(183455) 203-bom-1997 nimesulide im inj

8/6/2019 (183455) 203-Bom-1997 Nimesulide IM Inj

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THE PATENT ACT,1970

AS AMENDED BY THE PATENTS (AMENDMENT) ACT, 2002

SECTION 25

In the matter of application for Patent

No.183455 (203/BOM/1997)

and

In the matter of an opposition thereon to the

grant of a patent thereon.

M/s. Stoplik Services India Pvt. Ltd., ApplicantPlot No. A/465, Road No.28,

Wagle Industrial Estate, Thane,

Mumbai 400 604, Maharashtra, India.

V/s.

M/s. Panacea Biotec Ltd., OpponentB-1 Extn./A-27, Mohan Co.op.Indl.Estate, Mathura Road,

New Delhi 110 044.

HEARING HELD ON 23RD

AUGUST, 2004

Present:

1. Ms. Bhartee Gupta For the Opponent

2. Shri Pankaj Borkar Examiner of Patents & Designs

3. Shri Mangesh L.Mokash Examiner of Patents & Designs

4. Dr. Suhas Kulkarni Examiner of Patents & Designs

Applicant neither present nor represented.

D E C I S I O N

1. An Application for Patent made on 4th April,1997 by M/s. Stoplik Services India

Pvt. Ltd, an Indian company Plot No. A/465, Road No.28, Wagle Industrial Estate,Thane,


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Mumbai 400 604, Maharashtra, India (herein referred to as the Applicant) for their

invention A process for the preparation of novel therapeutic injectable analgesic

composition, accompanied by complete specification. The application was duly

examined under the Act and was accepted under serial No.183455. The acceptance was

notified in the official Gazette dated 8th

January, 2000.

2. M/s. Panacea Biotec Ltd.,B-1 Extn./A-27, Mohan Co.op. Indl. Estate, Mathura

Road,New Delhi 110 044 ( herein referred to as the Opponent) filed a Notice of

Opposition on Form 7 on 01.02.2000 to the grant of patent to the application through

their agents M/s. Kan & Krishme, New Delhi.

3. The Opponents Written Statement & Evidence alongwith Annex A to U under

Rule 36 of Patents Rules,1972 was filed on 27.03.2000.

4. The Applicant on being informed of this opposition filed their Reply Statement

under Rule 37 of Patents Rules, 1972 through their agents M/s. Lall Lahiri & Salhotra,

New Delhi 110 017 on 29.05.2000 without any evidence

5. The Opponents M/s. Panacea Biotec Ltd., have executed a fresh Power of

Attorney on 3rd July, 2000 in favour of Nagpaul & Associates, New Delhi 110 008.

6. Opponent has been asked to file the Opponents Evidence in reply strictly

confined to the matters in the Applicants evidence u/r.40 of Patents Act, 1970 by this

office letter dated 14.06.2000. The Opponent submitted that in their letter dated July

01,2000 that the Applicants have not filed their Evidence under Rule 37, the Opponents

are not in a position to file their evidence in reply under Rule 40 which is required to be

strictly confined to matters in Applicants evidence filed under Rule 37.

7. The case was referred to me and thereafter received by me on 14.06.2004. The

hearing notice was duly issued to both the parties for attending the hearing fixed on 23 rd

August,2004 at 11.00 a.m. On the appointed day the hearing was attended by


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Ms. Bhartee Gupta from the Opponent side duly filing the Power of Attorney in her

favour at the time of hearing. The Applicant have not informed the office about their

desire of being heard or not to be heard.

8. In the Notice of Opposition the Opponent relied upon the grounds stipulated

under clause (a), (b), (c ), (d), (e), (f), (g), (h) of sub-section (1) of Section 25 of the

Patents Act,1970 (hereinafter referred to as The Act). These grounds in brief may be

stated as wrongfully obtaining, prior publication, prior claiming, prior public

knowledge & prior public use in India, obviousness and lack of inventive step, not

an invention within the meaning of this Act, insufficiency of the described method as

defined in the complete specification, & failure to disclose information required under

Section 8 of the Act. But the Opponent restrict on clause (a),(b),(d),(e) & (f) of sub-

section (1) of Section 25 of the Patents Act,1970 concluded that clause (c ) ,(g) & (h)

regarding prior claiming, insufficiency description and failure to disclose information

u/s.8 respectively dropped by the Opponent in their Full Written Statement and at the

time of hearing.

