Patent Term Adjustment

In Sawstop Holding LLC v. Vidal, the Federal Circuit upheld the USPTO’s interpretation of the Patent Term Adjustment (PTA) statute that limits the availability of PTA for time spent appealing an Examiner’s rejection.

Under current USPTO Patent Term Adjustment (PTA) rules, an applicant can be charged a Patent Term Adjustment (PTA) deduction for “applicant delay” before examination commences if the application is not “ready for examination” within eight months of its filing date (or national stage commencement date). While that rule first came into effect with the December 18, 2013 Patent Law Treaty rule changes, we have been seeing more pre-examination PTA deductions since the USPTO implemented the Supernus-related PTA changes July 16. 2020. While those changes expressly altered the PTA rules surrounding Preliminary Amendments, applicants may be surprised to be charged PTA deductions for correcting Sequence Listing errors.

In Chudik V. Hirshfeld, the Federal Circuit upheld the USPTO’s determination that a Patent Term Adjustment (PTA) award for “C” delay is not available when an examiner reopens prosecution after an Appeal Brief is filed, because an award for “C” delay requires actual appellate review. The court warned of the consequences of filing a Request for Continued Examination (RCE) early in the examination process instead of pursuing an appeal right away, because that prevented an award for “B” delay over the time periods at issue. While not at issue in this case, patent holders may be wondering when the USPTO will start calculating PTA correctly under the 2019 Supernus decision that found error in the USPTO’s approach to calculating “applicant delay.”

One of the most confusing—and frustrating—aspects of the USPTO’s Patent Term Adjustment (PTA) rules is the mismatch between the PTA rules and the Information Disclosure Statement (IDS) rules. In, Gilead Sciences, Inc. v. Lee, the Federal Circuit upheld one such mismatched PTA rule, but the court’s opinion did not address the inconsistency with the applicable IDS rule. Stakeholders caught in the gaps between the PTA rules and the IDS rules may be able to salvage some PTA under Supernus.

The Federal Circuit decision in HZNP Medicines LLC v. Horizon Pharma USA, Inc. is a good reminder that even standard “patent lingo” can cause trouble down the line. Now that the court has denied rehearing en banc (with Judges Lourie, Newman, O’Malley, and Stoll dissenting), practitioners should be aware of the risks of invalidity for indefiniteness that may arise from the “consisting essentially of” transitional phrase used in claim drafting.

In Supernus Pharmaceuticals, Inc. v. Iancu , the Federal Circuit held that the USPTO cannot charge a Patent Term Adjustment (PTA) deduction for “applicant delay” during a period when the applicant “could have done nothing to advance prosecution.” The PTA deduction at issue was charged under 37 CFR § 1.703(c)(8) for an Information Disclosure Statement (IDS) filed after a Request for Continued Examination (RCE) had been filed, but the USPTO proposes to make changes to other PTA rules to comply with the court’s interpretation of 35 USC § 154(b)(2)(C).

The USPTO has announced new procedures patent holders can follow to obtain additional Patent Term Adjustment (PTA) under the Federal Circuit’s January 2019 decision in Supernus Pharm., Inc. v. Iancu.

In a long-awaited decision in Supernus Pharmaceuticals, Inc. v. Iancu (argued December 2017), the Federal Circuit held that the USPTO improperly imposed a Patent Term Adjustment (PTA) deduction for “applicant delay” during a period when the applicant “could have done nothing to advance prosecution.”

The USPTO has devised a plan to address the IDS PTA deduction error that incorrectly charges a Patent Term Adjustment (PTA) deduction for Information Disclosure Statements (IDSs) filed with a “safe harbor” statement.