Regadenoson – USA

Regadenoson – USA

On Apr. 08, 2021, Delaware court granted Plaintiff’s motion as Defendants failed to meet their burden to show the applicability of the “common interest doctrine”.


This is a Hatch-Waxman case involving Plaintiff (Astellas/Gilead) and Defendant (Dr. Reddy’s Laboratories/DRL) for product, Lexiscan (regadenoson) with respect to discovery dispute. Plaintiffs requested that the Defendants should produce certain documents that have either withheld entirely or have partially redacted. These documents were related to Defendants’ communications with Euticals Inc. / Albany Molecular Research Inc. (API supplier). Defendants argued that these documents are protected by the “common interest doctrine”.


“The common interest doctrine is an exception to the general rule that an applicable privilege will be deemed waived if the relevant materials are disclosed to a third party. Generally, attorney-client privilege protects the communication between attorney & client, which is of legal nature. But when the client needs to disclose certain documents to third party then this privilege does not apply. These communications with third party then can be covered under common interest doctrine during discovery”. 


To prove that the common interest doctrine protects certain materials from discovery, the party asserting the doctrine bears the burden to show that an underlying privilege has been established, and that:

(1) the communications-at-issue are made by separate parties in the course of a matter of common legal interest;

(2) the communications are designed to further that common legal interest; and

(3) the privilege has not been waived.


In this instant case, Defendants provided the Court with four sets of documents which are mostly related to ‘patent status’ report shared by third party regarding its API. Defendants argued that the documents-at-issue “reflect the obvious and long-standing common legal interest between DRL and Euticals—preparing to defend against Plaintiffs’ infringement allegations. Court said that Defendants’ argument has some merit, which involve a discussion of some arguably legal issue with regard to the Euticals API – even if the discussions are undoubtedly taking place at a time in which one party (Euticals) is trying to convince another party (DRL) to engage in a commercial transaction (i.e., to convince DRL to purchase the API from Euticals).


But, Court said that with regard to what was happening in the relevant time period (2015 to 2017), Defendants have not met their burden to demonstrate that DRL and Euticals then shared a common legal interest. Specifically, these communications happened between April 2015 to August 2017.  And yet DRL (1) did not select Euticals to be its API supplier until October 2018; (2) did not submit its paragraph IV certification until March 2019; and (3) was not sued by Plaintiffs until June 2019. Indeed, even as of 2017, not only was DRL still over a year away from agreeing to enter into any type of commercial relationship with Euticals, but DRL was then still apparently considering five different potential regadenoson API suppliers. It is a bridge too far to conclude that in 2015-2017, Defendants and Euticals sufficiently and concretely anticipated that they would be involved in litigation regarding the API—when they would not even agree to go into business together until years later. Therefore, in 2015-2017 time frame, the prospect of DRL and Euticals sharing a common legal interest was too remote, contingent and uncertain to allow for invocation of the common interest doctrine.


Moreover, in order to demonstrate the existence of a common legal interest, the party with the burden should either point to evidence of an existing written agreement between it and the third party, or failing that, at least cite to some other evidence indicating that a common legal interest had been solidified at the relevant time. The record here similarly fails to evidence the existence of a concrete common legal interest between DRL and Euticals in the April 2015 to August 2017 time period.


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