Delhi High Court
Centrient Pharmaceuticals ... vs Dalas Biotech Limited on 27 January, 2021
IN THE HIGH COURT OF DELHI AT NEW DELHI
Judgment delivered on: January 27, 2021
+ CS(COMM) 218/2019, CC(COMM) 19/2019, I.As. 6162/2019,
6163/2019, 8121/2019, 9209/2019, 12312/2019, 13321/2019,
15057/2019 & 7923/2020
CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. ANR.
..... Plaintiffs
Through: Mr. C.M. Lall, Sr. Adv. with
Ms. Nancy Roy, Adv.
versus
DALAS BIOTECH LIMITED
..... Defendant
Through: Mr. Nalin Kohli, Adv with
Ms. Nimisha Menon, Adv. &
Mr. Vivek Ranjan, Adv.
CORAM:
HON'BLE MR. JUSTICE V. KAMESWAR RAO
JUDGMENT
V. KAMESWAR RAO, J
I.A. 15057/2019
1. By this order I shall decide this application filed by the
plaintiffs under Order XI Rule 2 CPC, as amended by the
Commercial Courts Act, 2016 read with Section 151 CPC for
discovery by interrogatories filed on behalf of the plaintiffs. The
prayer made in the application is the following:
"IN THE PREMISES STATED ABOVE, IT IS
THEREFORE, MOST RESPECTFULLY PRAYED
THAT, THIS HON'BLE COURT MAY BE PLEASED
TO:-
a) Allow the present application be allowed in the
interest of justice, thereby directing the Defendant to
file its response to the aforementioned interrogatories
within the time stipulated by this Hon'ble Court;
b) any further order as this Hon'ble Court may deem
fit in the facts and circumstances of the instant case."
2. It is the case of the plaintiffs and submitted by Mr. Lall,
learned Senior Counsel appearing for the plaintiffs that the
aforesaid suit has been filed by the plaintiffs seeking permanent
injunction against the defendant restraining the defendant from
violating and infringing the rights of the plaintiffs in its patent
being IN 247301 titled as "Process for preparing Amoxicillin
Trihydrate".
3. According to Mr. Lall, the plaintiffs have discharged the
onus to prove infringement of the suit patent in its plaint by way
of test reports. However, the defendant has completely failed to
discharge the burden of proof as stipulated in Section 104A (1)
(b) of the Patents Act. In substance, the submission of Mr. Lall
in support of this application is that the defendant, who has filed
written statement had in paragraph 94 disclosed its alleged
process for manufacture of Amoxicillin Trihydrate, which
according to him, is ambiguous and not suitable for filing with
the regulatory authorities.
4. He qualifies his submission by stating that the defendant
purposefully and deceitfully adds optionality to key sections of
the process that are covered by the suit patent of the plaintiffs. In
this regard, he has drawn my attention to paragraph 94 wherein
according to him, the defendant has defined "whether or not the
"Penicillin G Acylase Enzyme" is Immobilized or non-
Immobilized." According to him, any commercially viable
manufacturing process for enzymatic amoxicillin must utilize an
"Immobilized" enzyme. He stated that the defendant has in fact
using immobilized enzyme has deliberately not mentioned it to
fall outside the scope of the claims. He qualifies his submission
by stating that the defendant depicting in their written statement
that after the crude Amoxicillin Trihydrate is separated,
"Penicillin G Acylase enzyme is washed with water".
5. According to him, this is an indication that the defendant
is actually using enzyme that has been immobilized and are
hiding the fact from the Court. That apart, he stated that the
"Penicillin G Acylase" enzyme is expensive, inasmuch as it costs
approximately 25 USD per KG, which would be higher than the
current market price for amoxicillin API which is approximately
22 USD per KG. Therefore, the enzymatic manufacturing process
is only commercially viable if the enzyme is immobilized and re-
used.
6. According to him, by using "/" symbol the defendant is
inferring that either a salt of PHPGM, likely PHPGME.HCL or
PHPGME may be used interchangeably. He stated that it is
unlikely that the defendant used the salt of PHPGME because the
salt is more soluble in water and would necessitate the use of a
base for pH control in the enzymatic conversion. HPGM free
base has a low solubility and therefore has a high yield in
isolation. Therefore, the defendant's disclosed process is
contradictory and interchanging of a salt of HPGM and the
HPGM free base would require two different processes.
7. He vehemently argued that the defendant has stated that
an "acid solution is added into crude amoxicillin mixture till
clarity is achieved; (the acid used may be Nitric Acid / Sulphuric
Acid / Hydrochloric Acid)". According to Mr.Lall, these solvents
are not interchangeable in a single process; particularly if that
process is cGMP approved. The argument of Mr.Lall is that the
defendant is misleading by referring to three separate acids for
use in the crystallization solution. Apart from hydrochloric acid,
the defendant claims the use of sulfuric or nitric acid.
