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.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

 
In association with
Related Topics
 
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions