Preliminary Discovery & Patents

August 2018

CATHERINE CHANT | Special Counsel

Case note: Pfizer Ireland Pharmaceuticals -v- Samsung Bioepis AU Pty Ltd [2017] FCAFC 193

Preliminary discovery can be a useful mechanism to determine:

  • the identity of a party against whom you may be able to obtain relief for breach of your IP rights; or

  • whether you have the right to relief for breach of your IP rights against a party whose identity is known to you.

The Full Court of the Federal Court recently considered item 2 in Pfizer Ireland Pharmaceuticals -v- Samsung Bioepis AU Pty Ltd [1] (Pfizer Samsung Case)

In that case, the Full Court ordered Samsung Bioepis AU Pty Ltd (Samsung) to give Pfizer Ireland Pharmaceuticals and other companies (together Pfizer) preliminary discovery so they could determine whether to commence proceedings against Samsung for infringement of process patents. The case was an appeal against the decision of a single judge of the Federal Court (Primary Judge) refusing preliminary discovery.

Rule 7.23(1) of the Federal Court Rules 2011 provides for a prospective applicant to apply to the Court for preliminary discovery of documents from a prospective respondent if the prospective applicant:

  • reasonably believes they may have the right to obtain relief from the prospective respondent;

  • after making reasonable enquiries, does not have sufficient information to decide whether to commence proceedings; and

  • reasonably believes that the prospective respondent has/had or is likely to have/have had in their control documents directly relevant to the question of whether the prospective applicant has a right to relief and inspection of the documents would assist in making the decision.

Pfizer’s patents related to the bioprocessing of proteins and polypeptides that could be used in the production of etanercept. Etanercept was the active ingredient in Pfizer’s product ENBREL, a drug used for the treatment of autoimmune diseases. It was also the active ingredient of Samsung’s drug BRENZYS. Pfizer’s patents were published before Samsung began developing the BRENZYS drug and it was accepted that Samsung had the opportunity to review them.

The evidence of Pfizer’s expert was that, given the biosimilarity of the 2 drugs and the close similarity of their glycolsylation profiles, Samsung may be using the same upstream bioprocessing as Pfizer, and Pfizer’s patents, to produce BRENZYS. Pfizer’s Assistant General Counsel (Pfizer’s Counsel) relied on the evidence of Pfizer’s expert to form the view that Pfizer may have the right to obtain relief against Samsung.

The Primary Judge preferred the expert evidence for Samsung that biosimilarity tells one nothing about the process of manufacture and believed that Pfizer’s infringement claims were speculative. However, on appeal, the Full Court found that the correct question was not who of the experts was more persuasive or to be preferred. It was whether the views of Pfizer’s expert “so lacked foundation that reliance on them by” Pfizer’s Counsel failed to “demonstrate that he reasonably believed that Pfizer may have a right to obtain relief”[2].

The views of Pfizer’s expert were not “shown to have been outlandish or absurd”[3] and even if the Primary Judge preferred the expert evidence of Samsung, that did not provide the answer to the central question of whether Pfizer reasonably believed that it may have the right to obtain relief. The Full Court found that it did.

The rule regarding preliminary discovery remains one to be “beneficially construed”[4] and is a useful mechanism for prospective applicants who do not yet know whether they have a case against a prospective respondent. They need not make out a prima facie case against the prospective respondent. They need not believe that they do have a case. Preliminary discovery “is about those who do not know that they have a case but believe that they may.”[5]

[1] [2017] FCAFC 193

[2] Paragraph 70

[3] Per Perram J at paragraph 163

[4] Apache Northwest Pty Ltd -v- Newcrest Mining Ltd [2009] FCAFC 39 at [63] per Flick J

[5] Per Perram J at paragraph 108