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Commercial Court Refuses Preliminary Injunction Restraining Sale of Generic HIV Drug


The Commercial Court has refused an application brought by US-based biopharmaceutical company Gilead Sciences (the plaintiff) for a preliminary injunction against generic pharmaceutical manufacturers Mylan and Teva (the defendants).  The application was brought in a case concerning the defendants’ plan to market a generic version of the plaintiff’s antiretroviral drug, Truvada®.

Truvada®, an antiretroviral medication for the treatment of HIV/AIDS, is protected by an Irish Supplementary Protection Certificate (the SPC).  The SPC extends until February 2020 certain intellectual property rights first granted to the Plaintiff by a now expired European Patent.  The defendants allege that the SPC is invalid but did not intend to “clear the way” by seeking its revocation prior to launch of their products in Ireland.  The plaintiff sought a preliminary injunction restraining the defendants from launching their products onto the Irish market pending a full trial.

On 7 November 2017, Mr Justice McGovern refused to grant the preliminary injunctive relief requested.  Relying on the well-established test for the granting of interlocutory injunctions set out by the Supreme Court in Campus Oil v Minister for Industry and later followed and summarised by Mr Justice Clarke in Okunade v Minister for Justice, the Court made a number of findings:

  • The Court agreed with the plaintiff that there was a fair, bona fide or serious question to be tried. 
  • However, the Court found that damages would be both an adequate remedy for the plaintiff, and capable of assessment. The Court was also satisfied that the defendants were in a position to meet any award of damages that might be made.
  • Finally, the Court took into account the fact that the case had been admitted to the Commercial List meaning that it would be heavily case-managed and would likely proceed to trial at an early date.

Given that the second limb of the test for an interlocutory injunction had not been met (i.e. damages were an adequate remedy for the plaintiff), the Court found that it was not necessary for it to consider separate issues going to the balance of convenience, such as:

  • Whether damages would be an adequate remedy for damage suffered by the defendants as a result of a preliminary injunction.
  • The relevance of Teva’s claim that it would lose “first mover advantage” were a preliminary injunction to be granted.
  • The importance afforded to preservation of the status quo

This decision confirms that the well-established test for the granting of interlocutory injunctions applies in the same way to applications for interlocutory injunctions where patent infringement is alleged. The adequacy (or otherwise) of a remedy in damages will continue to be a key battleground in such applications.

Contributed by: Laura Scott & John Sugrue

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