Idorsia Pharmaceuticals, Ltd. v. Iancu

Case: 19-2346 Document: 35 Page: 1 Filed: 05/11/2020

NOTE: This disposition is nonprecedential.

United States Court of Appeals for the Federal Circuit ______________________

IDORSIA PHARMACEUTICALS, LTD., Plaintiff-Appellant

v.

ANDREI IANCU, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Defendant-Appellee ______________________

2019-2346 ______________________

Appeal from the United States District Court for the Eastern District of Virginia in No. 1:17-cv-00922-TSE- TCB, United States District Judge T. S. Ellis, III. ______________________

Decided: May 11, 2020 ______________________

THOMAS HOXIE, Hoxie & Associates, LLP, Millburn, NJ, for plaintiff-appellant. Also represented by CORY S. POKER.

PETER JOHN SAWERT, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA, for defendant-appellee. Also represented by KAKOLI

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CAPRIHAN, BRIAN RACILLA, THOMAS W. KRAUSE; G. ZACHARY TERWILLIGER, KIMERE JANE KIMBALL, Office of the United States Attorney for the Eastern District of Vir- ginia, United States Department of Justice, Alexandria, VA. ______________________

Before CHEN, HUGHES, and STOLL, Circuit Judges. STOLL, Circuit Judge. Idorsia Pharmaceuticals, Ltd. appeals the district court’s summary judgment upholding the U.S. Patent and Trademark Office’s patent term adjustment (PTA) deter- mination for U.S. Patent No. 8,518,912. Specifically, Idorsia challenges the PTO’s calculation of “A Delay,” whereby a patent’s term is adjusted when the PTO fails to respond to certain events or filings by statutorily enumer- ated examination deadlines. Because the district court cor- rectly concluded that the PTO examiner’s first of three restriction requirements satisfied the notice requirement of 35 U.S.C. § 132, and thus ended the accumulation of A Delay for the ’912 patent, we affirm. BACKGROUND I Idorsia’s predecessor in interest in the ’912 patent, Actelion Pharmaceuticals, Ltd., filed U.S. Patent Applica- tion No. 12/745,358 as a national stage application under 35 U.S.C. § 371. Following a preliminary amendment, the ’358 application included independent claim 1 and depend- ent claims 2–14 and 16. Claim 1 is a compound claim re- citing a chemical formula with the group P(O)R5R8. Claim 1 also recites various options for substituents R5 and R8. On March 14, 2012, the PTO examiner issued a re- striction requirement. The examiner identified six inven- tion groups for all pending claims that were “independent

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and distinct from each other because they [we]re directed to structurally dissimilar compounds that lack a common core” based on the possible variations for the group P(O)R5R8. J.A. 598. The examiner stated that “[r]es- triction [wa]s required under 35 U.S.C. [§ ]121,” J.A. 597, which grants the PTO the authority to limit a patent appli- cation claiming “two or more independent and distinct in- ventions” to one invention for continued prosecution. In response to the restriction requirement, Actelion notified the examiner by telephone that the examiner’s defined in- vention groups omitted certain subject matter from the scope of the claims. The examiner agreed and indicated that he would issue a new restriction requirement. Actelion did not elect any of the invention groups in the initial restriction requirement. About one month later, on April 18, 2012, the examiner issued a second restriction requirement that superseded and replaced the first restriction requirement. The exam- iner divided all pending claims into eight distinct invention groups. Actelion notified the examiner by telephone that the invention groups set forth in the second restriction re- quirement omitted claimed subject matter. The examiner agreed and indicated that he would issue a third restriction requirement. Actelion did not elect any of the invention groups in the second restriction requirement. On June 21, 2012, the examiner issued a third re- striction requirement, which divided all pending claims into three distinct invention groups. Actelion filed a re- sponse to the third restriction requirement, electing one of the three invention groups, and traversed the restriction. The ’358 application issued as the ’912 patent on Au- gust 27, 2013. That same day, the PTO issued an initial PTA determination for the ’912 patent of 314 days, which included 229 days of A Delay. The PTO awards A Delay for delays arising from the PTO’s failure to act by certain enu- merated deadlines. Relevant to this case, A Delay is based

