A judge has granted F. Hoffman La-Roche’s request for a temporary order blocking Sandoz from making or selling a biosimilar version of its patented biologic used to treat various cancers and rheumatoid arthritis.
Switzerland-based Roche has marketed and sold its biologic drug Mabthera in Australia since 1999, and is the registered owner of a number of patents related to methods for using rituximab to treat various conditions, including certain cancers and rheumatoid arthritis. It claims that by seeking to register its biosimilar product Riximyo on the Australian Register of Therapeutic Goods, Sandoz threatens to infringe certain claims of four of its rituximab patents.
Roche sought an emergency injunction blocking Sandoz from supplying, importing, making, selling or keeping rituximab 500mg/50mL and 100mg/10mL concentrated injection vials, and an order compelling Sandoz to notify the Department of Health and the Minister for Health of the injunction and informing them that it could no longer provide assurances that it could supply the drug, until further notice.
Roche argued that without the injunction, Sandoz’s products would likely be listed on August 1 and that it would suffer incalculable harm. Sandoz told the court it shouldn’t order the injunction because the Roche’s patents were invalid for lack of inventive step and obviousness, and that the injunction sought was too broad. In response, Roche said that Sandoz’s cross claim of invalidity was merely arguable and that it didn’t weaken the strength of its overall infringement case.
Justice Stephen Burley granted the temporary injunction on Tuesday, finding that, based on the expert evidence offered by both sides, Roche’s cross-claims of invalidity and obviousness were merely arguable and not highly arguable, as Sandoz had claimed.
“Having regard to the conflicting evidence going to a number of aspects of the case on lack of inventive step, in my view it is apparent that the invalidity case is arguable, but it is not, for present purposes (and I emphasise, on a provisional view), possible for me to conclude that it is strongly arguable, as Sandoz urges. Put another way, the evidence of the experts on both sides appears to be rational and persuasive and, having regard to the differences between them, I can see no rational basis for concluding other than that the lack of inventive step is arguable,” Judge Burley said.
The judge also agreed with Roche that it would suffer considerable loss unless the injunction was granted, including loss of market share; a 16 percent price drop, as mandated under the PBS; additional price decreases resulting from competition from Sandoz and other generics manufacturers and other price decreases due to mandatory price disclosure obligations under the PBS.sandoz
The judge accepted Roche’s argument that were it to ultimately triumph in the case but not be granted a temporary injunction, it would not be able to raise the prices for its drug back to earlier levels.
“I accept that if the present injunction is refused, but at trial a final injunction is granted, the evidence indicates that the prospect that Roche would be in a position to restore its prices to their present level is remote,” Judge Burley said.
The judge also agreed that without the injunction, Roche would likely face generic competition from Sandoz and at least one other generics rival, raising “significant complexities in the calculation of damages”.
However, Judge Burley was not convinced by Roche’s argument that it would suffer loss of goodwill related to price increases were a final injunction to be granted.
“Roche has asserted that it will also suffer reputational harm in the event that a final injunction is granted, but an interlocutory injunction is not, because it will attempt to raise the price of Mabthera towards the level that it enjoyed in the halcyon days of its monopoly. The market will look askance at this act, and its reputation will suffer. I give this consideration little weight, given the nature and sophistication of the market,” the judge said.
In granting the injunction, the judge declined to extend the injunction beyond the expiration date of one the patents, instead fixing the end date for the injunction at August 11, 2019.
F. Hoffman La-Roche was represented by Katrina Howard SC with 9 Selborne Chambers, Angus Lang with Tenth Floor Chambers, Clare Cunliffe with List G Barristers and solicitors with Spruson & Ferguson. Sandoz was represented by Bruce Caine QC with List A Barristers, Neil Murray with Tenth Floor Chambers and Luke Merrick with List G Barristers and solicitors with King & Wood Mallesons.
The case is F. Hoffman La-Roche AG v Sandoz Pty Ltd.
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