Delhi High Court
Symed Labs Ltd. vs Glenmark Pharmaceuticals Ltd. ... on 19 January, 2015
Author: G.P. Mittal
* IN THE HIGH COURT OF DELHI AT NEW DELHI
Pronounced on: 19th January, 2015
+ CS (OS) NO. 678/ 2013
SYMED LABS LTD. ..... Plaintiff
Through: Ms. Shwetasree Majumdar, Advocate
with Mr. Prithvi Singh, Advocate and
Mr. Rajeshwar, Advocate
versus
GLENMARK PHARMACEUTICALS LTD. AND ANR.
..... Defendants
Through: Mr. Rajeev K. Virmani, Senior
Advocate with Ms. Rajeshwari H.,
Advocate, Mr. S. Hariharan,
Advocate, Mr. Tahir Abdul Tabbur,
Advocate, Ms. Anindita Mitra,
Advocate and Ms. Aparna, Advocate
CORAM:
HON'BLE MR. JUSTICE G.P. MITTAL
I.A. No. 5908/ 2013 (Order XXXIX Rules 1 and 2 CPC) and I.A. No.
5417/ 2013 (Order VII Rules 10 and 11 CPC) in CS (OS) No. 678/ 2013
1. By virtue of this application, the Plaintiff seeks an ad interim
injunction restraining the Defendants, their agents, etc. from
manufacturing, selling, offering for sale, advertising or directly or
indirectly dealing in the product Linezolid manufactured in a manner
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 1 of 30
so as to result in infringement of the Plaintiff‟s registered patent
IN213062 (IN „062) and the registered patent IN213063 (IN „063).
2. The Plaintiff filed the suit with the averments that the processes for
preparation of Linezolid as disclosed in the prior art were tedious and
cumbersome in as much as (i) the prior art processes involve use of
highly flammable and dangerous reagents like n-butyl lithium in
hexanes; (b) handling of n-butyl lithium is very difficult at lab scale
and in commercial scale operations; (c) the reaction between N -
carbobenzyloxy - 3 - fluoro - 4 - morpholinyl aniline and (R) -
glycidyl butyrate in tetrahydrofuran in the presence of n-butyl
lithium/hexane should be performed at extremely low temperatures (-
780C to -160C) under very strict control of reaction conditions;
processes involving extremely low temperatures are undesirable for
large-scale operations since they require special equipment and an
additional reactor, adding to the cost, thereby making the processes
commercially unviable; (d) the processes require longer reaction time
and the yield and purity of the product obtained is very low; (e) the
processes involve the use of highly toxic and expensive reagents like
benzyl chloroformate, sodium azide and (R) - glycidyl butyrate,
Palladium on Carbon; (f) the processes involve the use of tedious and
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 2 of 30
cumbersome procedures like prolonged reaction time periods, multiple
process steps, column chromatographic purifications, multiple
isolation/ re-crystallizations etc; (g) the processes involve the use of
multiple and excess amounts of hazardous solvents like n-hexane,
heptanes, dioxane and tetrahydrofuran; (h) the processes involve the
use of highly toxic reagents like phosgene, pyridiium p-
toluenesulfonate; (i) methods involving column chromatographic
purifications are generally undesirable for large-scale operations,
thereby making the processes commercially unfeasible; (j) the overall
processes generate a large quantity of chemical waste which is
difficult to treat etc.
3. It is the case of the Plaintiff that in an effort to develop a more
economical, safe and commercially viable process for preparation of
Linezolid, the Plaintiff developed novel processes involving novel
intermediates that have been patented vide IN „062 and IN „063.
4. The novelty and inventive steps of IN „063 as claimed by the Plaintiff
are as under :-
"(i) Alleged use of R-Epichlorohydrin and N, N-
Carbonyldiimidazole as a key starting materials for first
time in synthesis of Linezolid to obtain compound called
CHFA-compound IV;
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 3 of 30
(ii) Production of novel intermediate compound called
CHFA;
(iii) Carbonylating CHFA with carbonylating agent
N,N-carbonyldiimidazole) to obtain Zodiac-4 as key
intermediate;
(iv) Reacting Zodiac-4 with potassium phthalimide to
produce Compound of Formula-VII (phthalimidomethyl
oxazolidinone compound), which is further converted to
Linezolid;"
5. Similarly, novelty and inventive steps of IN „062 are:-
"(i) Reacting CHFA with Potassium phthalimide to
obtain PHPFMA (Compound of Formula-IV);
(ii) PHPFMA is a novel intermediate;
(iii) Carbonylating PHPFMA with carbonylating
agent N, N-carbonyldiimidazole to obtain amino methyl
phthalimide, which is converted to Linezolid;"
6. It is urged that novel intermediate compounds claimed in the suit
patents "N - [3 - Chloro - 2 - (R) - hydroxprophy1] - 3 - fluoro - 4 -
morpholinyl - anlaniline" (CHFA) (claimed in Claims 18 and 19 of IN
„063) and "N - 3 [Phthalimido - 2 - (R) - hydroxprophyl] - 3 - fluoro
- 4 (morpholinyl) aniline" (PHPFMA) (claimed in Claims 23, 24 and
25 of IN „062) are exclusively formed/ generated and used in the
processes for the production of Linezolid as claimed in the suit patents
whereas those intermediates are not formed (indeed, there is no
possibility of them forming) in the prior art processes for preparing
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 4 of 30
Linezolid. The structural formulae of these two claimed intermediate
compounds "N - [3 - Chloro - 2 - (R) - hydroxypropy] - 3 - fluoro -
4 -morpholinylaniline" (CHFA) and "N - [3 - Phthalimido - 2 - (R) -
hydroxypropyl] - 3 - fluoro - 4 - (morpholinyl) aniline" (PHPFMA)
are being extracted below for the sake of clarity and convenience:
Thus, the presence of any of the aforesaid compounds in the final
product (Linezolid) would be indicative of the fact that the said
product has been prepared by using the patented processes of the
Plaintiff.
