W.P. (C) Nos. 332 of 2010 & 13295, 12006, 8393, 8392 & 8389 of 2009 page 1 of 25 * IN THE HIGH COURT OF DELHI AT NEW DELHI 32. + W.P.(C) No. 332 of 2010 M/S UCB FARCHIM SA ..... Petitioner Through: Mr. Sudhir Chandra, Sr. Advocate with Mr. Sanjay Kumar, Ms. Arpita Sawhney and Mr. Sukhdev, Advocates. versus M/S CIPLA LTD. & ORS ..... Respondents Through: Mrs. Prathiba M.Singh with Ms. Saya Choudhary and Mr. Kapil Wadhwa, Advocates for R-1. WITH 31. + W.P.(C) No. 13295 of 2009 COLORCON INC. ..... Petitioner Through: Mr. Sudhir Chandra, Sr. Advocate with Mr. Sanjay Kumar, Ms. Arpita Sawhney and Mr. Sukhdev, Advocates. versus IDEAL CURES PVT LTD & ORS. ..... Respondents Through: Mr. Chetan Sharma, Sr. Advocate with Mr. Sanjay K. Tiwari, Advocate for R-1. WITH 30. + W.P.(C) No. 12006 of 2009 YEDA RESEARCH & DEVELOPMENT CO. LTD. ..... Petitioner Through: Mr. Sudhir Chandra, Sr. Advocate with Mr. Sanjay Kumar, Ms. Arpita Sawhney and Mr. Sukhdev, Advocates. W.P. (C) Nos. 332 of 2010 & 13295, 12006, 8393, 8392 & 8389 of 2009 page 2 of 25 versus NATCO PHARMA LTD & ORS. ..... Respondents Through: Mr. Chetan Sharma, Sr. Advocate with Mr. Sanjay K. Tiwari, Advocate for R-1. WITH 29. + W.P.(C) No. 8393 of 2009 ELI LILLY & CO. ..... Petitioners Through: Mr. Sudhir Chandra, Sr. Advocate with Mr. Sanjay Kumar, Ms. Arpita Sawhney and Mr. Sukhdev, Advocates. versus AJANTA PHARMA LTD. ORS ..... Respondents Through: Mr. Rajeev Kumar Virmani, Sr.Advocate with Mr. H.V. Chandola, Advocate for R-1. WITH 28 + W.P.(C) No. 8392 of 2009 ELI LILLY & CO. ..... Petitioner Through: Mr. Sudhir Chandra, Sr. Advocate with Mr. Sanjay Kumar, Ms. Arpita Sawhney and Mr. Sukhdev, Advocates. versus AJANTA PHARMA LTD. ..... Respondent Through: Mr. Rajeev Kumar Virmani, Sr.Advocate with Mr. H.V. Chandola, Advocate for R-1. AND 27. + W.P.(C) No. 8388 of 2009 ELI LILLY & CO. ..... Petitioner W.P. (C) Nos. 332 of 2010 & 13295, 12006, 8393, 8392 & 8389 of 2009 page 3 of 25 Through: Mr. Sudhir Chandra, Sr. Advocate with Mr. Sanjay Kumar, Ms. Arpita Sawhney and Mr. Sukhdev, Advocates versus RANBAXY LABORATORIES LTD & ORS. ..... Respondents Through: Mr. Ayush Sharma, Advocate for R-1. CORAM: HON'BLE DR. JUSTICE S. MURALIDHAR 1. Whether Reporters of local papers may be allowed to see the judgment? Yes 2. To be referred to the Reporter or not? Yes 3. Whether the judgment should be reported in Digest? Yes O R D E R 08.02.2010 1.These six petitions raise an important question of law concerning the maintainability of a writ petition under Article 226 of the Constitution to challenge an order passed by the Controller of Patents („Controller‟) either allowing or rejecting a pre-grant opposition filed under Section 25 (1) of the Patents Act, 1970 („Patents Act‟). 2. Before discussing the facts of the individual cases the scheme of the Patents Act, particularly after the amendment to the relevant provisions by way of Patents (Amendment) Act, 2005 („Amendment Act‟) as well as the judgment of the Supreme Court in J. Mitra & Company v. Assistant Controller of Patents & Designs (2008) 10 SCC 368 require to be examined. The statutory scheme of the relevant provisions of the Patents Act 3. Section 15 of the Patents Act states that where the Controller is satisfied that the application for grant of patent, or any specification or any other W.P. (C) Nos. 332 of 2010 & 13295, 12006, 8393, 8392 & 8389 of 2009 page 4 of 25 document filed in pursuance thereof, does not comply with the requirement of the Patents Act or the Rules, “the Controller may refuse the application or may require the application, specification or other documents, as the case may be, to be amended to the satisfaction before he proceeds with the application or refuse the application on failure to do so.” 4. Prior to its amendment in 2005 with effect from 1st January 2005, Section 25 (1) of the Patents Act provided that at any time within four months from the date of advertisement of the acceptance of a complete specification “any person interested may given notice to the Controller of Patents („Controller‟) of opposition to the grant of patent on the grounds set out in Section 25 (1) (a) to 25(1) (k) of the Patents Act. Section 25 (2), prior to the 2005 amendment, stated that when any such notice of opposition is given, the Controller shall notify the applicant (for a patent) and give to the applicant and the opponent an opportunity of being heard before deciding the case. Therefore, at the pre- grant stage, prior to the amendment in 2005, the Controller could either refuse the patent application or require the applicant to make amendments to the satisfaction of the Controller and if such changes were not made as directed, he would refuse the application. Therefore Section 15 of the Patents Act contemplated either eventuality resulting from a decision of the Controller on a pre-grant opposition under Section 25(1) i.e. the grant of the patent with or without amendments, or the refusal of the patent. 