Delhi High Court
Roche Products (India) Private Limited ... vs Cadila Healthcare Limited And Others on 24 February, 2020
Author: Rajiv Sahai Endlaw
Bench: Rajiv Sahai Endlaw
* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Date of decision: 24th February, 2020
+ CS(COMM) 1119/2016, IA No.10019/2016 (u/O XXXIX R-1&2
CPC), IA No.10020/2016 (u/O II R-2 CPC) & IA No.10021/2016
(u/S 80(2) CPC).
ROCHE PRODUCTS (INDIA) PRIVATE
LIMITED AND OTHERS ..... Plaintiffs
Through: Mr. Gopal Subramanium & Mr.
Sandeep Sethi, Sr. Advs. with Mr.
Darpan Wadhwa, Ms. Samiksha
Godiyal, Mr. Abhishek Tewari, Mr.
Tanmay Singh, Ms. Roshni
Namboodiry, Mr. Talha Abdul
Rehman & Mr. Pavan Bhushan,
Advs.
Versus
CADILA HEALTHCARE LIMITED & ORS ..... Defendants
Through: Mr. P. Chidambaram, Sr. Adv. with
Ms. Bitika Chattrapati, Mr. Kapil
Midha & Ms. Neha Khanduri,
Advs. for D-1.
Mr. Sanjay Jain, ASG with Mr.
Rishi Kant Singh, Mr. Krishnanu
Barua & Ms. Natasha Thakur,
Advs. for D-2&3.
AND
+ CS(COMM) 540/2016, IA No.6087/2016(u/O.XXXIX R-1&2
CPC), IA No.2698/2017(u/O.VII R-11 CPC) & IA
No.2699/2017(u/S. 151 CPC).
F. HOFFMANN-LA ROCHE LTD & ORS .... Plaintiffs
Through: Mr. Darpan Wadhwa, Sr. Adv. with
Mr. Vishal Gehrana, Ms. Deepti
Sarin, Mr. Shravan Sahny, Ms.
Sonali Jain & Mr. Sanjeet Ranjan,
Advs.
Versus
CS(COMM) Nos. 1119/2016 & 540/2016 Page 1 of 31
DRUGS CONTROLLER GENERAL OF INDIA & ORS ... Defendants
Through: Mr. Amit Mahajan, CGSC with Mr.
Apoorv Singhal, Adv. for UOI.
Mr. Ashish Prasad & Mr. Ashish
Virmani, Advs. for D-3.
CORAM:
HON'BLE MR. JUSTICE RAJIV SAHAI ENDLAW
1. CS(COMM) No.1119/2016 has been instituted by the three
plaintiffs, namely (a) Roche Products (India) Private Limited; (b) F.
Hoffmann-La Roche, AG; and, (c) Genentech Inc., against (i) Cadila
Healthcare Ltd. (Cadila); (ii) Drugs Controller General of India (DCGI);
and, (iii) Department of Biotechnology (DoB), Ministry of Science &
Technology, for
A. declaration:-
(i) that Cadila‟s drug has not been tested as, and is not, a
biosimilar product under applicable law;
(ii) that the approvals dated 30th March, 2012 and 18th
September, 2012 by the Review Committee on Genetic
Manipulation (RCGM) of the preclinical protocol and
preclinical test results respectively of Cadila‟s drug
and Clinical Trials Registry - India (CTRI) registration
bearing no.l CTRI/2014/05/004605 and the DCGI‟s
approval dated 10th March, 2014 in relation to clinical
trial protocol of Cadila‟s drug are invalid and are not
in accordance with applicable law;
CS(COMM) Nos. 1119/2016 & 540/2016 Page 2 of 31
(iii) that the manufacturing authorization dated 28th
October, 2015 granted by the DCGI to Cadila for
Cadila‟s drug is invalid; and,
(iv) that the no objection dated 21st January, 2016 for
Cadila‟s drug, for the additional indications i.e.
HER2+metastatic gastric cancer and HER2+ early
breast cancer, is invalid.
B. Permanent injunction to restrain:-
(i) Cadila from selling, marketing and / or distributing its
drug in the Indian market as „Trastuzumab‟ or
otherwise, pursuant to the manufacturing authorization
dated 28th October, 2015 granted by DCGI;
(ii) Cadila from selling, marketing and / or distributing its
drug in the Indian market as „Trastuzumab‟ or
otherwise for the additional indications i.e. HER2+
early breast cancer and HER2+ metastatic gastric
cancer pursuant to No Objection dated 21 st January,
2016 granted by the DCGI;
(iii) Cadila from representing its drug as „Trastuzumab‟;
(iv) Cadila from representing its drug as a biosimilar
version of the plaintiffs‟ „Trastuzumab‟ or of
HERCEPTIN®, HERCLONTM or BICELTIS® or
from claiming similarity and / or comparability with
„Trastuzumab‟ or with HERCEPTIN®, HERCLONTM
CS(COMM) Nos. 1119/2016 & 540/2016 Page 3 of 31
or BICELTIS®, until biosimilarity between Cadila‟s
drug and the plaintiffs‟ „Trastuzumab‟ is established
pursuant to appropriate tests under the Drugs and
Cosmetics Act, 1940 (the Drugs Act), the Drugs and
Cosmetics Rules, 1945 (the Drugs Rules) and the
Guidelines on Similar Biologics, 2012 (the Biosimilar
Guidelines);
(v) Cadila from relying upon or otherwise referring to the
plaintiffs‟ trade marks HERCEPTIN®, HERCLONTM
or BICELTIS® or any data relating to the plaintiffs‟
„Trastuzumab‟ marketed as HERCEPTIN®,
HERCLONTM or BICELTIS® including data relating
to its manufacturing process, safety, efficacy and sales
in any press releases, public announcements, package
insert, promotional, sales, marketing or other material
for its drug; and,
(vi) DCGI from issuing the final package insert approval in
relation to Cadila‟s drug to Cadila.
