Richards Layton & Finger
 

Chief Judge Stark Denies Motion to Dismiss Hatch-Waxman Claim

June 5, 2019

In Belcher Pharmaceuticals, LLC v. International Medication Systems, Ltd., No. 18-960-LPS-CJB (Mar. 31, 2019), Chief Judge Stark denied the defendant’s motion to dismiss for failure to state a claim. The defendant had filed a new drug application under 21 U.S.C. § 355(b)(2) with a Paragraph IV certification that the patent-in-suit was invalid, prompting the litigation.

The defendant argued that, because the complaint lacked allegations of fact indicating how the accused product practices any claim of the asserted patent, the plaintiff failed to satisfy the plausibility pleading standard of Iqbal and Twombly. Chief Judge Stark agreed instead with the plaintiff that alleging the statutory artificial act of infringement of filing a new drug application sufficed to state a claim in a Hatch-Waxman action.

According to the Court, it was consistent with the nature of a Hatch-Waxman litigation to require the plaintiff to allege only the submission of the drug application, since patentees are constrained by reasons of time and access in what they can learn about the accused product before suit. The accused product itself is not available for sale, and even though the defendant in this case gave the plaintiff confidential pre-complaint access to its application, the statute does not require that such access be granted. Moreover, patentees have 45 days from the receipt of a Paragraph IV certification to decide whether to bring suit in order to obtain the stay of FDA approval of the accused product, and often receive several Paragraph IV certifications at the same time.

Key Point: To state a claim for infringement in a Hatch-Waxman litigation, the Court found that there was no distinction between the submission of a new drug application and an abbreviated new drug application—the submission of either was a statutorily sufficient artificial act of infringement for the purpose of stating a claim.