' C.M.A. No, 8823 of 1989 is an application under section 31 of the Patents and Designs Act, 1911 read with Order XXXIX, Rules 1 and 2 and section 151, C.P.C. Which was filed by the plaintiffs, whereupon ad interim injunction was granted by this Court on 21-12-1989, and was continued from time to time. C.M.A. No, 3201 of 1990 is an application under Order XXXIX, Rule 4 read with section 151, C.P.C.
Made by the defendant for vacating the above ad interim injunction. By this order I propose to dispose of both these applications.
2. The plaintiffs are a pharmaceutical group of companies, engaged in the discovery, development, manufacture and marketing of safe and effective medicines. A drug or compound known as `ranitidine' was discovered and developed by Glaxo and is marketed in Pakistan by plaintiff No,3 in the form of its 'hydrochloride salt' under the brand name `Zantac', which has proved to be a highly effective medicine for treatment of peptic ulcer. Ranitidine/ranitidine hydrochloride is the subject of patents in the name of plaintiffs Nos.1 and 2 in a number of countries including Pakistan. Pakistan Patent No, 126632 relates to the processes for preparing ranitidine/ranitidine hydrochloride and pharmaceutical compositions containing the same. The plaintiffs' claim is that ranitidine hydrochloride or Zantac is the world's largest selling prescription medicine with annual sales of over 1,000 million pounds sterling. It is alleged that the defendants have flagrantly violated the plaintiffs' patents mentioned above and are openly selling a drug containing ranitidine as its hydrochloride salt, which has also serious implications for plaintiff No,3, the Pakistani subsidiary of Glaxo, which is selling medicine under their permission. Though the defendants; are not selling drug in the name Zantac, but they are selling it under the name `ranitidine' giving it out on the label as well as stating in the literature that the drug contains ranitidine hydrochloride and have thereby committed breach of the provisions of Patents and Designs Act, 1911. Alongwith the suit an application for interim injunction is made for restraining the infringement.
3. The defendants have contested the suit and the application. Their main plea is that the drug manufactured and sold by them differs from the drug under patent manufactured and sold by the plaintiffs. The defendants have obtained their registration of `Rantid tablets' with the Director- General, Ministry of Health, Government of Pakistan on 10-12-1984. Even at the time of the registration the plaintiffs had lodged an objection, but the same was overruled. Besides this it was contended that the plaintiffs would not suffer irreparable loss, nor was the balance of convenience in their favour.
4. I have heard Mr. Khalid Anwar, learned counsel for the plaintiffs and Mr. Sultan Ahmed, learned counsel for the defendants.
5. The drug in question bearing the generic name `ranitidine' was admittedly discovered and developed by the plaintiffs. It is in the form of its `hydrochloride salt i.e, `ranitidine hydrochloride', which is active ingredient of the medicine which is sold by the plaintiffs in Pakistan under the brand name Zantac'. The defendants are also selling the same medicine, but under the name Rantid. The leaflets which are attached with the medicine clearly state and admit that it contains `ranitidine hydrochloride'. The descriptions of the defendants' and plaintiffs' leaflets are given as below:-- "(Rantid Tablets) Each table contains: Ranitidine 150 mg. (as the hydrochloride)
'10 tablets.
' Zantac tablets ' Ranitidine ' Each tablet contains ' 150 mg. Ranitidine (as the hydrochloride)
' 10 tablets."
6. Dr. Woodhouse, Director of Pharmaceutical Analysis, Glaxo Group Research Ltd. Who is a Pharmaceutical Expert has filed affidavit stating that the chemical name given to ranitidine hydrochloride in defendants' leaflet is of that precise compund or drug which was invented by the plaintiffs. From the other side affidavit of Obaidullah Khan is filed, but he is not a Pharmaceutical Expert, and therefore, it would appear that the affidavit of Dr. Woodhouse is more reliable and believable. Reliance was also placed on the world famous publication known as 'Martindale', 29th Edition (1989). This is a standard work of reference which is published under the directions of the Council of the Royal Pharmaceutical Society of Great Britain. Page 1104 of this publication contains the chemical name of ranitidine as discovered manufactured and sold by the plaintiffs. This is reproduced hereinbelow alongwith the chemical name used by the defendant in its leaflets. It can be seen that both are absolutely identical:
(a) Chemical name used by defendant in its leaflets.
"N. N-Dimethy 1-5 (2- (1-m ethylamino-2- nitrovinylamino) ethy 1 thiomethy 1) furfury 1 amine."
(b) Chemical name of Plaintiff's drug given in Martindale.