9. The Applicants invention is defined and limited by the statement of claims in

their specification which reads as follows:-

1. A process for the preparation of novel Therapeutic Injectable Analgesic

Composition containing Nimesulide for intra-muscular administration

comprising:

(a) forming a homogenous solution of 5% to 12% w/v ofDimethylacetamide and 20% to 50% w/v of Benzyl benzoate in a

container and by adding thereto 3% to 7% w/v of Nimesulide

while slowly stirring the said mixture at a temperature between

25-30o C.


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(b) forming a solution of 0% to 10% w/v of Benzyl alcohol or 5% to10% w/v of pharmaceutically acceptable hydrophilic or lipophilic

surfactant and 30% to 65% w/v of Ethyl oleate;

(c) adding the solution formed in step (a) to the solution formed instep (b) under slow stirring till a homogenous solution of the

Injectable Analgesic Composition is formed.

2. A process as claimed in claim 1 wherein the step (a) 10% w/v of

Dimethylacetamide and 40% to w/v of Benzyl benzoate are mixed and to that is

added 5% w/v of Nimesulide.

3. A process as claimed in claim 1 wherein step (b) 2% w/v of Benzyl

alcohol and a portion of 30% to 65% w/v of ethyl oleate are mixed.

4. A process for the preparation of novel Therapeutic Injectable Analgesic

Composition containing Nimesulide for intra-muscular administration as claimed

in claim 1 and substantially as hereinbefore described with reference to the

accompanying examples 6 and 7.

10. I shall consider the statements, evidence of the parties and the arguments at the

hearing together.

11. Now I shall deal with the grounds of opposition relied upon by the Opponents

taking into account the evidence available on record and the arguments put forward by

the Opponent at the hearing. I have to take up the Opposition grounds one by one.

Now I shall discuss the first ground under section 25(1)(a) which is as follows:-

that the Applicant for the patent or the person under or through whom he claims,

wrongfully obtained the invention or any part thereof from him or from a person under or

through whom he claims.


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Ms. Bhartee Gupta who appeared on behalf of the Opponent at the hearing stated

that the Patent Application No.203/BOM/1997 (183455) filed on 04.04.1997 in the name

of Stoplik Services India Pvt.Ltd. for an invention A process for the preparation of

novel therapeutic injectable analgesic composition is wrongfully obtained by Stoplik

Services India Pvt. Ltd. She has submitted documents taken from the website

http://stoplik.8m.com which is the Applicants website reflecting the same contact

address as given in the Applicants Patent Application. She stated that as per the

documents, Applicants are dealing with compression packing, yarn packing, insitu mold

and zero compression packing and they are not from the pharmaceutical side, which has

been clearly reflected in the document. They have wrongfully obtained their companys

patent from different specifications and documents referred in annexure as stated in their

written statement of opposition and affidavit of Dr. Amarjit Singh dated 25.03.2000.

Sl.No.

The Specifications Date of publication/ Grant ReferredAnnexure

(i)

US 5,688,829 18.11.1997(priority from Indian

Patent Application 2046/Del/95,

2047/Del/95 & 2048/ Del/ 95 allfiled on 08.11.1995.

A

(ii) South Africa 96/4598 23.09.1997 B

(iii) Norway 302334 23.02.1998 C

(iv) Vietnam SCO 301/96 Jan.1999 D

(v) Kazakhastan 6686 16.11.1998 E

(vi) Zimbabwe 119/96 18.07.1997 F

(vii) Nigeria RP 13136 04.05.1998 G

(viii) Bangladesh 1002838 24.11.1998 H

(ix) New Zealand 299481 16.01.1998 I
http://stoplik.8m.com/http://stoplik.8m.com/


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(x) Australia 693720 09.04.1998 J

(xi) Pakistan 135394 25.11.1998

(priority from 2046/Del/95,2047/Del/95 & 2048/ Del/ 95 all

filed on 08.11.1995.

K

(xii) Japan 2875988 14.01.1999 L

(xiii) Russia 2141845 27.11.1999 M

(xiv) Uganda UG/P/96/00002 10.05.1999(priority from 2046/Del/95,

2047/Del/95 & 2048/ Del/ 95 all

filed on 08.11.1995.

N

(xv) Korea 215194 21.05.1999 O

(xvi) European P.A. 96304461.5 17.12.1997

(Publication No. EP 0 81259 1 A1.