7. It is averred that Defendant no. 1 is a limited company based in India
and is dealing in the manufacture and supply of both active
pharmaceutical ingredients (APIs) and finished doses forms of various
pharmaceutical formulations while Defendant no. 2 is its subsidiary. It
is averred that Defendant no. 1 is engaged in the manufacture and sale
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 5 of 30
of Linezolid in finished dosages forms (tablets) and I.V. injections
whereas Defendant no. 2 is engaged in manufacturing, purchase and
sale of Linezolid API/ bulk drug.
8. It is the case of the Plaintiff that sometime in December, 2012, the
Plaintiff learnt that the Defendants were manufacturing Linezolid in
finished doses forms and I.V. injections and selling them under the
brand name „LIZOLID‟ in the open market. The Plaintiff obtained
three samples of Linezolid manufactured by the Defendants (bearing
Batch Nos. 081200672, 05121501 and 05120995) and analysed the
same using the High Performance Liquid Chromatography-Mass
Spectrometry (HPLC-MS) method. The samples disclosed the
presence of PHPFMA and Zodiac-4, which are the key intermediates
in the Linezolid manufacturing processes as claimed in the suit patents
IN „062 and IN „063.
9. Thus, the Plaintiff concluded that the Defendants were infringing the
Plaintiff‟s suit patents.
10. Therefore, the Plaintiff sent a legal notice dated 02.01.2013 to
Defendant no. 1 complaining about infringement of the suit patents.
Defendant no. 1 issued a response dated 17.01.2013 denying any
infringement activity.
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 6 of 30
11. During the pendency of the suit, the Plaintiff obtained two fresh
samples bearing Batch Nos. 081200550 dated May, 2012 and
05122366 dated September, 2012 and upon testing, the three
compounds/ markers of the Plaintiff being CHFA, PHPFMA and
Zodiac-4 were detected in scientifically and statistically significant
levels in every sample of the Defendants. It is the case of the Plaintiff
that the three samples from various batches which were got tested by
the Plaintiff in its own lab were also submitted for further testing in a
renowned independent scientific laboratory i.e. the Indian Institute of
Chemical Technology (IICT), a Central Government Organisation
which also confirmed presence of earlier said three molecules (CHFA,
PHPFMA and Zodiac-4), which were exclusive to the Plaintiff‟s
patented processes.
12. It is thus, averred that the Plaintiff who has expended huge amount,
effort, time and money in developing and inventing the patented
processes is entitled to protect the same and the Defendants are liable
to be injuncted from manufacturing, selling, offering for sale etc. the
API Linezolid manufactured in a manner so as to result in
infringement of the Plaintiff‟s registered patents IN „062 and IN „063.
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 7 of 30
13. The Plaintiff claims jurisdiction of this Court to entertain and try this
suit on the ground that the Defendants are doing business within the
territorial jurisdiction of this Court; they also have their branch office
at Najafgarh Road Industrial Area, Moti Nagar, New Delhi. It is stated
that the Defendants are also carrying on their business in general and
in the unfinished products in New Delhi through M/s Diksha Medicos,
1956, Outrem Line, Kingsway Camp, New Delhi and M/s Safdarjung
Medicos, Shop No. 5, Near Metro Station, Safdarjung Hospital Gate
no. 2 (Opp. AIIMS), New Delhi.
14. The Defendants have contested the suit by way of filing a written
statement to the plaint and reply to the injunction application stating
that the processes as well as the intermediates claimed in the suit
patents are not the novel. It is averred that intermediates obtained in
the process of manufacture of Linezolid as claimed by the Plaintiff
has been known in the pharmaceutical industry for a long time prior to
the Plaintiff‟s alleged development of the process or the intermediates.
