The biotech discovery process is very different than designing a machine or computer program where the intent and use of the invention is known from the beginning. Patent applicants often add information to an application as new clinical data comes in. While a drug cannot be modified after the application, the scientist may collect additional clinical data, conduct a literature search to provide new findings from the field or dig through old lab notebooks for evidence that their drug will hit the specific disease targets named in the application.
The patent and trademark office said the changes would help prevent abuses of the system. Some legal scholars have argued the biotech industry takes advantage of the patent process, and submits applications before new drug candidates have been thoroughly investigated. In these cases the patent application is used to curtail competitors while the research process continues. This goes against the fundamental nature of the patent process, which has never allowed a patent application to serve as a "hunting license." The USPTO also said the changes would help cut down on paperwork. The agency received more than 467,000 applications in 2007, and about 30 percent were continuations. There are currently about 760,000 backlogged applications awaiting review.
The rule changes also limited applications to 25 claims -- the items named in a patent that define the diseases a new drug will treat