2. CS(COMM) No.1119/2016 first came up before this Court on 19th
August, 2016 when Cadila, being on caveat, appeared through counsel
and the counsels were heard at length on the aspect of maintainability of
the suit. It was inter alia the contention of the senior counsel for Cadila
that the approval granted by the DCGI and DoB to Cadila‟s drug is
appealable under Rule 122DC of the Drugs Rules, as under:-
CS(COMM) Nos. 1119/2016 & 540/2016 Page 4 of 31
"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 inquiry into the
matter as is considered necessary, may pass such order
in relation thereto as it thinks fit."
It was however felt that the presence of the counsel for the DCGI
and the DoB was necessary to adjudicate the aspect of the admissibility of
the suit; hence the presence of the Additional Solicitor General (ASG)
was sought.
3. On 29th August, 2016, the learned ASG was heard on the aspect of
maintainability by the plaintiffs of the appeal under Rule 122DC of the
Drugs Rules, against the approval granted by the DCGI and DoB to
Cadila and it was enquired from the senior counsel for the plaintiffs, that
once the law permits an approval as a new drug to be given to others on
account of being biosimilar to the new drug of the plaintiffs, what cause
of action on the ground of misrepresentation, passing off, copyright
violation and dilution of goodwill, can the plaintiffs have if an approval is
given by the Authorities constituted to grant such approval, save as to the
validity of the approval. Hearing was adjourned to 26th September, 2016,
for the counsel for the plaintiffs to address on the aspect of cause of action
if any to the plaintiffs de hors the validity of the approval granted by
DCGI and DoB to Cadila. Hearing was adjourned from time to time. The
senior counsel for the plaintiffs were finally heard on 10th November,
2016 and orders reserved. The senior counsel for the plaintiffs, on that
date handed over a note of arguments and liberty was granted to the
CS(COMM) Nos. 1119/2016 & 540/2016 Page 5 of 31
counsel for Cadila to also, if so desires, hand over a note of arguments.
Written submissions have since been handed over by the counsel for
Cadila. However this order remained on back burner for the reasons
contained later in this order.
4. It is the plea of the plaintiffs in the plaint in CS(COMM)
No.1119/2016, that (i) Genentech INC., in the year 1990, developed a
biological drug containing the active ingredient „Trastuzumab‟, a
humanised monoclonal antibody which binds specifically to the human
epidermal growth factor receptor 2 (HER2) protein and is designed to
target and block HER2 protein overexpression, and in addition, also
triggers an immune response in the body to destroy the particular cell it
attaches to, thereby having a two-fold role in containing and curing
certain forms of cancer; (ii) between 1992 and 1998, extensive global
clinical trials (Phase I, Phase II and Phase III) were carried out by
Genentech INC., to test the safety, efficacy and quality of „Trastuzumab‟
for the indication, HER2+ metastatic breast cancer; (iii) „Trastuzumab‟,
after rigorous tests to confirm its safety, efficacy and quality, received
manufacturing and marketing approvals worldwide; (iv) the said drug has
been sold by the plaintiffs worldwide since 1998 under the trade mark
HERCEPTIN® for the treatment of HER2+ metastatic breast cancer and
subsequently also for the treatment of HER2+ early breast cancer and
HER2+ metastatic gastric cancer; (v) in India, „Trastuzumab‟ has been
marketed under the brand name HERCEPTIN®, for more than 12 years,
as targeted therapy for the treatment of the two additional types of cancer
aforesaid; the plaintiffs also import and market the said drug in India
under the brand name HERCLONTM and the said drug is also distributed
CS(COMM) Nos. 1119/2016 & 540/2016 Page 6 of 31
by one of the plaintiffs under the brand name BICELTIS®; (vi) the import
and marketing of the drug in India began after approvals dated 11th
October, 2002, 7th August, 2006 and 13th April, 2010 under Rule 122A of
the Drugs Rules by the DCGI; (vii) DCGI and DoB, on 15th September,
2012 framed the Biosimilar Guidelines to provide a legal framework for
the evaluation and approval of biosimilar drugs in India and to introduce a
regime for comparative testing between a purported biosimilar drug and
an innovator biological drug; (viii) biological drugs are synthesized by
cells of living organisms as opposed to chemical drugs which are
produced by chemical synthesis; biosimilars are not generic or
bioequivalent drugs and cannot be a generic equivalent of the innovator
biological drug owing to the structural and manufacturing complexities
involved in the production of biopharmaceuticals; (ix) testing and
approval of biosimilar drugs in India is regulated under (a) the Drugs Act,
the Drugs Rules and the Biosimilar Guidelines; (b) Rules for the
Manufacture, Use, Import, Export and Storage of Hazardous
Microorganisms / Genetically Engineered Organisms or Cells, 1989,
notified under the Environment (Protection) Act, 1986; (c) Recombinant
DNA Safety Guidelines, 1990; (d) Guidelines for Generating Preclinical
and Clinical Data for r-DNA Vaccines, Diagnostics and Other
Biologicals, 1999; (e) Central Drugs Standard Control Organisation
Guidance for Industry, 2008; and, (f) Guidelines and Handbook for
Institutional Biosafety Committees, 2011; (x) Cadila‟s drug, sought to be
marketed in India as a purported biosimilar version of „Trastuzumab‟ of
the plaintiffs, is a recombinant DNA (r-DNA) drug and which is a „new
drug‟ under Rule 122E of the Drugs Rules and import and / or
CS(COMM) Nos. 1119/2016 & 540/2016 Page 7 of 31
manufacture of „new drugs‟ for clinical trials or marketing is regulated
under Part XA read with Schedule Y of the Drugs Rules; (xi) the
Biosimilar Guidelines provide a detailed and structured process for
comparison of the similar biologic with the reference biologic to ensure
that the similar biologic is comparable in quality to the reference biologic
and can be safely used in the treatment of specified diseases or disorders;
