by Dennis Crouch
Supernus is an important case that may substantially extend the patent term adjustment (PTA) for your client. You’ll need to review the case files of recently issued cases to determine whether PTA was reduced by some supplemental filing (such as a late IDS). You may get the time back with a showing that the delay was reasonable. Deadlines in this area are tight. – DC
Supernus Pharmaceuticals, Inc. v. Iancu (Fed. Cir. 2019)
This case involves calculation of patent term adjustment (PTA) that extends the 20-year patent term due any delays in obtaining the patent. The statute attributes most delays to the USPTO (extending PTA), but some are attributed to the patent applicant (reducing PTA). With regard to PTA reduction, the statute particularly calls-out late office action responses as “failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.” 35 U.S.C. 154(b)(2)(C). In addition, the statute particularly gives the PTO Director authority to “prescribe regulations” that spell-out the times where PTA should be reduced due to an applicant’s failure to engage in such reasonable efforts.
This case involves supplemental filings by a patent applicant that potentially delay prosecution. The dates here are important:
- February 2011, Supernus (the patentee here) filed a request for continued examination (RCE) in the case;
- August 2012, Sandoz filed an opposition in the the parallel European case that cited 10 new documents.
- September 2012, Supernus received notice of the opposition from its European counsel.
- November 2012, Supernus filed an information disclosure statement providing the cited documents.
When the patent issued, the USPTO caculated the patent-term-adjustment as 1,260 days. Although that adds years to the patent term, the patentee wanted more. In particular, the PTO had reduced the term by 646-days — the entire time from the filing of the RCE until the filing of the IDS. The PTO stood-by its calculation and cited its regulation that PTA is reduced by any “submission” by the applicant “after a reply has been filed” by the applicant. 37 C.F.R. 1.704(c)(8). Under the regulation, the PTA reduction is calculated as the number of days between the original “reply” filing (here, the RCE) and the later “submission” (here, the IDS).
Supernus has a legitimate complaint. The statute says that PTA should be reduced when the applicant has failed to engage in reasonable efforts. Here, Supernus apparently had no knowledge of the new documents for at least 18-months (Feb 2011 – Aug 2012). In fact, one of the documents (the opposition itself) had not even been created yet. The point here is that even a highly reasonable actor could not have submitted the documents during that 18-month period.
A difficulty for Supernus is that the Federal Circuit previously upheld this particular regulation ( 37 C.F.R. 1.704(c)(8)) — finding it “reasonable.” Gilead Scis., Inc. v. Lee, 778 F.3d 1341 (Fed. Cir. 2015).
On appeal here, the Federal Circuit has distinguished Gilead and sided with the patentee. In Gilead, the information found in a late-filed IDS was already known to the patentee — thus it was proper to attribute the entire delay to the applicant. The basic holding in Gilead was that the PTO does not have to prove that applicant delay actually caused a delay in issuance.
Here, the court focused on whether the PTA reduction can exceed “time during which the applicant failed to engage in reasonable efforts to conclude prosecution.” After considering the language of the statute, the court concluded that the USPTO is only permitted to reduce PTA for periods where the applicant acted in an unreasonable manner. This conclusion follows easily from the statute:
The period of adjustment of the term of a patent under paragraph (1) shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application.
35 U.S.C. § 154(b)(2)(C)(i) (emphasis added by the court).
Although the PTO has authority to regulate this area, it does not have authority to contravene the statute — as such the office acted inappropriately here. “We find the USPTO’s PTA reduction to be inconsistent with the PTA statute and, as a result, we accord no deference to the USPTO’s application of the regulations at issue in these circumstances.”
The PTO will now need to think-up some new regulations. Two potential solutions.
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The patent at issue – U.S. Patent No. 8,747,897 – is somewhat interesting in the way that it claims the use of polyvinyl pyrrolidone (PVP) as a “complexing agent” in its pills.