1. This is an application under Order XXXIX Rules 1 & 2 read with Section 151 CPC, moved by the plaintiffs seeking interim injunction against defendant restraining them from manufacturing, importing formulating or offering for sale and selling Rosiglitazone, in the form of any of its pharmaceutical with addition to any other pharmaceutical ingredients and from infringing plaintiffs' Patent No. 133856, 136289, 136427 and 136429, on account of plaintiff's exclusive marketing rights under Block Box Patent Application No. 218/98, 341/2000 and 342/2000 in any manner.
2. Precisely, the facts leading to the case are that the Plaintiff Nos. 1 to 3 are corporation organized in U.S.A. and U.K. while the Plaintiff No. 4 is a Group of companies. The plaintiffs are dealing in pharmaceutical Chemical Groups operating throughout the world with the strategy of innovation and globalization to respecialize in production, research and marketing the pharmaceutical being the world leader. The Glaxo SmithKline Group of Companies had several subsidiaries associated companies situated worldwide with a vast net work of distribution of its product. The Plaintiffs Nos. 1 to 3, after the successful research invented a novel product of substantial therapeutic importance including its process manufacture and formulation composition, known as Rosiglitazone for the treatment of diabetes type-II, the Plaintiffs Nos. 1 to 3 are the proprietor in Pakistan having Pakistani patents relating to the process of the manufacturer of the Rosiglitazone Bearing No. 133856, 136429, 136428 and 136289, the Plaintiffs Nos. 1 to 3 were registered as patentee by the Government of Pakistan under the Patent & Design Act 1911. The aforementioned patentees are also proprietor of other investions relating to the Rosiglitazone per Black Box Patent Application moved by the Plaintiffs Nos. 1 to 3 Bearing Nos. 218/98 dated 26.2.1998, No. 341/2000 dated 19.4.2000, (Priority U.K date 20.4.1999) and Bearing No. 342/2000 dated 19.4.2000 (Priority UK date 30.4.1999), the above referred Black Box Patent Application would be examined by the patent office after 31.12.2004, in accordance with the provision of Patent Ordinance, 2000 and Article 70 (8 & 9) of The TRIPS Agreement. The patents equivalent and corresponding to Pakistan Black Box Patent applications were granted in Europe, New Zealand, Australia, where the plaintiffs group of companies had obtained marketing approval from the concerned authorities, the Rosiglitazone is produced and marketed exclusively by the plaintiffs. During the process of examination of the above referred applications by the Pakistan Patent Office notices of acceptance of application were duly issued by the Controller of the Patents & Designs, the applications advertised for possible opposition and claim were laid open for public inspection even subsequent to the grant of patent no third party has ever filed revocation petition to challenge the validity of the Letters Patents in Pakistan. The name Rosiglitazone was adopted by the plaintiffs known in many other countries worldwide. The plaintiffs came to know through market sources that the employees of the defendants were canvassing and announcing to the doctors and in the trade that they had obtained patent registration from the Ministry of Health for manufacturing Rosiglitazone formulating and marketing pharmaceutical products containing Rosiglitazone in the form of Rosiglitazone maleate salt under the trademark Rosita (2 mg 4 mg Tablets) and they will soon introduce such products in the market on the large scale, on further query from the market it transpired that the defendant had made supply of small quantity of its infringing Rosiglitazone products in the market without taking pre-launch seminars against the norms of the industry, the defendants are packaging pharmaceutical and had infringed the product Rosiglitazone under trademark "Rosita" unauthorizedly formulated, marketed and selling the same in the market by infringing the plaintiffs' patent mark and imitated the plaintiffs' patents, which can only be prepared under the patents and Black Box Patents Application of the plaintiffs, which is a threatened violation of the plaintiffs' patent rights, entitling them for grant of injunction against the defendants. The plaintiffs had prima facie case, balance of convenience in their favour and in case of refusal they will suffer irreparable loss and injury.
3. On the other hand, the defendant set up the case that the plaintiff were granted Patent No. 133856 the formula claimed in claim 7 is 5 [4-(2-(NMethyl-N-(2-Pyridyl) amino) ethroxy) benzl] thiozolidin-2, 4-dione Maleic acid Salt. On comparison as given in Merck index, the formula is not exactly the same. The Patent No. 133856 may be any derivative of thiozolidinedione based on E.P.
