Working Paper: NBER ID: w27579
Authors: Michael D. Frakes; Melissa F. Wasserman
Abstract: We explore how the Patent Office may improve the quality of issued patents on “secondary” drug features by giving examiners more time to review drug-patent applications. Our findings suggest that current time allocations are causing examiners to issue low quality secondary patents on the margin. To assess the merits of expanding ex ante scrutiny of drug-patent applications at the agency, we set forth estimates of the various gains and losses associated with giving examiners more time, including reduced downstream litigation costs and added personnel expenses, along with both the static gains and dynamic innovation losses associated with earlier generic entry.
Keywords: pharmaceutical patents; patent examination; ex ante regulation; generic entry; patent validity
JEL Codes: I18; O34
Edges that are evidenced by causal inference methods are in orange, and the rest are in light blue.
| Cause | Effect |
|---|---|
| examiner promotions (M51) | patent outcomes (O34) |
| current time allocations for patent examiners (J22) | issuance of low-quality secondary patents (L15) |
| time constraints (C41) | likelihood of issuing invalid secondary patents (L49) |
| increasing examination time by 50% (C41) | reduction of invalid patents (O34) |
| increasing examination time by 50% (C41) | accelerate generic entry (L49) |
| time reductions (C41) | patent validity outcomes (L49) |