Rules about interlocutory injunction in Singapore in pharma

by | Jul 24, 2018

Supreme Court of Singapore ; Millennium Pharmaceuticals Inc v. Drug Houses of Australia Pte Ltd, [2018] SGHC 149 – 26 June 2018

On June 26, the Supreme Court of Singapore had the opportunity to detail the rules about interlocutory injunction in Singapore within the pharma sector.

This decision from the Supreme Court of Singapore is interesting for three main reasons.

First, it teaches us that a patentee who seeks a « quia timet » injunction takes upon himself the burden of proving that it is reasonably certain that what the defendant is threatening and intending to do will cause imminent and substantial damage to the plaintiff.

Second, the Supreme Court quoted several case law from UK and India to reach its conclusion refusing the preliminary injunction.

The Supreme Court has notably cited the very old and landmark UK case « American Cyanamid Co v Ethicom » Ltd [1975] AC 396, in which a set of guidelines were developed to establish whether a patentee merited the granting of an interlocutory injunction.

The main « American Cyanamid » guidelines have been taken into account by the Supreme Court of Singapore to reach its conclusion refusing the preliminary injunction :

  • Whether there is a serious question to be tried ;
  • whether damages were an adequate remedy for a claimant if an injunction was not granted ;
  • What would be the balance of convenience of each party should the order be granted.

In this case, the Supreme Court of Singapore concluded that a the plaintiff was not able to show, on its summons for interlocutory injunction, that there was a “serious question to be tried” and that damages would not be an adequate remedy for it in the event it succeeded at trial.

Finally, the Supreme Court of Singapore reminds the obligations of generic manufacturers regarding the respect of patent rights. According to the Court, an applicant seeking to register a therapeutic product – if a patent is in force in respect of said therapeutic product to which the application relates, the applicant is not the proprietor of the patent, the proprietor has not consented  to nor acquiesced in the grant of the registration – must make one of the following two types of declarations:

  • a “Category A3” declaration, if the applicant is requesting for registration to be granted after the patent expires ; an application with a Category A3 declaration may not be made earlier than 18 months before the patent expires ; or
  • a “Category B” declaration, if in the applicant’s opinion and to its best belief, the patent is invalid or will not be infringed by the doing of the act for which registration is sought.

Notes:

House of Lords, American Cyanamid Co v Ethicon Ltd [1975] AC 396 (“American Cyanamid”) (darts-194-304-A-en) ; Eng & Wales High Court, Cephalon, Inc and Others v Orchid Europe Limited and Generics (UK) Ltd (t/a Mylan) [2010] EWHC 2945 (darts-355-889-A-en) ; High Court of Delhi, Merck Sharp & Dohme Corporation and another v Glenmark Pharmaceuticals FAO (OS) 190/2013 (darts-290-499-D-en).

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