Key Points:

• Court rejects post-filing NDA amendments as grounds for early dismissal in Hatch-Waxman litigation.
• Rule 12(b)(6) review limited to the complaint and properly considered documents, not later-modified FDA submissions.
• Allegations of future infringement tied to FDA approval are viable under the Hatch-Waxman framework.

A Tight Boundary

A judge in the District of New Jersey refused to dismiss a Hatch-Waxman patent infringement action, holding that a generic drug maker's post-filing amendments to its new drug application cannot override the well-pleaded allegations in the complaint or convert an extraneous regulatory submission into a basis for dismissal.

The ruling by U.S. District Judge Stanley R. Chesler reinforces the tight boundary between the pleading stage and the evolving regulatory record, a boundary that takes on outsized importance in pharmaceutical patent disputes where the content of an NDA (or ANDA) is often further developed during the ongoing litigation.

For branded manufacturers and generics alike, the decision is a pointed reminder that the courthouse and the FDA operate on separate timelines and that changes made to a drug application after suit is filed do not rewrite the facts a court must accept as true.

The Complaint and Motion to Dismiss

According to the complaint, Defendant Tris Pharma, Inc. submitted a new drug application to the FDA pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act to market a generic version of Plaintiff Jazz Pharmaceuticals Ireland Limited’s branded pharmaceutical Xyrem®.

Tris sent a notice letter to Jazz that said Tris’s NDA included Paragraph IV certifications to seven of Jazz’s patents. Jazz accordingly filed suit claiming, in part, infringement of these seven patents, consistent with the Hatch-Waxman statutory scheme.

Amended NDA Does Not Supersede Original

In its motion to dismiss, Tris first argued that subsequent to the submission of the Paragraph IV certifications to Jazz, it amended the NDA by providing Section 505(b)(2)(B) statements that “replace Tris’s previous Paragraph IV certifications.” Tris argued that the complaint should be dismissed because its “proposed changes to the NDA exclude the uses covered by the patents at issue.”

The Court denied Tris’s motion, crediting in large part Jazz’s argument in opposition that the Proposed Amended NDA that Tris sought to place before the Court was extraneous to the complaint and could not be considered on a motion to dismiss. The Court held under Third Circuit law that a 12(b)(6) motion to dismiss “cannot succeed by arguing that the facts alleged in the Complaint are no longer true” because “the non-conclusory allegations are taken as true for the purpose of deciding a 12(b)(6) motion.”

The Court emphasized that Tris “does not reckon with this essential principle: on this motion, the Court does not find facts, but instead takes the non-conclusory allegations in the Complaint as true,” further noting “Tris has given this Court no controlling authority for the proposition that this bedrock principle does not apply here.”

The Court rejected Tris’s argument that it should consider the Proposed Amended NDA on two grounds: “1) as required by law, the Court takes the non-conclusory allegations in the Complaint as true; and 2) Tris has not persuaded that, under the circumstances of this case, the Court may look to the contents of a document cited in the Complaint that has been subsequently modified.”

The Court noted that the Third Circuit has identified three exceptions to the general rule that matters extraneous to the pleading itself are not to be considered on a motion to dismiss.

The exceptions are:

• documents attached to or submitted with the complaint
• documents whose contents are alleged in the complaint and whose authenticity no party questions, but which are not physically attached to the pleading
• documents that the defendant attaches to the motion to dismiss if they are referred to in the plaintiff’s complaint and are central to the claim

Tris’s Proposed Amended NDA did not fall into any of these three exceptions, the Court found, requiring denial of the motion to dismiss. Specifically, the Court found that the original NDA was not attached to the complaint (exception one); the proposed NDA is not alleged in the complaint (exception 2), and the proposed NDA was not attached in full to the motion to dismiss nor was it referenced in the complaint (exception 3).

Subclaims for Future Infringement

The Court also addressed Tris’s argument that certain contingent subclaims in Jazz’s complaint should be dismissed, which Tris argued were “contingent future claims, should the FDA approve the NDA, for direct infringement under § 271(a), induced infringement under § 271(b), and contributory infringement under § 271(c).”

For example, from Count 1: “Unless enjoined by this Court, upon FDA approval of Tris’s NDA, Tris will infringe/induce infringement/contributorily infringe . . .” (Compl. at ⁋⁋ 31, 32, 33).

The Court denied the motion as to these subclaims, holding Tris’s framing “has taken the purported contingent subclaims out of the context in which they appear, and argued as if they are stand-alone claims pled without facts which make them plausible.” The Court held these were “not independently-asserted claims.”

In the context of claims brought under the Hatch-Waxman Act, which “allows present adjudication of infringing activity that is likely to occur in the future,” the Court characterized these claims as “the allegations of contingent future violation of Section 271 (a, b, and c) to be infringement contentions, not unsupported additional claims.”

As an alternative basis, the Court reviewed Federal Circuit precedent and found the claims “may be viewed as sub-claims under the umbrella of the claims under Section 271(e)(2),” which allows patentees to assert claims for induced infringement.

Paul W. Kalish and Jonathan J. Madara are members of the IP Litigation team in Fox Rothschild’s Princeton, NJ office and write about patent litigation decisions in the District of New Jersey. Contact Paul at pkalish@foxrothschild.com or 609.895.6751 and Jonathan at jmadara@foxrothschild.com or 609.844.7428.

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