*1* wp.211.10.judgment.sxw kps I N THE HIGH COURT OF JUDICATURE AT BOMBAY ORDINARY ORIGINAL CIVIL JURISDICTION WRIT PETITION NO.211 OF 2010 Neon Laboratories Pvt.Ltd. ) Represented by its Power of Attorney Holder ) having its registered office at Damji Shamji ) Industrial Complex, Mahakali Caves Road ) Andheri (E), Mumbai 400 093. ) Maharashtra, India. ).. Petitioner Versus 1) Troikaa Pharma Limited ) having its registered office at Commerce ) House, 1, Satyamarg, Bokadev ) Ahmedabad 380 054, Gujarat, India. ) 2) Union of India ) through the Secretary, Department of ) Industrial Policy and Promotion ) Ministry of Industry and Commerce ) Udyog Bhavan, New Delhi 110 011. ) 3) Controller General of Patents & Designs ) having its office at Bhoudik Sampada ) Bhavan, S.M. Road, Near Antop Hill Head ) Post Office, Antop Hill, Mumbai 400 037. ) 4) Assistant Controller of Patents & Designs ) The Patent Office at Mumbai having its ) office at Bhoudik Sampada Bhavan, ) S.M. Road, Near Antop Hill Head Post ) Office, Antop Hill, Mumbai 400 037. ).. Respondents Mr.Anand Grover with Ms.Lorraine Misquith and Mr.Prakash Mahadik for the Petitioner. Mr.Ravi Kadam, Advocate General, with Mr.Vishal Kanade, Mr.Hiren Kamod and Mr.Himanshu Kane for the Respondent No.1. Mr.Advait M. Sethna with Mr.H.V.Mehta, for the Respondent Nos.2 to 4. *2* wp.211.10.judgment.sxw CORAM : MOHIT S. SHAH, CJ & S.C.DHARMADHIKARI, J. Reserved on : 21st October, 2010. Pronounced on : 26th November, 2010 JUDGMENT (Per S.C.Dharmadhikari, J): 1 This petition under Article 226 of the Constitution of India is directed against the grant of Patent No.231479 dated 04.03.2009 vide Patent Application No.96/MUM/2005 evidenced by Annexure-U to the petition and the order dated 03.06.2009 (Annexure-Z to the petition). 2 The Petitioner is a company registered under the Indian Companies Act, 1956 and has its registered office at the address mentioned in the cause title. It is a pharmaceutical company manufacturing, distributing, marketing and exporting pharmaceutical products particularly active pharmaceutical ingredients and finished dosage forms. 3 The Respondent No.1 is also a company incorporated under the Indian Companies Act, 1956 and has its registered office in the State of Gujarat at the address mentioned in the cause title. It filed the above Patent Application which has been allowed by the authorities, who are Respondent Nos.2 to 4 to this Writ Petition. 4 It is stated that on 01.02.2005 the Respondent No.1 filed a patent application accompanied by a provisional specification before the Patent Office at Mumbai which was registered with the aforesaid registration number. Annexure-A to the petition is a copy of provisional specification. It is stated that the Respondent No.1 subsequently filed *3* wp.211.10.judgment.sxw complete specification on 25.01.2006 which is annexed as Annexure-B to the petition. It is stated that the patent was sought in respect of “Injectable preparations of Diclofenac and its pharmaceutically acceptable salts”. It is stated that the main object of the alleged invention is to provide injectable formulations of water soluble salts of Diclofenac which causes less pain at the injecting site and can be administered by intra-deltoid route in addition to intra-gluteal and slow intra-venous route. It is stated that on 30.01.2006, the Respondent No.1 filed an International Application under the Patent Cooperation Treaty (PCT) bearing International Application No.PCT/IN206/000033 claiming priority on the basis of Indian Patent Application mentioned and numbered as above. A copy of International Application is annexed as Annexure-C to the petition. 5 On 14.09.2007, the Petitioner, through its agent, inquired from the Respondent No.4 as to whether a request for examination had been made by the Respondent No.1 with respect to the said patent application. On 15.10.2007, the Respondent No.4 informed the Petitioner that the request for examination had been made on 30.10.2006. This information was given vide Annexure-D to the petition. It is stated that on 29.10.2007 the Petitioner filed a representation by way of opposition under Section 25(1) of the Patents Act, 1970 r/w Rule 55(1) of the Patents (Amendment) Rules, 2005. The Petitioner requested for hearing on this representation. A copy of this representation is marked as Annexure-E to the petition. 6 It is stated that the Respondent No.4 issued the first examination report on 14.01.2008. In the report, various requirements were set out and compliances were sought with regard to the same. In the *4* wp.211.10.judgment.sxw meanwhile, on 05.02.2008 the Respondent No.1, through its agent, filed a reply statement to the opposition of the Petitioner and served copy thereof on the Petitioner. A copy of this reply statement is annexed as Annexure-G to the petition. 