4. 030.6228 is not for the compound of Rosiglitazone. Black Box applications were advertised in the Gazette of Pakistan, do not show the title of the invention, still pending the Patent No. 136289 granted under Application to 220198, Black Box Application No. 218198 were filed on the same day having same specification. Copy of Patent No. 0306228 with malafide object to get the benefit treated under GATT and Trips agreement. It is averred that dishonesty of the plaintiff is more clear from the facts, that under Patent No. 136289 and Black Box Application No. 218198, filed same specifications, the subject-matter of EP Patent No. 0306228 dated 26.8.1988, copy of the said patent was submitted by the plaintiff in Patent No. 133856 a foreign patent, after the lapse of ten years. The plaintiffs had obtained the patents in negation of law, the defendants had filed revocation petition for cancellation of the said patents. The defendants is a reputable corporate group with a sale and marketing in pharmaceutical and health care business since 1974 with the group turnover around US $ 70 Million and acquired the position based on quality and professionalism and marketing ethics. The defendants from National pharmaceutical publication accessible worldwide learnt about the composition compound of the drug commonly known as Glitazone Bind PPARY patent involved in prescription in numerous Metabolism insulin "sensitizers" without increasing insulin secretion. These are of three type (a) Rosiglitazone (b) Pioglitazone (c) Trogilitazone, the defendants were already manufacturing, selling the drug under the brand. The Ministry of Health, Government of Pakistan, had granted the drug registration under the name of "Rosita" on account of the success of the brand "Rosita" plaintiffs started harassing and threatening the defendants under the garb of alleged patents and proceeded to file suit based on malafides.
5. I have heard Mr. Moeen Qamar, learned counsel appearing for the plaintiffs and Mr. Abdul Hameed Iqbal, learned counsel appearing of the defendants.
6. Learned counsel for the plaintiffs has contended that after the grant of the plaintiffs registration containing products were launched in Pakistan during the month of April, 2004. The defendant had obtained registration from the Ministry of Health for manufacturing and marketing products Rosiglitazone under the trademark Rosita by infringing the plaintiffs patent for treatment of Diabetes Mellitus Type-II.
7. Learned counsel appearing for the plaintiffs has contended that the process of manufacturing as well as ingredients of the medicine launched and marketed by the defendants are the same, which is registered with the patents granted to the plaintiffs in UK as well as in Pakistan, the defendants did not rebut the position by disclosing the process of manufacturing of Rosiglitazone, they are admittedly involved in the product by processing and manufacturing of product in Pakistan. It is urged that the plaintiffs have filed their Black Box Patent Application prima facie case is made out in their favour, in case of refusal they shall suffer irreparable loss and balance of convenience is also in favour of the plaintiffs. In support of the above contentions the reliance has been placed on the following case law:--
(i) Smith Kline & French Laboratories Limited v/s Pakistan Pharmaceutical Products Limited (1991 CLC Karachi Note 69).
8. The dictum laid down is that onus was on the defendants to establish the process of the preparation of two products was not the same. The defendants having failed to establish otherwise, plaintiffs' evidence was sufficient to establish that the product of the defendant and the process of its manufacture was the same as that of plaintiffs' product.
9. (ii)Messrs Annor Textile Mills Ltd. v/s Messsrs Sh. Ashfaq and 2 others (1986 M LD 1535).
10. Relevant portion is at Page No. 1539 In which it is held that best evidence, which could be produced was possession of the defendants, which they have withheld, therefore, the presumption is drawn against the defendants.
(iii) Farbwerke Hoechst Aktiengesellschaft vormals Meister Lucius & Burning a Corporation etc. u/s Unichem Laboratories and others (AIR 1969 Bombay 255).
11. Relevant portion at Page Nos. 260 to 261, the dictum laid down is that Mr. Mistree's contention was that there was nothing in the evidence on record to show that manufacture of Uni-Tolbid Tablets or Tolbutamid by Defendants Nos. 1 and 3 was carried out by using the processes mentioned in the plaintiffs patent and the plaintiff, therefore, have not proved the alleged infringement of the said patent by Defendants 1 and 3. An infringement in plaintiffs' patent in respect of process of the manufacture of the medicinal product where the defendant admit that the drug, which they manufactured under different name is a drug in respect of which the plaintiffs obtained their patent on presumption that the defendants' drug has been produced by the patent process by which it is alleged to be an infringement can be drawn against the defendants under the general provision contained in Section 114 of Evidence Act, moreover, though the general burden of establishing the case of infringement undoubtedly rest on the plaintiffs in accordance with the Section 114 Evidence Act, the burden of proving particularly fact viz, the process by which the defendants product is being prepared by the defendants would be on the defendants. Since that is the fact especially within the terms of Section 114 Evidence Act. It is impossible for the plaintiffs to know of the precisely process that product is being prepared by the defendants and it is precisely to that sort of the case that Section 106 intended to apply.
