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2007 CLD 1570

ENGLISH PHARMACEUTICAL INDUSTRIES through Partner/Proprietor/

Citation2007 CLD 1570
CourtSupreme Court of Pakistan
Case No.Civil Petitions Nos. 388 and 389 of 2006 Civil Petitions Nos. 388 and 389 of
Date2006-06-20
Judge(s)Faqir Muhammad Khokhar, Chaudhry Ijaz Ahmed, M. Javed Buttar
ResultLeave refused

ORDER

M. JAVED BUTTAR, J.---These petitions involving identical issue, are being decided by this common order.

2. On 23-1-2006 respondents (plaintiffs) instituted two suits against the petitioner (defendant) in the Court of District Judge, Lahore, as provided in section 60 of the Patents Ordinance No.LXI of 2000, for the grant of perpetual injunction to restrain the petitioner from committing any infringement and/or counterfeiting and/or imitation of plaintiffs Patent(s)

(registered) and for damages etc. Along with the suits, applications under Order XXXIX, rules 1 and 2 read with section 151, C.P.C. Were also filed by the plaintiffs for the grant of interim injunction. The learned trial Court/Additional. District Judge, Lahore, vide his common order dated 27-4-2006 dismissed the said applications, ad interim stay orders were vacated and the petitioner's Company was directed to maintain a complete statement of accounts of production and sale of the medicine in question in the market and submit the duly certified copies on fortnightly basis in Court and also furnish the copies of the same to the learned counsel for the plaintiffs. It was also observed that the observations in the said orders were tentative in nature and the same shall have no bearing on the merits of the case. Respondent's Appeals (F.A.Os. Nos.147 and 148 of 2006) were disposed of by a learned Judge in Chambers of Lahore High Court vide his common order dated 18-5-2006. The stay order as prayed by the plaintiffs was not granted, however, certain conditions were imposed on the petitioners. The operative part of the said order which is impugned before us, reads as follows:-- "29. Accordingly, on the touchstone of public interest arising on account of the medical emergency in the country as well as the expiry of the appellants original patent, balance of convenience is found to be in favour of the respondent. Therefore, it is ordered that the respondent shall supply the contract quantity of its product LAMIVUDINE to the Government of Pakistan. In doing so, however, the respondent shall not supply its produce either in the market or to any other person. On account of the fact that the respondent shall be deriving advantage from a commercial bargain that derogates alleged patent rights of the appellants, therefore, to safeguard the interests of the appellants, it is directed that prior to making supply of medicine to the Government of Pakistan the respondent shall submit in the trial Court a bank guarantee of a scheduled commercial bank in the amount of the respondents contract value supplied to the Government of Pakistan, issued in favour of the appellants for its encashment by the appellants if they succeed in establishing before the competent Court their case of infringement of their patent by the respondent.

30. Parties to appear before trial Court on 29-5-2006 for implementing above terms. Appeals disposed of in the foregoing terms."

3. The petitioners/defendants are aggrieved of the above conditions imposed upon. Them especially the condition of submission of bank guarantees. Hence, these petitions for leave to appeal.

4. The plaintiffs alleged that they were engaged in the business, inter alia, of manufacturing and or formulating and sale of pharmaceutical products, backed up by a vast network of agents and distributors and licensees selling its products all over the world. It was pleaded in the plaint that plaintiff No.1 respondent No.1 invented a compound with the name "LAMIVUDINE", subsequently developed and marketed by plaintiffs Nos.2 and 3 and they were the proprietors of the Pakistani patents relating to processes for the manufacturing, bearing Patents Nos.132128, 13268, 133215, 134736 and 135072, which were obtained by them from the Controller of Patents, Government of Pakistan for the manufacturer of "LAMIVUDINE" and also relied upon the Patent Application No.304 of 1998 moved by them for the extension of the patent. It was asserted that under Patent Ordinance, 2000, the term of patent is twenty years and the defendants were producing products containing "LAMIVUDINE" in violation of the patentee rights of the plaintiffs. It was further asserted that the defendant had not disclosed the process whereby he was producing the products containing "LAMIVUDINE", as such the defendant was violating patent process of the plaintiffs as described in the plaint and sought perpetual injunction for restraining the defendant from manufacturing, preparing, processing, importing, exporting and selling its products.

5. It was alleged that plaintiffs had invested millions of U.S. Dollars upon the invention of "LAMIVUDINE" compound, they got registered patent processes, they are the patentees under the relevant law, the process mentioned by the defendant in ,the written statement was not different to the process described in para.4 of the plaint, the same is copy of patented process of the plaintiffs, the plaintiffs are the patentees of the above said patent numbers, which stand registered by the Government of Pakistan under the Patent and Design Act, 1911, their Application bearing No.304 of 1998. Filed on 31-3-1998 in respect of Patent No.132128, for the extension of patent, pertaining to "LAMIVUDINE" compound, was pending and it was argued that the same shall be deemed to have been allowed as it had not been decided so far, that the end product of the "LAMIVUDINE" is out come of the above said five patents and the same is being marketed by them in the trade name of "ZEFFIX" in Pakistan for the treatment of Hepatitis-B viral infection. It was further alleged that the product of the petitioner/defendant was referred to the expert and they had pointed out that the defendant had used the patent process of the plaintiffs in their product.

