Pfizer quest for Samsung Bioepsis etanercept documents continues

Date: 18 November 2021
Court:  Federal Court of Australia
Judge: Burley J

Background

In December 2016 Pfizer Ireland Pharmaceuticals (Pfizer) filed a preliminary discovery application against Samsung Bioepis AU Pty Ltd (SBA). The Full Court ultimately overturned Burley J’s initial refusal of the application, allowing Pfizer access to SBA’s confidential manufacturing information to ascertain whether SBA’s products would infringe any of its three relevant patents. The exact scope of the discovery to be provided was the subject of further dispute, and discovery orders were not made until May 2019. Those orders expressly contemplated Pfizer making a further request for documents, if the documents discovered were insufficient to allow it to determine whether to commence patent infringement proceedings. In September 2020 Pfizer filed a further preliminary discovery application accordingly, and that application was the subject of this judgment.

Key Issues

In support of its new application, Pfizer put on evidence from its solicitor setting out various matters “on information and belief” from an independent expert engaged by Pfizer who had reviewed the discovery documents already provided. Pfizer’s senior corporate counsel also gave evidence that, on the basis of a report provided to him by the independent expert, he believed that Pfizer did not have sufficient information to assess the patent infringement case and the potential costs and risks of the litigation. SBA’s responding expert evidence was to the effect that the documents already discovered contained sufficient information to determine whether its process fell within the scope of the relevant patent claims.

In addition to seeking additional discovery from SBA, Pfizer:

• argued that there was an obligation of continuing discovery under the existing orders. Such an obligation arises in the course of standard discovery and requires the party subject to discovery to discover additional documents falling within relevant categories which are created or come into the party’s possession after the date at which discovery is given. Pfizer argued that this duty applied in this case to capture documents relating to further batches of the relevant products produced after the original discovery was given;

• sought Sabre orders, so named after the Sabre Corporation case¹ in which the Court held that it had power to order a party to take steps to access and discover documents in the power or possession of another party, where there is a real likelihood that the first party would be given access to the documents. Such orders may be appropriate, for example, where documents are in the possession of another company within a corporate group which is not party to the litigation. Here, Pfizer sought an order that SBA seek documents from four other parties involved in the manufacture of SBA’s Brenzys products – SBA’s parent company, Samsung Bioepis Co Ltd, Biogen MA Inc, and two companies within the Fujifilm group. SBA agreed to seek documents within the relevant categories from its parent company but resisted an order requiring it to seek the documents from the other companies.

Outcome

In line with the Full Court’s decision in the first discovery application, Burley J accepted that it was sufficient that Pfizer’s expert provide a reasonable basis for contending the relevance of the additional documents sought, notwithstanding that such relevance could ultimately be disproven. This requirement was satisfied in respect of some categories of documents. In other cases, he considered that the documents were not necessary, noting that it was not legitimate to seek documents in preliminary discovery “for additional comfort”.

Burley J further rejected any duty of ongoing discovery in respect of preliminary discovery orders, noting the much more confined purpose of preliminary discovery. He held that no such continuing obligation arises unless expressly required in the orders, noting that such orders “would not be lightly made”.

As to the Sabre orders sought, while Burley J accepted that the Court had power to make a Sabre order in the context of preliminary discovery, he refused to do so in this case. Noting again the distinction between preliminary discovery and standard discovery which “serves to demonstrate that the Court would be slow to accept that mechanisms developed to aid discovery processes should be automatically be applied where there have been no pleadings and proceedings proper have not been commenced”, he was not persuaded that such orders were appropriate.

Implications

Burley J’s application of the Full Court’s test for preliminary discovery is perhaps uncontroversial. Of interest is the limited approach that he took to any duty of ongoing discovery and the availability of Sabre orders in the context of preliminary discovery, given that a claim that the applicant’s legal rights have been infringed has necessarily not even been commenced in that context.

1. (1993) 46 FCR 428