B. Braun Melsungen Ag & Ors. vs Rishi Baid & Others
2009 Latest Caselaw 1378 Del

           THE HIGH COURT OF DELHI AT NEW DELHI
%                                   Judgment delivered on: 15.04.2009

+            IA 1234/2008 in CS(OS) 186/2008 (u/O 39 R 1 & 2 CPC)

B. BRAUN MELSUNGEN AG & ORS.                               ... Plaintiffs


                                   - versus -


RISHI BAID & OTHERS                                        ... Defendants

Advocates who appeared in this case:
For the Plaintiffs    : Mr Arun Jaitley, Sr Advocate with Mr Praveen Anand,
                        Ms Binny Kalra, Ms Ishani Sahiwal and Ms Taapsi Johri
For the Defendants    : Mr Dushyant Dave, Sr Advocate with Mr Pallave Sisodia,
                        Mr Rajesh Bhardwaj, Mr Vaibhav Vutts and
                        Mr Rajeev Ranjan Kumar


CORAM:-
HON'BLE MR JUSTICE BADAR DURREZ AHMED

      1.

Whether Reporters of local papers may be allowed to see the judgment ? YES

2. To be referred to the Reporter or not ? YES

3. Whether the judgment should be reported in Digest ? YES

BADAR DURREZ AHMED, J

1. The plaintiffs seeks an ad interim injunction restraining the

defendants from making, selling, distributing, advertising, exporting,

offering for sale and in any other manner dealing in or with safety I.V.

catheters / cannulae or other device or apparatus that infringes the

subject matter of the plaintiffs‟ registered patent number 210062. The

plaintiffs also seeks an ad interim injunction restraining the defendants

from manufacturing, selling, offering for sale, distributing, exporting,

advertising or dealing in any safety I.V. catheters / cannulae under the

trademark „VASOFIX® Safety™‟ or any other mark which uses the

plaintiffs‟ alleged confidential information, know-how, trade secrets,

data, technical input, drawings, materials and / or any other resource

derived by the defendants from the plaintiffs.

2. According to the plaintiffs, the plaintiff No. 1 (B. Braun

Melsungen AG), which is a company incorporated in Germany,

supplies the global healthcare market with products for anesthesia,

intensive medicine, cardiology, surgery as well as services for

hospitals, general practitioners and the home care sector. The plaintiff

No.1 is said to innovate products and services with the object of

optimizing working procedures in hospitals and medical practices all

over the world and also focuses on improving safety for patients,

doctors and nursing staff. The plaintiff No.2 [B. Braun Medical (India)

Pvt. Ltd] is a wholly owned subsidiary of B. Braun Medical Industries

Sdn. Bhd., which, in turn, is a 100% subsidiary of the plaintiff No. 1.

3. It is alleged that the plaintiff No. 2 launched its state of art

production facility at Chennai on 30.01.2007 for the manufacture of

products for the healthcare market. The plaintiff No. 1, inter alia, has a

product which is an intravenous (I.V.) catheter, which is also known as

I.V. cannula, with an injection port and self-activating needle stick

protection.

4. According to the plaintiff an I.V. catheter is a device through

which intravenous fluids are administered directly into a patient‟s

vascular system. The catheter is inserted into a patient‟s vein by a

healthcare worker by using a handheld placement device which

includes a sharp tip needle. The needle is positioned in the interior

hollow portion of the catheter with its tip extended slightly beyond the

edge of the catheter. The end of the apparatus opposite the needle tip is

made up of the needle connected to a needle hub, which is capable of

being held by the healthcare worker during the insertion procedure. As

stated in the plaint, the insertion procedure contains four basic steps:-

(1) The healthcare worker inserts the needle and catheter

together into the patient‟s vein;

(2) After insertion into the vein with the needle point, the

catheter is forwarded into the vein of the patient by the

healthcare worker pushing the catheter with his or her

finger;

(3) The healthcare worker withdraws the needle by grasping

the hub end (opposite the pointed end) while at the same

time applying pressure to the patient‟s skin at the insertion

site with his or her free hand; and

(4) The healthcare worker then tapes the now inserted catheter

to the patient‟s skin and connects the exposed end of the

catheter (the catheter hub) to the source of the fluid to be

administered into the patient‟s vein.

5. A problem, which was faced in the aforesaid procedure, was

that after the withdrawal of the needle from the patient‟s vein, the

healthcare worker, who is at that point of time involved in at least two

urgent procedures, had to place the exposed needle tip at a nearby

location and address the tasks required to accomplish the needle

withdrawal. There was a danger of the exposed needle tip resulting in

an accidental needle stick which left the healthcare worker vulnerable

to the transmission of various dangerous blood borne pathogens,

including AIDS and hepatitis. The plaintiffs‟ invention of the safety

I.V. catheters is said to have solved the problem and results in the

prevention of accidental needle sticks. It is stated in the plaint by the

plaintiffs that the safety I.V. catheters have been developed by several

entities to achieve this result with a protective needle guard for use

with a hypodermic needle. It is, however, alleged that patents applied

for by several parties were cited and overcome in the plaintiff‟s patent

applications in India and other countries.

6. It has been alleged on the part of the plaintiffs that the prior

art safety I.V. catheters exhibited one or more drawbacks and had

limited the usefulness and full acceptance by healthcare workers. The

plaintiffs‟ product is a safety I.V. catheter in which the needle tip is

automatically covered after needle withdrawal to prevent the healthcare

worker from making accidental contact with the needle tip. According

to the plaintiffs, they enjoy patent protection for the said invention in

several countries including India where the patent has been registered

under No. 210062 in favour of the plaintiff No. 1 with effect from

18.08.1998.

7. In the course of arguments before this Court, great stress was

laid on independent claim 28 of the plaintiffs‟ patent No. 210062. The

same reads as under:-

"Claim 28:

An IV catheter including:

 A tubular catheter;

 A needle having a needle shaft and a tip, said needle being received within said tubular catheter when in a ready position, the needle comprising a bulge in its shaft;  A catheter hub attached to the proximal end of said tubular catheter, said catheter hub having a hollow interior enclosed by an interior wall;

 said needle being movable between said ready position in which said tip is outside of said catheter hub and a retracted position in which said tip is within the interior of said catheter hub;

 a needle guard comprising:

 a proximal wall for engaging with the bulge in the shaft of the needle to prevent the removal of the needle from the needle guard;

 a distal wall engaged by said needle shaft when said needle is in said ready position;

 a section of a transverse segment of said needle guard being urged by said needle shaft into retaining relation within said catheter hub when said needle is in the ready position;  said distal wall extending from said transverse segment and engaging the needle spaced from said needle tip when said needle is in said ready position and movable within the interior of said catheter hub to a blocking position distal of said needle tip when said needle is in its retracted position;  the engaging of the needle and the urging of said section of the transverse segment into retaining relation with the catheter hub in the ready position being both achieved by engagement of the distal wall of the needle guard with the needle shaft;

 said section of said transverse segment being a curved section in retaining contact with the interior wall of the catheter hub, for providing engagement of the needle guard when transitioning from the ready position to the blocking position at a fixed longitudinal position within the catheter hub."

8. The plaintiff No. 1 markets the said safety I.V. catheters in

India through the plaintiff No. 2. The plaintiff No. 1 is said to

manufacture the product in Malaysia through its subsidiary in that

country, namely, B. Braun Medical Industries Sdn. Bhd. The said

safety I.V. catheter is being marketed by the plaintiff under the brand

„VASOFIX® Safety™‟ at least since June, 2004 in India and it is

allegedly presently sold in over 45 countries throughout the world.

9. The defendant No. 3, namely, Poly Medicure Limited is a

company registered in India under the Companies Act, 1956 and the

defendants 1 and 2 are the Executive Director and Managing Director

in the said defendant No. 3 company. According to the plaintiffs, Poly

Medicure Limited has been manufacturing a basic I.V. catheter bearing

the brand name „ACCUCATH‟ for and on behalf of the plaintiff No.1

under an exclusive agreement executed on 10.02.2005. It is alleged

that under the terms of the said agreement Poly Medicure Limited was

authorized to manufacture I.V. catheters as a contract manufacturer,

according to the applicable specifications and regulatory conditions

prescribed by the plaintiff No.2 and also for packaging and labeling

these in accordance with the plaintiff No.2‟s specifications. The

agreement had an initial validity period of two years and was to

continue for a further period of one year unless terminated earlier.

10. It is further alleged that the plaintiffs have been marketing

and selling two types of I. V. catheters in India:- „Vasofix®‟ for more

than two decades and „VASOFIX® Safety™‟, which is the improved

safety I.V. catheters, since June, 2004. It is alleged that the plaintiff

No. 2 had appointed Poly Medicure Limited as a contract manufacturer

to manufacture low cost I.V. catheters under the trademark

„ACCUCATH‟ and as a result of which Poly Medicure Limited became

aware of the plaintiffs' propriety safety product as mentioned above

which was being manufactured in the plaintiff No.1‟s Malaysian plant.

It is alleged that the defendant No. 1 also visited the said Malaysian

unit on at least one occasion.

11. The allegation further is that Poly Medicure Limited was

provided with all relevant technical knowledge for manufacture of

„ACCUCATH‟. But, though Poly Medicure Limited was contracted to

manufacture only „ACCUCATH‟, information provided to it by the

plaintiffs aided the said Poly Medicure Limited in manufacturing a

safety I.V. catheter also. It is alleged that the defendants have

approached the plaintiffs with specific problems faced by them while

making the „ACCUCATH‟ catheters and that the plaintiffs have solved

these problems by going in depth and providing effective solutions. It

is alleged that the plaintiffs had reposed complete trust in the

defendants while providing them with sensitive data, processes, trade

secrets and confidential information. It is specifically pointed out that

the plaintiffs did not authorize or appoint the defendants to be contract

manufacturers for the „VASOFIX® Safety™‟ I.V. Catheter at any point

of time. Apparently, the plaintiff No. 2 and the defendants also entered

into a confidentiality /secrecy agreement executed in March-April,

2006.

12. It is alleged that in November, 2006 at the international trade

show at Dusseldorf in Germany, an officer of the plaintiff No. 1

noticed the defendants‟ booth at the said trade show and it is alleged

that one of the defendants‟ representative met the said officer and with

a view to impress him, showed a product stated to be a prototype of a

safety I.V. catheter. It is alleged that the said officer of the plaintiff

No. 1 was not given an opportunity to examine the prototype but was

concerned that the same may violate the plaintiff No.1‟s intellectual

property. He requested for a sample of the prototype but the same was

not provided by the defendants.

13. It is then alleged that in the trade show organized in

November, 2007, the plaintiffs‟ representative visited the booth set up

by Poly Medicure Limited and was given samples of the latter‟s safety

I.V. cannula. The sample was allegedly dissected by the plaintiffs,

analyzed and photographed from various angles and, in their opinion,

infringed the plaintiffs‟ Indian Patent No. 210062. According to the

plaintiffs, the defendants‟ sample, which was labeled as „Safety I.V.

cannula‟ under the brand name „Poly Safety‟, obtained in November,

2007 contained all the elements of claim 28 of Patent No. 210062.

