F HOFFMANN-LA ROCHE LTD & OTHERS v. DRUGS CONTROLLER GENERAL OF INDIA & OTHERS

15. Plaintiffs are, in fact, challenging the competence and the discretion vested in DCGI to grant approvals as an expert body. It is not for the Courts, in exercise of ordinary original civil jurisdiction to consider review or adjudicate on the decisions of an expert body such as DCGI. It has been repeatedly held in many judgments that granting of licenses, approvals, permissions are domains of the regulatory authorities and Courts must exercise restraint as they lack the necessary expertise to substitute their decisions for those of the expert bodies.

16. Cadila filed a suit before the High Court of Bombay on 30.11.2015 seeking declaration and injunction against the Plaintiffs from interfering with the launch and marketing of its biosimilar drug, as the registered office of Cadila is in Mumbai. Instead of defending the suit, Plaintiffs have indulged in forum shopping by filing the present suit, which is even otherwise barred by the provision of Section 10 CPC.

17. Plaintiffs have heavily relied on the order passed by the Supreme Court on 17.12.2019 in Genentech Inc. and Others v. Drugs Controller General Of India and Others, (2020) 13 SCC 371, against the order of the Division Bench of this Court dated 18.09.2019, passed in FAO(OS) 181/2016, wherein judgment dated 25.04.2016 passed by the learned Single Judge permitting Reliance to launch its drug ‘TrastuRel’, a purported biosimilar to Plaintiffs’ HERCEPTIN, HERCLON and BICELTIS with INN ‘Trastuzumab’, with certain conditions, was challenged. However, the reliance is misplaced as the Supreme Court did not deal with the issue of maintainability. Appeal arose from the order of the Division Bench in an application filed by Reliance seeking parity with Biocon and Mylan and had nothing to do with an application under Order VII Rule 11 CPC. Further, the Supreme Court observed that the views expressed in the order were for the purpose of that appeal and shall have no bearing on the proceedings pending before the High Court. Once the observations of the Supreme Court were not meant to apply to the ‘Reliance suit’ itself, they cannot be used to the advantage of the Plaintiffs in another suit. On 28.04.2016, the Division Bench in FAO(OS) 132/2016 in Biocon’s case directed that the position as obtaining on 24.04.2016 i.e. prior to impugned judgment dated 25.04.2016, shall continue to operate till the next date of hearing. Same order was passed in the case of Mylan on the same date in FAO(OS) 133/2016. On 03.03.2017 these two appeals were listed along with FAO(OS) 226/2016 filed by the Plaintiffs herein along with two other appeals and a further order was passed by the Division Bench permitting Biocon and Mylan to sell ‘Trastuzumab’ under their brand names CANMAb and HERTRAZ, respectively, in respect of all three indications on the basis of approved package insert which was marked as ‘A’ and was taken as part of the record. In the meanwhile, Biocon and Mylan were directed to maintain accounts with respect to the said products and all previous directions were superseded by these interim directions. In the order dated 11.02.2020 passed in FAO(OS) 132/2016, the Division Bench observed that since the issue of maintainability of the suit was raised in the appeal itself, there was no reason to entertain a separate application on the same issue, which implies that the question of maintainability of Biocon/Mylan suit was left open for adjudication. Moreover, the Division Bench in FAO(OS)(COMM) 120/2020, by an order dated 04.03.2021, arising out of order dated 24.02.2020 in the present case, granted liberty to Cadila to prefer an application for rejection of plaint, conscious of the fact that suits pertaining to Reliance and Biocon/Mylan were pending in which judgments had been passed on 25.04.2016 and also being aware of the order passed by the Supreme Court, which means that the present application must be decided uninfluenced by the orders in the other two suits.

18. Even otherwise, reliance by Plaintiffs on the judgments dated 25.04.2016 in the Reliance and Biocon/Mylan suits, is misconceived. Cadila has never used Plaintiffs’ trademark HERCEPTIN for selling its biosimilar ‘Trastuzumab’ and the plaint together with the documents filed therewith fails to disclose or establish any use of HERCEPTIN by Cadila and this is the distinguishing factor, since in the Reliance and Biocon/Mylan suits the orders were passed in the backdrop of the fact that Defendants were using Plaintiffs’ trademark HERCEPTIN.

CONTENTIONS ON BEHALF OF PLAINTIFFS:-

19. It is denied that the plaint discloses no cause of action or that the Plaintiffs have no legal right to institute the present suit and the contentions raised by Cadila are wholly misconceived. While adjudicating an application under Order VII Rule 11 CPC, the Court is not to go into the merits of the Defendant’s case and is only required to examine the plaint on a demurrer and the documents filed along with the plaint to see if it discloses any cause of action to sue the Defendant. Plaint has to be read meaningfully and as a whole and can only be rejected if it is wholly vexatious and meaningless. [Ref. Sejal Glass Limited v. Navilan Merchants Private Limited, (2018) 11 SCC 780; Abdul Gafur and Another v. State of Uttarakhand and Others, (2008) 10 SCC 97; Popat and Kotecha Property v. State Bank of India Staff Association, (2005) 7 SCC 510; and Srihari Hanumandas Totala v. Hemant Vithal Kamat and Others, (2021) 9 SCC 99]. In the present case, the plaint clearly discloses a cause of action as Plaintiffs seek to enforce their common law rights of passing off and also challenge the non-compliance of the applicable laws including Biosimilar Guidelines by the Defendants while granting approval to Cadila for its purported biosimilar drug.

20. Section 9 CPC gives an inherent right to every person to institute a suit of civil nature and Civil Courts have jurisdiction to determine all such disputes unless their Authority is barred by a Statute. [Ref. Ganga Bai v. Vijay Kumar and Others, (1974) 2 SCC 393 and Dhannalal v. Kalawatibai and Others, (2002) 6 SCC 16]. Only an express or implied bar under a Statute can oust the Civil Court’s jurisdiction and no subordinate legislation can be invoked for the ouster. Cadila has not cited any Statute which bars the jurisdiction of this Court. Averments in the plaint, which have to be taken to be true and correct for deciding the present application, show that DCGI has issued approvals to Cadila in violation of provisions of Drugs Act, Drugs Rules and Biosimilar Guidelines and it is trite that Civil Court’s jurisdiction is not barred if Statutory Authorities do not act in compliance with the Statute, which is also the cause of action pleaded in the plaint. [Ref. Secretary of State v. Mask and Company, 1940 40 LR 222; Dhulabhai Etc. v. State of MP and Another (In All The Appeals), (1968) 3 SCR 662; Mohmmad Din and Others v. Imam Din and Another, 1947 SCC OnLine Lah 82; and Firm Seth Radha Kishan (Deceased) Represented By Hari Kishan and Others v. Administrator, Municipal Committee, Ludhiana, (1964) 2 SCR 273].

21. The suit is not barred on account of an alternative remedy available to the Plaintiffs, as contended by Cadila under Rule 122DC of the Drugs Rules. Pursuant to Rule 97 of Rules 2019, Rule 122DC has been deleted and there is no corresponding appeal provision under Rules 2019. The Rules 2019 clarify that right to appeal before the Drug Regulator i.e. DCGI is restricted to the aggrieved applicant. It is a settled law that procedural laws in force must be applied on the date when the suit or proceedings come for trial or disposal. In Sudhir G. Angur and Others v. M. Sanjeev and Others, (2006) 1 SCC 141, while confirming these principles, Supreme Court held that if the Courts have jurisdiction to try a suit when it comes for disposal it cannot refuse to exercise jurisdiction only on account of the fact that it had no jurisdiction to entertain it when the suit was instituted. With the coming into force of Rules 2019 and deletion of Rule 122DC, there exists no alternative remedy for the Plaintiffs to enforce their legal rights and this position is affirmed by the order of the Court passed on 24.02.2020.

22. In any event, Rule 122DC was never an alternative remedy available to the Plaintiffs since DCGI cannot adjudicate on the grievances raised in the present suit pertaining to infringement of legal rights of the Plaintiffs arising out of common law and intellectual property rights. Remedy under Rule 122DC is only available to ‘aggrieved person’ who is before the Regulator in the first instance and is thereafter aggrieved by an adverse order and not a third party who is aggrieved as a consequence of such order, as the Plaintiffs. [Ref. Amlanabha Das v. State of West Bengal & Ors., 2006 SCC OnLine Cal 693 and Northern Plastics Ltd. (supra)]. Plaintiffs were neither aware of the approval process for ‘VIVITRA’ in the first instance nor were they required to be represented before the Regulator during the process of grant of approval and were therefore never in a position to challenge the approvals within the time limit i.e. 60 days. The Rule does not cover appeals against approvals granted under Part XA as it is limited to appeals against orders passed by DCGI under Part XA and Plaintiffs have not challenged any such order. The Rule also does not protect or enforce the rights of an innovator and the procedure of granting approvals to manufacturers of biosimilar drugs does not involve a lis between the manufacturers of the innovator drug and the manufacturers of the biosimilar drugs and neither does DCGI determine such rights of the parties. In any event, existence of an alternative remedy never bars a Civil Court’s jurisdiction and this test is applicable only to writ petitions, where Courts exercise discretionary jurisdiction.

23. While deciding an application under Order VII Rule 11 CPC, only averments in the plaint are to be seen and defences in the written statement are immaterial and where the plaint prima facie discloses cause of action it cannot be rejected. Plaintiffs have disclosed several causes of action which are evident from a plain reading of the plaint. Causes of action set out by the Plaintiffs are: (a) Cadila’s ‘VIVITRA’ has been approved for manufacturing and distribution by DCGI without following the procedure under Drugs Act, Drugs Rules and Biosimilar Guidelines; (b) Cadila is claiming similarity between ‘VIVITRA’ and ‘Trastuzumab’ without establishing biosimilarity between the two drugs through appropriate tests as per applicable rules and guidelines; (c) due to inherent differences in the composition of a biosimilar and an innovator biological drug and inadequate testing of ‘VIVITRA’ and failure to establish its biosimilarity and comparability with ‘Trastuzumab’, DCGI erred in approving ‘VIVITRA’ as ‘Trastuzumab’; (d) Cadila is passing off ‘VIVITRA’ as a drug with same nature, description, composition, quality, efficacy and safety as Plaintiffs’ ‘Trastuzumab’; (e) Cadila’s misrepresentation will impede doctors and patients from making informed decisions in relation to use of ‘VIVITRA’ for treatment of HER 2+ metastatic breast cancer, HER 2+ early breast cancer and HER 2+ metastatic gastric cancer as well as regarding therapeutic benefit, quality, efficacy and safety of ‘VIVITRA’; (f) misrepresentations will dilute Plaintiffs’ reputation and goodwill in relation to ‘Trastuzumab’ and brand names HERCEPTIN, HERCLON and BICELTIS; (g) reproduction/use of Plaintiffs’ data relating to ‘Trastuzumab’ by Cadila in its marketing material and test dossier is impermissible in the absence of adequate testing and violates Plaintiffs’ copyright in the data; and (h) internationally, an established biosimilar drug, approved after complete and adequate testing may be entitled to use INN assigned to the innovator biological drug with a qualifier but the position is different in India. In any event, usage of INN does not carry with it the right to copy and freely rely upon innovator’s data attached to that specific INN.

24. Present suit is based on an action for extended passing off i.e. passing off in relation to characteristic, composition and quality of a product. This concept has been upheld by Indian Courts in multiple cases and it is being held that five characteristics should be present for a valid cause of action for extended passing off viz.

(i) misrepresentation; (ii) made by a trader in course of trade; (iii) to prospective or ultimate consumers; (iv) calculated to injure goodwill/business of another trader; and (v) causing actual damage to the business or goodwill of the trader who brings an action to Court. All ingredients are satisfied in the present case. Plaintiffs being innovator of ‘Trastuzumab’, market the drug under the INN Trastuzumab, which describes the active ingredient and is associated with the tested and proven safety, efficacy and quality of the drug and by misrepresenting ‘VIVITRA’ as ‘Trastuzumab’, Cadila has sought to pass off ‘VIVITRA’ as being of ‘same description’ as ‘Trastuzumab’ in terms of all its features such as active ingredient, composition, safety, efficacy and quality and amounts to extended passing off. Any deficiency in ‘VIVITRA’ on account of inadequate testing will dilute Plaintiffs’ goodwill in ‘Trastuzumab’. [Ref. Erven Warnink Besloten Vennootschap and Another v. J. Townend & Sons (HULL) Ltd. and Another, [1979] A.C. 731; B.K. Engineering Co. v. UBHI Enterprises (Regd.) & Anr., 1984 SCC OnLine Del; Cadila Health Care Ltd. v. Cadila Pharmaceuticals Ltd., (2001) 5 SCC 73; Satyam Infoway Ltd. v. Siffynet Solutions (P) Ltd., (2004) 6 SCC 145; Genentech Inc. and Others v. Drugs Controller General Of India and Others, (2020) 13 SCC 371; Ellora Industries v. Banarsi Das Goela, 1979 SCC OnLine Del 198; and The Scotch Whisky Association and Another v. Pravara Sahakar Shakar Karkhana Ltd.,

25. Contrary to Cadila’s assertions in the application, Plaintiffs have not asserted any rights premised on the patent, which has expired in

2013. In any event, Plaintiffs never had a patent over the drug ‘Trastuzumab’ per se and its patent was for a mixture of the unmodified molecule. An identical argument was rejected by the Court in judgment dated 25.04.2016 in Reliance suit. Since Plaintiffs’ claim does not emanate from its patent, the question of ever-greening of patent or stifling competition does not arise and therefore reliance on the judgment of the Supreme Court in Novartis AG v. Union of India and Others, (2013) 6 SCC 1, is misplaced as the said judgment inter alia deals with practices developed in certain jurisdictions wherein a trifling change is made to an existing product and claimed as a new invention to extend an expired patent in light of Section 3(d) of the Patents Act, 1970.

