ISSUE 1: THE SEIZURE MARKET
74 Warner-Lambert argued that the primary judge erred in principle in his assessment of the strength of their case by rejecting (in the sense of discounting entirely) relevant evidence. In particular, it submitted that there was clear evidence that the seizure indication for which Lyrica is registered could account for a very small percentage of the total market for pregabalin only and that it was likely that Apotex-Pregabalin would be dispensed by retail pharmacists for the treatment of pain much more often than it would be dispensed by them for the treatment of seizures.
75 As to Pfizer Australia's 2005 application for PBS listing for Lyrica in respect of the seizure indication (see 70 of the primary judge's reasons), it was submitted that his Honour's reliance upon this evidence was misplaced. Warner-Lambert submitted that the 2005 application did not contain any market or prescribing data, that the forecasts included in the application were nearly 10 years old, and that they were given on the assumption that Lyrica would be listed on the PBS with a seizure indication and be promoted by Pfizer Australia accordingly. Warner-Lambert also relied on the fact that the Pharmaceutical Benefit Advisory Committee (PBAC) rejected the claim, apparently advanced in support of the application for PBS listing, that pregabalin was significantly more effective than a comparable treatment for seizures which was already listed on the PBS.
76 As to the primary judge's reliance on the CMI and the API for Lyrica (see 70 of his reasons), Warner-Lambert submitted that his Honour was wrong to give any weight to the fact that the CMI and the API describe the seizure indication. Warner-Lambert submitted that these documents say nothing about the extent to which Lyrica is used for that indication.
77 As to the primary judge's reliance upon Apotex's sales forecasts, and his conclusion (see 70 of his reasons) that there was no "demonstrated reason to doubt the genuineness of Apotex's own assessment that there is a viable non-PBS market for the use of pregabalin in the treatment of seizures", Warner-Lambert submitted that there was no evidence to indicate that Apotex had undertaken such an assessment or at least not one based upon any identified information or experience as to the size of the seizure market. In particular, it was submitted the assessment referred to by the primary judge reflected no more than an unsupported and, in any event, erroneous assumption made by Mr Millichamp as to the size of the seizure market.
78 Apotex submitted that it was open to the primary judge to conclude that Warner-Lambert had not made good their claim that there was essentially no market in Australia for pregabalin for the seizure indication. In support of this submission particular reliance was placed on Pfizer Australia's 2005 PBS application which Apotex submitted was cogent evidence, on which the primary judge was entitled to rely, that directly contradicted the argument that there was no market for Lyrica for the treatment of seizures. Apotex also placed considerable reliance on Apotex's three year sales forecasts exhibited to Mr Millichamp's affidavit, the genuineness of which was not put in issue by Warner-Lambert at the interlocutory hearing.
79 In our view the evidence before the primary judge provided strong support for Warner-Lambert's argument that Lyrica is only rarely prescribed for the treatment of seizures and that the seizure market is very small even to the point where it might be said (with sales quite possibly accounting for less than 0.25% of the market) that there was essentially no market for pregabalin in Australia as an anti-seizure medication.
80 As is apparent from our summary of the evidence, Mr Dimopoulos' evidence, supported by evidence from Professor Schug and Dr Jackson, provided strong support for Warner-Lambert's argument that there was essentially no market, or at least only a very small market for pregabalin in the treatment of seizures. None of the witnesses called by Apotex directly contradicted Mr Dimopoulos' evidence on this issue. In particular, Mr McEvoy was conspicuously silent on the issue. He did not respond in his affidavit to Dr Jackson's evidence that he (Dr Jackson) had never seen a prescription for Lyrica for use in the treatment of seizures. We do not know, for example, whether Mr McEvoy has ever knowingly dispensed Lyrica for treatment of seizures.
81 As to Pfizer Australia's 2005 PBS application, we do not consider that it demonstrates the existence of a significant market for the use of Lyrica in the treatment of seizures. In particular, we do not understand it to contradict the clear evidence given by Mr Dimopoulos in 2014 to the effect that Lyrica is only rarely prescribed for the treatment of seizures. Apart from the fact that Pfizer Australia's 2005 application was almost 10 years old, it is important to recognise that the projected market referred to in the document was based upon two implicit assumptions, first, that Lyrica would receive a PBS listing for the seizure indication, and second, that Pfizer Australia would promote the sale of Lyrica to doctors for that particular indication. Another relevant fact is that Pfizer Australia's 2005 PBS application was put forward on the basis that pregabalin (600 mg) was significantly more effective than gabapentin (1800 mg) (the relevant comparator), a claim that the PBAC did not accept.
82 Nor do we think the Apotex forecasts upon which the primary judge relied should have been given any weight. We say this in circumstances where neither the relevant document (Exhibit Confidential RM-12) nor Mr Millichamp's evidence indicated the basis for the assumption made as to the size of the seizure market. This is not a matter of questioning the genuineness of the Apotex's forecasts, but merely recognising that the evidence does not disclose any basis for this key assumption. If it was based on empirical evidence of some description, one would still need to know whether it was further assumed that there would be a PBS listing for Apotex-Pregabalin for the seizure indication. The primary judge's reasons suggest that the forecast was not predicated on a PBS-listing for the seizure indication but whether or not it was prepared on that basis is not apparent from the evidence.
83 In our view, Warner-Lambert's submissions on this issue should be accepted. In particular, we consider the primary judge erred in finding that the evidence relied upon by Warner-Lambert was insufficient to demonstrate, on a prima facie basis, that the market for pregabalin for the treatment of seizures was virtually non-existent or (as we would prefer to express it) extremely small. In our view the evidence from Mr Dimopoulos, which found support in the prescribing data upon which he relied, as well as Dr Jackson's and Professor Schug's evidence, was sufficient to establish, to a prima facie level, that the seizure market for pregabalin was indeed extremely small. It is important to note that none of the evidence relied upon by Apotex contradicted Mr Dimopoulos' evidence, supported by the other witnesses to whom we have referred, that Lyrica was rarely prescribed for seizures. We include here not only the evidence from Mr Millichamp but also the evidence of Mr McEvoy who might reasonably be expected to have at least some knowledge as to the extent to which Lyrica is dispensed for the treatment of seizures by pharmacists working in the Terry White group of pharmacies.