Thus, it is averred that the suit patents are liable to be revoked on the
grounds as set out in the counter claim filed by the Defendants.
15. It is averred that the Plaintiff has alleged PHPFMA as a novel
intermediate compound in Indian Patent IN „062 and has based the
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 8 of 30
suit on the alleged presence of PHPFMA with Zodiac-4 in the
products of the Defendants. It is the case of the Defendants that
scrutiny of the proceedings of the European Patent office pertaining to
EP1768967 corresponding to Indian Patent IN „062 has revealed that
the Plaintiff had specifically not patented and had disclaimed
PHPFMA as a novel intermediate and reference to PHPFMA has been
deleted from the claims of the said European Patent which clearly
establishes that PHPFMA is not a novel intermediate as claimed by
the Plaintiff.
16. It is urged that the Plaintiff and Defendant no. 1 had long standing
business relationship since the year 2003 and Defendant no. 1 was
granted the drug license to manufacture and sell Linezolid API in
2002 and it has been selling „Linezolid‟ tablets in open market to the
knowledge of the Plaintiff since then.
17. It is claimed that the suit filed by the Plaintiff and the prayer of ad
interim injunction is misconceived as mere presence of Zodiac-4 and
PHPFMA in the final product of the Defendants cannot be indicative
of infringement of the Plaintiff‟s patents as these compounds can be
found even if other processes of prior art are followed for
manufacturing Linezolid.
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 9 of 30
18. It is further the case of the Defendants that the Plaintiff has not filed
the analysis report of its own product and on analysis of the Plaintiff‟s
Linezolid, the intermediates CHFA, PHPFMA and Zodiac-4 were not
found when tested by the Defendants. It is averred that the Defendants
have made huge investment and set up plant and machinery and are
already manufacturing Linezolid API by their own process for at least
twelve years to the knowledge of the Plaintiff without any objection
having been raised by the Plaintiff.
19. The veracity of the Plaintiff‟s claim is also questioned on the ground
that in the pre-suit lab reports, presence of CHFA was not found
whereas in post-suit analysis, suddenly CHFA was also deducted in
the product of the Defendants.
20. It is thus, stated that the onus of proof on the Plaintiff to prove
infringement was not shifted upon the Defendants under Section 104-
A of the Patents Act, 1970. The Defendants, have therefore, prayed for
dismissal of the injunction application for want of any prima facie
case, balance of convenience or irreparable loss and injury to the
Plaintiff.
21. In the replication, the existence of prior commercial relationship
between the Defendants and the Plaintiff has not been denied. At the
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 10 of 30
same time, it has been stated that a few sporadic invoices filed by the
Defendants to show that they had purchased insignificant quantity of
Linezolid API from the Plaintiff is of no consequence when the
Defendants‟ utilisation of Linezolid API is believed to be
approximately 4000 kgs. per month, whereas total sale of Linezolid
API by the Plaintiff to the Defendants over a period of ten years since
2003 is only 2816 kgs.
22. In order to succeed for grant of injunction, the Plaintiff has to show
that it has a good prima facie case, the balance of convenience lies in
its favour and that if injunction sought for is not granted, it will suffer
an irreparable loss and injury.
23. Before adverting to the facts with regard to the infringement of the
Plaintiff‟s patented process, the Plaintiff will have to prima facie
satisfy that this Court has territorial jurisdiction to entertain the present
suit. In this regard, the Plaintiff has not only stated that the Defendants
are functioning from their branch office at Najafgarh Road but has
also given the names of two distributors through whom the
pharmaceutical preparation manufactured through the patented
processes is being sold by the Defendants in New Delhi.
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 11 of 30
24. Although the Defendants have denied the jurisdiction of this Court to
entertain the present suit, but at the same time it has not been disputed
that Defendant no. 1 has its branch office at Najafgarh Road within the
jurisdiction of this Court. It has also not been disputed that the
pharmaceutical preparation allegedly manufactured through the
claimed patented processes is being sold by the Defendants through
their distributors in New Delhi as alleged in the plaint. What has been
stated by the Defendants is that the alleged cause of action could only
relate to manufacture of Linezolid API and since the Defendants did
not have any manufacturing facility at New Delhi, this Court will not
have jurisdiction to entertain and try the suit.
25. I am not inclined to agree with the submission raised on behalf of the
Defendants. If the Defendants are selling their product in a particular
area, the Court having jurisdiction over the area will have territorial
jurisdiction to entertain the suit. Reference in this connection may be
made to Hindustan Lever Ltd. v. Lalit Wadhwa and Anr., 2007 (35)
PTC 377 (Del) and Teva Pharmaceutical Industries Ltd. and Ors. v.
Natca Pharma Ltd., 2014 (59) PTC 124 (Del) DB. Thus, prima facie
this Court will have territorial jurisdiction to entertain the present suit.
