SUPERNUS PHARMACEUTICALS, INC., UNITED THERAPEUTICS CORPORATION v. ANDREI IANCU, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE
2017-1357
United States Court of Appeals for the Federal Circuit
January 23, 2019
Appeal from the United States District Court for the Eastern District of Virginia in No. 1:16-cv-00342-GBL-IDD, Judge Gerald Bruce Lee.
DOUGLAS H. CARSTEN, Wilson, Sonsini, Goodrich & Rosati, PC, San Diego, CA, argued for plaintiffs-appellants. Also represented by VERONICA SUSANA ASCARRUNZ, ADAM WILLIAM BURROWBRIDGE, Washington, DC.
SHAUN R. SNADER, United Therapeutics Corporation, Washington, DC, for plaintiff-appellant United Therapeutics Corporation.
R. TRENT MCCOTTER, Office of the United States Attorney for the Eastern District of Virginia, Alexandria, VA, argued for defendant-appellee Andrei Iancu. Also represented by KAKOLI CAPRIHAN, BRIAN RACILLA, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA.
Before DYK, SCHALL, and REYNA, Circuit Judges.
Supernus Pharmaceuticals, Inc. and United Therapeutics Corp. appeal the entry of summary judgment by the U.S. District Court for the Eastern District of Virginia. The district court determined that, based on this court‘s decision in Gilead Sciences, Inc. v. Lee, the U.S. Patent and Trademark Office‘s calculation of the patent term adjustment for the patent at issue was correct, and that summary judgment was warranted as a matter of law. We reverse the district court‘s grant of summary judgment because the patent term adjustment in this case went beyond the period during which the applicant failed to undertake reasonable efforts and thereby exceeded the limitations set by the patent term adjustment statute.
BACKGROUND
I.
The life of a patent, the period of time during which the exclusive nature of a patent is in effect, is measured in years and days and is referred to as the “term” of the patent or “patent term.” Prior to June 8, 1995, the term of a patent was seventeen years, measured from the date that the patent issued to its expiration date seventeen years later. See Merck & Co. v. Kessler, 80 F.3d 1543, 1547 (Fed. Cir. 1996).
When the United States entered the World Trade Organization, it assumed certain obligations and commitments under
In addition to extending the patent term from seventeen years to twenty years, Congress passed the patent term adjustment (“PTA“) statute in 1999 in an effort to discourage delay in the patent application process. See Pub. L. No. 106-113, § 1000(a)(9), 113 Stat. 1501, 1536 (1999) (codified at
Section 154(b)(1) outlines three types of delays caused by the USPTO, known as Types A, B, and C, that can result in a PTA. Adjustments for a Type A delay apply when the USPTO fails to provide a notification under
As noted above, the statute recognizes that conduct by the applicant may also cause delay in the examination or prosecution of the application. Section 154(b)(2)(C) authorizes the USPTO to reduce the total amount of PTA for Type A, B, and C delays by deducting the number of days equal to the period of time that “the applicant failed to engage in reasonable efforts to conclude prosecution of the application.” Id.
The Director of the USPTO has promulgated such regulations:
Submission of a supplemental reply or other paper, other than a supplemental reply or other pa-per expressly requested by the examiner, after a reply has been filed, in which case the period of
adjustment set forth in § 1.703 [that extends the patent‘s term due to USPTO delay] shall be reduced by the number of days, if any, beginning on the day after the date the initial reply was filed and ending on the date that the supplemental reply or other such paper was filed . . . .
Id.
The USPTO has also promulgated regulations that permit an applicant to file an information disclosure statement (“IDS“) up to the end of the patent examination process, while providing incentives for an applicant to submit any necessary IDS promptly. Id.
II.
The relevant facts in this case are not in dispute. Appellant Supernus Pharmaceuticals, Inc. (“Supernus“) is the owner and assignee of the patent at issue, U.S. Patent No. 8,747,897 (“the ‘897 patent“), titled “Osmotic Drug Delivery System.” Co-Appellant United Therapeutics Corp. (“UTC“) is the exclusive licensee of the ‘897 patent. UTC assisted in the prosecution of the patent application and took action as the applicant in that capacity. Supernus and UTC are collectively referred to herein as “Supernus.”
On April 27, 2006, Supernus filed U.S. Patent Application No. 11/412,100 (“the ‘100 application“). On August 20, 2010, the USPTO issued a final rejection. On February 22, 2011, Supernus filed an RCE, which removed the finality of the rejection and permitted the examiner to consider additional information submitted by Supernus.
