Xspray and BMS settled the litigation for the Dasatinib outside of the court.

Case No 1:22-cv-00964-RMB-MJS2023

Plaintiff and Counter-Defendant: BRISTOL-MYERS SQUIBB CO.,

Defendant and Counter-Claimant: XSPRAY PHARMA AB

Drug Product: Sprycel® Dasatinib Tablet (Applicant: BMS)

Dasynoc® dasatinib (Applicant: Xspray)

 

Patent(s)-in-Suit: 

US7491725 (“the ’725 patent”),

US8680103 (“the ’103 patent”), and

US8242270 (“the ’270 patent”)

 

FACTUAL AND PROCEDURAL BACKGROUND:

·        Bristol-Meyers Squibb (“BMS”) owns the patents-in-suit and sells Sprycel, a drug used to treat chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

·        The patents-in-suit claim various crystalline forms of dasatinib. BMS asserts that Xspray filed an ANDA seeking to market a non-crystalline (i.e., amorphous) dasatinib product under the trade name Dasynoc.

·        BMS alleged that it received a letter from Xspray on or about January 13, 2022, notifying it that Xspray included a certification in its application pursuant to 21 U.S.C. § 355(b)(2)(A)(IV) (a “Paragraph IV Certification”) that certain claims of BMS’s ‘725 and ‘103 patents are invalid or will not be infringed by Xspray’s new drug.

·        BMS also alleged in its initial complaint that the Paragraph IV Certification received from Xspray notified it that Xspray had sought approval from the U.S. Food and Drug Administration (“FDA”) “to launch a generic version of BMS’s Sprycel (dasatinib) with 100mg dosage strength.”

·        Xspray contends that it applied for a NDA, not an ANDA, because it intends to market a new and improved drug and not merely a generic version of BMS’s reference drug.

·        BMS received a second Paragraph IV Certification from Xspray on May 17, 2022, informing it that Xspray had filed an amendment to its NDA to include five additional dosage strengths: 15 mg, 36 mg, 50 mg, 57 mg, and 70 mg.

·        BMS filed an Amended Complaint in that second-filed action on August 2, 2022, asserting infringement of the ‘270 Patent in addition to the ‘725 Patent and the ‘103 Patents (the two Orange Book-listed patents asserted in BMS’s initial complaint).

·        On September 23, 2022, Xspray filed the Motion for Judgment on the Pleadings, which is now ripe for adjudication

·        On October 19, 2022, as agreed by the parties, the Court consolidated both actions, designating Civil No. 22-964 as the lead case which we are going to brief.

·        Xspray argues that “while DASYNOC includes no longer patented dasatinib, it is not covered by BMS’s narrow patents on specific crystalline forms.” According to Xspray, the litigation need not proceed any further .

·        BMS argues that the Court should deny Xspray’s motion because the pleading standard for this Hatch-Waxman action has already been met given BMS’s specific allegations “that Xspray filed an NDA that relies on BMS’s application for Sprycel.”

·        BMS also argues that the general references to Xspray’s NDA in the Amended Complaint, including the fact that it was filed, “do not incorporate the entire NDA” for purposes of deciding the pending motion for judgment on the pleadings.

·        The Third Circuit made clear that “[a] motion for judgment on the pleadings under Rule 12(c) ‘is analyzed under the same standards that apply to a Rule 12(b)(6) motion.’” Wolfington v. Reconstructive Orthopaedic Assocs. II PC, 935 F.3d 187, 195 (3d Cir. 2019) (quoting Revell v. Port Auth. of N.Y. & N.J., 598 F.3d 128, 134 (3d Cir. 2010)).

“clearly establishes that no material issue of fact remains to be resolved and that [it] is entitled to judgment as a matter of law.”

ANALYSIS

    A. Xspray’s NDA is Not Properly Before the Court in Deciding the             Pending Motion for Judgment on the Pleadings

·        The court analyzed the several argument presented by BMS on the matter that and Xspray’s NDA is not properly before the court in deciding the pending motion for judgment on pleadings. Since the complain has amended due to increase the other concentrations BMSR give tact it did not rely on any specific portion of Xspray’s NDA it's amended complaint the court agrees on the same but at the same time BMS also did not explicitly cite any of the specific section or other contents of the NDA in its amended complaint.

·        Interestingly BMS did not rely upon any of the specific pages and documents from the nearly 60,000 pages in the year that X spray no urges the court to consider the evidence of non infringement prior to any fact discovery.

B. The Amended Complaint States Plausible Claims of Patent Infringement

·        BMS argues that its Amended Complaint properly pleads claims of patent infringement by alleging that on May 18, 2022, Xspray sent it a letter “stating that Xspray had included [the Paragraph IV Certification] in the Xspray NDA, pursuant to 21 U.S.C. § 355(b)(2)(A)(IV), that, inter alia, certain claims of the ’725 and ’103 Patents are either invalid or will not be infringed by the commercial manufacture, use, sale, offer to sell or importation into the United States of the Xspray NDA Products.”

·        Amended Complaint also expressly alleges that “Xspray seeks approval from the FDA to engage in the manufacture, use, offer to sell, sale, or importation of the Xspray NDA Products prior to the expiration” of the patents asserted. [Amended Complaint ¶¶ 32 (the ’725 Patent), 44 (the ’103 Patent), 56 (the ’270 Patent).

·        The the analysis of point A&B is only summarize for the procedural aspect so that court may proceed further.

    C. Even if the Court Considered the NDA, It Raises Material Issues of         Fact Regarding Whether Crystalline Forms of Dasatinib Are Actually         Permitted in Xspray’s New Drug

·        Finally, even if Xspray’s NDA were integral to or explicitly relied upon in BMS’s Amended Complaint, the Court could not rely on the portions Xspray argues prove non-infringement.

·        This 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.

Xspray cites other cases where based on the specific facts alleged, Xspray raises a good point that sometimes, “Hatch-Waxman cases do get dismissed, and that they can get dismissed by considering the ANDA or NDA.” [Docket No. 50.] For example, in Astrazeneca, the Federal Circuit affirmed the dismissal of a complaint based on the defendant’s ANDA filings.

For example, Xspray cites Otsuka Pharm. Co. v. Zydus Pharms. USA, but in that case dismissal of the underlying complaint was affirmed because “[e]ach [d]efendants’ ANDA … included a “section viii” statement, certifying that the applicant would not see approval for any indications or uses asserted to be covered” by the patent at issue.

 Xspray is on fair notice of the allegations of patent infringement being made against it, including whether its new drug includes any of the crystalline forms of dasatinib claimed under the ‘725, ‘103, or ’270 Patents. 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.”

CONCLUSION

Finally, Xspray’s case cites failed to convince the court that a motion for judgment on the pleadings may be granted based upon the contents of an NDA, which was neither integral to nor specifically referenced in an amended complaint, particularly when such contents are in direct conflict with the allegations and claims set forth in the amended complaint, as well as other parts and documents of the same NDA.

At best, the record presently before the Court includes conflicting factual allegations. Considering those allegations in the light most favorable to the non-movant and the contents of the Amended Complaint, the pending motion shall be denied.

Further the outside of the court oh 11th of September 2023 the PR discloses that BMS and Xspray pharma will proceed to file a dismissal with the United States District Court for the District of New Jersey, eliminating the need for any additional litigation on this matter. LINK

This settlement provides clarity on the launch date of our leading product, Dasynoc™, benefiting the market. It also allows Xspray to shift its focus towards ensuring a successful product debut in 2024. 

Court copy https://business.cch.com/ipld/Bristol-MyersSquibbvXsprayPharma.pdf