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 12 of 30
26. Apart from claiming that there was nothing novel in the process
patents IN „062 and IN „063 of the Plaintiff, the Defendants have
claimed that way back in the year 2002, Director General, Health
Services, Government of India permitted the Defendants to
manufacture Linezolid. It is true that by a letter dated 01.04.2002,
Defendant no. 1 was granted a drug licence to manufacture Linezolid
IV injections and subsequently, by a letter dated 02.04.2003,
Commissioner, Food & Drug Control Administration allowed
Defendant no. 1 to manufacture certain drudges including Linezolid.
However, it may be noted that these licences simply permitted
Defendant no.1 to manufacture Linezolid and Linezolid IV. The
Defendants could have either manufactured Linezolid by prior art
processes or could have purchased Linezolid API from the market to
manufacture the licensed product. Therefore, mere grant of licence by
letter dated 01.04.2002 and its renewal is of no consequence and
subsequent grant of licence by the commission is also of no
consequence.
27. It is urged by the learned Senior Counsel for the Defendants that the
claim made by the Plaintiff is contradictory inasmuch as the initial test
report did not disclose the presence of CHFA while suddenly presence
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 13 of 30
of CHFA was found in the same sample tested post filing of the
written statement by the Defendants. The learned Senior Counsel for
the Defendants has urged that CHFA, PHPFMA and Zodiac-4 being in
public domain, no inference can be drawn that presence of these
compounds in a particular product is indicative of the infringement of
the suit patents.
28. It is true that presence of CHFA is not claimed in the initial test report
when the suit was filed by the Plaintiff. However, it is possible that
the test for detection of CHFA was not done. In any case, in the
opinion of the Plaintiff, presence of PHPFMA and Zodiac-4 itself in
the samples (belonging to the Defendants) made the Plaintiff conclude
that the Plaintiff‟s patented processes in IN „062 and IN „063 have
been infringed by the Defendants. It may be noted that the Plaintiff
does not possess any patent in respect of Linezolid API. It claims only
process patents to manufacture Linezolid API by IN „062 and IN „063
because the prior art processes were tedious and cumbersome and the
manufacture cost was much higher than the cost of manufacture of
Linezolid by the process patents. I have already extracted earlier the
inventive steps of IN „062 and IN „063 in paras 4 and 5 of this order.
The Plaintiff has in the patent processes stated as to how R -
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 14 of 30
Epichlorohydrin and N, N - Carbonyldiimidazole are synthesised to
obtain CHFA-compound 4. Thereafter, in IN „063, a different process
is used and in IN „062, another process is used to obtain Linezolid.
However, the Defendants have not disclosed their process of
manufacturing Linezolid API. But, at the same time, they say that they
have not used the Plaintiff‟s process to obtain Linezolid. In Raj
Prakash v. Mangat Ram Chowdhary and Ors., AIR 1979 Del. 1, a
Division Bench of this Court held that the simplest way to find out if a
process patent has been infringed is to compare the process of the
Plaintiff with the process of Defendant and a person would be guilty
of infringement if he makes what is in substance the equivalent of the
patented article. In para 25 of the Report, the Division held as under:
"(25) The patented article or where there is a process then
the process has to be compared with the infringing article or
process to find out whether the patent has been infringed.
This is the simplest way and indeed the only sure way to find
out whether there is piracy. This is what was done in the
hair-pin case. above-referred lo, and is. Indeed, always
done. Unessential features in an infringing article or
process are of no account. If the infringing goods are made
with the same object in view which is attained by the
patented article, then a minor variation does not mean that
there is no piracy. A person is guilty of infringement if he
makes what is in substance the equivalent of the patented
article. Some trifling or unessential variation has to be
ignored. There is a catena of authority in support of this
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 15 of 30
view. We need not cite all those cases which were brought to
our notice at the Bar. Suffice it to quote the words of Lord
Denning, M. R. in Beecham Group Limited v. Bristol
Laboratories Ltd. and another, 1967 (16) R.P.C. 406 :-
"THE evidence here shows that in making hetacillin
in the United States the defendants use a principal
part of the processes which are protected here by
the English patents. The importation and sale here is
prima facie an infringement. There is a further
point. A person is guilty of infringement if he makes
what is in substance the equivalent of the patented
article. He cannot get out of it by some trifling or
unessential variation .............. On the evidence as it
stands, there is ground for saying that hetacillin is
medically equivalent to ampicillin. As soon as it is
put into the human body, it does after an interval, by
delayed action, have the same effect as ampicillin.
In these circumstances, I think there is a prima facie
case for saying there was an infringement. The
process is so similar and the product so equivalent
that it is in substance the same as ampicillin."
29. It may be noted that the instant case does not relate to infringement of
any product. It relates to the infringement of the patent processes.