(xii) Cadila has filed a suit before the High Court of Bombay seeking to
restrain the plaintiffs from interfering with and / or preventing Cadila
from launching and marketing its drug; however no interim injunction has
been granted to Cadila in the said suit; (xiii) that the plaintiffs have learnt
that Cadila, on 30th March, 2012 received permission from RCGM to
conduct preclinical toxicity studies on Wistar rats and New Zealand
rabbits and results of which preclinical toxicity studies were approved by
RCGM on 18th September, 2012, even though Cadila failed to conduct
preclinical pharmacology studies in relation to its drug and arbitrarily
chose to conduct preclinical studies on Wistar rats and New Zealand
rabbits, even though preclinical trials for „Trastuzumab‟ were conducted
by the plaintiffs on pregnant monkeys with no scientific justification
provided therefor and there were other deficiencies / lacunas and owing
whereto Cadila‟s drug is not in compliance with the Drugs Act, Drugs
Rules and Biosimilar Guidelines and Cadila has not conducted studies to
establish biosimilarity between Cadila‟s drug and the plaintiffs‟
„Trastuzumab‟; (xiv) notwithstanding the aforesaid, DCGI has granted
manufacturing authorization to Cadila‟s drug; (xv) though the plaintiffs,
in order to obtain information under the Right to Information Act, 2005
made a representation to DCGI, but no adequate response thereto has been
CS(COMM) Nos. 1119/2016 & 540/2016 Page 8 of 31
received; (xvi) Cadila‟s drug purportedly developed for treatment of the
same forms of cancer as the plaintiffs‟ „Trastuzumab‟, competes directly
with plaintiffs‟ „Trastuzumab‟ and the plaintiffs‟ apprehend that owing to
the lacunas / deficiencies aforesaid in testing the biosimilarity of Cadila‟s
drug with the plaintiffs‟ „Trastuzumab‟, Cadila‟s drug will not have the
same efficacy and result, and thereby dilute the goodwill and copyright of
the plaintiffs and their drug „Trastuzumab; and the same will also amount
to passing off and misappropriation by Cadila of the plaintiffs‟
„Trastuzumab‟; and, (xvii) Cadila, without undertaking the preclinical
studies on the relevant animal species and without undertaking the
necessary clinical trials will use the data relating to the plaintiffs‟
„Trastuzumab‟ in the package insert for its drug amounting to violation of
the rights of the plaintiffs with respect thereto.
5. Though the plaint is replete with details of dissimilarity between the
drug of the plaintiffs and the drug of Cadila and the deficiencies / lacunae
in terms of the Drugs Act, the Drugs Rules and the Biosimilar Guidelines
in grant of approval by the DCGI and DoB to Cadila‟s drug but on the
aspect of considering the maintainability of the suit, there is no need to go
into the said details in this judgment.
6. On going through the contents of the plaint, two questions arose in
my mind as to the maintainability thereof. Firstly, that once Cadila is
entitled under the law to manufacture and market a drug biosimilar to that
of the plaintiffs, after obtaining the requisite approvals from the DCGI
and DoB and once Cadila had obtained such approvals, whether this
Court, in a Civil Suit, could sit in appeal over those approvals so obtained
CS(COMM) Nos. 1119/2016 & 540/2016 Page 9 of 31
by Cadila. Secondly, whether the proceedings in the present suit were
liable to be stayed under Section 10 of the Code of Civil Procedure, 1908
(CPC) owing to the suit previously instituted by Cadila against the
plaintiffs and pending in the Bombay Courts.
7. The senior counsel for Cadila, appearing on caveat on 19th August,
2016, informed and contended that, (i) Cadila‟s drug had obtained the first
marketing authorization on 28th October, 2015 and packaging insert
approval on 22nd December, 2015 and had on 25th December, 2015
launched the drug; (ii) marketing authorization was subsequently also
obtained on 21st January, 2016 and subsequent packaging insert approval
obtained on 3rd March, 2016; (iii) the plaintiffs in the present suit have not
sought any interim relief with respect to the marketing authorization
already obtained by Cadila; (iv) Cadila has already effected sales worth
Rs.17 crores; (v) the suit of the plaintiffs does not qualify as a
„commercial suit‟ and has been wrongly labeled as such; (vi) Rule 122DC
of the Drugs Rules provides for a remedy of appeal against the approvals
granted by DCGI and DoB to Cadila; and, (vii) attention was invited to
Guidelines 8.4 and 13 (n), (o) and (p) of the Guidelines on Similar
Biologics: Regulatory Requirements for Marketing Authorisation in India,
2016 filed by the plaintiffs themselves at page 16 of the Part-III Vol-I file,
to contend that approvals obtained by Cadila‟s drug could not have been
granted without assessment of safety and the definitions of „Reference
Biologic‟, „Similar‟ and „Similar Biologic‟ in the said Guidelines.
8. Per contra, the senior counsel for the plaintiffs, on 19th August,
2016 drew attention to pages 1099 to 1104 of Part-III, Vol-IV file, being
CS(COMM) Nos. 1119/2016 & 540/2016 Page 10 of 31
paras 75 to 78 and 84 to 86 of the judgment dated 25 th April, 2016 of this
Court in CS(OS) No.355/2014 titled Roche Products (India) Pvt Ltd. Vs.
Drugs Controller General of India (later reported as 2016 SCC OnLine
Del 2358) to contend that (i) Rule 122DC supra does not cover appeals
against approvals granted under Part XA of the Drugs Rules and is limited
only to appeals against orders passed by DCGI under Part XA of the
Drugs Rules; (ii) thereunder also the remedy of appeal would be available
only to a person who is before the DCGI in the first instance; (iii) the said
Rules do not protect or enforce the right of the innovator drugs; (iv) the
summary procedure of an appeal does not allow complicated questions of
fact, on the basis of evidence, to be decided; and, (v) thus the Civil Court
has jurisdiction. The senior counsel for the plaintiffs also drew attention to
pages 611 and 618 of the Part-III, Vol-III file, to contend that the
approvals are pre-trial approvals and the trial was initiated to be
completed and is still in phase-III stage.