14. According to the learned counsel for the plaintiffs 90% of

the defendants‟ safety cannula is ACCUCATH. The relationship

between the plaintiffs and the defendants for over four years permitted

or allowed the defendants to derive knowledge and expertise in that

field. And, after having gained the knowledge, the defendants have

come out with their own safety I.V. catheter which carries all the

elements as set out in claim 28 of the plaintiffs‟ Patent No. 210062.

This is, therefore, a clear violation and infringement of their said

registered patent and, therefore, they are entitled to the injunction that

they seek straightaway.

15. Mr Arun Jaitley, the learned senior advocate who appeared

on behalf of the plaintiffs, submitted that what is relevant in such a case

is the patent and not the manifestation of it. He submitted that it is,

therefore, necessary to compare the defendants‟ product with the

plaintiffs' patent and then ask the question as to whether claim No. 28

is incorporated in the defendants‟ product. If the answer is in the

affirmative, then it would be a clear case of infringement and the

plaintiffs would be entitled to the injunction. He further submitted that

minor additions are immaterial. The essential features, which

collectively amount to an invention, must only be seen.

16. The learned counsel referred to the decision of the High

Court of Madras in the case of Bajaj Auto Limited v. TVS Motor

Company Limited: 2008 (36) PTC 417. The said decision was pointed

IA 1234/2008 in CS(OS) 186/2008 Page No.10 of 35 out to show that there is a difference in the rights of patentees after the

amendment to the Patents Act, 1970 which came into effect on

20.05.2003. Going through the said decision, it appears that an

argument had been raised that after the amendment to Section 48 of the

Patents Act, 1970, the position was that once a patentee files a suit for

infringement based on the patent granted to him, it ought to be prima

facie presumed to be valid until the same is set aside in the manner

known to law either by revocation under any one of the grounds

under Section 64 of the Patents Act, 1970 or in any other manner.

After analyzing the amendment, the learned Single Judge of the Madras

High court was of the view that the difference in the said provision

before and after the amendment was that prior to the amendment, the

patentee was conferred an exclusive right to use, either by himself or

through agents or licencees and also to sell or distribute the inventions

in India. The patent to which the patentee was entitled to the exclusive

user, related to an article or substance and to a method or process of

manufacturing the substance. After the amendment, the right which is

conferred on the patentee in respect of the product and in respect of the

process is an exclusive right to prevent third parties from using or

selling etc. The learned Single Judge came to the conclusion that while

ascertaining as to whether a plaintiff has a prima facie case or not, even

though no presumption of the validity of the patent can be drawn, ,

after the amendment, a patent obtained by a party is certainly to be

IA 1234/2008 in CS(OS) 186/2008 Page No.11 of 35 given greater significance. It was, therefore, concluded that the patent

obtained by the patentee in that case could be given more weight for

deciding the prima facie case, however, the onus of „proving‟ the

prima facie case about the validity of the patent and its infringement is

still on the plaintiff and the amendment to Section 48 by Act 32 of

2002 had not made any significant change on the celebrated principle

of prima facie case to be proved by the plaintiff before granting an

order of injunction pending disposal of the suit.

17. The learned counsel also referred to the said decision to

indicate what are the parameters for examination of the balance of

convenience. He referred to paragraph 61 of the said decision wherein

the decision of the Court of Appeal in Corruplast Ltd. v. George

Harrison (Agencies) Ltd.: 1978 RPC 761 was quoted. It was observed

that in every case of this kind, the function of the Court must be to

consider which course, either the granting or withholding of an

injunction, is the one which is likely to make it easy for the trial court,

when the issues in the action have been decided, to adjust the rights of

the parties and do justice between them.

18. The learned counsel also referred to the decision of a learned

Single Judge (S.K. Kaul, J.) of this Court in the case of J. Mitra & Co.

Pvt. Ltd. V. Kesar Medicaments: IA No. 11883/2006 in CS(OS)

IA 1234/2008 in CS(OS) 186/2008 Page No.12 of 35 2020/2006 decided on 22.02.2008 with particular reference to the

portion of mosaicing. The learned Judge quoted Terrell on Patents

(16th Edition, 2006) wherein the concept of mosaicing is explained as

under:-

"The mosaicing of individual documents or prior uses is not permissible, unless it can be shown that the skilled person, confronted with a particular citation, would turn to some other citation to supplement the information from the first. Whether he would do so is a question of fact".

A further reference was made to the decision in Technograph v. Mills

and Rockley: (1972) R.P.C 346 where Lord Reid observed:-

"When dealing with obviousness, unlike novelty, it is permissible to make a „mosaic‟ out of the relevant documents, but it must be a mosaic which can be put together by an unimaginative man with no inventive capacity."

Referring to Bilcare Ltd. v. Amartara Pvt. Ltd: 2007 (34) PTC 419

(Del), the learned Judge noted that as per the legal position set out in

the said decision, it would not be a defence to show that various

components in the patented product are known separately. The

combination of such components may be patentable. The Court

concluded that it would not be permissible for a defendant to rely on

different documents disclosing different components / features of the

product to plead that the product of the patent was known.