26. Cadila has raised a misconceived contention that Plaintiffs are challenging the competence of DCGI to grant valid marketing or manufacturing licenses for biosimilar drugs and exercise of discretion to permit supervised and approved appropriate phases of clinical trials. Plaintiffs have not challenged the power of a regulatory authority but have only brought to light that the said authorities have an obligation to regulate the procedure in accordance with provisions of the applicable Drugs Act, Drugs Rules and Biosimilar Guidelines and that by approving Cadila’s ‘VIVITRA’, they have acted in breach of the obligations and thus the jurisdiction of this Court is not barred to adjudicate on this issue.

27. Contention of Cadila that present suit is not maintainable in view of an earlier suit instituted before the High Court of Bombay is equally misconceived. Section 10 CPC is not a ground for rejection of a plaint under Order VII Rule 11 CPC. In Srihari Hanumandas Totala (supra), the Supreme Court, while deciding whether res judicata could be a ground for rejecting a plaint under Order VII Rule 11 CPC held that since an adjudication of the plea of res judicata requires consideration of pleadings, issues and decision in the previous suit, such a plea is beyond the scope of Order VII Rule 11 CPC, where only the statements in the plaint are to be perused. The observations will equally apply to the contention predicated on Section 10 CPC. The suit before the Bombay High Court is an anti-suit/threat action filed by Cadila against the Plaintiffs and the issues raised are distinct and different to attract Section 10 CPC.

28. Plaint is even otherwise not vulnerable to rejection as similar and analogous issues were subject matter of consideration before the learned Single Judge of this Court in CS(OS) 3284/2015 (Reliance suit). The suit was filed by Genentech Inc. as Plaintiff No. 1 and Plaintiffs No. 1 and 2 herein i.e. Roche Products (India) Private Limited and F. Hoffman-La Roche, AG. Plaintiffs claimed restraint against Reliance as a qua timet action against launch of a biosimilar version ‘TrastuRel’ of Plaintiffs’ ‘Trastuzumab’. The main contention in the suit was that ‘TrastuRel’ had not been adequately tested for HER 2+ metastatic breast cancer in accordance with the Drugs Act, Drugs Rules and Biosimilar Guidelines. Similar issues as raised in the present case were raised by the Defendants to oppose the suit that Plaintiffs had no cause of action and locus standi; there was an implied bar of law under Rule 122DC of Drugs Rules; ever-greening of an expired patent; use of INN by other biosimilar manufacturers; Plaintiffs’ attempt was to stifle competition in the market and no concept of extended passing off existed in law. All these issues were dealt with by the learned Single Judge in the judgment dated 25.04.2016 and the objections were rejected. Similar contentions raised in CS(OS) 355/2014 by biosimilar manufacturers namely, Biocon Limited, Mylan Inc. and Mylan Pharmaceuticals Private Ltd. were also negated. The order was upheld by the Supreme Court in Genentech Inc. and Others v. Drugs Controller General Of India and Others, (2020) 13 SCC 371 and the Supreme Court after setting aside the order of the Division Bench, directed that the interim directions given by the learned Single Judge on 25.04.2016 will become operational. Once similar issues were raised in the earlier suits and identical objections have been rejected and the suits are pending consideration, it cannot be argued by Cadila that no cause of action arises in favour of the Plaintiffs or that the suit is barred by law. I.A. 2698/2017 (under Order VII Rule 11 CPC, by Defendant No. 3) in CS(COMM) 540/2016:-

29. Hetero is a Company registered at Hyderabad under the Companies Act and is engaged in manufacture and marketing of drugs including biosimilar drugs in India and major markets worldwide under valid approvals granted by DCGI. The suit has been filed by the Plaintiffs inter alia seeking a declaration that approval granted by DCGI to Hetero for clinical trial protocol and marketing its drug claimed to be a purported biosimilar version of Plaintiffs’ ‘Bevacizumab’ be declared invalid as also for permanent injunction restraining Hetero from representing its drug as biosimilar of ‘Bevacizumab’ and launching, introducing, selling or marketing in the Indian market, until appropriate tests and studies have been conducted and approvals have been obtained.

CONTENTIONS ON BEHALF OF HETERO:-

30. Jurisdiction of the Civil Court is barred under the Drugs Act and Drugs Rules which are a complete code. Approval for manufacture and sale of a ‘new drug’ has been granted by an expert body constituted under a Statute only after it was satisfied that requisite procedures were followed and there was no doubt on the safety and efficacy of Hetero’s drug. Rule 122DC provides an efficacious alternative remedy of appeal against any order passed by the Licensing Authority under the Drugs Act. Rule 122DC provides a remedy to any person aggrieved by an order of the Licensing Authority under Part XA of the Drugs Rules and the approval granted to Hetero squarely falls within the definition of ‘Order’ contemplated by Rule 122DC. Reliance on the judgment of the learned Single Judge in ‘Reliance suit’ dated 25.04.2016 is misplaced since the judgment is per incuriam as the Court has failed to consider the fundamental principle of law that if an action is taken under a self-contained Statute, with a remedy of appeal then jurisdiction of a Civil Court is barred. Hetero relied on the judgments of the Supreme Court in Premier Automobiles Ltd. v. Kamlekar Shantaram Wadke of Bombay and Others, (1976) 1 SCC 496; Chandrakant Tukaram Nikam and Others v. Municipal Corporation of Ahmedabad and Another, (2002) 2 SCC 542; Raja Ram Kumar Bhargava (Dead) by LRs v. Union of India, (1988) 1 SCC 681; and State of A.P. v. Manjeti Laxmi Kantha Rao (Dead) by LRs and Others, (2000) 3 SCC 689, for the proposition that if an adequate remedy is provided under an Act, Civil Court does not have jurisdiction to entertain a suit in respect of such remedy.

31. Plaint lacks material particulars and is wholly vexatious and fails to meet the basic requirement of disclosing a cause of action which is a bundle of facts giving a right to sue. Plaint is silent on the question whether there is any bar in law against Hetero to manufacture, market and sell its drug under INN ‘Bevacizumab’, especially when DCGI has authorized and certified that Hetero’s drug is compliant with the procedures envisaged in law. There is no identification of the data in the plaint which is allegedly misappropriated or violates Plaintiffs’ copyright.

32. Plaint does not disclose any cause of action. There is no challenge to the provisions of the Drugs Act, Drugs Rules and Biosimilar Guidelines. Most of the paragraphs in the plaint either contain a factual narrative or contain a comparison between the two rival drugs and/or have references to the authorization/approval given to Hetero’s drug. Remaining paragraphs while adverting to the purported irregularities pertaining to clinical trial of Hetero’s drug are merely in the nature of statements of facts and the guidelines required to be followed. Allegations in the context of dilution of goodwill are bald with insufficient averments and do not disclose a cause of action in favour of the Plaintiffs and/or how they are aggrieved. There are no pleadings to support the allegation of misrepresentations amounting to alleged passing off against Hetero. Plaintiffs have been unable to plead how Hetero’s drug is biosimilar to Plaintiffs’ ‘Bevacizumab’ or why the approvals granted by an expert body are illegal. Plaintiffs are only trying to create an illusion of cause of action through clever drafting and despite elaborate pleadings, no clear right to sue emerges from the reading of the plaint. [Ref.: Dilip Vasant Shetye and Another (supra) and Raghwendra Sharan Singh (supra)].

33. Allegations that Plaintiffs’ goodwill in INN ‘Bevacizumab’ is likely to be diluted, are ex facie illegal and baseless. Admittedly, Plaintiffs do not have a patent in India for the Reference Biologic Drug marketed by them under the brand name ‘Avastin’ and insofar as ‘Bevacizumab’ is concerned, being an INN, Plaintiffs cannot assert any right over the same. Allegations of passing off are equally misconceived as nothing has been pleaded or shown how Hetero is misrepresenting and causing confusion amounting to passing off, when in fact Hetero is selling its own drug with due authorization and approval from Statutory Authorities.

34. The dispute sought to be raised by the Plaintiffs is not a ‘commercial dispute’ within the meaning of Section 2(1)(c) of the Commercial Courts Act, 2015. Going by the plain demurrer of the plaint, at the highest there is an allegation that Hetero uses INN ‘Bevacizumab’, which cannot come under the purview of the said Act as INN is a public property on which no party can claim proprietary right, much less intellectual property right.

CONTENTIONS ON BEHALF OF THE PLAINTIFFS:

35. Contentions raised by the Plaintiffs in CS(COMM) 540/2016 are more or less the same as aforementioned, save and except, a few additional grounds which are primarily focused on factual aspects and are adverted to hereinafter. Plaintiffs’ ‘Bevacizumab’ is a recombinant humanized monoclonal antibody that selectively binds to and neutralises the biologic activity of human vascular endothelial growth factor and has been approved for use in over 100 countries worldwide. Approval to ‘Bevacizumab’ was received in India on 17.01.2005 and was launched in the same year. In India, Plaintiffs received approval to market the product for various indications including metastatic colorectal cancer, persistent, recurrent or metastatic carcinoma of cervix etc. while Defendant No. 3/Hetero Drugs Limited (‘Hetero’) received market authorization only for one indication i.e. metastatic colorectal cancer in India. Hetero has not followed the procedure prescribed under the applicable laws for manufacturing and marketing its drug, which is a ‘new drug’ under Rule 122E of Drugs Rules and the approvals granted by DCGI are invalid and against the Drugs Act, Drugs Rules and Biosimilar Guidelines.

36. By referring to its drug as biosimilar to Plaintiffs’ ‘Bevacizumab’, Hetero has misrepresented the nature of tests to which its drug was subjected for the purpose of testing its safety and efficacy and thus compromising the safety of prospective patients. Moreover, by referring to its drug as ‘Bevacizumab Injection’ Hetero has also misled consumers into believing that the ingredient of Hetero’s drug is ‘Bevacizumab’ itself. This is per se false since ‘Bevacizumab’ is a biological product and can have no generic equivalent. A biological drug can at best contain a drug similar to Plaintiffs’ ‘Bevacizumab’. Moreover, biosimilarity of any drug can be tested only after the drug undergoes the procedure prescribed by law.

37. Genuineness or legality of cause of action cannot be a ground for rejection of plaint and under Order VII Rule 11 CPC the Court can only examine the cause of action by a reading of the plaint itself. While adjudicating the application, Court is not to go into merits of the Defendant’s case and is only required to see whether contents of the plaint, being treated as the gospel truth, discloses a cause of action and locus standi to sue the Defendant. In Mayar (H.K.) Ltd. and Others v. Owners & Parties, Vessel M.V. Fortune Express and Others, (2006) 3 SCC 100, the Supreme Court held that plaint cannot be rejected on the basis of allegations made in the written statement or even in an application for rejection of the plaint. So long as the plaint discloses some cause of action, which require determination by the Court, mere fact that in the opinion of the Judge the Plaintiff may not succeed, cannot be a ground for rejection.

38. Plaintiffs have cause of action and locus standi to file the instant suit and enough averments in the plaint and material in the form of documents is on record to evidence that. Plaintiffs are the innovator and developer of the biological drug ‘Bevacizumab’, which is a reference product of Hetero’s drug and this is demonstrated by reference to the Clinical Trial Protocol (CTP) filed with the Clinical Trials Registry of India. Hetero’s drug is non-compliant with necessary guidelines and mandatory procedure in law and did not complete even the mandatory phases of human trial and thus the approvals granted by official Defendants is invalid and contrary to statutory provisions.

39. Hetero’s drug is likely to be imputed to Plaintiffs’ ‘Bevacizumab’ which will lead to dilution of Plaintiffs’ reputation and goodwill built over many years and will cause irreparable injury to the Plaintiffs, particularly, if there is a mishap. Hetero has also misused the data relating to Plaintiffs’ ‘Bevacizumab’ and deceptively assigned to its drug the INN ‘Bevacizumab’. It is evident that Hetero is passing off its purportedly biosimilar drug as being same with respect to therapeutic quality, safety and efficacy as Plaintiffs’ ‘Bevacizumab’, which is wholly wrong. Importantly, Plaintiffs’ ‘Bevacizumab’ is approved in India as well as globally for treatment of multiple indications whereas Hetero has approval only for metastatic colorectal cancer and in view of major difference in the indications, there is likelihood of substitution of Hetero’s drug even when Plaintiffs’ ‘Bevacizumab’ is prescribed by a medical practitioner and may be mistakenly administered to patients with other indications. Pertinently, both medical practitioners and chemists identify the drugs with their non-proprietary name which is ‘Bevacizumab’ in the present case.

CONTENTIONS ON BEHALF OF DCGI:-

40. DCGI has not filed reply to the applications. A written note of arguments has been filed by DCGI only in CS(COMM) 1119/2016 and therefore the Court does not have the stand of the said Defendant on facts pertaining to CS(COMM) 540/2016. The stand of DCGI in CS(COMM) 1119/2016 is that the legal position under the Drugs Act and Drugs Rules is clear and unambiguous that before any drug is allowed to be manufactured for sale, it must go through a rigorous and thorough examination to enable the Competent Authorities to arrive at a conclusion that the drug is safe and efficacious. Examination involves three stages: (i) initial evaluation for safety and efficacy as per procedure prescribed; (ii) when the drug is allowed for sale there is a period in which it remains under observation; and (iii) on completion of period of observation, standards for manufacture and sale of drug is by and large identified and it is easier to obtain a license for manufacture and sale of the drug.

