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ARTICLE · 26 JUNE 2020

Final Rules On PTA Calculations In View Of Supernus

Oblon
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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...

United StatesIntellectual Property
Oblon, McClelland, Maier & Neustadt, L.L.P
Oblon, McClelland, Maier & Neustadt, L.L.P
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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

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