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on the time that passes between the date that is “14 months after” the “date of commencement of the na- tional stage under section 371 in an international applica- tion” and the date that the PTO “provide[s] at least one of the notifications under section 132 or a notice of allowance under section 151.” 35 U.S.C. § 154(b)(1)(A)(i); see also 37 C.F.R. § 1.703(a)(1). Following Actelion’s request for reconsideration of PTA, the PTO issued a final decision calculating a total of 346 days of PTA, including 261 days of A Delay, based on its determination that the examiner’s second restriction re- quirement stopped the accrual of A Delay. Actelion then sued the PTO in the U.S. District Court for the Eastern District of Virginia, challenging the PTA determination. In March 2016, the district court remanded the case to the PTO to reconsider its PTA calculation in light of Pfizer, Inc. v. Lee, 811 F.3d 466 (Fed. Cir. 2016). Order, Actelion Pharm. Ltd. v. Lee, No. 15-1266 (E.D. Va. Mar. 2, 2016), ECF No. 23. Thereafter, the PTO issued its final determi- nation of PTA for the ’912 patent, which totaled 311 days of PTA, including 226 days of A Delay, based on its finding that A Delay stopped accruing after the examiner’s first re- striction requirement. II Idorsia brought the instant lawsuit pursuant to 35 U.S.C. § 154(b)(4)(A), the Administrative Procedure Act (APA), and the Fifth Amendment of the U.S. Constitution, challenging the PTO’s PTA determination. Specifically, Idorsia argued that A Delay continued to accrue for an ad- ditional 99 days after the date calculated by the PTO be- cause the first and second restriction requirements did not meet the notice requirement of 35 U.S.C. § 132. The parties cross-moved for summary judgment. The district court granted summary judgment in favor of the PTO, holding that the first restriction requirement com- plied with § 132 based on the standard set forth in this

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court’s Pfizer decision. Idorsia Pharm. Ltd. v. Iancu, 393 F. Supp. 3d 445, 453–54 (E.D. Va. 2019). Idorsia appeals. We have jurisdiction pursuant to 28 U.S.C. §§ 1295(a)(1), (a)(4)(C). DISCUSSION We review the district court’s grant of summary judg- ment de novo, “applying the same standard as the district court.” Pfizer, 811 F.3d at 470 (quoting Voter Verified, Inc. v. Premier Election Sols., Inc., 698 F.3d 1374, 1379 (Fed. Cir. 2012)). The PTO’s PTA decisions are reviewed in accordance with the APA. 35 U.S.C. § 154(b)(4)(A). Under the APA, a court may set aside the PTO’s actions only if they are “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). We hold that under Pfizer, the examiner’s first restriction requirement met the notice requirement of § 132 and thus ended the accrual of A Delay for the ’912 pa- tent. I A Delay stops accruing when the PTO “provide[s] at least one of the notifications under section 132.” 35 U.S.C. § 154(b)(1)(A)(i). A written restriction requirement quali- fies as a “notification[] under section 132.” Pfizer, 811 F.3d at 471–72. Section 132 provides, in pertinent part: Whenever, on examination, any claim for a patent is rejected, or any objection or requirement made, the Director shall notify the applicant thereof, stat- ing the reasons for such rejection, or objection or requirement, together with such information and references as may be useful in judging of the pro- priety of continuing the prosecution of his applica- tion . . . . 35 U.S.C. § 132(a).

