Newron Pharmaceuticals S.p.A v Arrotex Pharmaceuticals Pty Ltd (Access Regime and Costs)

What the judgment does make clear is that the documents concerned Arrotex's confidential information surrounding its safinamide formulation. The Court treated the earlier order as an extraordinary one because it compelled a business to provide confidential information to a commercial competitor for that competitor's commercial benefit. That description was not rhetorical. It became central to the Court's approach to both confidentiality and costs.

The access issue narrowed before the hearing. Newron and Zambon had initially proposed six people who should be allowed to inspect the documents. To narrow the dispute, they pressed only for access by two external IP advisers, Ms Ampollini and Ms Bertuccio, and left the position of the other four people for another time.

Arrotex did not object to those two advisers seeing the documents in principle. Its objection was to the terms of access. It wanted each adviser to give a confidentiality undertaking in a form approved by Arrotex that also included two additional restrictions. First, each adviser would promise not to be involved in future patent prosecution relating to safinamide or products containing safinamide in Australia or elsewhere.

Secondly, each adviser would promise to use the documents only for the Australian proceedings, including any ensuing infringement proceeding or appeal, and not for any legal proceeding in another jurisdiction.

Newron and Zambon said those extra conditions were unnecessary because the existing confidentiality undertaking already limited use of the documents to permitted purposes and included an express submission to the Court's jurisdiction. Arrotex argued that enforcement would be more difficult if there were a breach by people outside Australia and that those advisers were not subject to the same professional obligations to Australian courts as local practitioners.

Importantly, the Court was not deciding whether the patents had been infringed. It was also not deciding whether the patents were valid, whether Arrotex's product was bioequivalent in a way that established infringement, or whether Newron and Zambon would ultimately sue. The judgment is confined to access, suppression orders and costs after preliminary discovery had already been granted.

That limitation matters because some of the reasoning on costs referred to the way the preliminary discovery application had been run, including scientific evidence that came close to addressing the ultimate infringement question. But the Court was still dealing with a procedural application, not a final merits hearing.

As a result, the Court allowed Ms Ampollini and Ms Bertuccio to inspect the documents under the existing confidentiality undertaking and did not impose Arrotex's proposed additional restrictions. In particular, the Court did not prevent them from future work surrounding safinamide litigation or patent prosecution.

On costs, the Court separated the costs of producing the documents from the legal costs of the application itself. For production costs, the Court ordered the prospective applicants to pay Arrotex's reasonable costs of collating, reviewing and providing the documents required by the orders made on 29 October 2025. The judge said that, given the extraordinary nature of the remedy, the work involved in providing preliminary discovery should properly be borne by those obtaining the benefit of the documents.

For the legal costs of the application itself, the Court declined to make an immediate costs order. Instead, it made a contingent order. If Newron and Zambon commenced proceedings alleging infringement of Australian Patent Numbers 2007263328 and or 2008334778 by 31 January 2026, the costs of the proceeding, except in relation to paragraph 2 of the originating application, would be costs in the cause of that infringement proceeding.

If they did not commence such proceedings by that date, there would be no order as to costs, with the intention that each party bear its own costs of the application.

The Court said this approach reflected all the circumstances, including that preliminary discovery is not regular winner-takes-all litigation, that Arrotex had no control over whether the applicants would later sue, and that Arrotex's scientific defence had come close to addressing the ultimate issue in any infringement case. Costs relating to paragraph 2 of the originating application, the samples issue, were reserved because that issue had been deferred.

If your business is resisting access to confidential material, this case shows that broad concerns may not be enough. Arrotex argued that overseas recipients created enforcement difficulties and were not subject to the same professional obligations as Australian practitioners. The Court accepted those concerns were relevant in principle, but still required something more concrete. Because no specific risk was identified, the Court did not impose the extra restrictions sought.

That is a practical point for any business trying to protect technical know-how, formulations, official source or other sensitive information. If you want tighter controls, identify the actual risk. Explain why the existing undertaking is insufficient. Show how the proposed recipient's role, future work, or location creates a real problem in this case, not just a theoretical one.

If your business needs overseas advisers, experts or patent professionals to review confidential material, this decision is helpful but not automatic. The Court did not say overseas recipients always get access. It said there was no reason for a different regime here, given the express submission to the Court's jurisdiction, the existing confidentiality undertaking, the Harman obligation, and the absence of any specific identified risk.

Businesses should therefore prepare carefully drafted undertakings and be ready to explain why those protections are enough.

The judgment also shows the importance of separating different cost categories. Production costs and application costs are not the same thing. A court may place the burden of production on the party seeking the benefit of the documents, while leaving the legal costs of the application to be determined later or absorbed by each side if no main proceeding is filed.

The judgment also highlights the importance of procedural housekeeping. The parties agreed on the form of suppression orders covering confidential material on the court file and parts of the earlier reasons. The Court was prepared to make final suppression orders with liberty to apply. That shows confidentiality protection may involve more than just undertakings between parties. It can also involve court file restrictions and suppression of parts of the reasons.

Finally, the orders created a commercial decision point. Newron and Zambon had until 31 January 2026 to decide whether to commence infringement proceedings. That date mattered because it determined what would happen to the legal costs of the preliminary discovery application. Businesses using preliminary discovery should therefore build a clear internal timetable for reviewing the produced material, obtaining advice, and deciding whether to sue before any court-imposed deadline expires.