7 Similarly, the Respondent No.1 filed a reply to the first examination report on 22.02.2008, a copy of which is annexed as Annexure-H to the petition. Similarly, some statement was filed by the Respondent No.1 which was in response to the first examination report, a copy of which is separately annexed as Annexure-I to the petition. 8 The Petitioner had filed a rejoinder to the reply statement of the Respondent No.1 and prayed that a date be fixed for oral hearing. A copy of the rejoinder filed on 14.05.2008 and covering letter are annexed as Annexures-J and K respectively to the petition. It is stated that the Respondent No.4 informed the parties that the hearing in the matter would be held on 09.07.2008 but at this hearing when the agents of both parties were present, the Respondent No.1 challenged the locus-standi of the Petitioner and urged that the Petitioner was not entitled to make any oral representation or file any document. The first Respondent’s agent did not make any oral representation. When the agent of the Petitioner proceeded with oral representation, the agent of the Respondent No.1 pointed out that they intended to file an amended set of claims to the patent application made by the Respondent No.1. It is stated that thereafter both sides agreed that the hearing would be held after the amended claims are filed. 9 It is stated that on 14.07.2008 the Respondent No.4 in response to the reply sent by the Respondent No.1, issued the second *5* wp.211.10.judgment.sxw examination report and informed the Respondent No.1 that the proposed amendments were beyond the scope of original description and they could not be allowed as per Section 59 of the Patents Act, 1970. It is urged that original specifications had 11 claims whereas the Petitioner was unaware that there were additional claims made in the amended specifications. The Petitioner is prejudiced because it was not afforded an opportunity to oppose the additional claims. 10 It is stated that in such circumstances the Respondent No.1 filed a reply to the second examination report on 28.07.2008 and a copy of this reply was forwarded by the Respondent No.4 to the Petitioner together with the amended specifications and such copies are annexed as Annexure N, O and P to the Writ Petition. The Petitioner also filed its opposition to the amended claims vide Annexure Q to the petition and also sent a letter on 07.10.2008 requesting the Respondent No.4 to take the opposition on record. The Petitioner also requested by its letter dated 30.12.2008 for a personal hearing in the light of the opposition to the amended claims. There was no response, according to the Petitioner, to these communications and therefore, the Petitioner sent a letter dated 06.05.2009 objecting to the course adopted by the Respondent No.4, namely, allowing amendment of claims after the hearing was concluded. Attention of the Patent Controller was invited to Rule 55(5) and 55(6) of the Patents Rules in this behalf. 11 It is stated that the Petitioner did not hear anything from the authorities and therefore, a general search was conducted, during the course of which, the Petitioner was surprised to notice that the Patent No. 231479 was granted. The same was published in the Patent Office Journal *6* wp.211.10.judgment.sxw dated 27.03.2009. A copy of this publication is annexed as Annexure U to the petition. Thereafter, the Petitioner requested for inspection of the documents but there was no response. Later on a search was conducted on website of the Indian Patent Office which revealed that the patent was granted on 04.03.2009. There was no indication about the decision made on the opposition. The Petitioner also obtained the copies of relevant documents from the record. More than three months after the grant of patent, the Respondent No.4 forwarded to the Petitioner, an order dated 03.06.2009 dismissing the representation by way of opposition filed by the Petitioner and allowing the amendment to the claims. A copy of this order is annexed as Annexure-Z to the petition. As already stated above, the patent granted and the order passed on 03.06.2009, being Annexures U and Z to the petition are under challenge in this Writ Petition. 12 This Writ Petition was filed on 12.01.2010. On being served with a copy of this Writ Petition, affidavit in reply has been filed by all the Respondents. 