41. The statutory regime applicable to manufacture and sale of a ‘new drug’ which is defined under Rule 122E is under Rule 122. Rule 122B provides that no new drug shall be manufactured without approval of Licensing Authority defined under Rule 21(b). Sub-rule (2) of Rule 122B provides that manufacturer of a new drug shall submit data as given in Appendix-1 to Schedule Y including results of clinical trials carried out in the country in accordance with guidelines specified in Schedule Y. Under sub-rule (2A) the Licensing Authority, after being satisfied that the drug, if approved, to be manufactured as raw material or as finished formulation, shall be effective and safe for use in the country, shall issue approval in Form 46 and/or Form 46A, as the case may be, subject to further conditions stated therein. Form 44 is an elaborate Form and requires the ‘new drug’ proposed manufacturer to submit details along with the application, including the new drug’s chemical and pharmaceutical information, animal pharmacology/toxicology, human/clinical pharmacology (phase I), exploratory clinical trials (phase II), confirmatory clinical trial (phase III), bio-availability dissolution and stability study data, regulatory status in other countries and marketing information along with application for test license.

42. In the instant case, the pre-clinical study data submitted by Cadila was reviewed by experts in the Review Committee of Genetic Manipulation (RCGM) at a meeting held on 22.02.2012. The RCGM, being satisfied with the consistency of the process and product, product characterisation and specifications, granted permission to conduct toxicology studies vide letter dated 30.03.2012. After this permission, Cadila conducted comparative animal toxicity as per Biosimilar Guidelines and comparative toxicological studies were conducted to evaluate safety of similar biologic ‘Trastuzumab’ developed by Cadila. After conducting comparative studies, data was submitted for review and animal study findings were discussed in the meeting of RCGM held on 28.08.2012. RCGM recommended Cadila to approach DCGI for guidance and approval on 18.09.2012. Cadila submitted an application on 22.10.2012 for conduct of phase III study. The proposal was to conduct comparative phase III clinical trial so as to compare Cadila’s ‘Trastuzumab’ and innovator ‘Trastuzumab’ of Roche in terms of Pharmacokinetics (prime end point) and efficacy as secondary end point. Trial also assessed safety including immunogenicity of Plaintiffs’ ‘Trastuzumab’. Proposal to conduct phase III clinical trial was deliberated in the New Drugs Advisory Committee (oncology and hematology) meeting dated 02.08.2013 and certain recommendations were given. Based on Cadila’s response, matter was again deliberated in the meeting held on 27.11.2013 and permission was granted to conduct phase III study on 10.03.2014. A total of 102 subjects were randomized in 2:1 ratio and 100 out of them were included in the ITT population. Total 93 subjects completed the entire study treatment as per protocol population. After phase III clinical trial, Cadila submitted an application in Form 44 for grant of permission/approval for manufacture of bulk drug and new drug formulation in Forms 46 and 46A. Proposal was discussed in 30th SEC meeting held on 18.08.2015 and the committee recommended granting approval for manufacture of bulk drug and new drug formulation for metastatic breast cancer indication. Committee also recommended marketing authorization of ‘Trastuzumab’ for the said indication and in another meeting held on 27.10.2015, the Committee approved the package insert with some modifications/conditions. Thereafter, approval for manufacture of new drug formulation and bulk drug was accorded for indication HER 2+ metastatic breast cancer for two strengths namely, Trastuzumab 440 mg and 150 mg lyophilized for solution for infusion containing Trastuzumab as a drug substance. License to manufacture drug was issued on 27.12.2015 and the artwork of the label etc. was approved on 22.12.2015, where package insert was only for indication HER 2+ metastatic breast cancer. Subsequent thereto, approval was granted on 21.01.2016 for use of the drug in two other indications viz. early breast cancer and metastatic gastric cancer. All the decisions have been taken consciously by the experts being a part of the relevant committees and in consonance with the provisions of the Drugs Act, Drugs Rules and Biosimilar Guidelines and no infirmity exists in the decision making process.

43. In Boehringer Ingelheim India Pvt. Ltd. v. Drugs Controller General of India and Another, 2019 SCC OnLine Del 10709, the Court was dealing with a writ petition inter alia praying for revocation of the marketing approval granted to Respondent No. 2 therein for its drug ‘Tenectase’ used for treatment of Acute Ischemic Stroke. The controversy involved was whether marketing approval was in accordance with Drugs Act and Drugs Rules. It was held by the Court that subject of clinical trials cannot be viewed in a straightjacket formula and it would be open for DCGI to mould the extent of clinical trials, keeping in view the objectives sought to be achieved. The extent of clinical trial required and whether they can be abbreviated is a matter to be considered by experts and no interference is warranted in proceedings under Article 226 of the Constitution of India, unless it is established that the same is malafide, capricious or fails the Wednesbury test i.e. no sensible person could arrive at the said decision. In Mithilesh Garg and Others v. Union of India and Others, (1992) 1 SCC 168, the Supreme Court held that grant of permits etc. are matters within the comprehension of the Transport Authorities and it is for the said Authority to take into consideration all relevant factors at the time of quasi-judicial consideration of applications for grant of permits. It is the Statutory Authority which under the Act is bound to keep a watch on the erroneous and illegal exercise of power in granting permits. Reliance was placed on the judgment of the Supreme Court in Jasbhai Motibhai Desai v. Roshan Kumar, Haji Bashir Ahmed and Others, (1976) 1 SCC 671, where the Supreme Court held that where the Appellant has not been denied or deprived of a legal right and has not sustained injury to any legally protected interest, he has no legal peg for a justiciable claim to hang on.

44. I have heard learned Senior Counsels for the parties and learned Central Government Standing Counsel for DCGI and examined their respective contentions.

45. This judgment decides two applications filed under Order VII Rule 11 CPC by which Cadila and Hetero call upon this Court to reject the respective plaints in the two suits. From a reading of the applications and the arguments canvassed, broadly, rejection is sought on four grounds: (a) suit is impliedly barred by law as the Plaintiffs have failed to avail the alternative and efficacious remedy of filing an appeal under Rule 122DC of the Drugs Rules; (b) plaints do not disclose any cause of action and Plaintiffs have no locus standi to institute the suits; (c) competence of the drug regulatory authority i.e. DCGI and exercise of discretion by it cannot be challenged in a Court of ordinary original civil jurisdiction since DCGI regulates manufacture and marketing of biosimilar drugs in India under the Drugs Act and Drugs Rules, which are a complete code, with inbuilt mechanisms of regulation and remedies; and (d) suit against Cadila is barred by Section 10 CPC on account of an earlier suit filed by it before the Bombay High Court. Before examining the grounds for rejection of the plaints, it would be pertinent to have a close look at the provisions of Order VII Rule 11 CPC to understand the grounds on which a plaint can be rejected. Order VII Rule 11 CPC is extracted hereunder, for ready reference:- “ORDER VII PLAINT

11. Rejection of plaint: The plaint shall be rejected in the following cases:— (a) where it does not disclose a cause of action; (b) where the relief claimed is undervalued, and the plaintiff, on being required by the Court to correct the valuation within a time to be fixed by the Court, fails to do so;

(c) where the relief claimed is properly valued, but the plaint is returned upon paper insufficiently stamped, and the plaintiff, on being required by the Court to supply the requisite stamp-paper within a time to be fixed by the Court, fails to do so;

(d) where the suit appears from the statement in the plaint to be barred by any law.”

46. There are four grounds on which a plaint can be rejected at any stage and the applicants have invoked sub-Rules (a) and (d) of Rule

11. The guiding principles which are required to be kept in mind while deciding an application under Order VII Rule 11 CPC have been laid down and affirmed and re-affirmed by the Supreme Court in several judgments and I may allude to a few hereinafter. In Sopan Sukhdeo Sable and Others v. Assistant Charity Commissioner and Others, (2004) 3 SCC 137, the Supreme Court held as under:-

47. In Madanuri Sri Rama Chandra Murthy v. Syed Jalal, (2017) 13 SCC 174, the Supreme Court observed as under:-

48. In Dahiben v. Arvindbhai Kalyanji Bhanusali (Gajra) Dead Through legal representatives and Others, (2020) 7 SCC 366, deliberating on the provision of Order VII Rule 11 CPC, the Supreme Court held:- “23.2. The remedy under Order 7 Rule 11 is an independent and special remedy, wherein the court is empowered to summarily dismiss a suit at the threshold, without proceeding to record evidence, and conducting a trial, on the basis of the evidence adduced, if it is satisfied that the action should be terminated on any of the grounds contained in this provision.

23.3. The underlying object of Order 7 Rule 11(a) is that if in a suit, no cause of action is disclosed, or the suit is barred by limitation under Rule 11(d), the court would not permit the plaintiff to unnecessarily protract the proceedings in the suit. In such a case, it would be necessary to put an end to the sham litigation, so that further judicial time is not wasted.

23.4. In Azhar Hussain v. Rajiv Gandhi [Azhar Hussain v. Rajiv Gandhi, 1986 Supp SCC 315. Followed in Manvendrasinhji Ranjitsinhji Jadeja v. Vijaykunverba, 1998 SCC OnLine Guj 281: (1998) 2 GLH 823] this Court held that the whole purpose of conferment of powers under this provision is to ensure that a litigation which is meaningless, and bound to prove abortive, should not be permitted to waste judicial time of the court, in the following words: (SCC p. 324, para 12)

xxx xxx

23.6. Under Order 7 Rule 11, a duty is cast on the court to determine whether the plaint discloses a cause of action by scrutinising the averments in the plaint [Liverpool & London S.P. & I Assn. Ltd. v. M.V. Sea Success I, (2004) 9 SCC 512], read in conjunction with the documents relied upon, or whether the suit is barred by any law.

23.12. In Hardesh Ores (P) Ltd. v. Hede & Co. [Hardesh Ores (P) Ltd. v. Hede & Co., (2007) 5 SCC 614] the Court further held that it is not permissible to cull out a sentence or a passage, and to read it in isolation. It is the substance, and not merely the form, which has to be looked into. The plaint has to be construed as it stands, without addition or subtraction of words. If the allegations in the plaint prima facie show a cause of action, the court cannot embark upon an enquiry whether the allegations are true in fact. D. Ramachandran v. R.V. Janakiraman [D. Ramachandran v. R.V. Janakiraman, (1999) 3 SCC 267; See also Vijay Pratap Singh v. Dukh Haran Nath Singh, AIR 1962 SC 941].

23.13. If on a meaningful reading of the plaint, it is found that the suit is manifestly vexatious and without any merit, and does not disclose a right to sue, the court would be justified in exercising the power under Order 7 Rule 11 CPC.

23.14. The power under Order 7 Rule 11 CPC may be exercised by the court at any stage of the suit, either before registering the plaint, or after issuing summons to the defendant, or before conclusion of the trial, as held by this Court in the judgment of Saleem Bhai v. State of Maharashtra [Saleem Bhai v. State of Maharashtra, (2003) 1 SCC 557]. The plea that once issues are framed, the matter must necessarily go to trial was repelled by this Court in Azhar Hussain case [Azhar Hussain v. Rajiv Gandhi, 1986 Supp SCC 315. Followed in Manvendrasinhji Ranjitsinhji Jadeja v. Vijaykunverba, 1998 SCC OnLine Guj 281: (1998) 2 GLH 823].

23.15. The provision of Order 7 Rule 11 is mandatory in nature. It states that the plaint “shall” be rejected if any of the grounds specified in clauses (a) to (e) are made out. If the court finds that the plaint does not disclose a cause of action, or that the suit is barred by any law, the court has no option, but to reject the plaint.

24. “Cause of action” means every fact which would be necessary for the plaintiff to prove, if traversed, in order to support his right to judgment. It consists of a bundle of material facts, which are necessary for the plaintiff to prove in order to entitle him to the reliefs claimed in the suit.

24.1. In Swamy Atmananda v. Sri Ramakrishna Tapovanam [Swamy Atmananda v. Sri Ramakrishna Tapovanam, (2005) 10 SCC 51] this Court held: (SCC p. 60, para 24)

24.2. In T. Arivandandam v. T.V. Satyapal [T. Arivandandam v. T.V. Satyapal, (1977) 4 SCC 467] this Court held that while considering an application under Order 7 Rule 11 CPC what is required to be decided is whether the plaint discloses a real cause of action, or something purely illusory, in the following words: (SCC p. 470, para 5)

49. In Saleem Bhai v. State of Maharashtra, (2003) 1 SCC 557, the Supreme Court held that while deciding an application under Order VII Rule 11 CPC, the Court only needs to look at the averments in the plaint. The power can be exercised at any stage of the suit but only the averments in the plaint are germane and pleas taken by the Defendant in the written statement would be wholly irrelevant at that stage and therefore even a direction to file the written statement without deciding the application under Order VII Rule 11 CPC cannot but be a procedural irregularity, touching the exercise of jurisdiction of a Court.

50. From a reading of the aforementioned judgments, the broad principles that emerge are that remedy under Order VII Rule 11 CPC is an independent and special remedy, where a suit can be dismissed at the threshold or at any stage, if the Court is satisfied that any of the grounds mentioned therein exist, so that a litigation which is meaningless or on the face of it is bound to prove abortive, should not proceed further. It is a power which is a drastic one and has to be carefully exercised and only when the conditions enumerated in Rule 11 of Order VII CPC are strictly fulfilled. While deciding the application, the Court can only examine the plaint on a demurrer as well as the documents filed along with the plaint. Defence set up by the Defendant in the written statement is wholly immaterial, irrelevant and extraneous while adjudicating the application and cannot be adverted to. The averments in the plaint have to be taken to be correct in their entirety and the test is to see whether on the pleaded facts, a decree can be passed. Plaint has to be read and construed meaningfully as it stands, without addition or subtraction of words and only if on a meaningful reading it is found that the suit is manifestly vexatious and without merit, the Court will be justified in rejecting the plaint.

51. At the cost of repetition, Rule 11 of Order VII provides four grounds on which the Court can consider rejection of the plaint if an application is filed viz. (a) plaint discloses no cause of action; (b) relief claimed is undervalued and the Plaintiff on being required by the Court to correct the valuation within a fixed time, fails to do so;

(c) where the relief claimed is properly valued but the plaint is written upon paper insufficiently stamped, and the plaintiff, on being required by the Court to supply the requisite stamp-paper within a time to be fixed by the Court, fails to do so; and (d) where the suit appears from the statement in the plaint to be barred by any law.

52. Taking shelter under Order VII Rule 11(d) CPC, rejection of the plaints is sought on two-fold grounds. The first contention that the plaints are barred by law on account of the failure of the Plaintiffs to avail the remedy of appeal under Rule 122DC of the Drugs Rules only merits rejection. For ready reference, Rule 122DC is as follows:- “122DC. Appeal.- Any person aggrieved by an order passed by the Licensing Authority under this Part, may within sixty days from the date of such order, appeal to the Central Government, and the Central Government may after such enquiry into the matter as is considered necessary, may pass such order in relation thereto as it thinks fit.”

53. Rule 122DC was deleted at the time of amendment and there is no corresponding provision in Rules 2019, providing a remedy of appeal to the Central Government, against an order of the regulator. Present suits were filed prior to the amendment and thus the short question that arises is whether the Plaintiffs had a remedy of appeal under Rule 122DC, which they failed to avail and if so, does that lead to the suits being barred by law, necessitating rejection of the plaints. Plain reading of Rule 122DC shows that it enables ‘any person aggrieved’ by an order passed by the Licensing Authority under Part XA, to appeal against the order to the Central Government, within a period of 60 days from the date of the said order. This Court tends to agree with the Plaintiffs that the expression ‘any person aggrieved’ would mean and connote a person/party who is before the regulator in the first instance and is directly aggrieved by an order of the Licensing Authority refusing to grant or renew the license and not to one, who is not before the regulator directly, but has a grievance consequent upon grant/renewal of license, as the Plaintiffs herein. This is the only plausible interpretation of Rule 122DC and is fortified by the fact that approvals granted in favour of biosimilars are admittedly never notified to the innovators of the drug such as the Plaintiffs nor is any information available otherwise. There is also no provision under the Drugs Rules for serving copies of permission of license upon the third parties other than the one applying for permission. In the absence of such a provision or the approval being placed in public domain, the effected third party will never be in a position to file an appeal within the prescribed limitation period of 60 days. Therefore, in my view, the scheme of Rule 122DC is not intended by the Rule makers to apply to a party such as the Plaintiffs.

54. Relevant it is to note that this very objection of failure to resort to the remedy of appeal under Rule 122DC was raised by the Defendant in the Reliance suit, questioning the maintainability and was negated by the Court in the judgment in Genentech INC and Others v. Drugs Controller General of India and Others, 2016 SCC OnLine Del 2572, deciding an application under Order XXXIX Rules 1 and 2 CPC. It is important to highlight that the Court had recorded a concession given by the learned Additional Solicitor General, appearing on behalf of the Regulator that Rule 122DC does not protect or enforce the rights of the manufacturer of the innovator drug and the procedure of granting approvals to manufacturers of biosimilar drugs does not involve a lis between the manufacturer of an innovator drug and a biosimilar drug. It was conceded that since DCGI does not determine the rights of innovators at the time of granting approvals to new drug manufacturers, Plaintiffs were entitled to file a civil suit to protect their rights in relation to their drug ‘Trastuzumab’, in the absence of any other alternative and efficacious remedy being available. This Court is persuaded to concur with the view taken in the said judgment, as an added reason, to hold that remedy of appeal under Rule 122DC was not a path available to the Plaintiffs and there is no other alternative remedy under the Drugs Rules/Act, precluding them from approaching this Court. Suits are thus not barred by law and plaints cannot be rejected on this ground. Relevant paragraphs from the judgment in Genentech INC and Others v. Drugs Controller General of India and Others, 2016 SCC OnLine Del 2572, are as follows:-

55. Second ground on which objection under Order VII Rule 11(d) CPC is taken is lack of jurisdiction of a civil Court to entertain a challenge to the decision of a regulatory authority acting within the confines of Legislations such as the Drugs Act. Section 9 CPC provides that the Courts shall have jurisdiction to try all suits of a civil nature, excepting suits of which their cognizance is either expressly or impliedly barred. In Secretary of State (supra), it was laid down by the Judicial Committee that ouster of the jurisdiction of a Civil Court is not to be lightly inferred and can only be ousted and excluded, if there is an express provision of law so providing or is clearly implied. This issue also came up before this Court in Ganga Ram Hospital Trust v. Municipal Corporation of Delhi, 2001 SCC OnLine Del 622, and the Court held that except where a civil suit is specifically barred under a particular Statute, there can be no bar to a civil suit. A suit for its maintainability requires no authority of law and it is enough that no Statute bars the suit, as the jurisdiction of a Civil Court is all embracing. The Court also examined implied bar as distinguished from an express bar, which may arise in a situation where a Statute for instance creates a special right and lays down a special remedy for exercising the right. Delving on this issue, the Court held that an implied bar need not be readily inferred as exclusion of jurisdiction of a Civil Court is a serious matter and cannot be encouraged. Legal rights ought to be normally given effect to rather than curtailed by inviting implied bars to jurisdiction and the reason is simple. Wherever Legislature intends to bar institution of civil suits, it does not hesitate in saying so in the Statute itself. The Court also observed that the mere fact that a Statute provides for certain remedies is not sufficient to exclude jurisdiction of Civil Courts as the right to approach the Civil Court is an inherent right which normally cannot be taken away or presumed to be taken away and is too strong a right to be denied by indirect means and thus only a specific bar could take it away. In that context, the Court referred to Sections 169 and 170 of the Delhi Municipal Corporation Act, 1957 and held that Section 169 provides for a remedy of appeal against levy or assessment of any tax, while Section 170 lays down conditions to exercise the right, but neither of the two provisions contain a bar against a civil suit to challenge the levy/assessment of tax under the Act and at best it could be argued that in view of the remedy of appeal, party should have recourse to the same. Wherever Legislature intends to create a specific bar to a civil suit it so provides in the Statute as in the case of matters relating to unauthorized constructions, where Section 347E provides a complete bar to the power of Civil Court to entertain suits/applications etc. in respect of a notice, appealable under Section 343 or Section 347B. Relevant passages from the judgment are as follows:-

19. Possibly it could be argued that in view of (he provision of appeal contained in section 169 of the Act a civil suit to challenge the levy and assessment of tax under the Act should be impliedly taken as barred. In our view such an argument cannot be accepted. It is well established that an implied bar should not be readily inferred. There is a genuine reason for this. The reason is that court should not lean in favour of curtailing civil rights or inherent rights of parties. The code itself contains safeguards against frivolous suits being brought before courts. First is the power of the court to reject a plaint under Order VII Rule 11 CPC. Next the burden is heavy on the plaintiff who brings a suit to establish his/her case in accordance with law before relief can be available. Lastly courts are fully empowered to impose costs in case of frivolous litigation being brought before them. The power of imposition of costs is left to the discretion of the courts. For instance if the plaintiff fails to establish that the levy and assessment of tax is contrary to the statute or that the Corporation failed to follow the procedure prescribed under the Act before levy and assessment of tax, the suit may be dismissed with costs.

20. It will normally depend on the nature of the statutory provision whether a civil suit can be said to be barred. Whenever a plea is raised before a civil court that its jurisdiction is excluded either expressly or by necessary implication to entertain claims of a civil nature, the court naturally has to consider the provision in the statute in the first instance. If the statute contains a specific bar, it will be end of the matter. In the absence of a specific bar the nature of statutory remedy will have to be considered. The court has to consider whether the statutory remedy is adequate and efficacious. Where the exclusion of the civil court's jurisdiction is expressly provided for, the consideration as to the scheme of the statute in question and the adequacy or the sufficiency of remedies provided for by it may be relevant, it cannot, however, be decisive. But when exclusion is pleaded as a matter of necessary implication such consideration would be very important and, in conceivable circumstances, might even become decisive. Kamala Mills Ltd. v. State of Bombay, AIR 1965 SC 1042.

21. This brings us to the issue whether the remedy of appeal provided under section 169 of the Act is adequate and efficacious. It has been argued that the remedy by way of appeal is neither adequate nor efficacious. The District Judge who hears the appeal has limited powers. It is a truncated right of appeal. He cannot decide questions of law, for which he has to refer the matter to the High Court. He cannot dispense with the requirement of pre-deposit contained in Section 170 (b) nor he can reduce the amount. He has no power to order refund of the amount deposited in the event of success of the assessee in the appeal. There is no doubt that the right of appeal under section 169 cannot be compared with the powers of a civil court in a civil suit. A statute while giving the right of appeal, may confer finality on the decision of the appellate Tribunal and may provide that decision of the Tribunal cannot be questioned in a civil court. In such a case a civil suit may have to be held to be barred. Both the channels cannot be said to be open to the aggrieved party simultaneously and it can exercise its choice about the remedy to be pursued.

22. An important question which needs to be considered in this connection is whether the statutory remedy is adequate and equally efficacious or it is too onerous.

23. Even when a statutory remedy is adequate it may turn out to be highly onerous and it may be impossible for an aggrieved party to avail of the same. Often the statutory remedies are saddled with a condition that before the remedy can be availed of the aggrieved party has to deposit the amount in dispute with the Appellate Tribunal or elsewhere as the case may be. In the Delhi Municipal Corporation Act which is under consideration section 170 (b) lays down a condition that the amount in dispute in the appeal has to be deposited by the appellant in the office of the Corporation before an appeal can be heard. This provision is often difficult to comply and it renders the remedy highly onerous leading to negation of right of appeal. A party which cannot afford to deposit the amount in dispute will not be able to exercise the right of appeal. The constitutional validity of this provision has “been upheld by the Supreme Court in Shyam Kishore v. M.C.D., AIR 1992 SC 2279 but the Supreme Court was not concerned with the controversy which is under consideration in the present appeals i.e. whether in view of this remedy being saddled with the requirement of pre-deposit, a civil suit to challenge the levy and assessment of tax can be said to be barred. This aspect has been subject matter of decisions of the Apex Court on various occasions. In Himmatlal Harilal Mehta v. State of Madhya Pradesh, 1954 SCR 1122 it was held by the Supreme Court that if the remedy provided by the Act is of an onerous and burdensome character, it can hardly be said to be an adequate alternative remedy. Before the appellant can avail of it he has to deposit the whole amount of tax. Such a provision can hardly be described as an adequate alternative remedy. It renders the right of appeal illusory and not real.

24. Again in M.G. Abrol, Addl. Collector of Customs, Bombay and Another v. Shantilal Chhotelal and Co., AIR 1966 SC 197, it was observed:

25. In Indian Hotels Company Limited v. New Delhi Municipal Council, 63 (1996) DLT 163 a Division Bench of this Court held that the condition of pre-deposit amounts to negation of the right of appeal. The requirements of pre-deposit makes the remedy too onerous. To illustrate the point the court gave several examples. The following observations contained in the said judgment highlight the issue:

56. Objection to a Civil Court’s jurisdiction was raised in a similar fashion in the suits filed by the Plaintiffs against Reliance and Biocon/Mylan. The issue of Civil Court’s jurisdiction was deliberated upon at length by the Court in Genentech INC and Others v. Drugs Controller General of India and Others, 2016 SCC OnLine Del 2572, and the objection was rejected. The judgment was carried to the Division Bench and thereafter to the Supreme Court. After deliberating on the issue, the Supreme Court directed that the interim directions given by the learned Single Judge on 25.04.2016 would come into operation. This Court is conscious of the observation of the Supreme Court that the views expressed in the order were only for the purpose of that appeal and would have no bearing in the proceedings pending in the High Court, however, the reference is only to show that the Supreme Court did not interfere with the order of the learned Single Judge, wherein question of maintainability on the ground of alternate remedy of appeal as well as jurisdiction of Civil Court was raised by Reliance, but was rejected. Relevant observations in the judgment in Genentech INC and Others v. Drugs Controller General of India and Others, 2016 SCC OnLine Del 2572, dealing with the jurisdiction of the Court under Section 9 CPC, albeit tentative but with which I concur, are as follows:-

66. In case the prayer made in the application is examined, it is evident that the plaintiffs were seeking an injunction for launching, introducing the drug by the defendant No. 3, an injunction from representing as biosimilar products until appropriate tests and studies are conducted including guidelines on similar biologics and injunction from press releases and relying upon or referring to the plaintiffs trade mark claiming similarity of two drugs.

67. The plaintiffs have claimed that the defendant No. 3 is infringing their legal rights and will make a misrepresentation is they are allowed to use the data and to claim biosimilar product. Their main concern is that without establishing the safety and efficacy as required under the Act, Rules and Guidelines 2012, they are not entitled to claim that it is a biosimilar drug of the innovator and would not be entitled to use the data of the plaintiffs and give references in its package insert, carton and publicity materials by making the false statement and misrepresentation. Otherwise, independently, they are entitled to market drug in question without any such references. If the clinical trials are not conducted, the Regulatory Authority is liable to take action under Rule 122 DB. But if the references of biosimilar are made by the defendant No. 3 for promoting and selling the drug in question, the plaintiffs are entitled to file the suit. The decisions are referred by the counsel for the plaintiffs. Even written-submissions filed on this point are almost same.

