Intellectual Property Update Novartis AG v Pharmacor Pty Limited [2022] FCAFC 58

After Novartis filed its evidence in answer on the validity of its patents from four experts with the same qualifications, Pharmacor took issue with the number of Novartis’ experts and the overlapping nature of their qualifications and evidence. The primary judge, Burley J, agreed and excluded two affidavits entirely, and limited the portions of a third upon which Novartis was permitted to rely at trial. Justices Yates, Beach and Moshinsky refused Novartis’ application for leave to appeal from Burley J’s decision.

The two patents concern a method of treating relapsing-remitting multiple sclerosis in which a daily dose of 0.5 mg of fingolimod is administered orally. Pharmacor seeks revocation of the patents, and filed evidence in support from one neurologist. In response, Novartis filed evidence from four neurologists. Pharmacor objected to Novartis calling four neurologists, and sought an order that the primary judge make an order under FCR 5.04 item 16, limiting the number of expert witnesses to be called.

At a case management hearing, on the premise that Novartis had one main neurological expert witness (Professor Barnett), Burley J ordered that the evidence of two of the remaining three witnesses (Professor Giovannoni and Professor MacCombe) be excluded, and that the evidence of the third (Professor Lublin) be excluded other than in respect of factual (rather than opinion) evidence (and associated background and contextual evidence).

Novartis sought leave to appeal in relation to one of the witnesses whose evidence had been excluded (Professor Giovannoni) and the witness whose evidence had been partially excluded (Professor Lublin). Professor MacCombe’s evidence was not in issue on the application for leave to appeal given concessions Pharmacor had made in the interim. Novartis alleged that:

• the primary judge had erred in finding that Novartis was only permitted to rely on the evidence of Professor Barnett and was not permitted to rely on evidence from Professor Giovannoni and Professor Lublin on the ground that the evidence involved overlapping witnesses; or

• to the extent that it was open to find that the relevant evidence was substantially duplicative, his Honour erred in finding that discretionary factors weighed in favour of the order excluding the evidence.

To succeed in obtaining leave, Novartis needed to demonstrate that the decision was attended with sufficient doubt to warrant its being reconsidered and that substantial injustice would result if leave was refused, assuming the decision was wrong. It is worth noting that, given the interlocutory nature of Burley J’s decision, regardless of the outcome of the application for leave to appeal, Novartis would be allowed to re-agitate the issue with the primary judge and would be able to appeal the decision as part of any substantive appeal in due course.

Novartis submitted that the evidence of Professor Giovannoni was necessary to enable it to advance a different theory as to the skilled team and the hypothetical task relevant to the question of whether the claimed invention was inventive or obvious.

Justices Yates and Moshinsky rejected the submission that the evidence was not substantially duplicative, given that Professor Barnett and Professor Giovannoni had a similar title and expertise in multiple sclerosis, each discussed the common general knowledge and the same prior art in their affidavits, and each expressed the same opinion as to the prior art. Although there was a difference in the task which each was set (Professor Barnett identified fingolimod as a drug of interest, whereas Professor Giovannoni had been instructed to assume it was of interest), the difference did not have practical significance.

Justices Yates and Moshinsky did not accept that the exclusion of evidence had the effect of limiting Novartis to responding to the case framed by Pharmacor, rather than advancing a different positive case, because the submission turned on transplant studies which were in evidence through a separate pharmacist witness, Professor Kirkpatrick. To the extent that Novartis wished to have a neurologist express opinions about the transplant studies, Novartis had accepted Professor Barnett could do so, and Burley J had indicated it was open to Novartis to apply to adduce further evidence from Professor Barnett on this issue. The authors note that, given the trial is only two months away, this might not be an efficient course (and Beach J suggested an alternative, discussed below). Although Professor Giovannoni had personal knowledge of the trials, his evidence was not premised on the basis of that personal knowledge (because he put it to one side in addressing the hypothetical task).

Although Yates and Moshinsky JJ accepted that there were differences in the background and experience of the three experts, they did not consider that these differences were sufficient to justify calling multiple experts of the same discipline, particularly since the notional skilled addressee is not an avatar for experts, but a tool of analysis. They concluded that the approach taken by Burley J in excluding the evidence was consistent with modern case management on the Federal Court of Australia Act 1976 (Cth).

Justice Beach, who concurred, provided some helpful elaboration. In relation to overlapping expert evidence:

• First, he observed that the default position was that a party should not adduce expert evidence from more than one expert in a single discipline, unless it telegraphed its intention to do so to the other side and the Court (although he accepted that evidence could be called from persons in separate recognised divisions in a single discipline).

• Second, he observed that where the default position was departed from, it should be justified before evidence was filed and served. Such justifications may require establishing that different questions had been asked of different experts (and why that was necessary); that different experts had different knowledge and experience (and why that justified calling two experts); or that one of the experts was in substance a witness of fact, but establishing these matters would not suffice if the evidence was substantially duplicative.

• Third, he observed by reference to the Intellectual Property Practice Note (IP-1) that proper case management required ensuring the effective use of expert evidence and eschewing potentially duplicative evidence.

• Fourth, he observed that the docket judge was likely to have little tolerance for an agreed position of each party relying on multiple overlapping experts.

In relation to Professor Lublin, whose factual evidence was allowed but opinion evidence was excluded, Beach J noted that it was unclear what power Burley J was relying on in excluding the opinion evidence but concluded in any event that Novartis had not shown any substantial injustice, because Novartis had the right to challenge the exclusion of parts of Professor Lublin’s evidence on any substantive appeal.

Further, Beach J noted that Burley J could revisit his interlocutory ruling on Professor Lublin’s evidence, particularly since Professor Lublin would give evidence anyway. In this regard, Beach J expressed some scepticism about whether Professor Lublin’s excluded evidence was substantially duplicative of Professor Barnett’s evidence. Indeed, he expressed the view that it would be more convenient to reinstate the evidence of Professor Lublin regarding the transplant studies rather than have Professor Barnett address them.

In conclusion, the Full Court’s judgment:

• emphatically confirms that a judge can limit the number of experts, apparently for any reason, but certainly where there is an appearance of overlap;

• confirms that a judge may object to duplication even where the other party does not;

• affirms that the primary judge could revisit his judgment to exclude parts of an expert’s evidence;

• leaves in doubt what power may be exercised to exclude parts of an expert’s evidence where those parts are relevant (or arguably so); and

• clarifies that the refusal to grant leave to appeal does not shut Novartis out from arguing on any appeal in the substantive proceedings that the decision to exclude was wrong.

In practice, where a practitioner intends to rely on the evidence of two or more expert witnesses who have overlapping expertise, the practitioner should ensure that it is clear that: (a) the experts are addressing different questions and why it is convenient/necessary for that to occur; or (b) that one is giving evidence as to matters of fact, and reduce the appearance of overlap. Where evidence is well progressed, and there is an appearance of overlap, practitioners should consider choosing one expert and ensuring that that expert covers all relevant topics, unless there is a compelling reason for the overlap. We note that Novartis was an extreme case, given that there were four experts, and that it is rare for a counter-party to bring an application of this kind, rather than apply for a costs order (although that practice may change as a result of this decision). We also note that it may be difficult for a primary judge to adjudicate on an issue of overlap without seeing the evidence which a party to proposes to file.