9. The learned ASG, on enquiry whether the remedy of appeal under
Rule 122DC supra is available to the plaintiffs against the grant of
approvals by DCGI to Cadila, answered in the affirmative and on specific
query whether the appeal, if preferred by the plaintiffs would be
entertained or dismissed as not maintainable, after obtaining instructions
answered that the appeal would be entertained. On further query whether
the limitation of 60 days from the date of the order to prefer an appeal
against the order of the DCGI, provided for in Rule 122DC would come
in the way of the plaintiffs, the learned ASG stated that the time limit is
not sacrosanct and though there is no provision in the Rules empowering
for condonation of delay in preferring appeal but since there is no
CS(COMM) Nos. 1119/2016 & 540/2016 Page 11 of 31
prohibition also, the Central Government as the Appellate Authority is
empowered to extend the time.
10. The following other submissions were made by the counsels on the
aspect of maintainability of the suit:-
A. By learned ASG:-
(i) that the drug of Cadila has been held by the DCGI and
the DoB to be biosimilar to the drug of the plaintiffs
under Rule 122B of the Drugs Rules;
(ii) that a biosimilar drug is a „new drug‟ within the
meaning of Rule 122E of the Drugs Rules; attention in
this regard is invited to explanation (i) to the said Rule;
(iii) that a permission / approval is also an „order‟ within
the meaning of Rule 122DC and is appealable under
the same;
(iv) that Cadila, for the subject drug has approval under
Rule 122B(1)(a) of the Drugs Rules;
(v) that Rule 122DC provides for appeal against an „order‟
of the DGCI irrespective of whether the order is
administrative or quasi judicial;
(vi) per Rule 21, a licence is an order;
(vii) that for grant of approval for manufacturing a new
drug under Rule 122B, the Licencing Authority has to
record its satisfaction;
CS(COMM) Nos. 1119/2016 & 540/2016 Page 12 of 31
(viii) that there can be no other meaning of „order‟ within
the meaning of Rule 122DC, except of grant or refusal
of licence / permission sought and the remedy of
appeal is available to a third party also;
(ix) a grant or refusal of licence is an „order‟; attention in
this regard is invited to Rules 62B(3) and 122M which
provide for appeal by any person aggrieved by an
order of the DCGI granting or refusing a licence;
(x) Rule 122DC was introduced along with Rule 122DB
and both use the word „order‟;
(xi) subsequent thereto, Rules 122DAB(3) & (7) were
introduced which also use the word „order‟;
(xii) the word „order‟ is also used in Rule 122DAC(3),
which was also introduced subsequently;
(xiii) it matters not whether only approval or license is
issued or formal order is issued inasmuch as grant of
approval/license is after recording satisfaction and
would constitute an „order‟;
(xiv) merely because the decision is in the form of a grant of
license, and not an „order‟ as understood in the courts
would not negate the appealability thereof; and,
(xv) attention was drawn to Form 45 and Form 45A to
contend that merely because the form of the order is
prescribed does not mean that it ceases to be an order.
CS(COMM) Nos. 1119/2016 & 540/2016 Page 13 of 31
B. By Mr. Darpan Wadhwa, Advocate for the plaintiffs:-
(i) Part XA of the Drugs Rules had no provision for
appeal till December, 2001 when Rules 122DB and
DC were added; and,
(ii) that the said Rules have to be read in the context of the
other Rules in Part XA and the words „any person
aggrieved‟ in Rule 122DC can only mean the applicant
to the DCGI as others / third parties do not even come
to know of the grant or refusal of licence.
(learned ASG responded that approvals by the DCGI
are immediately put on the website of the DCGI and
come out in the public domain; even otherwise as soon
as a new drug surfaces in the market, the public knows
of it and it is not as if the launch / marketing of a new
drug is hidden from anyone)
(iii) that no hearing is given to third parties before grant or
refusal of licence;
(learned ASG referred to P.H. Paul Manoj Pandian
Vs. Mr. P. Veldurai (2011) 5 SCC 214 to contend that
the way the Central Government understands Rule
122DC is that there is an appellate provision)
(iv) if permission/approval is refused, there is no appeal
under Rule 122DC;
(learned ASG controverted and said it is maintainable)
CS(COMM) Nos. 1119/2016 & 540/2016 Page 14 of 31
(v) that the acts of Cadila in any case amount to
misrepresentation, passing off, copyright infringement
and dilution of goodwill of the plaintiffs and their drug
and the suit is maintainable on the said grounds;
(vi) that Cadila is using the proprietary information of the
plaintiffs pertaining to the Phase-I and Phase-II trials
conducted by the plaintiffs and which have admittedly
not been carried out by Cadila; and,
(vii) Cadila cannot tell the public that tests conducted by the
plaintiffs are the tests conducted by Cadila as is being
done by Cadila.
C. By Mr. Kapil Sibal, Sr. Advocate for the plaintiffs:-
that there is no procedure for the DCGI or the DoB to
issue Public Notice of the applications for licence or to
give opportunity to third parties to intervene at that
stage and once that is so, the remedy of appeal cannot
be available to third parties.
