| Pharmaceuticals scuttle for filing of patents in US | | | | Extension. |
| market and for the extensions filed patents. | | | | Patent Term Adjustment: |
| Innovator seeks supplementary protection for their | | | | 1. Utility and plant patents issued from original |
| innovation apart from the patent term and all types | | | | applications, other than designs, filed on or after May |
| of exclusivity. Such type of extension for protection | | | | 29, |
| can be achieved by Patent Term Extension or | | | | 2000 can apply for Term Adjustment. |
| Adjustment. | | | | 2. Under 35 U.S.C. § 154 |
| Patent Term Extension and Adjustment are not | | | | 3. Adjustment is only possible by delay due to:a) PTO |
| same; these are possible from certain specified types | | | | failure to take certain actions within specified time |
| of delays that may occur due to pending of patent | | | | frames (35 U.S.C. § 154(b)(1)(A)). 14 + 4 + 4 + 4 |
| application before patent Office or for the clinical | | | | months rule. Called as - A Delayb) PTO failure to |
| trials. | | | | issue a patent within three years of the filing date |
| Differences: | | | | (35 U.S.C. § 154(b)(1)(B)). Called as - B Delayc) |
| Patent Term Extension: | | | | Delays due to interference, secrecy order, or |
| 1. Utility and plant patents issued from original | | | | successful appellate review (35 U.S.C. § |
| applications other than designs, filed on or after June | | | | 154(b)(1)(C)). Called as - C Delay |
| 8, 1995, and before May 29, 2000 can apply for | | | | 4. Includes day-for-day credits to the normal twenty |
| Extension. | | | | year term by PTO, and any overlap of delays is not |
| 2. Under 35 U.S.C. § 156 | | | | credited as Term Adjustment. |
| 3. Extension is only possible by delay due to:a) | | | | 5. The term delayed by PTO is compensated by |
| Interference proceedings under 35 U.S.C. 135(a),b) | | | | extension, offset applicants delay and overlap time |
| Secrecy orders under 35 U.S.C. 181, orc) Successful | | | | period. |
| appellate review. | | | | 6. Term Adjustment is not limited to one patent & is |
| 4. Extension or restoration is based on the length of | | | | applicable for many patents which ever gets delay by |
| clinical trials and other factors involved in the | | | | PTO. |
| submission of the relevant NDA, by FDA. | | | | 7. Applicant has 180 days from grant to seek judicial |
| 5. The patent term that may be restored is five | | | | review of the PTO adjustment determination. |
| years. | | | | 8. Any applicant can apply for adjustment; also Term |
| 6. Only one patent is eligible for the extension and | | | | Adjustment can be further lengthened by Extension. |
| must be applied before its expiry. | | | | Hence, innovator companies are beneficial for PTO |
| 7. The application for extension has to be submitted | | | | delays which lead to extension of their monopoly |
| within 60 days of FDA approval of the product. | | | | right through Patent Term Extension or Adjustment. |
| 8. Only innovator companies can apply Patent Term | | | | |