13 In the reply affidavit filed by the Respondent Nos.2 to 4 and particularly by the Assistant Controller of Patent & Designs, it is stated that the Petitioner had filed pre-grant opposition for unamended/ originally filed claims. Based on that, the Respondent Nos.2 to 4, at the hearing held on 09.07.2008, acknowledged this fact. However, the Respondent No.4 sent the amended claims after the hearing vide a letter dated 11.09.2008 (Annexure-O to the petition) and for this amended claims the Petitioner had filed response on 07.10.2008 vide Annexure R to the petition. It is contended that the Respondent Nos.2 to 4 had already heard the Petitioner and in their objection/letter dated 07.10.2008 the *7* wp.211.10.judgment.sxw Petitioner did not submit any relevant evidence against the amended claims. The Petitioner had relied on the representation filed earlier which was already considered and heard by the Respondent No.4. It is stated that the amendment of claims is in accordance with Rule 55(5) of the Patents Rules. It is stated that the Petitioner failed to make any relevant arguments against the amended claims as all aspects that were listed in the response of the Petitioner were already dealt in the hearing conducted on 09.07.2008. This is what is stated at page Nos.3 and 4 of the reply affidavit:- “I say and submit that Para No.3 [sub-para ‘u’ - II (v)] deals with the amended claims, for which the Respondent No.2-4 submit that the claims were amended after the hearing. The Amendment of Claims is in accordance with Rule 55(5) of the Indian Patents Rule 2003. These amendments are with in the scope of the disclosure in the Patent application. The Petitioners had failed to make any relevant arguments against the amended claims as all the aspects that were listed in the response of the petitioner were already dealt with in the hearing that was conducted on July 9th 2008. All the data on the viscosity are well supported in the examples that are disclosed in the patent specification, the claims relied on the disclosures given in the examples, and therefore the amendments are well within the scope of the patent specification. The Respondent respectfully respectfully submits that under Section 43 it found the patent application in order for the grant of a patent. Further, the amendments to the claim were within the scope of the invention. In view thereof, no separate hearing is required to be given, in terms of Rules 5 of the 2003 Rules. I say and submit that Para No.3 (sub-para ‘u’- II (vi)) deals with the fact that petitioner was not reheard on its opposition to amended claims. The Respondent No. 2-4 submit that the opportunity to comment on the amended claim was given to the petitioner. Petitioner had filed his response to the amended claim and the same was duly considered before grant of the Patent. The petitioner, in response merely relied on the representation filed *8* wp.211.10.judgment.sxw earlier. No relevant information/prior art were provided by the petitioner. The amendment of the claims after hearing and petitioner’s response was up to the satisfaction of the respondent; hence, respondent did not give any further hearing.” 14 Thus, it is urged that the Petitioner was given an opportunity to comment on the amended claims and file their response. Further hearing, in such circumstances, is not necessary. The discretion conferred by the Patents Rules has been properly exercised and there was no error in not hearing the Petitioner further. The Respondent Nos.2 to 4 then justified the grant on merits. 15 The Respondent No.1 has filed a reply affidavit of one K.Srinivas, General Manager (Legal). Reply is on facts wherein all dates and events are set out. The Respondent No.1 does not dispute that the hearing was conducted at the Patent Office, Mumbai on 09.07.2008. Further it does not dispute that it served upon the Petitioner a copy of the amended specifications and the amended set of claims. This was done on 11.09.2008. In the reply affidavit dated 19.04.2010 in paragraph No.4 this is what is stated by the Respondent No.1:- “4. I say and submit that in any event, the Petitioner and/or his agent must have and/or ought to have taken inspection of the file pertaining to the Respondent’s said application and noticed that on 30th October, 2006, Respondent No.1 had filed amended specification including amended claims (16 in no.). In the circumstances, the Petitioner could not have feigned ignorance of the amended claims filed on 30th October, 2006. The Petitioner was and is also aware that the claims subsequently submitted by Respondent No.1 on 28th /30th July, 2008 were almost identical to those which were already filed by Respondent No.1 on 30th October, 2006. It is significant to note that in its response dated *9* wp.211.10.judgment.sxw 7th October 2008 to the amended claims, the Petitioner has not advanced any new case or evidence. The Petitioner also did not rely upon any added or new matter. In fact, the Petitioner’s contentions in its said response dated 7th October 2008 were same as those contained in the previous pleadings and evidence and in the arguments advanced on 9th July, 2008. Thus, the Petitioner being all along aware of the amended claims before filing the pre-grant opposition, cannot complain that the Petitioner did not get an opportunity to advance oral submissions on the amended claims.” 