P

(xvii) India 1389/Del/95 Priority from 2046/Del/95,2047/Del/95 & 2048/ Del/ 95 all

filed on 08.11.1995.

Q

(xviii) India 955/Del/96 WTO Mailbox Application. R

(xix) Sri Lanka 11013 20.09.1996 S

(xx)Laboratory Report T

(xxi) Clinical trials U

At the hearing the Opponent has given their whole stress on the complete

specification filed by them with the Indian Patent Application No. 2048/Del/1995 filed

on 08.11.1995. She stated that if we go through the present application under opposition

and the Application No. 2048/Del/1995 mostly it is identical or substantially identical.

She has compared the different paragraphs of 2048/Del/1995 and the alleged invention.

She stated that all the figures, not only the way of writing but the way of presenting is

also substantially same including the grammatical mistakes. On Controllers enquiry

when did they apply and get the licence from the Drug Controller, she replied that they


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apply just before or after grant of Patent and it takes 2 to 3 months to get the licence and

said that Drug Controller never publish the clinical data. The fact is that the two

specification 2048/Del/1995 & 203/BOM/1997 are substantially identical or ditto copy.

The complete specification filed by the Opponents with their application 2048/Del/1995

established beyond any iota of doubt that the subject matter of the complete specification

filed by Patent Application No. 203/BOM/1997 has been obtained by the Applicant from

the Opponents as it is quite not possible drafting prepared by the two different persons

would be substantially identical with each other as in the present case. She also stated

that their product is in the market, but from the Applicant side there is no product in

market even if they got the Patent. They are not the pharmaceutical company, so they are

not manufacturing the instant drug and they have not gone to Court for the same product

manufactured by us.

12. The Applicant in their Reply Statement vehemently denied that the text of the

above Patent Application have wrongfully obtained from the Opponents. In this regard

they have given the details of application/specification and date of publication/grant as

referred by me above and stated that the above list indicates that the allegation of the

Opponent that the application was in public domain at the time of filing the opposed

application is false and fabricated. These cases came in public domain i.e. published or

granted only after filing of the alleged invention. In US, Pakistan & Uganda priority has

been taken from the Indian Application, which have not been examined or accepted at the

time of filing of this invention. The Applicants have failed to understand that when the

applications are not in public domain and an Inventor or the Applicant for the opposed

Patent and the cited Patent are not the same, how can the two applications be similar in

text and claims. The Applicant deny all the allegations made by the Opponents and state

that the Opponents have merely cited facts which bring out that Patents on Nimesulide


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have been accepted in other countries. The Applicant had no knowledge of the existence

of the Patents and filing of these Patents in India and abroad and it was only in the

knowledge of the Opponents and their agents that same applications have been filed in

India and abroad. The Applicants vehemently denied the false and fabricated allegations

made by the Opponent.

13. Now I shall consider the submission of both the parties carefully.

From the study of the different enclosures (Annexure A to U) of the Opponent

filed with Written Statement of Opposition and Opponent evidence by way of Affidavit, I

find that different specifications (i) to (xviii)(Annexure A to R) as stated above was

published or granted in that respective countries after filing of this Patent Application

No.203/BOM/1997 which has been filed on April 4,1997. The Application Nos.

2046/Del/95, 2047/Del/95 & 2048/ Del/ 95 from which priority have been claimed for

applications filed in US, Pakistan & Uganda have not been published or accepted before

the filing of the alleged invention. Also the application No.1389/Del/95 (Annexure Q)

& 955/Del/96 (Annexure R) have not been published before the filing of the

Applicants invention. The Application No. 955/Del/96 is a WTO Mailbox application as

it is screened under Drug (product) category which is yet to be examined. Annexure T

& U are Laboratory Report and toxicity report respectively. Regarding Application No.

11013 filed at Sri Lanka published on September 20,1996; Opponents merely stated in

their Written Statement of Opposition and Opponents evidence that the subject matter of

the alleged invention under Patent Application No. 203/BOM/1997 having Patent No.

