Abbey Laboratories Pty Ltd v Virbac (Australia) Pty Ltd (No 3)

Abbey Laboratories Pty Ltd v Virbac (Australia) Pty Ltd (No 3) [2025] FCA 1179 is a Federal Court patents decision about a veterinary pour-on formulation for cattle. It is not a trade mark dispute. The case was about whether key claims in Virbac’s patent were valid and, if valid, whether Abbey’s Levamox Duo product infringed them.

Abbey brought revocation proceedings, arguing that the challenged claims lacked novelty and inventive step. Virbac responded with a cross-claim for infringement. The Court ultimately found that Abbey infringed claims 1 to 10, 13, 15, 16 and 18, while claims 19, 20 and 21 were invalid and revoked. The orders also included an injunction, destruction or delivery up of stock and related materials, and a later inquiry into damages or an account of profits.

The commercial setting was the animal health market for cattle parasite treatments. Virbac held Australian Standard Patent No. 2012227241, entitled Veterinary Topical Formulation. The reasons describe the patent as dealing with a pour-on anthelmintic formulation for cattle involving a selected levamisole active ingredient and a macrocyclic lactone dissolved in a stable non-aqueous system.

The specification, as summarised by the Court, was directed to practical livestock-farming problems. It discussed the importance of controlling gastrointestinal parasites, the problem of resistance to existing anthelmintics, and the attraction of combining actives from different classes. It also identified practical formulation goals, including a ready-to-use topical product, acceptable shelf-life stability, improved transdermal absorption and reduced tendency to run off the animal’s back before absorption occurred.

The reasons also describe the patent’s discussion of prior formulations and solvent choices. The specification referred to earlier patents and products, including formulations associated with Eclipse, Saturn and Outlaw, and explained perceived disadvantages in some earlier approaches. It then described studies said to have been undertaken to improve stability and other performance features, including solvent selection work and the use of viscosity modifying agents to reduce run-off.

Abbey wanted to clear the way for its own product, Levamox Duo Pour-On for Cattle. It commenced proceedings on 29 May 2024 seeking revocation of certain claims. Virbac cross-claimed for infringement. The judgment states that, if the patent was valid, there was no issue that Abbey had offered to sell and supply Levamox Duo in Australia since about 4 December 2024 and had actually sold, supplied and kept it for those purposes since about 9 January 2025.

There was an important procedural step before the final hearing. On 17 December 2024, the Court refused Virbac’s application for an interlocutory injunction restraining the launch and sale of Levamox Duo, on the basis that the balance of convenience did not favour an injunction. That meant Abbey was not stopped at the interim stage. But the Court made clear in the final reasons that the question of final liability still had to be decided after a full hearing.

The final hearing was originally scheduled to start on 12 May 2025 but was adjourned by consent because of the personal circumstances of one of the expert witnesses. The hearing then took place from 2 to 10 September 2025. That procedural history matters because it shows how patent disputes can unfold over time while commercial decisions continue in the background.

The central legal questions were straightforward to state but technically demanding to answer. First, were the challenged claims of Virbac’s patent invalid because they were not novel or did not involve an inventive step within the meaning of the Patents Act 1990 (Cth), when compared with the prior art base before the priority date? Second, if the relevant claims were valid, did Abbey’s Levamox Duo product infringe them?

The catchwords show that the Court dealt with broader patent law issues as part of that analysis. On inventive step, the Court considered legal principles concerning prior art, common general knowledge and obviousness. The reasons also indicate that expert witnesses were required to undertake the task of developing the relevant kind of anthelmintic product using knowledge as at the priority date, and that the Court concluded Abbey’s expert evidence did not reflect the position of the person skilled in the art.

On novelty, the Court addressed whether it was necessary to consider a notional set of claims in valid form, as discussed in earlier authority referred to in the catchwords as Du Pont. The catchwords state that the Court held the language of the Patents Act did not require the Court to determine the hypothetical validity of a notional claim, that the notional-claim requirement added unnecessary complexity, and that comparison with the prior art document should instead be undertaken claim by claim. The catchwords then state that each of the contested claims was held to be novel.

The catchwords also show that the Court dealt with an evidence issue about whether a Ferrcom inference could apply to expert evidence. The Court said contemporary practice requires expert reports to declare that all appropriate inquiries have been made and no matters of significance omitted, and concluded that the Ferrcom inference was superseded in that context. For business readers, the practical point is that expert evidence in technical litigation is not just background support. It can materially affect whether a validity challenge succeeds or fails.

On 24 September 2025, Jackman J made declarations and orders that produced a split result on the patent claims but a strong practical result for Virbac. The Court declared that Abbey and Abbey Animal Health had infringed each of claims 1 to 10, 13, 15, 16 and 18 of the patent. The Court also declared that claims 19, 20 and 21 were, and at all material times had been, invalid.

