| Who Requests |
Anyone (patentee, third party, or USPTO Director). |
Not the patent owner. |
Patent owner only. |
USPTO Director. |
| When Can You Request? |
Anytime during enforcement. |
Most commonly nine months after the grant of a patent. |
Anytime. |
Automatically when FDA approval concludes. |
| Information Considered |
Patents, printed publications, and statements made by the patent owner in federal court or the USPTO. |
Patents and printed publications. |
Anything. |
FDA-submitted information. |
| Grounds for Institution |
35 U.S.C. §§ 102 and 103 (novelty and obviousness only). |
35 U.S.C. §§ 102 and 103 (novelty and obviousness only). |
Any (including 35 U.S.C. §§ 101, 102, 103, and 112). |
Any (including 35 U.S.C. §§ 101, 102, 103, and 112). |
| Who Examines |
Usually, three patent examiners from CRU who did not examine the original patent application. |
PTAB (a panel of three administrative law judges). |
Patent examiner from CRU who did not examine the original patent application. |
Three senior patent examiners. One of those examiners is familiar with clinical trials and how to interpret FDA information. |
| Time to Determine If There Is a Substantial New Question of Patentability |
Three months. |
Three months (to determine if there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged). |
Three months. |
One year. |
| Speed of Prosecution |
Special dispatch. |
Decision is made twelve months after institution of IPR. |
Special dispatch. |
Not special. |
| Public Proceedings |
Open to public via Public PAIR. |
Open to public via PTAB E2E (PTAB end-to-end system). |
Open to public via Public PAIR. |
Confidential until final certificate issued. |