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., Plot No. A/465, Road No.28, Wagle Industrial Estate, Thane, Mumbai 400 604, Maharashtra, India. V/s. M/s. Panacea Biotec Ltd., B-1 Extn./A-27, Mohan Co.op.Indl. Estate, Mathura Road, New Delhi 110 044.

Applicant

Opponent

HEARING HELD ON 23RD AUGUST, 2004 Present: 1. Ms. Bhartee Gupta 2. Shri Pankaj Borkar 3. Shri Mangesh L.Mokash 4. Dr. Suhas Kulkarni … … … … For the Opponent Examiner of Patents & Designs Examiner of Patents & Designs Examiner of Patents & Designs

Applicant neither present nor represented.

DECISION
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,

1

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 Opponent’s 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 Opponent’s Evidence in reply strictly

confined to the matters in the Applicant’s 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 Applicant’s 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 Applicant’s 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 23rd August,2004 at 11.00 a.m. On the appointed day the hearing was attended by 2

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 subsection (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 Applicant’s 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 of Dimethylacetamide 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. 3

(b)

forming a solution of 0% to 10% w/v of Benzyl alcohol or 5% to 10% 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 in step (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”.

4

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 Applicant’s website reflecting the same contact address as given in the Applicant’s 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 company’s 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. (i) US

The Specifications

Date of publication/ Grant

Referred Annexure ‘A’

5,688,829

18.11.1997(priority from Indian Patent Application 2046/Del/95, 2047/Del/95 & 2048/ Del/ 95 all filed on 08.11.1995. 23.09.1997 23.02.1998 Jan.1999 16.11.1998 18.07.1997 04.05.1998 24.11.1998 16.01.1998

(ii) (iii) (iv) (v) (vi) (vii) (viii) (ix)

South Africa Norway Vietnam Kazakhastan Zimbabwe Nigeria Bangladesh New Zealand

96/4598 302334 SCO 301/96 6686 119/96 RP 13136 1002838 299481

‘B’ ‘C’ ‘D’ ‘E’ ‘F’ ‘G’ ‘H’ ‘I’

5

(x) (xi)

Australia Pakistan

693720 135394

09.04.1998 25.11.1998 (priority from 2046/Del/95, 2047/Del/95 & 2048/ Del/ 95 all filed on 08.11.1995. 14.01.1999 27.11.1999 10.05.1999 (priority from 2046/Del/95, 2047/Del/95 & 2048/ Del/ 95 all filed on 08.11.1995. 21.05.1999 17.12.1997 (Publication No. EP 0 81259 1 A1. Priority from 2046/Del/95, 2047/Del/95 & 2048/ Del/ 95 all filed on 08.11.1995. WTO Mailbox Application.

‘J’ ‘K’

(xii) (xiii) (xiv)

Japan Russia Uganda

2875988 2141845 UG/P/96/00002

‘L’ ‘M’ ‘N’

(xv) (xvi)

Korea

215194

‘O’ ‘P’

European P.A. 96304461.5

(xvii)

India

1389/Del/95

‘Q’

(xviii) (xix) (xx) (xxi)

India

955/Del/96

‘R’

Sri Lanka

11013

20.09.1996

‘S’ ‘T’ ‘U’

Laboratory Report Clinical trials

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 Controller’s enquiry when did they apply and get the licence from the Drug Controller, she replied that they 6

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 7

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 Applicant’s 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 Opponent’s 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 8

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 (Edmund’s 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”. 9

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 made in India on or after the 1st day of January 1912; or (ii) in India or elsewhere, in any other document provide that the ground specified 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.

10

Sl. No. (i)

The Specifications US 5,688,829

Date of publication/ Grant 18.11.1997(priority from Indian Patent Application 2046/Del/95, 2047/Del/95 & 2048/ Del/ 95 all filed on 08.11.1995. 23.09.1997 23.02.1998 Jan.1999 16.11.1998 18.07.1997 04.05.1998 24.11.1998 16.01.1998 09.04.1998 25.11.1998 (priority from 2046/Del/95, 2047/Del/95 & 2048/ Del/ 95 all filed on 08.11.1995. 14.01.1999 27.11.1999 10.05.1999 (priority from 2046/Del/95, 2047/Del/95 & 2048/ Del/ 95 all filed on 08.11.1995. 21.05.1999 17.12.1997 (Publication No. EP 0 81259 1 A1. Priority from 2046/Del/95, 2047/Del/95 & 2048/ Del/ 95 all filed on 08.11.1995. WTO Mailbox Application.

