all, she said, not enough time has elapsed since the advent of this technology to provide an extensive repertoire of judicial holdings to provide guidance. There are probably less than 10 US Federal Circuit decisions that concern matters that could be classified as biotechnology. Secondly, many patents cover materials and methods that do not constitute final products; most of the activity in this field is still at the research and development stage. It is unclear to many, she noted, whether exclusivity is the appropriate mechanism to encourage invention in this context.

The patent system is supposed to strike a balance between the contribution made by the efforts of the research community to progress in useful areas with the reward that results from limited exclusivity. In the case of the pharmaceutical industry, there is the perception in some quarters that this balance is not correct, because the prices permitted by virtue of exclusivity are thought to be too high.