8. He stated that sulphuric acid is impossible for use with
amoxicillin; therefore, at a low pH the sulphuric acid salt of
amoxicillin precipitates out of solution. Therefore, one cannot
add sulphuric acid "till clarity is achieved". Further, a solid
sulphuric acid salt of amoxicillin is neither acceptable for human
consumption, nor is it an approvable product. Similarly, he stated
that the use of nitric acid is technically possible, but has the risk
of formation of nitrosamines that are potentially toxic.
9. In other words, it is his submission that the defendant is
making fraudulent claims about the use of sulfuric acid and nitric
acid, to hide use of hydrochloric acid in the process. This stand
of the defendant is purposeful to create a list of optional acids for
use in this step because they are aware that hydrochloric acid is
the most efficient solvent applied in the crystallization step and
the use of such solvent would be within the claims of the suit
patent. According to Mr.Lall, as the defendant has sought
approval of the regulatory authority, it is incumbent for them to
place before Court the process filed by the defendant to
manufacture of Amoxicillin Trihydrate, as according to him, no
regulatory authority would allow a company to submit a process
with three possible acid solutions that could be used
interchangeably. Further, the defendant claims in step 10 that it
"increase the pH by addition of NaOH or NH3 until full
crystallization of Amoxicillin Trihydrate occur(s). At pH (of) 1.6
crystallization should be observed at (a) temperature (of) 23-
28°C". He states that the defendant is again misleading the Court
as according to him, the crystallization may start at a pH of 1.6,
as the defendant is using batch operation manufacturing as
evidenced by the use of seeding for crystallization, the pH would
necessarily need to be raised to up to a pH of 5, which represents
the minimum solubility of amoxicillin.
10. According to him, the calculated solubility at pH of 1.6 is
48 mmol/kg, whereas the calculated solubility at pH of 5 is 4.7
mmol/kg, representing a tenfold decrease in solubility at a pH of
5. Therefore, should the defendant stop crystallization at a pH
1.6 the yield would be commercially unviable.
11. He stated that the defendant has not disclosed the correct
process being used by it for manufacturing of Amoxicillin
Trihydrate and has been evasive in its written statement regarding
infringement of the suit patent. In other words, the defendant is
unable to discharge the burden of proof as stipulated in Section
104A of the Patents Act.
12. It is in this above background, the plaintiffs served a
notice dated August 02, 2019 upon the defendant to produce the
documents for inspection. The defendant sent a preliminary
response on August 17, 2019 informing the plaintiffs that the
defendant would be taking additional seven days time to respond
to the notice to produce documents. Finally, a detailed response
was sent to the plaintiffs on August 29, 2019, whereby the
defendant refused to produce any other approvals / applications
made to the regulatory authorities. The documents sought for by
the plaintiffs and the response of the defendant is as under:
S. Document sought Response by Defendant
No to be produced
1. Copies of all The Defendant has already placed
manufacturing on record the Drug
approvals Manufacturing License received
obtained by the from the Drug Controller, Jaipur,
Defendant for Rajasthan bearing License No.
manufacture of Raj.2144 pertaining to
Amoxicillin Amoxicillin Trihydrate, along
Trihydrate by the with subsequent renewals. The
process described initial license and subsequent
in paragraph 94 of renewals have been applied as
the written per Rule 76 of the Drugs and
statement. Cosmetics Rules, 1945 which does
not provide for any requirement
of disclosure of specific
manufacture process while
procuring or renewing a license
to manufacture drugs.
Accordingly, your request is
contrary to the statutory
requirements.
2. Copy of the Copy of the Drug Manufacturing
complete Drug License approval for manufacture
Manufacturing of Amoxicillin Trihydrate as
license approved granted by Drug Controller to
by the Drug Dalas Biotech has been filed by
Controller, Jaipur, the Defendant before the Hon‟ble
Rajasthan bearing Delhi High Court. However, we
license are again providing you with a
No.Raj.2144 copy of the same along with all
subsequent renewals, which are
attached herewith as Annexure A
(Colly).
