Pfizer has successfully appealed an earlier decision of the Federal Court of Australia that denied it access to Samsung Bioepis’ confidential material about how it produces its biosimilar BRENZYS (etanercept).

BRENZYS was approved by the Australian Therapeutic Goods Administration (TGA) in July 2016 and was listed on the publicly-subsidised Pharmaceutical Benefits Scheme (PBS) on April 1, 2017.

PBS listing of BRENZYS triggered a statutory price reduction of 16% in the publicly-subsidised price paid for Pfizer’s ENBREL.

In the court proceeding, Pfizer sought an order for preliminary discovery of confidential documents Samsung Bioepis lodged with the TGA to determine whether to commence proceedings against Samsung Bioepis for patent infringement.

Specifically, Pfizer suspected that the process by which the BRENZYS products are made (BRENZYS Process) might infringe one or more of its patents, but required more information in relation to the BRENZYS Process to ascertain whether it infringes the claims of the three patents identified.

At first instance Justice Stephen Burley found, among other things, that Pfizer’s in-house expert, Dr Neysi Ibarra, failed to give evidence of her observations, the source of her knowledge or any other evidence that went toward the manner in which she assessed that the process by which ENBREL is made as falling within the claims and thus the evidence did not rise above mere speculation.

The Full Court decision, comprising three separate judgments, makes it plain that the threshold requirement for preliminary discovery is lower than that applied by Justice Burley.

In particular, Chief Justice James Allsop found that “it is misleading and distracting to use ‘speculation’ as the relevant enquiry” and that there “appears to be a real scientific contest” in relation Dr Ibarra’s evidence (at [70]).

While recognising that there were decided cases to the contrary, Justice Nye Perram also provided the following practical observation (at [121]):

"In practice, to defeat a claim for preliminary discovery it will be necessary either to show that the subjectively held belief does not exist or, if it does, that there is no reasonable basis for thinking that there may be (not is) such a case. Showing that some aspect of the material on which the belief is based is contestable, or even arguably wrong, will rarely come close to making good such a contention."

The matter has been remitted back to Justice Burley to determine the final form of the orders providing for preliminary discovery including any questions of confidentiality and costs of the initial application.

Samsung Bioepis has until January 2, 2018 to seek special leave to appeal to the High Court of Australia should it wish to challenge the Full Court’s decision.