Applicant should carefully review the PTO’s PTA especially when applicant filed corresponding applications in foreign patent offices
| February 4, 2019
Supernus Pharmaceuticals, Inc. et al. v. Iancu
January 23, 2019
Before Reyna, Dyk, and Schall. Opinion by Reyna.
Summary:
The Federal Circuit held that the PTO’s reduction of the patent term for a Supernus patent due to applicant delay (of filing an information disclosure statement after filing an RCE) is not correct because there is nothing Supernus could have done during the period of time from the filing of an RCE and the receiving of a communication from a foreign patent office to conclude the prosecution of the application.
Details:
Patent Term Adjustment (PTA) statute of 1999: 35 U.S.C. §154(b)
- §154(b)(1)(A)-(C): delays caused by the PTO
- Type A delay: the PTO fails to provide a notification under 35 U.S.C. §132 or a Notice of Allowance within 14 months of filing date.
- Type B delay: the PTO fails to issue a patent after 3 years have passed between the filing date and the date of allowance.
- Type C delay: for delays that are excluded from Type B delay due to derivation proceedings, secrecy orders, or successful appeals.
- §154(b)(2): delays caused by applicants
Supernus Pharmaceuticals, Inc. is the owner and assignee of U.S. Patent 8,747,897 (“the ’897 patent”), and United Therapeutics Corp. is the exclusive licensee of the ’897 patent.
Relevant timelines:
- 4/27/06: Supernus filed U.S. application and international application claiming priority from the U.S. application (international application gave rise to EP application).
- 8/20/10: the PTO issued a final OA.
- 2/22/11: Supernus filed an RCE.
- 10/13/11: the EPO issued the EP application as EP patent.
- 8/21/12: the EPO notified Supernus’s European patent counsel that a Notice of Opposition was filed by Sandoz to the EP patent.
- 9/11/12: Supernus received a letter from its European patent counsel regarding the EPO notification.
- 11/29/12 (79 days later from 9/11/12 and 100 days from 8/21/12): Supernus filed a supplemental IDS citing the EPO notification.
- 9/10/13: the PTO issued a first OA responding to Supernus’s RCE.
- 1/10/14: Supernus filed a response.
- 2/4/14: the PTO issued a Notice of Allowance.
- 6/10/14: the U.S. application issued as the ’897 patent (PTA of 1,260 days).
PTO
The PTO attributed 2,321 days to the PTO delay (1,656 days for Type A delay and 665 days for Type B delay). The PTO reduced 2,321 days by 175 days to account for overlapping Type A and Type B delays and 886 days for applicant delay. Out of 886 days, 646 days were assessed for the 2/22/11 filing of the RCE and the 11/29/12 filing of the IDS.
PTA of 1,260 days = 2,321 days – 175 days – 886 days.
Supernus filed a request for Reconsideration of PTA because the deduction of 646 days was improper. The PTO rejected the request because citing Gilead, filing the IDS after filing of the RCE “interferes” with the PTO’s ability to process an application.
District Court
Supernus appealed to the U.S. District Court for the Eastern District of Virginia. The district court granted summary judgment in favor of the PTO because the PTO did not err in the PTA calculation for the ’897 patent.
Federal Circuit
First of all, the Federal Circuit held that Gilead did not apply in this case. In Gilead, the patent owner brought an action challenging the PTO’s assessment of a 57-day applicant delay in calculating PTA reduction based on Gilead’s delay during examination between its reply to a restriction requirement and its submission of a supplemental IDS (disclosing other co-pending Gilead patent applications). However, the Federal Circuit held that the issue in this case is whether the PTO may reduce PTA by a period that exceeds the “time during which the applicant failed to engage in reasonable efforts to conclude prosecution.” (35 U.S.C. §154(b)(2)(C)(i)). The Federal Circuit held that Gilead did not answer this issue.
Supernus conceded that it failed to engage in “reasonable efforts” for the last 100 days of the 646-day period. However, Supernus argued that there was nothing Supernus could have done during the 2/22/11 filing of the RCE and the 8/21/12 receiving of the EPO communication.
The Federal Circuit agreed with Supernus’s arguments. The Federal Circuit held that there was no action Supernus could have done to advance prosecution of the patent during the 546-day period because the EPO communication did not exist yet. The Federal Circuit held that the PTO’s interpretation of the statute “would unfairly penalize applicants, fail to incentive applicants not to delay, and fail to protect applicants’ full patent terms.”
Finally, the Federal Circuit held that the PTO’s additional 546-day assessment is contrary to the plain meaning of the statute because “the 646-day total reduction is not equal to a period of time during which Supernus failed to engage in reasonable efforts to conclude the prosecution of the ’897 patent (35 U.S.C. §154(b)(2)(C)(i)). In addition, the Federal Circuit held that the PTO’s decision is not consistent with the intent of Congress because Congress intended that the PTA statute not adversely impact applicants who could have done nothing to advance the prosecution.
Therefore, the Federal Circuit held that the district court erred in granting summary judgment in favor of the PTO.
Takeaway:
Applicant should carefully review the PTO’s PTA especially when applicant filed corresponding applications in foreign patent offices and submitted IDSs to the PTO citing communications from foreign patent offices.
Applicant should advise foreign patent counsels to forward the communications from foreign patent offices as soon as possible for a timely filing of IDSs.