3. Copy of the Site The Site master file is a
Master File for confidential document comprising
Manufacture of information related to
Amoxicillin manufacturing facility (layout and
Trihydrate by the equipment), officials (in-house
Defendant and external expoerts being
retained), organizational chart for
all personnel, premises, different
drugs being manufactured or in
the pipeline to be manufactured
shortly, documentation, details of
loan license, testing laboratories,
etc. which is required as per the
Drugs and Cosmetics Act to be
maintained at the Defendant‟s
premises. The Defendant
considers the information
contained therein as confidential,
especially as the Plaintiffs are its
business rival. Accordingly, the
Defendant objects to the request
for production and inspection of
site master file. It is imperative to
state that there is no „patent
linkage‟ in India and all quarries
related to drug approvals,
facilities, etc. lie exclusively in the
domain of Drug Controller and
under the guise of the present
notice, it is not permissible for the
Plaintiff to seek such information.
4. Copy of the Master Master Formula Records /
Formula Records Records of production are
pertaining to maintained by a company in
license granted to compliance of requirements of the
Dalas Biotech Drugs and Cosmetics Act. Such
from the Drug record contains information
Controller, Jaipur, related to Defendant‟s facilities,
Rajasthan bearing employees, equipment used,
License No. analytical procedures, batch
Raj.2144 analysis, reference standard,
testing data etc. As Plaintiffs are
the Defendant‟s business rival,
the Defendant objects to the
request for production and
inspection of the same.
5. The application The Defendant is currently unable
made by Dalas to locate a copy of the original
Biotech Limited application as filed by it in the
for obtaining the year 2002, as it is an old record
Drug dating back more than 15 years,
Manufacturing and has undertaken appropriate
license for step towards locating the same.
manufacture of The Defendant is also taking steps
Amoxicillin towards procuring a copy of the
Trihydrate filed same from the concerned Drug
before the Regulatory Authority. Further,
Rajasthan Drug the Defendant has previously filed
Control the manufacturing approval
Organization granted to it by the Drug
Controller along with subsequent
renewals. Accordingly, in view of
the fact that the final granted
approval has already been placed
on record, the present request by
the Plaintiffs is without merit.
6. Copy of the The Defendant has not submitted
Common any "Common Technical
Technical Document" to the Drug
Document Controller Rajasthan as the
submitted to the Drugs and Cosmetics Act, 1940
Drug Controller, does not contain any requirement
pertaining to the same.
Rajasthan. Accordingly, the present request
is contrary to any statutory
requirement and without merit.
13. According to Mr.Lall, the reasons given by the defendant
are totally untenable and the defendant is purposefully evading
production of the documents, as it is clear that the defendant is
manufacturing Amoxicillin Trihydrate with identical process
claimed and granted in the suit patent. The reasons given by the
defendant is that the Drugs and Cosmetics Rules do not provide
for disclosure of the manufacturing process and does not show
bona fide on the part of the defendant.
14. He stated that through the process disclosed by the
defendant in paragraph 94 of the written statement, it is incapable
of getting approval from any regulatory authority. Hence, it is
imperative that the defendant should be directed to disclose the
aforesaid documents as sought, for appropriate adjudication of
the case. According to him, the documents disclosed surely will
depict the manner in which the defendant has followed the
process for manufacturing of Amoxicillin Trihydrate.
15. On the other hand, Mr. Nalin Kohli, learned counsel
appearing for the defendant would oppose the application filed by
the plaintiffs by stating that the documents sought by the
plaintiffs are not relevant for the effective adjudication of the
dispute on the following grounds:
a) Regulatory approvals procured by the defendant for
manufacture of Amoxicillin Trihydrate, is not the subject matter
of the present suit, and neither this Court is the appropriate
judicial forum to adjudicate the disputes in a patent
infringement suit.
b) The details of defendant's manufacturing unit/facilities,
which again is not relevant to the present dispute.
16. Mr. Kohli stated that the allegation of the plaintiffs in the
plaint is qua infringement of its patent being IN 247301 wherein
it has been asserted that the claimed process is being used by the
defendant to produce Amoxicillin Trihydrate, is baseless and a
written statement has been filed by the defendant to the plaint
explaining the position.
17. According to Mr. Kohli, the information which has been
sought by the plaintiffs in the present application filed by the
plaintiffs only with an intention to get privy to the regulatory
approvals granted in favour of the defendant along with use of
other ingredients / chemicals. The said information is not the
subject matter of the present suit.
18. He stated that the burden to prove the patent infringement
lies on the plaintiffs by first proving that the product obtained by
the defendant is identical to the product obtained by the patented
process. According to him, the plaintiffs have filed a manipulated
test report to discharge its burden, which is challenged by the
defendant. In addition, the defendant, by way of positive
evidence, has also submitted third party test reports to prove that
the product obtained by the process employed by the defendant is
not identical to the product the plaintiffs claim to obtain by the
impugned patented process. He submitted that all such evidences
are required to be proved by the parties by way of expert
testimonies and cross-examination at the stage of trial and not by
interrogatories.