5. Prior to its amendment in 2005, against an order under Section 15 refusing a patent and against an order under Section 25, an appeal lay in terms of Section 116 of the Patents Act to the High Court. Prior to 2005, there was no W.P. (C) Nos. 332 of 2010 & 13295, 12006, 8393, 8392 & 8389 of 2009 page 5 of 25 provision for a post-grant opposition. However, the 2005 amendments brought a significant change in this scheme. 6. In 2002 amendments were made to the Patents Act to provide for appeals to the Intellectual Property Appellate Board (IPAB) in terms of the newly inserted Section 117 A instead of appeals to the High Court under Section 116. However, these amendments were not notified till 2nd April 2007. Meanwhile another major set of amendments were introduced with effect from 1st January 2005 under the Amendment Act of 2005. For the first time a provision was made, in the form Section 25 (2) to provide for a post-grant opposition. Section 25(1) concerning pre-grant opposition remained more or less the same and sub-clauses (a) to (k) set out the various grounds on which a pre-grant opposition could be filed. It also incorporated the pre-grant opposition procedure which required the Controller to hear the opposer. While under the amended Section 25 (1) „any person‟ could file a pre-grant opposition [as against only an „interested‟ person under the pre-amended Section 25 (1)], only an „interested‟ person could file a post-grant opposition under Section 25 (2) of the Patents Act as amended. The post-grant opposition had to be filed “at any time after the grant of the patent but before the expiry of a period of one year or from the date of publication of grant of the patent.” The amended Section 25(2) sets out the grounds on which such post-grant opposition could be made. Under Section 25 (3) when such post-grant opposition notice is given, the Controller simultaneously with notifying the patentee shall also constitute an Opposition Board which would then conduct the examination of such opposition and submit its recommendations to the Controller. Section 25(4) states that thereafter the Controller shall make an W.P. (C) Nos. 332 of 2010 & 13295, 12006, 8393, 8392 & 8389 of 2009 page 6 of 25 order, after giving the patent holder and the opposer an opportunity of being heard and pass an order either to maintain or to amend or to revoke the patent. Under Section 25(6) in the event the Controller orders that the patent shall be maintained subject to amendment of the specification or any other document, the patent shall stand amended accordingly. 7. Simultaneous with the introduction of the remedy of a post-grant opposition, the Amendment Act 2005 also amended Section 117A to provide an appeal against an order passed under Section 25(4) by the Controller on the post-grant opposition which could be an order “either to maintain or to amend or to revoke the patent.” Therefore as it presently stands, after the amendment in 2005, while Section 117A provides an appeal to the IPAB against an order under Section 25 (4), it does not expressly provide an appeal against an order in a pre-grant opposition under Section 25(1) of the Patents Act. What is significant however is that Section 117A does continue to provide an appeal to the IPAB against an order of the Controller under Section 15 of the Patents Act. The decision in J.Mitra & Co. case 8. Before discussing the ratio of the judgment in J. Mitra& Co., the facts of that case may be noticed briefly. On 14th June 2000 J. Mitra filed an application for the grant of a patent. A pre-grant opposition was filed by Span Diagnostics Ltd. („Span‟) in 2000. On 23rd August 2006 the Controller rejected Span‟s pre-grant opposition. As on that date against an order rejecting the pre-grant opposition under Section 25, an appeal was available to Span before the High Court under Section 116 of the Patents Act (it must be W.P. (C) Nos. 332 of 2010 & 13295, 12006, 8393, 8392 & 8389 of 2009 page 7 of 25 clarified here that although Section 117 A was inserted in the Patents Act in 2002, it was not notified till 2nd April 2007 and therefore as on August 2006 the older regime of an appeal before the High Court under Section 116 continued). Consequently, Span filed FAO Nos. 292 and 293 of 2006 in the High Court on 17th