India: Injunction Denied To Braun: Principle Same, Process In Device Different

Last Updated: 12 October 2009

The rise in awareness regarding transmittable life threatening diseases in the 1990s had lead to steps being taken to protect health care workers. One such mode was to bring about modifications and variations in medical devices. IV Catheters constituting commonly used medical devices may also pose as a potential carrier of diseases to hospital officials. In this respect, the modification and changes made to these devices has also lead to yet another patent dispute in its respect vide B. Braun Melsungen AG v. Mohinder Paul & Anr. 2009 (40) PTC 593 (Del.) The Court pronounced herein that while the principle(s) behind the working of the devices may be same and not patentable, in view of the process for one of the functions/steps being different, a case for infringement was not made out.

Braun filed a suit for permanent injunction against Mohinder Paul and his co-party in respect of them having brought out a product in the market known as MEDIFLON SAFETY, which is alleged to infringe Braun' Patent No.210062. The patent application, which was in respect of IV Catheters had been filed by Braun on 18th August 1998 and granted on 17th September 2007, the primary claim of which was said to be Claim no. 21. Braun's invention was said to address a problem that persisted in existing catheters – i.e. susceptibility of healthcare workers to dangerous blood-borne pathogens transmitting diseases including AIDS and Hepatitis. The product was marketed as "Vesofix Safety" and provided a protective guard on the tip of the injection needle which while drawing out from its catheter engages with the needle tip by detaching and shielded it during removal, thus ensuring that the handler is never exposed to the needle tip.

Paul in his written statement stated that the claim made by Braun regarding the invention was falsely claimed since the same was a well-known product in the market and various companies had introduced safety IV catheters to protect health workers from accidental needle pricks. To support this contention, they cited US Patent No.5599310 granted to M/s Johnson & Johnson Medical Inc in January 1997. The language of the specification was said to be plagiarized. Further they contended that the grant of the patent to Braun was wrong and invalid, alongside Braun being guilty of material concealment; thus, the suit filed becoming liable to rejection.

Distinguishing the working of the two products in contention, Paul submitted that the working of the two were entirely different, thus resulting in no infringement or overlap. They also submitted that in the light of Sections 64(1) (e) and (f) of the Patents Act, 1970 the patent was hollow and liable to be cancelled. Braun on the other hand submitted that the registration of a patent created a monopoly in their favour and that the Court could not presume invalidity of the patent at the time of disposing of an application under Order 39 Rules 1 & 2 of Civil Procedure Code. They said that they only to establish that there was a violation of their patent. They stated that the exclusive use or right to sell the products based on the patented inventions stimulates new inventions and hence encourages the companies to invest in developing new products and new technology. In this light, they asserted that the Courts should, necessarily protect the registered patent. To rebut the contention that Safety IV Catheters were already well known, they contended that a new patent may be granted for an inventive step in an existing process or product. They stated that claim 21 of the application had fully described the invention and its operative use and method by which it is to be performed. The best method of performing the invention as known to them needed to be disclosed and owing to a mere overlap or similarity between the claims made by them and an earlier patent registered in the US, the defence raised was baseless.

The Court examining the invention, took note of its features as well as the cited prior art. The Court although opined that the idea of the device was not new, however, looked at the presentation regarding the device. The Court identified that the novel feature lay in the manner in which the needle guard was devised and located. Braun contended that their product as demonstrated in the Court incorporated a double metal strip locking devise and that the single strip device used by Paul was nothing but a copy of their patented invention. The Court heeding a ear to this, examined the two devices to examine and distinguish their individual features vis-à-vis its working. The court also drew an analogy to the already existing product having procured Patent No.0554841 and stated that the idea of getting the needle within the housing was of neither parties, but already known. Further the Court also went on to examine other issued US patents, viz. US Patent No.5584810, 5423766 and 5135504 and pronounced that from these descriptions, it became apparent that no inventive step existed in widening the portion of the needle tip or increasing the diameter. The invention was in fact said to relate back to a prior art devoid of a real inventive step or invention having been made by Braun.

The Court opined that concerns of pharmaceutical manufacturers vis-à-vis protection of health care workers from being exposed to diseases rose particularly in the 1990s, leading to several devices and modes being devised by various companies. The Court opined that the products under contention were based on the same principle on which catheters operated and that the same was not subject to being patented. Braun's patent was said to have been procured for the process of securing the needle tip and that the same had not been copied by Paul, in as much as their process of securing the needle tip was different. In this view, a prima facie case of infringement was said to be absent and that the application made under Order 30 Rules 1&2 was liable to be dismissed.

© Lex Orbis 2009

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