' This is an application under Order XXXIX, rules 1 and 2 read with section 151, C.P.C. Moved by the plaintiffs, seeking interim injunction against the defendant restraining them from infringing plaintiffs patent Nos,134571, 134730, 134743, 134762 and 135143 and from manufacturing, making, importing, packing, formulating, marketing, launching and/or selling Alendronate Sodium or any products containing Alendronate itself or as its sodium salts or any other variation thereof in any form in any manner and under any name by using or adopting any process identical to or equivalent to or substantially similar to or incorporating the essential steps of any of the process, formulations, compositions subject-matter of patent number referred above.
' For grant of such relief, briefly stated, the case of plaintiffs is that plaintiff No,1 is a pharmaceutical and chemical group operating throughout the world. Its activities are focused on the service of mankind, seeking to improve both their life and quality of life. To achieve their goal plaintiffs group of companies are committed to research and development in an effort to discover, invent and develop, inter alia, new chemical and pharmaceutical products and compounds including processes for their manufacture and formulations thereof. In the year 1999 they had spent US dollars 2.068 billion on their research and development programs. The plaintiff No,1 who is engaged in the business of manufacturing, formulating and selling pharmaceutical products, inter alia, including Alendronate and Alendronate Sodium, which is a newly invented drug found particularly effective against the disease of Osteoporosis, which results in thinning and weakening of bones.
Further case of the plaintiffs is that they have been successful in discovering and developing new chemical and pharmaceutical entities of major significance and in the last 5 years they have developed 15 drugs and vaccines and this process of research is continued at high cost. Amongst the completely novel invented products of the plaintiffs one is Alendronate which is the active ingredient, in the form of sodium salt, contained in the pharmaceutical products sold by the plaintiffs. In Pakistan plaintiff No,1 is proprietor of Patent Nos,134571, 134730, 134743, 134762 and 135143 relating to process for the manufacture of Alendronate and its acceptable salts and compositions which are duly registered with the Government of Pakistan under the Patents and Designs Act, 1911.
(hereinafter referred to as the Act of 1911). The plaintiffs are marketing this product under the Trade Mark "FOSAMAX". According to the plaintiffs they have learnt from reliable sources that the defendant have obtained drug registration from the Ministry of Health. Government of Pakistan, for manufacturing, formulating and marketing tablets containing Alendronate Sodium under the name 'OSTAD' which is threatened violation of their patent rights entitling them for grant of injunction against the defendant. The plaintiffs have prima facie case and balance of convenience is in their favour and in case of refusal of injunction they shall suffer irreparable loss and injury.
2. On the other hand, case of defendant-company Messrs Hilton Pharma (Pvt.) Ltd., is that they are leading pharmaceutical concern engaged in the manufacturing and marketing of medicines and other pharmaceutical products in Pakistan. Since 1976 they have made substantial investment in this field and have earned considerable goodwill and sizeable share in the market. In the year 1999 they have got registered their pharmaceutical product "OSTAD" with the Ministry of Health.
Government of Pakistan, and have also incurred huge expenditures in publicizing the said product in the market. This new product of defendants-company, which is yet to be introduced in Pakistani market, contains chemicals ingredient "Alendronate Sodium" manufactured from one of the many other known processes for manufacturing the said chemical ingredient. For this purpose raw material has been imported from Messrs Supriya Chemicals, India. Further case of the defendant is that the allegations of plaintiffs that use of "Alendronate Sodium". In defendant's product "OSTAD" constitutes infringement of their process patents registered in Pakistan are baseless as the plaintiffs have failed to disclose and have deliberately concealed that there are several different processes known in the prior art in Pakistan for manufacturing "Alendronate Sodium" and its Sodium Salt which can be manufactured by any of those prior published process apart from the process protected under Pakistani Patent No,134571. Further case of the defendant is that plaintiffs' patent lack novelty as the same was known in terms of its indicated use in the treatment of Osteoporosis years before the date of the first Pakistani Patent No,134571 and subsequent Patents Nos,134730, 134743, 134762 and 135143. It was discovered in the year 1980, first used in 1991 and sold in 1993. Apart from it information to produce Alendronate was available in patent office library since 1983 as well as in H.E.J. Karachi University since 1986. Defendant also raised plea of difference in price of raw material by parties to dislodge the plaintiffs' claim for grant of interim injunction.
