1. ' MUHAMMAD TASNIM, J.---Through this common order I shall dispose of C.M.As. Nos.5437 and 5780 of 2010. C.M.A. No,5457 of 2010 is under Order XXXIX, rules 1 and 2, C.P.C. Filed by plaintiffs and C.M.A.
2. No,3780 of 2010 has been filed by defendant under Order XXXIX, rule 4, C.P.C. Through C.M.A. No,5437 of 2010 the plaintiffs have prayed to grant temporary injunction till the decision of the suit, restraining the defendant and all persons claiming through or under it jointly or severally from making and/or importing and/or packing and/or formulating and/or marketing and/or stocking for sale and/or offering for sale and/or selling Gemcitabine itself and/or Gemitabine in the form of any of its pharmaceutically acceptable salts and/or Gemcitabine with addition of any other pharmaceutical ingredient/element/compound in any form or manner under any name whatsoever per se, and that Gemcitabine which is manufactured and/or formulated by using or adopting, in any manner, any process identical to or equivalent to or substantially similar to or incorporating the essential steps of any of the processes and formulation(s)/ compositions patented under Patents Nos. 133749, 134897 and 134971 and Gemcitabine in any form in infringement of first plaintiffs patents in respect of Gemcitabine.
3. ' Facts leading to the above matter as set out in the plaint are as under:-- ' The plaintiff No,1 is an American company whereas plaintiff No,2 is a Pakistani company. It is claimed by the plaintiff that plaintiff No,1 is one of the major pharmaceutical companies and such company is engaged in the business, inter alia, of manufacturing and selling of pharmaceutical products including but not limited to Gemcitabine. The plaintiff No,2 is also engaged in manufacturing and selling pharmaceutical products and is responsible for marketing and selling Gemcitabine in Pakistan but the second plaintiff is part of a group of companies wholly or partly owned by the first plaintiff, either directly or indirectly through further subsidiaries. It is further claim of the plaintiffs that plaintiff No,1 is the proprietor in Pakistan of, amongst others, Pakistan Patents No,133749, No,134897 and No,134971 relating to processes for the manufacture of Gemcitabine, etc., granted to it by the Government of Pakistan under the Patents and Designs Act, 1911. It is further claimed by plaintiff No,1 that it came to their knowledge that the defendant has applied for and/or obtained drug registration from the Ministry of Health for manufacturing and/or importing and/or formulating and/or marketing pharmaceutical products containing Gemcitabine under the name Gemita 200 mg and Gemita 1 gm injections and its representatives and employees are orally canvassing and announcing to the doctors and in the trade that they would soon introduce Gemcitabine products in the market. In the circumstances the present suit was filed for permanent injunction and damages. Along with the suit the plaintiff also filed an application being C.M.A.
4. No,6805 of 2007, under Order XXXIX, rules 1 and 2, C.P.C. The afore-said application was taken up by the Court on 7-8-2007 and notice was ordered to be issued to the defendant. Upon service of notice defendant filed its counter-affidavit and written statement in the proceedings. Defendant in its counter-affidavit mainly stated that the processes employed by Messrs Dabur Pharma Limited India, who are the business partners of the defendant in Pakistan and from whom the end product of Gemcitabine will be purchased by the defendant, use their own unique and individual process for manufacturing/synthesis of the compound Gemcitabine and which is different from the process claimed by the plaintiff. It is further stated that the process which Messrs Dabur India use is already patented in the United States of America i,e, the process employed by Dabur Pharma Limited for manufacture of Gemcitabine is the subject-matter of US Patent No,7.235.647 B2 issued to Dabur Pharma Limited by the United States Patents and Trade-mark Office (USTPO) on June 26, 2007. It is also stated that the USTPO had considered Eli Lilly and Company's US Patent No,5,606,048; 5,808,048 and 5,637,688 the equivalents of Pakistan Patents Nos.133749, 134897 and 134971 respectively during examination of Dabur Pharma's Limited US Patent application No,11/332,830 (filed on January 13, 2006) for the Gemcitabine Hydrochloric Process and found it to be not only novel and sufficiently inventive over the processes disclosed in Eli Lilly and Company's US Patent Nos.5,606,048; 5,808,048 and 5,637,668 and thereby allowed Dabur Pharma's Limited US Patent Application No,11/332,830 for grant and issuance as US Patent No,7,235,647 B2 on June 26, 2007. It is further stated in the afore-said counter-affidavit that the process employed by the Messrs Dabur Pharma India in manufacture of the compound Gemcitabine is distinct and unique and no relevance of any nature can be drawn by the plaintiff with the process employed by Dabur Pharma India, who are the business partners of the defendant in Pakistan and from whom the defendant will purchase the end product containing Gemcitabine. The chemical formulae explained in detail for the process of manufacture of Gemcitabine, different empirical formulae and the various other types of chemical reactions have no relevance or nexus with defendants.