D. By Mr. Gopal Subramanium, Sr. Advocate for the plaintiffs:-
(i) the appellate remedy is only for the applicant and not
for the innovator;
(ii) innovator can only come to the Civil Court;
(iii) the question for adjudication is whether the drug of
Cadila is biosimilar to the drug of the plaintiffs;
CS(COMM) Nos. 1119/2016 & 540/2016 Page 15 of 31
(iv) the package insert of the drug of Cadila says that the
drug of Cadila is biosimilar to the drug of the
plaintiffs;
(v) that the innovator can also initiate quia timet action;
(vi) role of Appellate Authority under Rule 122DC is only
limited to correct an act of omission and commission
of the DCGI;
(vii) that though the patent of the drug of the plaintiffs has
expired but Cadila cannot still use the data;
(viii) the right to claim a drug to be biosimilar to the drug of
another does not include a right to ride on the
reputation and goodwill of the other;
(ix) in a proceeding for claiming a drug to be a biosimilar
drug, innovator is a stranger and is not in the picture;
(x) that it is the case of the plaintiffs that there are
statutory non-compliances by the DCGI and the DoB
and other authorities in grant of permissions to Cadila
and such statutory non-compliances are subject to the
jurisdiction of the Civil Court; and,
(xi) that intellectual property rights include data rights and
the plaintiffs, having rights in the data pertaining to
trials conducted by the plaintiffs, are entitled to come
to the Civil Court to seek restrain on unfair use thereon
by Cadila.
CS(COMM) Nos. 1119/2016 & 540/2016 Page 16 of 31
11. The senior counsel for the plaintiffs in his written submissions has
referred to:-
(i) Ganga Bai Vs. Vijay Kumar (1974) 2 SCC 393 - holding
that there is a distinction between right of suit and the right of
appeal and a right of appeal inheres in no one and an appeal
for its maintainability must have clear authority of law;
(ii) Secretary of State Vs. Mask and Co. AIR 1940 PC 105,
Dhulabhai Vs. State of MP AIR 1969 SC 78, Mohammad
Din Vs. Iman Din 1947 SCC OnLine PC 48, State of Kerala
Vs. Ramaswami Iyer and Sons AIR 1966 SC 1738, Ganga
Ram Hospital Trust Vs. Municipal Corporation of Delhi
2001 SCC OnLine Del 622 (DB), Firm Seth Radha Kishan
Vs. Administrator Municipal Committee, Ludhiana AIR
1963 SC 1547, K.S. Venkataraman and Co. Vs. State of
Madras AIR 1966 SC 1089 - to contend that Civil Court‟s
jurisdiction is not barred if the statutory authority does not
act in compliance with the statute or fundamental principles
of judicial procedure;
(iii) Dhulabhai supra to contend that ouster of Civil Courts
jurisdiction should not be readily inferred and that while
considering the existence of an implied bar, it is necessary to
examine the remedies provided under a statute and the
scheme of such statute to determine if such remedy would be
available to the plaintiff.
CS(COMM) Nos. 1119/2016 & 540/2016 Page 17 of 31
(iv) Premier Automobiles Ltd. Vs. Kamlekar Shantaram Wadke
(1976) 1 SCC 496 - to contend that where the suit is to
enforce a right under the general law or common law and not
merely a right created under a statute, there is no implied bar
to jurisdiction, Md. Sharfuddin Vs. R.P. Singh AIR 1961 SC
1312 and State of Maharashtra Vs. Iqbal Mohammed
Memon 1998 SCC OnLine Bom 482 (DB).
(v) Northern Plastics Ltd. Vs. Hindustan Photo Films Mfg. Co.
Ltd. (1997) 4 SCC 452 on the meaning of „person aggrieved‟.
(vi) Dhannalal Vs. Kalawati Bai (2002) 6 SCC 16 - to contend
that there can be no bifurcation of causes of action.
(vii) N.R. Dongre Vs. Whirlpool Corporation (1996) 5 SCC 714,
Bayer Corporation Vs. Union of India 2010 SCC OnLine
Del 541 (DB), K.G. Khosla Compressors Limited Vs. Khosla
Extrakting Limited 1985 SCC OnLine Del 232 and K.
Ramdas Shenoy Vs. Chief Officers, Town Municipal
Council, Udipi (1974) 2 SCC 506 - to contend that passing
off action is maintainable.
(viii) Erven Warnik Besloten Vs. Townend and Sons [1979] A.C.
731, B.K. Engineering Co. Vs. UBHI Enterprises 1984 SCC
OnLine Del 288 (DB), Ellora Industries Vs. Banarsi Das
Goela 1979 SCC OnLine Del 198, The Scotch Whiskey
Association Vs. Pravara Sahakar Shakar Karkhana Ltd.
AIR 1992 Bom 294 - on extended passing off action.
CS(COMM) Nos. 1119/2016 & 540/2016 Page 18 of 31
(ix) T.V. Venugopal Vs. Ushodaya Enterprises Limited (2011) 4
SCC 85 - to contend that Cadila is seeking to market its drug
„Vivitra‟ as „Trastuzumab‟ of the plaintiffs.
12. The counsel for Cadila has handed over a compilation of following
judgments:-
(i) NDMC Vs. Satish Chand (2003) 10 SCC 38;
(ii) Jasbhai Motibhai Desai Vs. Roshan Kumar, Haji Bashir
Ahmed (1976) 1 SCC 671;
(iii) Rukhmabai Vs. Lala Laxminarayan AIR 1960 SC 335;
(iv) The State of Uttar Pradesh Vs. Janki Saran Kailash
Chandra (1973) 2 SCC 96;
(v) Rajasthan State Road Transport Corporation Vs. Bal
Mukund Bairwa (2009) 4 SCC 299;
(vi) Ravi Yashwant Bhoir Vs. District Collector, Raigad (2012)
4 SCC 407;
(vii) State of Assam Vs. Barak Upatyaka D.U. Karamchari
Sanstha (2009) 5 SCC 694;
(viii) National Institute of Mental Health and Neuro Sciences Vs.
C. Parameshwara (2005) 2 SCC 256;
(ix) Prism Entertainment Pvt. Ltd. Vs. Prasad Productions Pvt.
