India: Delhi HC Denies Injunction For Patent Infringement Of Braun’s Catheter

Last Updated: 22 July 2009

The High Court of Delhi seems to have become one amongst the few Courts in India where Patent litigation is being pro-actively pursued. Off late, dealing with Safety IV Catheters, a Plea for an ad interim injunction was filed by Germany based B.Braun Melsungen AG along with its Indian counterpart vide B. Braun Melsungen AG & Ors. vs. Rishi Baid & Ors. IA 1234/2008 in CS (OS) 186/2008 (u/O 39 R 1 & 2 CPC) to restrain a local player Poly Medicure from infringing their patent.

B. Braun Melsung AG (hereinafter Braun) engaged in the global healthcare market, along with its co-parties moved to seek an ad interim injunction to restrain Rishi Baid and others from infringing their rights as under S. 48 of the Patents Act, 1970 with respect to safety I.V. catheters/cannulae or any other device or apparatus that infringes their Patent No. 210062. Braun sought relief in respect to the trademark VASOFIX Safety and others which use confidential information, know-how, trade secrets, data, technical input, drawings, materials and/or any other resource derived by Rishi Baid and others from Braun.

Braun claimed to be suppliers in the global healthcare market with products for anesthesia, intensive medicine, cardiology, surgery as well as services for hospitals, general practitioners and the home care sector. They also stated to be working towards optimizing working procedures in hospitals and medical practices all over the world, and focused on improving safety for patients, doctors and nursing staff. Their wholly owned subsidiary B. Braun Medical Industries Sdn. Bhd. Said to be owners of B. Braun Medical (India) Pvt. Ltd (hereinafter Braun India) which was also a party to the suit.

Braun describing an I.V. catheter to be a device to administer intravenous fluids directly to a patient' vascular system, the working of the same was also described to involve the following steps:

  1. The healthcare worker inserts the needle and catheter together into the patient's vein;
  2. After insertion into the vein with the needle point, the catheter is forwarded into the vein of the patient by the healthcare worker pushing the catheter with his or her finger;
  3. The healthcare worker withdraws the needle by grasping the hub end (opposite the pointed end) while at the same time applying pressure to the patient's skin at the insertion site with his or her free hand; and
  4. The healthcare worker then tapes the now inserted catheter to the patient's skin and connects the exposed end of the catheter (the catheter hub) to the source of the fluid to be administered into the patient's vein.

Braun identifying that the danger of the exposed needle tip resulting in an accidental needle stick which may put the healthcare workers in a position vulnerable to the transmission of various dangerous blood borne pathogens, including AIDS and hepatitis, stated that their invention of safety I.V. catheters solves the problem and results in the prevention of accidental needle sticks. They claimed that the safety I.V. catheters had been developed by several entities to achieve this result with a protective needle guard for use with a hypodermic needle.

They stated that the prior art safety I.V. catheters exhibited one or more drawbacks and possessed limited usefulness, yet had been fully accepted by healthcare workers. Braun's product was said to be a safety I.V. catheter in which the needle tip is automatically covered after needle withdrawal to prevent the healthcare worker from making accidental contact with the needle tip. Braun claiming to enjoy patent protection for the said invention in several countries apart from India as well.

The Court laying stress laid on independent claim 28 of Braun's patent describing its inclusions. Braun claimed that they manufactured the product in Malaysia and was marketing the same in India through Braun India under the brand VASOFIX Safety since June, 2004 in India. They claimed to be selling the product in over 45 countries throughout the world.

Braun alleged Poly Medicure Limited to be manufacturing a basic I.V. catheter bearing the brand name "ACCUCATH" for and on behalf of Braun under an exclusive agreement, whereby Poly Medicure Limited was authorized to manufacture I.V. catheters as a contract manufacturer, according to the applicable specifications and regulatory conditions prescribed by Braun India. The agreement had an initial validity period of two years which was to continue for a further period of one year unless terminated earlier. Braun claimed to have been selling two types of I. V. catheters in India

Braun alleged that Poly Medicure Limited having all relevant technical knowledge for manufacture of "ACCUCATH" stated that they had approached Braun with problems faced while manufacturing the same and that Braun solved these problems by going in depth and providing effective solutions. Braun having reposed complete trust in Poly Medicure had supplied them with sensitive data, processes, trade secrets and confidential information. Braun clarified that at no point where they authorized or appointed to be contract manufacturers for the VASOFIX Safety I.V. Catheter, but had entered into a confidentiality /secrecy agreement.