5. ' On 15-8-2007 the Court on C.M.A. No,6805 of 2007 passed the following order:-- "Counter-affidavit is proposed to be filed, copy has been supplied to the plaintiff. Mr. Moin Qamar points out that in para 2, second part, the defendants have mentioned that they have not yet purchased gemcitabin for sale or any other purpose in Pakistan and its application for registration under the Drug Act is pending consideration therefore it is apparently clear that at the moment there is no apprehension of marketing of the product. Since it is stated that the drug is not being market, the launching of the drug will be subject to prior intimation to this Court."
6. ' In terms of afore-said order the defendant filed statement dated 29-4-2010 which contained the following:-- "It is submitted on behalf of the defendant above named that the honourable Court vide its order dated 15-8-2007 was pleased to direct the defendant to intimate this honourable Court before launching of their drug which is subject-matter of the instant proceedings. That through this statement the defendant hereby informs this honourable Court that it intends to launch their drug having generic name "Gemcitabin" under the name and style of "Gemita" on 3-5-2010 which is end product of Messrs Dabur Pharma Limited, India. All arrangements for launching of the drug have been made. The defendant has also obtained registration of the said drug vide Health Ministry letter dated 28-5-2009 (copy of registration letter is annexed herewith)."
7. On 30-4-2010 the afore said statement was fixed for consideration and orders by the Court. Notice whereof was issued to the plaintiffs for 21-5-2010. On 21-5-2010 after hearing the parties following consent order was passed:--
(1) "By consent, statement dated 29-4-2010 is taken on record.
(2) Parties' counsel agree that order dated 15-8-2007 be confirmed and stay application be disposed of in terms indicated in order dated 15-8-2007. Learned counsel for plaintiff further prays that plaintiff be permitted to repeat similar application as and when necessity arises. Plaintiff may repeat such application. If learned counsel for plaintiff repeats such application same be considered in accordance with law. C.M.A. No,6805 of 2007 is disposed of in the above terms.
(3) To come up on 25-5-2010 for settlement of issues, on which date parties' counsel shall file their proposed issues. If they agree, they may also file consent issues."
8. ' On 26-5-2010 present C.M.A. No,5437 of 2010, under Order XXXIX, rules 1 and 2, C.P.C., was filed by the plaintiffs along with an urgent application (C.M.A. No,5436 of 2010). The afore-said application (C.M.A. No,5447 of 2010) was taken up in Court and after hearing the learned counsel for the plaintiffs following order was passed:--
(1) "Granted.
(2) It is, inter alia, contended by the learned counsel for the plaintiffs that plaintiff No,1 is the inventor of a compound known by the non-proprietary name of Gemcitabine and is the proprietor in Pakistan of Patents, No,133749, No,134897 and No,134971 relating to the process for the manufacture of Gemcitabine, The plaintiffs are manufacturing, marketing and selling its product containing the active ingredient. Gemcitabine by the trade name of Gemzar in the local market.
9. Learned counsel submits that, in utter disregard of the plaintiffs' statutory patent rights in their invention relating to Gemcitabine, the defendant is importing, packing, formulating, advertising and selling its product containing Gemcitabine by the brand name of Gemita. Thus, the defendant is causing irreparable loss to the plaintiffs. The learned counsel, therefore, submits that the defendant may be restrained from importing, packing, marketing and selling its products containing Gemcitabine by the name of Gemita or any other trade name.
10. ' Notice to the defendant for 3-6-2010. Till then the defendant is restrained from producing, marketing or selling any product containing Gemcitabine either by the name of Gemita or by any other name."