October 2006 to challenge the rejection of its pre-grant opposition by the Controller under Section 25(1) of the Patents Act. 9. An objection was taken by J. Mitra & Co. to the maintainability of the appeal before the High Court on the ground that the appeal was required to be transferred to the IPAB in terms of Section 117 G notified with effect from 2nd April 2007. By a judgment dated 1st April 2008 the High Court held that in view of the fact that Section 25 (2) which provided for a post-grant opposition was introduced only on 4th April 2005 and Section 117 A was notified with effect from only 2nd April 2007, the appeal filed by Span in the High Court on 17th October 2006 under Section 116 was maintainable before it. However, even while it noted that no appeal against an order under Section 25 (1) of the Patents Act was maintainable before the IPAB, the High Court transferred the said appeal also to the IPAB because Section 117 G mandated that “all appeals against any order or decision of the Controller” would get transferred to the IPAB. 10. Faced with the above anomalous situation, J. Mitra & Co. filed a Special Leave Petition in the Supreme Court challenging the order of the High Court. After analyzing the various provisions of the Patents Act, the Supreme Court in para 29 (SCC, p. 381) held as under: W.P. (C) Nos. 332 of 2010 & 13295, 12006, 8393, 8392 & 8389 of 2009 page 8 of 25 “29. In the present case, the Legislature intended to provide for two types of scrutiny followed by one statutory appeal to the Appellate Board against "post-grant proceedings". The Legislature intended to have a dichotomy between "pre- grant opposition" and "post-grant opposition". However, the Legislature intended that there shall be only one statutory appeal against grant of patent. The Legislature intended to obliterate appeal from "pre-grant proceedings", which existed earlier. However, it was left to the Executive to bring the enacted law into force vide notification. For some unknown reasons, the amended Sections 116 and 117A(2) were not brought into force till 2.4.07 whereas the concept of "pre- grant" and "post-grant" oppositions were brought into force w.e.f.1.1.2005. This is where the legislative intent got defeated during the interregnum. It is during this interregnum that respondent No. 3 filed its FAO No. 293/06 in the High Court under Section 116, as it stood on 19.10.06 under the Patents (Amendment) Act, 1999. On that date, the amended Section 117A, suggested by Patents (Amendment) Act, 2005, was not brought into force. On 19.10.06 the old law prevailed under which an appeal lay before the High Court. Respondent No. 3, in both the cases, preferred first appeals to the High Court under Section 116 as it then stood. They are FAO No. 292/06 and FAO No. 293/06. We have to decide the fate of these pending appeals. One more aspect needs to be mentioned. Under the Patents (Amendment) Act, 2005, appeal is provided to the Appellate Board against the order of the Controller under Section 25(4). However, that statutory appeal is maintainable only in "post-grant opposition" proceedings whereas respondent No. 3 herein has instituted first appeals under the law then prevailing, challenging the Order rejecting "pre-grant opposition" dated 23.8.06.” W.P. (C) Nos. 332 of 2010 & 13295, 12006, 8393, 8392 & 8389 of 2009 page 9 of 25 11. It was noticed by the Supreme Court that there were hardly one or two matters of that nature that were pending in the High Court. It was observed that Span could not be left without a remedy. Consequently, it was ordered that the two appeals filed by Span should be heard and decided by the High Court. An observation in para 31 of the order “that the Appellate Board after 2nd April 2007 is entitled to hear appeals only arising from orders passed by the Controller under Section 25(4) i.e. in cases of orders passed in “post-grant opposition” is what has given rise to the present round of litigation. 