19. Mr Arun Jaitley also referred to the following decisions:-

IA 1234/2008 in CS(OS) 186/2008 Page No.13 of 35 (1) K. Ramu v. Adyar Ananda Bhavan Muthulakshmi Bhavan:

2007 (34) PTC 689 (Mad.); (2) Wockhardt Limited v. Hetero Drugs

Ltd. & Ors: 2006 (32) PTC 65 (Mad.) (DB); (3) Ajay Industrial

Corporation, Delhi v. Shiro Kanao of Ibaraki City, Osaka, Japan:

1983 PTC 245; (4) Telemecanique & Controls (I) Ltd v. Schneider

Electric Industries SA: 94 (2001) DET 865 (DB). In this decision, it

was observed that undoubtedly a patent creates a statutory monopoly

protecting the patentee against any unlicensed user of the patented

device. Thus, once a violation is established in a case of a registered

patent, subject of course, to the patent being used, it will not be

permissible to contend that the said patentee is not entitled to an

injunction. It was also observed that monopoly of the patent is the

reward of the inventor. (5) N. R. D. Corporation of India v. D. C.

& G. Mills Co. Lt.: AIR 1980 Delhi 132. In this decision, a learned

Single Judge of this Court noted that for the grant of temporary

injunction, the principles applicable to the infringement of patent

actions are that there is a prima facie case, that the patent is valid and

infringed, that the balance of convenience is in favor of the

injunction being granted and that the plaintiff will suffer an

irreparable loss. However, it may be noticed that in this decision

itself it is noted that it is also a rule of practice that if a patent is a

new one, a mere challenge at the Bar would be quite sufficient for a

refusal of a temporary injunction, but if the patent is sufficiently old

IA 1234/2008 in CS(OS) 186/2008 Page No.14 of 35 and has been worked, the court would, for the purpose of temporary

injunction, presume the patent to be valid one. If the patent is more

than six years old and there has been actual user, it would be safe for

the Court to proceed on this presumption. The last decision referred

to by the learned counsel for the plaintiffs was the case of

American Cyanamid Company v. Ethicon Limited: 1975 RPC 513

wherein it was observed that the object of the interlocutory

injunction is to protect the plaintiff against injury by violation of his

right for which he could not be adequately compensated in damages

recoverable in the action if the uncertainty were resolved in his

favour at the trial. It was further observed that the plaintiff‟s need

for such protection must be weighed against the corresponding need

of the defendant to be protected against injury resulting from his

having been prevented from exercising his own legal rights for which

he could not be adequately compensated under the plaintiff‟s

undertaking in damages if the uncertainty were resolved in the

defendant‟s favour at the trial. The court must weigh one need

against another and determine where "the balance of convenience"

lies.

20. Mr Dushyant Dave, the learned counsel appearing on behalf

of the defendants, submitted that the registration of the patent by itself

is not sufficient for the grant of an interlocutory injunction. Secondly,

IA 1234/2008 in CS(OS) 186/2008 Page No.15 of 35 he submitted that the registration itself is questionable. He also

submitted that there was no case made out for an unfair business

practice. Mr Dave referred to the agreement dated 17.01.2007 between

the defendants and the plaintiff No. 2. He referred to Clause 10.1 of

the said agreement which is at page 306 of the documents filed by the

plaintiffs and forms part of the non-competition clause. As per the

clause 10.1, the parties agreed that they shall not compete with each

other in respect of the products except those already being

manufactured and marketed by Poly Medicure Limited as listed in

Schedule 4 and those in the pipeline as listed in Schedule 5. Serial No.

15 of Schedule 4 clearly indicates "Safety I.V. Cannulas". From this,

Mr Dave submitted that it was well within the knowledge of the

plaintiffs that the defendants were already engaged in the manufacture

of safety I.V. cannulae on the date on which the said agreement was

entered into, that is, on 17.01.2007. Yet, the plaint does not mentioned

this very crucial and important fact.

21. Mr Dave drew my attention to the report in respect of the

Audit which was got conducted by the plaintiffs in the defendants plant

between 10th -12th October, 2005. The report is at page 213 of the

plaintiffs‟ documents. Clause 2.3.4, which refers to future planned

changes, clearly indicates in sub-Clause (4) that the Audit party was

aware of "introduction of new products which includes Safety IV

Catheter ...............". Mr Dave pointed out that as early as in

IA 1234/2008 in CS(OS) 186/2008 Page No.16 of 35 October, 2005, the plaintiffs were aware that it was within the future

plans of the defendants to manufacture safety I.V. catheters. He

submitted that this fact was also not disclosed in the plaint. Mr Dave

then referred to Audit report dated 05.10.2007, which is at page 62 of

the documents filed by the defendants. In para 1.9.3 (6), it is clearly

indicated that "Polymed had launched their safety IVC to the market in

the Middle East and Europe since July, 2007". Mr Dave submitted that

this fact has also not been mentioned in the plaint. Mr Dave also

referred to the documents beginning at page 72 of the defendants‟

document, which is a rate contract of the Government of India, Director

of Supplies and Disposals, Shastri Bhawan, 26 Haddows Road,

Chennai- 600006, which prescribes the rate contracts for supply of I.V.

cannula valid from 01.07.2007 to 30.06.2008. As per serial Nos. 25,

26, 27, 28, 29, 30 and 31, which pertain to Poly Medicure Limited,

safety I.V. cannula is clearly indicated and mentioned therein.

22. Mr Dave then went on to explain the dubious circumstances

under which the present patent was obtained. On 27.05.2005, with

reference to patent application No. 1857/MAS/98, there is an

intimation from the Patent Office at Chennai to De Penning & De

Penning that the said application had been found in order for grant.

However, letters patent would be issued only after disposal of the pre-

grant opposition, if any, under Section 25 (1) of the Patents Act, 1970.