The Court certified under s 19 of the Patents Act that the validity of claims 1 to 10, 13, 15, 16 and 18 had been questioned unsuccessfully in the proceeding. It then revoked claims 19, 20 and 21 pursuant to s 138(3). So Abbey succeeded in knocking out some claims, but not the claims that ultimately supported the infringement findings and final relief.

The relief granted went well beyond declarations. From 22 October 2025, each cross-respondent was restrained from infringing the surviving claims, including by manufacturing in Australia or importing into Australia Levamox Duo, selling or supplying it, offering to do those things, or authorising, procuring, inducing or joining in a common design with others to do them. This is a practical reminder that final patent injunctions can be framed broadly enough to catch direct and indirect involvement in supply.

By the same date, the cross-respondents were ordered to destroy or deliver up to Virbac on oath all Levamox Duo, together with all advertising, promotional and packaging material relating to the product, in their possession, custody, power or control in Australia. For a business, that is a major operational consequence. It affects not only stock on hand but also marketing assets and packaging inventory.

The Court also ordered an inquiry as to damages or an account of profits. That means the financial consequences were left for a later stage. The reasons note that, as is conventional in intellectual property litigation, pecuniary remedies are often heard and determined subsequently. The matter was listed for case management in relation to assessment of pecuniary remedies on 31 October 2025, and there were also directions for costs submissions.

The originating application was otherwise dismissed. In practical terms, the case shows that a party can obtain partial success on revocation and still face a commercially serious loss overall if the surviving claims are enough to establish infringement and support injunctive and monetary relief.

The first point is that this case is about patents, not trade marks. That matters because the commercial risks and legal tests are different. The dispute was not about whether Abbey’s branding looked too similar to Virbac’s. It was about whether Abbey’s product fell within valid patent claims after the Court tested those claims against novelty and inventive step challenges.

The second point is that launching during litigation can be commercially dangerous even if interim relief is refused. Abbey commenced proceedings before launch, which shows it was trying to deal with the patent risk proactively. It also avoided an interlocutory injunction in December 2024. But the final result still exposed it to declarations of infringement, a final injunction, destruction or delivery up orders, and a later monetary inquiry. A business should not read a refusal of interim relief as a green light on the merits.

The third point is that claim-by-claim analysis matters. The Court revoked claims 19, 20 and 21, but that did not save Abbey because claims 1 to 10, 13, 15, 16 and 18 survived and were infringed. Businesses sometimes focus on broad technical themes and assume that if they can attack part of a patent, the whole commercial problem disappears. This case shows the opposite. If enough claims remain and your product still falls within them, the practical outcome can still be severe.

The fourth point is that technical evidence must be built around the legal test. The catchwords indicate that the Court found Abbey’s expert evidence did not reflect the position of the person skilled in the art and that the expert had relied on greater knowledge than the common general knowledge attributable to that person. In patent cases, hindsight can be fatal. Businesses should ensure that technical experts are instructed carefully and that their evidence is tied to the correct date and legal framework.

The fifth point is operational planning. If a product launch is exposed to patent risk, businesses should think beyond the courtroom. The orders in this case show the kinds of practical consequences that can follow: stopping manufacture or importation, stopping sales and supply, destroying or delivering up stock, and losing packaging and promotional materials. That can affect distributors, warehousing, customer commitments and cash flow. It can also create a second phase of litigation over damages or profits.

Finally, this case is a reminder that a liability judgment may not be the end of the dispute. The money side can continue afterwards. Businesses should therefore budget for a longer litigation arc, including costs, remedial steps and later hearings on pecuniary remedies.

The patent in suit had a priority date of 23 September 2011. Abbey commenced the revocation proceeding on 29 May 2024. The Court refused an interlocutory injunction on 17 December 2024. The final hearing took place from 2 to 10 September 2025, and judgment and orders were delivered on 24 September 2025.

The injunction and destruction or delivery up orders were expressed to operate by or from 22 October 2025. The matter was also listed for case management on 31 October 2025 in relation to assessment of pecuniary remedies. If you need to rely on the current legal position, you should check whether there were later orders, a settlement on remedies, or an appeal.

This page is drawn from the Federal Court judgment for Abbey Laboratories Pty Ltd v Virbac (Australia) Pty Ltd (No 3) [2025] FCA 1179, including the catchwords, orders and part of the reasons. The extract clearly identifies the parties, the patent, the broad technical subject matter, the procedural history, the infringement findings, the invalid claims and the relief granted.

Because the published extract available here is truncated, some detailed reasoning is not fully visible, including the full technical analysis behind novelty, inventive step and the treatment of particular prior art documents. The overall result and orders are clear, but anyone relying on the case for a detailed legal proposition should read the full judgment and check for any later appellate or remedial developments.