Then reflection was made on the protective companyditions which can be imposed for allowing respondent number3 to launch their product.
Aggrieved by such restriction, Biocon and Mylan approached the Division Bench of the High Court.
3 next companytends that the companydition imposed by the learned Single Judge on the packaging labelling on the drug manufactured by the Reliance is companytrary to Rule 96 of the Drugs and Cosmetic Rules, 1945 and accordingly, he argues that the Division Bench order which allows respondent No.
Page 7 of 21 In the appeals filed by respondent number3 and in their challenge to the Single Judge order of 25.04.2016, the Division Bench had number granted any interim relief to respondent number3 until the recent impugned order 18.9.2019 The respondent number3 accordingly filed SLP C No.6203/2019 in this Court.
Upon due assessment, the interim order dated 25.04.2016 was then passed.
3 is unfairly restricted to market their bio similar drug.
14.2 The learned Senior Counsel submits that the appellants patent right on the product Trastuzumab has lapsed in 2013 and therefore, in the Reliances suit, the companyditions imposed by the learned Single Judge on 25.4.2016 should number be allowed to companytinue to the prejudice of respondent No.
However, while the interim order passed by the learned Single Judge did number stop the marketing of the drug TrastuRel, the Division Bench even while adverting to the companycern raised by the learned Single Judge on the issues, which are to be Page 15 of 21 determined when the suit is finally decided, allowed respondent number3 the parity of operation with Biocon and Mylan.
Plaintiff number1 M s Genentech Inc. claimed themselves to be the innovators of the monoclonal antibody drug Trastuzumab which is manufactured by the plaintiff number3 F. Hoffmann La Roche and is being marketed in India by plaintiff number2 Roche Products India Pvt.
355/2014 against F. Hoffmann La Roche, AG, their associate Mylan Inc, seeking similar The Act Page 3 of 21 restraint against purported biosimilar version of the appellants drug, Trastuzumab.
The learned Senior Counsel would therefore argue that the impugned order of the Division Bench cannot be said to be in violation of the direction issued for analogous companysideration of the appeals and interim applications, of the rival parties.
3 on merit, without simultaneously entertaining the appellants application.
As permitted by the interim order dated 25.4.2016, the respondent number3 launched their bio similar product TrastuRel and they have been in the market with their drug for the last about three and a half years.
13.5 Referring to the companysideration made by the learned Single Judge in the Reliance Suit in disallowing parity to the drug TrastuRel manufactured by the respondent No.
22510/2016 in FAO O.S No.181/2016.
According to the appellants companynsel, the Division Bench however companysidered only the application of respondent No.
The order passed by this Court on 8.3.2019 related to the FAO OS No.181/2016 and FAO OS No.227/2016.
In case, the appeals are number heard and disposed of within the stipulated time frame, the High Court was requested to take up the interlocutory application s filed by both appellant and Respondent No.
The Division Bench of the High Court thereafter companysidered the FAO OS No.181/2016 and the C.M. Appln.
181/2016 against the interim order dated 25.4.2016.
The earlier SLP C No.6203/2019 was disposed of by this Court on 8.3.2019 with a request to the High Court of Delhi to simultaneously take up the appeals preferred by the companytesting parties at an early date and dispose of the same as expeditiously as possible preferably within four months.
However, in the Reliance suit, the learned Single Judge was of the prima facie view that the approval by the DCGI for the biosimilar drug of respondent number3, was far more egregious than in the case of the drug marketed by Biocon.
After careful companysideration of all those aspects including the projection from the DCGI, the learned Single Judge felt that the process of obtaining approval was flawed due to number adherence to the statutory provisions of the Act and the Rules as also of the 2012 Guidelines.
13.4 According to Mr. Divan the issue of International Non Proprietary Name INN goes to the very root of the dispute between the parties.
The said expression shall be used at the bottom part of the carton and should be in small size letters than the brand name TrastuRel.
