Biosimilars – First interlocutory injunction in Australia

June, 2018

For the first time in Australia, an originator of a biologic therapy, Roche, has been granted interim relief in the Federal Court restraining Sandoz from launching a biosimilar on the basis that such supply would infringe treatment method claims patented by Roche. Partner, James Lawrence and Lawyer, Helaena Short discuss.

Background

Rituximab is a biologic therapy prescribed in Australia to treat a number of immunological conditions including lymphoma, chronic lymphocytic leukaemia and rheumatoid arthritis.

Hoffman-La Roche AG is the registered proprietor of a number of patents relating to certain methods of use of rituximab and Roche Products Australia Pty Ltd is the importer and supplier of the rituximab product ‘Mabthera’ in Australia (collectively, Roche). In 2017 Sandoz Pty Ltd (Sandoz) obtained a listing in the Australia Register of Therapeutic Goods (ARTG) for their biosimilar rituximab product ‘Riximyo’ – for the same indications as Mabthera.

More recently, Sandoz applied to have Riximyo listed on the Pharmaceutical Benefits Scheme (PBS) and it was anticipated that, but for an injunction, Riximyo would be listed on the PBS on 1 August 2018.

Significantly for Roche, the introduction of Riximyo to the PBS would automatically cause a 16% price reduction for Mabthera by moving it from the F1 to F2 PBS formulary. Furthermore, it was expected that Sandoz would reduce the price of Riximyo more than the mandatory 16% because it would be necessary to attract customers away from the Roche product, with evidence from the UK suggesting a possible price reduction in the order of 40% or more.

Mabthera is a high cost medication. Evidence read in the Federal Court demonstrated that for a public hospital, the dispensed price for Mabthera would be $2,641.56 per treatment. If subsidised under the PBS, adult patients make a co-payment of $39.50 and there is no cost to the hospital. However, if the treatment is not for a PBS listed indication (comprising a reasonable proportion of the purposes for which Mabthera is used) the full cost of the treatment is borne by either the hospital or patient unless the patient qualifies for a compassionate program.

Points of Claim

Roche sought interlocutory orders to restrain Sandoz from exploiting rituximab, on the basis that Sandoz would otherwise be infringing 4 asserted claims (from 4 separate patents) registered by Roche, relating to methods of treating particular medical conditions with rituximab, by operation of ss 117(1) and 117(2)(b) of the Patents Act 1990 (Cth) (Act).

Sandoz did not dispute that it proposed to infringe the asserted claims but cross-claimed that the asserted claims did not involve an inventive step because the claimed inventions would have been obvious having regard to information contained in a number of prior art documents to which a person skilled in the art may have had regard to (and possibly combined) pursuant to s 7(3) of the Act.

Reasons for the Decision

Burley J acknowledged that the principles concerning the granting of interlocutory relief are not controversial. Relevantly, the applicant must establish a ‘prime facie case’[1]  by demonstrating a sufficient likelihood of success to justify the preservation of the status quo pending trial, and the balance of convenience and justice should favour the grant of an injunction.

As Sandoz accepted that its proposed conduct would prime facie fall within the scope of the asserted claims, the decision turned on whether Sandoz had a sufficiently strong invalidity case so as to weigh materially in its favour on the question of balance of convenience.

As a result, a significant body of evidence going to this subject was read, with each side relying on the opinions of experienced and highly skilled medical practitioners specialising in haematology, rheumatology and oncology to support their respective positions.

Burley J acknowledged that the experts disagreed on matters of fact and opinion in several instances however reinforced the accepted view that an interlocutory hearing is not the place to make findings of fact or to resolve disputes of opinion.[2] Importantly, expert witnesses are not traditionally cross-examined at the interlocutory stage of proceedings.

Alternatively, forming the view that all of the evidence appeared to be rational and persuasive, Burley J concluded that there was no basis for concluding that the lack of an inventive step was anything more than ‘arguable’.[3] This yielded the conclusion that Sandoz had not displaced the argument that the infringement claim had sufficient merits of success.

Relief

Overall Burley J held that the balance of the case and justice favoured the granting of interlocutory injunctive relief however the form of such relief was critical, having regard to the interests of both parties.

In balancing the competing positions, having regard to the interests of justice, Burley J considered, inter alia, Sandoz’ argument that, having regard to three recent (or ongoing) Australian proceedings involving generic pharmaceutical products, the assessment of a claim for compensation by Sandoz was likely to be more complex, time consuming and costly than if Roche were required to engage in a damages enquiry at the end of the liability proceedings.[4]

In addition, Burley J considered the expiry date of two of the asserted patents to be highly relevant because it was unlikely that the proceedings would be concluded before the expiry of those two patents and therefore it was apparent that the outcome of the interlocutory hearing would likely be the final decision regarding injunctive relief for at least those two patents.

On the basis of current market figures, after 9 November 2019 (when the first two patents will have expired) over 50% of the purposes for which Roche supplies Mabthera for would not infringe the remaining patents. On this basis, Burley J was not minded to grant interim relief beyond such a date that the landscape of the balance of convenience and justice might be materially affected. Accordingly, although interim relief was granted in favour of Roche, as a compromise Sandoz is restrained from supplying for use, offering for supply or sale, supplying or selling rituximab only until 11 August 2019 (being the date of expiry of the oldest asserted patent.

Concluding remarks

Overall, while this decision is a ‘first’ in the context of biosimilars, it nevertheless re-affirms the likelihood that where a prime facie case for infringement has been established for a pharmaceutical product, if the patentee is the sole market participant for the particular product, there is a high likelihood that interlocutory relief will be granted given the PBS reimbursement consequences.

Contact Mills Oakley

For more information, please do not hesitate to contact:


James Lawrence | Partner
T: +61 2 8035 7838
E: jlawrence@millsoakley.com.au

Helaena Short | Lawyer
T: +61 2 8035 7847
E: hshort@millsoakley.com.au

 

[1] See Beecham Group Ltd v Bristol Laboratories Pty Ltd [1968] 118 CLR 618 at 622-623.

[2] at [90].

[3] at [153].

[4] at [185] referring to Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth (Federal Court of Australia proceeding no. VID 195 of 2009 and other related proceedings (Venlafaxine Proceedings); Apotex Pty Ltd v Sanofi-Aventis & Ors (Federal Court of Australia proceeding no. NSD 1639 of 2007 and other related proceedings (Clopidogrel Proceedings); Watson Pharma Pty Ltd v AstraZeneca AB (Federal Court of Australia proceeding no. NSD 2342 of 2011 and other related proceedings (Rosuvastatin Proceedings).

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