12. (iii)GLAXO GROUP LIMITED and othrs v/s AVERON (PRIVATE) LIMITED (1992 CLC Karachi 2382)
13. Learned counsel for the plaintiffs emphasized that the plaintiffs enjoy exclusively marketing rights in Rosiglitazone in terms of Section 12 of the Patent and Design Act 1911, as well as under Section 30(4) of the Patent Ordinance, 2000, on the basis of Black Box Patent applications in Pakistan approved by Worldwide Health Organization as generic name of the product subsequent thereof, the world came to know about the name of Rosiglitazone and it was granted in UK since 1999 and United Kingdom since 2000 under the trademark AVANDIA. It is next urged that after the plaintiffs had filed an application for grant of drug registration for Rosiglitazone with the Health Ministry of Pakistan, the requirements of the chemical trial were imposed, which delayed the registration, after chemical trials the registration was granted to the plaintiff's Rosiglitazone containing the product the Ministry of Health finally granted drug registration on November 23, 2003, whereas the Patent Rule 2003, were promulgated in December 23, 2003, which is a date subsequently to the accrual of exclusive marketing rights in favour of the plaintiff. It is urged that till the plaintiffs, patents are not revoked, they can enforce the same against the defendants. The defendants had obtained registration from the Ministry of Health under the trademark Rosita violated plaintiffs' mark, exclusive marketing right, launched the product by infringing.
14. Attention is also drawn to Annual Report that in research and Development of drug during the year 1999-2000 plaintiff had spend 2.3 Billion US Dollars beside untiring human intellectual and physical efforts. It is clear that on the date of the grant of Patent No. 133856 to the plaintiffs in Pakistan on Sept. 4, 1993, Act of 1911 was in force and requirement of novelty was local. The defendant had alleged that their process of producing Rosiglitazone is different from the patentee of the plaintiffs, or otherwise covered by plaintiffs Black Box Patent.
15. The onus to prove was on the defendant to establish that the process of preparation of two products was not the same.
16. The question arises for determination as to whether the plaintiffs patent have been infringed by the defendants by processing manufacturing and marketing the goods and whether the process of manufacturing of Rosiglitazone of the registered patent in favour of the plaintiffs and one in favour of the defendants are same and whether there is a novelty and were already moved in Pakistan before its registration under Act 1911. The learned counsel for the plaintiffs has contended that plaintiffs' Patent No. 133856 relates to Rosiglitazone a derivatives of Thiazolidinedione this specification also appears in Merck Index and physician desk reference. It is urged that Thiazoldinedione is not itself pharmaceutical product but the same is a chemical generic group.
17. The objection of defendants in relation to Patent No. 136429 and 136428 is illogical as the plaintiffs patents granted by the Controller from their title specification and claims clearly relateable to the process for production of the product Rosiglitazone. The legal aspect of the onus to prove is decided in number of authorities cited by the learned counsel appearing for the plaintiffs to thrash the legal aspect as to the onus to prove in such situation reliance is placed on Merc & Co. Ing. and others u/s Hilton Pharma (Put.) Ltd. (2003 C.L.D. Karachi 416), the dictum laid down is that for action of infringement of registered process patent of a drug in case of temporary injunction the onus to prove was on the defendant, which they had failed to discharge. The plaintiffs in order to show genuineness of their claim had offered to refer the product of the defendant to some expert for his opinion as to whether process of its preparation was different from the defendants' patent process, the defendants had not responded, Courts, in such circumstances drew adverse resumption against the defendants."
