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2011 MarsdenLR 2217

HIGH COURT MALAYA KUALA LUMPUR
B BRAUN MELSUNGEN AG & ANOR – Appellant
Versus
TERUMO KABUSHIKI KAISHA & ANOR – Respondent
[Suit No: D5(Ip)-22-2374-2008]



The court ruled that the defendants' product does not infringe the plaintiffs' patent, due to the absence of essential claim features; the plaintiffs' patent remains valid.

Headnote:(A) Patents Act 1983 - Sections 15 and 26B - Infringement of patent - Plaintiffs claim that defendants' product infringes their patent rights, while defendants argue non-infringement based on absence of patent features - Court finds Terumo Product lacks essential features of Claim 1 of the Braun Patent and dismisses infringement claim - The Braun Patent is declared valid. (Paras 204, 205, 206, 214, 216, 217)

(B) Validity of Patent - Court rules that the Braun Patent is entitled to its divisional status as it relates to the initial application - Defendants' arguments against novelty and inventive step are rejected, reinforcing the patent’s validity. (Paras 281, 295, 310, 311)

(C) Counterclaim - Defendants counterclaim for declaration of non-infringement and patent invalidation is allowed, rejecting plaintiffs' claims on the basis that the Terumo Product does not meet necessary patent features. (Paras 338, 343, 346)

(D) The court outlined the essential features of Claim 1 of the Braun Patent and determined that the Terumo Product does not possess these critical characteristics, leading to the dismissal of the plaintiffs' infringement action. (Paras 399, 415, 420) (E) Conclusion - It concludes that the Braun Patent remains valid while dismissing the plaintiffs' infringement claims and allowing the defendants' counterclaims. (Paras 421, 422, 423)

Table of Content
1. introduction to patent infringement case. (Para 1 , 2 , 3 , 4 , 5)

JUDGMENT

Introduction

In this action, the plaintiffs are suing the defendants for infringement of Malaysian Patent No. MY-136823-A entitled "Spring Clip as Needle Tip Protection for a Safety Catheter" (the Braun Patent).

The plaintiffs' safety intravenous catheter products, "Introcan Safety", "Vasofix Safety" and "Vasoscan Safety" are claimed to practice the Braun Patent.

The allegedly infringing product is the 1st defendant's safety intravenous catheter known as "Terumo Surshield Surflo 11" (the Terumo Product).

The defendants have raised a defence of non-infringement. In addition, the defendants counterclaim to invalidate for the reason that the invention of the Braun Patent is not a patentable invention under the Patents Act 1983 (the Act) .

The safety intravenous catheter product

To make the point under discussion easier to comprehend, it is useful to have an understanding of the product in question. The product that is the subject matter of this action is a safety intravenous catheter (IVC). An IVC is a product or device that is primarily used by health care workers to administer fluids directly into a patient's vascular system. The IVC comprises, among other components, a needle with a tip and a shaft.

The insertion procedure comprises 4 basic steps, namely:

a. The needle tip extending from the catheter tube penetrates the patient's vein;

b. The catheter is inserted into the vein over the needle tip by the health care worker pushing the catheter hub;

c. The health care worker then withdraws the needle leaving the catheter in the vein;

d. The health care worker then fastens the inserted catheter hub to the patient's skin, and connects the open end of the catheter hub to the source of the fluid to be administered into the patient's vein.

After the insertion procedure has been completed and the needle withdrawn from the catheter, an exposed needle tip can lead to an accidental or inadvertent needle stick injury, thereby exposing health care workers to a transmission of a multitude of dangerous blood borne pathogens.

The 1st plaintiff's safety IVC and the Terumo Product are products devised to, among other objectives, automatically cover a needle tip when the needle is withdrawn from the catheter hub, to thereby prevent health care workers from accidentally sticking themselves with the needle tip.

The parties

The 1st plaintiff is B. Braun Melsungen AG, a company incorporated under the laws of the Federal Republic of Germany. The 1st plaintiff has its principal offices at Carl-Braun-Strasse 1, 34212 Melsungen, Federal Republic of Germany.

The 1st plaintiff carries on business as, inter alia , manufacturer, distributor, supplier and exporter for the global healthcare market by supplying products for anesthesia, intensive medicine, cardiology, extra corporeal blood treatment and surgery, as well as services for hospitals, general practitioners and the homecare sector.

The 2nd plaintiff is B. Braun Medical Supplies Sdn Bhd, a company incorporated in Malaysia.

The 1st defendant is Terumo Kabushiki Kaisha, a company incorporated in Japan, having its principal offices at 44-1, 2-chome, Hatagaya Shibuya-ku, Tokyo, Japan. The 1st Defendant manufactures and produces for sale a range of medical products including disposable medical products, that is, single-use products to eliminate the risk of infection due to re-use of medical supplies and to provide safety for both patients and medical staff.

The 2nd defendant is Summit Company (M) Sdn Bhd, a company incorporated in Malaysia. The 2nd defendant carries on business as a trading company which mainly supplies products for clinics, hospitals and general pharmaceutical use.

The trial

The trial of this action was heard in this Court on 1.11.2010 to 4.11.2010 and 8.3.2011 to 10.3.2011.

The Plaintiffs' evidence was led through 3 witnesses, namely Kevin Woehr (PW1); Mr Noel J.Akers (PW2) and Mr Lam Chee Hong (PW3).

The defendants ca

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