District of Delaware Denies Request to Extend 30-Month Stay

In Covis Pharma GmbH v. Eugia Pharma Specialties Ltd., the United States District Court for the District of Delaware recently granted both the Plaintiffs’ and Defendants’ requests to stay the litigation, but denied the Plaintiffs’ additional request to toll the statutory 30-month stay under 21 U.S.C. § 355(j)(5)(B)(iii).

The case arose under the Hatch-Waxman statute from the Defendants’ submission of an Abbreviated New Drug Application (“ANDA”) to the FDA seeking approval to market generic versions of the Plaintiffs’ Makena® Autoinjector product prior to the expiration of the Plaintiffs’ patents covering the product. Under Hatch-Waxman, after the complaint’s filing, the FDA cannot approve the Defendants’ ANDA for 30 months (the statutory “30-month stay”). The parties’ stay requests stemmed from the FDA’s issuance of a Proposal to Withdraw Marketing Approval for the NDA covering Makena® Autoinjector and subsequent Complete Response Letter advising that because of the Proposal to Withdraw Marketing Approval, the Defendants’ ANDA could not be approved. See 21 U.S.C. § 355(j)(4)(I) (“the approval under subsection (c) of this section of the listed drug referred to in the application under this subsection has been withdrawn or suspended for grounds described in the first sentence of subsection (e) of this section”). Because of the risk of the 30-month stay expiring during the withdrawal period of the NDA covering Makena®, the Plaintiffs also sought to toll the 30-month stay.

Citing the Federal Circuit’s decision in Eli Lilly & Co. v. Teva Pharms. USA, Inc., 557 F.3d 1346, 1350 (Fed. Cir. 2009) and the District of Delaware’s decision in In re Brimonidine Pat. Litig., No. 07-1866, 2008 WL 4809037, at *3 (D. Del. Nov. 3, 2008), the Delaware District Court acknowledged that it could extend the 30-month stay if the Defendants “fail[ed] to reasonably cooperate in expediting the action.” But, while the Plaintiffs did argue that the Defendants failed to engage in discovery and expedite the proceeding, the record did not reflect that the Defendants had engaged in “uncooperative discovery practices” or had taken frivolous legal positions. Thus, the court concluded that an extension of the 30-month stay was not warranted.

Gibbons will continue to monitor and report developments in Hatch-Waxman litigation.

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