IA 1234/2008 in CS(OS) 186/2008 Page No.17 of 35 On 10.09.2007, a letter was written by the new attorneys of the plaintiff

to the Controller of Patents, Chennai with regard to the said patent

application No. 1857/MAS/1998. As per the said letter, Form 13 in

duplicate to bring on record the change in address of the applicant and

the attested copy of General Power of Attorney, were submitted. The

said Form 13 indicated that the change of address for service from De

Penning & De Penning to Anand and Anand, Advocates. This

application was received at the Patent Office on 13.09.2007. The

patent No. 210062 in respect of application No. 1857/MAS/98 was

granted to the plaintiff No. 1 for the I.V. catheters w.e.f. 18.08.1998.

However, the date of the grant was 17.09.2007, as indicated by a copy

of the patent certificate, which is at page 2 of the plaintiffs‟ documents.

The claim that was granted is set out at pages 3-9 of the plaintiffs‟

documents.

23. However, what is interesting and which has been pointed out

by Mr Dave is that on 19.09.2007, that is, after the grant of the patent,

on 17.09.2007, an application is sent by the new attorneys of the

plaintiffs indicating the desire of the plaintiffs to amend the claims by

way of correction and explanation. In the so-called amended claim the

original claims 1-54 were sought to be cancelled and the amendments

set out were exactly those which form part of the patent granted on

17.09.2007. On the basis of these circumstances, Mr Dave submitted

IA 1234/2008 in CS(OS) 186/2008 Page No.18 of 35 that there is certainly something more than meets the eye. Otherwise,

how could the claims, which were sought to be amended on

19.09.2007, be part of the patent granted two days earlier on

17.09.2007?

24. The learned counsel further pointed out that at the time of

application for the patent the same was made in respect of "spring clip

safety I.V. catheter". However, in the complete specifications at page

753 of the defendants‟ documents the title given is "an I.V. catheter".

In fact, the patent which has been granted is also for an invention

entitled "an I.V. catheter".

25. Based on these and other circumstances, Mr Dave submitted

that:-

(i) The plaintiffs have suppressed material facts;

(ii) The grant of the patent in favour of the plaintiff No. 1 is coloured by fraud;

(iii) Injunction cannot be granted in favour of the plaintiff particularly when the patent is new and is seriously objected to;

(iv) The defendants have already commenced production and sale of their safety I.V. cannula and the same is to the knowledge of the plaintiff and, therefore, no injunction can be granted in favour of the plaintiff; and

(v) Mere grant of a patent is not sufficient and, apart from the establishment of prima facie case, the considerations of balance of convenience and irreparable loss have also

IA 1234/2008 in CS(OS) 186/2008 Page No.19 of 35 to be looked into before a Court can grant an injunction in favour of the plaintiff.

26. Elaborating on the plea of suppression, Mr Dave submitted

that the plaint has been very cleverly drafted in the sense that in

paragraph 9 of the plaint, although there is a reference of safety I.V.

catheters having been developed by several entities and paragraph 10

of the plaint also makes a reference to prior art safety I.V. catheters, but

they have been stated to exhibit drawbacks which have allegedly been

removed by the plaintiffs‟ invention. Then, it is alleged, in paragraph

12 of the plaint only the effective date of the patent had been disclosed

but not the date of grant. Paragraph 14 of the plaint makes no reference

to the 54 claims filed earlier but cancelled subsequently. He also

submitted that there is no reference to the fact that Poly Medicure

Limited was already a substantial market player in I.V. catheters prior

to the agreement dated 10.02.2005. There is also no mention of the fact

that the plaintiffs were aware of the defendants manufacturing and

selling of safety I.V. catheters as far back as in 2005 and definitely in

October, 2007. He submitted that the entire story of the plaintiffs

coming to know of the defendants safety I.V. catheters in the trade

show in November, 2006 is a compete travesty of truth. He submitted

that the cause of action disclosed in the plaint for the grant of an

injunction is that the defendants were allegedly yet to commence

production and sale of their safety I.V. cannula. This is completely

IA 1234/2008 in CS(OS) 186/2008 Page No.20 of 35 belied by their own Audit report mentioned above where it is indicated

that Polymed had launched the safety I.V.C in the market since July

2007. He also submitted that the plaint carries no mention of

Schedules 4 and 5 of the agreement dated 17.01.2007 which

specifically excludes safety I.V. cannulae/ catheters from the

non-compete clause. Mr Dave submitted that the entire focus and

stress of the plaint is premised on the ground that the defendants are yet

to launch and that there is imminent threat of sales being commenced

whereas, in fact, the defendants had already commenced manufacture

and sale of its safety I.V. cannula much prior to the filing of the suit

and that too to the knowledge of the plaintiffs as already indicated

above.

27. Mr Dave further submitted that the claims 1-54, which had

been advertised and to which objections were invited, were in fact

cancelled and the amendments were not at all advertised and the patent

was granted in respect of the new claims and, in particular claim 28.

Mr Dave also referred to Rules 81 and 82 which clearly indicated that

if there were substantial amendments, they ought to be published. He

submitted that the post-grant proceedings of making an entirely new

claim of a patent in the garb of amendment, is contrary to law, vitiated

by fraud, collusion and irregularities. He submitted that thus there is a

strong prima facie case for revocation of amended patent 210062 under

IA 1234/2008 in CS(OS) 186/2008 Page No.21 of 35 Section 64 (o) of the Patents Act, 1970. He submitted that the grant of

patent in the instant case on 17.09.2007 is on replaced claims 1-28 but

termed as additions/ amendments which were filed only on 19.09.2007.

