IP Law Daily, PATENT—D.N.J.: Xspray’s motion for judgment in Bristol-Myers Squibb Hatch-Waxman Act suit denied, (May 12, 2023)

By Jonathan Anderson

The court should not consider a new drug application when it is neither integral to nor referenced in an amended complaint.

A federal district court in New Jersey has denied a motion for judgment on the pleadings. Brought by the defendant in a Hatch-Waxman Act lawsuit. The court found that it is not proper to consider a new drug application (NDA) when it is neither integral to nor referenced in an amended complaint. Further, the court said that even if it were to consider the NDA, such evidence is not determinative of the conflicting, factual allegations set forth in the amended complaint. The record at best includes conflicting factual allegations, and when considered in the light most favorable to the non-movant and the contents of the amended complaint, denial of the motion is warranted (Bristol-Myers Squibb Co. v. XSpray Pharma AB, April 25, 2023, Bumb, R.).

Background. Plaintiff, Bristol-Meyers Squibb Co. (BMS), markets the pharmaceutical drug dasatinib, sold under the name Sprycel, which is used to treat chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. BMS alleges that a new drug produced by defendant, Xspray Pharma AB (Xspray), infringes on three patents intended to protect BMS’ investment in dasatinib: U.S. Patent Nos. 7,491,725 (the ‘725 patent), 8,680,103 (the ‘103 patent), and 8,242,270 (the ‘270 patent).

BMS recognizes and Xspray does not dispute, that each of the patents at issue are “directed to various crystalline forms of dasatinib,” and although the ‘725 and ‘103 patents are listed in the Orange Book for dasatinib/Sprycel, BMS also asserts infringement of the ‘270 patent because it “describes and claims other crystalline forms of dasatinib.”

On January 13, 2022, BMS allegedly received a paragraph IV notification that certain of BMS’s ‘725 and ‘103 patents are invalid or will not be infringed by Xsray’s new drug. Xspray further alleged that the notification revealed that Xspray had sought approval from the Food and Drug Administration (FDA) “to launch a generic version of” of Sprycel with 100mg dosage strength. Xspray alleged that it applied for a New Drug Application under 21 U.S.C. § 355(b)(2) because it intends to market a new and improved drug. On February 23, 2022, BMS filed suit against Xspray, and BMS later received a second paragraph IV certification from Xspray disclosing that it had filed an amendment to its NDA to include five additional dosage strengths. BMS subsequently filed another lawsuit against Xspray asserting infringement.

On September 23, 2022, Xspray filed a motion for judgment on the pleadings, arguing that its drug no longer includes patented dasatinib and is no longer covered by BMS’s “narrow patents on specific crystalline forms.” (Some of the arguments that Xspray advanced were redacted from the decision).

BMS in response contended that the court should deny Xspray’s motion, arguing that the pleading standard has already been met because BMS alleged that Xsrpay’s NDA relies on BMS’s Sprycel application. (BMS also advanced arguments that were redacted from the decision).

NDA not properly before the court. First, the court found that the NDA is not properly before it for purposes of deciding the pending motion. Xspray’s motion foundationally relied upon the contents of the NDA and not the sufficiency of BMS’s claims in the amended complaint. BMS argued that it did not rely on any specific portion of Xspray’s NDA in the amended complaint, and the court agreed, writing: “BMS did not rely upon any of the specific pages and documents from the nearly 60,000-page NDA that Xspray now urges the Court to consider as evidence of non-infringement prior to any fact discovery.”

Plausible patent infringement claims. Second, the court held that the amended complaint states plausible claims of patent infringement because it “allows reasonable inferences to be drawn that Xspray is liable for the infringement alleged,” and that BMS’s pleadings put Xspray on notice of the claims.

Material issues of fact. Third, the court concluded that even if Xspray’s NDA were integral to or explicitly relied upon the amended complaint, the court could not rely on the portions Xspray argues prove non-infringement because “[t]his would be in direct conflict with other portions of the NDA, which BMS argues show that infringing levels of crystalline dasatinib is permitted in Xspray’s new drug,” raising a question of material fact. Further, the court observed that the “Federal Circuit has cautioned that in cases such as this ‘where the subject matter is a compound capable of existing in multiple crystalline forms, or mixtures thereof, the ultimate question of infringement is not so simple,’” warranting additional discovery.

The Case is No. 1:22-cv-00964.

Attorneys: Liza M. Walsh (Walsh Pizzi O’Reilly Falanga LLP) for Bristol-Myers Squibb Co. Gene Y. Kang (Rivkin Radler LLP) for XSpray Pharma AB.

Companies Bristol-Myers Squibb Co.; XSpray Pharma AB

Cases: Patent NewJerseyNews