12. The challenge in these writ petitions is two types of orders of the Controller in a pre-grant opposition filed under Section 25(1) of the Patents Act. One allowing such opposition and refusing the grant of patent. The other, rejecting the opposition and granting the patent. Arguments have been advanced by learned counsel appearing for the applicants for the grant of patent whose applications have been refused by accepting the pre-grant opposition. Arguments have also been advanced on behalf of those who had filed pre-grant oppositions which have either been allowed or rejected. Distinction between pre-grant and post-grant opposition 13. In the first instance a distinction has to be drawn between a pre-grant opposition and a post-grant opposition. While a pre-grant opposition can be filed under Section 25 (1) of the Patents Act at any time after the publication of the patent application but before the grant of a patent, a post-grant opposition under Section 25(2) of the Patents Act has to be filed before the W.P. (C) Nos. 332 of 2010 & 13295, 12006, 8393, 8392 & 8389 of 2009 page 10 of 25 expiry of one year from the date of the publication of the grant of patent. A second significant difference, after the amendment of 2005, is that a pre-grant opposition can be filed by „any person‟ whereas a post-grant opposition under Section 25(2) can be filed only by „any person interested‟. It may be noticed that the application for revocation of a patent in terms of Section 64 of the Patents Act can also to be filed only by „any person interested‟. In other words, the post-grant opposition and the application for revocation cannot be filed by just about any person who is not shown to be a person who is „interested‟. A third significant difference is that the representation at the stage of pre-grant is considered by the Controller himself. Rule 55 of the Patents Rules requires the Controller to consider the „statement and evidence filed by the applicant‟ and thereafter either refuse to grant the patent or require the complete specification to be amended to his satisfaction. Of course, in that event notice will be given to the applicant for grant of patent who can file his reply and evidence. This Court finds merit in the contention that the pre-grant opposition is in fact „in aid of the examination‟ of the patent application by the Controller. The procedure is however different aspect as far as the post-grant opposition is concerned. There in terms of Section 25 (3), the Controller has to constitute an Opposition Board consisting of such officers as he may determine and refer to such Opposition Board the notice of opposition along with other documents for its examination and recommendations. After receiving the recommendations of the Opposition Board, the Controller gives the patentee and the opponent an opportunity of being heard. The Controller then takes a decision to maintain, amend or revoke the patent. The fourth major difference between the pre-grant and the post-grant opposition is that while in terms of Section 117 A an appeal to the IPAB is maintainable against W.P. (C) Nos. 332 of 2010 & 13295, 12006, 8393, 8392 & 8389 of 2009 page 11 of 25 the order of the Controller in a post-grant opposition under Section 25(4) of the Patents Act, an appeal has not been expressly been made available against an order made under Section 25(1) of the Patents Act. 14. There are two possible situations arising from the order passed by the Controller in a pre-grant opposition. Where the pre-grant opposition is rejected, the aggrieved person would obviously be the person who has filed the pre-grant opposition. Where the Controller accepts the pre-grant opposition and therefore refuses the grant of patent or suggests amendments which are then not carried out by the applicant resulting in the refusal of the grant of patent, the aggrieved person obviously would be the applicant for the patent. Where the pre-grant opposition is rejected and patent is granted 15. In the first eventuality, where the pre-grant opposition is rejected, it is apparent from the decision in J. Mitra and from a reading of Section 25 with Section 117A that as long as the person who has filed that opposition happens to be a person interested, he would, after 1st January 2005 [the date with effect from which Section 25 (2) came into force although the provision was introduced only on 4th April 2005] have the remedy of filing a post-grant opposition. He can, after 2nd April 2007, also file an application before the IPAB under Section 64 of the Patents Act for revocation of the patent. In other words, as explained by the Supreme Court in J. Mitra & Co. as long as that person is able to show that he is a person „interested‟, he is not without a remedy after his pre-grant opposition is rejected. He in fact has two remedies. W.P. (C) Nos. 332 of 2010 & 13295, 12006, 8393, 8392 & 8389 of 2009 page 12 of 25 Even if his post-grant opposition is rejected, he can thereafter file an appeal to the IPAB under Section 117A. Against the decision of the IPAB in either event he will have the remedy of seeking judicial review in accordance with law by filing a petition in the High Court. At this juncture it may be noticed that in an order dated 2nd March 2009 in SLP (C) No. 3522 of 2009 (Indian Network for People with HIV/AIDS v. F.Hoffman-La Roche) the Supreme Court permitted the unsuccessful pre-grant opposer, who had challenged the rejection of his opposition by the Controller, to participate in the post-grant stage. 