Patentability and maximum protection of intellectual property in proteomics and genomics.
The patenting of inventions in the proteomics and genomics fields has been prolific in the last few years and should continue in that vein for some years to come. The ingenuity by which inventions can be claimed increases so that even computerized methods for finding useful drugs based on the underlying genomic and proteomic information find their way into patents. However, with the increasing number of patents invalidated and the increasing number of exceptions to patent infringement; the value of new biotechnology patents is being whittled away. First, it may be hard to find potential infringers who improperly practice the claimed invention. Second, these potential infringers may practice in areas of the world where there is no patent protection. Third, the practice may be held by a court not to be infringing activity because it has as its aim the development of a new drug. Finally, the claims may be held invalid for lack of written description or enablement as the courts find mechanisms or reasons to narrow the allowable claims. With this setting, we must consider what can be done to best protect this new generation of inventive activity. Moreover, we must consider the possible demise of the drug pipeline should this trend to narrow protection continue.