Lannett Holdings Inc. v. AstraZeneca AB

Addressing the one-year time bar for filing an inter partes review (IPR) petition, the Patent Trial and Appeal Board (PTAB or Board) found petitioner's arguments regarding proper service and jurisdiction unpersuasive and rejected the generic drug maker's petitions as time barred under 35 USC §315(b). Lannett Holdings Inc. v. AstraZeneca AB, IPR2015-01630 (PTAB, Feb. 2, 2016) (Yang, APJ). 

At issue is an AstraZeneca patent directed to formulations of the anti-migraine drug zolmitriptan for nasal applications. The patent claims a formulation of zolmitriptan that achieves fast relief while maintaining high efficacy, without causing any irritation or side effects. AstraZeneca filed two actions for patent infringement. The first action stated that "AstraZeneca AB is the owner by assignment of the [] patent and has the right to sue for patent infringement." The second action stated that "AstraZeneca AB and AstraZeneca UK Limited own all rights, title and interest in the [] patent." Zeroing in on this discrepancy, Lannett filed a motion to dismiss the first action based on the judicial admission in the second action that AstraZeneca UK is a co-owner of the patent and should have been a named party. The district court denied the motion to dismiss without prejudice, subject to renewal after completion of discovery.

Lannett later filed petitions for IPR of two AstraZeneca patents, including the patent at issue in the two lawsuits. The Board determined that the petitions were time barred because they were filed one day after the one-year filing deadline. Per 35 USC §315(b), an IPR may not be instituted "if the petition requesting the proceeding is filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent."

In an effort to save the petitions, Lannett argued that AstraZeneca's service of its complaints was ineffective under Delaware law and could not trigger the one-year bar. Specifically, Lannett claimed that AstraZeneca's registered agent, CSC Entity Services, is a limited liability company and that therefore the complaint should have been served "personally to any manager" of CSC. Here, the proof of service only showed CSC, and not an individual, having accepted service, and so the service was defective. The Board disagreed, explaining that the corporate status of the petitioner, not the registered agent, dictates the appropriate procedure for service. In this case, the petitioner (Lannett) is a corporation, and under Delaware law service of process on a corporation "shall be made by delivering a copy personally to . . . the registered agent of the corporation . . . ." As such, AstraZeneca's service was proper.

Lannett also raised a jurisdictional argument, which largely tracked its motion to dismiss in the first action. Specifically, Lannett argued that the first action was jurisdictionally deficient for failure to name AstraZeneca UK as a party, and a jurisdictionally deficient action does not trigger the § 315(b) time bar. The Board disagreed, noting that the district court did not dismiss the first action, but instead allowed the parties to conduct discovery into the ownership question. In this case, despite almost one year of discovery, Lannett was unable to present any evidence to demonstrate the level or type of interest AstraZeneca retains in the patent. The Board agreed with the district court's conclusion that the statement in the second action—that AstraZeneca UK is a co-owner of the patent—was not sufficient evidence to show that AstraZeneca UK is an indispensable party in the first action. In other words, the Board declined to conclude that the district court lacks jurisdiction over the first action.

Timing Is Everything – Meeting the One-Year Filing Deadline for IPR

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