Presence of CHFA, PHPFMA and Zodiac-4 is a strong indicator of the
fact that the Plaintiff‟s patented processes have been used because the
Defendants have not come forward explaining the process which they
have used to obtain Linezolid API.
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 16 of 30
30. The Plaintiff has obtained test reports not only from its own lab but
also from independent labs, like Dr. Reddy‟s Lab and Indian Institute
of Chemical Technology (IICT).
31. In the case of Farbewerk Hochst Aktiengesellschaft Vormals Meister
Lucius and Bruning a Corporation etc. v. Unichem Laboratory &
Ors., AIR 1969 Bom 255 relying upon the Canadian Patents Act, a
Division Bench of the Bombay High Court held that in an action for
infringement, where the invention relates to the production of a new
substance, any substance of same chemical composition and
constitution shall in absence of any proof to the contrary be deemed to
have been produced by the patented process which it is alleged to be
an infringement of. It was further held that although initially the
burden of establishing the case of infringement rests upon the
Plaintiff, the burden to prove the Defendant‟s process would be upon
the Defendant as it is impossible for the Plaintiff to know the same.
Paras 7 and 11 of the report are extracted hereunder:
"7. Turning to the first three issues which embody the
questions in controversy between the parties on the merits of
the present case, it may be stated that issues Nos. 1 and 2
relate to the subject of infringement, whilst issue No. 3
relates to the question of the validity of the plaintiffs' patent
No. 58716. I will proceed to deal with the question of
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 17 of 30
infringement which is the subject matter of issues Nos. 1 and
2. It was contended by Mr. Mistreat for the defendants that
the plaintiffs have led no evidence on issue No. 1 and they
must therefore, fail on that issue, as well as on issue No. 2
which is consequential thereto. Mr. Mistreat contention was
that there is nothing in the evidence on record to show that
the manufacture of Uni-Tolbid tablets or Tolbutamide by
defendants Nos. 1 and 3 was carried out by using the
processes mentioned in the plaintiffs patent No. 58716 and
the plaintiffs have, therefore, not proved the alleged
infringement of the said patent by defendants Nos. 1 and 3,
the onus in regard to which lay on the plaintiffs. It is true
that, as stated by Halbury, (3rd edn.) Vol. 29 p. 106 para
218, the onus as to infringement lies on the plaintiff. In the
Canadian Patent Act there is a specific statutory provision
viz., Section 41 (2), which lays down that in an action for
infringement where the invention relates to the production of
a new substance, any substance of the same chemical
composition and constitution shall, in the absence of proof
to the contrary, be deemed to have been produced by the
patented process which it is alleged to be an infringement.
Though there is no corresponding provision in the Indian
Patents and Designs Act, I see no reason why a presumption
to the same effect should not be drawn by the me against the
defendants in the present case under the general provisions
contained in S. 114 of the Indian Evidence Act, since it is
admitted by the defendants that it is the very drug
Tolbutamide, in respect of which the plaintiffs have obtained
their patent No. 58716, that they have prepared and sold.
Moreover, though the general burden of establishing the
case of infringement undoubtedly rests on the plaintiffs as
laid down in the statement from Halsbury mentioned above
which is in accordance Act, the burden of proving a
particular fact viz., the process by which Tolbutamide is
being prepared by the defendants would be on the
I.A.s No. 5908/ 2013 and 5417/ 2014 in CS (OS) No. 678/ 2013 Page 18 of 30
defendants, since that is fact "especially" within their
knowledge within the terms of Section 106 of the Indian
Evidence Act. It is impossible for the plaintiffs to know by
what precise process Tolbutamide is being prepared by the
defendants and it is precisely to that sort of a case that
S. 106 is intended to apply. The defendants have not led any
evidence whatsover in regard to the same. That, however, is
not all. The first question that arises is, what is the
infringement complained of by the plaintiffs in the present
suit. in the opening sentence of para 4 of the plaint it is no
doubt stated in very wide terms that the first defendants have
infringed the plaintiffs' said patent No. 58716. That
averment is not limited to infringement of any particular
claim or claims in the plaintiffs said patent. In the following
sentence of the said paragraph, however, it is stated that the
first defendants have manufactured, prepared and sold Uni-
Tolbid tablets or Tolbutamide manufactured in accordance
with or by the use of the invention disclosed in the complete
specification of the plaintiffs' said patent "and claimed in
claims 1 and 11". It is not necessary for me to decide on a
construction of the said paragraph of the plaint whether the
latter averment should be read as restricting the general
averment with which the said paragraph opens, as
contended by Mr. Mistreat for the defendants, in view of the
fact that Mr. Blanco White has conceded that, on the suit as
framed, the infringement that has been complained of is
infringement only of claims Nos. 1 and 11 of the plaintiffs'
said have argued this case throughout on that footing, and I
must therefore, proceed to deal with the same on the basis
that the infringement complained of is infringement only of
claims Nos. 1 and 11 of plaintiffs' said patent.