68. It is settled law that Section 9 of the Code provides that civil court shall have jurisdiction to try all suits of a civil nature excepting the suits of which their cognizance is either expressly or impliedly barred. To put it differently, as per Section 9 of the Code, in all types of civil disputes, civil courts have inherent jurisdiction unless a part of that jurisdiction is carved out from such jurisdiction, expressly or by necessary implication by any statutory provision and conferred on other Tribunal or Authority. Thus, the law confers on every person an inherent right to bring a suit of civil nature of one's choice, at one's peril, howsoever frivolous the claim may be, unless it is barred by a statute. Even as per the decision referred by defendant No. 1 in the case of State of Andhra Pradesh (supra) it is held that the normal rule of law that the civil courts have jurisdiction to try all suit and such exclusion is not readily inferred and the presumption to be drawn.

69. It is trite and debated time and again that the rule of pleadings postulate that a plaint must contain material facts. When the plaint read as a whole does not disclose material facts giving rise to a cause of action which can be entertained by a civil court, it may be rejected in terms of Order 7, Rule 11 of the Code. Similarly, a plea of bar to jurisdiction of a civil court has to be considered having regard to the contentions raised in the plaint if averments disclosing cause of action and the reliefs sought. a) In Smt. Ganga Bai v. Vijay Kumar (1974) 2 SCC 393, this Court had observed as under: “There is an inherent right in every person to bring suit of a civil nature and unless the suit is barred by statute one may, at ones peril, bring a suit of one's choice. It is no answer to a suit, howsoever frivolous the claim, that the law confers no such right to sue. A suit for its maintainability requires no authority of law and it is enough that no statute bars the suit.” b) In Dhannalal v. Kalawatibai (2002) 6 SCC 16, relying on the afore-extracted observation in Ganga Bai's case (supra), this Court had held as follows: “Plaintiff is dominus litis, that is, master of, or having dominion over, the case. He is the person who has carriage and control of an action. In case of conflict of jurisdiction the choice ought to lie with (1974) 2 SCC 393 (2002) 6 SCC 16 the plaintiff to choose the forum best suited to him unless there be a rule of law excluding access to a forum of plaintiff's choice or permitting recourse to a forum will be opposed to public policy or will be an abuse of the process of law.”

70. Originally the suit was filed as Quia Timet Action. It is settled law that such an action is maintainable. If a party fears or apprehends, then the injunction may be passed by the court on some threatened act being done in future, would cause him substantial damage where monetary relief would not be an adequate or sufficient remedy. In a quia timet action, the court passes an injunction as a preventive measure so as to prevent the future occurrence of the wrong on the basis that the reasonable apprehension of the injury to be occurred in future rather than waiting for the perfection of the wrong. In the case of Kuldip Singh v. Subhash Chander Jain, (2000) 4 SCC 50: AIR 2000 SC 1410 in para 7 it is held that “A quia timet action is a bill in equity. It is an action preventive in nature and a species of precautionary justice intended to prevent apprehended wrong or anticipated mischief and not to undo a wrong or mischief when it has already been done. In such an action the Court, if convinced, may interfere by appointment of receiver or by directing security to be furnished or by issuing an injunction or any other remedial process”

71. It is not disputed by all that there is no specific bar of civil court jurisdiction in the Act and Rules. It is also admitted position that the main dispute is between the private parties i.e. plaintiffs and defendant No. 3. It is not denied by the defendants that the suit is not filed against any government employees who were involved in the process of approvals. It is admitted by the defendant No. 1 that as per Act and Rules there is no procedure for cross-notice or to hear the grievances of the plaintiffs that the authority has not considered the clinical trials properly or to send the copy of the approvals and backed up documents who claimed himself as an aggrieved party.

72. In view of the attendant circumstances discussed above, I have already observed as to how the plaintiffs have an enforceable right to seek an interdict the court and the court can exercise the jurisdiction not merely on the basis of private lis between the parties but by invoking the public interest doctrine which also guide the courts, still, I am discussing the provisions of Section 9 of the Code of civil procedure in order to discuss the plea raised by the defendant in relation to the ouster of the jurisdiction. Section 9 of the Code of Civil Procedure (“CPC”) mandates that civil courts have the jurisdiction to determine all disputes of a civil nature, unless their jurisdiction is barred under a statute, either expressly or by necessary implication. It is settled law that if the appropriate authority has acted in violation of the fundamental principles of judicial procedure that may tend to make the proceedings illegal and void, then Civil Court's jurisdiction may not be taken away which has under those circumstances have the jurisdiction to examine the non-compliance with such provisions of the statute. There is inherent right in every person to bring a suit of a civil nature unless the suit is barred expressly and impliedly. (See Dhulabhai v. State of Madhya Pradesh (1968) 3 SCR 662, Abdul Gafur v. State of Uttarakhand (2008) 10 SCC 97, Dwarka Prasad Agarwal v. Ramesh Chander Agarwal (2003) 6 SCC 220, Harbanslal Sahnia v. Indian Oil Corporation (2003) 2 SCC 107, State of Madhya Pradesh v. Bhailal Bhai (1964) 6 SCR 261, State of Kerala v. Ramaswami Iyer and Sons (1966) 3 SCR 582, Secretary of State v. Mask and Company (1940 40 LR 222).

73. It is also settled law that the exclusion of the jurisdiction of the civil courts is not to be readily inferred, but that such exclusion must either be explicitly expressed or clearly implied. Even if jurisdiction is so excluded, the civil courts still have jurisdiction to examine into cases where the provisions of the Act have not been complied with, or the statutory tribunal has not acted in conformity with the fundamental principles of judicial procedure. If consequence of the same is that, it affects the civil right of the party, then the civil suit is maintainable. In the case of Mohammad Din v. Imam Din, AIR 1948 PC 33 it laid down the principle that where the tribunals do not act in conformity with the fundamental rules of judicial procedure or where the rules of the law are not followed, the civil court has jurisdiction and to this extent no ouster can be inferred)

74. The decision in the case of Mohammad Din (supra) has been followed by the courts in India from time to time including the High Courts of Punjab and Haryana in the case of and also by Allahabad High Court recently in 2010 in the case of Shivdhesar Singh v. Union of India, 2011 2 AWC 1202.

75. Applying the dictum of Mohammad Din (supra) which still holds the field and followed by the courts, the present suit cannot be said to be barred in the present form. I find that the judgments cited by Mr. Sibal on the breach of the statutory duty are also distinguishable in the facts of the present case as it is not merely the case of the breach of any statutory duty but also the violation of the rules of the judicial procedure by not following the guidelines framed by the controller on his own and granting the approvals on the basis of different regime in an undue haste when the Supreme Court order also mandated the conducting of the clinical trial. All this have the bearing on the rights of the plaintiffs giving them right to enjoin the defendants till the time the defendants accomplish the onerous task of seeking approvals as per the bio similar regime framed in the form of the guidelines.”

57. In view of the wealth of judicial precedents referred to above, there is no substance in the contentions of Cadila and Hetero that this Court lacks the jurisdiction to entertain the present suits and plaints be rejected under Order VII Rule 11(d) being barred in law. It is not the case of the Defendants that in order to claim biosimilarity, a drug is not required to be rigorously tested in accordance with the procedures laid down in the Drugs Act, Drugs Rules and the Biosimilar Guidelines to establish its similarity or near similarity to the innovator reference biologic on every parameter. Plaintiffs have questioned the validity of clinical trials conducted by Cadila and Hetero and grant of approvals by the regulator as being non-compliant with the prescribed mandatory procedure under the applicable laws. Plaintiffs seek declaration that the approvals are non est as well as restraint orders against representation of the impugned drugs as biosimilars till appropriate tests are conducted, raising concerns of safety and efficacy in public interest and dilution of their goodwill due to passing off. Plaintiffs have categorically averred that they do not question the competence or discretion of the Regulatory Authority to grant approvals to biosimilars but lay a siege to the manner in which the approvals have been granted i.e. the decision making process, within the contours of the legal and statutory framework regulating the same. It is not disputed by any of the Defendants that there is no specific bar of Civil Court jurisdiction under the Drugs Act or Rules. It is an admitted position that the regulatory regime does not envisage a procedure for cross-notice or grant of opportunity to the drug innovator at the pre-grant stage of approvals to bring to the attention of the Authority that the mandatory pre-clinical/clinical trials have not been properly conducted and/or any other violation of the procedure. Therefore, if in a given case approvals are questioned, then as observed by the Court in the Reliance suit, Plaintiffs cannot be prevented from enforcing a right to enjoin the defendants till they accomplish the onerous task of establishing that the approvals for manufacturing, distributions and sales were in consonance with the biosimilar regime in the form of Drugs Act/Rules and Guidelines. In these circumstances, Civil Court’s powers can be invoked to interdict the resultant consequences of impugned actions.

58. The sheet anchor of the arguments of Cadila and Hetero is that plaints do not disclose ‘cause of action’ and Plaintiffs have no locus standi to institute the suits. In order to examine this contention for the purpose of adjudicating if the plaints deserve rejection, it would be necessary to examine the pleadings in the plaints, since adjudication of an application under Order VII Rule 11 CPC is circumscribed by scrutiny of the averments in the plaint and the accompanying documents alone.

59. In Liverpool & London S.P. & I Association Ltd. v. M.V. Sea Success I and Another, (2004) 9 SCC 512, the Supreme Court highlighted the purpose and object underlying Order VII Rule 11(a) CPC and held that when no cause of action is disclosed, Courts will not unnecessarily protract the hearing of a suit. Having regard to the legislative policy adumbrated by various amendments to CPC, Courts would interpret the provision in a manner so as to save expenses, achieve expedition and avoid Court’s resources being used up in cases which will serve no useful purpose. It was at the same time reiterated that for considering whether a plaint discloses a cause of action is a question of fact for which the averments in the plaint must be held to be correct and then the test is as to whether if the averments in the plaint seen in entirety, are taken to be correct, could a decree be passed. Cause of action is a bundle of facts required to be pleaded and proved for obtaining relief claimed in the suit. The Supreme Court cautioned that although the provision authorizes the Court to reject a plaint on the failure of the Plaintiff to disclose a cause of action but at the same time, this would not mean that the averments in the plaint or the documents relied upon although disclose a cause of action, plaint could be rejected on the ground that averments are not sufficient to prove the facts stated therein. In ascertaining whether a plaint discloses a cause of action, Court is not required to make an elaborate inquiry into doubtful or complicated questions of law or fact. So long as the claim discloses some cause of action or raises some questions fit to be decided by a Judge, the mere fact that the case is weak and not likely to succeed is no ground for striking it out. The purported failure of the pleadings to disclose a cause of action is distinct from the absence of full particulars. In Liverpool & London S.P. & I Association Ltd. (supra), it was held as follows:-

60. In Vijai Pratap Singh and Another v. Dukh Haran Nath Singh and Another, AIR 1962 SC 941, the Supreme Court observed:-

61. The expression ‘cause of action’, has been the subject matter of discussions and deliberations in several cases by the Supreme Court. [Ref: Kusum Ingots & Alloys Ltd. v. Union of India and Another, (2004) 6 SCC 254, and Liverpool & London S.P. & I Association Ltd. (supra)]. ‘Cause of action’ is a bundle of facts, which are required to be pleaded and proved for the purpose of obtaining relief claimed in the suit. In Rajasthan High Court Advocates’ Association v. Union of India and Others, (2001) 2 SCC 294, the Supreme Court observed that the expression ‘cause of action’ means every fact which, if traversed, would be necessary for the Plaintiff to prove to support his right to a judgment of the Court. In other words, it is a bundle of facts which taken with the law applicable to them gives the Plaintiff a right to relief against the Defendant. Relevant paragraph is as follows:-

62. It would help to refer to the following passage from Halsbury’s Laws of England:- “Cause of action has been defined as meaning simply a factual situation the existence of which entitles one person to obtain from the Court a remedy against another person. The phrase has been held from earliest time to include every fact which is material to be proved to entitle the plaintiff to succeed, and every fact which a defendant would have a right to traverse. 'Cause of action' has also been taken to mean that particular act on the part of the defendant which gives the plaintiff his cause of complaint, or the subject matter of grievance founding the action, not merely the technical cause of action.”

63. It is trite that the question whether a suit discloses a cause of action or not, has to be decided on the basis of averments in the plaint on a mere demurrer and if pleadings in the plaint read in conjunction with the documents filed along with the plaint disclose that Plaintiff has a right to sue the Defendant, the plaint cannot be rejected as lacking cause of action under Order VII Rule 11 CPC. It is not permissible at this stage for the Court to examine the defence set up by the Defendant and nor is the Court to enter into an inquiry or a mini trial to ascertain if Plaintiff has a chance of success finally, when the suit is adjudicated on merits. Essentially, whether the plaint discloses a cause of action is a question of fact, which has to be gathered only on the basis of asseverations made in the plaint in its entirety and taking the same to be correct. This legal position is supported by the plain language of Rule 11 viz.: ‘where it does not disclose a cause of action’. The emphasis is clearly on ‘it’ i.e. the plaint and therefore, disclosure of cause of action has to be seen within the confines of the plaint.

64. Present applications are thus to be decided by the guiding principles laid down by the Supreme Court in the above judgments. Before going forward, a little backdrop will be necessary. As per the averments in the plaints, Plaintiffs herein are globally engaged in the business of healthcare in the fields of pharmaceuticals and diagnostics. In CS(COMM) 540/2016, Plaintiffs have predicated their case on being innovators and developers of biological drug ‘Bevacizumab’, a recombinant humanized monoclonal antibody that selectively binds to and neutralizes the biologic activity of human vascular endothelial growth factor (‘VEGF’). It is pleaded that ‘Bevacizumab’ contains human framework regions with antigen binding regions of a humanized murine antibody that binds to VEGF. ‘Bevacizumab’ is produced by recombinant DNA technology in a Chinese Hamster ovary mammalian cell expression system in a nutrient medium containing the antibiotic gentamicin and is purified by a process that includes specific viral inactivation and removal steps. The Plaintiffs’ ‘Bevacizumab’ consists of 214 amino acids and has molecular weight of approximately 149,000 daltons.

