Mayne Pharma Int. v. Merck Sharpe & Dohme (MSD) (USPTO as intervenor)
Docket No. 2018-1593 (IPR2016-01186)
LOURIE, DYK, O’MALLEY
June 21, 2019
Brief summary: Board IPR time bar and claim construction/invalidity determinations affirmed.
Summary: Mayne appealed the USPTO’s (Board’s) IPR final written decision (FWD) concluding that claims 2, 6 and 9-14 of US 6,881,745 relating to compositions of “about 100 mg of an azole antifungal drug” (that are practically insoluble in aqueous media) and “one or more polymer[s] having acidic functional groups…wherein in vivo the composition provides a mean Cmax of at least 100 ng/ml” (or at least 800 ng/ml) are unpatentable for anticipation or obviousness. The FC panel opinion explained that Mayne argued Merck & Co., Inc. (MCI), MSD’s parent company, was a real party in interest and the Board eventually agreed but rejected Mayne’s argument that the petition should have been time-bared under § 315(b). The Board concluded the challenged claims were anticipated by “Kai” or obvious over the combination of Kai, “Sangekar”, and “Babcock”. Mayne continued argued in this appeal that Merck should have been time-barred under § 315(b), and that “the Board could not allow a correction” of the real party in interest “without resetting the petitions filing date” which would be “more than a year after the service of Mayne’s complaint against” MCI. The FC panel, however, found no error with the Board’s actions (e.g., “no evidence suggesting that MSD intended to conceal MCI’s identity”, “Mayne was aware of MCI” as evidenced by parallel court proceedings, “unwinding the proceedings based on a strict view…would be at odds with the PTO policy expressed in § 42.1(b)”, PTO can change change RIP without changing the filing date (Lumentum, IPR2015-00739 (2016); WiFi One, FC 2018). MSD argued that the FC could not hear Mayne’s real-party-in-interest appeal under § 314(d) and Cuozzo (US 2016), but since the FC panel found no error with the Board’s decision it did not address this issue.
Maybe also that the Board erred “by declining to limit the claims to nontoxic compositions that produce the claimed pharmacokinetic profile in humans”, and therefore “under its proffered, narrower constructions, the claims should be patentable.” Mayne argued the Board “should have adopted the construction adopted by the District of Delaware in companion litigation, which limited the claim scope to compositions suitable for pharmaceutical use…thus avoiding the cited references.” The FC panel disagreed, finding “pharmaceutical composition” not to be “limited to nontoxic compositions” (e.g., “[b]ecause the specification is silent as to whether the claimed pharmaceutical composition is limited to being nontoxic, there is no basis to import such a limitation into the claim”, substantial extrinsic evidence), the BRI “of the claims is not limited to humans” (“with clear explanation of the meaning of the term in vivo in the patent,” limiting the claims to humans “would be in direct conflict with specification”) (AIA Eng’g, FC 2011; Power Int., FC 2015). Thus, the Board decision was affirmed.