Generic manufacturers seeking to put an end to Hatch-Waxman Act patent litigation over a branded company’s Orange Book-listed patents can seek to do so by converting from Paragraph IV (“PIV”) patent certifications to Paragraph III (“PIII”) certifications. In a recent case, the District of Delaware held that such conversions, after litigation has been commenced, do not strip federal courts of subject matter jurisdiction over the branded company’s patent infringement claims, but nonetheless granted judgment on the pleadings dismissing the infringement claims at issue without prejudice as failing to present a ripe controversy on which relief could be granted.
The Hatch-Waxman Act, codified as 21 U.S.C. § 355(j), created a statutory mechanism for resolving patent disputes between generic manufactures seeking FDA approval to make and sell generic versions of patent-protected drug products. When filing an Abbreviated New Drug Application (ANDA), the generic manufacturer must file a certification under one of several statutory sub-paragraphs as to any patents listed in the FDA’s “Orange Book” as covering the branded product.1 Among other things, the generic manufacturer can certify that it does not seek FDA approval to market its generic product until after the patent expires (a PIII certification), or that it believes the patent is invalid or will not be infringed, and therefore it is seeking FDA approval to market its product prior to patent expiration (a PIV certification). Filing a PIV certification is deemed to be an “artificial act” of patent infringement that typically provokes a Hatch-Waxman Act suit by the branded manufacturer seeking to enjoin the FDA from approving the generic manufacturer’s ANDA until after its patent expires.
What happens, however, if in order to save litigation costs or some other strategic reason, the generic manufacturer no longer seeks approval to sell its product prior to expiration of one or more of the Orange Book-listed patents? The statute allows the company to indicate that by converting its patent certification from a PIV to a PIII certification, but will that bring an end to any litigation over the patent at issue? The District of Delaware addressed this situation in H. Lundbeck A/S v. Apotex Inc., 18-88-LPS, 2020 WL 3507795 (D. Del. June 26, 2020).
The H. Lundbeck Decision
Sandoz had filed Paragraph IV certifications against four patents owned covering polymorphs of the drug vortioxetine. In response, H. Lundbeck sued Sandoz under the Hatch-Waxman Act for infringement of those patents.2 Over a year later, Sandoz amended its ANDA, converting its PIV certifications to PIII certifications, thereby agreeing not to seek FDA approval to launch its generic until after those polymorph patents expired. Sandoz then moved to dismiss H. Lundbeck’s claims for infringement of those patents under Federal Rule of Civil Procedure 12(b)(1) for lack of subject matter jurisdiction.
The Court denied the motion. It noted that the issue in a Rule 12(b)(1) motion “is the court’s very own power to hear the case.”3 In particular, Sandoz argued that “[t]he sole trigger for suit – Sandoz Inc.’s original Paragraph IV certifications – no longer exists, leaving the Court without the jurisdictional hook established by the Hatch-Waxman Act.”4 The Court disagreed.
Citing recent case law from the Federal Circuit and the District of Delaware, it held that “when a defendant in an ANDA lawsuit converts a Paragraph IV certification to a Paragraph III certification during the course of a lawsuit, the Court is ‘not deprived of jurisdiction under 35 U.S.C. § 271(e)(2) and 35 U.S.C. § 1338(a) because it is sufficient that the case was initially certified under Paragraph IV.’”5 Further, the Court held that such conversions “do not moot the case unless defendants meet ‘the formidable burden of showing that it is absolutely clear the alleged wrongful behavior could not reasonably expected to recur.’”6 It found that Sandoz could not meet that “formidable burden,” primarily because it refused to stipulate that it would not reconvert its PIII certification back to a PIV certification, stating that it “simply cannot state with any certainty what its business strategy will be nearly seven years from now.”7 Even though the possibility of such a re-conversion was entirely speculative, with no showing of any intent or likelihood that Sandoz would do so, that hypothetical possibility was enough, in the Courts’ eyes, to warrant denial of the motion to dismiss.
However, that was not the end of the story. Sandoz also moved, in the alternative, for judgment on the pleadings that H. Lundbeck failed to state a claim on which relief may be granted, and the Court granted that motion. H. Lundbeck only sought relief under 35 U.S.C. § 271(e)(2), which deems it to be an act of infringement to submit an ANDA if the purpose is to make and sell the proposed generic drug product before expiration of the patent. The Court held that by converting its certification regarding the polymorph patents to a PIII certification, it was now only seeking approval to sell its generic product after those patents expired.8 The Court held that “[t]herefore, it is presently clear that [H. Lundbeck] cannot obtain relief on [its] claim[s] for infringement under § 271(e)(2).”9 For purposes of judgment on the pleadings, the hypothetical possibility that Sandoz might reconvert was insufficient to forestall dismissal. Rather, the Court reasoned that “as [H. Lundbeck’s] claim is not ripe for adjudication, it follows that there is no relief the Court may properly grant.”10 Accordingly, “because ‘no relief could be afforded under any set of facts that could be proved,” the Court granted judgment in Sandoz’s favor as to the claims for infringement of the polymorph patents, and dismissed those claims without prejudice.11
The Court’s ruling on the motion for judgment on the pleadings raises questions regarding whether those claims presented a “case or controversy” sufficient to sustain the Court’s jurisdiction over them under Article III of the Constitution, but the parties apparently did not argue and the Court did not decide that issue.
Although the Court granted the relief Sandoz sought—dismissal of the infringement claims relating to H. Lundbeck’s polymorph patents—it was very careful to explain what it believed to be the proper doctrinal basis for doing so. Its holding that conversion from a PIV certification to a PIII certification does not strip the court of subject matter jurisdiction of Hatch-Waxman infringement claims suggests that under appropriate circumstances, such claims might remain viable. However, branded pharmaceutical companies seeking to resist dismissal of their claims despite a generic manufacturer’s decision to convert to a PIII certification will need to point to more than just the hypothetical possibility of a reconversion back to a PIV certification in explaining why a ripe dispute on which relief can be granted nevertheless remains.
1) See 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV).
2) See 35 U.S.C. § 271(e)(2).
3) H. Lundbeck, 2020 WL 3507795, at *3 (quoting Petruska v. Gannon Univ., 462 F.3d 294, 302 (3d Cir. 2006) (internal quotation marks omitted)).
5) Id. at *4 (quoting Sanofi v. Lupin Atlantis Holdings Sa, 2017 WL 384062, at *1 (D. Del. Jan. 26, 2017)).
6) Id. (quoting Sanofi, 2017 WL 384062, at *2).
7) Id. (citing Sanofi, 2017 WL 384062, at *2).
8) Id. at *5.
10) Id. at *6.