3. I have heard the arguments of Mr. Moin Qamar, Advocate, for the plaintiffs and Mr. Makhdoom All Khan and Mr. Zain Shaikh. Advocates for defendant.
4. Learned counsel for the plaintiffs in his arguments referred in details relevant background and facts about registration of process Patents Nos,134571, 134730, 134743, 134762 and 135143 in Pakistan in favour of the plaintiff No,2. He also referred sections 3, 6, 9, 10, 12 and 29 of the Act of 1911 and sections 30, 60 and 61 of the Patents Ordinance, 2000 to justify his claim for grant of interim injunction. Referring to the medicine "OSTAD", which the defendant-company intend to launch, learned counsel contended that it has been specifically pleaded by the plaintiffs that the process of manufacturing this medicine by the defendant is the same which is already registered process patent of the plaintiff but despite that the defendants have not come forward to rebut this position by disclosing the so-called different process of manufacturing Alendronate Sodium which is admittedly involved in their product "OSTAD" and raw material is imported by defendant from Supriya Chemicals, India. Learned counsel referred to bunch of document filed by the plaintiffs alongwith the plaint, including various chemical formulations to give force to his submissions that plaintiffs have prima facie case in their favour and in case of refusal of interim injunction irreparable loss will be caused to them and that the balance of convenience subsists in favour of the plaintiffs which would justify grant of such relief. In the end learned, counsel again emphasized that the process of manufacturing the product of defendant-company viz. 'OSTAD" for which import of raw material has been made by them from Supriya Chemical, India is the same as already registered patent in Pakistan in favour of the plaintiffs and therefore the plaintiff is entitled for grant of interim injunction. He also extended his proposal/officer that if the defendant's product viz. "OSTAD" which is proposed to be manufactured and marketed by them, is provided to Court then the same can be referred for expert opinion and at this stage withholding of information about such alleged different process of manufacturing gives strong presumption against the defendant. In support of his arguments, learned counsel placed reliance on the following cases:- 0) Smith Kline & French Laboratories Limited and another v. Pakistan Pharmaceutical Products Limited (1991 CLC Note 69 at p.52); (ii) Messrs Annor Textile Mills Ltd. v. Messrs Sh. Ishfaq and 2 others (1986 MLD 1535); (iii) Mst. Basri through L.Rs, and others v. Abdul Hamid through L.Rs, and others (1996 MLD 1123); (iv) Ferbwerke Hoechst Aktiengesellschaft vormals Meister Lucius & Bruning a Corporation etc. v. Unichem Laboratories and others (AIR 1969 Bombay 255); Glaxo Group Limited and 2 others v. Evron (Private) Limited and another (1992 CLC 2382); (vi) Smith Kline & French Laboratories Ltd. And another v. Ferozs Sons Laboratories Ltd. And another (1992 MLD 2226); (vii)
Glaxo Group Limited and 2 others v. Pakistan Pharmaceutical Products (Pvt.) Limited (1991 MLD 85);
(viii) Sandoz Limited and another v. Pakistan Pharmaceutical Products Limited (1987 CLC 1571); (ix)
Rexona Proprietary Ltd. v. 'Majid Soap Works (PLD 1956 Sind 1); (x) S. Muhammad, Din & Sons v. Sh.
Nabi Bakhsh & Sons (Regd.) and others (1987 CLC 759) and (xi) Messrs Tariq Retaurant v. Messrs Tabaq Restaurant (1987 SCMR 1090).
5. In reply to the pleas raised by the defendant in their written statement that at this stage when the product of the defendant has not been marketed the suit on the basis of mere allegation of threatened action is not maintainable. Learned counsel contended that there is no denial of such assertions of the plaintiffs from the defendant side and therefore, the suit is maintainable in law. In this context learned counsel relied upon the cases, Rohtas Industries Ltd. And others v. Indian Hume Pipe Co. Ltd. (AIR 1954 Patna 492) and Glaxo Group Limited and 2 others v. Evron (Private) Limited and another (1992 CLC 2382).