16. The law is well settled that notwithstanding that a High Court has the power and the jurisdiction under Article 226 of the Constitution to interfere with the orders of any statutory authority which is of a quasi-judicial nature, it will decline to exercise such jurisdiction where there is an efficacious alternative statutory remedy available to the aggrieved person. See for e.g., Special Director v. Mohd. Ghulam Ghouse (2004) 3 SCC 440 [para 5 at page 443] Uttaranchal Forest Development Corp. v. Jabar Singh (2007) 2 SCC 112 [paras 43-45 at page 137], U.P. State Spinning Company Ltd. v. R.S. Pandey (2005) 8 SCC 264 [paras 11-24 at pages 270-275], Titaghur Paper Mills Company Ltd. v. State of Orissa (1983) 2 SCC 433 [para 6 at pages 437-438; paras 8 & 9 at page 439; para 12 at page 441], Karnataka Chemical Industries v. Union of India (2000) 10 SCC 13 [para 2 at page 14] Assistant Collector of Central Excise v. Jainson Hosiery Industries (1979) 4 SCC 22 [para 1 at page 23] and U.P. State Bridge Ltd. v. U.P. Rajya Setu Nigam S. Karamchari Sangh (2004) 4 SCC 268 [para 11 at pages 275-276; para 17 at page 278]. W.P. (C) Nos. 332 of 2010 & 13295, 12006, 8393, 8392 & 8389 of 2009 page 13 of 25 17. Counsel for the parties have drawn the attention of this Court to a recent decision of the Division Bench of the Bombay High Court in Glochem Industries Ltd. v. Cadila Healthcare Ltd. (its decision dated 6th November 2009 in Writ Petition No. 1605 of 2009). Although in that case the petitioner whose pre-grant opposition had been rejected was obviously a person „interested‟ the High Court overruled the objections as to maintainability since it took the view that the Controller‟s order in that case suffered from obvious jurisdictional errors. The Bombay High Court nevertheless noted that “it is a matter of prudence and discretion as to whether this court should entertain the writ petition or not” and that in the facts and circumstances of that case it was “not proper to non-suit the petitioners at the threshold on this count.” To this Court it appears that the settled law as explained in several decisions of the Supreme Court (which incidentally have not been adverted to by the Bombay High Court in Glochem) makes it clear that this Court should not entertain the writ petition, not because it does not have the power or jurisdiction, but because the petitioner has an efficacious alternative statutory remedy to exhaust. 18. To summarise this part of the discussion, as regards persons who have not succeeded in the pre-grant opposition stage to prevent the grant of a patent, and are persons „interested‟ within the meaning of Section 25(2) and Section 64 of the Patents Act, their remedy against the rejection of their pre-grant opposition is to file a post-grant opposition under Section 25(2) and await the decision of the Controller. If they are still aggrieved by that decision under W.P. (C) Nos. 332 of 2010 & 13295, 12006, 8393, 8392 & 8389 of 2009 page 14 of 25 Section 25(4) of the Patents Act, they can file an appeal before the IPAB in terms of Section 117A of the Patents Act. Where the pre-grant opposition is by a third party 19. It was contended by some of the counsel appearing for those who filed the pre-grant opposition, that where the pre-grant opposer is a third party and not a person „interested‟, then such a person would not have the remedy of either filing a revocation under Section 64 or a post-grant opposition under Section 25(2). In that event the remedy under Article 226 of the Constitution cannot be shut out to such a person. This was countered by learned counsel for the applicants for grant of patent by submitting that the legislature consciously intended not to give persons who are not interested further opportunities to challenge the grant of a patent as that would make the whole process extremely cumbersome for the applicant for a patent. Consequently, it is submitted that the said legislative scheme cannot be substituted by the Court and that there was nothing unreasonable in not entertaining a writ petition at the instance of such person. 20. In the first place this Court would like to observe that none of the applicants who have filed a pre-grant opposition in these cases, and whose applications have either been accepted or rejected, are persons who are not „interested persons‟. Therefore this question is purely academic as far as this batch