ANWAR ZAHEER JAMALI, J.--- This order will govern the disposal of C.M.A. No. 7184/98, application under Sections 29 and 31, Patents and Designs Act, 1911 (hereinafter referred to as the Act of 1911) read with Order 39, Rules I and 2 and Section 151, CPC pending in Suit No. 1924/98, and a similar application being C.M.A. No. 7186/98 in Suit No. 1025/98, as not only the facts in these two suits are same but also the question for determination is same.
2. Briefly stated, the case of M/s. Pfizer Limited and Pfizer Laboratories (Pvt.) Limited, the plaintiffs in both the above-referred suits is that they are holder of Pakistan Patent No. 130621 for which they had applied in the year 1986 and sealed in 1989. This patent relates to a pharmaceutical compound called "Amlodipine Besylate", sold by the plaintiffs under the trade name "Norvasc".
Under section 12 of the Act of 1911, the plaintiffs have the exclusive right to use, sell and manufacture their patent for a period of 16 years from 1986. This patent was neither challenged during the period when the patent application of the plaintiffs was under scrutiny before the patent office nor was challenged thereafter prior to the present litigation, which commenced in the year 1998.
3. On 21.2.1998 the plaintiffs served a registered notice to M/s. Atco Laboratories, the defendant in Suit No. 1024/1998 and M/s. Himont Pharmaceuticals (Pvt) Limited and M/s. Squares Pharmaceuticals (Pvt.) Limited, the defendants in Suit No. 1025/98, informing them about their patent No. 130621 and its infringement by them. However, the defendants in their reply disputed such allegations of infringement. The grievance of the plaintiffs is that the defendants in the two suits have been manufacturing/selling their above-referred patented pharmaceutical compound "Amlodipine Besylate" in Pakistan under different trade names which is in violation of -plaintiffs rights under the patent No. 130621. On these facts in the prayer clause of the plaint plaintiffs prayed for permanent injunction against the defendants restraining them from infringing patent No. 130621 by manufacturing, importing, stocking or selling any products containing the compound "Amlodipine Besylate" or any variation thereof in any form or in any manner whatsoever. Besi ies, plaintiffs also prayed for an account of all profits accrued to' the defendants by manufacturing, marketing and selling of their products, further delivering up of all these stocks and Rs. 30 minion as damages in each suit.
4. The plaintiffs also 'field Misc. Application sunder disposal for interim relief in both the suits. Prayer made therein reads as under: "It is respectfully prayed on behalf of the plaintiffs that this Hon'ble Court may, for the reasons stated in the accompanying affidavit, be pleased to restrain the defendant, its employees, -agents, representatives, dealers; distributors and all persons claiming through or under them. From, directly or indirectly, infringing the plaintiffs patent No. 130621 and from (whether directly or indirectly) manufacturing, importing, stocking for sale, or selling any products containing the compound amlodipine besylate or any variation thereof in any form or in any name whatsoever (including without limitation, pharmaceutical preparations containing amlodipine as an active substance)."
For grant of such interim relief, in their identical supporting affidavits to these applications, the plaintiffs in addition to the facts stated in the plaint, asserted that the defendants are illegally and fraudulently importing, manufacturing and selling their patented pharmaceutical compound "Alodphine Besylate" which is covered by patent No. 130621 and was discovered and developed by the plaintiffs laboratories following research and development costs running into millions of pounds. Such conduct of the defendants is flagrant violation of the provisions of the Act of 1911, and unless the defendants are restrained the same will result in irreparable loss and injury to the plaintiffs company. The plaintiffs have prima facie case and balance of convenience is also in their favour for grant of such interim relief.