6. Rebutting the above submissions of Mr. Moin Qamar, Mr. Makhdoom All firstly emphasized that in Pakistan there is no concept of product patent. Before January, 2005 and only process patent is available. He contended that for this purpose the burden is squarely on the plaintiffs who have to show the alleged infringement of their process by the defendant. On facts he contended that there is no infringement of registered patent processes of the plaintiffs as the process through which Alendronate Sodium used in "OSTAD" has been manufactured is entirely different. He contended that mere non-disclosure of such different process by the defendant cannot be legally taken as a negative presumption against them. To Add force to his submissions he placed reliance upon Parke Davis & Co. v. Allen & Hanburys 70 (1953) RPC 123. Mr. Makhdoom Ali Khan next contended that the plaintiffs patent lacks novelty as even from the documents produced by them it is evident that Alendronate Sodium was discovered in the year 1980 and before it was registered as process patent in Pakistan in favour of plaintiffs at least three out of seven known processes were published. Learned counsel urged that not only discovery of Alendronate Sodium was made in 1980, but it was first used in 1991 and since then it is in use in different countries, therefore, there was no novelty, justifying any interim relief to the plaintiff. In this context learned counsel placed reliance on the following cases:--
(a) Lallubhai Chakubhai Jariwala v. Chimanlal Chunilal & Co. (AIR 1936 Bombay 99); (b) Tajuddin v.
Haji Mushtaque and another (1985 CLC 2182); (c) Messrs Bishwanath Prasad Radhey Shyam v.
Messrs Hindustan Metal Industries (AIR 1982 SC 1444); (d) V. Manioka Thevar v. Messrs Star Pough Works, Melur (AIR 1965 Madras 327); (e) Messrs Niky Tasha India Private Ltd. v. Messrs Faridabad Gas Gadgets Private Ltd. (AIR 1985 Delhi 136) and (f) Messrs The Mont Balanc Industry (Regd.) v.
Abdul Aziz (1980 CLC 396).
' In the end learned counsel referred to the import price of the raw material used in the products of the plaintiffs and the defendant and submitted that the plaintiffs are importing Alendronate Sodium from abroad at the cost of U.S. Dollars 45,800 per K.G. While cost of import incurred by the defendant is only 350 U.S. Dollars per K.G. In this context he referred the case of Atco Lab. (Pvt.)
Limited v. Pfizer Limited and others (2002 CLC 120) to give support to his arguments that such huge difference in price is also a relevant point to be considered by this Court while granting or refusing equitable relief of injunction.
7. In reply to the above Mr. Moin Qamar contended that the difference in sale price of two products is negligible i,e, less than 10%. Therefore, the case Atco Laboratories (supra) is distinguishable. He also contended that as the product of the defendant-company has not been launched in the market as yet therefore, the view taken by this Court in that case, with reference to balance of convenience and irreparable loss and injury, is also not attracted in the present case. Learned counsel referred the cases Rexona Proprietary Ltd. v. Majid Soap Works (PLD 1956 Sindh 1). Silver Cotton Textile Mills Ltd. And another v. Bawany Violin Textile Mills (1963 PTD Karachi 79) and S. Muhammad Din & Sons v. Sh. Nabi Bakhsh & Sons (Regd.), and others (1987 CLC 759) to show that in all these cases interim injunction was granted and the request for refusal of injunction with direction to maintain accounts was declined. With reference to arguments of Mr. Makhdoom All Khan about difference in the process of preparation of Alendronate Sodium by Supriya Chemical, India and the registered patent processes of the plaintiffs in Pakistan, learned counsel contended that since Alendronate Sodium, which admittedly used in "OSTAD", is imported from India and the defendant is only importer of such raw material, how can defendant, whose knowledge is hearsay, state that process of preparation of Alendronate Sodium is different. He also contended that even the principal company manufacturing Alendronate Sodium viz. Supriya Chemical, India have not cared to certify such fact.
8. Mr. Zain Shaikh with the permission of the Court, made his submissions in reply to the reply arguments of Mr. Moeen Qamar and contended that mere non-filing of such certificate from Supriya Chemical, India or nondisclosure of different process cannot be made basis for drawing and adverse presumption against the defendant or for grant of injunction in favour of plaintiffs. He further contended that in case injunction is allowed in favour of the plaintiffs that will afford an opportunity to the plaintiffs to exploit and misuse their monopoly in the field which will be against the public interest and public policy and therefore, injunction application is liable to be dismissed.