This demonstrates the fraud played on the statutory authority and the

statute itself. He submitted that the application of 18.08.1998 for the

grant of patent was in respect of claims 1-54 all of which were sought

to be cancelled only on 19.09.2007 and substituted by claims 1-28 for

which the statutory procedure and safeguards could not have been

followed. He submitted that there had been no examination of claims

1-28 as mandatorily required to ascertain as to whether the same

involved a new invention and even an invention involving an inventive

step. He submitted that issues like existence of prior art and existing

knowledge / anticipation, conditions precedent for grant of patent, had

not even been adverted to. Consequently, he submitted that the grant

of patent was void ab initio and the plaintiff can derive no right from

the same.

28. Mr Dave also submitted that it is an admitted position that

insofar as the ordinary I.V. catheter is concerned, it finds its place in a

crowded field with many manufacturers worldwide. He submitted that

the essential features of a safety I.V. catheter are (i) Needle guard to

cover needle tip when taken out from vein of the patient after use; (ii)

Bulge in needle to prevent needle coming out without the needle guard;

IA 1234/2008 in CS(OS) 186/2008 Page No.22 of 35

(iii) Catheter hub to retain the needle guard till use and to release it

after use; and (iv) Functional arrangement of these integers. It was

contended that the patent obtained by the plaintiff was anticipated and

made obvious by prior art and knowledge and as such lacks any

inventiveness. As an illustration, he referred to U.S Patent

No. 5,135,504 of 04.08.1992 with text and drawing therein. The said

patent shows all the features of a safety I.V. catheter. The same have

been published and commonly known by several manufacturers world

over. The said U.S. Patent No. 5,135,504 is in respect of needle tip

guard. The abstract indicates that it is in respect of a guard for the tip

of intravenous needle which operates automatically when the needle is

withdrawn from the intravenous catheter. The background of the

invention which is given in the said U.S. patent under the head

„description of the prior art‟ clearly indicates that to help / prevent

heath care workers from becoming infected by hepatitis or AIDS or the

like from an accidental needle prick, it would be desirable to have a

guard which covers the tip of an intravenous needle after use. If further

reads that many such guards have been previously disclosed by

hypodermic needles and syringes in general but no guard has yet been

manufactured specifically when the needle is withdrawn from the

catheter. It goes on, obviously it would be desirable to have a guard

automatically enclose the sharp end of the needle when it is withdrawn

from the catheter, thus, preventing the possibility of infection from an

IA 1234/2008 in CS(OS) 186/2008 Page No.23 of 35 accidental needle prick during subsequent handling. Thereafter, the

summary of the invention, brief description of the drawings and

detailed description of the drawings is given. Ultimately, what is

claimed is set out. What is claimed is an intravenous catheter insertion

kit and a needle guard comprising, inter alia, a flexible catheter and its

attached hub; an insertion needle assembly, the insertion needle having

a slightly flared distal tip such that the needle diameter at the said tip is

slightly larger than the uniform diameter proximal of the said tip; and

................ whereby the said enlarged needle diameter captures the

said needle tip guard and the needle tip becomes enclosed by the said

guard when the said needle is withdrawn from the said hub and

catheter.

29. Consequently, it was submitted by the learned counsel that

the features as indicated in claim 28 of the plaintiffs patent when read

alongside the said U.S. Patent No. 5,135,504 indicate that all the

features of a safety I.V. catheter were published, commonly known and

applied world over by several manufacturers. The learned counsel also

referred to the list of prior art which refers to several U.S. patents and

the European Patent.

30. It was also submitted that the safety I.V. catheter of Poly

Medicure Limited is quite different in many ways to that of the

IA 1234/2008 in CS(OS) 186/2008 Page No.24 of 35 plaintiffs‟ product/ patent. It was pointed out that the needle guard of

the Poly Medicure safety cannula is made of pink coloured plastic in an

axial position whereas the plaintiffs‟ patent pertains to a steel clip in

transverse segment. For the engagement of the needle guard with the

catheter hub there is a circumferential recess on the distal end of the

needle guard which retains position due to the annular ring on the

catheter hub in the product of the defendant as against the curved

section on the needle guard and hollow interior wall on the catheter hub

of the plaintiff‟s product. There is no bulge in the defendants‟ safety

I.V. catheter but a crimp on the needle to lock with the distal end of the

needle guard on retraction. According to the defendants, these features

are unique and have been developed by Poly Medicure Limited through

its own research and development efforts at its own unit.

31. Mr Dave, therefore, contended that no case for an ad interim

injunction has been made out.

32. In rejoinder, Mr Arun Jaitely, the learned senior counsel

appearing for the plaintiffs submitted that there is no suppression on

the part of the plaintiffs. The suit is for infringement of a patent and all

the essential elements, which are necessary for claiming the said relief,

have been set out in the plaint. He also reiterated that Section 48 of the

Patents Act, 1970 was amended in 2003 and because of the amendment

IA 1234/2008 in CS(OS) 186/2008 Page No.25 of 35 an exclusive right has been given to the patentee to prevent a third

party from infringing the said patent.

33. As regards the allegation of concealment of material facts,

the learned counsel submitted that the plaintiffs did mention prior art.

For example, in paragraph 9 of the plaint, the expression „existing

safety catheters‟ has been used. So also it is stated that the field of

other safety I.V. catheters is a crowded one. It has been pointed out

that there are other safety catheters in the market but they have same

problems which have been overcome by the plaintiffs‟ invention.

With regard to the amendments in the claim application, he submitted

that the amendment was only to the claims and not to the specifications,

abstract or title. Claims 1-28 have been narrowed down from 1-54.

The additional claim and all the amended claims were linked to the

earlier claims. Therefore, further publication was not necessary.

