The US Court of Appeals for the Federal Circuit in Purdue Pharma L.P. v. Collegium Pharm. Inc. addressed a unique situation in November 2023 whereby the Patent Trial and Appeal Board failed to issue its Final Written Decision within the time prescribed by the statute. Analyzing the statutory language and relevant legislative history, the Federal Circuit held that the Board retains its authority to issue a Final Written Decision even after the statutory deadline has passed.
After Purdue Pharma L.P. (Purdue) brought suit against Collegium Pharmaceutical Inc. (Collegium) for infringement of its patent, Collegium petitioned the Patent Trial and Appeal Board (the Board) for post grant review (PGR) of the patent, filing its petition on March 13, 2018. [1] The Board ultimately instituted PGR with its one-year deadline to issue its Final Written Decision falling on October 4, 2019. [2]
On September 24, 2019, Purdue filed a Notice of Bankruptcy Filing and Imposition of Automatic Stay, resulting in the Board staying the case. [3] With the one-year deadline for the Board to issue its Final Written Decision approaching, on October 2, 2019, the chief administrative patent judge found good cause existed to grant a six-month extension for the bankruptcy court to assess whether the automatic stay applied to PGRs. [4] The Board advised that “Petitioner should seek any relief it deems appropriate from the Bankruptcy Court.” [5]
Despite this advisement from the Board, and despite the fact that the parties disagreed about whether the bankruptcy court’s Automatic Stay provision applied to PGRs, neither party (1) sought clarification or guidance from the bankruptcy court or (2) asked the bankruptcy court to lift the stay during the six-month extension period. [6] The six-month extension expired on April 4, 2020, and on July 2, 2020, Purdue requested the bankruptcy court partially lift the automatic stay to allow the district court case to proceed. [7] Collegium opposed, asserting that the stay must also be lifted for the PGR if lifted for the district court case. [8] The bankruptcy court agreed with Collegium, and on September 1, 2020, it lifted the stay for both the PGR and the district court case. [9]
After the stay was lifted, on September 11, 2020, Purdue filed a motion to terminate the PGR, arguing that the Board no longer had authority to issue a Final Written Decision because the statutory 18-month deadline had passed. [10] The Board denied Purdue’s motion, noting that “[a]pplying the principles from the Supreme Court cases assessing statutes without consequences for noncompliance with time limits, we hold that, under the circumstances of this case, the AIA’s silence as to a consequence for timely issuing a final written decision does not divest us of our authority to issue our final written decision.” [11] The Board issued its Final Written Decision finding the claims of the patent unpatentable. [12]
Purdue appealed and asserted that the Board lost its statutory right to issue a Final Written Decision because it failed to meet the deadline established by 35 USC § 326(a)(11) and 37 CFR § 42.200(c). [13]
The Federal Circuit disagreed with Purdue and affirmed the Board’s Final Written Decision. [14] In reaching this conclusion, the court analyzed the language of the relevant statutes, which state the following:
35 USC § 326(a)(11):
(a) Regulations—The Director shall prescribe regulations—
...
(11) requiring that the final determination in any post-grant review be issued not later than 1 year after the date on which the Director notices the institution of a proceeding under this chapter, except that the Director may, for good cause shown, extend the 1-year period by not more than 6 months, and may adjust the time periods in this paragraph in the case of joinder under section 325(c)[.]
37 CFR § 42.200(c):
(c) A post-grant review proceeding shall be administered such that pendency before the Board after institution is normally no more than one year. The time can be extended by up to six months for good cause by the Chief Administrative Patent Judge, or adjusted by the Board in the case of joinder.
Specifically, the court referenced the Supreme Court's position that “if a statute does not specify a consequence for noncompliance with statutory timing provisions the federal courts will not in the ordinary course impose their own coercive sanction.” [15] Noting that the “statute at issue here does not provide consequences for non-compliance with the deadline,” the court stated that “following the Supreme Court’s rule, the Board has authority to issue a Final Written Decision even after the deadline proscribed in the statute has passed absent any contrary indication in the language, structure, or legislative history of the statute.” [16]
No Indications in Statutory Language That Board Cannot Issue Final Written Decision After Deadline
The court began by addressing Purdue’s assertion that there are indications in the statutory language that the Board loses its authority to issue a Final Written Decision after the statutory deadline has passed. [17]
First, the court disagreed with Purdue that the use of “shall” and “requiring” in Section 326(a)(11) deprive the Board of authority to issue its Final Written Decision after the deadline. The court noted that this argument contravenes the Supreme Court’s decision in Brock v. Pierce Cnty., 476 US 253, 266 (1986). [18] In Brock, the Supreme Court held that the use of “shall” does not automatically divest an agency of jurisdiction to act after a specified time.