"N. N-Dimethy 1-5 [2- (1-Methylamine-2-Nitrovinylamino) ethyl thiomethy-1] furfural 1 amine."
7. It is, therefore, clear that the defendants imitated the drug of the plaintiffs. The plaintiffs patent has thus been infringed. Mr. Khalid. Anwar also placed reliance on the case of Sandoz Ltd. v.
Pakistan Pharmaceutical products Ltd. Reported in 1987 CLC 1571, wherein a similar infringement of trade mark was alleged against the defendants and interim injunction was granted against them.
In that case the patented drug was `Ketotifen' which Sandoz Ltd. Were selling under the trade name `Zaditen'. The defendants Pakistan Pharmaceutical Products Ltd., who are also defendants in this suit started manufacturing and/or importing and marketing Capsules and Syrup containing K.H.F.
Under the trade name of `Katifen'. The Court came to the conclusion that the description on the defendants' packets creates an impression that the base of defendants' drug `Katifen' is similar to the drug `Ketotifen' (Hydrogen Fumerate) which is associated with the name of the plaintiff as their exclusive product and which has now earned a worldwide reputation as cure for asthma, and therefore, the infringement of the patent was obvious. Hence the Court came to the conclusion that the plaintiffs had made out a strong prima facie case. The defendants were restrained by interim injunction from importing, marketing or publicising any product under the name `Ketotifen' or reproducing the chemical or structural formula of that drug on any of their products in any form.
8. Mr. Sultan Ahmad Shaikh, who appeared for the defendants, contended that the defendants' drug was registered with the Director-General, Ministry of Health on 18-6-1985. The plaintiffs had lodged an objection for rejection of the defendants' application, but the same was overruled. The defendants were, therefore, manufacturing `Rantid tablets' under the valid and legal permission granted by Ministry of Health. The contention of the defendants' Advocate does not hold any water.
The registration of a drug with the Ministry of Health and permission to manufacture the same cannot take out the drug from the purview of the provisions of Patents and Designs Act (II of 1911) if the same amounts to an infringement of a patent registered thereunder. Similar view was taken in the case of Sandoz Ltd. (supra).
9. Mr. Sultan Ahmad Shaikh further contended that the defendants were manufacturing the drug for the last 5-6 years. The grant of temporary injunction was likely to cause destruction of defendants' trade and the balance of convenience was, therefore, in favour of refusing injunction.
He relied upon Hari Chand Anand v. The Singer Manufacturing Co. AIR 1933 Lah. 1046 and AEG Telefunken Pakistan Ltd. v. Electric Concern Corporation 1985 CLC 155. I have gone through both these rulings. Neither of these rulings applies to the facts of the present case. In the case of Hari Chand (supra) the defendant was allegedly infringing since long the plaintiffs trade-mark for certain articles of sewing machine, while in the case of AEG Telefunken Pakistan Ltd. (supra) the defendant was allegedly importing and marketing 'circuit braker' and infringing the plaintiffs trade mark. In both these cases the Court instead of granting interim injunction, granted a direction to the defendant to submit accounts of sales to the Court. The case in hand is not a case where the plaintiff remained silent and connived at the infringement of the defendant. At the very inception it had lodged objections to the registration of the plaintiff's products to the Ministry of Health. It has also filed the present suit. Moreover, the drug of the plaintiff is a life saving drug and its imitation or infringement is likely to cause great hazard to the public at large apart from the financial loss that it would cause to the plaintiff. Hence the balance of convenience lies in favour of granting interim injunction rather than refusing it. Similar view was taken in the case of Sandoz Ltd. (supra). The case in hand is on a better footing than the Sandoz's case in that in Sandoz case the Pharmaceutical Expert Dr. I.H. Qureshi had opined that it was not possible to state that whether the method and process of the drug of the defendant was similar to the plaintiff's still the Court granted interim injunction, while in the case in hand the opinion' of the Pharmaceutical Expert Dr. Woodhouse is in favour of the plaintiff, and has not been satisfactorily rebutted by the defendant by producing the evidence of any Pharmaceutical Expert against the same. I am, therefore, satisfied that the plaintiff has a strong prime facie case, the balance of convenience is in his favour and he would suffer imrreparable loss if interim injunction is not granted. Hence I grant interim injunction restraining the defendants from manufacturing, importing, selling, stocking for sale or marketing any drug or medicine containing `Ranitidine/Ranitidine Hydrochloride under the name of `Rancid' or any other name pending the disposal of the suit. Civil Miscellaneous Applications No, 8832 of 1989 and 3201 of 1990 stand disposed of accordingly.