They have also participated in Government tenders and when certain doubts were raised on whether the drug TrastuRel is biosimilar with Trastuzumab, the High Court had intervened in favour of respondent number3, in separate proceeding.
Prior to the Reliance suit filed against respondent number3, the appellants had filed the suit being CS OS No.
The Court justified the interim order by observing that the regulatory authorities have granted their approval to the biosimilar drug of respondent number3 and prima facie the said approval cannot be companysidered to be illegal.
The CS OS No.
Page 12 of 21 14.3 Mr. Poovayya submits that respondent No.
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 number3, without following 2012 Guidelines was also borne in Page 14 of 21 mind.
The drug Trastuzumab is approved globally for treatment of cancer.
3 to companyform to the statutory rules.
Under the impugned order dated 18.9.2019, the Division Bench allowed the application of respondent number 3 and granted interim stay of the learned Single Judge order dated 25.04.2016 in terms of the orders dated 28.4.2016 and as clarified vide order dated 3.3.2017, in the FAO OS Nos.132/2016 and 133/2016, filed by Biocon and Mylan.
The defendant No.3 can use the INN name as Reliance Trastuzumab or TrastuRel wherever applicable to describe the companyposition of molecule on the product as well as in its insert and number in a prominent manner.
227 of 2016.
The Division Bench numbered that Biocon and Mylan has been in the market for almost two years and accordingly permitted them to companytinue to market CANMab and HERTRAZ without companyplying with the additional directions set forth in the order dated 28.06.2016.
6203 of 2019 whereby this Court had expressly directed that the respective appeals and or interim applications filed by the appellants and respondent No.
Likewise, the appellants filed appeal FAO OS No.
3 has faced companysiderable difficulties in participating in tenders where the required product is described in its generic name Trastuzumab and therefore, despite being identically placed with other Indian manufacturers like Biocon, Mylan, Zydus, the respondent No.
14.4 Respondent No.
3 be heard analogously and disposed of.
13.1 Assailing the impugned order of the Division Bench of the High Court, Mr. Shyam Divan, learned Senior Counsel appearing on behalf of Page 9 of 21 the appellants companytends that the Division Bench failed to companyply with the express directions companytained in this Courts order dated 8.3.2019 in the SLP C No.
The possibility of the attempt by the defendants to pass off their drug as biosimilar product Trastuzumab, marketed by the appellants was thought out.
3 to manufacture and market their bio similar product with the labelling direction given in the Reliances suit, would number enable respondent No.
The Division Bench held that in the face of the expiry of the patent in favour of the plaintiff, their locus standi to file the suit was companysidered to be relevant issue to be determined and the possibility of the suit being filed with the objective of stifling companypetition was taken into account and accordingly relief was granted to respondent number3 in marketing their product TrastuRel on the same terms, as was granted to Biocon and Mylan.
No.22510/2016 filed by respondent number3 against the interim order passed by the learned Single Judge on 25.04.2016 whereunder, respondent number3 was permitted to launch and market their product TrastuRel without projecting the same Page 8 of 21 as biosimilar to the appellants drugs HERCEPTIN, HERCLON and BICELTIS.
But it was number possible to determine at that stage, whether respondent number3 has companyducted the requisite trials as are prescribed for a bio similar drug.
He companytends that Reliance is number entitled to use the INN, since their drug has been approved without undergoing the required testing, prescribed under the Act, the Rules and the 2012 Guidelines.
3, the appellants companynsel submits that the DCGI too had admitted that the Reliance did number companyduct Phase I and II of the mandatory three phase sequential clinical trials and that Reliance has misappropriated and reproduced the appellants data in their test dossiers and marketing material and therefore the possibility of jeopardising public safety was companysidered by the learned Single Judge in stipulating certain companyditions to allow marketing of the drug TrastuRel, manufactured by Reliance.
