Newron Pharmaceuticals S.p.A v Arrotex Pharmaceuticals Pty Ltd (Application for Preliminary Discovery)

This dispute began before any substantive patent infringement case had been filed. Newron and Zambon said they held rights in two Australian patents relating to high purity safinamide and the processes used to produce it. Safinamide mesilate is the active ingredient in Xadago, a Parkinson’s disease medicine. The Court recorded that Xadago was the only safinamide product then available on the Australian market.

Arrotex, a generic supplier, had obtained four ARTG registrations for safinamide products approved as generic versions of Xadago. It expected those products to be listed on the PBS and supplied in the near future. That expected launch created commercial urgency. The applicants wanted information before the generic products entered the market, or at least before they had to decide whether to start infringement proceedings without knowing enough about the products.

So the applicants did not ask the Court to decide infringement at this stage. Instead, they sought preliminary discovery under rule 7.23 of the Federal Court Rules 2011 (Cth). In practical terms, they were asking for targeted disclosure so they could decide whether there was a proper basis to sue for actual or threatened patent infringement.

The reasons identify two patents: Australian Patent No. 2007263328 and Australian Patent No. 2008334778. They were described as relating to both the product and the process of producing high purity safinamide. The patents also referred to ralfinamide, but that compound was not relevant to this application.

The Court recorded that the patents protected both high purity safinamide itself and the processes by which it was made. The reasons state, in substance, that safinamide containing two specified impurities at less than 0.03% by weight was said to be covered by the patents, regardless of the process used, and that the patents also protected particular processes that produced that high purity result.

Some matters were not in dispute on the application. It was not contested that Xadago contained high purity safinamide in accordance with the patents. It was also not disputed that the Arrotex products contained safinamide and had been approved as generic versions of Xadago. However, the actual level of purity of the Arrotex products was a contested factual issue, and the reasons show that the process issue was not actively explored by evidence from Arrotex at this stage.

The applicants initially sought documents and samples, but during argument foreshadowed a narrower first step. They proposed that the application be confined in the first instance to documents, with any later request for samples to be considered after the documents had been reviewed if that became necessary.

The applicants’ case was built largely on inference rather than direct proof. That is common in preliminary discovery applications, because the whole point is that the applicant says it does not yet have enough information to know whether to sue.

Zambon’s general counsel, Rosella De Dominicis, gave evidence that she was the person primarily responsible for legal decisions about possible infringement concerns. She said she was informed by others within the business, including patent personnel. Her evidence set out the patents’ statements about certain impurities and the claimed safety concerns said to arise where impurity levels were above the threshold discussed in the patents.

A central part of the applicants’ reasoning came from the regulatory material. The reasons state that the Australian Product Information for the Arrotex products contained the same enzyme statement as the Xadago Product Information and therefore relied on the same clinical studies. The Court also recorded that Arrotex had not conducted its own clinical trials. According to the applicants’ evidence, there were no studies capable of supporting those statements other than studies carried out using high purity safinamide with impurity levels below the threshold described in the patents.

From that, Ms De Dominicis said she would not expect a generic pharmaceutical company to seek approval of a safinamide mesilate medicine with impurity levels above 0.03%. She inferred that the Arrotex products must have been approved on the basis of bioequivalence with Xadago and that nothing available to her suggested the products differed from Xadago in efficacy and safety. On that basis, she believed, but did not know, that the Arrotex products may contain high purity safinamide and or may be made using the patented processes.

Importantly, she also said she was not in possession of sufficient information to form a view about whether proceedings should be commenced. That is a key feature of a rule 7.23 application. The applicant is not meant to prove the whole case. It must show a reasonable belief that it may have a right to relief and that it needs information to decide whether to sue.

Arrotex did not challenge whether Ms De Dominicis genuinely held the belief she expressed. Instead, the available reasons show that it attacked the reasonableness of that belief. It relied on solicitor evidence and, more significantly, expert evidence from Professor Michael Roberts.

Professor Roberts’ evidence addressed bioequivalence, pharmaceutical equivalence, impurities, safety and quality assessment, and the patents themselves. The reasons record his opinion that bioequivalence does not require exact equivalence to the originator product. He said the relevant guidelines focus on whether the rate and extent of bioavailability fall within acceptable limits, not whether the generic has the same impurity profile as the originator. He also said the bioequivalence guidelines do not require a determination that two products have the same, or even similar, levels of impurities.

On safety and quality, the reasons record his view that the TGA independently assesses impurity information against regulatory standards through the Common Technical Document process, rather than simply comparing the generic’s impurity profile with the originator’s profile. That was important because it undermined the applicants’ attempt to move from generic approval and product information to an inference that the generic product must contain the same high purity safinamide as Xadago.