183455 dated 4th April, 1997 anticipate from the subject matter of the Sri Lankan Patent

Specification and so the alleged invention is lacking in novelty. On this ground they have

to state only how the invention is wrongfully obtained. Most of the documents are in

foreign language and Opponent did not bother to provide us a translation thereof. Also at


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the hearing Ms.Bhartee Gupta given their whole stress on the Indian Patent Application

No. 2048/Del/95 filed by them in Delhi. She has compared text of this application with

the text of the alleged invention and shows the similarities in the different paragraphs of

the impugned Patent Application NO.203/BOM/1997 (183455) with the different

paragraphs of Indian Patent Application No.2048/Del/1995. At the hearing she has not

referred other applications for the ground of wrongfully obtaining. The referred

Application No.2048/Del./1995 was not published or accepted before the date of filing of

Application No.203/BOM/1997. So this application is not in public domain at the time of

filing of the alleged invention. These documents were confidential and could be made

open to the public only after advertisement of acceptance or publication as per the laws of

those countries. It is difficult to prove how it is wrongfully obtained. Also other grounds

of opposition are there to prove if any substantial similarities are there.

14. In this connection I would refer to the following in Terrel on the Law of Patents

11th Edition pages 167 & 168.

PATENT STOPPED IN CLEAR CASE ONLY

An opposition upon this ground (obtaining) usually involves the credibility of

witnesses, and will not be decided against the Applicant unless there is very little

doubt on the facts, since the Opponents always has an opportunity of having the

question tried by the Courts on a petition to revoke the Patent (Edmunds Patent,

Griff.P.C. 281).

Also according to the Patent Law by P. Narayanan (Third Edition) -

where it is alleged that the invention is obtained from the Opponent, the burden

of proof is on the Opponent; suspicious circumstances are not sufficient to

conclude that the invention was obtained.


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In view of above cited authority an application for patent can be refused only if a

clear case of obtaining is established by the opponent with sufficient evidence furnished

by the Opponent. If the Opponent intention is to show the similarities I shall deal it in

the other opposition ground. In the present case Opponent have failed to establish their

case on this ground.

15. Now I shall deal with the second ground of opposition prior publication

specified under clause (b) of sub-section (1) of Section 25 of the Act. It is stated as

follows:

that the invention so far as claimed in any claim of the complete specification

has been published before the priority date of the claim-

(i) in any specification filed in pursuance of an application for a Patent madein India on or after the 1st day of January 1912; or

(ii) in India or elsewhere, in any other document provide that the groundspecified in sub-clause(ii) shall not be available where such publication

does not constitute an anticipation of the invention by virtue of sub-section

(2) or sub-section (3) of Section 29.

The Opponent in their Written Statement of Opposition and Opponents Evidence

submitted that the invention as described in the specification and claims of the Patent

Application No. 183455 has been defined and described in the several Patents granted

and published. So all these granted and published Patents anticipates the subject matter

disclosed in Indian Patent Application No. 203/BOM/1997 (183455) dated April 4,1997

& so lacks in novelty. They relied upon the following documents filed as Annexure for

the above ground of opposition filed along with Full Written Statement of Opposition and

with the Opponents evidence.


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(xix) Sri Lanka 11013 20.09.1996 S

(xx) Laboratory Report T

(xxi) Clinical trials U

The Opponents filed the particular annexure against particular cited specifications

as referred above in their Written Statement and Opponents Evidence and submitted that

Applicants invention in claims 1 to 4 are anticipated from the cited documents.

At the hearing Ms. Bhartee Gupta, the Opponent has given their whole stress on

the Patent Application filed in Sri Lanka having Patent No. 11013 and granted on 20th

September, 1996. She has compared different paragraphs of 11013 and the alleged

invention and stated that even the way of writing and presenting the description is same.

She has then compared the claims of alleged invention with the Sri Lanka Patent No.

11013. She stated by perusal of the text and the claims of the said impugned Patent

application No.203/BOM/1997 and the text and the claims of the said Sri Lanka Patent

No.11013 it would be evident that the invention disclosed and claimed in the said

impugned Patent application No.203/BOM/1997 is substantially identical to the invention

disclosed and claimed in the said Sri Lanka Patent No.11013.

Consequently, the Opponent most humbly submitted that the invention disclosed

and claimed in the said impugned Patent application No.203/BOM/1997 was a published

document to its filing date viz; 04.04.1997 no valid patent can be granted to the

Applicants on the said impugned Patent application No.203/BOM/1997.