11. ' Upon service of order dated 26-5-2010 the defendant filed C.M.A. No,5780 of 2010, under Order XXXIX, rule 4, C.P.C. Praying therein to discharge, vary and/or set aside the order dated 26-5-2010 passed on C.M.A. No,5437 of 2010. The afore-said application was taken up in Court on 1-6-2010 and passed the following order:-- "Notice for 3-6-2010, to be taken up at 11-00 a.m. Learned counsel has invited my attention to the order dated 30-4-2010 whereby he has placed on record a statement in terms of order dated 15-8- 2007 regarding the launching of the product Gemita. He has further invited my attention to order dated 21 May, 2010 whereby the afore-said statement dated 29-4-2010 was taken on record by consent of the parties. Effect of the statement dated 29-4-2010 shall be considered during the course of hearing of the relevant application. Office to fix all the application in Court on the next date i,e, 3-6-2010."
12. ' On 3-6-2010 arguments of the parties on both the listed applications were heard and order was passed on the same day.
13. ' Mr. Mueen Qamar, learned counsel for the plaintiffs, has submitted that plaintiff No,1 is the inventor of the compound known by the non-proprietary name of Gemcitabine and is the proprietor in Pakistan under Pakistan Patent No,133749, No,134897 and No,134971 relating to the processes for the manufacture of Gemcitabine. He further submitted that plaintiffs are manufacturing, marketing and selling their products containing the active ingredient Gemcitabine under the trade name Gemzar in the local market. Learned counsel for the plaintiffs has further submitted that plaintiffs are pioneer of Gemcitabine product in Pakistan as well as on worldwide bases.
14. ' The Gemcitabine product are now been prescribed more and more for the treatment of different type of cancer. Learned counsel for the plaintiffs further submitted that defendant by importing and is manufacturing or making and marketing its product Gimita containing Gemcitabirie which has infringed the rights and interest of the plaintiffs. Learned counsel for the plaintiffs further submitted that if defendant is allowed to market the Gemcitabine under the brand name of Gernita it shall cause irreparable loss to the plaintiffs. He in the end submitted that defendant be restrained from, importing, packing, marketing and selling its product containing Gemcitabine by the name of Gemita in the local market.
15. ' In support of afore-said contentions learned counsel for the plaintiffs has invited my attentions to section 2(t), 7, 8, 29, 30, 31, 61 and 69 of the Patents Ordinance, 2000. Learned counsel in support of his contention also placed reliance on the following case law:- 0) Glaxo Group Limited and others v. Evron (Pvt.) Limited and another 1992 CLC 2382,
(2) English Pharmaceutical Industries and another v. Shire Biochem Inc. And others 2007 CLD 1570,
(3) Glaxo Group Limited and others v. Pakistan Pharmaceutical Products (Pvt.) Limited 1991 M LD 85,
(4) Sandoz Limited and another v. Pakistan Pharmaceutical Products Limited 1987 CLC 1571,
(5) Smith Kline and French Laboratories Ltd. And another v. Ferozsons- Laboratories Ltd. And another 1992 M LD 2226,
(6) Rohtas Industries Ltd. And others v. Indian Hume Pipe Co. Ltd. AIR 1954 Patna 492,
(7) MERC and Co. Ing. And others v. Hilton Pharma (Pvt.) Ltd. 2003 CLD 407,
(8) Pfizer Limited and another v. Wilson's Pharmaceuticals 2002 CLD 1653,
(9) Khawaja Tahir Jamal v. Messrs A.R. Rehman Glass 2005 CLD 1768,
(10) Smith Kline Beecham Corporation and others v. Pharma EVO (Pvt.) Ltd. 2006 CLD 716, ' As against the above Mr. Abid S. Zuberi, learned counsel for the defendant, has submitted that Messrs Dabur Pharma Limited India, who are the business partners of the defendant in Pakistan and from whom the end product of Gemcitabine is being purchased by the defendant, use their own unique and individual process for manufacturing/synthesis of the compound Gemcitabine and which is different from the process claimed by the plaintiffs. Learned counsel further submitted that the process which Messrs Dabur Pharma Ltd. India use is already patented in the United States of America i,e, the process employed by Dabur Pharma Limited for manufacture of Gemcitabine is the subject matter of US Patent No,7.235.647 B2 issued to Dabur Pharma Limited by the United States Patents and Trade-mark Office (USTPO) on June 26, 2007. Learned counsel for the defendant further submitted that USTPO had considered Eli Lilly and Company's US Patents No,5,606,048; 5,808,048 and 5,637,688 the equivalents of Pakistan Patents Nos.133749, 134897 and 134971 during examination of Dabur Pharma Limited's US Patent application No,11/332,830 (filed on January 13, 2006) for the Gemcitabine Hydrochloric Process and found it to be not only novel and sufficiently inventive over the processes disclosed in Eli Lilly and Company's US Patent No,5,606,048; 5,808,048 and 5,637,688 and thereby allowed Dabur Pharma Limited's US Patent application No,11/332,830 for grant and issuance as US Patent No,7,235,647 B2 on June 26, 2007.