Ltd. 2006 SCC OnLine Cal 228;
(x) Jai Hind Iron Mart Vs. Tulsiram Bhagwandas 1952 SCC
OnLine Bom 66 (DB);
CS(COMM) Nos. 1119/2016 & 540/2016 Page 19 of 31
(xi) Dropati Devi Vs. Jaswant Singh 2008 SCC OnLine Del
1083;
(xii) T. Arivandandam Vs. T.V. Satyapal (1977) 4 SCC 467; and,
(xiii) Bright Enterprises Private Limited Vs. MJ Bizcraft LLP
2016 SCC Online Del 4421 (DB).
13. CS(COMM) 540/2016 was instituted by the same three
plaintiffs against (i) DCGI; (ii) DoB; and, (iii) Hetero Drugs Limited
(HDL), for
A. declaration:-
(i) that HDL‟s drug, a purported bio-similar version of
the plaintiffs‟ „bevacizumab‟ drug had not been
tested as a bio-similar product under the applicable
laws;
(ii) that HDL‟s CTRI registration No.
CTR/2015/05/005757 dated 8th May, 2015, last
modified on 4th August, 2015, is invalid and not in
accordance with applicable laws;
(iii) that the approval granted on 28th April, 2015 by
DCGI to HDL‟s Clinical Trial Protocol for HDL‟s
drug is invalid and not in accordance with
applicable laws;
(iv) that marketing authorization if any, granted by
DCGI to HDL‟s drug is invalid;
CS(COMM) Nos. 1119/2016 & 540/2016 Page 20 of 31
B. permanent injunction to restrain:-
(i) HDL from launching, introducing, selling,
marketing and/or distributing a bio-similar version
of plaintiffs‟ „bevacizumab‟;
(ii) HDL from representing HDL‟s drug to be bio-
similar to the plaintiffs‟ „bevacizumab‟;
(iii) HDL from marketing and/or manufacturing its
drug;
(iv) HDL from relying upon data pertaining to
plaintiffs‟ „bevacizumab‟
(v) HDL from using the name „bevacizumab‟.
14. CS(COMM) No.540/2016 first came up before this Court on
16th May, 2016 and was adjourned to 24th May, 2016 and 2nd June,
2016. On 2nd June, 2016, the counsels for the defendants, appearing
on caveat, took the plea that the suit was not maintainable because of
the right of appeal under Rule 122DC of the Drugs Rules. The said
suit was also adjourned from time to time for hearing on the said
aspect concerning the maintainability of the suit. Ultimately, vide
order dated 9th January, 2017, leaving the said question open,
summons of the suit were ordered to be issued. Thereafter, HDL filed
an application under Order VII Rule 11 of the CPC for rejection of the
plaint.
CS(COMM) Nos. 1119/2016 & 540/2016 Page 21 of 31
15. At that stage, on 7th December, 2017, CS(COMM) 540/2016
also came up before the undersigned when the counsels stated that part
of the controversy for consideration was the same as in CS(COMM)
1119/2016 in which orders had been reserved on 10th November,
2016. Thereafter CS(COMM) 540/2016 was adjourned from time to
time to await the orders reserved in CS(COMM) 1119/2016 and
during which hearings it was informed that appeals before the
Division Bench against the judgment dated 25th April, 2016 in CS(OS)
355/2014 filed by the plaintiffs herein against Biocon Ltd. (Biocon),
Mylan Inc. and Mylan Pharmaceuticals Ltd. (Mylan) were pending
consideration. In the said judgment, a Co-ordinate Bench of this
Court, with respect to maintainability of that suit entailing the same
controversy as in CS(COMM) No.540/2016 and CS(COMM)
No.1119/2016 i.e. viz-a-viz Rule 122DC of the Drugs Rules, had held
as under:-
"85. With regard to other objection raised by the
defendants about the exclusivity of civil jurisdiction
impliedly bar under Rule 122DC. Rule 122DC does not
cover appeals against approvals granted under Part XA -
this rule is limited to appeals against orders passed by the
DCGI under Part XA of the Rules. The terms "order" and
"approval"/"permission" have distinct meanings under
Part XA of the Drugs Rules (refer to Rule 122DAB(3),
Rule 122DAB(7), 122DAC(3), 122DAC(4), 122DB and
Rule 122B(2A)). In the present suit, the plaintiffs have not
challenged any "order" passed by defendant No. 1 under
Part XA of the Drugs Rules. It does not confer a right on a
third party to challenge an approval granted under Rule
122B - Rule 122DC applies to a person who is
CS(COMM) Nos. 1119/2016 & 540/2016 Page 22 of 31
immediately and directly aggrieved by an order of the
licensing authority, inter alia, refusing to grant licence to
himself or to renew licence, and not to one who is
consequently aggrieved, like the plaintiffs in the present
case.
86. No doubt as Rule 122DC contains the appeal
provision, the benefit of the appeal would be accrued only
to a person who is before the regulator in the first
instance and who would, therefore, have the knowledge of
the order issued by the regulator. The said party is
expected to file an appeal within 60 days from the date of
the order, as contemplated under Rule 122DC. In the
present case, approval for drug of defendant No. 2 was
not made available to the plaintiffs. Accordingly, this
provision is not applicable to the plaintiffs in the present
case. The approvals of bio-similar in favour of defendant
No. 2 of innovator drugs are admittedly never notified of
approvals granted or given any information available to
manufacturers of innovator drugs.
87. The said Rule does not protect or enforce the right of
the innovator drugs. Even Mr. Sanjay Jain, learned ASG
appearing on behalf of the defendant No. 1, has admitted
that the procedure of granting approvals to manufacturers
for biosimilar drugs does not involve a lis between the
manufacturer of the innovator drug and the manufacturer
of the biosimilar drug. Defendant No. 1 does not
determine the rights of such parties at the time of granting
approvals to drug manufacturers. Therefore, the plaintiffs
(i.e. the manufactures of the innovator drug in the present
case) are entitled to file a civil suit to protect their rights
in relation to the plaintiffs' Trastuzumab as efficacious
remedy under this Rule is not available. (See Ganga Ram
Hospital v. Municipal Corporation of Delhi (2001 (60)
DRJ 549 at paragraph 20)."