The Applicant in its Reply statement regarding prior publication, state that all the

details disclosed by the Opponents themselves about the prior publication is wrong as

none of the alleged Patent referred by the Opponents was published before April 4,1997,

the filing date of subject Patent Application. Then they referred the publication date and


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application No. of cited documents as given above. Since, it was no way open to the

public or was in public domain, hence, the Applicant of subject Patent in no possible way

had the access to these alleged Patents. In view of this they stated that the objection

under the clause of prior publication is baseless and vague. Opponents have not

furnished the English translated copy of the document of Norway Patent Application

No.302334 (Annexure C), Kazakhstan Patent No.6686 (Annexure E), Russian Patent

No. 2141845(Annexure M) & Korean Patent No.215194 (Annexure O). Copy of

complete specification of Vietnam Patent No. SCO 301/96 (Annexure D), Zimbabwe

Patent No. 119/96 (Annexure F), Bangladesh Patent Application No. 1002838

(Annexure H), New Zealand Patent Application No. 299481 (Annexure I) , Pakistan

Patent Application No.135394 (Annexure K), Japan Patent Application No. 2875988

(Annexure L) and Patent application filed at Republic of Uganda having application

UG/P/96/0002 (Annexure N) have not been provided.

They stated that in the absence of the submission of the documents and the

English translation of the said documents, these documents should not be taken on record

and no evidence and allegation should be accepted with reference to these documents.

Regarding US Patent No.5688829 (Annexure A) & EP Patent No. 0812591A1

(Annexure P) they stated that the cited specification claiming a therapeutic injectable

analgesic pharmaceutical composition for intra-muscular administration i.e relates to

product while the alleged Patent Application No.203/BOM/1997 (183455) is claiming a

process for the preparation of novel therapeutic injectable analgesic pharmaceutical

composition containing Nimesulide for intra-muscular administration.

So they contend that the cited patents are not a proper and valid prior anticipation

of the Applicants invention as claimed by the Opponents in their application under

opposition.


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16. I have carefully considered both the submission made by the Applicant &

Opponent. Before analyzing the publication cited by the Opponent the meaning of

anticipation must be clear in the mind.

What is anticipation?

The dictionary meaning of the word anticipation is act of anticipating,

previous notion etc.

It was held in Canadian General Electric Company Vs. Fada Radio

A.I.R.1950 P.C. 1 by Judicial Committee as follows:-

Any information as to the alleged invention given by any prior publication must

be for the purpose of practical utility equal to that given by the subsequent patent. The

latter invention must be described in the earlier publication that is held to anticipate it, in

order to sustain the defence of anticipation. Where the question is solely one of prior

publication, it is not enough to prove that an apparatus described in an early specification

could have been used to produce this or that result. It must also be shown that the

specifications contain clear and unmistakable directions so to use it. It must be shown

that the public have been so presented with the invention that it is out of the power of any

subsequent person to claim the invention as his own.

Test of anticipation:

The law regarding anticipation derives from Lord Westburys statement in Hill

v. Evans 31 L.J. Ch.457 at page 463 where he observed The anticedent statement, must,

in order to invalidate the subsequent patent be such that a person of ordinary knowledge

of the subject would at one perceive and understand and be able to practically to apply

the discovery without the necessity of making further experiments must, for the

purposes of practical utility be equal to that given by the subsequent patent


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So the publication relied upon by the Opponent for this ground must satisfy the

following requirements:

(i) it must have been effected before the priority date of the claim which isthe subject of attack by the Opponent, and

(ii) such publication may include any specification filed in pursuance of anapplication for a patent made in India on or after 1st January,1912, or any

other document published anywhere, and

(iii) the claim attacked must be contained in any of the said publication.From the study of the different enclosures (Annexure A to U) of the Opponent

filed with the Written statement of opposition and Opponents Evidence by way of

Affidavit I find that different specifications (i) to (xvi) (Annexure A to P) was

published or granted in that respective countries after filing of this Patent application

No.203/BOM/1997 (183455) which has been filed on April 4,1997. The Applications

2046/Del/95, 2047/Del/95 & 2048/Del/95 for which priority have been claimed for

application filed in US, Pakistan & Uganda have not been published or accepted before

the filing of the alleged invention. Also the application No.1389/Del/95 (Annexure Q)

& 955/Del /96 (Annexure R) have not been published before filing of the Applicants

invention. The Application No. 955/Del/96 is a WTO Mailbox application as it is

screened under Drug (product) category and which is yet to be examined. I agree with

the Applicants that the Opponent has not taken care to provide the English translation of

Annexure D, E, L, M, & O. Also specification regarding filing at China,

Zimbabwe, Bangladesh, New Zealand, Pakistan, Uganda, Korea & Japan has not been

supplied.