16. ' Mr. Abid S. Zuberi, learned counsel for the defendant, has challenged the maintainability of present application under Order XXXIX, rules 1 and 2, C.P.C. On the ground that similar application was disposed of by the Court without granting any injunction by consent, hence present application is not maintainable for the same relief. He further argued that there is no difference between the text of stay application filed by the plaintiffs earlier being C.M.A. No,6805 of 2007 and the present application being C.M.A. No,5437 of 2010 except one word "Launching" which was used in C.M.A.
17. No,6805 of 2007 but such word is not appearing in C.M.A. No,5437 of 2010 otherwise the entire application is verbatim. He further submitted that earlier application was taken up by the Court on the first date of hearing i,e, 7-8-2007 and only notice was ordered by the Court but no injunction was granted to the plaintiffs. On 15-8-2007 also no injunction was granted.
18. ' However, it was observed in the order dated 15-8-2008 as under:-- ' Since it is stated that the drug is not being marketed, the launching of the drug will be subject to prior intimation to this Court."
19. ' Learned counsel for the defendant further submitted that in compliance of afore-said order statement dated 29-4-2010 was filed in Court. He further submitted that such statement was fixed in Court for orders on 30-4-2010. Thus, a notice was issued to the plaintiffs for the next date of hearing. Learned counsel for the defendant further submitted that on 21st May, 2010 by consent of the parties statement dated 29-4-2010 was taken on record. He further submitted that by consent of the parties order dated 15-8-2007 was confirmed on 21-5-2010 and stay application C.M.A.
20. No,6805 of 2007 was disposed of in the terms indicated in the order dated 15-8-2007. Learned counsel for the defendant further submitted that plaintiffs were allowed to repeat similar application as and when necessity arises. However, it was ordered that if such application is made same shall be considered in accordance with law.
21. ' Learned counsel for the defendant further submitted that after passing of order dated 21-5-2010 the present application C.M.A. No,5437 of 2010 was filed in Court on 26-5-2010. It was further argued by learned counsel for defendant that no special circumstances have taken place in between five days. Neither the circumstances have changed nor any development has taken place. He further submitted that the only obligation of the defendant was to lay information before the Court with regard to marketing or launching the product of the defendant. He further submitted that defendant acted bona fide and statement dated 29-4-2010 was filed in Court. Notice whereof was served upon the plaintiffs who did not file any objection to the marketing of the product Gemita containing Gemcitabine by the plaintiff. He further submitted that plaintiffs gave consent for taking on record the statement dated 29-4-2010 by the Court. Learned counsel further argued that it is not open to the plaintiffs at this stage to repeat the same application after a gap of only five days without showing any justification.
22. ' Mr. Abid S. Zuberi, learned counsel for the defendant, has submitted that relief claimed in the earlier application and the present application is the same and when the earlier application has been disposed of by consent in terms of earlier order dated 15-8-2007 there is no justification for filing the application under disposal. Learned counsel for the defendant has submitted that after disposal of earlier stay application matter was posted for settlement of issues, hence he prayed that issues be settled and evidence on commission be recorded to adjudicate upon the matter finally. He further submitted that present application cannot be decided without recording of evidence.
23. ' Mr. Abid S. Zuberi, learned counsel for the defendant, in the end submitted that in view of his above submissions the present application merits no consideration and is liable to be dismissed. He further submitted that ad interim order passed on 26th May, 2010 on the application C.M.A. No,5437 of 2010 be recalled as serious prejudice is being caused to the defendant. He further submitted that defendant has already launched its product under intimation to the Court and if it is stopped from selling or marketing its product serious prejudice would be caused to the defendant and it shall not be practically possible to lift the entire medicines from the market which has already been marketed.
24. ' I have heard the learned counsel for the parties and have gone through the record so also the provisions of Patents Ordinance, 2000 as also the case-law cited by the learned counsel for the plaintiffs.
