Biogen International GmbH v Pharmacor Pty Ltd

[2021] FCA 1591

Patents – interlocutory injunction – weak prima facie case – invalid extension of term – balance of convenience otherwise finely balanced

In this proceeding, the applicants (collectively, Biogen) made an application for an interlocutory injunction in proceedings for patent infringement and misleading or deceptive conduct to restrain the respondent (Pharmacor) from launching its dimethyl fumerate (“DMF”) products.

On 14 July 2021, Pharmacor obtained a listing for its DMF products on the Australian Register of Therapeutic Goods (“ARTG”).  It then sought listing of those products on the Schedule of Pharmaceutical Benefits pursuant to the Pharmaceutical Benefits Scheme (“PBS”).

Biogen sells DMF products in Australia under the name “Tecfidera” for the treatment of multiple sclerosis.  Biogen International GmbH is the patentee of Australian patent number 752733 titled “Utilisation of dialkyl fumerates” (the “Patent”), which relates to the use of dialkyl fumerates for preparing pharmaceutical products for use in transplantation medicine or for the therapy of various autoimmune diseases.

On 20 October 2014, the Commissioner of Patents granted an application for an extension of the term of the Patent from 29 October 2019 to 29 October 2024.

For the purposes of the application, Pharmacor admitted that its products fell within all of the asserted claims, except claim 17.  In defence of the grant of interlocutory injunctive relief, Pharmacor argued that the extension of the Patent term was wrongly granted.  Pharmacor also argued that the patent claims asserted against it are invalid for want of novelty.  Pharmacor confined its novelty attack to one prior art document:  Australian patent application no. 21393/99 (the “593 Application”).  Accordingly, when assessing the application for interlocutory relief, Rofe J unsurprisingly concluded that Biogen had demonstrated a very strong prima face case on infringement, but with the important qualification: assuming that the asserted claims are extant and valid.

As to Pharmacor’s provisional attack on the Patent for want of novelty, Rofe J observed that the novelty argument came down to a question of construction: whether the asserted claims include within their scope active ingredients other than dialkyl fumerates.  On that question, her Honour expressed the view that the relevant claim did not include active ingredients other than dialkyl fumerates, and that Pharmacor had impermissibly sought to “expand the boundaries” of the claim by adding glosses drawn from other parts of the specification.  On that basis, Rofe J held that, for the purposes of the interlocutory hearing, the 593 Application does not anticipate the asserted claims.

The claim for contravention of the Australian Consumer Law brought by Biogen (for failure to warn customers of the risk of infringement) did not take Biogen any further.  As Rofe J observed, for the purposes of the application, the Australian Consumer Law case stands or falls with the patent infringement case.

Justice Rofe’s decision primarily depended on her consideration of Pharmacor’s attack on the extension of term which had been granted in respect of the Patent.  Pharmacor argued, inter alia, that the relevant claim of the patent (on which the extension of term was said by Biogen to be based) was not a claim for a pharmaceutical substance per se – as is required by section 70 of the Patents Act 1990 (Cth) – because it was a purpose limited product claim which claimed an actual achievement of a therapeutic act as a functional technical feature.

Her Honour agreed that the specified therapeutic purpose was, at least on a provisional view, an essential integer of the claim and that there is a sufficiently strong prospect that the extension of the Patent may have been wrongly granted.  By “sufficiently strong”, her Honour considered that that issue “alone is likely to be sufficient to conclude that no injunction should be granted”. 

Arguably, in light of that finding, her Honour need not have moved on to consider the balance of convenience, because Biogen had not established a prima facie case of infringement.  Her Honour then observed that “the question of whether or not Biogen has demonstrated a sufficient likelihood of success to justify the preservation of the status quo requires consideration of the basket of discretionary factors which I discuss below”, which suggested that it may have been necessary to consider the balance of convenience.  But later her Honour concluded that Pharmacor’s case that the extension of term was wrongly granted was sufficiently strong, at a provisional level, to qualify the conclusion that Biogen has a prima face case on infringement and only addressed the question of balance of convenience “for completeness”.

As to the various discretionary factors relevant to the assessment of the balance of convenience, for Biogen, those factors included pricing impacts that would be caused by the launch of Pharmacor’s DMF products, including the 25 per cent mandatory price reduction of the price of Tecfidera and ongoing downward pressure on price due to generic discounting, a significant loss in Tecfidera’s market share, negative impacts on Biogen Australia’s operations, and the likelihood of irreparable and unquantifiable harm.  For Pharmacor, the relevant factors included the difficulties inherent in quantifying damages when an injunction of this nature is granted, the loss of its “first mover” advantage, and the likelihood that Biogen would, by its own actions, destabilise the status quo by introducing a new product. 

After setting out the various factors relevant to balance of convenience, Rofe J observed that the factors were quite evenly balanced.  Her Honour noted that, on the evidence, the calculation of loss in either scenario would be of considerable complexity, such that it was not possible at the provisional level to determine which damages calculation exercise would be more complex.

Her Honour also observed that the impending introduction into the market of a new treatment for MS for which Biogen had sought TGA approval – Vumerity – was a factor which tended against the granting of the interlocutory relief sought.  Pharmacor argued that Biogen intended to alter the market by shifting patients from its DMF product (Tecfidera) to its new product (Vumerity), and that that would significantly diminish the market in which the Pharmacor DMF products could compete such that there was no relevant status quo to protect.  Justice Rofe agreed, observing that Vumerity would have a profound impact on the DMF market such that it would be very different from (and likely much smaller than) its current state.  A very similar issue arose in Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd [2019] FCAFC 28; (2019) 139 IPR 409, where there was a real concern that the patentee would destroy the market for the allegedly infringing product by the time the matter was finally heard and determined.

Justice Rofe ultimately concluded that the balance of convenience did not favour the grant of an injunction to restrain the launch of Pharmacor’s DMF products.  When combined with her Honour’s provisional assessment of the strength of Biogen’s prima facie case, her Honour held there was insufficient likelihood of success in all the circumstances to justify the grant of the injunction sought, and dismissed Biogen’s application.

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