......
......
11. It may be stated that the formula shown in Figure 6 is
the formula of Tolbutamide. As already stated above, in view
the admitted position, in the suit as framed, I am concerned
in this case only with claims Nos. 1 and 11 which are in
respect of what may be called 'process patents", but I have
thought it appropriate to refer incidentally to claim No.22
also, in which the patent claimed is of the substances
resulting from the processes comprised in those claims and
in the other claims that claim No.1 is the main claim which
covers compounds obtained by the chemical reaction
specified therein, either directly to form a urea linkage, or
indirectly to form a linkage readily convertible into urea
linkage. It is the plaintiffs' case that claim No.11 falls within
the latter part of claim No.1, in so far as it deals with the
processes by which thioureas are converted to the
corresponding urea linkage by being treated with agents
eliminating sulphur, the radicals R and R.1 having for the
purpose of claim No.11 the same limitations in regard to the
number of Carbon atoms as they are required to have for the
purposes of claim No.1. In my opinion, that is the proper
construction of claims Nos. 1 and 11 and the proper
position, therefore, is as stated by Mr. Blanco White, that
claims Nos. 1 and 11 must stand or fall together and that if
claim No.11 is infringed, claim No.1 must necessarily be
infringed. It may be mentioned that Tolbutamide is one of
the compounds which the plaintiffs claim to have prepared
by the processes patented by them in their said patent
No.58716 which would in addition, comprise numerous
other compounds which could also be prepared by those
processes. Since the case of the first defendants in
paragraph 4 of their Written Statement is that they are
preparing the compound Tolbutamide by the process of
desulphurisation of benzene-sulphonyl thioureas with
Hydrogen peroxide, in order to prove their case of
infringement what the plaintiffs have to prove is that the
process of synthesising the compound Tolbutamide by
desulphurisation of benzenesulphonyl thioureas with
Hydrogen peroxide is a process which would fall within
claim No.11. Mr. Mistreat has stated that he does not
contest the proposition that it makes no difference for the
purpose of the present case whether the defendants purchase
thiourea, or prepare it themselves. Mr. Blanco White is, in
my opinion, right when he contends that claim No. 11 is as a
matter of plain language, - and that us how a claim should
be construed as stated in the passage from Halsbury -
referred to earlier wide enough to include desulphurisation
of thioureas by any chemical substance, including Hydrogen
peroxide which the defendants claim to use. Since claim
No.11 is unambiguous in its terms it would not, in my
opinion, be right to seek to construe it by reference to
anything stated in the body of the specification Ex. A. Mr.
Balnco White has rightly contended that in view of the
admissions made by the defendants in their Written
Statement in the present case, it became unnecessary for the
plaintiffs to lead any evidence at all to prove infringement
on the part of the defendants. As stated in Section 58 of the
Indian Evidence Act, facts which are admitted need not be
proved. The admissions on which Mr. Blanco White has
relied are to be found in paragraph 4 of the Written
Statement of the first defendants, which has been adopted by
the third defendant in its Written Statement. Those
admissions are: (1) that the thioureas used as the starting
material in their process is the very starting material
mentioned in claim No.11 of the plaintiffs' patent; though
there is a formal denial, the Written Statement itself shows
that, in point of fact, it is the same; (2) that the defendants
have been synthesising their drug by the process mentioned
in the second defendants' patent No. 64323, which consists
of the preparation of substituted benzensulphonyl ureas from
the corresponding substituted benzenesulphonyl-thioureas
by desulphurization with Hydrogen peroxide; (3) that the
drug which is the end product is Tolbutamide which the
defendants have been synthesizing and selling; and (4) that
Tolbutamide is one of a class of sulphonyl ureas. In my
opinion, there can be no doubt that these facts admitted on
the pleadings are sufficient to show that claim No. 11 in the
plaintiffs' specification (Ex. A) is necessarily infringed by
the defendants. Claim No. 1 covers both the direct as well as
the indirect methods of manufacture of sulphonyl ureas. The
fact that, as Dr. Aumuller has deposed, the plaintiffs in
practice adopt the direct method in the production of
Tolbutamide for sale is immaterial. The question is not as to
the method actually followed by the plaintiffs, but is whether
the method followed by the defendants, which is an indirect
method, is covered by any of the claims in the plaintiffs'
patent. Even a cursory look at claim No.11 is sufficient to
show that it is wide enough to cover all methods of
eliminating sulphur from thioureas, whether the
desulphurisation is effected,, by means of Hydrogen
peroxide, or by the use of any other substance. Whether
claim No. 11, so widely worded, is valid in law is a totally
different question which will be dealt with by me separately
at the appropriate place later on. Suffice it to say that from
the facts admitted in the pleadings, the conclusion that claim
No. 11 has been infringed by the defts. must follow and that
in view of those admissions it was unnecessary for the
plaintiffs to lead any evidence to prove infringement on the
part of the defendants. As claim No. 11 is comprised in the
wider claim contained in claim No. 1, it must follow that
claim No. 1 has also been infringed by the defendants. I
would, therefore, answer issues Nos. 1 and 2 in favour of the
plaintiffs."
