Justice Burley of the Federal Court of Australia (NSW Registry) has delivered in June 2024 an important decision on the scope of documentary discovery in the ongoing litigation between Pfizer (Pfizer Ireland Pharmaceuticals and Pfizer Australia) and several competitors concerning Australian Patent No. 2005280034, titled “Production of polypeptides” (the Pfizer Patent). The ruling provides timely guidance on the Court’s strict approach to discovery and its expectations regarding efficient case management under section 37M of the Federal Court of Australia Act 1976 (Cth).
Justice Burley declined to order discovery of Pfizer’s research and development materials but required production of a narrower category of documents directly relevant to the respondents’ pleaded lack‑of‑best‑method case. The judgment also includes pointed observations on the respondents’ inventive‑step pleading, which at the time involved more than 80 permutations of common general knowledge and prior art.
Background
Pfizer alleges that Organon, Samsung Bioepis, MSD, and two Arrow entities (together, the Respondents) infringed the Pfizer Patent through their manufacture of etanercept, a biologic used to treat autoimmune diseases and marketed by Pfizer as ENBREL®. The Respondents deny infringement and counterclaim that the patent is invalid on several grounds, including lack of novelty, lack of inventive step, inutility, and failure to disclose the best method.
Before filing affidavit evidence, the Respondents sought discovery in two categories:
- Category One: Research and development documents relating to the invention between August 2002 and August 2004, said to be relevant to lack of inventive step and inutility.
- Category Two: Pre‑filing documents concerning the production of etanercept or “TNFR‑Ig” as described in Example 16 of the Pfizer Patent, said to be relevant to the lack‑of‑best‑method ground.
The Court’s Decision
Category One – Discovery Refused
Justice Burley declined to order production of Category One documents for two principal reasons:
1. Direct relevance requirement
Under the Federal Court Rules, discoverable documents must be directly relevant to the issues raised in the pleadings or affidavits. Lack of inventive step is assessed objectively—whether the invention would have been obvious to a skilled person—not by reference to the inventors’ own research pathway. As such, the patentee’s R&D documents are of only secondary significance. The Respondents’ pleadings did not suggest that the inventors’ path to the invention was relevant.
2. Proportionality and efficiency (s 37M)
Section 37M requires the Court to ensure the “quick, inexpensive, and efficient” resolution of proceedings. Justice Burley considered the request for Category One documents to be “an exercise in fishing.” Even absent oppression, the burden of locating, reviewing, and managing such documents would add unnecessary cost and delay.
Justice Burley also rejected the argument that Category One documents were relevant to inutility. However, he noted that if Pfizer later filed inventor affidavits, the position may change.
Observations on the Inventive‑Step Pleading
In addressing Category One, Justice Burley commented on the Respondents’ inventive‑step case, which relied on common general knowledge alone or in combination with numerous prior art documents—over 80 permutations in total. He described this as a “poorly focused, scattergun approach” and indicated that such breadth was inconsistent with efficient case management. The Respondents have since undertaken to streamline their case.
Category Two – Discovery Ordered
Justice Burley ordered production of Category Two documents (in a narrower form than originally sought). These documents were directly relevant to the pleaded lack‑of‑best‑method ground. The Respondents allege that Example 16 sets out the best method but omits information that the inventors likely possessed at the filing date. Justice Burley noted that this pleading was supported, at least in part, by the declaration of co‑inventor Dr Denis Drapeau, filed by Pfizer in response to the discovery application.
Key Takeaways for Patent Litigants
- Discovery remains tightly confined. The Court will only order production of documents that are directly relevant to the issues in dispute.
- Proportionality is central. Section 37M continues to guide the Court’s approach to efficient, cost‑effective case management.
- Inventive‑step pleadings must be disciplined. Broad, unfocused combinations of prior art risk judicial criticism and may be curtailed.
- Best‑method challenges require careful attention. Where the pleadings and evidence point to potential omissions in the specification, targeted discovery may be ordered.
Justice Burley’s decision reinforces the Federal Court’s commitment to disciplined litigation practice and provides valuable guidance for parties navigating complex patent disputes in Australia.
*Former in-house counsel for Pfizer in charge of IP Enforcement in Africa, Asia & Australia