5. In their written statements the defendants M/s. Atco Laboratories in Suit No 1024/98 and M/s Himont Pharmaceuticals (Pvt.) Limited and Squares Pharmaceuticals (Pvt.) Limited defendants in Suit No 1025/98, while disputing the claim of the plaintiffs challenged the grant of patent No. 130621 in favour of the plaintiffs and stated that the earlier patents of the plaintiffs company No. 128705 and 1282,77 were relating to the same chemical compound, which have already expired and the disputed patent No. 130621 is not an invention but a discovery which could not be registered as patent. The defendants further stated that their products sold in the market under different names viz. "Cardiosil" and "Amlod" are being manufactured 'through a different process and thus there is no infringement of patented rights of the plaintiffs' company. The defendants stated in detail the pricing of medicine (Norvasc) sold by the plaintiffs company and similar medicines sold by other companies in other countries including India to show exorbitant price charged by the plaintiffs for their patented medicine in Pakistan. They also filed number of certificates issued by various qualified and experienced persons in the field of pharmacy/organic chemistry to substantiate their contention that the process of their medicine is different from one of the plaintiffs and thus there is no infringement of patented rights of the plaintiffs company.
6. In reply to the injunction application defendants reiterated the same facts and further urged that for grant of interim injunction, pre-requisites, prima facie case, balance of convenience and irreparable loss and injury do not exist in favour of the plaintiffs and on the principles of equity and public policy also plaintiffs are not entitled for grant of injunction in their favour.
7: On 24.8.1998, in both the suits this Court while ordering notice to the defendants passed ad interim, orders .Whereby the . Defendants were restrained from manufacturing their respective disputed drugs i.e. "Amlod" and "Cardiosil" till then. Since thereafter these ad-interim orders have been extended from date to date and are still in force.
8 I have heard Mr. Muneeb Akhtar, Advocate, for M/s. Pfizer and Mr. Munawar Ghani, Advocate, for M/s. Atco Laboratories, Himont Pharmaceuticals (Pvt.) Limited and Squares Pharmaceuticals Limited the defendants in the two suits at length and they have also filed written synopse5 of their arguments.
9. Mr. Munib Akhtar in his lucid but detailed arguments referred to the pleadings of the parties and almost all the documents filed by them in support of their respective contentions and contended that since the year 1986 pharmaceutical compound "Amlodepine Besylate" is a registered patent of the plaintiffs M/s. Pfizer Ltd. And under Section 12 of the Patent and Designs Act, 1911 plaintiffs are entitled for its exclusive use for a period of 16 years which has not expired as yet. Referring to the question of infringement of such patented right by the defendants and answering to the pleas of defendants in this regard, learned counsel referred to the formula of patent No. 130621, two affidavits of Dr. Elias J. Corey and the other affidavits of Thomas C. Crawford, Dr. S. Ronaq Raza Naqvi, Mr. Jean Louis Comte, Dr. V.M. Kopelevich and Mr. Masood Raza, who for detailed reasons given in their respective affidavits confirmed such infringement of patent No. 130621. Learned counsel strongly relied the case of Glaxo Group Limited and 2 others Vs. Everon (Pvt.) Ltd. And another (1992 C.L.C. 2382) and stressed that similar pleas in defence when taken by the defendants in those proceedings were thoroughly considered and discarded by a Division Bench of this Court in its order passed in appeal and temporary injunction was granted to protect infringement of patent Learned counsel also relied upon following other cases:-
(1) Glaxo Group Ltd. And 2 others Vs. Pakistan Pharmaceutical Products (Pvt.) Ltd. (1991 M.L.D. 1985).
(2) Sandoz Ltd. And another v. Pakistan Pharmaceutical Products Ltd. (1987 C.L.C. 1571).
(3) Glaxo Group Ltd. And 2 others Vs. Evron (Pvt.) Ltd. And another (P.L.D. 1991 Karachi 252).
(4) Smith Kline and French Laboratories Ltd. v. Ferozesons Laboratories Ltd. And another (1992 M.L.D.
2226).
On the other hand Mr. Munawar Ghani, Advocate also argued in detail the case of defendants and stressed on the following points:
(a) The patent No. 130621 was obtained by the plaintiffs through misrepresentation and concealment of full facts as the same was subject-matter of earlier patent No. 128705 of the plaintiffs company which expired on 11.3.1998 thus the disputed patent No. 130621 is a mere duplication of the earlier one to seek extension of time for enjoying of monopoly.
(b) In patent No. 130621 there is no novelty, innovation or newness . Even the plaintiffs M/s. Pfizer Laboratories Lid. In their "public warning" in daily "Dawn" dated 8.9.1996 have conceded that "Amlodipine" was subject-matter of their earlier Pakistan Patent No. 128705.
