7. The proposed Guidelines Violate Established Principles of Law

Article 18.53(1)(b) and (c) of the CPTPP requires that legal remedies are available to the patent holder and that it has adequate time and opportunity to seek such remedies. These requirements are already met in Malaysia by provisions in its Patents Act as well as in its Rules of Court 2012.

Section 59 of the Patents Act provides that a patent holder may initiate infringement proceedings where there is likelihood of “imminent infringement”, while Section 60 provides that if the patent holder “proves imminent infringement the Court shall grant an injunction to prevent infringement and any other legal remedy”.

Order 29 of the Rules of Court 2012 set outs the provisions for applying for interim injunction. Order 29 in fact allows for ex parte (from one party) injunctions whereby injunctions can be granted within 24 to 48 hours to the applicant where the legal conditions are met. Where an injunction is granted ex parte, it is strictly limited in duration: the order automatically lapses 21 days from the date it is granted unless it is continued or confirmed by the court, and an inter-partes (between parties) hearing must be fixed within 14 days of the ex parte order. This time bound structure ensures that while the affected party has been given a prompt opportunity to be heard, the remedy is provisional and the court is able to quickly reassess the correctness and necessity of the injunction, thereby reinforcing proportionality and fairness of the system.

Critically, in granting an ex-parte injunction, the court must first be satisfied that there is a serious question to be tried, and if so, must then consider whether damages would be an adequate remedy and, if not, where the balance of convenience lies. In the Court of Appeal case of Motor Sports International Ltd (Servants or Agents or Agents at Federal Territory of Labuan) & Ors v Delcont (M) Sdn Bhd [1996] 3 CLJ 483; [1996] 2 MLJ 605, His Lordship Gopal Sri Ram JCA (as he then was) succinctly held as follows:

"The provisions of O 29 r 2A were introduced by amendment in order to ensure that ex parte injunctions of any sort were not granted willy-nilly but only in cases where they were truly called for. In order to ensure that the policy behind the introduction of r 2A is not defeated, high courts must demand strict compliance with its terms. More so, when the relief applied for is in the nature of a Mareva or an Anton Piller type of injunction because of the incalculable harm and damage that may be caused to a defendant by the grant of either of these orders."

The standards for granting interim measures is reflected in the High Court´s judgment in Lim Choong Huat & Ors v Syntlz Enterprise Sdn bhd & Ors [2010] 1 CLJ 860, wherein His Lordship reminded that the Patents Act 1983 “makes the court the ultimate adjudicator to decide on the validity of the patent; however, pure registration of the patent alone does not give any certainty to the patentee of his right as a valid patent holder… it cannot be said that prima facie the patentee has the exclusive right of making, using or selling etc of his product. The Act only gives the true and first inventor a limited monopoly, as a reward for the invention. The question whether he is the true and first inventor can seldom be determined at the application stage at the patent office”.

In this context, NPRA’s proposal to grant automatic stay on the regulatory approval process upon receiving evidence of legal proceedings undermines the existing procedure under Order 29 of the Rules of Court 2012 and runs counter to established Malaysian law. The courts have consistently treated interim injunctions as exceptional remedies, subject to strict legal and procedural safeguards, precisely to avoid premature deprivation of a person/entity’s legitimate rights without full inter-partes scrutiny. By contrast, a Category‑4‑based regulatory stay would impose an effective de facto bar on market entry to the detriment of the defendant, based solely on mere initiation of legal proceedings, bypassing the requisite judicial scrutiny required under Order 29. Such an action amounts to a extrajudicial quasi-injunctive mechanism that is beyond NPRA´s jurisdiction and power.