9. I have carefully considered the arguments advanced by the learned counsel and also perused the case record as well as the case-law referred by them at the bar.
10. At this stage the crucial points for consideration for deciding the fate of listed application are that whether the process of manufacturing of Alendronate Sodium, one which is registered patent in favour of plaintiffs and the other adopted by defendant are same or not and whether the process Patent Nos,134571, 134730, 134743, 134762 and 135143 are novelty or the same were already known and in use much prior to its registration in Pakistan under the Act of 1911, as process patent in favour of the plaintiffs. As to the first point, I find much force in the submission of Mr. Moeen Qamar that non-disclosure of their manufacturing process by the defendant about their product OSTAD, despite specific plea raised by the plaintiffs and in this regard from time to time gives presumption in favour of plaintiffs and against the defendant. Submission of the learned counsel also finds support from the fact that the defendant is only importer of such raw material from Messrs Supriya Chemical, India and that company has not issued any certificate/document in favour of the defendant denying the claim of the plaintiffs that the process used by them in the preparation of Alendronate Sodium is not different from the one registered in favour of plaintiffs in Pakistan. The legal aspect as to the onus of proof in such situations has been discussed in some cases as under:-
(a) Farbweke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning A Corporation etc. v.
Unichem Laboratories and others (AIR 1969 Bombay 255): "In the Chanadian Patent Act there is a specific statutory provision viz. Section 41 (2) which lays down that in an action for infringement where the invention relates to the production of a new substance any substance of the same chemical composition and constitution shall in the absence of proof to the contrary, be deemed to have been produced by the patented process of which it is alleged to be an infringement. Though there is no corresponding provision in the India Patents and Designs Act. I see no reason why a presumption to the same effect should not be drawn against the defendants in the present case under the general provisions contained in section 114 of the Indian Evidence Act. Since it is admitted by the defendants that it is the very drug Tolbutamide, in respect of which the plaintiffs have obtained their Patent No,58716 that they have prepared and sold. Moreover, though the general burden of establishing the case of infringement undoubtedly rests on plaintiffs as laid down in the statement from Halsubry mentioned above which is in accordance with section 101 of the Indian Evidence Act, the burden of proving a particular fact viz, the process by which Tolbutamide is being prepared by the defendant would be on the defendants, since that is a fact 'especially' within knowledge within Evidence Act. It is impossible for the plaintiffs to know by what precise process Tobutamide is being prepared by the defendants and it is precisely to that sort of a case that section 106 is intended to apply."
(b) Messrs Annor Textile Mills Ltd. v. Messrs Sh. Ishfaq and 2 others (1986 MLD 1535): "The best evidence which could be produced was in possession of the defendants which they have withheld. Presumption is drawn against the defendants."
(c) Mst. Basri through L.Rs, and others v. Abdul Hamid through L.Rs, and others (1996 MLD 1123): "Admittedly the deed of power of attorney being in possession/power of the respondents, it should have been produced by them in evidence in support of their case. Failure to produce the same in evidence as such will give rise to a presumption that the same if produced in evidence would have gone against the version of the respondents, therefore, it cannot be held that respondent No,3 was authorised to sell the land in dispute hence, findings of the learned two Courts below on Issue No,3 to the effect that respondent No,3 was authorised to sell the land on the basis of the authority in his favour are incorrect and as such are reversed."
