The Federal Circuit recently held a generic drug developer lacked Article III standing to appeal an adverse patentability determination by the Patent Trial and Appeal Board (PTAB) because it failed to prove that it suffered an injury in fact necessary to establish standing.
Apotex filed a petition for an inter partes review (IPR) challenging the validity of Novartis' U.S. Patent 9,187,405 (the '405 Patent), which generally covers methods for treating relapsing multiple sclerosis. The Board instituted proceedings and subsequently joined several other generic companies as petitioners to the proceeding, including Argentum. At the conclusion of the IPR, the Board held that the petitioners failed to show the claims were unpatentable and the petitioners appealed. Before the opening briefs were filed in the appeal, Novartis settled with all of the petitioners except Argentum. Novartis then filed a motion to dismiss the appeal on the basis that Argentum, the only remaining petitioner, lacked Article III standing.
Argentum opposed Novartis' motion and, in doing so, argued that it suffered at least three concrete "injuries-in-fact" that confer standing. First, Argentum argued that it faced a real and imminent threat of litigation based on its joint development of a generic version of Novartis' Gilenya® product for patients with relapsing multiple sclerosis (MS). To bolster its argument, Argentum pointed to the fact that an Abbreviated New Drug Application (ANDA) was in the process of being filed, and further noted that Novartis had already sued multiple companies that sought to develop generic Gilenya®. The Federal Circuit rejected this argument, noting that no ANDA had been filed, any ANDA for generic Gilenya® will be filed by Argentum's manufacturing and marketing partner KVK-Tech, and Argentum provided no evidence that it, rather than KVK-Tech, would bear the risk of any infringement suit.
Second, Argentum contended that it faced severe economic injury because a "looming infringement action by Novartis" threatened the investments it made in developing a generic version of Gilenya® and preparing an ANDA. Argentum's purported investments included renovations to KVK-Tech's manufacturing facilities used to manufacture drugs developed through their joint collaboration. The Federal Circuit noted, however, that this evidence was not specific to Gilenya®, crediting testimony that KVK-Tech's new manufacturing facility will be used to produce multiple generic drugs, including drugs unrelated to the '405 Patent. For that reason, the Federal Circuit found the evidence insufficient to establish economic harm. The Federal Circuit also found that Argentum's allegations that it "invested significant man-power and resources to [the Gilenya® ANDA]" and that it will lose $10–50 million per year in lost profits once the Food and Drug Administration (FDA) approves the ANDA were conclusory and speculative and, therefore, did not establish an injury-in-fact that is "concrete and particularized."
Third, Argentum argued it would be harmed absent relief because IPR estoppel prevents it from raising the validity issues in a future infringement action. In dismissing this argument, the Federal Circuit pointed to its own precedent, explaining that "we have already rejected invocation of the estoppel provision as a sufficient basis for standing."
Thus, because Argentum failed to establish an injury sufficient to confer Article III standing, the Federal Circuit dismissed the appeal without reaching the merits of the Board's ruling on the '405 Patent claims.
Argentum Pharms. LLC v. Novartis Pharms. Corp., 2018-2273 (Fed. Cir. Apr. 23, 2020)
Practice Tip: A petitioner who seeks to appeal an IPR decision for which there is not a co-pending or related litigation must present evidence of a concrete and particularized injury to establish standing. This may include evidence indicating that an infringement suit is imminent or other economic harm. However, such evidence must be specific and tied to the claims at issue. Conclusory or speculative assertions will not suffice. And, when not included in the record before the PTAB, the evidence must be presented at the Federal Circuit.
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