Invalidity cross-claim blocks interlocutory injunction

The Full Court has upheld Burley J’s refusal to grant Sanofi-Aventis an interlocutory injunction over Alphapharm’s SEMGLEE insulin solution for an injector pen. The significance here is that this is an unusual case where the (alleged) infringer’s cross-claim has negatived the patentee’s prima facie case of infringement. The Full Court also affirmed his Honour’s approach to balance of convenience issues.

Burley J found a clear case that Alphapharm’s product fell within claim 1 of Sanofi-Aventis’ patent. His Honour found, however, that Alphapharm’s cross-claim that the patent was invalid for lack of novelty was sufficiently strong that “it was doubtful” Sanofi-Aventis had made out a prima facie case of infringement.

Since the Interpharma case, cross-claims by alleged infringers that the patent is invalid have not enjoyed much success as the Court has approached matters on the basis that it is the patentee’s “title” to interlocutory relief which is in issue.

What was different here was that the invalidity cross-claim was not “merely” a triable issue. It was of such strength that Burley J considered (provisionally) the patent was invalid. The Full Court explained the correct approach at [14]:

…. A case for invalidity which is merely arguable, of itself, does not undermine the existence of a prima facie case of infringement which has otherwise been found to exist. However, a sufficiently strong case of invalidity may well qualify the conclusion that there is a prima facie case of infringement at all. Far from reasoning contrary to the approach in Interpharma and Janssen, the primary judge was applying the same reasoning, albeit with an outcome not to Sanofi’s liking because his Honour was satisfied that Alphapharm’s case on invalidity was sufficiently strong to qualify (indeed, virtually to negate altogether) Sanofi’s prima facie case of infringement. Further, it is Sanofi’s submissions which have conflated the relevance of the competing cases on invalidity. What is relevant is the strength of the case that the claim or claims said to be infringed are invalid. The primary judge at [118] found that “the lack of novelty case advanced by Alphapharm is sufficiently strong (at the provisional level) to qualify (in the sense contemplated in Interpharma at [17]) the conclusion that Sanofi has a probability of success”. ….

Sanofi-Aventis argued that the weight of the balance of convenience in its favour was a factor in considering its prima facie case of infringement. This argument failed both at the level of principle and on the facts.

First, the Full Court accepted that the strength of a plaintiff’s prima facie case is relevant to consideration of the balance of convenience. Balance of convenience, however, did not affect the assessment of the strength of the prima facie case of infringement. At [8], the Full Court explained:

…. The strength of the prima facie case is relevant to the balance of convenience, but the weighing process involved in evaluating where the balance of convenience lies does not affect the assessment of the existence or strength of the prima facie case. As was said in Samsung at [59] “[t]he critical integer in the test …is the need for the Court to assess the strength of the probability of ultimate success on the part of the plaintiff. The strength of that probability will depend upon the nature of the rights asserted and the practical consequences likely to flow from the grant of the injunction which is sought”. ….

Secondly, Burley J had apparently considered the respective losses relatively finely balanced on the question of balance of convenience, but had ultimately considered the difficulties of calculating Alphapharm’s losses outweighed the difficulties in calculating Sanofi-Aventis’.

In particular, the Full Court considered that Burley J had not inappropriately undervalued Sanofi-Aventis’ position as a long standing incumbent. For example at [51], their Honours explained:[1]

… Sanofi had not demonstrated a sufficient likelihood of success in all of the circumstances to justify the preserving of the status quo. Each case turns on its own facts so it is not the point that in GenRx and Warner Lambert the preservation of the status quo was given considerable weight. In neither case was the strength of the prima facie case undermined in the same way as in the present case. In neither case was there a suggestion of market circumstances similar to the present case given the primary judge’s reference in [174] to the real possibility of Alphapharm’s prospective market disappearing as a “significant aspect” of this matter. Faced with the primary judge’s reasons, Sanofi’s submission that his Honour failed to take into account the disruption of the status quo as a material consideration is untenable. His Honour weighed all those matters but the balance favoured Alphapharm not Sanofi.

Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd [2019] FCAFC 28 (Jagot, Yates and Moshinsky JJ)


  1. One can only speculate how the 1336 paragraphs Jagot J had to write to work out the quantum on an undertaking as to damages in Sigma v Wyeth concentrated her Honour’s appreciation of this issue!  ↩

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