Now I referred to the Patent Application No.11013 filed at Sri Lanka (Annexure

S) Opponent has discussed in details regarding this document at the hearing. The

referred Sri Lankan Patent was published before the date of the impugned Patent


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Applicants invention in Patent Application No.203/BOM/1997 (183455).

Example 6

Sri Lanka Patent No.11013

Example 1

Process for the preparation of Injectable

Analgesic composition:

a. Mix 10 g of Dimethylacetamide and 40g of Benzyl benzoate in a container

fitted with a stirrer at slow speed of1000-1200 rpm at a temperature of 27o .

Add 5g of Nimesulide in small

increments and stir till completelydissolved.

b. Mix 10 g of a pharmaceuticallyacceptable hydrophilic or lipophilic

surfactant and an amount of Ethyl oleatein a container fitted with a stirrer at

room temperature.

c. Add the mixture obtained in step (a) tothe mixture obtained in step (b) under

slow stirring and stir for 30 minutes.

Make up the volume upto 100 ml withEthyl oleate and filter through 0.22

nylon membrane filter to make it sterile.


Analgesic composition:

a. Mix 10g of Dimethylacetamide and 40gof Benzyl benzoate in a container fitted

with a stirrer at slow speed of 1000-1200rpm at a temperature between 25 to 30oC.

Add 5g of Nimesulide in small increments

and stirred till completely dissolved.

b. Mix 10g of cremophor EL and an amount

of Ethyl oleate in a container fitted with a

stirrer at room temperature.

c. Add the mixture obtained in step (a) to themixture obtained in step (b) under slow

stirring and stir for 30 minutes. Make up

the volume upto 100 ml with Ethyl oleateand filter through 0.22 nylon membrane

filter to make it sterile.

Example 7 Example 2


Analgesic composition:a. Mix 20g of Dimethylacetamide and 76g

of Benzyl benzoate in a container fittedwith a stirrer at slow speed of at a

temperature of 25o . Add to the mixture

obtained 10g of Nimesulide in small

amounts at a time and stir tillcompletely dissolved.

b. Mix 4g Benzyl alcohol and an amountof Ethyle oleate in a container fittedwith a stirrer at room temperature.

c. Add the mixture obtained in step (a) tothe mixture obtained in step (b) underslow stirring and stir for 30 minutes.

Make up the volume upto 200 ml with Ethyl

oleate and filter through 0.22 nylon membranefilter to make it sterile.


Analgesic composition:a. Mix 20g of Dimethylacetamide and 76g

of Benzyl benzoate in a container fittedwith a stirrer at slow speed of at a

temperature of 25o to 30oC. . Add to the

mixture obtained 10g of Nimesulide in

small amounts at a time and stir tillcompletely dissolved.

b. Mix 4g Benzyl alcohol and an amount of

Ethyle oleate in a container fitted with astirrer at room temperature.

d. Add the mixture obtained in step (a) to themixture obtained in step (b) under slowstirring and stir for 30 minutes.

Make up the volume upto 200 ml with Ethyl

oleate and filter through 0.22 nylon membranefilter to make it sterile.


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Comparison of both the documents 183455 & Sri Lanka Patent No.11013 as stated above

along with the examples given in these both application shows the following common

features.

(i) It is a process for the preparation of novel therapeutic injectableanalgesic composition for intra-muscular composition.

(ii) Making solution of 5% to 12% w/v of Dimethylacetamide and 20%&to 50% w/v of benzyl benzoate and adding 3% to 7% Nimesulide in it

with stirring at temperature 25-30o

C (Step a).

(iii) Making solution of 0% to 10% w/v of Benzyl alcohol and 30% to 65%w/v of ethyl oleate and adding under slow stirring to above solution

(Step b & c).

Step (b) of claim 1 of 183455 given as

Forming solution of 0% to 10% w/v of Benzyl alcohol or 5% to 10% w/v of

pharmaceutically acceptable hydrophilic or lipophilic surfactants and 30% to 65% w/v

of ethyl oleate.

Here we have to look the meaning of or which is used as conjunction.

According to the different dictionary meaning of or given as follows:-

(1) The Online Plain Text English Dictionary.