25. ' From the perusal of application C.M.A. No,6805 of 2007 and the present application C.M.A. No,5437 of 2010 it appears that both the applications are the same except the word "launching" has been used in C.M.A. No,6805 of 2007 but the word "launching" is missing from the present application. It is to be noted that earlier no injunction was operating in the matter but condition was imposed upon the defendant to the effect that prior launching the medicines defendant shall communicate the Court about its proposed action. From the perusal of statement dated 29-4-2010 filed by the defendant it appears that in compliance of order dated 15-8-2007 the defendant has placed the required information before the Court. Notice of such statement was served upon the plaintiffs who did not file any objection. On the contrary on 21st May, 2010 they consented to for taking the afore- said statement on record without any objection. A perusal of the statement filed by defendant would show that defendant has specifically stated therein its intention to launch its product containing Gemcitabine under the name and style of Gemita on 3-5-2010 meaning thereby that on 21-5-2010 when statement of defendant was taken on record by consent of plaintiffs' counsel the product of, defendant was already launched in the market.
26. ' The matter does not end here. On the same day C.M.A. No,6805 of 2005 under Order XXXIX, rules 1 and 2, C.P.C. Was disposed of by the Court by confirming the order dated 15-8-2007 which contained only one condition about the information to be laid by the defendant prior launching its product. It would be seen that since last three years no injunction was operating in this case except the condition mention hereinabove. Once such condition was met by the defendant and that too same was accepted by the plaintiffs side without filing any objection and further consented to for taking such statement on record and further agreed for disposal of application C.M.A. No,6805 of 2007 by confirming the order dated 15-8-2007. The plaintiffs side has failed to point out any justification for filing the present application C.M.A. No,5437 of 2010 for the same relief as asked for in C.M.A. No,6805 of 2007. Only by deleting one word "launching" from the present application will not create a changed circumstance for filing of present application for injunction. , ' The point which requires consideration at the moment is as to whether plaintiffs can repeat the similar application for the same relief in spite of the fact that earlier stay application seeking the same relief has been disposed of by order dated 21-5-2010 without pointing out any changed circumstances or justification for the relief prayed for. It is further pointed out that when statement was filed by the defendant side it was brought to the notice of plaintiffs calling their objections about the launching or marketing of the defendant's product. The plaintiffs ought to have objected or filed objection to such statement but the plaintiffs side did not take any step in this behalf. On the contrary they consented to for taking the statement on record by the Court. It would be noted from the record that as per statement dated 29-4-2010 filed by defendant its product containing Gemcitabine was to be launched on 3-5-2010. It will further be seen that when statement of defendant was taken on record by consent of plaintiffs' counsel the product of defendant was in the market. No objection to launching or marketing the product of defendant was raised by the plaintiff side. The present C.M.A. No,5437 of 2010 was filed in Court on 26-5-2010 on which date as well product of defendant was in the market. From the examination of the above it shall be noticed that no new situation or circumstance has changed from 3-5-2010 to 26-5-2010 i,e, from the date of launching the date of filing of C.M.A. No, 5432 of 2010. All the provisions of Patents Ordinance, 2000 cited by the learned counsel for the plaintiffs are not applicable in the circumstances of the case. _ ' The judgments cited by the learned counsel for plaintiffs-are distinguishable on facts and do not apply to the circumstance of the case as none of the judgments cited by the learned counsel for plaintiffs has dealt with the point which is under consideration regarding the maintainability of present application. In view of above it is apparent that plaintiffs have failed to point out any plausible reason, justification and circumstance for repeating similar application for same relief.
27. Even otherwise, the defendant has taken the plea that it has no concern with the process employed by the plaintiffs for manufacturing of Gemcitabine. It is further case of defendant that defendant's product is distinct and unique and has no relevance with manufacturing process of plaintiff product. It is further case of defendant that chemical formula, empirical formula is different than the plaintiffs B Gemcitabine. Since there is disputed question of facts are involved same cannot be resolved without recording of evidence of the parties.
28. ' In this view of the matter the application C.M.A. No,5437 of 2010 merits no consideration and it is accordingly dismissed. Interim order passed on 26-5-2010 is hereby recalled.
29. ' C.M.A. No,5780 of 2010 filed by defendant with regard to discharge, vary and/or set aside the order dated 26-5-2010 passed on C.M.A. No,5437 of 2010. Notice of this application was served upon the plaintiff's side but no counter-affidavit has been filed. Since C.M.A. No,5437 of 2010 has been dismissed as above consequently this application is allowed.
30. ' Both the applications listed above were disposed of vide order dated 3-6-2010 and above are the reasons for the same.