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In Pfizer, we held that § 132 “merely requires that an applicant ‘at least be informed of the broad statutory basis for [the rejection of] his claims, so that he may determine what the issues are on which he can or should produce ev- idence.’” 811 F.3d at 472 (alteration in original) (quoting Chester v. Miller, 906 F.2d 1574, 1578 (Fed. Cir. 1990)). We explained that § 132 also requires that the examiner’s rejection be “sufficiently informative to allow [the appli- cant] to counter the grounds for rejection.” Id. at 473–74 (citations omitted). As to this second requirement for no- tice, we reaffirmed our precedent holding that § 132 “is vi- olated when a rejection is so uninformative that it prevents the applicant from recognizing and seeking to counter the grounds for rejection.” Id. at 471–72 (quoting Chester, 906 F.2d at 1578). II In this case, Idorsia does not dispute that the exam- iner’s first restriction requirement provided notice of the statutory basis for the examiner’s rejection, namely, that restriction was required under 35 U.S.C. § 121. Rather, the parties’ dispute focuses on whether the first restriction re- quirement was “sufficiently informative to allow [Actelion] to counter the grounds for rejection.” Pfizer, 811 F.3d at 473–74. We agree with the district court and the PTO that under Pfizer, the examiner’s first restriction require- ment for the ’912 patent satisfied the notice requirement of § 132. The examiner’s first restriction requirement asserted that all pending claims of the ’358 application were subject to the restriction requirement. The first restriction re- quirement also defined the invention groups available for election, and articulated the reasons that the examiner be- lieved that the ’358 application claimed multiple distinct inventions. Moreover, Actelion was able to respond to the first restriction requirement and successfully oppose the examiner’s description of the multiple invention groups,

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which demonstrates that Actelion was able to understand the examiner’s proposed invention groups and prepare re- sponsive arguments. Thus, as in Pfizer, the first restriction requirement, when “[v]iewed as a whole,” provided “ade- quate grounds on which” Actelion could “recogniz[e] and seek[] to counter the grounds for rejection.” 811 F.3d at 472 (alterations in original) (quoting Chester, 906 F.2d at 1578). Idorsia contends that neither the first nor the second restriction requirements qualifies as sufficient notice un- der § 132. In particular, Idorsia argues that the examiner’s defined invention groups’ omission of subject matter from the scope of the claims violates § 132 because “Actelion plainly lacked the necessary information to determine how to proceed.” Appellant’s Br. 26. Idorsia attempts to distin- guish Pfizer on the ground that in Pfizer, the restriction re- quirement at issue omitted dependent claims from the defined invention groups, not subject matter from inde- pendent claims. We reject Idorsia’s overly narrow reading of Pfizer. A restriction requirement need not be correct to satisfy the statutory notice requirement. See Univ. of Mass. v. Kap- pos, 903 F. Supp. 2d 77, 86 (D.D.C. 2012) (“UMass”) (reject- ing as “irrelevant to . . . calculating A delay” the question of whether or not “it was necessary [for the applicant] to persuade the Examiner to revise the restriction require- ment” to correct certain errors). Actelion’s and the exam- iner’s “exchanges concerning the challenged restriction requirement were part of the typical ‘back and forth’ pro- cess of patent prosecution.” Pfizer, 811 F.3d at 475–76 (quoting UMass, 903 F. Supp. 2d at 86). Although this pro- cess “often involves changes in both the applicant’s and ex- aminer’s positions, an examiner’s reissuance of an office action in response to an applicant’s suggestion does not au- tomatically mean that an application has been ‘delayed’ for purposes of patent term adjustment.” Id. at 475 (quoting UMass, 903 F. Supp. 2d at 86). Section 132 “does not

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award additional A delay if an applicant successfully con- vinces the PTO that the Office action was erroneous.” UMass, 903 F. Supp. 2d at 86–87. Indeed, the “underlying purpose of PTA is to compensate patent applicants for cer- tain reductions in patent term that are not the fault of the applicant, not to guarantee the correctness of the agency’s every decision.” Pfizer, 811 F.3d at 476 (internal quotation marks omitted) (quoting UMass, 903 F. Supp. 2d at 86). Based on the record evidence, we agree with the PTO and the district court that Idorsia’s alleged delay is “not the type of error for which the Act was intended to compen- sate.” Id. We have considered Idorsia’s other arguments, but we do not find them persuasive. The PTO properly calculated the length of PTA for the ’912 patent. Accordingly, we con- clude that the district court did not err in granting sum- mary judgment in favor of the PTO. CONCLUSION For the foregoing reasons, we affirm the judgment of the district court. AFFIRMED COSTS No costs.