16 In response to these affidavits, the Petitioner filed two rejoinders and while dealing with the affidavit of the Respondent No.1, it reiterated that the comparison of the amended claims dated 30.10.2006 and 30.07.2008 shows that there are significant differences in the claims. In paragraph No.5 of the rejoinder affidavit filed by the Petitioner in June, 2010, it is pointed out as to how the claims contain differences. Exhibit-B to the rejoinder is a statement pointing out the differences. Therefore, it is denied that the Petitioner responded to the arguments advanced by the Respondent No.1’s agent on the basis of the amended claims filed on 30.10.2006. It was pointed out that the Petitioner had no access to the amended claims and at the hearing held on 09.07.2008, the Petitioner could only oppose the claims in the original specifications. The Petitioner in the rejoinder specifically urged that they were not furnished the copies of claims as amended on 30.10.2006 nor were they available on the file. Therefore, the amended claims were never discussed at the hearing held on 09.07.2008. Reliance is placed upon the rules to urge that there is denial of opportunity of hearing and therefore, the orders are contrary to the principles of natural justice. *10* wp.211.10.judgment.sxw 17 While responding to the affidavit in reply filed by Respondent Nos.2 to 4, the Petitioner in the rejoinder affidavit dated 18.06.2010 stated that there was no fair hearing. It is stated that the impugned order does not state that the amended claims are within the scope of disclosures made in the patent application. The Petitioner relied upon the comparison table of the original claim, amended claims and granted claims dated 30.07.2008. It is stated that the amended claims were filed on 30.07.2008 and the copy of amended specifications was made available to the Petitioner only on 11.09.2008 much after the date of hearing. Therefore, it is fallacious to say that the amended claims were dealt with at the hearing held on 09.07.2008. In paragraph No.3 of this rejoinder affidavit it has been stated that the impugned order dated 03.06.2009 is based on the amended claims regarding which no hearing was given to the Petitioner. It is also relevant to note, according to the Petitioner, that the second examination report was issued on 14.07.2008 which is after the date of hearing held on 09.07.2008. There is no question of any discretion and the Controller must comply with the principles of natural justice and requirement of law. It is also contended that in addition to the list of brands marketed in India by several companies, lot of Diclofenac Injections are available in India. 18 A sur-rejoinder has been filed by the Respondent Nos.2 to 4 on 27.07.2010 and in paragraph No.4(ii), this is what is stated:- “4(ii) With reference to paragraphs 3 of the rejoinder, I say and submit that, the Respondents offered a hearing to the Petitioner on July 9, 2008 based on the set of claims which were under examination. The Petitioner relied on the originally filed claims (dated January 25, 2006) on the date of hearing. The applicant had amended the originally filed claims on October 30, 2006 in response to *11* wp.211.10.judgment.sxw International Search Report by filing Form 13. The First Examination Report was issued to the applicant on January 14, 2008 which was replied on February 22, 2008 by the applicant. Subsequently, Second Examination Report was issued on July 14, 2008 and its reply was filed on July 30, 2008, with amendments in claims, and the same was communicated to the Petitioner on September 11, 2008. The amended claims made by the applicant are within the scope of the disclosure and are supported by examples in the patent application. The petitioner has replied to the office letter dated September 11, 2008 on October 7, 2008 and relied therein on the documents submitted by them earlier as part of the petition like Annexure IX, Annexure XI and Annexure IV along with the alleged additional document Annexure E (European Patent Application EP 1,574,221 having publication date September 14, 2005). EP 1,574,221 is published after the date of filing of the instant patent application i.e. 96/MUM/2005 dated February 1, 2005. Moreover, the petitioner had mislead the Patent Office by submitting the EP 1,574,221 equivalent of Patent Application No.WO2005/092387 which belongs to the same family of Patents and inter alia discloses the same prior art as that of Patent Application No.WO2005/086763 which was a part of the documents submitted in the statement of opposition and hence was already considered. The Petitioner’s response to the amended claims was therefore duly and properly considered, scrutinized and examined including EP 1,574,221 and it was after such detailed examination found that the Petitioner had no additional documents or information to rely upon. Hence, the Petitioner’s contention of further hearing under the guise of Rule 55(6), is misconstrued and misleading.” 