At times, a rights holder may suspect that its rights are being infringed, but has insufficient information of the infringer’s conduct to decide whether to start court proceedings. Preliminary discovery may be available to obtain documents from the suspected infringer to assist in making that decision. However, there must be a reasonable belief of infringement as preliminary discovery will not be available where the infringement is just suspected. This was made clear in the recent Federal Court decision of Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCA 285 (Pfizer v SBA).

Pfizer makes the biological medicine Enbrel. It has been sold in Australian since 2003 and is used to treat various autoimmune diseases. In July 2016, SBA registered two pharmaceutical products with the Australian Register of Therapeutic Goods (ARTG). The products were called Brenzys and contained the same active ingredient found in Enbrel, etanercept. ARTG registration is required for sale of a pharmaceutical on the Australian market.

Pfizer suspected SBA to be infringing three of its patents in manufacturing Brenzys. The patents related to various processes for manufacturing certain classes of biological products, but not to the products themselves.

Pfizer was not able to determine, on the information it had, what processes were used to manufacture Brenzys. It was unsure whether infringing processes were in fact used.

To obtain ARTG registration, Brenzys needed to be ‘biosimilar’ to Enbrel, which required similarity on a number of criteria. The products did not have to be identical or made by the same processes.

In receiving ARTG registration, SBA provided documents regarding the processes used to manufacture Brenzys to the Therapeutic Goods Administration (TGA). These documents were confidential, and it was these documents Pfizer wanted by preliminary discovery.

In the Federal Court, preliminary discovery is governed by Rule 7.23. It is a requirement of the Rule that the:

‘… prospective applicant … reasonably believes that he or she may have the right to obtain relief in the Court from the prospective Respondent whose description has been ascertained.’

Although there are other matters which must be satisfied by Rule 7.23, in this case the question turned to whether Pfizer reasonably believed that SBA was infringing one or more of its patents.

Pfizer argued that it had a reasonable basis for believing Brenzys was made using a process within the claims of the Pfizer patents, including:

  1. Brenzys had a peculiar level of similarity to Enbrel.
  2. Similarity between the products enables the inference that the process used to make each is similar.
  3. Process used by Pfizer to make Enbrel fell within the claims of its patents.
  4. Process used by SBA to make Brenzys may likewise fall within the Pfizer patents.

The judge said that there were problems with this chain of reasoning.

Pfizer’s evidence that its product was made by a process that fell within the claims of its patents was weak. Pfizer did not provide full details of the process used to make Enbrel. Its expert evidence was considered by the judge to be failing to set out the basis for the opinions given, and although admissible, was of little weight.

His Honour held that the fact that Enbrel and Brenzys were similar did not indicate what processes were used to make either product. It therefore did not follow that Enbrel was made by a process that fell within the claims of the Pfizer patents. Pfizer’s belief was really no more than speculation, and was not good enough.

Pfizer also argued that SBA did not actually deny in correspondence or in the running of the case that it used the patented processes, and so an inference should be drawn by the court that SBA did in fact infringe under the Jones v Dunkel principle. Although the judge said such inferences could be drawn in a preliminary discovery context, such an inference should not be drawn in this case because the evidence was not sufficient to call for an explanation by SBA. The judge held that SBA was ‘entitled to remain passive’.

The judge went on to consider that the other requirements of Rule 7.23 were satisfied.

Even where the various criteria of the Rule are satisfied, the court has discretion whether to order preliminary discovery. His Honour decided he would not exercise his discretion assuming that he was wrong in finding against Pfizer in relation to its ‘reasonable belief’. This was primarily because Pfizer did not disclose to the court full details of its own process used in making Brenzys.