Collegium Pharmaceutical Inc【COLL】株式ニュース

Official COLLEGIUM PHARMACEUTICAL, INC. press release

Purdue v. Collegium: Upholding The Board's Authority To Issue A Final Written Decision Even After The Statutory Deadline Has Passed
December 08, 2023 at 05:11 am EST

On November 21, 2023, the Federal Circuit in Purdue Pharma L.P et al. v. Collegium Pharm., Inc. (i) affirmed that the Patent Trial and Appeal Board (“Board”) has authority to issue a Final Written Decision after the statutory deadline has passed, and (ii) affirmed the Board's determination that claims 1-17 of U.S. Patent No. 9,693,961 (“'961 patent”) are unpatentable for lack of written description.1 Regarding the Board's authority, the Federal Circuit concluded that the Board's failure to comply with the statutory deadline does not deprive it of authority to render a final determination.2 On the merits, the Federal Circuit determined that neither the specification of the '961 patent nor its priority application provide adequate written description support.3

I. BACKGROUND

Purdue Pharma L.P. (“Purdue) owns the '961 patent, titled “Pharmaceutical Formulation Containing Gelling Agent,” issued on July 4, 2017.4 The '961 patent is directed to preventing or deterring “the abuse of opioid analgesics by the inclusion of at least one aversive agent in the dosage form.”5 The aversive agent “helps to prevent injection, inhalation, and/or oral abuse by decreasing the attractiveness of the dosage form to a potential abuser.”6 Representative claim 1, in relevant part, recites:

A method of preparing an abuse deterrent controlled release dosage form comprising:
combining oxycodone or a pharmaceutically acceptable salt thereof as active agent, polyglycolyzed glycerides, a C12 to C40 fatty acid or a mixture thereof, carnauba wax and beeswax, to form a homogenous mixture, wherein the oxycodone or pharmaceutically acceptable salt thereof is the sole active agent in the dosage form; . . . .7

In September 2017, Purdue sued Collegium Pharmaceutical, Inc. (“Collegium”) for infringement of the '961 patent.8 In March 2018, Collegium petitioned the Board for post grant review (“PGR”) of claims 1-17 of the '961 patent.9 Purdue argued that the '961 patent was not subject to PGR because it claimed priority to an application filed before March 16, 2013, i.e., a pre- America Invents Act (“AIA”) application.10 The Board found that the '961 patent was eligible for PGR because the pre-AIA application “did not contain sufficient written description support for the claimed invention, and the effective filing date was therefore after March 16, 2013.” 11The Board also found that the '961 patent specification likely lacked written description.12 Accordingly, the Board instituted PGR.13 Under 35 US.C. § 326(a)(11), the Board had one year to issue a Final Written Decision subject to a six-month extension for good cause.14

Upon Purdue filing a Notice of Bankruptcy and Imposition of Automatic Stay, the Board stayed the PGR proceeding.15 The parallel district court infringement case was also stayed.16 As the one-year deadline for the Board to issue a Final Written Decision approached, the Board found good cause to extend the stay “so the bankruptcy court could assess whether the automatic stay applied to PGRs.”17 After the six-month extended deadline had passed, the bankruptcy court lifted the stay for both the district court case and the PGR proceeding.18

Purdue moved to terminate the PGR proceeding, arguing that “the Board no longer had the authority to issue a Final Written Decision as the 18-month deadline had passed.”19
The Board denied Purdue's motion and held 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.”20 The Board issued its Final Written Decision, finding all claims unpatentable for lack of written description and anticipation.21 Purdue Appealed.22

II. FEDERAL CIRCUIT DECISION

A. THE BOARD'S AUTHORITY

As “a matter of first impression,” the Federal Circuit held 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.”23 35 US.C. § 326(a)(11) provides:

(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)24

1. STATUTORY LANGUAGE AND STRUCTURE

Purdue advanced several arguments based on the language and structure of section 326(a)(11). Each was rejected by the Federal Circuit.

