Australia's first biosimilar interlocutory injunction.
Sandoz is unable to sell its rituximab biosimilar (RIXIMYO) in Australia until at least 19 August 2019, after an order by the Federal Court of Australia made on 12 June.
Sandoz had threatened to supply RIXIMYO in Australia, having obtained a registration and applying to list RIXIMYO on the Pharmaceutical Benefits Scheme (PBS). There was also evidence in the interlocutory hearing that it was likely that RIXIMYO would be 'a' flagged, meaning that when a doctor prescribes rituximab by reference to the brand name MABTHERA that the biosimilar product can be dispensed by a pharmacist, unless the doctor indicates on the prescription that it cannot be substituted.
If RIXIMYO was listed on the PBS, Roche's Mabthera would have suffered the automatic 16% statutory price drop for the payments it is paid by the Commonwealth Government for the drug. This price drop will increase to 25% on 1 October 2018.
Roche sought interlocutory relief, alleging that RIXIMYO would infringe the claims of 5 method of treatment patents and Sandoz accepted that Roche had a prima facie case of infringement (that its supply would be for the use for an claimed method of treatment). However, Sandoz contended that the balance of convenience tilted in its favour, such that an interlocutory injunction should not be granted. In particular, Sandoz said that:
- it has a strong case that the relevant claims of Roche's patents are invalid for lack of inventive step;
- the expiry dates of at least 2 of the patents are fast approaching (August and November 2019); and
- not every sale by Sandoz of RIXIMYO would necessarily be an infringing use of Roche's patents.
Justice Burley found that that while Sandoz had an arguable lack of inventive step case, he was still minded to grant the interlocutory injunction to preserve the status quo pending final resolution of the matter.
However, having regard to the looming expiry of 2 patents, Justice Burley did not consider it appropriate to permit any interlocutory injunction to extend beyond the expiry of the first patent on 11 August 2019.
While the evidence suggested that only 8% of the use of RIXIMYO would be non-infringing at this point in time, as each patent expired (in particular 2 in the next 18 months), the proportion of threatened infringement would diminish. On the evidence before the Court, over 50% of the uses that Roche supplies for may not be the subject of the asserted claims. This may well tilt the balance of convenience in Sandoz's favour when the injunction is reconsidered before its expiry in August 2019.
Biosimilars in Australia
There are presently 12 biosimilar medicines listed on the Australian Register of Therapeutic Goods, 8 of which are subsidised by the Australian Government on the PBS, including Etanercept and Infliximab.
A series of initiatives by the Australia Government will soon be introduced aimed at further increasing the use of biosimilar medicines in Australia including:
- encouraging the prescribing of a biosimilar brand by doctors rather than the reference biological; and
- the introduction of streamlined authority for prescribing biosimilars (as opposed to telephone or written authorisation for prescribing which is required for some medicines listed on the PBS).
We expect that the introduction of these biosimilar uptake drivers should stimulate more prescription and substitution of biosimilars in the Australian market.
However, injunctions like this injunction against Sandoz may deter the competition sought by the Commonwealth government in the biologic market.