Or (conj.): A particle that marks an alternative; as, you may read or

may write,-- that is, you may do one of the things at your

pleasure, but not both. It corresponds to either. You may

ride either to London or to Windsor.


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(a) does a particular document or action disclose the invention in such a wayas to make it part of the state of the art.

(b) Does the document or action make available the necessary information todestroy the novelty of the invention?

It is sufficient to destroy the novelty of the claimed process that, this process and

the known process are identical with respect to the starting material and reaction

condition since processes identical in these features must inevitably yield

identical products.

If surfactant also taken into consideration and looking examples (1 & 2) referred

in Sri Lankas Patent No. 11013 which shows-

(i) temperature range for mixing of dimethylacetamide and benzyl benzoatein step (a) is 25 to 30oC and same temperature range stated in the step (a)

of claim 1 of the alleged invention 183455.

(ii) Cremophor EL which is chemically a polyoxy ethylene glycolated castoroil, a natural vegetable oil triglyceride and as per the study of Ceremophor

EL it act as a surfactant.

In Sri Lankas Patent No.11013. Ceremophor EL a surfactant is used in

Example (1) to mix with ethyl oleate in step (b) instead of benzyl alcohol . In

Example (2) Benzyl alcohol is used to mix with ethyl oleate in step (b).

So Sri Lanka Patent 11013, also suggest that surfactant could be used in place of

benzyl alcohol as stated in step (b) of claim 1 of the alleged invention 183455.

A claim is bad for want of novelty if information about anything falling within its

scope has already been disclosed. Thus for example if a claim specifies

alternative, or defines the invention by reference to a range of values (eg.

Composition, temperature etc.) then the invention is not new if one of these

alternatives, or if a single example falling within this range, is already known.


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Thus a specific example is sufficient to destroy the novelty of a claim to the same

being defined generically.

So alleged invention clearly lacks novelty in respect of Sri Lankas Patent No.

11013.

Again I shall refer to page 8 of the alleged invention, which states that surfactant

may be used in the process.

Here Applicant used the word may be casually. I shall see the meaning of may

be which is used here.

According to Random House Websters unabridged Dictionary Edition 2001 (2nd

Edition) meaning of word may be is given as-

May be (adv.) 1. perhaps, possibly, may be Ill go too

(n.) 2. a possibility or uncertainty

So according to the meaning it shows uncertainty.

As per standard chemistry surfactant is a surface-active agent, and are included as

excipients in many drug formulations. Similarly one or other type of surfactant is used

that shall function in same way in the claimed composition. Its function shall not be

changed. A pharmaceutical composition containing medical active compound with

diluents, excipient or carrier are considered to be clear. Medically active compound

which characterizes the composition, and the diluent, excipient or carrier being any

material suitable for the purpose and being selected by knowledge of the art or by non

inventive experiment. Presence of surfactant is shown in this invention. But the exact

purpose if any extra benefit or advantage they are getting by adding surfactant has not

been mentioned in the specification or alleged invention.

So in conclusion content of same ingredients including active ingredients with

their percentage used in composition mention of surfactant and temperature range in Sri

Lankan Patent 11013, applicants claim stand anticipated. Annexures T& U being a


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experiment report of Research & Development Laboratory of Panacea Biotec Ltd., &

clinical trial and experimental studies respectively, are also a support for anticipation.

In view of foregoing I should hold that the Opponent have succeeded in

establishing the ground of prior publication.

17. Now I shall deal with the third ground of opposition prior public knowledge and

public use specified under clause (d) of Sub-section (1) of Section 25 of the Act. It is

stated as follows:-

that the invention so far as claimed in any claims of the complete specification

was publicly known or publicly used in India before the priority date of the claim.

The Opponent in his Written Statement of Opposition and Evidence submitted

that several Patents granted and therefore published world wide for the subject matter of

the invention claimed in any claim of the complete specification. So these are publicly

known or publicly used in India before the priority date of India. Again they have

submitted the documents (Annexure A to U) referred for the ground of prior

publication.

The Applicant in their Reply Statement of Opposition submitted that none of the

cited Patent Applications were in public domain prior to the ground of alleged Patent

Application No.203/BOM/1997(183455) dated April 4,1997. Hence the invention

disclosed in the Patent Applications cannot be considered to be in prior public knowledge

or public use.

As regard to the ground of prior public knowledge and prior public use in India

Opponent have again relied upon the document produced on the ground of prior

publication under section 25 (1)(b).