32. Although there is no admission as to the presence of the compounds
CHFA, PHPFMA and Zodiac-4 by the Defendants in their product,
but in view of the various lab reports placed on record by the Plaintiff
including the report produced from IICT, it shall be concluded that
presence of CHFA, PHPFMA and Zodiac-4 was detected in the
samples of the Defendants‟ products tested by these laboratories.
33. It is urged by the learned Senior Counsel for the Defendants that
although the Plaintiff has placed on record the lab reports in respect of
the Defendants‟ samples, but at the same time the Plaintiff has not
filed any report in respect of its own production. That, in my view, is
totally unnecessary. The Plaintiff has explained in detail the processes
used by it and has also obtained the patents IN „062 and IN „063. Even
if some of the Linezolid API is manufactured by the Plaintiff by prior
art processes, that will not nullify the Plaintiff‟s claim if the Plaintiff
had valid patent processes.
34. It is very strenuously urged by the learned Senior Counsel for the
Defendants that the Plaintiff has concealed material facts from this
Court because the Plaintiff had abandoned and disclaimed PHPFMA
as a novel intermediate during the prosecution of the European Patent
no. 1768967 (corresponding to the Indian Patent no. 213062). It is
thus, argued that the claim of exclusivity of the Plaintiff to the
compound PHPFMA is misleading. It is further urged that the Plaintiff
has suppressed longstanding business relationship of supply of
Linezolid by the Plaintiff to Defendant no. 1 since the year 2003.
Defendant no. 1 was granted a drug licence in the year 2002 and it has
been selling Linezolid in the open market to the knowledge of the
Plaintiff since then. It is urged that the Plaintiff‟s plea of presence of
CHFA, PHPFMA and Zodiac-4 in the same sample of the Defendants‟
product is also completely contrary to the Plaintiff‟s own contention
that Zoidac-4 is formed in manufacture of Linezolid by use of process
of IN „063 and PHPFMA is formed in manufacture by use of process
of IN „062. It is argued that the Plaintiff seeks injunction by seeking
parity with two other similar suits filed against Optimus Pharma and
Sharon Bio-Medicine without disclosing that for the same patent, the
intermediate alleged to be novel in those suits were different i.e.
Zoidac-4. It is also averred that the factum of validity of the suit
patents was also challenged in the cases of Optimus Pharma and
Sharon Bio-Medicine by filing counter-claims and non disclosure of
the same is another material suppression which will disentitle the
Plaintiff from grant of an ad interim injunction. Thus, relying on the
judgments in S.P. Chengalvarya Naidu (dead) by L.Rs. v. Jagannath
(dead) by L.Rs. and Ors. (1994) 1 SCC 1, F. Hoffmann-LA Roche Ltd.
and Anr. v. Cipla Ltd., 159 (2009) DLT 243, Satish Khosla v. M/s Eli
Lilly Ranbaxy Ltd. and Anr., 71 (1998) DLT 1, B. Braun Melsungen
AG and Ors. v. Rishi Baid and Ors., 2009(40) PTC 193 (Del),
Standipack Pvt. Ltd. and Anr. v. M/s Oswal Trading Co. Ltd., AIR
2000 (Del) 23 and Sandeep Jaidka v. Mukesh Mittal and Anr., 211
(2014) DLT 401, it is urged that because of the suppression detailed
above, the Plaintiff has disentitled itself to seek equitable relief of
injunction.
35. The business relationship between the Plaintiff and Defendant no. 1
has not been disputed. The learned counsel for the Plaintiff has
pointed out that during a period of ten years, Defendant no. 1 had
intermittently purchased only 2816 kgs. of Linezolid API from the
Plaintiff. In my view, omission to refer to the purchase of Linezolid
API by Defendant no.1 from the Plaintiff is totally inconsequential.
Rather, the same strengthens the case of the Plaintiff that Defendant
no. 1 was purchasing Linezolid API from the Plaintiff to prepare
finished dosages of the pharmaceutical preparation because the
Defendants had not found it feasible to manufacture Linezolid API of
their own. The Plaintiff obtained the process patents IN „062 and IN
„063 w.e.f. December, 2007. The Defendants have not given the sale
figures of the finished dosages and quantum of manufacture of
Linezolid API since the year 2003. In the circumstances, an inference
can be raised that although initially the Defendants purchased
Linezolid API from the Plaintiff and others, later they started
manufacturing Linezolid API themselves by using the suit patented
processes.
