AstraZeneca AB v Pharmacor Pty Ltd (No 2)

AstraZeneca AB and AstraZeneca Pty Ltd were already in active Federal Court patent litigation against Pharmacor Pty Limited when this dispute arose. This judgment does not retell the full patent story. The court expressly said the relevant background appears in an earlier decision, AstraZeneca AB v Pharmacor Pty Ltd [2026] FCA 88, which dealt with AstraZeneca's interlocutory injunction application heard on 6 February 2026.

What this judgment does show is the pleadings position that existed before Pharmacor tried to change course. AstraZeneca's statement of claim, filed on 17 December 2025, pleaded that the patent would expire on 22 October 2027 and that the patent continued in force for its extended term until that date. Pharmacor's defence, filed on 16 January 2026, admitted that unless the patent was revoked earlier, the patent would expire on 22 October 2027.

That matters because Pharmacor later sought to amend its case. On 18 March 2026, it applied to amend its notice of cross-claim, statement of cross-claim, particulars of invalidity and defence. It also sought to withdraw any admission in its defence relating to the validity of the extension of the patent term. One of the proposed amendments was a challenge to the grant of the extension of term on the basis that the requirements of s 70(3) of the Patents Act had not been satisfied.

The court said there could be no dispute that Pharmacor had the opportunity to raise that allegation in its original pleadings but did not do so. Once that was accepted, the reason for the delay became important. Delay is relevant when a party asks for leave to amend late, and it is also relevant when a party wants to withdraw an admission that has already shaped the case.

To explain the delay, Pharmacor relied on affidavits from its solicitor. In substance, the evidence said that it was not until after the hearing on 6 February 2026 that Pharmacor, including its legal representatives, appreciated the merits of the extension of term and best method allegations it now wanted to introduce. The judge noted that this meant that, on some unidentified date after 6 February 2026, the patent term extension allegation was regarded by both Pharmacor and its legal representatives as having sufficient merit to add to the other attacks on the patent.

AstraZeneca then moved to test that explanation. By Notice to Produce dated 19 March 2026, it required Pharmacor to produce all documents recording consideration before 20 February 2026 by Pharmacor, or its legal representatives, of the validity of the extension of term of the patent. Pharmacor responded by applying on 25 March 2026 to set the notice aside. That application produced this judgment.

The immediate issue was whether Pharmacor's application to set aside AstraZeneca's Notice to Produce should succeed. That sounds narrow, but it raised a set of practical questions that come up often in commercial litigation. When one party explains delay by referring to what it and its lawyers thought or appreciated at a particular time, how far can the other side go in seeking documents to test that explanation?

The court identified three submissions made by Pharmacor in support of setting the notice aside. First, Pharmacor said the notice was too broad and operated more like a discovery category than a properly targeted notice. Secondly, it said the date used in the notice was wrong and should have been 6 February 2026 rather than 20 February 2026. Thirdly, it said the notice should be set aside because, on its face, it would require production of material subject to legal professional privilege.

Behind those procedural objections sat the more important privilege issue. Pharmacor was trying to justify a late amendment and withdrawal of an admission by saying that only after the 6 February hearing did it, including its legal representatives, appreciate the merits of the new allegation. The court therefore had to consider whether that evidence had put the subject matter of earlier consideration and related communications in issue. If it had, maintaining privilege over documents on that topic might be inconsistent with the position Pharmacor was asking the court to accept.

Downes J rejected Pharmacor's attempt to set aside the Notice to Produce. On the first issue, the judge accepted AstraZeneca's argument that the expression "appreciated the merits" was vague and was not the kind of candid explanation for delay the court expects when a party seeks an indulgence. The court also pointed out that Pharmacor's current pleading admitted the patent expired at the end of the extended term, subject only to revocation. In those circumstances, Pharmacor was not merely unaware of the extension. It had previously taken a position that did not challenge it. AstraZeneca was therefore entitled to test the evidence explaining the late change.

The judge also rejected the argument that the notice should be confined only to one particular basis of challenge. Because Pharmacor had already accepted the extended expiry date in its defence, the court considered AstraZeneca should be able to test whether Pharmacor and its lawyers had considered challenging the extension earlier and simply chosen not to do so.

On the date issue, the court rejected Pharmacor's submission that the notice should stop at 6 February 2026. Pharmacor's own evidence was that the merits were not appreciated until after 6 February 2026, but it did not specify when after that date. The court said it was therefore appropriate for the notice to refer to a date after 6 February, not before it. AstraZeneca had selected 20 February 2026 because that was the earliest date revealed by Pharmacor's evidence on which its lawyers took steps relating to the extension of term application, namely requesting copies of that application.

On privilege, the court said the usual course is not to set aside a notice simply because some responsive documents may be privileged. Instead, documents are produced and privilege is claimed where justified. But the court went further. It held that Pharmacor's evidence had put in issue whether, before 6 February 2026, Pharmacor and its legal representatives had considered the validity of the extension of term, and whether and when after that date it was determined that a challenge had sufficient merit to be advanced. To the extent documents recorded, evidenced or related to communications about those matters, there had been an implied waiver of privilege.