I have already discussed about the relevant Annexure in paragraph 16 ante and

have held that these annexure anticipates Applicants alleged invention claimed in the

specification & publicly known. No further evidence is required to prove on this ground.


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So the Opponent must succeed on this ground also.

18. Next I shall consider the ground of obviousness and lack of inventive step as

specified in clause (e) of Section 25 of the Act.

The Opponents on this ground also relied upon the publications cited by them on

the ground of prior publication and stated that in the Written Statement of Opposition and

Evidence.

Ms. Bhartee Gupta, Opponent agent submitted that the invention disclosed and

claimed in the said impugned Patent Application No. 203/BOM/1997 dated 04.04.1997 is

substantially identical as the invention disclosed and claimed in prior published and

granted Sri Lanka Patent Application No.11013 dated 24.06.1996.

The invention disclosed and claimed in the impugned Patent Application

No.203/BOM/1997 is obvious and lacks in inventive step, no valid Patent shall be

granted to the Applicants on the said impugned Patent Application. She also stated that

from different publication cited, it was obvious that a man in the art would have no

difficulty in carrying out the Applicants invention into practice with the help of cited

publications, accordingly the grant of Patent or Patent Application No.183455 might be

refused.

Applicant denied this change and stated that all the cited patents are

published/granted after the acceptance of alleged Patent Application No.203/BOM/1997

Sr.No.183455 dated April 4, 1997. So it means that the alleged Patent comes in public

domain prior to the patents cited by the Opponents. Also the Opponent statement was

contradictory so no evidence in this regard should be taken on record.

19. I have already held in paragraph 16 ante that the Annexure S completely

anticipate the Applicants invention. It is therefore, very obvious that a man in the art


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could have done the same thing as claimed by the Applicants. It is also clear that there is

no invention step in what the applicant have claimed. Also considering the prior

publication, which Applicant failed to prove, it is not necessary for me to state anything

more on the ground of obviousness of the applicants alleged invention.

The Opponents therefore succeed on the ground of obviousness and lack of

inventive step also.

20. Coming to the ground as specified in clause (f) of Section 25(1) of the Act; the

Opponents have stated there is no novelty in view of cited publications; the grant of

Patent on Patent Application No. 183455 might be refused. Ms. Bhartee Gupta repeated

the same thing at the hearing. Applicant in his Reply Statement of Opposition state that

the invention falls within the definition of invention as stipulated in section 2(1)(j) of

the Patents Act. So the Opponent failed to substantiate any of the grounds of opposition

relied upon by them and hence cost should be awarded to the Applicant.

21. A Patent is granted for an invention, which is new and useful. Since I have

already held in paragraph 16 ante that the Applicants alleged invention was anticipated

by the cited publications Annexure S to Opponents Written Statement of Opposition

and Evidence, it lacks in novelty. Accordingly the Applicants alleged invention is not an

invention as defined in Section 2(1)(j) of the Act and is not therefore patentable, thus

Opponents have succeeded on this ground too.

22. In view of my above findings & considering the statements and evidence filed by

the parties, arguments at the hearing and all the circumstances of this case, it is hereby

ordered that the grant of Patent on application for Patent No. 183455 shall be refused, and


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the Applicants shall pay Rs.16, 100/-(Rupees Sixteen Thousand One hundred) towards

the cost as per schedule Annexure hereto.

Dated this 18th

day of March,2005.

(A.T. PATRE)ASSTT.CONTROLLER OF PATENTS & DESIGNS

Copy to :

Lall Lahiri & Salhotra,

No. 128 Panchasheel Park,

New Delhi 110 017.

Nagpaul & Associates,5/10, West Patel Nagar,

New Delhi 110 008


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ANNEXURE

SCHEDULE OF COSTS

1. Stamp Fee for Power of Attorney Rs. 100

2. For Notice of Opposition to grant of Patent u/s.35 Rs. 5000

3. Written Statement of Opposition u/s.36 Rs. 2500

4. For Notice of intention to attend hearing Rs. 5000

5. For each relevant publication Rs. 1000

6. For everyday hearing before Controller Rs. 2500

----------------

TOTAL Rs.16100==========

(Rupees Sixteen Thousand One hundred)

Dated this 18th day of March,2005.

(A.T. PATRE)

ASSTT.CONTROLLER OF PATENTS & DESIGNS

(183455) 203-bom-1997 nimesulide im inj

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