Abstract
Synopsis
Petitioner seeking cancellation of patent claims in inter partes review (IPR) proceeding appealed an adverse decision of the Patent Trial and Appeal Board (PTAB), but the Federal Circuit dismissed the appeal because Petitioner failed to show that it had suffered an “injury in fact” necessary to establish Article III standing. Petitioner argued that it had demonstrated multiple injuries in fact arising out of a “real and imminent” threat of litigation, because Petitioner was jointly pursuing (along with its manufacturing and marketing partner, a company that did not join in the IPR petition) an Abbreviated New Drug Application (ANDA) to market a generic version of a branded drug (Gilenya) allegedly covered by the challenged patent. The Federal Circuit was not convinced, noting that no ANDA had been filed, and that any ANDA to be filed would be filed by Petitioner's manufacturing and marketing partner, not by Petitioner. The court found that Petitioner had failed to provide any evidence, “beyond generic statements,” showing that it would bear the risk of any infringement suit, or any other loss related to its involvement in the ANDA process.
On February 3, 2017, Apotex Inc. and Apotex Corp. (collectively, Apotex) filed a petition for inter partes review of Novartis Pharmaceuticals Corporation's U.S. Patent No. 9,187,405. The Board instituted proceedings on July 18, 2017, and granted Sun Pharmaceutical Industries, Ltd., Sun Pharmaceutical Industries, Inc., and Sun Pharma Global FZE's (collectively, Sun); Teva Pharmaceuticals USA, Inc. and Actavis Elizabeth LLC's; and Argentum Pharmaceuticals LLC's requests for joinder under 35 U.S.C. § 315(c). After institution, Patent Owner, Novartis, filed a contingent motion to amend. On July 11, 2018, the Board concluded that Apotex, Sun, Teva, Actavis, and Argentum (collectively, Petitioners) had not demonstrated unpatentability of the claims and denied the motion to amend as moot. Petitioners appealed the Board's findings. During the appeal process, all Petitioners other than Argentum settled their respective appeal with Novartis.
On August 29, 2018, before opening briefs had been filed, Novartis filed a motion to dismiss Argentum's appeal for lack of standing. Argentum opposed the motion on September 10, 2018, and included declarations of Jeffrey Gardner, Argentum's CEO, and Anthony Tabasso, President and CEO of KVK-Tech, Inc., Argentum's manufacturing and marketing partner.
Because we hold that Argentum lacks Article III standing, we dismiss the appeal and do not reach the merits of the Board's ruling on the claims of the ’405 patent.
Discussion
Although we have jurisdiction to review final decisions of the Board under 28 U.S.C. § 1295(a)(4)(A), an appellant must meet “the irreducible constitutional minimum of standing.” Amerigen Pharm. Ltd. v. UCB Pharma GmBH, 913 F.3d 1076, 1082 (Fed. Cir. 2019) (quoting Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992)). This holds true even if there is no such requirement in order to appear before the administrative agency being reviewed. To prove standing, Argentum bears the burden of showing that it has (1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision. Argentum must supply the requisite proof of an injury in fact when it seeks review of an agency's final action in a federal court, by creating a necessary record in this court, if the record before the Board does not establish standing. To establish injury in fact, an appellant must show that he or she suffered an invasion of a legally protected interest that is “concrete and particularized” and “actual or imminent, not conjectural or hypothetical.” An injury is particularized if it affects the appellant in a personal and individual way.
Argentum argues that it demonstrated at least three concrete injuries in fact. First, Argentum argues that without an opportunity to seek this Court's redress, it faces a real and imminent threat of litigation as it jointly pursues, along with its partner KVK-Tech, Inc., a generic version of Novartis' Gilenya® product for which they are in the process of filing an ANDA. It argues that given that Novartis already sued multiple generic companies to protect Gilenya®, “it is virtually certain that Novartis will sue Argentum and KVK,” which is “far from conjectural” and “constitutes an imminent injury for purposes of standing.”
Novartis argues that any ANDA to be filed for a generic version of Gilenya® will be filed by KVK, Argentum's manufacturing and marketing partner, and thus KVK, not Argentum, is at risk of being sued. And even if the litigation were personal to Argentum, it would not confer standing because it is merely conjectural. It argues that there is no evidence of concrete plans for future activity that creates a substantial risk of future infringement or will likely cause the patentee to assert a claim of infringement.
Citing our decision in Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc., Argentum responds that “showing a concrete injury-in-fact does not necessitate an already-filed ANDA.” (889 F.3d 1274, 1282–83 (Fed. Cir. 2018)). Argentum's contentions are unavailing. In Altaire, Altaire was the company which intended to file an ANDA and would be at imminent risk of being sued. We held that Altaire had standing because the threat of litigation was “real” and “imminent” and Altaire was affected “in a personal and individual way.” See Altaire, 889 F.3d at 1282–83. Unlike in Altaire, any ANDA to be filed will be filed by KVK, Argentum's manufacturing and marketing partner. No ANDA has been filed here, and Argentum has not provided evidence showing that it would bear the risk of any infringement suit or anything related to its involvement in the ANDA process beyond generic statements.
Second, Argentum argues that it will incur significant economic injury as its investments in developing a generic version of Gilenya® and preparing an ANDA would be at risk with a “looming infringement action by Novartis.” Specifically, it asserts that it will suffer at least $10–50 million per year in lost profits once the FDA grants provisional approval to the ANDA. Novartis argues that Argentum's alleged “economic injury,” which is entirely speculative and not personal to Argentum, does not suffice to establish injury in fact because it is not concrete or particularized.
Argentum has not provided sufficient evidence to establish an injury in fact through economic harm. Argentum's or KVK's purported investments include KVK's renovation of manufacturing facilities that “KVK intends to use … to manufacture drugs developed through its joint collaboration with Argentum.” However, Mr. Tabasso specifically states that “[t]he generic version of PAZEO®,” a drug unrelated to the patent at issue, “will be produced in KVK's new manufacturing space which will come online in the next year.” And Mr. Gardner declared that “Argentum has partnered with KVK … to develop generic versions of multiple generic drug products” without providing evidence specific to a generic Gilenya® product.
Argentum likewise has failed to provide sufficient evidence that it invested in KVK's generic Gilenya® product or ANDA. It stated only in generalities 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.” And its assertion that it will suffer at least $10–50 million per year in lost profits once the FDA grants provisional approval to the ANDA is both conclusory and speculative. This cannot suffice to establish an injury in fact that is “concrete and particularized” and “actual or imminent, not conjectural or hypothetical.”
Third, Argentum argues that absent relief from this court, Argentum would be estopped under 35 U.S.C. § 315(e) from raising the patentability and validity issues in a future infringement action. Novartis argues that Argentum has not shown that it will be harmed by estoppel where it has not established there is risk of an infringement suit. As the court stated in AVX, “we have already rejected invocation of the estoppel provision as a sufficient basis for standing.” 923 F.3d at 1362–63. Accordingly, we hold that Argentum has failed to prove that it has suffered an injury in fact necessary to establish standing.
Conclusion
We have considered the parties' remaining arguments and do not find them persuasive. Because Argentum failed to establish an injury sufficient to confer Article III standing, we dismiss the appeal.