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Catheter Wars

Issued: February 01 2012

Two decisions were recently issued by the Kuala Lumpur IP High Court concerning the Malaysian patents of B. Braun Melsungen, a leader in the global healthcare market. Today, we will take a closer look at the first of those decisions, namely, that rendered on an infringement suit against Terumo Kabushiki Kaisha.

The infringement dispute centered on B. Braun’s safety intravenous (IV) catheter that comprises a catheter hub, a catheter, a needle and a needle guard retained in a ready position within the hub. The needle guard has two resilient arms urged away from each other by the needle in the ready position.

B. Braun alleged that the defendant’s product, Terumo Surshield Surflo II, infringed its Malaysian patent MY-136823-A. In reply, Terumo asserted non-infringement and called into question the validity of B. Braun’s patent.

B. Braun’s Malaysian patent MY-136823-A is a divisional of Malaysian patent MY-126024-A and was accorded the filing date of the parent patent. Terumo alleged that the B. Braun patent should not have been accorded divisional status and hence, cannot benefit from the filing date (February 11, 2000) of the parent patent as its content extended beyond the original disclosure of the parent patent. Their allegation was based on the premise that the specification of the parent patent did not support recitation of one particular feature of the needle guard in Claim 1. If the claimed 2000 parent filing date of the B. Braun patent was invalid, then the 2004 divisional filing date would be the time bar by which novelty is judged, hence, rendering B. Braun’s own 1999 PCT publication as novelty defeating.

Justice Dato’ Azahar Mohamed found that there was sufficient basis in the original specification of the parent patent to support recitation of the needle guard feature in Claim 1 and upheld the claim to the earlier filing date and divisional status of the B. Braun patent. In the process, he affirmed the provisions of Section 26B of the Patents Act with regards to the filing of divisional applications and stated that “divisional claims may be directed to subject matter disclosed in any part of the parent specification as long as it does not extend beyond the scope of original disclosure.” This decision, although a sidebar in the infringement dispute, sets an important legal precedent for interpretation of Section 26B.

For some years, there has been a tendency for objections to be raised against divisional applications that do not relate to non-unity issues i.e. an interpretation that Section 26B provides for the filing of divisional applications only if the parent application comprises more than one invention. In fact, Section 26B only states that the content of the divisional must not go beyond the disclosure of the parent application. There is no mention of “lack of unity of invention” being a prerequisite for the filing of divisional applications anywhere in the Act. Ultimately, B. Braun’s patent was declared to be valid and subsisting, setting the stage for the infringement arguments to follow.

Upon conclusion of technical submissions, the Judge came to the opinion that three essential features of Claim 1 were missing from the Terumo catheter, namely, the resilient arms of the needle guard, the rear wall of the needle guard from which the arms extend and an increased diameter segment in the needle shaft.

When interpreting the features of Claim 1, the Judge held fast to the principle of purposive construction and that a claim must be construed in the context of the specification as a whole, further cementing the position of these rules for patent claim interpretation in local case law.

As has been the trend in recent local patent disputes, the testimony of expert witnesses played an important role in the decision on infringement.

In particular, with regards to the “resilient arms” feature, the Judge found evidence given by the fourth defense witness (DW4), a professor of mechanical engineering, to be “meticulous and plausible” and accepted his contention that arm T3 of the Terumo catheter was a rigid component and not at all resilient. The Judge observed that DW4’s testimony was “compelling and there is certainty in his demeanor” even under strenuous cross-examination. On the other hand, he was “quite unable to accept” and was not at all persuaded by the plaintiff’s attempts to contradict evidence provided by DW4 via their own expert witnesses.

As the dust settles on this chapter of the catheter wars, the validity of B. Braun’s patent was upheld, and the Terumo catheter was found to be noninfringing. It remains to be seen whether this decision will be appealed and if so, whether it will be upheld or overturned by the Court of Appeal.

Malaysia’s local case law is growing steadily as more local patent cases are being litigated. This development and the upcoming deluge of IP law reforms expected in the year 2012 is an encouraging indicator of the increasing maturity of Malaysia’s IP industry.

Henry Goh & Co
House of Henry Goh,
217 Jalan Imbi,
55100 Kuala Lumpur, Malaysia
T: +60 3 2118 8688
F: +60 3 2118 8777

About the Author

Oon Yen Yen is a registered patent, industrial design and trademark agent who specializes in the fields of biotechnology and chemistry at Henry Goh in Kuala Lumpur. Her main responsibilities as a patent agent include assisting clients in identifying patentable inventions, drafting of patent specifications, preparation, filing and prosecution of Malaysian and overseas patent and industrial design applications. She also advises on results of novelty searches, infringement and patentability opinions. Oon was appointed business development manager at the firm in 2008.


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