Federal Court of Australia

AstraZeneca AB v Pharmacor Pty Ltd (No 2) [2026] FCA 414

ORDERS

THE COURT ORDERS THAT:

1.    The parties confer and provide an agreed form of order, or competing orders, to the chambers of Downes J by 14 April 2026.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

DOWNES J:

1    The relevant background appears in AstraZeneca AB v Pharmacor Pty Ltd [2026] FCA 88, and the defined terms in that judgment are adopted in these reasons. That judgment determined AZ’s application for an interlocutory injunction which was heard on 6 February 2026.

2    By the Statement of Claim filed on 17 December 2025, AZ pleads that the Patent will expire on 22 October 2027 and that Pharmacor will engage in infringing conduct knowing “that the Patent was in force and continues for its extended term until 22 October 2027” (emphasis added).

3    By the Defence filed on 16 January 2026, Pharmacor admits that, unless revoked earlier, the Patent will expire on 22 October 2027.

4    By interlocutory application filed on 18 March 2026, Pharmacor applies to amend its Notice of Cross-Claim, Statement of Cross-Claim, Particulars of Invalidity and Defence. It also applies to withdraw any admission made in its Defence in relation to the validity of the extension of the term of the Patent.

5    One of the categories of amendments sought to be made relates to a proposed challenge to the grant of extension of term of the Patent on the basis that the requirements of s 70(3) of the Act were not satisfied (PTE allegation).

6    There can be no dispute that Pharmacor had the opportunity to raise the PTE allegation in its original pleadings, but did not do so.

7    It is common ground that an explanation for the delay is a relevant factor in determining an application to amend. Such an explanation is also relevant to justify the withdrawal of an admission.

8    The sole explanation appears in affidavits of a solicitor for Pharmacor in these or similar terms:

The reason the proposed amendments were not raised earlier is that it was not until after the hearing on 6 February 2026 that the Respondent/Cross-Claimant (including its legal representatives) appreciated the merits of the extension of term and best method allegations now sought to be introduced in the proposed amended pleadings.

9    Thus, following the hearing on 6 February 2026 on an unidentified date, the PTE allegation (and the associated challenge to the extension of the term of the Patent) was deemed by both Pharmacor and its legal representatives to be of sufficient merit to add to the other attacks on the Patent. Of course, Mr Miller can only be aware of the view taken by Pharmacor because there have been communications with it.

10    By Notice to Produce dated 19 March 2026 (Notice), AZ required Pharmacor to produce at the hearing of the application on 2 April 2026 the following:

All documents recording consideration before 20 February 2026 by the Respondent, or the Respondent’s legal representatives, of the validity of the extension of term of [the Patent].

11    By interlocutory application dated 25 March 2026, Pharmacor applied to set aside the Notice.

12    At the hearing on 2 April 2026, AZ called upon the Notice, and Pharmacor pressed its application to set aside the Notice. Depending on the outcome of the application and the review of any documents produced, AZ sought the opportunity to advance further submissions.

13    In support of its application to set aside the Notice, Pharmacor made three submissions, which I will address in turn.

14    First, Pharmacor submits that the Notice is in the nature of a discovery category and is not appropriately targeted to AZ’s “stated need” for the Notice — namely to test the explanation given for the delay in raising the s 70(3) extension of term argument now sought to be introduced by the proposed amendment. Rather, it submits that the Notice extends to any consideration of the validity of the extension of term of the Patent.

15    However, as AZ submits, the expression “appreciated the merits” is vague, and the fact that Pharmacor only “appreciated the merits” of the PTE allegation after the interlocutory hearing is not the kind of candid explanation for delay that the Court expects where a party seeks an indulgence. In circumstances where Pharmacor admits on its current pleading that the Patent expires at the end of the extended term (subject to revocation only), it was not only aware of the extension of the term of the Patent but formed a decision not to challenge the extension previously. That it now seeks to do so on one particular basis does not mean that the Notice should be similarly confined. AZ should be permitted to test that evidence in these circumstances.

16    Secondly, Pharmacor submits that the date in the Notice should be 6 February 2026 because, as delay after that date is conceded, the explanation for the delay is only relevant to the period prior to that date.

17    However, Pharmacor’s evidence is that the merits were not appreciated until after 6 February 2026, but the evidence does not specify when. Accordingly, it is appropriate that the Notice refer to a date after 6 February, not before it. AZ has selected the earliest date on which Pharmacor’s evidence reveals that it took steps relating to the extension of the term of the Patent, namely when Pharmacor’s lawyers requested copies of the extension of term application for the Patent on 20 February 2026.

18    Thirdly, Pharmacor submits that the Notice should be set aside because, on its face, it will require production of material which is the subject of legal professional privilege.

19    However, the usual course is for a party to produce documents in response to a Notice to Produce and then claim legal professional privilege in relation to any document which justifies such a claim. In any event, I am not persuaded that the potential production of privileged documents justifies the Notice being set aside in this case, especially having regard to the view I have formed about implied waiver, as set out below.

20    As the Notice will not be set aside, an expedient course is to require production of any documents which fall within the scope of the Notice and (a) are not the subject of any claim of legal professional privilege or (b) in relation to which legal professional privilege has been waived.

21    The current version of the Defence (in effect) accepts that the only basis upon which the Patent will expire earlier than 22 October 2027 is via revocation, with no challenge to the grant of the extension of the term of the Patent.

22    With that background and noting that an application to withdraw any admission is also advanced, Mr Miller’s evidence has put in issue whether, prior to 6 February 2026, there had been consideration by Pharmacor and its legal representatives of the validity of the extension of the term of the Patent and whether and when, after that date, there was further such consideration and it was determined by Pharmacor and its legal representatives that a basis for challenging the extension was recognised as having sufficient merit to be advanced.

23    For this reason, to the extent that documents may record, evidence or relate to communications about these matters, there has been an implied waiver. To that extent, maintenance of the privilege would be inconsistent with the case which Pharmacor wishes to put on the amendment application and its application to withdraw its admission.

24    I will direct the parties to confer and provide an agreed form of order, or competing orders, which reflect these reasons. In relation to such orders, I observe that:

(1)    AZ should be given an opportunity to make any further submissions which they seek to make in relation to Pharmacor’s amendment application, and file any further affidavit material, after review of any documents produced by Pharmacor. Such submissions should be no more than five pages in length, and the submissions and any affidavit material should be filed and served within a relatively short time frame, such as seven days after production;

(2)    Pharmacor should be given an opportunity to reply, in a comparable time frame after service of AZ’s submissions, with such submissions also limited to no more than five pages;

(3)    AZ should have its costs of the application to set aside the Notice.

Associate:

Dated:    9 April 2026