Argentum Pharmaceuticals v Novartis
Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corporation
No. 2018-2273 Fed. Cir. Before Circuit Judges Lourie, Moore, and Reyna.
In this appeal from the Patent Trial and Appeal Board, the Court held that Argentum lacks Article III standing and dismissed the appeal.
Standing requires that the Argentum “
- suffered an injury in fact,
- that is fairly traceable to the challenged conduct of the defendant, and
- that is likely to be redressed by a favorable judicial decision.”
The burden of proof was on Argentum to demonstrate standing. Argentum was pursuing a generic version of Novartis’ Gilenya® product, along with its partner KVK-Tech, Inc. They were in the process of filing an ANDA, but had not yet filed it. The ANDA would be filed by KVK. The Court indicated that KVK, not Argentum, may be at risk of being sued. However, “even if the litigation were personal to Argentum, it would not confer standing because it is merely conjectural.”
The Court also found that Argentum failed to provide sufficient evidence that it invested in KVK’s generic Gilenya® product or ANDA. General statements that both “KVK and Argentum have been diligent in working toward FDA submission of the ANDA” and that “Argentum has invested significant man-power and resources to the endeavor” were not sufficient to show “‘concrete and particularized’ and ‘actual or imminent, not conjectural or hypothetical’” injury. Argentum’s statements regarding potential lost profits were conclusory and speculative.
The Court further rejected Argentum’s argument that it would be estopped under 35 U.S.C. § 315(e) from raising patentability and validity issues in a future infringement action in the absence of relief here. The Court held that estoppel does not provide a sufficient basis for standing; § 315(e) does not constitute an injury in fact when a party is not engaged in activity that would give rise to a possible infringement suit.
Read more: Federal Bar member attorneys may access the full case summary by registered patent attorney B.C. “Bill” Killough in the May 2020 issue of Federal Circuit Case Digest
B.C. Killough is a registered patent attorney based in Charleston, SC. On behalf of his clients, Bill has obtained more than 300 United States patents, participated in prosecuting more than 100 foreign patent applications and he has filed more than 1000 trademark applications with the US Patent and Trademark Offices.