34. With regard to the date of grant of the patent being

17.09.2007 when the amendment application was dated 19.09.2007, he

submitted that the date of 17.09.2007 which is mentioned on the

certificate is a typographical error. He submitted that what is of

relevance in terms of Section 53 is that the term of the patent is from

the date of filing. This being the position, there would be no object or

reason or purpose behind concealing the date of grant because the term

IA 1234/2008 in CS(OS) 186/2008 Page No.26 of 35 of the patent does not run from the date of the grant but from the date

of filing. He also submitted that a pre-grant amendment does not

require publication. In this regard, he referred to Rule 81 (2) of the

Rules. He submitted that it is only a post-grant amendment which

requires publication. Therefore, the amendment in this case, being pre-

grant no publication was necessary. In this connection, he submitted

that the fee for amendments before grant is Rs 2,000/- and after grant is

Rs 4,000/-. He submitted, therefore, the fact that the fee to the extent

of Rs 2,000/- was paid in terms of serial No. 18 of Schedule 1 itself

indicates that the application for amendment had been made pre-grant.

From this, the learned counsel submitted that the date of 17.09.2007 on

the patent certificate is a typographical error and the application had

been made prior to the grant of the patent which was ultimately

published on 14.12.2007 vide Section 43 (2) of the said Act.

35. Mr Jaitely submitted that the application for amendment was

made on 19.09.2007. The application itself indicates that the patent

had not been granted till then. The fees for the pre-grant amendment

were paid on 21.09.2007. Apparently, a hearing was conducted on

24.09.2007 and thereafter the patent was granted. The factum of grant

of patent was recorded on 03.12.2007 and the same was got published

on 14.12.2007. On 19.12.2007 the Patent Registry sent a letter to the

plaintiff No.1 with regard to the grant of the patent. All these factors,

IA 1234/2008 in CS(OS) 186/2008 Page No.27 of 35 according to Mr Jaitely, lead to the only conclusion that the date of

17.09.2007 mentioned on the patent certificate is a typographical error.

He reiterated that no purpose would be served by ante-dating the date

of grant of the patent.

36. With regard to the US Patent No. 5,135,504, he submitted

that there was no ring in the plaintiffs‟ product and the technology is

entirely different. Mr Jaitely reiterated that this was a fit case for grant

of an ad interim injunction and the defendant ought to be injuncted as

prayed for.

37. I may also note that the learned counsel for the defendants

had referred to several decisions. One of them was the decision of the

Supreme Court in the case of B. P. Radhe Shyam v. Hindustan Metal

Industries: 1979 (2) SCC 511. In that decision the Supreme Court

observed that the fundamental principle of Patent Law is that a patent is

granted only for an invention which must be new and useful. That is to

say, it must have novelty and utility. The Supreme Court further

observed that it is essential for the validity of a patent that it must be

the inventor's own discovery as opposed to mere verification of what

was already known before the date of the patent. Elaborating further

on the subject, the Supreme Court observed that it is important to bear

in mind that in order to be patentable an improvement on something

IA 1234/2008 in CS(OS) 186/2008 Page No.28 of 35 known before or a combination of different matters already known,

should be something more than a mere workshop improvement; and

must independently satisfy the test of invention or an inventive step.

Mere collocation of more than one integer or things, not involving the

exercise of any inventive faculty, does not qualify for the grant of a

patent. It is obvious that this decision was cited in the context of prior

art. It is directed as a challenge to the validity of the plaintiffs‟ patent

No. 210062. This gains relevance in the context of Section 64 of the

Patents Act, 1970 which deals with revocation of patents. Sub-Section

(1) thereof provides that subject to the provisions contained in the Act,

a patent, whether granted before or after the commencement of the Act,

may, on the petition of any person interested or of the Central

Government or "on a counter-claim in a suit for infringement of the

patent", be revoked by the High Court on any of the grounds specified

therein. One of the grounds is that the subject of any claim of the

complete specification is not an invention within the meaning of the

Act. Another ground is that the invention so far as claimed in any

claim of the complete specification is not new, having regard to what

was publicly known or publicly used in Indian before the priority date

of the claim or to what was published in India or elsewhere in any of

the documents referred to in Section 13.

IA 1234/2008 in CS(OS) 186/2008 Page No.29 of 35

38. In the present case the defendants have preferred a counter-

claim and sought the revocation of the plaintiffs‟ patent. At this

juncture, it was also be pertinent to note Section 107 of the Patents Act,

1970, which relates to defences, etc, in suits for infringement. Sub-

section (1) stipulates that in any suit for infringement of a patent every

ground on which it may be revoked under section 64 shall be available

as a ground for defence. Therefore, all the pleas which may be taken

for seeking the revocation of a patent are also available as a defence in

an infringement suit.

39. Another decision referred to by the learned counsel for the

defendants was that of the Supreme Court in the case of Monsanto

Company v. Coramandal Indag Products (P) Ltd : (1986) 1 SCC 642.

A specific reference was made to paragraph 6 thereof wherein the

provisions of Section 64 (1) (d), (e) and (f) were discussed. The

Supreme Court observed that under Section 64(1) (d) a patent may be

revoked on the ground that the subject of any claim of the complete

specification is not an invention within the meaning of the Act. Under

Section 64(e), a patent may be revoked if the invention so far as

claimed in any claim of the complete specification is not new, having

regard to what was publicly known or publicly used in India before the

date of the claim, etc. Under Section 64(l)(f), a patent may be revoked

if the invention so far as claimed in any claim of the complete

IA 1234/2008 in CS(OS) 186/2008 Page No.30 of 35 specification is obvious or does not involve any inventive step having

regard to what was publicly known or publicly used in India or what

was published in India before the priority date of the claim. The

Supreme Court also observed that to satisfy the requirement of being

publicly known as used in Clauses (e) and (f) of Section 64(1), it was

not necessary that it should be widely used to the knowledge of the

consumer public. It is sufficient if it is known to the persons who are

engaged in the pursuit of knowledge of the patented product or process

either as men of science or men of commerce or consumers.