On the same day it filed the ‘100 application, Supernus filed international application PCT/US2007/009969, claiming priority from the ‘100 application. The international application gave rise to European Application No. 07755989.6. On October 13, 2011, the European Patent Office (“EPO“) issued the European application as European Patent EP2010189 (“the EP patent“). On August 21, 2012, the EPO notified Supernus‘s European patent counsel that a Notice of Opposition was filed by Sandoz AG to the EP patent, citing 10 documents (“the Sandoz Opposition“).
On September 11, 2012, Supernus received a letter from its European patent counsel disclosing the EPO notification and the Sandoz Opposition. Seventy-nine days later, or 100 days from the EPO notification of the Sandoz Opposition, Supernus submitted a supplemental IDS on November 29, 2012, informing the USPTO
On September 10, 2013, the USPTO issued a first Office Action responding to Supernus‘s RCE. On January 10, 2014, Supernus filed a response. On February 4, 2014, the USPTO issued a Notice of Allowance. On June 10, 2014, the USPTO issued the ‘897 patent, reflecting a PTA of 1,260 days, meaning that the USPTO had added 1,260 days to the patent‘s twenty-year term.
In calculating the PTA, the USPTO attributed 2,321 days to USPTO delay: 1,656 days for Type A delays (for the USPTO‘s failure to meet the mandated statutory response deadlines), and 665 days for Type B delays (for the USPTO‘s failure to issue the patent within three years of the application‘s filing date). See J.A. 80. Next, the USPTO reduced the PTA of 2,321 days by 175 days to account for overlapping Type A and Type B delays, and by 886 days for applicant delay to arrive at the total 1,260-day PTA. Relevant here, of the 886 days attributed to applicant delay, 646 days were assessed for the period between the February 22, 2011 filing of the RCE and the November 29, 2012 submission of the IDS. This appeal focuses on this 646-day reduction in the PTA due to purported applicant delay.
Supernus filed a request for Reconsideration of Patent Term Adjustment on grounds that the deduction of the 646-day period was improper.3 Supernus argued that ”
The USPTO rejected the request for reconsideration. The USPTO determined that under this court‘s decision in Gilead, submission of an IDS after the filing of a response to an election or restriction requirement is subject to a reduction under
Supernus appealed to the U.S. District Court for the Eastern District of Virginia and filed a motion for summary judgment on the grounds that
The district court granted summary judgment in favor of the USPTO. Id. at *8. The district court concluded that the USPTO did not err in the PTA calculation for the ‘897 patent and that this court‘s decision in Gilead foreclosed, as a matter of law, Supernus‘s statutory interpretation arguments that
Supernus timely filed this appeal. We have jurisdiction pursuant to
DISCUSSION
I. Standard of Review
This court reviews a district court‘s grant of summary judgment under the law of the regional circuit, in this case, the Fourth Circuit. See Mohsenzadeh v. Lee, 790 F.3d 1377, 1381 (Fed. Cir. 2015); Charles Mach. Works, Inc. v. Vermeer Mfg. Co., 723 F.3d 1376, 1378 (Fed. Cir. 2013). Applying the law of the Fourth Circuit, we review the grant of summary judgment de novo. Gallagher v. Reliance Standard Life Ins. Co., 305 F.3d 264, 268 (4th Cir. 2002). Patent term adjustment decisions of the USPTO are reviewed in accordance with the Administrative Procedure Act (“APA“).
II. Gilead
As a preliminary issue, we note that this court has grappled with the reasonableness of
In Gilead, the patent owner Gilead brought an action challenging the USPTO‘s assessment of a 57-day applicant delay in calculating PTA deduction, based on Gilead‘s delay during examination between its initial reply to a restriction requirement and its submission of a supplemental IDS disclosing two other co-pending Gilead patent applications. Id. at 1345-46. The district court granted summary judgment in favor of the USPTO, and we affirmed. Id. at 1346, 1350-51. Engaging in the Chevron analysis, this court concluded that Congress did not address the precise question
We conclude that Gilead does not foreclose Supernus‘s statutory interpretation argument. Supernus‘s argument is that any reduction in PTA may not exceed the “time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application.”