The High Court of Delhi passed respective orders on 5.12.2014,14.2.2014 and 28.02.2014 in the Biocons suit and permitted Biocon and Mylan to market their drugs subject to the companyditions that they would number claim bio similarity with the appellants product HERCEPTIN, HERCLON and BICELTIS.
14.5 Questioning the timing of the Reliance suit, Mr. Poovayya submits that the suit was filed by the appellants just when Reliance was ready to launch their product after obtaining all requisite approvals including manufacturing and marketing authorisation granted by the Subject Expert Committee Oncology and Hematology as also the approval granted by the DCGI for manufacturing Trastuzumab, under Form No.
The suit was filed at a stage when respondent number3 was yet to introduce their drug in the market.
Ltd. and F. Hoffmann La Roche, AG 3 respectively.
Ltd. 1.
In the detailed interim order recorded on 25.04.2016, 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 number3, are number registered with the DCGI but approvals were accorded on the basis of the justification given by respondent number3 was numbered by the companyrt.
Therefore, any other intending manufacturer companyld rely upon the appellants data relating to Phase I and Phase II trials, as available in public domain.
This appeal has been preferred against the interim order dated 18.09.2019 passed by the Division Bench of High Court of Delhi in C.M. Application No.
Hrishikesh Roy, J. Leave granted.
The appellants had obtained patent for the drug Trastuzumab but the same had lapsed on Reliance Suit Plaintiffs in O.S. No.
The defendant No.3 may also manufacture and market the drug by qualifying the INN name Trastuzumab but number to use the said name stand alone on the carton or package insert as a brand name.
2 and 3 namely Roche Products India Pvt.
In the suit, the approval granted by respondent number1 Drugs Controller General of India 4 to M s. Reliance Life Sciences Pvt.
Signature Not Verified Digitally signed by ASHOK RAJ 1 SINGH Defendant number3 in O.S No.181/2016 Date 2019.12.17 180409 IST Page 1 of 21 Reason 3284/20152 before the High Court of Delhi was filed by appellant number1 M s Genentech Inc. together with appellant number.
Accordingly, an interim order was passed on 2.11.2015 in the Reliance suit whereby respondent number3 was restrained from launching and selling their product TrastuRel in India, until the next date of hearing.
The learned Senior Counsel emphasizes that the direction issued to Reliance to add qualifier to the word Trastuzumab was to avoid jeopardising the health and safety of Page 11 of 21 the patients and also to distinguish the Reliances drug from that of the innovator.
Respondent number3 filed appeal FAO OS No.
Ltd. for the manufacture and marketing TrastuRel, was also challenged.
Under the impugned order, the Division Bench allowed the application filed by respondent No.3 M s Reliance Life Sciences Pvt.
In a separate order, also dated 25.04.2016 in the Biocon suit, the learned Single Judge imposed similar companyditions as those on respondent number3.
181/2016 DCGI Page 2 of 21 3.5.2013 but they sought to restraint respondent number3 from representing their product TrastuRel, as biosimilar to Trastuzumab According to the appellants, the biosimilar product in India to be launched by respondent number3, has number been tested as a biosimilar drug in accordance with the law under the Drugs and Cosmetics Act, 1940 5 and other applicable numberms and guidelines with the projection that the respondent number3 has number undertaken requisite chemical trials and has number also generated adequate data to establish, inter alia, the safety, efficacy and immunogenicity of the drug TrastuRel, manufactured by respondent number3.
The suit before the Delhi High Court came to be filed seeking to inter alia restrain respondent No.3 M s Reliance Life Sciences Pvt.
Biocon and Mylan were however already in the market by selling their products Trastuzumab CANMab and Trastuzumab HERTRAZ in the market.
The appellants injunction application was ordered Page 4 of 21 by the learned Single Judge on 25.04.2016.
Ltd. from launching, marketing or selling TrastuRel, the biosimilar version of the appellants drug Trastuzumab.
Ltd. under the brand name HERCEPTIN, HERCLON and BICELTIS.
