IP SPOTLIGHT 25 MAY 2020

“ Sanofi is the originator of the blockbuster multi-billion- dollar drug clopidogrel, an antiplatelet medication which is used to reduce the risk of stroke and heart disease. ”

market share” approach to calculating market share which was based on actual sales figures in the post injunction period, over the “bottom up” approach which was based on an analysis of the clopidogrel market during the injunction period. CONCLUS ION Nicholas J’s decision demonstrates the considerable difficulties that parties will face when seeking to draw on the usual undertaking as to damages. It also shows the importance of adducing evidence directly from the relevant decision makers where possible. The Court’s finding that the Commonwealth’s loss did not directly flow from the interlocutory injunction indicates that the Commonwealth may face difficulties establishing a claim for damages suffered due to delayed PBS price drops in other wrongful injunction cases, even if it is able to adduce sufficient evidence to prove a generic would have listed in the absence of the injunction. This decision comes after Justice Jagot’s decision in Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2018] FCA 1556 which also addressed the entitlement to damages pursuant to the usual undertaking. Interestingly, Nicholas J did not refer to Jagot J’s decision in his judgment. Nicholas J’s approach to some questions appears to be distinct from Jagot J’s approach. For example, Nicholas J considered that the appropriate counterfactual scenario was that the interlocutory injunction had been refused, whereas Jagot J preferred the approach that the application for the interlocutory injunction simply had not been prosecuted, rather than refused. There is clearly much to be deliberated in this developing area of law. Further, the significant difficulties faced by claimants to establish an entitlement to damages in the present environment may well draw interest from policy makers.

relevant event (i.e. interlocutory injunction) was removed from the equation. Other real world facts such as the timing of trial, final judgment or findings made are not assumed away. – – On the evidence, it was unlikely that Apotex would have continued to supply after the first instance decision was handed down due to exposure to damages, so the likely scenario was that Apotex would de-list the Apotex Product and cease supply until the determination of the appeal, rather than simply continuing to supply. – – The Commonwealth would have likely exercised its power to reverse the automatic price reduction of 12.5% caused by the initial listing of the Apotex Product (thereby reducing the damage suffered by the Commonwealth) once Apotex de-listed, because this power had been exercised by the Commonwealth in similar circumstances previously. – – The Commonwealth did not need to show that no other generics listed on the PBS as a direct result of the interlocutory injunction (rather than the patent proceeding), because even if other generics were deterred for other reasons, it does not follow that the Commonwealth did not suffer loss as a result of Apotex not being listed before them. – – The Commonwealth was “adversely affected” by the interlocutory injunction . –– None of the discretionary factors raised by Sanofi were sufficient to deny the Commonwealth’s claim for compensation . The delay in the Commonwealth notifying Sanofi that it would make a claim was explained; that the supply of the PI for the Apotex Products would have constituted an infringement of Sanofi’s copyright in its PI was irrelevant when the evidence showed that Sanofi would never have pursued Apotex for copyright infringement in its PI; it was not established that the manufacture of Apotex Products in Canada would have infringed a valid claim of the Canadian patent; and no further public interest considerations arose. –– To determine quantum, it was necessary to identify the market share that the Apotex Product would have achieved . Nicholas J preferred the “backdated actual

COMMON PATENT MISCONCEPTIONS

Many people, even those with significant experience with patents, harbour some misconceptions about the patent system, its advantages and risks. This article debunks a few of the more common mistakes.

ONLY GEN IUS I DEAS CAN BE PATENTED An invention need not be a genius idea to be patentable. An Australian standard patent (which provides 20 years’ protection) requires that the invention is “inventive” compared with what was known and published before the patent. A good way to think of an invention is as a solution to a problem. A solution is inventive if, at the date the patent was filed, the ordinary person working in the field would not have been directly led to try that solution with an expectation that it might well work. This is a relatively low bar to clear, and often allows patent protection to be obtained for relatively minor, incremental improvements over existing technology.

BINDHU HOLAVANAHALLI Associate

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