CS(COMM) Nos. 1119/2016 & 540/2016 Page 23 of 31
16. It was felt that a Co-ordinate Bench having held Rule 122DC to
be not a bar to the maintainability of a civil suit, though without
considering the use therein of the expression "Any person aggrieved"
which in Municipal Corporation for Greater Bombay Vs. Lala
Pancham of Bombay AIR 1965 SC 1008, Adi Pherozshah Gandhi
Vs. H.M. Seervai, Advcoate-General of Maharashtra, Bombay
(1970) 2 SCC 484, Paam Pharmaceutical (Delhi) Limited Vs. Union
of India 2000 SCC OnLine Del 620 (DB), Vinod Kumar Bhalotia Vs.
State of U.P. 1999 SCC OnLine All 1251 (DB), Md. Sharifuddin Vs.
R.P. Singh 1956 SCC OnLine Pat 94 (DB) and B.K. Ramachandra
Rao Vs. Kamapalappa 1962 SCC OnLine Kar 105 (DB) had been
held to have a wide connotation, and the matter was pending before
the Division Bench including on the said aspect, the judgment of the
Division Bench may be awaited.
17. It was also informed that the same plaintiffs as in these two
suits, besides the earlier suit against Biocon and Mylan, had also filed
yet another suit being CS(OS) No.3284/2015 against Reliance Life
Sciences Pvt. Ltd. (Reliance) and wherein also the same issue i.e. of
maintainability of the suit viz-a-viz Rule 122DC of the Drugs Rules
was raised and vide judgment dated 25th April, 2016 (reported as
Genentech Inc. Vs. Drugs Controller General of India 2016 SCC
OnLine Del 2572) the contention with respect to Rule 122DC had
been dealt with as in the judgment in the suit against Biocon and
Mylan.
CS(COMM) Nos. 1119/2016 & 540/2016 Page 24 of 31
18. It was yet further informed that vide the said judgments dated
25th April, 2016 in the suits against Biocon/Mylan and Reliance,
certain conditions had been imposed on Biocon/Mylan and Reliance
for the manufacture, marketing and advertisement of their respective
drugs, pending a final decision in the suits, and the Division Bench, in
the appeals aforesaid had stayed the said conditions imposed on
Biocon/Mylan and Reliance and position prevailing immediately prior
to 25th April, 2016 had been ordered to be continued. It was yet further
informed that vide ad interim order dated 3rd March, 2017 of the
Division Bench in the appeal preferred by Biocon and Mylan, the
conditions imposed on Biocon/Mylan vide orders of prior to the
judgment dated 25th April, 2016, were also vacated and against which
order the plaintiffs herein and therein had preferred SLP(C)
No.015532-015537/2017 but which were withdrawn on 11th August,
2017. It was yet further informed that the Division Bench, vide ad
interim order dated 18th September, 2019 in the appeal preferred by
Reliance had also set aside the conditions imposed on Reliance and
against which SLP(C) No.24727/2019 had been preferred by the
plaintiffs herein and therein and in which notice had been issued and
the order of the Division Bench vacating the conditions imposed by
the Single Judge on Reliance had been vacated.
19. On 27th January, 2020, the counsel for the plaintiffs mentioned
these two suits for listing owing to subsequent developments in the
matter and the suits were accordingly listed on 31st January, 2020.
CS(COMM) Nos. 1119/2016 & 540/2016 Page 25 of 31
20. On 31st January, 2020, it was informed that the Supreme Court
vide judgment dated 17th December, 2019 in SLP(C) No.24727/2019
had set aside the ad interim order of the Division Bench in the appeal
preferred by Reliance vacating the conditions imposed on Reliance
vide judgment dated 25th April, 2016, and had restored the order dated
25th April, 2016.
21. A perusal of the judgment dated 17th December, 2019 of the
Supreme Court however did not show the Supreme Court to have dealt
with the aspect of maintainability of the suits in the light of Rule
122DC of the Drugs Rules and the Supreme Court in the said
judgment, was only concerned with the orders of the Division Bench
of this Court vacating the conditions imposed on Reliance by the
Single Judge vide judgment dated 25th April, 2016, and which have
been ordered to continue.
22. Being of the view that the Co-ordinate Bench in the judgments
dated 25th April, 2016 in the suits against Biocon/Mylan and Reliance,
though had dealt with Rule 122DC but not in its entire perspective and
that the Supreme Court also in the judgment dated 17th December,
2019 had not touched upon the said aspect, after 31st January, 2020, I
started working on the judgment scheduled for pronouncement on 24 th
February, 2020. However, while working on the said judgment,
orders, both dated 11th February, 2020, of the Division Bench of this
Court in the appeal arising out of the Reliance suit and the appeal
arising out of the Biocon/Mylan suit came to the notice of the
undersigned. Vide order dated 11th February, 2020 concerning the
CS(COMM) Nos. 1119/2016 & 540/2016 Page 26 of 31
appeals by the plaintiffs herein arising out of the suit filed against
Reliance, the Division Bench, in view of paragraph 28 of the judgment
dated 17th December, 2019 of the Supreme Court in SLP(C)
No.24727/2019 as under:
"3. Para 28 of the order dated 17th December, 2019 of the
Supreme Court reads as under:
"28. 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 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 the CS (OS) No. 3284/2015
expeditiously and preferably within 12 months of
receipt of this order, In the meantime, to avoid
prejudice to respondent No. 3, whenever government
procurement is proposed for the drug by its generic
name „Trastuzumab‟, the Reliance should be allowed to
participate with their biosimilar product, without any
impediment. It is made clear that the views expressed
here is only for the purpose of this appeal and should
have no bearing in the proceeding pending in the High
Court.""
held as under:-
"4. Having considered the submissions of Mr. Sethi, and
having read the aforesaid order dated 17th December, 2019
of the Supreme Court as a whole, the Court is not persuaded
that the Supreme Court did not uphold the order dated 25th
April, 2016 of the learned Single Judge in its entirety. The
Court notes that the Supreme Court specifically directed that
the said order "is accordingly made operational" and also
requested that the suit itself to be disposed of "expeditiously
and preferably within 12 months of the receipt of this
order." If the issue regarding the deletion of the DGCI as a
CS(COMM) Nos. 1119/2016 & 540/2016 Page 27 of 31
party defendant were to be left open to be adjudicated upon
by this Court i.e. the Division Bench, it would inevitably
result in further delaying the disposal of the suit itself.
