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Mayne Pharma International Pty. v. Merck Sharp & Dohme Corp.

PTAB May Permit Corrections to Real Party in Interest Disclosure Without Adjusting Filing Date

Mayne Pharma International Pty. v. Merck Sharp & Dohme Corp., __ F.3d __, 2019 WL 2553514 (Fed. Cir. June 21, 2019) (LOURIE, Dyk, O’Malley) (PTAB) (3 of 5 stars)

Fed Cir affirms IPR decision that Mayne’s patent claims are invalid as anticipated or obvious. Mayne’s patent relates to pharmaceutical compositions of azole antifungal drugs. The Board’s institution of review did not contravene the time bar provision of § 315(b). The opinion describes how Merck Sharp & Dohne’s (“MSD”) petition did not name MSD’s parent company Merck & Co., Inc. (“MCI”) as a real party in interest, but after Mayne pressed the issue post-institution the Board permitted MSD to update its mandatory notice to include MCI without affecting the Petition’s filing date. The Board determined that permitting this amendment would serve the interests of justice per 37 C.F.R. § 42.1(b). It “did not plainly err” in that decision, and the opinion notes that MCI had agreed to be bound by estoppel. “In fact, Mayne was aware of MCI because MCI was a named defendant in parallel district court litigation and, had MSD named MCI as a real party in interest in its original petition, Mayne would be in the same position it is now.” Op. at 12. Because the Board committed no reversible error, the opinion declines to address whether the decision to institute is reviewable in these circumstances. The opinion also rejects Mayne’s argument that, per 37 CFR § 42.104(c), the Board lacks authority to permit amendment to petitions except in the case of clerical or typographical errors without changing the filing date. Though Mayne’s argument reflected PTO guidance from August 2015, “the Board thereafter changed its practice.” Op. at 13. The opinion discusses several Board cases, and citing Wi-Fi One, 878 F.3d 1364 (Fed. Cir. 2018), concludes, “A lapse in compliance [as to real party in interest] does not preclude the Board from permitting the lapse to be rectified, and we are unpersuaded that § 42.104(c) provides the exclusive means for correcting a petition.” Op. at. 14.

On the merits, the Board did not err in construing “pharmaceutical composition” broadly enough to cover toxic compositions without beneficial therapeutic properties, and the opinion discusses the evidentiary support for that construction. The Board also did not err in failing to limit claimed pharmacokinetic parameters to humans, particularly under the broadest reasonable interpretation standard. The opinion notes how the claims used the term “in vivo,” which the patent described as addressing animals. That a district court construed the term differently did not require a different outcome, per Power Integrations, 797 F.3d 1318 (Fed. Cir. 2015).

KEYWORDS: INTER PARTES REVIEW; CORRECTION OF PETITION; REAL PARTY IN INTEREST; CLAIM CONSTRUCTION