First, Purdue argued that the use of the terms “shall” and “requiring” in the statute “deprives the Board of authority to issue a Final Written Decision after the deadline.” The Federal Circuit rejected Purdue's argument as contrary to Supreme Court precedent.25 The Federal Circuit explained that the words “shall” and “requiring” in section 326(a)(11) are “equivalent” and, under Supreme Court precedent, do not divest the Board of authority to issue a final determination after the statutory deadline.26

Second, Purdue contended that “the 'negative words' of 'not later than 1 year' and 'by not more than 6 months' in the section 326(a)(11) show 'the acts required shall not be done in any other manner or time than that designated.'”27 The Federal Circuit dismissed Purdue's contention because “the Supreme Court has held that similar statutory language as that involved here does not result in a loss of authority.”28 Likewise, the Federal Circuit has also “held that a statute containing 'not later than' 'created timing provisions that are at best precatory rather than mandatory.'”29

Third, Purdue asserted that the Board lacked jurisdiction after the statutory deadline because section 326(a)(11) is linked to the Board's jurisdictional grant in section 6 of Section 326(c).30 The Federal Circuit disagreed with Purdue, finding that the statute did not include a “clear statement” that the procedural rule violation would deprive the Board of jurisdiction, as required by Supreme Court precedent.31

Fourth, Purdue argued that “the exceptions in section 326(a)(11) for 'good cause' and 'joinder' show those are the only two limited circumstances under which the Board may issue a Final Written Decision after the one-year deadline.”32 But the Federal Circuit disagreed, explaining that “'enunciation of two exceptions does not imply an exclusion of a third.'”33

Finally, the Federal Circuit emphasized that “section 328(a) mandates that the Board issue a Final Written Decision,” whereas other provisions of AIA, such as sections 315(b) and 321(c), “use quite different language to bar action after deadlines pass.”34 The Federal Circuit stated 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.”35

2. LEGISLATIVE HISTORY

The Federal Circuit also rejected Purdue's argument that the legislative history deprives the Board of authority to act after the statutory deadline passes.36

The Federal Circuit noted that “Congress enacted the AIA in part to replace inter partes reexaminations,” which “were lengthy and inefficient, often lasting three to five years,” with PGRs and IPRs “to make patent review expeditious[.]”37 The Federal Circuit explained that

[F]orbidding the Board to issue a Final Written Decision after the deadline has passed would go against Congressional intent. If the Board could not issue a Final Written Decision, the parties would be forced to pursue the issue in district court litigation. This is the exact opposite of the purpose of the AIA, which is meant to create a more efficient alternative to district court litigation.38

The Federal Circuit also explained that the Board may not ignore statutory deadlines because a party may seek a petition for a writ of mandamus from the court immediately upon the deadline's expiration to compel the agency to act.39
Thus, the Federal Circuit concluded that “the Board's failure to comply with the statutory deadline does not deprive it of authority thereafter to issue a final written decision.” 40

* * *

Upon assessing “whether the '961 specification adequately discloses the claimed polyglycolyzed glycerides ('PGGs') as an aversive agent,” the Federal Circuit upheld the Board's finding that “the claimed formulation was not disclosed,” and therefore, affirmed the Board's determination that the claims were invalid for lack of written description.41 Having affirmed the Board's invalidation of the claims under section 112, the panel declined to reach the issue of anticipation.42

III. CONCLUSION

If the Board fails to comply with the statutory deadline, the appropriate remedy for a party seeking issuance of a Final Written Decision is to petition for mandamus to compel a decision from the Board.

Footnotes

1. Purdue Pharma L.P et al. v. Collegium Pharm., Inc., No. 22-1482, at 2, 15 (Fed. Cir. Nov. 21, 2023) (“Slip Op.”) available at https://cafc.uscourts.gov/opinions-orders/22-1482.OPINION.11-21-2023_2225603.pdf

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