6. The case of the defendant on the other hand, was that the plaintiffs' parent Patent bearing No.132128 had already expired and as such no valid patent was presently in existence in favour of the plaintiffs and the other patents were merely patents of addition or improvements of process, they were no more in existence in view of lapse of the above said parent patent and these other patents were not inventions, they lacked novelty and were no more valid patents.

7. The plaintiffs applied for their first patent, which has been described above as the parent Patent bearing No.132128 for "LAMIVUDINE" before the Controller of patents on 8-2-1990 and the same was granted by the Controller of Patents on 23-5-1992 w.e.f. The date of filing i.e. 8-2-1990 for the term of sixteen years under the Patent and Designs Act, 1911 as the said Act provided the maximum period of patent as sixteen years. The Patent and Designs Act, 1911 was repealed on 2-12-2000 by the Patent Ordinance, 2000 which is in existence. The life of patent under the aforesaid Ordinance is twenty years but there is no specific provision in the said Ordinance for the extension of the terms of patents already granted for sixteen years under the old law to twenty years under the new law.

The repealing section 106 of the Ordinance, 2000 is silent in this regard and Rule 24(5) of the Patent Rules, 2003 provides that no renewal shall be granted to the patents under the Patent and Designs Act, 1911 after the expiry of terms of sixteen years. In this background, it was submitted on behalf of the petitioner/defendant that the patent obtained by plaintiffs/respondents stood expired on 8-2- 2006 and since there was no provision for extension or renewal of patent, therefore, the plaintiffs had no prima facie case. It was stressed by the defendant that the other patents were not independent patents and the same were merely patents of addition or improvements. The learned trial Court agreed with the contentions advanced on behalf of the petitioner. It was held that plaintiffs had no prima facie, case and there was no automatic extension of Patent No.132128.

As regards the balance of convenience in favour of the plaintiffs or the balance of inconvenience in favour of the -defendant/petitioner, the case of the defendant was that the process for the preparation of "LAMIVUDINE" being used by the' defendant for its product containing "LAMIVUDINE", was different from the patents of the plaintiffs, that the drug was being manufactured from raw material which was being imported and manufactured by Messrs Northeast General Pharmaceutical Factory, Shenyoung Fine Commercial, Factory Ltd. (hereinafter referred to as NEPGF) and the process of Messrs NEPGF was different from all the processes contained and claimed by the plaintiffs in, their above-said five patents and that the plaintiffs had not obtained exclusive marketing rights as provided under section 30 of the Ordinance.

8. Another relevant aspect of the instant proceedings is that Biocare Pharmaceutical Company an allied company of the petitioner's Company, participated in the tender on 10-4-2006 under Prime Minister's Program for Prevention and Control of Hepatitis-B in Pakistan and the contract was awarded to the said Company for the supply of "LAMIVUDINE Tablets". The trial Court also noted that plaintiff No.4 and Biocare participated in the tender and the prices quoted by the Biocare for the drug to be supplied to the General Public was muchless as compared to the prices quoted by plaintiffs firm as such the contract for the supply of the drugs in- the above said Prime Minister's Program, has been awarded to Biocare Pharmacuetical, by Ministry of Health, Government of Pakistan for treatment of thousands of poor patients of Hepatitis-B.

9. The trial Court thus concluded that plaintiffs' Patent No.132128 had expired on 8-2-2006, they had not been able to establish prima fade case and that the balance of inconvenience lied in favour of the defendant.

10. The learned Judge of the High Court, while refusing the interim injunctions as prayed for by the plaintiffs and holding that the balance of inconvenience was in favour of the petitioner but while, allowing the petitioner to supply the contract quantity of its product "LAMIVUDINE" to the Government of Pakistan, stopped it, from supplying its product either in the market or to any other person and also directed the petitioner that prior to supplying the above said medicine to the "Government of Pakistan, the petitioner shall submit in the trial Court, a Bank guarantee of a scheduled Commercial Bank in the amount of contract value, in favour of the plaintiffs for its encashment by the plaintiffs if they succeed in establishing before the competent Court, their case of infringement of their patent by the petitioner. It was also ordered that the product of the petitioner shall be tested and analysed by National Public Health Laboratory of Malaysia at Selangor and on its refusal or inability, by any other Laboratory, to be designated by the trial Court.

11. We have heard the learned counsel for the parties at length, especially the learned counsel for the petitioner and have also seen the available record.