(c) Patented process of the plaintiffs and the process through which defendants are manufacturing their pharmaceutical compound and selling it in the open market under the name of "Cardiosil" and "Amlod" are different and thus there is no infringement of the patented rights of the plaintiffs.
(d) The difference in the sale price of plaintiffs patented pharmaceutical compound i.e. Amlodepine Besylate sold under the name of "Norvasc" and that of the defendants sold under the names of "Amlod" and "Cardiosil" goes to show that:
(i) the plaintiffs have not approached this Court with clean hands;
(ii) grant of injunction in favour of the plaintiffs will be against the public policy and public interest;
(iii) on the principles of equity plaintiffs are not entitled for grant of injunction.
(e) The plaintiffs have no prima facie case for grant of injunction, balance of convenience does not lie in their favour, they will not suffer any irreparable loss and injury, and loss to their business, if any, which could be sustained by the plaintiffs due to refusal of injunction will be calcuble in terms of money and for that purpose this Court while declining injunction can pass appropriate conditional order.
Learned counsel, to fortify his above contentions, referred number of documents filed by defendants in two suits which contained different chemical formulas, the affidavits of many qualified and experienced persons in the field of pharmacy/organic chemistry, assigning their reasons to hold that the process of preparation of medicines (Norvasc) by the plaintiffs and (Cardiosil and Amlod) by the defendants is different and thus there is no infringement of patent No. 130621 held by the plaintiffs. In support of his contentions, learned counsel placed reliance on the following cases:
(1) Press Mebal Corporation Ltd. v. Nashir Sorabji Pochkhanawalla and another. (AIR 1983 Bombay 144);
(2) Rado v. John Tye and Sons Ltd. (1967 RPC 297);
(3) Brupat Ltd. And another v. Sandford, Marine Products Ltd. (1983 RPC 61);
(4) Hawker Siddeley Dynamics Engineering Ltd. v. Real Time Developments Ltd. (1983 RPC 395);
(5) Raj Parkash v. Mangat Ram Choudhary and others (AIR 1978 Delhi 1);
(6) SKM. S.A. And another v. Wagner Spraytech Ltd. And others (1982 RPC 497).
I-have carefully considered the arguments advanced by the learned counsel, gone through the written synopsis of arguments submitted by them and also minutely/examined the material placed on record by the parties.
It is well-settled principle of law that grant of injunction is a discretionary relief and the Courts while considering the question of grant, of such relief have to see the. Co-existence of prima facie case, balance of convenience and irreparable loss, and injury in favour. Of a party seeking such relief.
While dilating upon the merits of a case on these parameters the Courts can also take into consideration the dyer all conduct of a party i.e.
(a) Whether he has approached the Court with considerable delay and not acted vigilantly and promptly?
(b) Whether he has not approacted the Court with clean hands?
(c) Whether grant of injunction will be against public interest/public policy?
(d) Whether grant of injunction will place a party in an undue advantage which will perpetuate injustice?
(e) Whether the loss/damages likely to be suffered by a party due to refusal of injunction will be calculable in terms of money?
(f) Whether party approaching the Court for injunction has suppressed material facts and acted in a ma/a fide manner?
If answer to any of these queries is in affirmative, the relief of injunction being discretionary in nature can be declined having regard to the facts of each case.
(a) Elias J. Corey, Professor of Organic Chemistry at Harvard University, Cambridge, Massachusetts since 1959 who has also won various awards including the Noble Prize in Chemistry in the year 1990.
(b) Thomas C. Crawford, the holder of degree in Doctor of philosophy and in Organic Chemistry from the University of California at Loss Angeles. Presently working as Group Director, Process Research and Development Department; in the plaintiff company.
These two experts in their field, on the basis of their knowledge and experience and for the reasons stated in their respective affidavits have supported the plea of the plaintiffs company M/s. Pfizer Ltd. That at the hands of defendants pharmeutical companies, their patented rights are being violated. Had this been the admitted or undisputed position of the record it would have been much easier for the Court to conclude that prima facie case exists in favour of the plaintiffs, but in the instant case the defendants, who are hotly contesting and disputing this position for the reason put forth by their counsel in his argument, as recorded above, have also placed on record, besides other documents, the affidavits of:
(1) S. Venkataraman from Dr. Reddy's Laboratories Limited India.
