Patent reform legislation was introduced in the House and Senate last week. Over the course of the next few weeks, we will look at specific portions of the legislation and its impact on biotech. Both the House and Senate bill expand re-examination proceedings.
Under the legislation, ex Parte re-examination requests can be based on “prior art consisting of patents, printed publications, or evidence that the claimed invention was in public use or sale in the United States more than 1 year prior to the date of the application for patent in the United States…” (Section 5 of the Senate bill pertaining to Section 301. Citation of prior art).
Moreover, the universe of patents which can be challenged in this manner has been expanded to any patent in force today. Under current law, only patents and printed publication are the basis for re-exam and only for patents filed on or after November 1999.
We ask you to consider:
- What is the impact of this expansion on biotech patents?
- What constitutes public use or sale in the context of biotechnology?
- Are clinical tests performed in public institutions one year prior to the filing of a patent application possible examples of “public use or sale”?