First of its kind: Injunction restraining launch of biosimilar granted in Australia

The first interlocutory injunction restraining the launch of a biosimilar pharmaceutical product was granted by the Federal Court of Australia in a decision on 12 June 2018¹.

Background

The decision concerns the monoclonal antibody rituximab, a biologic therapy which is prescribed in Australia to treat a number of immunology conditions including lymphoma, chronic lymphocytic leukaemia and rheumatoid arthritis.

The applicants, F. Hoffman-La Roche AG and its Australian subsidiary Roche Products Australia Pty Ltd (Roche), own four patents relating to methods of use of rituximab in the treatment of a number of specified medical conditions. They supply a number of products in Australia under the MABTHERA brand which have rituximab as their active ingredient.

The respondent, Sandoz Pty Ltd (Sandoz), are planning to launch two biosimilar products called RIXIMYO.  They have obtained regulatory approval of similar scope to MABTHERA. Sandoz also applied to have RIXIMYO listed on the Pharmaceutical Benefits Scheme (PBS), with a view to launch later this year.

Roche, concerned that the effect of the PBS listing would be to cause a sequence of irreversible and harmful consequences to it, sought interlocutory relief preventing Sandoz from infringing 5 claims of four of their patents relating to rituximab.

The law applicable to interlocutory relief

The two main principles concerning the grant of interlocutory relief are:

  • whether the applicant for relief has established a prima facie case
  • whether the balance of convenience and justice favours the grant or refusal of an injunction.

The question of arguable case

For the purposes of the present application, Sandoz accepted that its proposed conduct would have infringed Roche’s asserted claims. Nevertheless, Sandoz contended they had established a strong case that the asserted claims are invalid for lack of inventive step.

Roche responded that the case advanced by Sandoz on the cross-claim was arguable, but no more, submitting that the overwhelming strength of its infringement case is not weakened by the existence of a merely arguable cross-claim.

With the question of Roche’s claim of infringement made out, the question before the Court was the strength of Sandoz’s invalidity challenge.  Upon consideration of conflicting evidence from a range of experts in relation to all four patents, Burley J surmised that the evidence did not permit any provisional conclusion as to the strength of the validity case beyond the observation that it is arguable.

The balance of convenience

Roche submitted that several factors favoured granting interlocutory relief –  particularly that the launch of a generic rituximab would cause losses to Roche that could not be adequately calculated or compensated by an award of damages. These included, for example, a 16% price drop mandated by the PBS, as well as loss of market share and loss of goodwill.

Sandoz submitted that the potential losses outlined by Roche were overblown and that its own losses by the granting of an injunction, which may later be overturned, would be harder to calculate and would result in greater irreparable harm.

Ultimately, Burley J found that the balance of convenience and justice favoured granting an injunction against Sandoz until 11 August 2019, the date upon which the first of the Roche patents is set to expire. Roche have also been granted leave to apply for continuation beyond this date, depending on circumstances at that time.

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¹F.Hoffman-La Roche AG v Sandoz Pty Ltd [2018] FCA 874

MChem(Hons) MCommrclLaw PhD AMRSC MRACI

Annabella is a registered patent and trade marks attorney specialising in the chemical sciences. She is particularly interested in the strategic role of intellectual property (IP) in the commercialisation process.