65. Plaintiffs’ drug ‘Bevacizumab’ is approved globally for the treatment of metastatic colorectal cancer (mCRC), locally recurrent or metastatic breast cancer (mBC), advanced metastatic or recurrent nonsmall cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer (mRCC), persistent, recurrent, or metastatic cervical cancer (CC), advanced epithelial ovarian cancer and newly diagnosed glioblastoma multiforme (GBM) and GBM after relapse or disease progression, front-line treatment of epithelial ovarian, treatment of platinum-sensitive and platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer and for the treatment of cervical cancer in the European Union (EU).

66. It is averred that extensive clinical trials for Plaintiffs’ ‘Bevacizumab’ began in 1997. The estimated cumulative clinical trial exposure to Plaintiffs’ ‘Bevacizumab’ until 2016 is 32,237 patients. On 26.02.2004, the drug was approved by the United States Food and Drug Administration as first anti-angiogenesis treatment for cancer. From the initial market approval in the United States on 26.02.2004 and until 2016, Plaintiffs ‘Bevacizumab’ has been approved for use in over 100 countries worldwide. ‘Bevacizumab’ was approved by the European Union and Japan on 12.01.2005 and 18.04.2007 respectively. Approval to market the product in India was received on 17.01.2005 and, accordingly, Plaintiffs’ ‘Bevacizumab’ was launched in India in the year 2005. In India, Plaintiffs received approval to market the product for various indications including persistent, recurrent or metastatic carcinoma of cervix, recurrent platinum resistant epithelial ovarian cancer, colorectal cancer, un-resectable advanced, metastatic, or recurrent non-squamous non-small cell lung cancer, glioblastoma with progressive disease, advanced or metastatic renal cell carcinoma, and advanced (FIGO Stages III B, III C and IV) epithelial ovarian, fallopian tube or primary peritoneal cancer.

67. Plaintiffs plead that Biosimilar Guidelines were framed to provide a regular pathway for similar biologics in India considering the safety, efficacy and quality of similar biologic. Guidelines provide a framework, in addition to the Drugs Act, for comparative testing of purported biosimilar drug with the innovator biological drug and are mandatory and binding since any deviation would be detrimental to public interest. Biosimilar drugs are stated to be biological drugs different from generic drugs and are manufactured by extracting genetic material from living organisms and by cultivation of cell lines and therefore it is not possible to exactly replicate the phases/steps involved in manufacture of innovator biological drug and it is for this reason that the active ingredient in the biosimilar and innovator biological drug is never identical and can at best be similar. In contrast, generic drugs i.e. chemical drugs are characterized by their chemical identity and therapeutic equivalence to the original, low molecular weight chemical drugs. It is further pleaded that it is mandatory for a manufacturer of a biosimilar drug to establish similarity with the innovator biological drug at each stage of product development and testing, such as comparative product characterization, pre-clinical i.e. animal trials and clinical trials and only once similarity is established can the drug be referred to as a biosimilar drug.

68. Plaintiffs have in detail brought out the step-wise regime of testing for the approval of a ‘new drug’ under the Drugs Rules and highlighted that all three phases of clinical trials are to be carried out as a mandate of Rule 122DA and that the trials must be conducted in a sequential manner, in consonance with paragraph 2(7)(i) of Schedule ‘Y’ of the Drugs Rules. Under Clause 8.[4] of Biosimilar Guidelines, immunogenicity data is required as a part of comparative pre-approval assessment of safety of the similar biologic to provide assurance of the absence of unexpected safety concerns. It is also averred that there are various regulatory authorities which are involved at different stages of testing and approval of biosimilar drugs such as the RCGM, which reviews the data upto the stage of evaluation of preclinical studies and is a committee which works under the Department of Biotechnology; CDSCO, headed by DCGI is responsible for grant of import/export licenses, clinical trial approvals and permission for manufacturing and marketing drugs under applicable laws; SEC evaluates clinical trial protocols and applications for manufacturing and marketing authorization for new drug substances of chemical and biological origin; and the technical and the apex committees, constituted pursuant to directions of the Supreme Court. Technical Committee evaluates recommendations of SEC, which are then forwarded to the Apex Committee for approval and based on this, DCGI reviews and approves the clinical trial protocols and applications for manufacturing and marketing authorization of new drugs.

69. Plaintiffs plead in the plaint that they became aware of phase III clinical trial of Hetero’s drug after it was registered with CTRI. The cause of action, as averred, arises out of alleged non-compliance of the Biosimilar Guidelines and mandatory procedures prescribed under the Drugs Act and Drugs Rules, as according to the Plaintiffs mandatory phases of human trial were also not completed before granting approval. Alleged irregularities before commencement of pre-clinical trials have been brought forth in the plaint, such as failure to adhere to guidelines on product characterization and it is stated that physiochemical and biological characterization of Hetero’s drugs are not similar to Plaintiffs’ ‘Bevacizumab’. Questions have been raised on the conduct of any Real Time Stability Test, where the biological drug is stored at recommended storage conditions and monitored until it fails the specification given. Instances have been pleaded with respect to alleged irregularities during pre-clinical trials. The allegations are that Hetero has not conducted pre-clinical pharmacology and pharmacokinetics studies and there is no data available publicly to establish conduct of comparative animal pharmacology study, comparative immune response studies or animal toxicology studies. No data is available to show that pre-clinical studies were conducted on animals which are used for reference biologic or on the primates/rodents and non-rodents as required under Schedule Y of the Drugs Rules.

70. Likewise, the plaint is replete with alleged irregularities during clinical trials as required under the Biosimilar Guidelines. There are no publicly available records of registration of phases I and II of clinical trials by Hetero. It is stated that there is violation of Rule 122DA read with Schedule Y of the Drugs Rules in terms of conducting all three phases of clinical trials in India in a sequential manner where data emerging from phase I trials must form the basis of phase II trials and the data from phase II trials should form the basis of phase III trials. Pleading is that combining or skipping various phases of clinical trials is neither justified nor permissible. After referring to several such purported irregularities and violation of the Biosimilar Guidelines, it is averred that in view of the inadequate assessment and clinical trials of Hetero’s drug, the latter’s drug cannot termed as biosimilar as per the applicable rules and therefore, DCGI has wrongly granted the approval.

71. It is further stated that Plaintiffs enjoy a formidable reputation by the sale of their popular drug ‘Bevacizumab’ and the justified and strong apprehension is that if Hetero’s drug, which has not been sufficiently and adequately tested, is marketed and sold as a biosimilar version and any deficiency comes forth regarding safety, efficacy, immunogenicity and/or quality, it would dilute Plaintiffs’ reputation and goodwill, built over several years. Plaint contains extensive pleadings on the common law right of passing off, both on facts and law, that vests in the Plaintiffs and can be enforced to prevent dilution of goodwill and misrepresentation in public interest, relying on the judgements in Laxmikant V. Patel v. Chetanbhai Shah and Another, (2002) 3 SCC 65 and Erven Warnink Besloten Vennootschap and Another (supra). It is also stated that Hetero appears to have misappropriated data relating to Plaintiffs’ ‘Bevacizumab’ including data relating to its manufacturing process, clinical trials, safety and efficacy. It is pleaded that wrongful use and/or reproduction of data relating to ‘Bevacizumab’ by Hetero in its package insert, promotional and other printed material is likely to deceive Plaintiffs’ patients and/or doctors that the data relating to clinical trials and safety and efficacy of Plaintiffs’ ‘Bevacizumab’ is applicable to Hetero’s drug. This would lead to inappropriate and unsafe switching of patients from one product to another and infringing of copyright in Plaintiffs’ package insert etc.

72. Pleadings exist with respect to use of INN ‘Bevacizumab’ illegally and malafidely by Hetero. It is the case of the Plaintiffs that existence of international nomenclature for pharmaceutical substances in the form of INN is important for clear identification, safe prescription and dispensing of medicines to patients and communication and exchange of information among the health professionals and scientists worldwide. A biosimilar is usually approved with corresponding INN of the innovator reference product and is in accordance with WHO Guidelines. Plaintiffs’ ‘Bevacizumab’ is used for a large number of indications such as Metastatic Renal Cell Carcinoma (mRCC) and persistent, recurrent or Metastatic Cervical Cancer (CC), or Recurrent Glioblastoma (rGBM), whereas, Defendant’s drug has been approved for the only indication i.e. Metastatic Colorectal Cancer. In this backdrop, by using identical INN, there is likelihood of substitution by Hetero’s drug in a case where Plaintiffs’ ‘Bevacizumab’ is prescribed by a medical practitioner.

73. In CS(COMM) 1119/2016, Plaintiffs plead that in 1990, Plaintiff No. 3 developed a biological drug containing the active ingredient Trastuzumab, a humanized monoclonal antibody produced by Chinese hamster ovary (CHO) cells, in which DNA coding for human pre-proinsulin and for humanized immunoglobulin chains along with two selectable markers have been inserted. Trastuzumab produced by these cells is thus a humanized antibody with both muran and human components and binds specifically to the human epidermal growth factor receptor 2 (HER[2]) protein and is designed to target and block HER[2] protein overexpression. Additionally, Trastuzumab also triggers an immune response in the body to destroy the particular cell it attaches itself to. Thus, ‘Trastuzumab’ has a two-fold role in containing and curing certain form of cancer. It is averred that between 1992-98 extensive global clinical trials (Phase I/II/III) were carried out by Plaintiff No. 3 to test the safety, efficacy and quality of Trastuzumab for the indication, HER 2+ metastatic breast cancer and the marketing and manufacturing approvals were received worldwide. Trastuzumab was also approved by the US Food and Drug Administration in September 1998 for metastatic breast cancer and by European Medicines Agency in August 2000 for the same. This biological drug has been sold worldwide since 1998 inter alia under the well-known trademark HERCEPTIN and the Plaintiffs were first to introduce a targeted biological treatment for this kind of cancer.

74. It is further averred that in India ‘Trastuzumab’ has been marketed under the brand name HERCEPTIN for more than 12 years and the medical community associates the innovator monoclonal antibody with the Plaintiffs and Plaintiff No. 3’s trademark HERCEPTIN, which has thus acquired extensive goodwill and a distinctive reputation. Approval was granted to the Plaintiffs for import and marketing of ‘Trastuzumab’ in India for treatment of HER 2+ metastatic breast cancer by DCGI on 11.10.2002 under Rule 122A of the Drugs Rules and thereafter, on 07.08.2006 and 13.04.2010 respectively, for HER 2+ early breast cancer and HER 2+ metastatic gastric cancer.

75. Averments highlight that the purpose of introducing Biosimilar Guidelines on 15.09.2012 was to evolve a legal framework for evaluation and approval of biosimilar drugs in India as also the distinction between biosimilar and generic drugs. Plaintiffs have enumerated the provisions of the Drugs Act, Drugs Rules and Biosimilar Guidelines to explain how the testing and approval of biosimilar drugs is a regulated regime. Step-wise regime for testing and approval of a ‘new drug’ under the Drugs Rules is also brought forth in detail which includes the provisions of Biosimilar Guidelines to understand the regulation of product characterization, pre-clinical studies, clinical trials etc.

76. With regard to Cadila’s drug, which is the subject matter of the suit, it is averred that after the suit was filed by Cadila before the Bombay High Court, Plaintiffs researched and became aware that on 30.03.2012, Cadila purportedly received permission from RCGM to conduct pre-clinical toxicity studies in Wistar rats and New Zealand rabbits and the results were approved on 18.09.2012, even though Cadila failed to conduct pre-clinical pharmacology studies in relation to its drug and despite the fact that Plaintiffs conducted pre-clinical trials on pregnant monkeys, with no scientific justification for a deviation in the choice of animal model. There is no record of an application to DCGI for permission to conduct clinical trials and record shows that permission was sought to carry out only Phase III clinical trials, without first conducting Phase I and II trials. On 10.03.2014, DCGI purportedly approved the clinical trial protocol for Phase III only and the protocol was registered on 19.05.2014. Cadila’s CTR was finalized and approved after Biosimilar Guidelines became effective on 15.09.2012. Rule 122DA mandates that all three phases of clinical trials are to be carried out for a ‘new drug’ and para 2(7)(i) of Schedule Y provides that trials should be conducted in a sequential manner i.e. data generated in phase I should form the basis of phase II trial and the latter should form the basis of phase III clinical trial. This mandate is also found in Clause 8 which provides that all three phases of human clinical trials must be carried out for a biosimilar drug. Several other violations of the applicable provisions of law have been pleaded extensively in the plaint, most of which are similar to the ones in the other suit and are not repeated for the sake of brevity.

77. Plaintiffs also plead that they enjoy a global reputation in relation to HERCEPTIN and Cadila’s drug purportedly developed for treatment of same forms of cancer as ‘Trastuzumab’, having not been sufficiently and adequately tested to be termed as a biosimilar product because of questions on its safety, efficacy, immunogenicity and quality, if found to be actually deficient will lead to dilution of Plaintiffs’ global reputation and goodwill built over several years in relation to ‘Trastuzumab’ and the trademarks ‘HERCEPTIN’, ‘HERCLON’ and ‘BICELTIS’.

78. Plaintiffs allege that Cadila has misrepresented its drug as a biosimilar to ‘Trastuzumab’, which is illegal and factually and scientifically flawed, in the absence of requisite trials for all three indications. The misrepresentation before the regulatory authorities and the SEC is likely to continue before the public, doctors and patients using ‘Trastuzumab’ and is in the nature of extended passing off. Cadila is also appropriating the business reputation of the Plaintiffs in relation to ‘Trastuzumab’ which provides an accepted and well-known treatment for certain forms of cancer worldwide and enjoys a global reputation. It is apparent that the misrepresentation is with a view to encash on the reputation of the Plaintiffs and take unfair advantage of the same. In the absence of sufficient independent data for Cadila’s drug and in view of the incorrect claim of comparability between Cadila’s drug and ‘Trastuzumab’, Cadila will use data relating to Plaintiffs’ ‘Trastuzumab’ including data regarding manufacturing process, clinical trials, safety and efficacy in the package insert and other promotional materials in order to publicize its drug and create a market for it, which ought to be restrained.

