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MNCs told to supply `patented' anti-cancer drug

Our Legal Correspondent

Chennai , Jan. 20

WHILE multinational anti-cancer drug manufacturers had prevented Indian drug firms from distributing the life-saving medicine on the ground that they held the patent rights and had also been granted the exclusive marketing rights (EMR) for these drugs under the Patents Act, the Madras High Court has come to the rescue of these unfortunate sufferers.

As an interim arrangement to ensure that these patients were able to obtain supply of the costly drugs, the court has ordered the foreign drug producers to arrange free supply of `Beta-crystalline' form of `Imatinib Mesylate' to all patients suffering from chronic myeloid leukaemia, and who were earning less than Rs 3,36,000 per month.

The order delivered by a Division Bench comprising Mr Justice P.D. Dinakaran and Mr Justice S.R. Singaravelu was a sequel to appeals filed by the Indian drug companies against the foreign patent-holders in respect of the life-saving medicine praying for vacating the exparte order of injunction dated January 20, 2004 by a single judge in favour of the latter, which was later made absolute.

In their suit, the respondents/plaintiffs (Novartis A.G. Schwarzwaldalee 215, Switzerland, their Indian associate, Novartis India Ltd, Mumbai & others) pleaded for a direction against the appellants herein (defendants in the suit), i.e., the Indian drug companies, for a permanent injunction restraining the Indian drug companies from selling the anti-cancer drug under the mark/name `Imatib', `IMALEK', `Imanis', `Zoleta' and `Temsan' so long as the EMR granted by the Controller of Patents on November 10, 2003 was subsisting.

The respondents/plaintiffs, in all the suits, contended, inter alia, that the EMR conferred an exclusive right to sell the life-saving drug for a period of 5 years, or till an order was passed in the patent claim in India, whichever was earlier.

They also contended that the element of `public interest' had also been taken care of for supply of free Glivec medicine by the programme called `Gipap', and, therefore, if injunction were not granted, they (respondents/plaintiffs) would suffer irreparable loss.

Resisting the suits, the appellants/defendants submitted that the first plaintiff (Novartis A.G) had obtained patent in the US and Canada in respect of `Pyramidine derivatives and processes for preparation thereof'.

No patent for `Imatinib Mesylate' was ever filed in India, and, therefore, there was no question of the plaintiffs being entitled to any protection on the basis of any patent that might still subsist abroad for `Imatinib' per se or for `Mesylate salt of Imatinib'.

The EMR granted was vague and indefinite, the appellants submitted. The cost of one capsule marketed by the plaintiffs was Rs 1,700, whereas, the cost of the drug in question sold by the Indian manufacturer averaged less than Rs 100 per capsule.

Appropriate test had never been carried out abroad in relation to `Beta-crystalline' form of `Imatinib Mesylate', and, therefore, granting marketing approval without conducting tests was not valid.

The single judge by an order dated April 28, 2004 made absolute the order of ex parte injunction granted on January 20, 2004.

Pointing out that according to the single judge, the balance of convenience lay in favour of the respondents/plaintiffs, stressing more on the EMR granted in their favour, under Section 24B of the Patents Act, 1970, the Division Bench said it was difficult to interfere with the single judge's order.

The Bench said that in response to the concern expressed by this court in the public interest, the respondents/plaintiffs, had come forward to relax the conditions imposed in the Gipap programme in public interest.

The counsel for the respondents/plaintiffs gave an undertaking to the following effect, pending disposal of the suit: Supply of Beta-crystalline form of Imatinib Mesylate will be made freely to all the patients, who are suffering from chronic myeloid leukaemia and were earning less than Rs 3,36,000 per month; in the case of patients who were entitled for insurance for treatment of the disease, any amount which fell short of insurance policy shall be met by the respondents/plaintiffs.

Similar concession would be extended to those who were covered under reimbursement scheme; the drug shall be supplied to the hospitals as per their requirement.

An affidavit of undertaking to the above effect would be filed by the respondents/plaintiffs.

Recording the undertaking of the counsel for the respondents/plaintiffs, the Bench confirmed the order of interim injunction dated April 28, 2004 of the single judge.

The parties were at liberty to agitate their respective contentions before the single judge. If any difficulty arose in implementing the above arrangement, the parties were at liberty to move this court by appropriate applications.

All the original side appeals were disposed of accordingly. Consequently, the connected petitions were closed.

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