A U.S. district court in Virginia on April 1 ruled against the U.S. Patent and Trademark Office, agreeing with international pharmaceutical company GlaxoSmithKline, which argued that proposed changes to the patent process would prevent the industry from protecting new inventions.
Last fall, the patent and trademark office approved regulatory rule changes that limited the number of times a patent application can be resubmitted. The rule changes also limited applications to 25 claims -- the items named in a patent that define the diseases a new drug will treat, and the scope of the intellectual property. In the past, claims and continuations have been unlimited, allowing the biotech industry to protect a wide range of clinical applications.
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.
