Purdue Pharma L.P. v. Accord Healthcare Inc.

OxyContin® (oxycodone HCl)

September 8, 2023

GENERICally Speaking

Case Name: Purdue Pharma L.P. v. Accord Healthcare Inc., C.A. No. 22-913-WCB, 2023 WL 5835811 (D. Del. Sept. 8, 2023) (Bryson, J.)

Drug Product and Patent(s)-in-Suit: OxyContin® (oxycodone HCl); U.S. Patents Nos. 11,304,908 (“the ’908 patent”) and 11,304,909 (“the ’909 patent”)

Nature of the Case and Issue(s) Presented: The patents-in-suit claim tablet formulations that are “tamper resistant.” Specifically, they claim technology that makes oxycodone HCl tablets that are “hard enough to resist crushing by abusers and viscous enough to deter intravenous abuse by abusers who manage to crush the tablets into particles and mix with water for injection.” In a prior action, Accord I, three patents in the same family as the patents-in-suit were held invalid as obvious. Accord moved for judgment on the pleadings, arguing that Purdue is barred from asserting the claims of the patents-in-suit because those claims are invalid for obviousness due to collateral estoppel from court’s findings in Accord I action. Accord’s motion was denied.

Why Defendants Prevailed: Purdue’s principal arguments were that: (i) Accord’s motion impermissibly asks the court to take judicial notice of the Accord I trial record; and (ii) Accord failed to demonstrate that collateral estoppel applied to the claims in this case. The court disagreed with the former and agreed with the latter.

Regarding the judicial notice argument, Purdue does not dispute that a court may take judicial notice of a prior proceeding, but argued that at the pleading stage the court may take notice of only the existence of the opinion, not for the truth of the facts asserted in the opinion. The court disagreed, citing extensive case law standing for the proposition that “[i]n the context of deciding a Rule 12(b)(6) motion that raises issue preclusion concerns ... it is axiomatic that a court must still consider the prior adjudication in order to determine whether issue preclusion bars that plaintiff’s claims.” In deciding that the court may take judicial notice of the earlier trial record, it noted that judicial notice did not extend to the evidence presented to the court at trial or transcripts of the proceedings that took place during the action.

Regarding the collateral estoppel argument, each of the independent claims in the patents-in-suit required “a plurality of convection heated particles of PEO [polyethylene oxide]” that “adhere to or fuse with each other within the matrix.” That limitation was not expressly recited in the claims in Accord I, and Judge Andrews did not discuss or decide whether the prior art asserted in that case disclosed that limitation. In response, Accord argued that those limitations were the inherent result of heating the PEO matrix as described in the prior art asserted in Accord I. But as noted, testimony offered during a prior proceeding cannot be the subject of judicial notice for purposes of finding facts. Moreover, finding inherency is a high standard. The statements in the shared specification of the patents-in-suit and those found invalid in Accord I related to curing and heating PEO are suggestive at best, which is insufficient to establish inherency. “As the specification demonstrates, a number of variables exist in the manufacturing process, such as the use of direct compression, the order and sequencing of compression and curing, the percentage of PEO that melts, the curing temperature and time, the use of a cooling step, and the equipment used in manufacturing.” Because the specification did not state or even imply that adherence and/or fusion is an inherent result of every combination of variables that involve curing PEO at a temperature above its softening temperature, and Judge Andrews did not decide any such questions in his Accord I opinion, those are factual matters that should be reserved for trial in the instant case.

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