18. The learned counsel appearing for the defendant has placed reliance on the case of MESSRS PLASTICRAFTERS LTD. KARACHI v/s MESSRS MANIAR INDUSTRIES LTD. (1980 CLC Karachi 826) it has been laid down that it may be pertinent to mention that there is distinction between the registration of trademark and the registration of Design & Patent in the formal case the trademark act and the rule framed thereunder contemplates the publication of a prior notice and hearing of objection to the application for registration etc. whereas under the Patent & Design Act the registration is granted secretly without any prior publication, in other words the effected parties have particularly to contest the application. The relief of grant .of interim injunction whether prima facie, there are some serious issues about the validity of the designs, said to be enforced pending adjudication in a competent Court, it will cause hardship to the effective parties. In case of (1) ATCO Lab. (Pvt.) Limited v/s PFIZER LIMITED and others (2002 Kar. CLD 120), it has been laid down if the loss and damages likely to be suffered by party due to refusal of calculable in the terms of money and whether the party breach the Court injunction as suppressed the material facts acted in the malafide manner relief of injunction is discretionary nature can be declined having regard to the facts of the each case.
(2) Tajuddin v/s Haji Mushtaq and others (1985 CLC Kar. 2182), the rule laid down is that principle as given for patent in cases of designs should be "new and original" and should not have been used prior to the date of application for registration. The plaintiff could not be allowed any hire having on the basis of copyright that defendants in challenge from foundation and question of validity of patent itself, therefore, prayer of injunction is disallowed in circumstances.
19. The learned counsel for the defendants has further contended that the plaintiffs have also claimed damages, easily calculated and the plaintiffs would not be entitled to the discretionary relief of injunction, to rebut the above contention, the learned counsel for the plaintiffs has contended the plaintiffs are also entitled for money decrees on account of partial compensation of the loss and damages for injury goodwill and reputation of the plaintiffs, therefore, the prayer of the injury to the goodwill and reputation to the plaintiffs is altogether different than the decree of the permanent injunction sought by the plaintiffs restraining the defendants for infringing and violating plaintiffs patent marks in respect of production of Rosiglitazone and its marketing.
20. It is spelled out from the record that the process of manufacturing of Rosiglitazone, one which is registered patent in favour of the plaintiff, and other of defendant are one and the same. The plaintiffs patent had novelty in use much prior to its registration. It is manifestly borne out that the defendants did not disclose their manufacturing process, it gives presumption in favour of the plaintiff against the defendant. The submission of the learned counsel appearing for the defendant that the plaintiffs patent locked novelty are without force.
21. The plaintiffs after the chemical trials as was demanded by the Government of Pakistan Health Department, protected their rights pertaining to the process patent registered in Pakistan: It is an admitted position that the defendants did not disclose the process of preparation of the pharmaceutical registered at "Rosita" only deny the case of the plaintiffs that patent was formal and process was available, which came to their knowledge through different journal and periodicals, the defendants had raised plea of manufacturing of the pharmaceutical similar that of the plaintiffs admittedly sold in the local market the packet bearing endorsed Rosiglitazone similar to the plaintiffs' latent granted to the plaintiff yet they had deliberately suppressed the process of its preparation failed to discharge the burden in consonance with law. The plaintiffs had placed on record the process of preparation of the pharmaceutical and had incurred billions of US Dollars upon the invention, process of manufacturing and its marketing, therefore, balance of convenience and irreparable loss lies in favour of the plaintiffs if they are not restrained from infringing the patent right of the plaintiffs by marketing the product Rosiglitazone in Pakistan.
22. The presumption of the exclusive right of use subsists in favour of the plaintiffs, as the defendants rectification obligations are subjudice. Prima facie defendants sought limitation of the patent process arisen out of process patent registered in Pakistan. On account of infringement the patent pieces the plaintiffs are entitled to grant of relief of injunction. There is no controversy on the point that the defendants products are registered with Director General Health, Government of Pakistan.
23. The question of infringement of the patent is altogether a distinct question, which is required to be adjudicated under the related law. The plaintiffs enjoying exclusive right of making selling and using novel invention throughout the Pakistan, which has now reached to point of turning high business the balance of convenience and irreparable loss is also in favour of the plaintiffs.
24. For the foregoing reasons, the plaintiffs application is hereby granted, consequently, the instant application is allowed and the defendants are restrained during the pendency of the suit, manufacturing, importing or offering for sale pharmaceutical Rosiglitazone.
25. The observations made hereinabove are tentative in nature, and shall not effect the merits of the case.