Referred Annexure ‘A’

(ii) (iii) (iv) (v) (vi) (vii) (viii) (ix) (x) (xi)

South Africa Norway Vietnam Kazakhastan Zimbabwe Nigeria Bangladesh New Zealand Australia Pakistan

96/4598 302334 SCO 301/96 6686 119/96 RP 13136 1002838 299481 693720 135394

‘B’ ‘C’ ‘D’ ‘E’ ‘F’ ‘G’ ‘H’ ‘I’ ‘J’ ‘K’

(xii) (xiii) (xiv)

Japan Russia Uganda

2875988 2141845 UG/P/96/00002

‘L’ ‘M’ ‘N’

(xv) (xvi)

Korea

215194

‘O’ ‘P’

European P.A. 96304461.5

(xvii)

India

1389/Del/95

‘Q’

(xviii)

India

955/Del/96

‘R’

11

(xix) (xx) (xxi)

Sri Lanka

11013

20.09.1996

‘S’ ‘T’ ‘U’

Laboratory Report Clinical trials

The Opponents filed the particular annexure against particular cited specifications as referred above in their Written Statement and Opponent’s Evidence and submitted that Applicant’s 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 12

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 Applicant’s invention as claimed by the Opponents in their application under opposition.

13

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 Westbury’s 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”

14

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 is the subject of attack by the Opponent, and (ii) such publication may include any specification filed in pursuance of an application 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 Opponent’s 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 Applicant’s 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 15

Application dated 04.04.1997. Sri Lanka Patent No.11013 dated 24.06.1996 granted on 20.09.1996 to the Opponents Patent Application (Annexure ‘S’). To substantiate the ground of prior publication we have to compare the claims of the alleged invention with the claims of Sri Lanka Patent No.11013. Applicants invention in Patent Application No. Sri Lanka Patent No.11013 203/BOM/1997 (183455). Claim 1,2 & 3 1. A process for the preparation of novel therapeutic injectable analgesic composition containing nimesulide for intra-muscular administration comprising: a. Forming a homogeneous solution of 5% to 12% w/v of Dimethylacetamide 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 25-30oC. b. Forming a solution of 0% to 10% w/v of Benzyl alcohol or 5% to 10% 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 in step (b) under slow stirring till a homogeneous solution of the injectable analgesic composition is formed. 2. A process as claimed in claim 1 wherein in step (1) 10% w/v of Dimethylacetamide and 40% w/v of Benzyl benzoate are mixed and to that is added 5% w/v of Nimesulide. Claims 7,8,9 7. A process for the preparation of novel therapeutic injectable analgesic composition containing nimesulide for intra-muscular administration which comprises the following steps: a. Mixing 5% to 12% w/v of Dimethylacetamide 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 till completely dissolved.

b.

Mixing separately 0% to 10% w/v of Benzyl alcohol and a portion of 30% to 65% w/v of Ethyl oleate;

c. Adding the mixture obtained in step (a) to the mixture obtained in step (b) under slow stirring resulting in the preparation of the desired analgesic composition. 8. The process as claimed in claim 6 wherein in step (a) 10% w/v of Dimethylacetamide and 40% 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 9. The process as claimed in claim 6 wherein (b) 2% w/v of Benzyl alcohol and a portion of step (b) 2% w/v of Benzyl alcohol and a portion 30% to 65% w/v of ethyl oleate are mixed. of 30% to 65% w/v of ethyl oleate are mixed.

The method carried out according to this invention, and scope restricted in above claims has been described in further details in the examples. The examples given these referred specification & compared as follows:16

