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Amerigen Pharmaceutics Ltd. v. UCB Pharma GmbH

ANDA Applicant Has Standing for IPR Appeal

Amerigen Pharmaceutics Ltd. v. UCB Pharma GmbH, __ F.3d __, 2019 WL 166677 (Fed. Cir. Jan. 11, 2019) (LOURIE, Chen, Stoll) (PTAB) (3 of 5 stars)

Fed Cir affirms IPR confirmation of various claims in UCB’s patent. The patent relates to Toviaz (fesoterodine), a treatment for urinary incontinence. Notwithstanding that Amerigen currently lacks FDA certification for its ANDA (and thus faces no possible infringement liability), Amerigen has constitutional standing for its appeal. Amerigen’s ANDA is tentatively approved, and will become approved when UCB’s patent expires or is invalidated. “We agree with Amerigen that it has standing to appeal from the Board’s decision because the launch of its tentatively approved drug is blocked by the [ ] patent, and invalidation of the patent would advance its drug’s launch.” Op. at 11. Citing Daiichi Sankyo, 781 F.3d 1356 (Fed. Cir. 2015), the opinion reasons the FDA’s Orange Book listing of the patent causes injury to Amerigen in the form of delayed approval of its proposed drug. Janssen Pharmaceutica, 540 F.3d 1343 (Fed. Cir. 2008), is not contradictory because that case was analyzing not the AIA, but the pre-modernization version of the Hatch-Waxman Act. That Janssen found delay to be “not a cognizable Article III controversy, but a result envisioned by the [Act],” 540 F.3d at 1361, did not mean that delay was a non-cognizable injury in the context of the AIA.

On the merits, the Board did not commit reversible error in rejecting Amerigen’s obviousness challenge, and its findings had sufficient support in the record.

KEYWORDS: HATCH-WAXMAN; INTER PARTES REVIEW; APPELLATE STANDING; ANDA; OBVIOUSNESS (NO)