379 F. Supp. 3d 326
D. Del.2019Background
- Belcher Pharmaceuticals owns U.S. Patent No. 9,283,197 (the '197 patent) and asserts Claims 6 and 7 against IMS.
- IMS filed a 21 U.S.C. § 355(b)(2) paper NDA for 0.1 mg/mL epinephrine and sent Belcher a Paragraph IV certification, triggering a 45-day window for suit.
- The parties negotiated confidential access to IMS's NDA and Belcher received the NDA before filing suit; Belcher sued within the 45-day period alleging infringement under 35 U.S.C. § 271(e)(2).
- IMS moved to dismiss under Rule 12(b)(6), arguing Belcher’s complaint contained only conclusory allegations and lacked factual specificity required by Iqbal/Twombly.
- Belcher argued that pleading the artificial act of infringement (AND/ANDA/NDA filing plus notice and claim identification) suffices in the Hatch‑Waxman context and that discovery will develop particulars.
- The Court denied IMS’s motion, holding that, given the Hatch‑Waxman framework and practical constraints on plaintiffs during the 45‑day window, Belcher’s allegations were sufficient to state a claim at the pleading stage.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether a Hatch‑Waxman Paragraph IV plaintiff must plead detailed factual claim‑by‑claim infringement at the 12(b)(6) stage | Belcher: pled ownership, receipt of Paragraph IV notice, NDA filing, and that IMS’s proposed product infringes Claims 6–7; this suffices given the statute’s creation of an "artificial" act of infringement | IMS: Iqbal/Twombly require factual content showing plausibility of infringement; conclusory statement that product meets claim limitations is inadequate, especially since Belcher had NDA access | Court: pleadings alleging ownership, receipt of Paragraph IV, filing of NDA, and that the proposed product will infringe are sufficient to survive a Rule 12(b)(6) motion in the Hatch‑Waxman context |
| Whether a 505(b)(2) paper NDA should be treated differently from an ANDA (505(j)) for pleading | Belcher: same Hatch‑Waxman purpose; same pleading standard applies | IMS: 505(b)(2) differs (requires clinical data), so should be treated differently | Court: no meaningful pleading distinction; both are statutory artificial acts of infringement and treated the same for pleading purposes |
| Whether dismissal is warranted because plaintiff’s infringement theory would concede patent invalidity | IMS: any plausible theory that IMS’s product infringes would show the invention was not new given IMS’s 2010 materials, so complaint is futile | Belcher: factual disputes exist about the 2010 materials, commercialization, and obviousness; not appropriate at pleading stage | Court: factual disputes and Rule 11 presumption of counsel’s good faith mean dismissal on that ground is unwarranted |
| Whether the complaint should be converted to summary judgment | IMS: alternatively, ask court to convert and consider extrinsic materials | Belcher: not raised as primary relief | Court: declined to convert; summary judgment may be sought later after discovery |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (factual content must permit reasonable inference of liability)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (complaint must plead plausible entitlement to relief)
- Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir.) (§ 271(e)(2) creates an artificial act of infringement sufficient for jurisdiction)
- Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990) (Hatch‑Waxman amendments create a unique, artificial infringement action to expedite generic entry)
- Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316 (Fed. Cir.) (submission of an ANDA defined as act of infringement but underlying infringement analysis remains)