12. It is submitted by the learned counsel for the petitioner that after an extensive discussion, the learned Judge of the High Court as well as the trial Court gave findings that neither a prima facie case of an infringement of any drug patent was made out nor balance of convenience or public interest titled in favour of the respondents, yet a direction was issued in the impugned judgment for submission of a Bank guarantee which was not sustainable on any principle of law, it is extremely difficult for the petitioner-Company to manage such Bank guarantee, the imposition of such condition has caused undue harm to the petitioner and given undue advantage to the respondents, that the direction to submit the process through which the drug, being supplied by the petitioner was manufactured, to Laboratory Test in Malaysia, is illegal and counter-productive, such directions are contrary to the law of procedure and are cumbersome, therefore, they are liable to be set aside, the law places burden on the plaintiff and not the defendant and since it had already been held by the trial Court that plaintiffs had no prima facie case and the balance of inconvenience was in favour of the defendant therefore, imposition of such conditions by the learned Judge of the High Court is illegal and is liable to be set aside, that the direction to submit the process of the petitioner's product to Laboratory Test in Malaysia has violated the legitimate interests of the petitioner and the process which has been developed by the Chinese, cannot be directed to be subjected to such a Laboratory Test, as contemplated in paras.24 and 25 of the impugned judgment -especially when the parties in Pakistan have only imported either the concentrated material or the formulated drug, that the public interest in suppressing epidemic of Hepatitis-B has been disregarded, that the plaintiffs participated in the open tender for supply of drug, the petitioners undertook to supply the same at the rate of Rs.23.50 for one tablet as against- the quoted rate given by the plaintiffs of Rs.104 per tablet which is beyond the reach of the general public, as such public interest prohibits the issuance of any injunction, that the impugned directions are oppressive to the local manufacturers/ distributors, that the invention covered by the plaintiffs Patent No.134736 is actually a patent of addition falling under section 39 of the Patent Ordinance, 2000, said patent is merely an improvement or modification of the original Patent No.132128 which expired on 7-2-2006 and under section 40 of the above Ordinance, patent of addition has also a life/term equal to the main invention, therefore, Patent No.134736 has also expired on 7-2-2006, hence, the impugned judgment is liable to be set aside and the plaintiffs applications for the grant of temporary injunction are to be dismissed in toto. It is also submitted that the order passed by the trial Court provided protection to the plaintiffs by ordering accounts to be maintained by the petitioner in respect of the supplies made by it. In support of his foregoing submissions, learned counsel has relied on Acto Lab Pvt. Ltd. v. Pfizer Ltd.

And others 2002 CLD 120; Biogen Inc. v. Medeva PLC 1997 RPC 1 and Bristol Myers Squibb Co. v. Baker Norton Pharmaceuticals Inc. 2001 RPC 1. The learned counsel representing respondents has opposed the contentions and has supported the directions issued in the impugned judgment.

12. We have .Given our anxious consideration to the entire facts and circumstances of the case. It was found in the impugned judgment that the infringing drug was manufactured by the petitioner in Pakigtan in October, 2005 i.e. During the admitted period of validity of Patent No.132128 which, according to the petitioner, expired on 7-2-2006. It was further held that the question whether Patent No.134736 constituted an independent patent being an inventive step rather than an improvement or modification of the original expired patent, was a matter of evidence that could not be presumed prematurely. It was concluded that the statutory "presumption under section 61

(1) (b) of the above Ordinance was available to the plaintiffs Patent No.134736 and, therefore, it was necessary that the interests of the plaintiffs be duly secured during the period the prima 'facie evidence of the patent-ability of the above patent is brought before the trial Court and although it may not be enough to grant interim injunction to the plaintiffs but the petitioner also has to establish the originality of its manufacturing process, hence the petitioner must disclose and establish its Chinese process for developing its allegedly infringing product It is for this reason that the learned Judge of the High Court ordered the reverse chemical analysis of the petitioner's product through a Laboratory in Malaysia or Singapore. The learned Judge was 'of the view that the plaintiffs had failed to make out a prima facie case for an immediate CLD injunctive order and denied the same to the plaintiffs and allowed the petitioner to supply its drug to Government in public interest but subject to certain conditions to safeguard the interests of the plaintiffs. Plaintiffs two suits are still pending. We are not inclined to pre-judge the issue lest it prejudices the case of either party. We need not discuss the merits of the case in depth because in that regard the Courts have already drawn prima facie conclusions against the plaintiffs who have not assailed the impugned judgment. The issue before us is only in regard to the directions issued in the impugned judgment, which have been discussed above. Learned counsel for the petitioner has not been able to point out any illegality in the issuance of such directions. We are of the view that the impugned judgment is rather in favour of the petitioner and the above directions, of which the petitioner is aggrieved, are in the interests of justice and have been competently issued. They would not cause any irreparable loss to the petitioner. Such directions are with reasons and not arbitrary. We find the said reasons to be cogent. Therefore, we are not inclined to interfere in the lawful exercise of discretion by a Court of competent jurisdiction. In view of the above mentioned, we find no merit in these petitions which are dismissed. .

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