(2) Mohammad Osman Bhatti, Retd. Controller of Patents and Designs, Government of Pakistan.
(3) Prof. Dr. S.M. Lfzal Ph. D. In 'Organic Chemistry from University of Wales, U.K. .
(4) Dr. C.M. Ashraf having qualification of Ph. D. From U.K. In Organic Chemistry.
(5) Prof. Rashid lqbal, having degree of Ph.D. From the University of London, U.K. Head of Organic Chemistry Section, Department of Chemistry, Quaid-i-Azam University, Islamabad.
These persons, who also seem to be highly qualified and experienced in their field have disputed the case of plaintiffs and supported that of defendants.
10. In rejoinder to all these assertions from the defendants' side again the plaintiffs have filed affidavits of (i) Dr. Professor S. Ronaq Raza Naqvi having qualification of Ph.D. In Chemistry from Cambridge University, (ii) Mr. Jean Louis Joseph Comte from Fribourg, Switzerland, (iii) Mr. Masood Raza, (iv) Dr. Elias J. Corey and (v) Mr. Vyacheslav Mikhailovich Kopelevich. These persons in their affidavits have again supported the case of the plaintiffs and disputed the case of the defendants.
Thus, it will be seen that before this Court there are two sets of documents, the veracity and authenticity whereof cannot be judged by this Court at this stage without recording of evidence of the parties and putting these witnesses to the test of cross-examination, if the parties opt to examine them in Court. The other contentions of Mr. Munawar Ghani noted at serial Nos. (a), (b) and (c) above, are also of such nature that same cannot be decided summarily at this stage. The fact remains that at this stage there is a serious challenge to the claim of infringement of patented right of the plaintiffs Pfizer Ltd. From the defendants' side. In this context, it is significant to note that under the ad interim orders passed in these suits the benefit of patent No. 130621 has already been availed by the plaintiffs for last almost three years. The result of operation of such ad interim injunction orders is sent the defendants in the two suits are out of their business and on highly disputed facts the plaintiffs are enjoying the benefit of their monopoly with regard to the patent No. 130621. In my humble view in the above circumstances it will not be just, fair and proper to hold that the plaintiffs have prima facie case in their favour for grant of injunction.
11. Looking the things from one angle, it may appear that pricing is not a relevant consideration for examining the question of infringement of a patent but from another same is material for considering the question of grant or refusal of equitable relief of injunction by the Court as any disproportionate and exorbitant pricing of a patented medicine and exploitation of monopoly by a company in this context may swing the balance of convenience against such party found exploiting such monopoly by over pricing and seeking an undue cover to such monopoly and exploitation through injunction.
With reference to the pricing of patented medicine in question Mr. Munib Akhtar, learned counsel for plaintiffs M/s. Pfizer Ltd. Candidly did not dispute before the Court that in Pakistan plaintiffs' company is selling their patented medicine under the name of "Norvasc" at a much (sic) plaint in Suit No. 1025/1998 the price of one pack of 20 tablets of 10 mg each for Rs.518.34 i.e. Rs. 25.917 per tablet and according to para (10)(iii) of the counter affidavit of Mr. Saeed Allahwala one pack of 20' tablets for Rs.270/- 4.e. 13.50 per tablet) while the same medicine under the name of AMLODGARD is being sold by the plaintiffs company in neighbouring country India at Rs.47.82 for one pack of 30 tablets of 5 mg i.e. Rs. 1,594 per tablet (see Annexure D/C to C.M.A: No. 3297/2001). When asked to explain this anomaly and glaring difference in the pricing of the same medicine by the plaintiffs' company in the two neighbouring countries, the only explanation extended by the learned counsel was that as their patented pharmaceutical compound is not a patented' pharmaceutical compound in the neighbouring country India therefore due to open competition in pricing of that product in that country with other companies manufacturing and selling the same medicine under the other branded names they have to keep their price competitive and as much low' as mentioned above. In other words the learned counsel conceded to the position that the monopoly in the patented medicine in Pakistan is being exploited by (sic) which is obviously against public interest.
