It is well known that German medical device manufacturer, B. Braun Melsungen AG, has been in Malaysia for the past 40 years and has earned a reputation over the years for their safety IV catheters. In fact, they have a huge production facility in Penang, a northern state in Peninsular Malaysia. A huge amount of resources and effort have been invested by B. Braun in establishing themselves as the manufacturer and supplier of their safety IV catheter products which are distinctly different from the general IV catheter products. Due to their efforts, they have successfully created a market for safety IV catheters in the healthcare and medical industry.
Recently, B. Braun (the plaintiff) successfully obtained an interlocutory injunction to prevent Med8 Sdn Bhd, Syed Nasir Bin Syed Agil, Pariaman Jati Sdn Bhd, Mohammad Hairun B. Ahmad @ Mohamed T/A HSQA Tech and GMMI Sdn Bhd (the defendants) from selling safety catheter products that the plaintiff claimed had infringed Malaysian Patent No. MY-143155-A, which is owned by B. Braun.
A review of the Malaysian Patent indicates that it claims a passive and fully automatic safety IV catheter, which is comparatively safer and more efficient than the existing safety devices. It also claims that the patented catheter prevents accidental needle stick injuries.
The plaintiff had requested for the IP Court to grant an interlocutory injunction as the infringing products incorporate the features as claimed in their Malaysian patent, may cause or increase safety risks including needle pricks and would result in consumers thinking it is the plaintiff’s safety IV catheters due to similarities in appearance.
To rebut the plaintiff’s contention, the defendants contended that their safety IV catheters have their own safety device that includes their own needle guard and locking means, which according to the defendants meant their products did not infringe the plaintiff’s patent. They also argued that their products are safe enough and have not caused any safety risks as claimed by the plaintiff. The defendants argued that their products would not confuse consumers as they bore different trademarks that enabled consumers to distinguish them clearly. The infringing products are being sold under the trademark “Med8” and bearing names such as Easy-Port Safety and Easy-Pen Safety.
The defendants also tried to attack the validity of the patent by alleging that the claims of the granted patent included matter beyond that disclosed in the parent application and therefore the patent was invalid. They argued that since MY-143155-A is a divisional patent of parent Malaysian Patent No. MY-141712-A, the claims of MY-143155-A would need to be based on the MY-141712-A description and drawings. The defendants claimed that the claims in MY-143155-A included matters not disclosed in the description and drawings of MY-141712-A and the claims of MY-143155-A were so broad that their scope included prior art patents for safety IV catheters.
Nonetheless, an analysis was conducted from the legal and technical perspective and it was found that the infringing products had indeed infringed all the claims in the Malaysian patent.
The IP Court agreed with the plaintiff’s claim that the infringing products have features as claimed in MY-143155-A and therefore allowed an interlocutory injunction for the application. The Court dismissed the defendants’ claim of the infringing product being distinguishable from the plaintiff’s product because the appearances of both the catheters are similar. The Court also held that since both the infringing products and the plaintiff’s products were packaged similarly, any differences present may not be noticeable to consumers. The trademark used on the infringing product was deemed insufficient to differentiate both products as they are also small and unnoticeable. Since the plaintiffs are market leaders of safety IV products, consumers would normally associate safety IV products to B. Braun. Plus, with the infringing product having safety risks, this may cause a loss of confidence and trust in the effectiveness of safety IV products in the market. As stated earlier, the plaintiff is the major supplier of safety IV products in Malaysia, so any negative incidences would consequently damage the hard-earned reputation of the plaintiff.
The Court has also decided that the injunction will not cause severe damage or loss to the defendants’ reputation and goodwill as they are relatively new to this industry, the manufacturing of their catheters were done outside of Malaysia and there are no evidence of related activities commenced in Malaysia. Thus, the Court has ruled in favor of B. Braun by maintaining the injunction order and ordering the defendants to pay B. Braun.
The Court did not consider the issue of whether MY-143155-A is valid or not as this would be attended to by the Court, should the defendants decide to file a patent revocation suit against the patent. For the purposes of this trial, the Court had assumed that the patent was valid.
This case clearly indicates the importance of obtaining a freedom to operate (FTO) opinion from an IP practitioner prior to entering the market. Successful businesses around the world consistently engage their IP practitioners to advise them on whether products that they are about to launch in a particular market infringe any patents in the country and if so, what actions that can be taken to ensure that the risk is eliminated or minimized. With a properly issued FTO opinion, risk of potential patent infringement such as the present case may be eliminated or reduced.
Please contact us at ipr@www.kass.com.my should you need any further consultation of FTO opinions.