Second, the court disagreed with Purdue’s reading of another Supreme Court case—French v. Edwards, 80 US 506 (1871). [19] Purdue argued that based on French, the “negative words” of “not later than 1 year” and “by not more than 6 months” in Section 326(a)(11) support prohibiting the Board from issuing a Final Written Decision after the statutory deadline. [20] The court disagreed, noting that French “did not involve a statutory deadline, and in later cases, the Supreme Court has held that similar statutory language as that involved here does not result in a loss of authority.” [21]
Third, the court disagreed with Purdue’s argument that when the time outlined in Section 326(a)(11) passes, the Board’s jurisdiction under Section 6 of 35 USC also passes. [22] As the court explained, the “mere mention [in Section 326(a)(11)] that PGRs shall be conducted ‘in accordance’ with section 6 or PGRs be conducted ‘pursuant to’ chapter 32 does not rise to the level of a clear statement that section 326(a)(11) is jurisdictional.” [23]
Fourth, the court disagreed with Purdue’s assertion that Section 326(a)(11)’s exceptions for “good cause” and “joinder” demonstrate that these are the only two scenarios where the deadline to issue a Final Written Decision can be extended beyond the one-year mark. [24] Relying on Barnhart v. Peabody Coal Co., 537 US (2003), the court explained that mentioning some exceptions in a statute does not automatically exclude others. [25]
Fifth, the court analyzed other related statutory provisions. For example, the court stated, “it is significant that section 328(a) mandates that the Board issue a Final Written Decision.” [26] Moreover, Section 315(b) and Section 321(c) each contain “explicit language denying agency power after a time deadline” by expressly barring the institution of an inter partes review or PGR after certain time events have lapsed. [27] Relying on these express statements in other sections of the statute, the court explained that “[h]ad Congress meant to deprive the agency of power in section 326(a)(11), it knew how to do it, and, significantly, it did not use language in section 326(a)(11) similar to that used in other sections.” [28]
Legislative History Supports Board Issuing Its Final Written Decision After Deadline
The court also analyzed the legislative history, noting that it also supported allowing the Board to issue a Final Written Decision after the deadline. [29] The court emphasized that denying the Board authority to issue decisions post-deadline would run counter to the America Invents Act's (AIA) intent of expediting patent reviews and providing efficient alternatives to litigation, stating that "forbidding the Board to issue a Final Written Decision after the deadline has passed would go against Congressional intent" and that "some of the work done during the PGR would be lost and the parties would have to duplicate briefing and arguments." [30]
The court also addressed Purdue’s assertion that allowing the Board to issue its Final Written Decision after the deadline “would mean nothing more than the undefined timing for reexamination that Congress disliked and replaced.” [31] In response, the court stated that Purdue’s assertion “is not accurate” and that while the Board must not ignore statutory deadlines, the appropriate remedy for parties affected by delay is mandamus, rather than assuming a loss of the Board’s authority to act. [32]
Parties before the Board in either inter partes reviews or PGRs should be mindful that the Board retains authority to issue its Final Written Decision even after the statutory deadline has passed. If the deadline has passed without a decision, practitioners can consider seeking mandamus relief to compel the Board to issue its decision.
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[1] Purdue Pharma L.P. v. Collegium Pharm., Inc., 86 F.4th 1338, 1340 (Fed. Cir. 2023).
[2] Id.
[3] Id.
[4] Id. at 1340-1341.
[5] Id. at 1341.
[6] Id.
[7] Id.
[8] Id.
[9] Id.
[10] Id.
[11] Id.
[12] Id.
[13] Id.
[14] Id. at 1339-1340
[15] Id. at 1342 (emphasis added).
[16] Id.
[17] Id.
[18] Id. at 1342-1343.
[19] Id. at 1343.
[20] Id.
[21] Id.
[22] Id.
[23] Id.
[24] Id.
[25] Id. at 1343-1344.
[26] Id. at 1344.
[27] Id.
[28] Id. (emphasis added).
[29] Id.
[30] Id.
[31] Id. at 1344-1345.
[32] Id. at 1345.