Applicants invention in Patent Application No. Sri Lanka Patent No.11013 203/BOM/1997 (183455). Example 1 Example 6 Process for the preparation of Injectable Process for the preparation of Injectable Analgesic composition: Analgesic composition: a. Mix 10 g of Dimethylacetamide and 40 a. Mix 10g of Dimethylacetamide and 40g g of Benzyl benzoate in a container of Benzyl benzoate in a container fitted fitted with a stirrer at slow speed of with a stirrer at slow speed of 1000-1200 1000-1200 rpm at a temperature of 27o . rpm at a temperature between 25 to 30oC. Add 5g of Nimesulide in small Add 5g of Nimesulide in small increments increments and stir till completely and stirred till completely dissolved. dissolved. b. Mix 10 g of a pharmaceutically b. Mix 10g of cremophor EL and an amount acceptable hydrophilic or lipophilic of Ethyl oleate in a container fitted with a surfactant and an amount of Ethyl oleate stirrer at room temperature. in a container fitted with a stirrer at room temperature. c. Add the mixture obtained in step (a) to c. Add the mixture obtained in step (a) to the the mixture obtained in step (b) under mixture obtained in step (b) under slow slow stirring and stir for 30 minutes. stirring and stir for 30 minutes. Make up Make up the volume upto 100 ml with the volume upto 100 ml with Ethyl oleate Ethyl oleate and filter through 0.22µ and filter through 0.22µ nylon membrane nylon membrane filter to make it sterile. filter to make it sterile. Example 7 Process for the preparation of Injectable Analgesic composition: a. Mix 20g of Dimethylacetamide and 76g of Benzyl benzoate in a container fitted with 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 till completely dissolved. b. Mix 4g Benzyl alcohol and an amount of Ethyle oleate in a container fitted with a stirrer at room temperature. c. Add the mixture obtained in step (a) to the mixture obtained in step (b) under slow stirring and stir for 30 minutes. Make up the volume upto 200 ml with Ethyl oleate and filter through 0.22µ nylon membrane filter to make it sterile. Example 2 Process for the preparation of Injectable Analgesic composition: a. Mix 20g of Dimethylacetamide and 76g of Benzyl benzoate in a container fitted with 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 till completely dissolved. b. Mix 4g Benzyl alcohol and an amount of Ethyle oleate in a container fitted with a stirrer at room temperature. d. Add the mixture obtained in step (a) to the mixture obtained in step (b) under slow stirring and stir for 30 minutes. Make up the volume upto 200 ml with Ethyl oleate and filter through 0.22µ nylon membrane filter to make it sterile.

17

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 injectable analgesic 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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(2)

Merriam-Webster Online. Or : Used as a function word to indicate an alternative <coffee or tea> sink or swim>, the equivalent or substitutive character of two words or phrases.

(3)

http://dictionary.reference.com/search?q=or Or : (a) Used to indicate an alternative, usually only before the last term of a series: hot or cold; this, that, or the other. (b) Used to indicate the second of two alternatives, the first being preceded by either or whether.

(4)

http://www.infoplease.com/dictionary/or 1. Used to connect words, phrases, or clauses representing alternatives: books or magazines; to be or not to be. 2. Used to connect alternative terms for the same thing: the Hawaliian, or Sandwich, Islands. 3. Used in correlation: either…….or, or………..or, whether……..or.

So meaning of ‘or’ is clear here and used in the sense that when benzyl alcohol is used in step (b), surfactant not to be used. OR when surfactant is used, Benzyl alcohol not to be used to mix with the ethyl oleate. So one ingredient of the two either benzyl alcohol or surfactant to be used at a time. That means even if benzyl alcohol is used it functions in a same way when surfactant is used to mix with ethyl oleate. So invention works even if surfactant is not used. Generally

there are two questions to be answered in order to determine whether or not an invention passes the novelty test, namely19

(a)

does a particular document or action disclose the invention in such a way as to make it part of the state of the art.

(b)

Does the document or action make available the necessary information to destroy 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 identical products. If surfactant also taken into consideration and looking examples (1 & 2) referred in Sri Lanka’s Patent No. 11013 which shows(i) temperature range for mixing of dimethylacetamide and benzyl benzoate in 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 castor oil, a natural vegetable oil triglyceride and as per the study of Ceremophor EL it act as a surfactant. In Sri Lanka’s Patent No.11013. Ceremophor EL a surfactant is used in inevitably yield

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. 20

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 Lanka’s 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 Webster’s unabridged Dictionary Edition 2001 (2nd Edition) meaning of word may be is given asMay be (adv.) 1. perhaps, possibly, may be I’ll 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 21

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 Applicant’s alleged invention claimed in the specification & publicly known. No further evidence is required to prove on this ground. 22

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 Applicant’s invention. It is therefore, very obvious that a man in the art 23

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 Applicant’s alleged invention was anticipated by the cited publications Annexure ‘S’ to Opponent’s Written Statement of Opposition and Evidence, it lacks in novelty. Accordingly the Applicant’s 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

24

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

25

ANNEXURE SCHEDULE OF COSTS

1. 2. 3. 4. 5.

Stamp Fee for Power of Attorney For Notice of Opposition to grant of Patent u/s.35 Written Statement of Opposition u/s.36 For Notice of intention to attend hearing For each relevant publication

… … … … …

Rs. 100 Rs. 5000 Rs. 2500 Rs. 5000 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

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