Braun stated that at an international trade show at Germany in November 2006, an official from Poly Medicure showed a product stated to be a prototype of a safety I.V. catheter and that he was not given an opportunity to examine the prototype but was concerned that the same may violate Braun's intellectual property. He requested for a sample of the prototype but the same was not supplied. In the show organized November, 2007, upon visiting the booth, Braun's official was given samples of the safety I.V. cannula. The sample was allegedly dissected by Braun, analyzed and photographed from various angles and, in their opinion, infringed their Indian Patent. According to Braun, Poly Medicure's sample was labeled Safety I.V. Cannula and branded as 'Poly Safety' obtained in November, 2007 contained all the elements of claim 28 of Patent No. 210062. Braun alleged that in view of their pre-existing relationship, Poly Medicure had gained knowledge and now had come out with their own safety I.V. catheter which carries all the elements as set out in claim 28 of the plaintiffs' Patent No. 210062.

The counsel for Braun averred that what was essential in the case was the patent and not its manifestation. He submitted that it was necessary to compare the product of Poly Medicure and Braun's patent to address the infringement and the incorporation of the specific Claim 28. He stated that if the answer is in the affirmative, then a clear case of infringement would be constituted entitling Braun to the injunction. He also submitted that minor additions were immaterial and the essential features, which collectively amount to an invention, must only be taken into consideration.

To substantiate his case, the decision of the Single Judge in Bajaj Auto Limited v. TVS Motor Company Limited: 2008 (36) PTC 417 was also brought to the fore. Herein, the learned Single Judge concluded that while ascertaining as to whether a plaintiff has a prima facie case or not, even though no presumption of the validity of the patent can be drawn, after the 2005 amendment to the Patents Act, a patent obtained by a party was certainly to be given greater significance. The decision was pointed out to show that there is a difference in the rights of patentees after the amendment to the Patents Act, 1970 which came into effect on 20.05.2003. Alongside, the decision of Corruplast Ltd. v. George Harrison (Agencies) Ltd. 1978 RPC 761 was also quoted, wherein it was observed that in every case of this kind, the function of the Court must be to consider which course, either the granting or withholding of an injunction, is the one which is likely to make it easy for the trial court, when the issues in the action have been decided, to adjust the rights of the parties and do justice between them. Further, the decision of the Delhi High Court in J. Mitra & Co. Pvt. Ltd. V. Kesar Medicaments: IA No. 11883/2006 in CS (OS) 2020/2006 was also referred to elucidate the concept of mosaicing, apart from several leading decisions.

The Counsel appearing on behalf of Poly Medicure submitted that the registration of the patent by itself was not sufficient for the grant of an interlocutory injunction. It was also submitted that the registration itself was questionable and that no case was made out for an unfair business practice. The agreement between Braun India and Poly Medicure was referred to point out that as per the clause 10.1, the parties agreed that they shall not compete with each other in respect of the products except those already being manufactured and marketed by Poly Medicure Limited. They contended that the plain omitted this fact. Other pieces of evidence were also supplied to the Court in support of their contentions.

The Counsel for Poly Medicure contending that under dubious circumstances under the patent was obtained by Braun, brought to the fore, a letter from the Chennai Patent Office which stated that the application was found in order for grant, subject to the filling of a pre-grant opposition under S. 25(1) of the Patents Act, 1970. It was also noted that subsequent to the grant of the patent, an application for the amendment of claims was submitted. He pointed out that this indicated this reflected that there was something more than that met the eye. Further, he pointed out that at the time of application for the patent the same was made in respect of "spring clip safety I.V. catheter". However, in the complete specifications the title was given is "an I.V. catheter" and that the patent had been granted in the same respect. In this pursuance, Poly Medicure averred that:

  1. Braun had suppressed material facts;
  2. The grant of the patent in favour of Braun was colored by fraud;
  3. Injunction could not be granted in favour of Braun particularly when the patent is new and is seriously objected to;
  4. Poly Medicure had already commenced production and sale of their safety I.V. cannula and the same is to the knowledge of Braun and, therefore, no injunction be granted in favour of the plaintiff; and
  5. Mere grant of a patent is not sufficient and, apart from the establishment of prima facie case, the considerations of balance of convenience and irreparable loss have also to be looked into before a Court can grant an injunction in favour of the Braun.