Professor Roberts also challenged the scientific basis for the impurity threshold discussed in the patents. The reasons record his opinion that the patent material did not provide a basis for saying that a product would be unsafe unless the relevant impurity was below 0.03% by weight, or for treating 0.03% as the appropriate safety threshold. He said the patent data did not provide human in vivo safety data and did not establish what level of enzyme inhibition or HERG channel effect would be unsafe. He also considered that some statements in the patents overstated toxicity because they ignored the role of dose.

The available reasons then move into his review of the Arrotex product information and calculations based on assumptions. However, the public text cuts off part-way through that discussion. That means the full detail of how the Court dealt with those calculations is not available here.

The legal issue was procedural but commercially important. The Court had to decide whether the applicants met the threshold for preliminary discovery under rule 7.23. The reasons show that the parties were broadly agreed on the governing principles, especially those drawn from the Full Court decision in Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd.

The Court recorded several key propositions from Pfizer. Rule 7.23 is a beneficial provision designed to let a person who believes it may have a right to relief obtain information needed to make a responsible decision about commencing proceedings. The focus is on what may be the position, not what has already been proved. The applicant must show a belief that it may have a right to relief, and that belief must be reasonable. A respondent can defeat the application by showing there is no reasonable basis for thinking there may be such a case.

The reasons also record the caution from Pfizer against allowing a preliminary discovery application to become a mini-trial or dress rehearsal for trial. That caution mattered here because Arrotex had put on substantial scientific evidence. The Court therefore had to assess whether the applicants still had a reasonable basis for their belief, while keeping the hearing within the proper limits of a pre-action discovery application.

The Court also had to consider discretion and confidentiality. Even if the threshold for preliminary discovery was met, the Court still had to decide whether to order it and on what terms. The reasons show that confidentiality was a live issue because the material sought could reveal trade-sensitive information to a commercial rival, and because the product launch itself was commercially sensitive.

The available orders show that the Court made confidentiality orders restricting access to the reasons until further order. The Court also ordered the parties to provide draft orders for preliminary discovery in accordance with the reasons by 31 October 2025 and listed the matter for a case management hearing on that date.

That strongly indicates the applicants succeeded in substance on the preliminary discovery application, at least to the point that the Court had decided preliminary discovery should be ordered and required the parties to settle the form of those orders. The reasons also show that, at the end of the hearing, the parties had not reached agreement on the terms of any preliminary discovery orders or the confidentiality regime that should apply if discovery were ordered.

However, the public text available here is incomplete. It does not include the full reasoning through to the end, and it does not set out the final categories of documents to be produced. It also does not show whether any later order was made for samples, or the final form of the confidentiality arrangements. So the safest reading is that the Court accepted the application in principle and moved the matter to the drafting and case management stage, but the exact scope of the resulting discovery cannot be stated with confidence from the available text alone.

For patent owners, this case shows that preliminary discovery can be a practical tool where you have a real concern about infringement but do not yet know enough to file a properly framed claim. That is especially relevant in regulated industries, where the most useful evidence may sit in the other side’s technical dossier, manufacturing records, product specifications or launch documents. The Court’s approach, as reflected in the available reasons, supports the idea that a rights holder does not need to prove infringement before seeking targeted information. It needs a reasonable basis to think there may be a claim and a genuine need for information to decide whether to sue.

For generic suppliers and other market entrants, the case is a reminder that public and regulatory-facing material can be used against you in a pre-action application. Product information, approval status as a generic, reliance on originator studies, and launch timing may all help an applicant build the inference needed to get through the rule 7.23 threshold. If your business wants to resist such an application, you may need evidence showing why those inferences do not reasonably support a possible claim.

The case also highlights the importance of confidentiality planning. The reasons show that both sides were concerned about who could see sensitive material and on what terms. If disclosure is ordered, the practical fight may shift quickly from whether discovery should happen to how it should happen, who can inspect the documents, and what protections are needed to avoid commercial harm.

Finally, businesses should remember what this case does not show. It does not establish that generic approval equals patent infringement. It does not establish that bioequivalence proves a patented impurity profile. And it does not decide the merits of the patent claims. It is a case about access to information before a final dispute is launched.

The judgment is dated 29 October 2025. The hearing took place on 22 October 2025. The orders required draft preliminary discovery orders to be provided by close of business on 31 October 2025, and the matter was listed for case management on 31 October 2025 at 2.15 pm.

The reasons themselves were subject to confidentiality restrictions until further order. The available public text is incomplete and appears to stop part-way through the Court’s discussion of the respondent’s expert evidence. Because of that, this page should be read as a careful explanation of the available reasons, not as a complete account of the final form of the orders.