79. Objections have been raised in the pleadings with regard to use of INN ‘Trastuzumab’ by Cadila for its drug. It is averred that in India, biosimilar is usually approved with the corresponding INN of the innovator’s reference product and the practice of approving and marketing biosimilars under the said INN is not in accordance with recommendations of WHO, which acknowledges the necessity to distinguish a similar biologic from innovator biological drug by use of unique biological qualifiers by the biosimilar manufacturers. Internationally, while an established biosimilar drug may be entitled to use INN but not without conducting necessary test and establishing biosimilarity under applicable laws. In the absence of such tests, Cadila’s drug cannot be permitted to be marketed as Plaintiffs’ ‘Trastuzumab’.

80. Having perused and examined the plaints, Court has to now see if they deserve rejection or the suits must proceed to trial. The yardsticks to see if the plaints pass muster are: (a) whether the averments in the plaints, which is the only germane factor, disclose a real cause of action or something purely illusory has been stated; (b) pleas taken by the Defendants in defence will be wholly irrelevant;

(c) meaningful and not formal reading of the plaints must be made and only if they are manifestly vexatious and meritless, not disclosing a clear right to sue, the power to reject the plaints will be exercised;

(d) clever drafting only to create the illusion of a cause of action must be nipped in the bud; (e) Court is not to consider a particular plea but the plaints have to be read as a whole without compartmentalisation, dissection, segregation and inversions of the language of various paragraphs in the plaints; and (f) it is the substance and not merely the form that has to be looked into and intention of the parties is to be gathered primarily from tenor and terms of the pleadings, taken as a whole, keeping in mind that no pedantic approach should be adopted to defeat justice on hair splitting technicalities. Order VI Rule 2(1) CPC states the basic and cardinal rule of pleadings and it is clear from a reading of the provision that pleadings are only required to state material facts and not evidence. Every pleading is therefore required to contain only a statement in a concise form of the material facts on which the party relies for its claim and ‘material facts’ means facts necessary to formulate a complete cause of action.

81. When the averments in the present plaints are considered and tested on the anvil of the above stated principles, the inexorable conclusion is that the plaints do not merit rejection at this stage. Meaningfully and holistically read, the causes of action set out in the plaints, on which Plaintiffs may or may not finally succeed, are: (a) drugs of Cadila/Hetero have been approved for manufacturing and distribution by the regulatory authority without following the procedures under Drugs Act, Drugs Rules and Biosimilar Guidelines; (b) Cadila and Hetero claim similarity with Plaintiffs’ ‘Trastuzumab’/ ‘Bevacizumab’, respectively without establishing biosimilarity through appropriate tests and conditions laid down in the applicable laws; (c) in view of inherent differences in the compositions of alleged biosimilar drugs and innovators’ biological drugs and inadequate testing, drugs of Cadila/Hetero should not have been approved and thus they should be restrained from promoting and marketing their respective drugs; (d) impugned actions of Cadila/Hetero are classic textbook cases of extended passing off and amount to dilution of the formidable and globally known reputation and goodwill of the Plaintiffs’ drugs, at the same time giving unfair and undue advantage to Cadila/Hetero; (e) potential deficiencies in the drugs of Cadila/Hetero will not only dilute and damage Plaintiffs’ reputation but will be detrimental to public interest as doctors, patients and other stakeholders in the medical community will be misled into believing that the drugs of Cadila/Hetero, claimed to be biosimilar are associated with Plaintiffs’ world known innovator drugs; and (f) in the absence of enough data of adequate testing pertaining to safety, efficacy, quality, composition, use of the INNs is not only legally impermissible but is adding to public confusion.

82. In deciding an application under Order VII Rule 11 CPC what is to be seen is if a right is asserted by a Plaintiff with supporting material and whether he is entitled to relief in law albeit the Plaintiff may not ultimately succeed in getting the relief. Supreme Court has consistently held that rejection of plaint is a drastic power and it is the duty of the Court to tread with caution and terminate the litigation only when it is found to be wholly meaningless or abortive. Certainly Plaintiffs are required to allege and aver some action done by the Defendants that gives rise to a cause of action. Can it be therefore said by a holistic and meaningful reading of the plaints in the present case that no cause of action is made out and the plaints are meaningless or vexatious, disclosing no ‘cause of action’ and to my mind the answer is an emphatic ‘No’.

83. Substantial part of the cause of action pleaded in the plaints relates to alleged non-compliance/violation of the Drugs Act, Drugs Rules and Biosimilar Guidelines. There is no dispute between the parties to the lis that these applicable laws are binding and have to be mandatorily followed. In fact, both Cadila and Hetero have taken a position that the field of biosimilars is governed by exhaustive Biosimilar Guidelines read in conjunction with Drugs Act and Drugs Rules and that the objective is to provide greater access to affordable healthcare for several lifesaving medicines. Guidelines publish a clear regulatory pathway outlining the requirements to ensure comparable safety, efficacy and quality of a similar biologic to an authorised reference biologic. It is admitted that applications are examined by experts in the field at each step of the process of grant of approval and only after thorough examination, a biosimilar drug is approved. DCGI reiterates that the legal position under the applicable laws is unambiguous and before a drug is allowed for manufacture or sale, it undergoes rigorous process of examination before the competent authorities arrive at a conclusion that the drug is safe and efficacious. Under the Drugs Rules and Biosimilar Guidelines, every drug has to necessarily go through three stages: (i) an initial evaluation for safety and efficacy; (ii) on successful evaluation the drug goes through a period in which it is allowed to be sold but remains under observation; and (iii) on completion of observation period once the standards are identified, it proceeds for consideration for grant of licence. Reference is made to the statutory regime under Rules 122B and 122E of the Drugs Rules. The application for permission to import and/or manufacture a ’new drug’ for sale or to undertake clinical trials has to be made in Form 44 accompanied by the requisite data. An elaborate procedure is laid down for Phase I, Phase II and Phase III clinical trials. Therefore, when Plaintiffs plead that the approvals granted to the impugned drugs violate the applicable laws for several reasons, spelt out in the plaints, it cannot be said that plaints disclose no ‘cause of action’, especially when Cadila/Hetero claim ‘biosimilarity’ with their well-known and approved drugs.

84. The Drugs Rules have been framed in exercise of powers conferred by Sections 6(2), 12, 33 and 33N of the Drugs Act by the Central Government and have a statutory flavour. Therefore, the provisions of the Drugs Act and Drugs Rules are enforceable in a suit under Section 9 CPC under the inherent jurisdiction of a civil Court and Defendants have been unable to point out any provision, whereby the jurisdiction of this Court is carved out, expressly or impliedly. Insofar as the Biosimilar Guidelines are concerned, the binding nature of these guidelines is not in dispute by either party and unless Defendants are able to show that they are in supersession of the statutory Rules or contradict any of the provisions of the Drugs Act or Drugs Rules, Court can enforce them and examine their alleged noncompliance/violations. In Union of India v. K. P. Joseph and Others, (1973) 1 SCC 194, a three-Judge Bench of the Supreme Court has held as under:-

85. This Court is not unmindful of the position in law that each plaint has to be independently examined to see if Plaintiff has set forth a cause of action as also of the order passed by the Division Bench in FAO(OS)(COMM) 120/2020 on 04.03.2021 in Cadila’s case, permitting the party to file an application seeking rejection of the plaint and a direction to this Court to decide the same on its own merit. Having independently examined the plaints on the touchstone of judicial precedents and the applicable law, the conclusion is that Plaintiffs have set out a cause of action. Nonetheless, Court also finds merit in the submissions of the Plaintiffs that the observations in the earlier judgements, in the suits against Reliance and Biocon/Mylan, both dated 25.04.2016, are relevant and persuasive since most of the issues arising in all the suits are similar.

86. Traversing through the litigation history of those cases, Plaintiffs herein filed CS(OS) No. 3284/2015 against Reliance Life Sciences Private Ltd., DCGI and Department of Biotechnology, seeking injunction against Reliance from launching, selling, marketing etc. the allegedly biosimilar drug ‘TrastuRel’ in the domestic market, for the indications for which the Plaintiffs market their drugs under the brand names ‘HERCEPTIN’, ‘HERCLON’ and ‘BICELTIS’, as also from representing its product ‘TrastuRel’ as biosimilar. The suit was filed after the patent had lapsed on 03.05.2013 and thus no rights were asserted as a patentee, as in these suits. The contentions raised and submissions made by the Plaintiffs in the Reliance suit are captured in paragraphs 11 to 29 of the judgment in Genentech INC and OnLine Del 2572 and at a glance it can be said that most of them are common to the present suits. Although initially limited restraint order was passed but subsequently, I.A. 23041/2015 under Order XXXIX Rules 1 and 2 CPC was decided by a detailed judgment permitting Reliance to launch and market ‘TrastuRel’ on the basis of approval from DCGI, with certain conditions and riders in the interest of public health and safety.

87. It is relevant to note that the Court while deciding the injunction application framed the following questions:- “i) Whether the plaintiffs have any right of action in the present case or not? If yes whether the suit is expressly or impliedly barred in law in view of the provisions of Drugs and Cosmetics Act 1945? ii) If the suit is maintainable, whether this Court is within its powers to embark upon the approvals granted by the Drug controller in relation to the drugs in case it impinges the civil rights of the plaintiff in order to protect the said civil rights or not? iii) What is the impact of the Guidelines on Similar Biologics framed in the 2012 under the aegis of Drug Controller of India/defendant No. 1 and the government of India, Ministry of Bio technology and whether these guidelines would have any bearing in relation to the grant of the marketing and manufacturing approvals by the defendant No. 1 especially granted after the framing of the said guidelines or not? iv) Whether the approval granted by the defendant No. 1 to defendant No. 3 by omitting the requirements of the clinical trials phase I and II would have any bearing upon the already granted approvals in the case of the similar biologics product or not and whether the defendant No. 3 has conducted all the clinical trials of drug as required under the strict provisions of the Act and Rules and Biosimilar Guidelines of 2012? v) Whether the common law remedy can be pursued by the plaintiffs for misrepresentation and false information allegedly made by the defendant No. 3 in view of peculiar circumstances of the present case?”

88. After recording the contentions of the respective parties, the Court captured the nature of disputes arising, as follows:-

89. The observations in the judgment are a reflection of the fact that upon due deliberation, Court was of the view that the suit was maintainable and nature of disputes flagged gave rise to a cause of action, requiring consideration. In CS(OS) 355/2014 filed by the Plaintiffs against DCGI, Biocon Limited, Mylan Inc. and Mylan Pharmaceuticals Private Limited also a restraint order was passed by a separate judgment dated 25.04.2016, concerning purported biosimilar version of Plaintiffs’ ‘Trastuzumab’. Biocon and Mylan approached the Division Bench of this Court in FAO(OS) No. 227/2016 and noting that they were in the market for almost two years, the Division Bench permitted them to continue to market ‘CANMab’ and ‘HERTRAZ’, without the directions or restrictions imposed on Reliance. Reliance also preferred an appeal being FAO(OS) No. 181/2016 and while initially no relief was granted, subsequently, vide order dated 18.09.2019, the Division Bench stayed the judgment of the learned Single Judge dated 25.04.2016, on multiple grounds viz. regulatory authorities had granted approval to Reliance’s biosimilar drug which prima facie could not be considered illegal; it was not possible at that stage to determine if Reliance had conducted requisite trials prescribed for a biosimilar drug; in the face of the expiry of the patent in favour of the Plaintiffs, their locus standi to file the suit was a relevant issue and the possibility of the suit being filed with the object of stifling competition was a relevant factor. This order of the Division Bench was challenged by the Plaintiffs before the Supreme Court in Genentech Inc. and Others v. Drugs Controller General Of India and Others, (2020) 13 SCC 371. The Supreme Court set aside the order of the Division Bench and allowing the appeal directed that the interim direction given by the learned Single Judge on 25.04.2016 will become operational with a further request to the High Court to dispose of the suit expeditiously. To avoid prejudice to Reliance, it was given the liberty to participate in Government procurements for the drug by its generic name ‘Trastuzumab’.

90. The grievances of the Plaintiffs ventilated in the Reliance suit have been referred to above and are not being repeated for the sake of brevity. This Court does not have the benefit of the written statement but from the judgement dated 25.04.2016 in Genentech INC and OnLine Del 2572, the defence taken by Reliance can be collated as follows:- (a) All necessary tests to establish efficacy, safety and comparability have been conducted and have the approval of the Committee of Experts. This Court cannot go into the merits and decision of the experts only because Plaintiffs lay a claim that the drug is not a biosimilar drug. (b) Manufacturer seeking to manufacture a similar drug can rely upon the data of the innovator available in public domain and after establishing safety and efficacy as required in Schedule Y can seek permission to manufacture an already approved new drug. There is no specific requirement in the rules for conduct of phase I or phase II trial for approval of a drug already approved outside the country. Even the need for phase III trials for a new drug approved outside India can be waived under Rule 122B(3) and Schedule Y(1)(3).

(c) Drugs Act is a complete code in itself and provides a mechanism for filing an appeal for challenging the approvals granted under the Act and thus there exists a bar to the jurisdiction of Civil Courts having ordinary original jurisdiction. If a Civil Court starts examining grant of approvals, it will undermine and/or usurp the powers of DCGI and its constituents comprising of expert bodies and committees.