In Gilead, Appellant Gilead had two other co-pending patent applications that it disclosed in the supplemental IDS. Gilead could have submitted the supplemental IDS disclosing its co-pending applications when it filed its response to the restriction requirement. Gilead, therefore, involved a period of time during which the applicant could have taken identifiable efforts to conclude prosecution but did not. Gilead focused on whether the statute required the applicant‘s failure to take reasonable efforts to have resulted in actual delay, as opposed to the potential to cause delay, to count towards reduction of PTA.
In contrast, this case is not about whether efforts taken by Supernus, or those it could have taken, resulted in actual or potential delay. Supernus contends, and the USPTO does not dispute, that Supernus could not have undertaken any efforts to conclude prosecution of the ‘100 application during the 546-day period between the filing of the RCE on February 22, 2011, and the EPO‘s notification of the Sandoz Opposition on August 21, 2012. J.A. 552-53; Appellant Br. 7 n.3; Appellee Br. 16-17.
In addition, the precise question addressed in Gilead was not the precise question under review in this case. In Gilead, the “precise question” reviewed by the court in its Chevron analysis was “whether a failure to engage in reasonable efforts requires conduct that actually causes delay.” Gilead, 778 F.3d at 1349. That question fell within the USPTO‘s gap-filling authority to determine what constitutes “reasonable efforts.” Id.;
Because Gilead involved different facts and a different legal question, Gilead is not controlling in this action. Cf. Fed. Election Comm‘n v. Wis. Right To Life, Inc., 551 U.S. 449, 456, 467 (2007) (Roberts, C.J., writing in non-majority section of the opinion of
III. Chevron Framework
A. The PTA Statute Answers the Precise Question
This case presents a question of statutory interpretation by an agency to which we apply the Chevron framework. The first step of our legal analysis, therefore, is to “ask whether the statute‘s plain terms ‘directly addres[s] the precise question at issue.‘” Nat‘l Cable & Telecomms. Ass‘n v. Brand X Internet Servs., 545 U.S. 967, 986 (2005) (quoting Chevron, 467 U.S. at 843). The precise question at issue in this case 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.”
We begin by looking at the plain language of the PTA statute. See United States v. Hohri, 482 U.S. 64, 69 (1987) (“[T]he ‘starting point in every case involving construction of a statute is the language itself.‘” (quoting Kelly v. Robinson, 479 U.S. 36, 43 (1986))); Suprema, Inc. v. Int‘l Trade Comm‘n, 796 F.3d 1338, 1346 (Fed. Cir. 2015) (en banc) (”Chevron‘s framework begins with the language of the statute.“). “Absent a clearly expressed legislative intention to the contrary, [the statute‘s plain] language must ordinarily be regarded as conclusive.” Consumer Prod. Safety Comm‘n v. GTE Sylvania, Inc., 447 U.S. 102, 108 (1980).
In this case, the pertinent language of the PTA statute is plain, clear, and conclusive. “Congress has supplied a clear and unambiguous answer to the interpretive question at hand.” Pereira v. Sessions, 138 S. Ct. 2105, 2113 (2018); see also Chevron, 467 U.S. at 842-43 (“If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress.“) On the basis of the plain language of the statute, we hold that the USPTO may not count as applicant delay a period of time during which there was no action that the applicant could take to conclude prosecution of the patent. Doing so would exceed the time during which the applicant failed to engage in reasonable efforts.
The PTA statute provides in pertinent part:
(b) Adjustment of patent term.—
. . . .
(2) Limitations.—
. . . .
(C) Reduction of period of adjustment.—
(i) 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.
A plain reading of the statute shows that Congress imposed two limitations on the amount of time that the USPTO can use as applicant delay for purposes of reducing PTA. 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 PTA statute requires that any PTA reduction be equal to the period of time during which an applicant fails to engage in reasonable efforts. The word “equal” is widely understood to mean “the same in amount, number, or size.” E.g., Equal, Cambridge Dictionary of American English 287 (2000). Stated differently, PTA reduction cannot exceed the period of time during which an applicant failed to engage in reasonable efforts. Thus, if there is no period of time during which the applicant could have but failed to engage in reasonable efforts, there can be no reduction to the PTA. The word “during” is similarly understood to mean “from the beginning to the end of (a particular period)” or “at some time between the beginning and the end of (a period).” E.g., During, Cambridge Dictionary of American English 267 (2000). The preceding “shall” “generally imposes a nondiscretionary duty.” SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1354 (2018); see also Kingdomware Techs., Inc. v. United States, 136 S. Ct. 1969, 1977 (2016) (discussing that “shall” is mandatory and connotes a requirement). Thus, the statutory period of PTA reduction must be the same number of days as the period from the beginning to the end of the applicant‘s failure to engage in reasonable efforts to conclude prosecution. PTA cannot be reduced by a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution because such time would not be “equal to” and would instead exceed the time during which an applicant failed to engage in rea-sonable efforts. This is consistent with the PTA extensions of “1 day for each day” granted for the A, B, and C types of USPTO delays.