The practical result was that documents within the scope of the notice had to be produced if they were either not privileged or privilege had been waived. The judge also indicated the next procedural steps. AstraZeneca was to have an opportunity to make further submissions and file further affidavit material after reviewing any produced documents. Pharmacor was to have a chance to reply. The court also said AstraZeneca should have its costs of the application to set aside the notice.

This judgment is a strong example of how conduct in litigation can affect privilege. Businesses often think of privilege as a fixed shield over communications with lawyers. In most situations, that is broadly right. But privilege can be waived, including by implication, where a party's own forensic choices make it unfair to keep the underlying material hidden.

Here, the key conduct was not simply that Pharmacor had legal advice. It was that Pharmacor relied on affidavit evidence saying that only after a particular hearing did it, including its legal representatives, appreciate the merits of a new challenge. That evidence was used to support a request for procedural indulgence, namely leave to amend late and to withdraw an admission. Once that happened, the timing and content of consideration of the issue became part of the controversy before the court.

The judge's reasoning is commercially important because it shows the difference between a general legal strategy discussion and a topic that has been affirmatively put in issue. The court did not say all privileged communications between Pharmacor and its lawyers were open for inspection. The waiver was narrower. It extended to documents that recorded, evidenced or related to communications about whether the validity of the extension of term had been considered before 6 February 2026, and whether and when after that date a challenge was recognised as having sufficient merit to be advanced.

That is a practical warning for any business involved in litigation. If your evidence says, in effect, "we only later realised this point had merit", the other side may be allowed to ask for documents showing whether that is really true. The more your explanation depends on what lawyers and decision-makers thought at a particular time, the more likely it is that the court will permit testing of that explanation.

The judgment also shows that a notice to produce will not usually be struck down just because privileged documents may exist. The ordinary approach is more granular. The receiving party produces responsive documents and claims privilege over particular documents where appropriate, subject to any waiver. That means businesses should not assume a notice can be defeated simply by pointing out that lawyers were involved.

In practice, this places pressure on document management. Businesses in litigation should keep legal advice channels organised, understand what their affidavits say about timing and decision-making, and review whether any explanation for delay could be seen as putting privileged subject matter in issue.

Although this was a patent case, the procedural lesson is much wider. The same issue can arise in contract disputes, shareholder fights, employment litigation, competition matters and regulatory proceedings. Any time a business asks the court to excuse delay, permit a late amendment, or let it withdraw an admission, the explanation for that change can become a live evidentiary issue.

The first practical point is to identify key arguments early. The court said there could be no dispute that Pharmacor had the opportunity to raise the patent term extension allegation in its original pleadings but did not do so. That finding made the explanation for delay central. For businesses, the message is straightforward: before pleadings are filed, review the available legal arguments carefully and understand what your defence, cross-claim or particulars are accepting or not challenging.

The second point is to treat admissions seriously. Pharmacor's existing defence admitted that unless the patent was revoked earlier, it would expire on 22 October 2027. Trying to withdraw an admission later is not just a drafting correction. It can affect how the court views the reliability of your explanation and whether the other side should be allowed to test it through documents.

The third point is to be precise in evidence. The judge criticised the phrase "appreciated the merits" as vague and not the kind of candid explanation expected when a party seeks an indulgence. If your business needs to explain delay, the explanation should be accurate and carefully framed. Vague timing language may invite broader document requests because the other side will say it needs to understand what really happened.

The fourth point is to think about privilege before evidence is filed, not after. Once a company relies on what it and its lawyers considered or concluded at a particular time, it may be too late to avoid a waiver argument. That does not mean you should never explain delay. It means the explanation should be prepared with a clear understanding of the privilege consequences.

Finally, if your business receives a Notice to Produce, remember that the existence of privileged material is not usually enough on its own to have the notice set aside. The court may require production of non-privileged documents and may also find that privilege has been waived for a defined category. A document-by-document review is often necessary.

The judgment is AstraZeneca AB v Pharmacor Pty Ltd (No 2) [2026] FCA 414, decided by Downes J in the Federal Court of Australia on 9 April 2026. The hearing took place on 2 April 2026. The matter was in the General Division, New South Wales Registry, within the Intellectual Property National Practice Area.

The orders recorded in this judgment were procedural. The court directed the parties to confer and provide an agreed form of order, or competing orders, to chambers by 14 April 2026. The reasons also indicated that AstraZeneca should be allowed to make further submissions after reviewing any documents produced, that Pharmacor should have a chance to reply, and that AstraZeneca should have its costs of the set-aside application.

There was also a correction noted in the judgment materials to paragraph 22. That does not change the practical point for business readers: the court treated Pharmacor's evidence as having put in issue both whether the extension of term had been considered before 6 February 2026 and when after that date it was regarded as sufficiently meritorious to advance.

This page should therefore be read as a procedural case note about amendment practice, notices to produce, legal professional privilege and implied waiver. It is not a full account of the underlying patent dispute.