Rituximab - Australia

On Jun 12, 2018, Federal Court of Australia granted Roche a preliminary injunction against Sandoz’s biosimilar on the basis prima facie case for infringement & validity of patents.

In the present interlocutory application the originator (Hoffman / Roche) seeks urgent orders to restrain a respondent (Sandoz) from launching a Rituximab biosimilar on the basis that the biosimilar will infringe some of the claims of four asserted patents. The respondent contends that the asserted claims are invalid for want of inventive step and that the balance of convenience and justice lies against the grant of the injunction sought.

Mabthera (Rituximab) is a biologic therapy prescribed in Australia to treat a number of immunology conditions including Non-Hodgkins Lymphoma (NHL), chronic lymphocytic leukaemia (CLL) and rheumatoid arthritis (RA) which is owned by Hoffman / Roche. Sandoz has applied to have RIXIMYO listed on the Pharmaceutical Benefits Scheme (PBS). On March 2018, a number of positive recommendations were made for the RIXIMYO products. The evidence suggests that it is likely that, absent an injunction, Sandoz’s products will be listed on 1 August 2018. Roche is concerned that the effect of the PBS listing will be to cause a sequence of irreversible and harmful consequences to it. It now seeks interlocutory orders to restrain Sandoz from infringing the patents; AU2008207357 (NHL patent), AU761844 (CLL patent), AU2005211669 (DLCBL patent) & AU2007242919 (RA patent).  Each of the claims is for a method of treating particular medical conditions using rituximab.

Sandoz argued invalidity arguments (lack of inventive step) based on various prior arts, with the common general knowledge. However, court was not persuaded by its Expert & held that Professor did not give evidence about the effects of the combination of these prior art documents, so there remains a question about whether this would occur. However, the evidence of the experts on both sides appears to be rational and persuasive and, having regard to the differences between them, court can see no rational basis for concluding other than that the lack of inventive step is arguable.

Alternatively, Roche has established a prima facie case for infringement of the asserted claims. Sandoz has by its evidence demonstrated that it has an arguable case for challenging the validity of those claims; however, the evidence does not permit a provisional view that rises above that level. The balance favors the preservation of the status quo and the rights protected by the asserted claims in respect of which a serious question to be tried as to the entitlement to final injunctive relief has been established. Overall, the balance of the case and justice lies in favor of the granting of interlocutory injunctive relief.