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

This decision is a procedural ruling in a pharmaceutical patent matter. It is not a judgment on patent infringement, patent validity, or final liability. The Court was dealing with what should happen after preliminary discovery had already been granted in an earlier decision.

The two questions were practical ones. First, who could inspect confidential documents that Arrotex had to produce? Secondly, who should bear the costs of the preliminary discovery process? The Court allowed two overseas external IP advisers to inspect the documents under the existing confidentiality undertaking, and it ordered the prospective applicants to pay Arrotex's reasonable document production costs. It did not make an immediate ordinary costs order for the application itself.

Newron Pharmaceuticals S.p.A and Zambon S.p.A were considering infringement proceedings against Arrotex Pharmaceuticals Pty Ltd. Before any substantive infringement case was filed, they obtained preliminary discovery in an earlier judgment delivered on 29 October 2025. That earlier order required Arrotex to produce documents so the prospective applicants could assess whether to commence proceedings.

When the parties returned to Court on 31 October 2025, the remaining disputes were narrower but commercially important. The Court had to settle the access regime for the documents to be produced and decide costs. The reasons expressly say they assume familiarity with the earlier preliminary discovery decision, so this judgment gives only a limited picture of the broader patent dispute.

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.

The Court had two main procedural issues to resolve. The first was whether the two external IP advisers located outside Australia should be allowed to inspect the preliminary discovery documents under the existing confidentiality regime, or whether extra conditions should be imposed because they were overseas and might later work on related patent matters.

The second was costs. The Court had to decide what costs order was appropriate where the prospective applicants had succeeded in obtaining preliminary discovery, but the remedy itself was exceptional and any later infringement proceeding had not yet been commenced. That required the Court to exercise the broad discretion under section 43 of the Federal Court of Australia Act 1976 (Cth).

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.

On access, Needham J held that there was no need for a different confidentiality regime for the two external IP advisers merely because they were located overseas. The judge noted that Arrotex had not identified any specific risk likely to arise from their receiving the documents. Arrotex had referred to the risk of conscious or unconscious misuse and the inconvenience of enforcement if there were a breach, but the Court said that was not enough to justify the extra restrictions sought.

The Court also took into account that the two advisers had previously been granted access to confidential annexures to an affidavit, although those annexures had been highly redacted. The existing confidentiality undertaking in Annexure B included an express submission to the Court's jurisdiction. The judge considered that feature, together with the Harman undertaking and the principles discussed in AstraZeneca AB v Medis Pharma Pty Ltd, adequately protected Arrotex's position.

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.

For business owners, the most useful lesson is not about patent doctrine. It is about how courts manage confidential information and costs when one business seeks pre-action disclosure from another. Preliminary discovery is not treated like ordinary litigation. The Court repeatedly emphasised its exceptional nature. That means the usual assumption that the winner gets costs may not apply in the same way.

If your business is seeking preliminary discovery, budget for the respondent's reasonable production costs from the outset. Those costs can include collating, reviewing and providing documents. Also budget separately for the legal costs of the application itself, because even a successful applicant may not receive an immediate costs order in its favour. The Court may defer that question or tie it to whether a substantive proceeding is later filed.

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.

This judgment is a reminder that access arrangements should be planned with precision. Before the hearing, businesses should identify exactly who needs access, why they need it, and what role they will play. If there are overseas advisers, that should be addressed directly in the proposed undertaking rather than left as an afterthought. The undertaking should clearly state the permitted purposes for which the documents may be used and should deal with submission to the Court's jurisdiction.

Businesses opposing access should focus on evidence and specificity. The Court was not persuaded by general references to inconvenience or abstract misuse risk. It looked for a particular risk likely to arise from these advisers receiving these documents. Without that, the Court preferred the existing confidentiality framework over broader restrictions on future work.

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.

The judgment was delivered by Needham J on 21 November 2025 in the Federal Court of Australia. It followed an earlier preliminary discovery judgment delivered on 29 October 2025 and a hearing on 31 October 2025 dealing with access and costs.

The orders made the future costs position depend on whether infringement proceedings were commenced by 31 January 2026. The samples issue in paragraph 2 of the originating application was deferred, and costs relating to that issue were reserved. The parties also had liberty to apply.

This page is based on the Federal Court of Australia judgment in Newron Pharmaceuticals S.p.A v Arrotex Pharmaceuticals Pty Ltd (Access Regime and Costs) [2025] FCA 1437. The reasons expressly assume familiarity with the earlier decision, Newron Pharmaceuticals S.p.A v Arrotex Pharmaceuticals Pty Ltd (Application for Preliminary Discovery) [2025] FCA 1321.

Because this judgment is confined to access, suppression orders and costs, it should be read as a procedural case note. It is not a complete public summary of the underlying patent dispute or the evidence that led to the grant of preliminary discovery in the first place.