12. Looking the things from another prospective it will be seen that plaintiffs' company can afford to sell their patented medicine to more than one billion citizens of the neighbouring country India and also to the citizens of many other countries, where their medicine has not been patented, at a very also price in comparison to the one being charged in Pakistan, without burdening them with the so-called amount spent by their company in the process of research and experiments, which is the only pretext for high pricing of their product in Pakistan and thus a different standard is being following which is being protected under the cover of patent law of this country. Besides, reference to an article published in "The Medicoment" weekly issue of October 15, to November 14, 1998 and an invoice dated 3.9.1998 filed by defendants Atco Laboratories (Pvt.) Ltd. Is also relevant to show that how the patented pharmaceutical compound Amlodepine Besylate which is available in the international market at dollars 230 per kg is being imported by the plaintiffs' company Pfizer Ltd. At an ostensible price of dollars 30,000/- per kg so that on one hand, they may justify their highly exorbitant pricing of his medicine in Pakistan and on the other hand to take away valuable foreign exchange from the country. In this context, it is also significant to note that Atco Laboratories (Pvt.) Ltd. (defendant in suit No. 1024/1998) have been selling their medicine under the name of AMLOD and one pack of 20 tablets is being sold for Rs.150/- i.e. Rs.7.50 per tablet while M/s. Himont Pharmaceuticals (Pvt.) Ltd. And Squares Pharmaceuticals (Pvt.) Ltd., defendants in suit No. 1025/1998 are selling their medicine in the market under the name of CARDIOSIL at a price of Rs.159/- for 20 tablets of 5 mg i.e. Rs.7.59 per tablet. In addition to this, as stated in the affidavit of Chief Executive of defendant Atco Laboratories dated 7.10.1999 certain other pharmaceuticals companies are selling their similar product at the following rates: S.NO. Product Company Pack MRP 1 AMLOCARD Pharmaceutics20's 120/- 2 SOFVAS Wilson's 20's 51/- 3 VESPIN Amson 20's 50/- It is pertinent to not that the patented pharmaceutical compound of the plaintiffs and similar other compounds manufactured by other pharmaceuticals companies are mainly used for treatment of high blood pressure and therefore the patients suffering from this ailment must be taking such medication out of necessity and thus it cannot be said that such treatment can be avoided by them without any serious risk to their health.
13. In the given circumstances it is clear that grant of injunction in favour of plaintiffs M/s. Pfizer Ltd.
Will place them in an undue and unjust advantage, it will be against public interest and also against the principles of equity.
Coming to the question of irreparable loss and injury and also considering the question of balance of convenience from yet another angle it will be useful to refer the case of Brupat Limited and another Vs. Sandford Marine Products Ltd. (1983 RPC 61). In this case Templeman L.J. While considering the question of grant or refusal of interlocutory relief of injunction in a case of infringement of patent, white allowing the appeal and thereby discharging the injunction on the defendants, observed as under:- "In order to decide whether and how long to extend the term the Court will consider the loss or damage suffered as a result of hostilities. In most, if not all, cases there will be evidence of the number of sales made before the war and of the number of sties made when the war began and the number of sales, which were made after the effect of the hostilities had passed off. There will be relevant statistics to which the Court can pay regard. The difficulty in the present case is that there is no past history, and future history will not necessarily be a guide as to what might have happened. An additional complication in the present case is that one of the financial backers of the defendants is very much concerned, with this present litigation and his attitude towards supplying finance for the present and future activities of the defendants may be materially affected by the ability of the defendants now to make and sell their Sea Claw anchors.
I have come to the conclusion that the plaintiffs can be protected and the defendants cannot. "the assessm ent of damages, if the plaintiffs succeed at the trial and no injunction- is granted in the meantime, has features of difficulty. For instance, how many [articles] would the plaintiffs have sold if their total monopoly had been preserved? How many spares and how much subsidiary equipment would they have sold? What prices would they have been able to command if there had been no competition in the market? And what is the impact of reduced sales on their other business and overheads? I agree that there are inevitable difficulties of this sort, but nothing in the evidence had convinced me that they are so formidable as to preclude the Court from arriving at a reasonably accurate assessm ent of any loss suffered. There will, after all, be a substantial number of known factors. The past sales of the plaintiffs are known: the ratio of spares "and so on" "their estimates of future sales volumes are know."