36. As far as the Defendants‟ contention that PHPFMA is not a novel
intermediate as held in European Patent no. 1768967 is concerned,
PHPFMA was affirmed to be a novelty by U.S. Patent Office (USPO)
and compound claims for PHPFMA was granted to the Plaintiff in
Claims 64 to 66 of U.S. Patent no. 7429661 B2. It is contended that
the Plaintiff had also reserved its right by filing a divisional petition in
respect of claims no. 42 and 41 (which inter alia is PHPFMA) during
the prosecution of EP 967. However, the divisional application could
not be filed within the deadline by the Plaintiff and hence, the same in
law cannot be construed as the Plaintiff having disclaimed the patent
claim over the novelty of PHPFMA. It is further urged by the learned
counsel for the Plaintiff that claims no. 1 to 41 of European Patent no.
17681967 and claims no. 1 to 63 of U.S. Patent no.7429661 cover the
process of preparation of Linezolid using the novel intermediate
compound PHPFMA. It is also urged that IN „062 contains both
claims for PHPFMA which is the relevant patent sought to be
injuncted from being infringed in the present proceedings and the
same was granted on 19.12.2007 in India i.e. sixteen months prior to
the grant of EP „967 and therefore, the contention that the Plaintiff‟s
application with regard to IN „062 was registered on a false
representation is erroneous. Thus, I tend to agree with the Plaintiff. In
my view, there cannot be said to be any suppression or much effect of
EP 1768967 on the suit patents IN „063 and IN „062.
37. As far as presence of PHPFMA and Zodiac-4 in the same sample of
Linezolid if manufactured according to either of the processes
disclosed in the suit patents is concerned, it is urged by the learned
counsel for the Plaintiff that owing to the unity of the starting
compounds and the reagents in the two patents and the easy
substitutability of the steps involved in both, it is a scientifically
possible result that traces of the compounds used as intermediates in
one process are also found when the other process is used. I have also
considered the factum of challenge of the suit patent by Optimus
Pharma and Sharon Bio-Medicine in the counter claims filed in the
earlier suits. The same, in no case, will amount to suppression of
material facts so as to disentitle the Plaintiff to the equitable relief of
ad interim injunction. The Plaintiff very well disclosed filing of the
suit against the earlier said two companies and obtaining an injunction
order against them. The Plaintiff has obtained process patents IN „063
and IN „062 in the year 2007. Admittedly, challenge to the patent
processes of IN „063 and IN „062 was not made either by Optimus
Pharma or Sharon Bio-Medicine before filing of the suits against
them. Similarly, the Defendants also did not lay any challenge or
applied for revocation of the Plaintiff‟s patents before filing of the
instant suit. In view of the non-challenge for six long years and
particularly when the Defendants themselves were purchasing
Linezolid API from the Plaintiff, it will be difficult to say at this stage
that there is any good ground of challenge to the Plaintiff‟s patent.
38. There is no dispute about the proposition of law that validity of a
patent can be challenged in a Court (Microsoft Corpn. v. 141 Ltd.
Partnersip Et Al, 564 US (2011), Chemtura Corpn. v. Union of India
(UOI) and Ors., 2009 (41) PTC 260 (Del) and Glaverbel S.S. v. Dave
Rose and Ors., 2010 (43) PTC 630 (Del)).
39. It is urged by the learned Senior Counsel for the Defendants that grant
of interlocutory injunction is a discretionary relief and the same ought
not be granted if damages are efficacious remedy. Reliance is placed
on Modern Food Industries India Ltd. v. M/s Shri Krishna Bottlers (P)
Ltd., AIR 1984 (Del) 119.
40. However, it may be noted that monopoly over the patent is the reward
of the inventors. The inventor spends a lot of time and money in
inventing a product or a process. As stated earlier, the Plaintiff‟s
patents are subsisting since the year 2007. In view of foregoing
discussion and facts and circumstances, I am convinced that the
Plaintiff has got good prima facie case in its favour. In my view,
protection to the patent processes ought to be granted to the Plaintiff
as damages will not be an efficacious remedy. Thus, there will be
irreparable loss and injury because of the long uninterrupted use of
patents, the balance of convenience also lies in favour of the Plaintiff.
41. In view of foregoing discussion, I hereby grant an ad interim
injunction restraining the Defendants, through their officers, directors,
agents and distributors from manufacturing, selling, offering for sale,
advertising or directly or indirectly dealing in the production of
Linezolid manufactured in a manner so as to result in infringement of
the Plaintiff‟s registered Patents IN „063 and IN „062 till the disposal
of the suit.
42. It may be mentioned that the observations made hereinabove are only
tentative and opinion made for the disposal of the application under
Order XXXIX Rules 1 and 2 CPC and the same shall not be taken as
an expression of my opinion on the merits of the case.
43. The applications stand disposed of.
44. List before the Joint Registrar on 19th February, 2015.
(G.P. MITTAL)
JUDGE
JANUARY 19, 2015
vk/ pst