40. A reference was also made to the decision of a learned Single

judge of the High Court of Bombay in the case of Novartis AG v.

Mehar Pharma and Anr.: 2005 (30) PTC 160 (Bom). In the said

decision, the learned Judge observed that the settled law appears to be

in relation to a patent, that the Court will not grant an interlocutory

injunction unless satisfied that (a) there is a real probability of the

plaintiffs succeeding in the trial of the suit, and (b) where the patent is

of a recent date, no interim injunction should be granted. More so,

when there is a serious question as to validity of the patent raised by

the defendants to be tried in the suit. A reference was also made to the

decision of this Court in Bilcare Limited (supra) wherein this Court

observed that the conspectus of the decisions is that it is not sufficient

for the grant of an injunction that a patent is registered and the strength

IA 1234/2008 in CS(OS) 186/2008 Page No.31 of 35 of the defence including the revocation application have to be looked

into. The decision of a Division Bench of this Court in the case of

Niky Tasha India Pvt. Ltd v. M/s Faridabad Gas Gadgets Private Ltd:

AIR 1985 Delhi 136 was also referred to by the learned counsel for the

defendants to indicate that normally interlocutory injunctions ought not

to be granted where damages would provide an adequate remedy

should the claim succeed. In the said decision the Division Bench

further observed that the rule with regard to grant of interlocutory

injunction is that the Court will not grant such an injunction unless it is

satisfied that there is a real probability of the plaintiff succeeding in the

trial of the suit. Where the design is of a recent date, as in the case

before the Division Bench, no injunction ought to be granted. It is

equally so when there is a serious question as to the validity of the

design to be tried in the suit and an application for cancelation has been

made. It is clear that the case before the Court in Niky Tasha India

Pvt. Ltd (supra) was one under the Designs Act but the principles

would be equally applicable to the present case which is under the

Patents Act.

41. Having examined the arguments advanced by the counsel for

the parties and the case law submitted by them, I am of the view that

the plaintiffs are not entitled to an ad interim injunction as prayed for

by them. It is clear that the registration of the patent per se does not

IA 1234/2008 in CS(OS) 186/2008 Page No.32 of 35 entitle the plaintiffs to an injunction. The defendants‟ case is also to be

examined and it is only after the entire case as a whole is considered

that the Court can come to a decision as to whether the plaintiffs are

entitled to an injunction or not. In the present case the patent is a

recent one and, prima facie, there is a serious challenge to the validity

of the patent. This has been amply demonstrated by the learned

counsel for the defendants in the course of his arguments noted above.

I have also noted that the revocation of a patent can be sought under

Section 64 of the Patents Act, 1970 by a defendant in an infringement

suit by way of a counter-claim. The defendants have already preferred

such a counter-claim. Apart from this, under Section 107 of the said

Act all the pleas available for revocation of a patent are also available

as a defence in a suit for infringement. The question of validity of the

plaintiffs‟ Patent No. 210062 is not free from doubt at this prima facie

stage. There are more reasons than one for entertaining such doubts.

One of the most important reasons is the existence of prior art. By way

of illustration, I have already referred to U.S Patent No. 5,135,504. In

fact, there are other such patents which were placed before this Court

and find place in the documents filed by the defendants. Prima facie,

the defendants have been able to show that, first of all, the field of I.V.

catheters is a crowded one. Secondly, needle guards, in one form or the

other, have been used for decades by several companies. Thirdly, the

IA 1234/2008 in CS(OS) 186/2008 Page No.33 of 35 defendants‟ safety I.V. catheter/ cannula is somewhat different from the

plaintiffs‟ Patent No. 210062.

42. Another important factor which goes against the plaintiffs is

that they did not come clean with the Court because there is no

reference in the plaint of the fact that the plaintiffs were already aware

that the defendants have started manufacturing and selling safety I.V

catheters/ cannulae. The audit reports referred to above, prima facie,

specifically point in this direction. The circumstance of safety I.V

catheters/ cannulae being excepted from the list of products to which

the non-compete clause of the agreement dated 17.01.2007 would

apply, has also not been mentioned in the plaint.

43. The rival contentions with regard to the alleged dubious

manner in which the patent was granted in favour of the plaintiff No.1

on 17.09.2007 when the application for amendment itself was made on

19.09.2007 is another circumstance which raises serious doubts. It is

true that the plaintiffs have tried to explain this by submitting that the

date of 17.09.2007 is a typographical error inasmuch as the patent was

granted much later. That, however, is a circumstance which will have

to be established as a fact in the course of trial. For the present, what is

necessary is that the allegation raised by the defendants cannot be

thrown out at the threshold.

IA 1234/2008 in CS(OS) 186/2008 Page No.34 of 35

44. For all these reasons, I hold that the plaintiffs have not been

able to establish a prima facie case nor is the balance of convenience in

favour of grant of an ad interim injunction in their favour.

Consequently, the present prayer for an ad interim injunction made by

the plaintiffs is rejected. The plaintiffs, however, can be protected as

was done in the case of Bilcare Limited (supra) by directing the

defendants to keep accounts of the manufacture and sales of the safety

I.V. cannula in question during the pendency of the suit and to make

the same available to the Court as and when directed by it. It is ordered

accordingly.

With these observations, this application is dismissed.

                                      BADAR DURREZ AHMED
                                          ( JUDGE )
April 15, 2009
SR




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