(d) Suit is otherwise barred by law in view of availability of an alternate remedy under Rule 122DC of Drugs Rules which provides a remedy of appeal to the Central Government against approval granted by DCGI and deletion of the rule by an amendment which came into effect on 19.03.2019 cannot aid the Plaintiffs. (e) Patent of the Plaintiffs has expired in 2013 and in the absence of patent protection no monopoly can be exercised by the Plaintiffs and the drug is thus in the public domain.

91. Almost similar defences were taken by Cadila and Hetero in the present suits, respectively. Relevance of mentioning the previous litigation is only to highlight that while Division Bench had stayed the judgment dated 25.04.2016 in the Reliance suit, the Supreme Court set aside the order of the Division Bench and vacated the stay and unequivocally held that the judgment dated 25.04.2016 is made operational. The logical inference is that the Supreme Court did not consider the suit to be devoid of cause of action or wholly vexatious or meritless, else the Supreme Court would not have passed a direction to continue the interlocutory injunction order as against a stay order passed by the Division Bench. Defendants contend that the Supreme Court was not examining the maintainability of the plaint and the observations cannot be used in the present suits. Be it ingeminated that this Court is not referring to the observations to decide the present applications on merits and the reference is solely for the purpose of bringing forth that the order of the Single Judge was upheld dealing with similar pleas as in the present suits and categorically noting two vital facts that the patent of the Plaintiffs had expired in 2013 and the Plaintiffs were not enforcing their patent rights but enforcing the common law right of extended passing off. The pleas in the present plaint thus cannot be brushed aside by a simplistic argument of the Defendants that no cause of action is made out. Relevant paragraphs from the order of the Supreme Court for the limited purpose of showing that the order of learned Single Judge was made operational are as follows:-

14.3. According to Mr Divan the issue of International Non- Proprietary Name (“INN”) goes to the very root of the dispute between the parties. He contends that Reliance is not entitled to use INN, since their drug has been approved without undergoing the required testing, prescribed under the Act, the Rules and the 2012 Guidelines.

17. Before we consider the rival contentions, at the outset it is noted that the Reliance suit is now pending for final disposal in the High Court. In the detailed interim order recorded on 25-4-2016 [Genentech Inc. v. Drugs Controller General of India, 2016 SCC OnLine Del 2572], the submissions of the learned ASG to the effect that the clinical trials of Phase I and Phase II for the drug manufactured by Respondent 3, are not registered with DCGI but approvals were accorded on the basis of the justification given by Respondent 3 was noted by the Court. Whether the injunction suit filed by the appellants is an abuse of the process of law and whether the approval was granted to the similar drug manufactured by Respondent 3, without following 2012 Guidelines was also borne in mind. The possibility of the attempt by the defendants to pass off their drug as biosimilar product “Trastuzumab”, marketed by the appellants was thought out. After careful consideration of all those aspects including the projection from DCGI, the learned Single Judge felt that the process of obtaining approval was flawed due to non-adherence to the statutory provisions of the Act and the Rules as also of the 2012 Guidelines. Then reflection was made on the protective conditions which can be imposed for allowing Respondent 3 to launch their product. Upon due assessment, the interim order dated 25-4-2016 [Genentech Inc. v. Drugs Controller General of India, 2016 SCC OnLine Del 2572] was then passed.

24. As regards the contention made by Mr Poovayya that the condition imposed by the learned Single Judge on the packaging/labelling is contrary to the statutory prescriptions, it must be borne in mind that the arrangement ordered [Genentech Inc. v. Drugs Controller General of India, 2016 SCC OnLine Del 2572] by the learned Single Judge has been in operation since 25-4-

2016. Therefore without a final decision on the suit on the basis of relevant evidence, the continuing arrangement in our opinion should not have been disturbed, on this count.

25. The appellants' suit before the Delhi High Court is not a trade mark action nor is it an attempt to enforce the appellants' patent, which admittedly expired in 2013. The suit is an action for extended passing off and to prevent the respondent from using the appellants' data and improper reference to its drug “Trastuzumab”. Therefore, the expiry of the appellants' patent right on the drug “Trastuzumab” may not have any direct bearing on the contention raised in the Reliance suit.

29. In view of the aforesaid, the impugned order is set aside and appeal is allowed. The interim direction given by the learned Single Judge on 25-4-2016 [Genentech Inc. v. Drugs Controller General of India, 2016 SCC OnLine Del 2572] is accordingly made operational. At the same time, as the Reliance's suit is pending since 2016, the High Court is requested to dispose of CS(OS) No. 3284 of 2015 expeditiously and preferably within 12 months of receipt of this order. In the meantime, to avoid prejudice to Respondent 3, whenever government procurement is proposed for the drug by its generic name “Trastuzumab”, Reliance should be allowed to participate with their biosimilar product, without any impediment. It is made clear that the views expressed here are only for the purpose of this appeal and should have no bearing in the proceeding pending in the High Court.”

92. Another facet of the cause of action pleaded by the Plaintiffs is the enforcement of their common law rights by alleging extended passing off, predicated on their formidable goodwill and reputation and alleged misrepresentation by Cadila and Hetero to the public by terming their drugs as biosimilar, including an objection to the use of the INNs. It is the pleaded case of the Plaintiffs that they are not asserting rights under the patent, which has expired in 2013 as also that Plaintiffs have no objection to the manufacture and sale of the impugned drugs by Cadila and Hetero as long as they are not claimed to be biosimilar and/or the parties do not use the INN, in the absence of the alleged non-compliance with the applicable laws. Looking at the plaints, there are enough averments in the plaints which brings to fore cause of action on a mere demurrer and supported by documents filed with the plaints.

93. Cadila and Hetero have urged that: (a) Plaintiffs have no statutory rights to claim injunction, their patent having expired in 2013; (b) data relating to ‘Trastuzumab’/ ‘Bevacizumab’ is available in the public domain and in the absence of right in the patent, no monopoly can be claimed and moreover, Indian law does not recognize data exclusivity protection; (c) Plaintiffs in CS(COMM) 1119/2016 have been marketing ‘Trastuzumab’ in India under the brand names ‘HERCEPTIN’, ‘HERCLON’ and ‘BICELTIS’, whereas Cadila markets its biosimilar ‘Trastuzumab’ under the trademark ‘VIVITRA’ while in CS(COMM) 540/2016, Plaintiffs sell their drug ‘Bevacizumab’ under the trade name ‘AVASTIN’ which is not the trademark or tradename used by Hetero; (d) ‘Trastuzumab’ or ‘Bevacizumab’ are INNs i.e. International Non-Proprietary Names and therefore, no proprietary rights can be claimed by the Plaintiffs by virtue of Section 13 of the 1999 Act and permitting an ex-patentee to claim any form of ownership in an INN on account of goodwill/reputation earned during currency of the patent, will entirely destroy the patent regime and will permit patentees to evergreen their patent by filing ‘passing off suits’ against manufacturers of generics/biosimilars; (e) concept of extended passing off only applies in an action brought by a class of traders sharing collective goodwill in a trademark and is inapplicable in the present suits; (f) no copyright can be claimed in a package insert of a drug; (g) in the absence of subsisting intellectual property rights, Plaintiffs are barred from filing suits under Section 2(1)(c) of the Commercial Courts Act, 2015; and (h) in the absence of any legal right or legally protected interests in ‘Trastuzumab’ or ‘Bevacizumab’, no cause of action can arise on the principle of damnum sine injuria. Reading of these objections fortifies the stand of the Plaintiffs that these are in the nature of defences raised by Cadila and Hetero and cannot lead to a conclusion that the plaints are devoid of cause of action. Applying the first principles of Order VII Rule 11 CPC, it is impermissible for the Court to travel outside the contours of the plaints and rely on the defences in the written statement. In Mayar (H.K.) Ltd. and Others (supra), the Supreme Court held as follows:-

94. Insofar as the contention of the Defendants regarding challenge to competence of regulatory authority in the suits is concerned, a categorical stand has been taken by the Plaintiffs that they are not challenging the competence and discretion of the Drugs Regulatory Authority i.e. DCGI, but the allegations are that provisions of the Biosimilar Guidelines and the applicable laws have been violated by the Defendants.

95. The contention of Cadila that the plaint in CS(COMM) 1119/2016 ought to be rejected as Cadila has instituted a suit before the Bombay High Court, prior to the present suit, seeking declaration as also injunction restraining the Defendants therein (Plaintiffs in the present suit) from in any manner interfering with Cadila’s regulatory processes/approvals/licences in respect of its biosimilar ‘Trastuzumab’, is without merit. Reading of Sections 10 and 11 CPC unequivocally suggests that the legislative intent behind enacting the said provisions is to avoid conflict of decisions on same issues by different Courts as also prevent multiplicity of proceedings. However, this to my mind, cannot be a ground for rejection of a plaint under Order VII Rule 11 CPC. Even assuming that Cadila is right that the two suits are predicated on an identical or similar cause of action, at the highest the present suit would be liable to be stayed till the disposal of the earlier suit and once the former suit is decided, the result may preclude this Court from adjudicating the present suit.

96. The judgments relied upon by the Defendants fall in two categories. Insofar as the judgments in T. Arivandandam (supra), I.T.C. Ltd. (supra), Raghwendra Sharan Singh (supra) and Dilip Vasant Shetye and Another (supra) are concerned, the propositions laid therein are beyond any debate. It is trite that if it appears to the Court that Plaintiff has set out a purely illusionary cause of action and no real cause of action is disclosed or the plaint is wholly vexatious and meritless, the suit must not continue and it is the duty of the Court to nip in the bud a litigation which is bound to be abortive with no cause of action being made out on a reading of the plaint on a demurrer. In fact, it is following this principle that this Court has examined the plaints and found in favour of the Plaintiffs that the plaints indeed disclose cause of action. Judgments in M.R. Mini Represented By Her Guardian And Father M.P. Rajappan (supra) and Northern Plastics Ltd. (supra) are inapplicable in the facts of the present suits. Plaintiffs have averred that they have earned formidable goodwill and reputation in their drugs in question worldwide including India and their drugs are known for quality, efficacy, safety and immunogenicity and Cadila and Hetero are attempting to ride on the goodwill to take unfair advantage of the same in selling their respective drugs by terming them as biosimilar, in the absence of conducting requisite tests and/or obtaining requisite approvals in consonance with the applicable laws. This, according to the Plaintiffs, is also leading to dilution of their goodwill earned over the years and in case Cadila and Hetero are permitted to launch/continue manufacturing or sale of their drugs claiming the same to be biosimilars to Plaintiffs’ innovator drugs, it has the potential to harm the public at large and in case of any unforeseen mishap, it is the Plaintiffs’ reputation and consequently their business is at stake. Predicating their case on these contentions amongst others, it is urged that Plaintiffs have legal right and interest and the cause of action to challenge the regulatory approvals and the manufacture and sale of the alleged biosimilar drugs by Cadila and Hetero. Therefore, in my view, the objection of Cadila and Hetero that there is no damage or injury and resultantly no cause of action in favour of the Plaintiffs, is an oversimplification and to state the least, an incorrect argument.

97. Reliance on the judgments in Premier Automobiles Ltd. (supra), Chandrakant Tukaram Nikam and Others (supra), Raja Ram Kumar Bhargava (Dead) by LRs (supra) and State of A.P. (supra), is misconceived. By a detailed finding in the earlier part of the judgment, this Court has already held how the remedy under Rule 122DC of the Drugs Rules is not available to the Plaintiffs and cannot be a ground to reject the plaints. Even otherwise, the judgments in Premier Automobiles Ltd. (supra) and Chandrakant Tukaram Nikam and Others (supra) relate to labour disputes where a statutory and efficacious remedy is provided under the Industrial Disputes Act, 1947 and are distinguishable. In Raja Ram Kumar Bhargava (Dead) by LRs (supra), Plaintiffs had sued the Defendant for recovery of interest on certain refunds of income tax and excess profits tax claimed to be statutorily due and payable by him under Section 66(7) of the Income Tax Act, 1922 on the refunds of the taxes. In the meantime, on 01.04.1962 the Income Tax Act, 1961 had come into force repealing the 1922 Act. Defendant resisted the suit contending that the same was not maintainable and was statutorily barred. The other question was whether the claim of the Plaintiffs was governed by the 1922 Act. The suit was dismissed on the ground that Civil Court had no jurisdiction to substitute its discretion to grant interest in place of the discretion vested in the Commissioner. The High Court reversed the finding but holding that provisions of 1922 Act did not govern the claim. The Supreme Court held that the question of maintainability turned on the scope of exclusionary clause in the Statute and the broad guiding consideration is that wherever a right, not pre-existing in common law, is created by a Statute and the Statute itself provides the machinery for enforcement of the right, both the right and the remedy having been created uno flatu, even in the absence of an exclusionary provision, the Civil Court jurisdiction is impliedly barred. The facts in the present cases are completely different where the Plaintiffs have no remedy under the concerned applicable laws and therefore, they cannot be precluded from invoking the ordinary civil jurisdiction of this Court. The judgment in State of A.P. (supra) is also inapplicable. The Supreme Court has held that exclusion of jurisdiction of Civil Court is not to be readily inferred and the test to be adopted while examining this question is: (i) whether legislative intention to exclude jurisdiction is explicit or clear by necessary implication; (ii) does the Statute provide adequate remedy in case of grievance against the order made under the Statute. This judgment, in my view, favours the Plaintiffs and relevant passage is as follows:-

98. For all the aforesaid reasons, this Court does not find merit in the contentions of Cadila and Hetero that the plaints merit rejection. Accordingly, the applications are dismissed.

JYOTI SINGH, J SEPTEMBER 11, 2023/Shivam/KA