05Mar 2019

Silvia Salvadori - Patent Term Adjustment Deductions — Important Lessons

In the recent decision Supernus Pharmaceuticals, Inc. v. Iancu, the Federal Circuit held that the USPTO wrongly imposed a Patent Term Adjustment (PTA) to the applicant for an Information Disclosures Statement (IDS) filed after a Request for Continued Examination (RCE).

Patent Term Adjustment Statute

The PTA statute establishes that an award in patent term should correspond to a deduction (of patent term) for any delay caused by the applicant’s failure to engage in activities that aim to conclude prosecution of the application. Under PTA rules, the USPTO can charge the applicant with a delay when the applicant files an IDS after having filed an RCE, but before the next Office Action or Notice of Allowance. 

Details of the Case

In the case at issue, a deduction was calculated for an IDS filed more than one year after the filing of an RCE. The submitted IDS contained information that was cited in an opposition of a related European application.

Furthermore, in this case, the USPTO also delayed the issuance — more than four months — of an Office Action after the RCE was filed.

Supernus Pharmaceuticals challenged the PTA deduction.

In a previous case, the Federal Circuit held that the interpretation of the [PTA] statute is reasonable insofar as it includes not only applicant conduct or behavior that results in actual delay, but also those conducts or behaviors having the potential to result in delays irrespective of whether such delays actually occurred.

In this case, the question is whether the USPTO may reduce PTA by a period that exceeds the time during which the applicant failed to engage in reasonable efforts to conclude prosecution.

According to the Federal Circuit, the language of the PTA statute is clear:

  • First, the statute expressly requires that any reduction to PTA be equal to the period of time during which an applicant fails to engage in reasonable efforts.
  • Second, the statute expressly ties reduction of the PTA to the specific time period during which the applicant failed to engage in reasonable efforts.

Final Takeaway

According to the Federal Circuit there was no action SupernusPharmaceuticals could have taken to advance prosecution of the 546-day delay because the European opposition had not yet been filed. Moreover, this decision provides a 30-day “safe harbor” for filing an IDS that cites information from a counterpart application without incurring a PTA deduction. As such, because the applicants did not fail to take available steps to conclude prosecution, the 546 days of applicant delay charged by the USPTO was contrary to the plain meaning of the statute. Even if under these particular circumstances the applicant was not penalized, the best practice is still to submit IDSs as early as possible.

Please contact me at silvia@salvadorilaw.com with questions or comments.

Silvia Salvadori, PhD

Silvia Salvadori, PhD