19 Further affidavit in reply has been filed on behalf of the Respondent No.1 on 06.10.2010 to bring on record the facts and documents which came to the first Respondent’s knowledge. It is stated that the Respondent No.1 came across two patent applications filed by the *12* wp.211.10.judgment.sxw Petitioner in relation to the grant of patent for “stable Anti-Inflammatory and Analgesic injectable compositions” and “stable Anti-Inflammatory and Analgesic injectable formulations”. It is stated that these applications were made by the Petitioner prior to the filing of the opposition to the first Respondent’s application. However, this was deliberately not disclosed either in the representation/opposition nor in the Writ Petition. It is stated that the application filed by the Petitioner on 21.08.2008 for grant of patent in relation to “stable Anti-Inflammatory and Analgesic injectable formulations” is similar to the first Respondent’s patent application 96/MUM/2005. Therefore, according to the Respondent No.1, the Petitioner has deliberately, dishonestly and with ulterior motive not addressed a word about two patent applications filed by it, therefore, the Writ Petition deserves to be dismissed on this ground alone. 20 Since this further affidavit was filed on 06.10.2010 we deemed it fit and proper to give opportunity to the Petitioner to respond to this further affidavit. The Petitioners have urged in their further affidavit that there is no suppression of material facts inasmuch as two applications made by them are to be decided independently and have no relevance with the first Respondent’s application for grant of patent. It is stated that the impugned orders are passed on the first Respondent’s application. The first Respondent as well as the Petitioner’s applications are in public domain and therefore, part of public record. In such circumstances, there is no question of any suppression and particularly in the light of the procedure that is provided by law. It is pointed out as to how the applications made by the Petitioner for grant of patent are in relation to a different subject matter a that of the first Respondent’s application and reliance is placed on Exhibit-A to the affidavit in reply *13* wp.211.10.judgment.sxw filed in October, 2010. 21 It is on this material that we have heard the learned counsel appearing for the respective parties. 22 Mr.Grover, learned Counsel appearing on behalf of the Petitioner, invited our attention to the Patents Act, 1970 and particularly the scheme thereunder in relation to the grant of patent. Mr.Grover submits that the Patents Act, 1970 has been extensively amended by the Patents (Amendment) Act, 2005. It is submitted by him that Sections 25 and 26 in the old Act have been substituted and the statements of objects and reasons/notes on clauses would show that the sections have been substituted for providing a remedy of making a representation by way of opposition by any person before the Controller before the grant of patent. This opportunity is to point out that the incomplete specifications, source and geographical origin of biological material used in the invention and anticipation of invention by the knowledge, oral or otherwise available within any local or indigenous community in India or elsewhere and also for prescribing the procedure to deal with such opposition. 23 Mr.Grover was vehement in submitting that Chapter-V is entitled as “the opposition proceedings to grant of patent”. He submits that Section 25(1) provides for a procedure before grant of patent whereas Section 25(2) provides for an application to revoke the patent. In the submission of Mr.Grover, these are two distinct proceedings with different consequences. Therefore, it will not be proper to hold that Section 25(1) and Section 25(2) deal with the same situation. Mr.Grover submits that the grounds of opposition are set out in Section 25(1) (sub- *14* wp.211.10.judgment.sxw clauses (a) to (k)). The Legislature has taken care to exhaust the grounds and sub-section (1) provides that if a person who has submitted his representation by way of opposition requests for being heard, the Controller shall hear him and dispose of such representation in such a manner and within such period as may be prescribed. He submits that the word “prescribed” has been defined as prescribed by rules made under the Patents Act. Relying on Rule 55 falling in Chapter-VI of the Patents Rules, Mr.Grover submits that when the Controller intimates the Applicant that the specifications require amendment, then, there is a discretion either to refuse or grant the patent on the application originally filed or require the complete specifications amended to the satisfaction of the Controller, before the patent is granted. Mr.Grover relies upon Rule 55(6) and submits that it is only after considering the representation which is made in opposition and the submissions made during the hearing, that the Controller can reject the representation and grant the patent or accept the representation and refuse the grant. Mr.Grover submits that the hearing that is contemplated on request is in relation to both. There cannot be