11. Reverting to other point, submissions of Mr. Makhdoom All Khan as to the prior knowledge, use and lack of novelty of plaintiffs' patents have also little force as admittedly in the local market in Pakistan except plaintiffs none else had been manufacturing/marketing any B medicine containing Alendronate Sodium prepared with the registered process patents in favour of the plaintiffs and undisputedly their patents are registered since the year 1995-96, without being challenged by anybody. Indeed, by virtue of section 29(2) of the Act, 1911 or section 60(2) of Patents Ordinance, 2000 the defendant, without filing separate proceedings, can take every ground in defence on which a patent can be revoked, but fact remains that till such controversy is decided by some competent forum the presumption of its validity and exclusive right of use will subsist in favour of plaintiffs and thus the plaintiffs are well within their rights to seek assistance of the Court to avoid infringement of their process patents by anybody else. If the assertions of the defendant with reference to seven different previously known processes to produce Alendronate are carefully analyzed then it will be seen that the allegations of prior use and knowledge are mainly with reference to foreign markets though under the Act of 1911 such use relates to only prior use in Pakistan (see Form 1-A of Act of 1911). In the present suit process patents were granted in favour of plaintiffs during the year 1995-96, when Act of 1911 was in force, and this suit was also instituted on 29-6-2000 i,e, before enforcement of Patents Ordinance, 2000, therefore, the issue of prior use is to be viewed with reference to the local market of Pakistan. In addition to it Patent Nos,4407761, 4621077, 5366965 and 1913956 do not relate to Alendronate or process of manufacturing Alendronate Sodium. While Patents Nos,4922007, 5019651 and other documents viz. Annexures A-7 and A-8 to the written statement, have been assigned to the plaintiffs Messrs Merck & Co. Thus on the basis of material available on record it seems that the plaintiffs have prima facie case to seek protection of their rights arising out of their process patents registered in Pakistan. The contention of Mr. Makhdoom All Khan as to the premature nature of the suit has also no force as defendant in their written statement have not disputed that they intend to produce, manufacture and market their product with the trade name "OSTAD" which will contain Alendronate Sodium and the defendant have already imported raw material for this purpose from Supriya Chemical India. In my view in such circumstances Court will not wait for actual infringement but threatened action of infringement would also entitle patentee for grant of interim relief to safeguard his patent rights and to avoid its infringement.
12. It may again be mentioned that admittedly, the defendant have not disclosed the process for preparation of Alendronate Sodium which is used in their produce "OSTAD" and even Supriya Chemical have not assisted them to unfold such process to substantiate their defence in this regard. In my view mere denial of claim of the plaintiffs by the defendant without unfolding anything more in that context, though specially in their knowledge, is not enough to dislodge the claim of the plaintiffs at this stage. Moreso as the defendant themselves are only importers of raw material of Alendronate Sodium from Messrs Supriya Chemical, who have firsthand knowledge of such process, but have chosen to remain silent in this regard. On perusal of case record, at this stage, it appears that defendant have deliberately withheld necessary information and avoided to place on record relevant material regarding the process of preparation of Alendronate Sodium, though this is a fact which could be only in their knowledge. On these facts, by virtue of Article 122 of ganun-e-Shahadat Order, 1984, burden of proof is on defendant, which they have failed to discharge. Besides, it is also pertinent to mention that to show genuineness of their claim the plaintiffs have offered to refer the product intended to be launched by defendant viz. "OSTAD" to some expert for his opinion that whether the process of preparation of Alendronate Sodium used/followed for that purpose is different from that of plaintiffs' patent process, but defendant did not respond by making any, definite statement in this behalf. In such circumstances this Court cannot resist but to draw an adverse presumption against the defendant as to the process of preparation of Alendronate Sodium. Similarly the plea of difference in pricing has also little relevancy in the present case as despite huge difference in import price of raw material imported by the litigating companies the sale price of each tablet "FASAMAX" is Rs,65.80 and the proposed sale price of each tablet "OSTAD" is Rs,59.20. Thus the difference in sale price is negligible, rather considering the cost of production based on the imported raw material it appears that defendant will be making much more profit if their product is allowed to be marketed in Pakistan. To sum up, it will be seen that the pleas of prior use, knowledge and lack of novelty, use of different process, premature nature of suit and difference in pricing raised by defendant are on weak footing, therefore, plaintiffs cannot be non-suited from grant of injunction on these grounds. It may be observed that at this stage only a tentative assessment of parties' case is to be made by the Court to enable it to see whether three prerequisites for grant of injunction exist in favour of a party or not.
On such assessm ent I am of the view that the plaintiffs have succeeded to make out prima facie case for interim relief prayed in the listed application, balance of convenience also exists in their favour and they will suffer irreparable loss and injury if the defendants are not restrained from infringing their patent rights by marketing their produce "OSTAD" in Pakistan.
13. A careful reading of case-law referred by the learned counsel for the parties will show that on different points view taken by this Court is duly supported with the cases referred by the learned counsel for the plaintiff, as mentioned above, while the cases referred on behalf of the defendant are on different premises. Thus distinguishable and not applicable to the present case.
14. In view of the above discussion. C.M.A. No,4397 of 2000 is allowed as prayed.