19. He relied upon the judgment of the Supreme Court in Raj
Narain v. Smt. Indira Nehru Gandhi & Anr. (1972) 3 SCC 850
to contend that the questions that may be relevant during cross-
examination are not relevant as interrogatories. Further, it is the
settled position of law that interrogatories cannot be used as a
substitute for cross-examination and are much narrower in scope
than cross-examination. Further, the information sought by the
plaintiffs is confidential information and ought not to be allowed
to be disclosed, particularly when the plaintiffs are the business
rival of the defendant.
20. The case of the plaintiffs that the stand taken by the
defendant in paragraph 94 of the written statement is ambiguous
and not suitable to be filed before a regulatory authority to obtain
manufacturing approval for the production of Amoxicillin
Trihydrate, which the defendant denies, inasmuch as the plaintiffs
have based their arguments only on the basis of apprehensions
and conjectures and not on any evidence. Rather an attempt is
being made by the plaintiffs to collect the evidence in its favour
rather than proving its case on the basis of evidence available
with it and also by way of cross examination. He seeks the
dismissal of the application.
21. Having heard the learned counsel for the parties, the issue
which arises for a decision in this application is whether the
defendant should be directed to answer the interrogatories
detailed by the plaintiffs in para 18 of this application.
22. The plea of Mr. Lall, primarily is that the written
statement of the defendant being vague, the interrogatories are
required to be answered by the plaintiffs for proper adjudication
of the case. This is said by Mr. Lall because the defendant has
added optionality to the process purposefully to show that the suit
parent has not been infringed like (i) Penicillin G Acylase
enzyme is immobilized or non-immobilized; (ii) by using the "/"
symbol, the defendant inferring that salt of PHPGM, likely
PHPGME.HCL or PHPGME may be used interchangeably; (iii)
three separate acids are used in crystallization etc.
23. Mr. Lall's submission was that the defendant must answer
(i) to disclose the process for manufacturing Amoxicilin
Trihydrate as disclosed in para 94 to any statutory authorities; (ii)
does the Site Master File in relation to manufacturing of
Amoxicilin Trihydrate under license from RDSCO contain flow
charts mentioning procedure and process flow? (iii) does the
Master Formula Records in relation to manufacture of
Amoxicilin Trihydrate under License from RDSCO contain
detailed stepwise processing, instructions and the time taken for
each step? (iv) does the Master Formula Records in relation to
manufacture of Amoxicilin Trihydrate under License from
RDSCO contain name, quantity, and reference number of all the
starting materials to be used as well as any substance that may
disappear in the course of processing? if yes, to provide copies of
the relevant pages of the Master Formula Record.
24. Having noted the broad submissions of Mr. Lall in
support of this application, I may at the outset state that as a
general rule interrogatories are to be allowed whenever the
answer to them will serve either to maintain the case of the party
administering them or to destroy the case of the adversary.
25. Insofar as the plea that written statement is vague, it was
the submission of Mr. Kohli that the written statement filed by
the defendant explain its position that the process does not
infringe the patent of the plaintiffs. In other words, the written
statement filed by the defendant is not vague. Mr. Kohli has
primarily stated that since the regulatory approvals procured by
the defendant for manufacturing of Amoxicilin Trihydrate is not
the subject matter of the present suit, such an information cannot
be sought for, by the plaintiffs. Though, the plea of Mr. Kohli is
not appealing, what is important is, there is a burden on the
plaintiffs to prove that the patent infringement lies on the
plaintiffs by first proving that the product obtained by the
defendant is identical to the product obtained by the patented
process.
26. It was submitted by Mr. Kohli that the plaintiffs have
filed a manipulated test report to discharge its burden, which is
challenged by the defendant. That apart, I find, the attempt of the
plaintiffs is to discover the fact, what constitute the exclusive
evidence of the opponent's case. Further, the attempt is also for
doing a roving and fishing inquiry, which cannot be allowed
through the process of interrogatories.
27. The plea of Mr. Lall that the defendant has added
optionality to the process to contend that the patent has not been
infringed, can be taken care of by the plaintiffs through the
process of cross examination of the defendant's witness to test
the credibility of the stand of the defendant. In other words,
interrogatories by the plaintiffs to extract something, which it
could do so in the course of cross examination, cannot be
allowed.
28. Under such circumstances, this Court is of the view that
the application filed by the plaintiffs calling upon the defendant
to file response to the interrogatories cannot be allowed. I do not
see any merit in the application. The same is dismissed.
V. KAMESWAR RAO, J
JANUARY 27, 2021/aky/ak