The “equal to” limitation ensures that applicants will be charged the full amount of time corresponding to their own delay. See Gilead, 778 F.3d at 1348-49 (“[I]t appears Congress‘s primary intent was to penalize applicant conduct as opposed to the results of such conduct.“). By the same token, the “equal to” limitation protects applicants by ensuring that PTA can only be reduced by periods of time during which the applicant failed to engage in such efforts. See id. at 1344 (“[B]ecause the duration of a patent is no longer solely predicated on its date of issuance, delays in the patent examination process decrease the length of an applicant‘s patent term.“); H.R. Rep. No. 106-287, pt. 1, at 50 (1999) (“[N]o patent applicant diligently seeking to obtain a patent will receive a term of less than the 17 years as provided under the pre-GATT standard.” (footnote omitted)). The expressed legislative intent is consistent with the plain language of the statute. The USPTO cannot, therefore, count as applicant delay any period of time during which there were no efforts in which the applicant could have engaged to conclude prosecution of the patent. See SAS Inst., 138 S. Ct. at 1355 (“Where a statute‘s language carries a plain meaning, the duty of an administrative agency is to follow its commands as written, not to supplant those commands with others it may prefer.“).
A period of time including no identifiable efforts that could have been undertaken cannot be “equal to” the period of failure to undertake reasonable efforts under the terms of the statute. To conclude otherwise renders the PTA statute‘s “reasonable efforts” language superfluous. This understanding of the plain language makes practical sense and is consistent with the legislative history because Congress intended the PTA statute to discourage dilatory conduct by patent applicants
B. The USPTO‘s Assessment of Applicant Delay is Inconsistent with the PTA Statute
As shown in the figure below, the USPTO reduced the PTA by 646 days due to applicant delay. Supernus concedes that it failed to engage in “reasonable efforts” for the last 100 days of the 646-day period. It states, however, that there was nothing it could have done during the period of time from the filing of the RCE and original IDS to the EPO communication.
Appellant Br. 8 (reproduced and modified).
We agree with Supernus that there were no efforts that it could have taken in the period of time during the preceding 546 days. The record is silent as to what Supernus could have done to conclude prosecution during the 546-day time period, beginning with the filing of the RCE/IDS on February 22, 2011, and ending on the date of the EPO notification, August 21, 2012. Nor does the USPTO contend that Supernus could have undertaken any “reasonable efforts” during the 546-day time period to conclude prosecution. To the contrary, the facts indicate that there was no action Supernus could have taken to advance prosecution of the patent during the 546-day period, particularly because the EPO notice of opposition did not yet exist. Here, the USPTO‘s interpretation of the statute would unfairly penalize applicants, fail to incentivize applicants not to delay, and fail to protect applicants’ full patent terms. The USPTO‘s additional 546-day assessment as applicant delay is contrary to the plain meaning of the statute because the 646-day total reduction is not equal to a period of time during which Supernus failed to engage in reasonable efforts to conclude prosecution of the ‘897 patent. The USPTO‘s interpretation of the PTA statute applied in these circumstances exceeds the statutory limitations for PTA reduction and therefore, the USPTO actions are “in excess of statutory . . . authority.” See
This decision is consistent with the intent of Congress. Congress chose to speak plainly to the precise issue by setting limitations on the period of PTA reduction. See City of Arlington v. FCC, 569 U.S. 290, 296 (2013) (“Congress knows to speak in plain terms when it wishes to circumscribe, and in capacious terms when it wishes to enlarge, agency discretion.“). Congress intended that the PTA statute not adversely impact applicants like Supernus who could have
CONCLUSION
The USPTO argues that
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. See Wyeth, 591 F.3d at 1372. We have considered the USTPO‘s remaining arguments and find them unpersuasive. We conclude that the district court erred in granting summary judgment in favor of the USPTO. Based on the foregoing reasoning, we reverse the district court‘s summary judgment order and remand for further proceedings consistent with this opinion.
REVERSED AND REMANDED
COSTS
No costs.