Judge Noreika just addressed an issue that rarely comes up in D. Del.: whether a patent should be delisted from the Orange Book for non-compliance with the Hatch-Waxman listing requirements. Although the issue itself is uncommon, the decision highlights the difficulty of winning a Rule 12 motion that hinges on early-stage claim construction.
The plaintiff sued "for infringement of five patents, only one of which . . . is listed in the Orange Book." The defendants counterclaimed that the Orange Book patent "must be delisted because it claims a 'system,' not a drug product, or method of using a drug, as required by" the Hatch-Waxman Act. The defendants then moved for judgment on the pleadings on their delisting claim.
Judge Noreika rejected the argument that the issue was not ripe for adjudication, finding that the defendants had a right to bring their delisting counterclaim "regardless of whether [they] had certified against the listed patent."
She denied the motion, however, primarily because the "[d]efendants' arguments depend in no small part on claim construction and the question of whether the claimed 'system' includes methods of using the approved product."
During the claim construction process, “[t]he court may, in its discretion, receive extrinsic evidence in order ‘to aid the court in coming to a correct conclusion’ as to the ‘true meaning of the language employed’ in the patent.” Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995). As such, the vast majority of courts have held claim construction to be inappropriate on a motion under Rule 12. See, e.g., Nalco, 883 F.3d at 1349; In re Bill of Lading, 681 F.3d at 1343 n.13; Encore Dermatology Inc. v. Glenmark Pharms. Ltd., No. CV2002509KMESK, 2020 WL 7586958, at *3 (D.N.J. Dec. 22, 2020); Deston Therapeutics LLC v. Trigen Laboratories Inc., 723 F. Supp. 2d 665, 670 (D. Del. 2010); Yangaroo Inc. v. Destiny Media Techs., No. 09–462, 2009 WL 2836643, at *3, (E.D. Wis. Aug. 31, 2009). “To engage in the claim construction process upon review of a motion to dismiss [or, here, a motion for judgment on the pleadings] would be to go beyond the scope of a court's traditional gatekeeping role in reviewing such a motion; it would instead amount to a more in-depth evaluation of the merits of a plaintiff’s case.” Pragmatus AV, LLC v. Yahoo! Inc., No. 11-902-LPS-CJB, 2012 U.S. Dist. LEXIS 161874, at *22 (D. Del. Nov. 13, 2012). The Court agrees with these cases and will decline to engage in claim construction at this early stage of the case.
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