Final Rules on PTA Calculations in View of Supernus

June 24, 2020 – Article

Although long overdue, the U.S. Patent and Trademark Office (USPTO) released its Final Rule Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu (85 Fed. Reg. 36335-36342, June 16, 2020). Unfortunately, the Final Rule does not fully address Supernus.

In Supernus Pharms., Inc. v. Iancu, 913 F.3d 1351 (Fed. Cir. 2019), the Court reinforced the position that it first held in Wyeth v. Kappos, 591 F.3d 1364, 93 U.S.P.Q. 2d 1257 (Fed. Cir. 2010), aff’g, Wyeth v. Dudas, 580 F. Supp. 2d 138, 88 U.S.P.Q.2d 1538 (D.D.C. 2008) that the USPTO cannot consider the application delayed under § 154(b)(1)(B) during the period before it has been delayed. The situation in Supernus was that the USPTO reduced the patent term adjustment for the filing of an Information Disclosure Statement (IDS) disclosing a European opposition 646 days after the filing of a Request for Continued Examination. However, the IDS was filed 100 days after receiving notification from the European Patent Office (EPO).  The Federal Court held that the USPTO cannot reduce the patent term adjustment for the 546-day period when the applicant was unaware and could not be aware of the European opposition. 

Even though Supernus was decided on January 23, 2019, the USPTO has only now released its Final Rule. This Final Rule, in effect, states that the USPTO will not reduce patent term adjustment for applicant delay during a time period when applicant could have done nothing to advance prosecution, but only for very specific reasons. The USPTO specifically modifies the language of 37 CFR §1.704(c)(2) (deferral of issuance), 37 CFR §1.704(c)(3) (abandonment of an application), 37 CFR §1.704(c)(6) (filing of a preliminary amendment), 37 CFR §1.704(c)(9) (submission after a Patent Trial and Appeal Board or Federal court decision), and 37 CFR §1.704(c)(10) (submission after a Notice of Allowance). The USPTO states that the amendments to these sections are because these section specify a period of reduction corresponding to the consequences to the USPTO of the applicant’s failure to engage in reasonable efforts to conclude prosecution, rather than ‘‘the period from the beginning to the end of the applicant’s failure to engage in reasonable efforts to conclude prosecution,’’ as provided for in Supernus. 913 F.3d at 1359.

Curiously, despite the fact that Supernus was decided on January 23, 2019, the USPTO has stated that the Final Rule only applies to cases filed on or after May 29, 2000 in which a Notice of Allowance is mailed on or after July 16, 2020. 

Although this Final Rule is a step in the right direction, this Final Rule still makes no effort to change 37 CFR §1.704 to address the actual holding in Supernus nor announces any new initiative for the USPTO to properly calculate patent term adjustment taking into account Supernus. Instead, the USPTO subscribes to the notion that such circumstances are “a rare occurrence” and puts the burden entirely upon applicants to monitor and to seek correction (see, Patent Term Adjustment Procedures in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu; 84 Fed. Reg. 20343-20345, May 9, 2019).