Clearly, that result was not envisaged by the directions of
the Supreme Court reproduced hereinabove.
5. For the aforementioned reasons, the Court is unable to
agree with Mr. Sethi that any aspect of the interim order
dated 25th April, 2016 of the learned Single Judge in CS
(OS) 3284/2016 remains to be adjudicated upon by this
Court.
6. Consequently, FAO (OS) 227/2016 is also disposed of as
having been rendered infructuous as a result of the order
dated 17th December, 2019 of the Supreme Court in C.A.
No. 9491/2019. The pending applications are also disposed
of."
23. However vide order dated 11th February, 2020 of the Division
Bench in the appeal filed by Biocon against the judgment dated 25th
April, 2016 of the Single Judge, the appeal was adjourned for hearing
to 16th July, 2020 observing as under:-
"3. The issue whether the suit was maintainable has been
raised as a ground in the appeal itself. The Court therefore
does not see any reason to separately entertain an
application for considering the said issue. Accordingly, the
application is disposed of."
24. In the light of order dated 11th February, 2020 of the Division
Bench in the appeal filed by the plaintiffs herein against the order
dated 25th April, 2016 in the suit filed against Reliance, holding that
the Supreme Court vide judgment dated 17th December, 2019 had
upheld the order dated 25th April, 2016, also dealing with Rule
122DC, in entirety, it was felt that after the said order it is not open to
CS(COMM) Nos. 1119/2016 & 540/2016 Page 28 of 31
the undersigned to foray into the said aspect. The counsels were
accordingly informed and asked to appear on 20th February, 2020.
25. On 20th February, 2020, while it was the contention of the
senior counsels for the plaintiffs that had the Supreme Court felt the
suit to be not maintainable in view of Rule 122DC, it would not have,
vide judgment dated 17th December, 2019, vacated the order of the
Division Bench staying the conditions imposed on Reliance vide
judgment dated 25th April, 2016, it was the contention of the senior
counsel for the defendants that in light of the order dated 11 th
February, 2020 in the appeal preferred by Biocon, the question is still
very much open before the Division Bench.
26. However the need for the undersigned to adjudicate the said
rival contentions also is not felt because the senior counsel for the
plaintiffs has also handed over in the Court a notification dated 19th
March, 2019 of the Ministry of Health and Family Welfare
(Department of Health and Family Welfare) notifying the New Drugs
and Clinical Trial Rules, 2019 (the New Rules). The senior counsel for
the plaintiffs contended that in the New Rules, there is no equivalent
of Rule 122DC supra.
27. On enquiry, whether any provision has been made qua pending
appeals, the senior counsel for the plaintiffs states that there is no such
provision and there were no pending appeals.
28. The senior counsel for the defendants have not controverted.
CS(COMM) Nos. 1119/2016 & 540/2016 Page 29 of 31
29. I have perused the New Rules. Rule 97 thereof inserts the
following Rule after Rule 122DA of the Drugs Rules.
"122DAA. Non-application of certain rules for
new drugs and investigational new drugs for human
use. - Part XA and Schedule Y shall not be application
in respect of new drugs and investigational new drugs
for human use from the date of coming into force of the
New Drugs and Clinical Trials Rules, 2019, and the
references in respect of human use made in the these
rules shall respectively be omitted, and the construction
thereof shall be construed accordingly and shall stand
amended with all cogent meaning of the grammar."
30. I also find the New Rules to be, though, in Rules 53 and 60
thereof in Chapter VIII titled "Manufacture of New Drugs or
Investigational New Drugs for Clinical Trial, Bioavailability or
Bioequivalence Study or for Examination, Test and Analysis" and in
Rule 68 thereof under Chapter IX titled "Import of New Drugs and
Investigational New Drugs for Clinical Trial or Bioavailability or
Bioequivalence Study or for Examination, Test and Analysis",
providing for a remedy of appeal against the decision of the DCGI to
the Central Government as under Rule 122DC supra but, as distinct
from the expression "any person aggrieved‟ used in Rule 122DC
supra, using the expression "an applicant who is aggrieved by the
decision of the Central Licencing Authority". It is thus clear that
under the New Rules the remedy of appeal is confined to the applicant
before the DCGI and is not available to others such as the plaintiffs
herein.
CS(COMM) Nos. 1119/2016 & 540/2016 Page 30 of 31
31. With the deletion of the provision of appeal, on account
whereof the maintainability of the suit was challenged, the said
challenge has become infructuous.
32. Resultantly, the suits have to proceed.
33. I clarify that I have in this order/judgment not dealt with the aspect
of stay of proceedings in CS(COMM) No.1119/2016 owing to the suit
previously instituted by Cadila against the plaintiffs and pending in the
Bombay courts and on which aspect arguments were not heard during the
hearings aforesaid.
34. Pleadings in the two suits, if not completed, be completed with
written statement/reply being filed within 30 days and
replication/rejoinder thereto within further 30 days thereafter.
35. List for framing of issues, if any and for hearing of other
pending applications, on 12th May, 2020.
RAJIV SAHAI ENDLAW, J.
FEBRUARY 24, 2020 „pp/AK‟..
CS(COMM) Nos. 1119/2016 & 540/2016 Page 31 of 31