But considering the defendants, the learned Lord Justice came to the conclusion:- "That the likelihood of any damages being an adequate remedy if they prove right at the trial is very, much less, for in their case there are virtually no certainties. They havt not been selling their equipment long enough to. Establish a clear sales pattern; there will be no actual sales which can be used to assess the demand that there might have been if the defendants had been free to sell.
The answer given, that they have their own estimates of future sales to go on, seems to me to be an inadequate one because; without the experience of the market, it is really quite impossible to say whether or not those estimates are well-founded."
All those observations apply with force to the present case, although the exact facts of two cases differ. Both in the SKM case and in the present case we have this difficulty of a plaintiff who is well in the field and a defendant who is just starting. In those circumstances it is easier to assess the damages of the plaintiffs than it is to assess the damages of the defendants."
14. In the facts and circumstances of the present case, the above principle is fully attracted and I am also in agreement with such conclusion. As a result I have no hesitation to hold that neither balance of convenience lie in favour of the plaintiffs nor they will suffer any irreparable loss and injury in case of refusal of 'injunction and the loss, if any, which may be sustained by the plaintiffs' company due to refusal of injunction, would be calculable in terms of money and to protect their interest an appropriate order could be passed by this Court while disposing of the injunction applications.
Coming to the case-law referred and relied by Mr. Muneeb Akhtar, Advocate, it may be observed that there is no cavil to the principles propounded in these cases, but in the facts and circumstances of the present case as discussed above in details, the same are quite distinguishable.
15. For the forgoing reasons, while dismissing the two injunction applications C.M.A. No. 7184/98 in Suit No. 1024/98 and C.M.A. No. 7186/98 in Suit No. 1025/98 and vacating the ad interim orders in operation it is further ordered that the defendants M/s. Atco Laboratories (Pvt.) Limited. It suit No 1024/98, M/s. Himont Pharmaceuticals (Pvt.) Limited and Squares Pharmaceuticals (Pvt.) Limited in Suit No. 1025/98 shall maintain a complete and honest monthly statement of accounts of production and sale of their questioned medicine in the market and on monthly basis and without fail submit duly certified true copies of such statements with the Nazir of this Court and another copy thereof be supplied to the learned counsel for M/s. Pfizer Ltd. Or their attorney. In case M/s. Pfizer Ltd. Are not satisfied in any manner about such statements of production and sale filed by the defendants in Court it will be open for them to move a proper application for appointment of Commissioner for monitoring such process to ensure rendition of correct and fool proof accounts by the defendants in this regard.
Orders on C.M.A. No. 3609/1999 in J.M. 24/1999 Through this application petitioners M/s. Atco Laboratories (Pvt.) Ltd. Have mainly prayed for an interim order for suspension of registration of patent No.. 130621, issued in favour of respondents M/s. Pfizer Ltd.
Mr. Munawar Ghani, learned counsel for petitioners and Mr. Munir Akhtr, learned counsel for respondents in this case have-argued this application alongwith C.M.A. No 7184/1998 in suit No. 1024/1998 and C.M.A. No. 7186/1998 in, Suit No. 1025/1998 which have been disposed of by me in terms of the order passed above. The relevant facts of the parties' respective case, contentions of their counsel and the case-law referred by. them have already been noted in the above order hence same need not be reproduced here.
For disposal of C.M.A. No. 3609/1999, at this stage, it will suffice to observed that admittedly, the respondents M/s. Pfizer Ltd. Are availing the benefits of registration of patents No. 130621 in their favour since 1986 and before commencement of present round of litigation in the year 1998, the petitioners or anybody else had not challenged registration of their patent No. 130621. The respondents under Section 12 of the Patent and Designs Act, 1911 are entitled to avail the benefit of this patent for a period of 16 years from 1986 and uptill now they have already availed such benefit for more than 15 years. Thus, at this belated stage no case for suspension of their registration and grant of relief prayed in C.M.A. No. 3609/1999 is made out by the petitioners. In addition to this the factual controversy raised by the parties cannot be resolved without recording of evidence and therefore at this stage, the petitioners have no prima facie case for grant of interim relief.
The parties have already been put to terms in the .Above order and for this reason too this application is liable to be dismissed.