India: EMR – Is it Turning out to be a Myth?

Last Updated: 13 February 2006
Article by Manisha Singh

Preface

The period of trial is a period of uncertainty as the existence of a legal right and its alleged violation both are contested. These issues remain uncertain till they are resolved in a trial. During the pendency of a trial interlocutory injunction is granted to mitigate the risk of injustice or to protect the plaintiff against any injury afflicted by violation of his right if the issues were to be resolved in the favour of the plaintiff. The injury is the loss occurred to the plaintiff which cannot be compensated by damages recoverable in the action.

Factual Background

Wockhardt limited, a pharmaceutical company appellant in the instant case is the holder of Process Patent, EMR and Drug Licence for the manufacture of a pharmaceutical preparation, Nadifloxacin 1% Cream under the trademark NADOXIN.

Dates & Events

Date: 08.05.2000 -The appellant applied for Process Patent for benzoquinoliziness on the ground that it had invented the admixture composition.

Date: 28.03.2002 - The appellant made an application for Product Patent, which was treated as a mail box application.

Date: 27.04.2002 - The appellant obtained manufacturing licence for the pharmaceutical preparation Nadifloxacin 1% Cream from the Drugs Controller general of India The appellant started manufacturing and commercially marketing the said product from 2002 onwards.

Date: 06.06.2003 - After through examination by the Controller of Patents, Process Patent was granted to the appellant with effect from the date of application.

Date: 17.07.2003 - The appellant applied to the office of the Controller of Patents and Designs for grant of Exclusive Marketing Right (EMR) in respect of the product of the invention under Section 24-A of the Patents Act, 1970. After necessary scrutiny and examination an EMR was granted for a maximum period of five years.

Date: 15.12.2003 to 16.07.2008 - The five year period of Exclusive Marketing Right. This EMR certificate confers an exclusive right on the appellant to sell and distribute in India the pharmaceutical composition, containing benzoquinoliziness, Nadifloxacin 1% Cream under the provisions of the Patents Act, 1970.

Hetero Drugs Ltd., the Respondent started manufacturing and selling the same product thus infringing the Patent and EMR granted to the appellant.

Date: 14.09.2004 – The Drugs Controller general granted the manufacturing licence to the respondent to manufacture Nadifloxacin 1% Cream by adopting US Patent 1981 and Japan Patent 1983 under the trademark NADIDERM.

Since the licence was granted to the respondent without hearing the appellant, a writ petition was filed in Delhi High Court. No interim orders were passed.

In retaliation the respondent filed a writ petition in Bombay High Court challenging the EMR granted to the appellant. No interim orders were passed.

Under these circumstances, the appellant filed a suit before the learned single judge of the Madras High Court, for permanent injunction restraining the respondent from infringing the Patent and EMR and also restraining them from manufacturing the admixture composition, invented by the appellant. On the pleas and arguments the single learned judge dismissed the application of the appellant holding that the manufacturing and marketing licence granted by the Drugs Controller general for NADIDERM was not on the basis of the admixture composition of the appellant but was only by adopting US Patent and Japan Patent.

The suit went before the Division Bench in appeal where after elaborate and protracted arguments two points for determination were considered.

[1] Whether the order of the learned single judge would suffer from any infirmity, and

[2] Whether the appellant is entitled to the grant of interim injunction pending the suit

Decision

It was held that the respondent itself has submitted in the writ petition presented before the Bombay High Court that it is manufacturing the same product which is being manufactured by the appellant in pursuance of their EMR therefore it is not in dispute that that the appellant is the holder of the Process Patent and EMR, for manufacture of Nadifloxacin 1% Cream under the trademark NADOXIN and the manufacture of identical Nadifloxacin 1% Cream under the trademark NADIDERM by the respondent is clear violation of the Process Patent and EMR of the appellant thus the Court has to necessarily prevent the other party by affording appropriate relief by granting injunction. The other factual detail ignored and overlooked by the learned single judge is the affidavit of the expert filed by the appellant that reveals that the appellant’s process is different from the US Patent, which can only manufacture ointments other than cream products.

Thus prima facie the US Patent & Japan Patent can only manufacture ointment and not cream and the respondent is manufacturing a cream which it cannot be allowed to manufacture as long as the EMR granted in favour of the appellant is valid and subsisting. Where there are prima facie materials the balance of convenience lies in favour of the appellant. Therefore the learned single judge’s order is set aside. The appellant is entitled to injunction filed in the suit so that he may not suffer from irreparable injury, as loss suffered in sale of the Cream during the five-year period of EMR would not be compensated by damages.

Comments

The interlocutory remedy prayed for and granted is intended to preserve in status quo, the rights of parties which may appear on a prima facie case to prevent injustice, if any.

The grant of an interlocutory injunction is the discretion of the court. Following tests are to be applied. (a) Whether the plaintiff has a prima facie case. (b) Whether the balance of convenience is in favour of the plaintiff; and (c) Whether the plaintiff would suffer an irreparable injury, if his prayer for interlocutory injunction were disallowed.

© Lex Orbis 2006

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