Poly Medicure elaborating upon the plea of suppression submitted that the plaint had been very cleverly drafted and several aspects related to the patent had been misrepresented. Elucidating on these, the plaint was said to lay entire focus and stress of the plaint premised on the ground that the defendants were yet to launch and that there was an imminent threat of sales being commenced whereas, in fact, the defendants had already commenced manufacture and sale of its safety I.V. cannula much prior to the filing of the suit and that too to the knowledge of Braun. It was also averred that the amendments to the claims were not published, while the patent was granted in respect of the amended claims, pertinently Claim 28. He submitted that the post-grant proceedings of making an entirely new claim of a patent in the garb of amendment, was contrary to law, vitiated by fraud, collusion and irregularities and invited a strong prima facie case for revocation under Section 64 (o) of the Patents Act, 1970. He also submitted that issues like the existence of prior art and existing knowledge / anticipation, conditions precedent for grant of patent, had not been adverted to and consequently, the grant of patent was void ab initio.

Revisiting the invention's application, the counsel for Poly Medicure also contended that U.S. Patent No. 5,135,504 indicated all the features of a safety I.V. catheter, which were published, commonly known and applied world over by several manufacturers, apart from the list of prior art which referred to several U.S. and European Patents cited. He also differentiated the catheter manufactured by Poly Medicure from that of Braun's in declining a case for ad interim injunction being present.

In reply to these averments, the counsel for Braun denied the suppression of facts. Stating the ongoing litigation to be a suit for infringement of a patent, Section 48 of the Patents Act, 1970 was brought to the fore and the amendment brought to it, in 2003 was said to accord an exclusive right to the patentee to prevent a third party from infringing the said patent. With regard to the amendments in the claim application, it was submitted that the amendment was made only to the claims and not to the specifications, abstract or title. Claims 1-28 has been narrowed down from 1-54, the additional claim and all the amended claims were linked to the earlier claims. Therefore, further publication of the same was not vouched as necessary. As regards the amendment being filed after the grant of the patent, a typographical error was said to have occurred. He furnished the relevant dates and stated that the grant of patent took place on 03.12.2007 and the same was published on 14.12.2007.Further, in view of Section 53 it was said that the term of the patent was from the date of filing and in this position, no object or reason or purpose behind concealing the date of grant existed because the term of the patent dated back from the filling date and not grant date. It was also submitted that a pre-grant amendment did not require publication.

The Court in addressing the contentions raised by both sides took note of several long standing precedents. The Court also noted the fact that the grounds elucidated for revocation under S.64 could also be raised as a defence to infringement under S. 107(1) of the Patents Act, 1970. The Court stated that Poly Medicure's case also needed to be examined without which a decision as to the injunction could not be arrived at. The Court stated that Poly Medicure had already preferred revocation as a counter-claim to the suit for infringement. Further, the question of validity of Braun's Patent No. 210062 was said not free from doubt at this prima facie stage, especially in view of existence of prior art. The Court also noted that a difference between the products of the two parties did exist. Furthermore, the Court also examined that suppression of material facts in the plaint as also the alleged dubious manner in which the patent was granted in favour of Braun could not be ignored.

The Court held that Braun in their contentions had not been able to establish a prima facie case nor the balance of convenience in favour of grant of an ad interim injunction in their favour. However, as adjudicated in the Bilcare Limited case, Poly Medicure was directed to keep accounts of the manufacture and sales of the safety I.V. cannula in question during the pendency of the suit and to make the same available to the Court as and when directed by it.

© Lex Orbis 2009

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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