Millennium Pharmaceuticals v. Natco Pharma Ltd.

2. The appellant, an U.S Company filed the Indian National Phase Patent Application No. 5633.DELNP/2006 (hereinafter referred to as the subject application) on 27th September, 2006.

3. The respondent No. 4 examined the patent application and the first examination report was issued on 14-1-2009. On or around the same date 14 January, 2009 an official communication was sent by the Patent office Delhi enclosing the notice intimating the filing of 3rd Party opposition to the appellant directing them to file the reply statement under rule 55(4) of the Patent Rules 2003 (hereinafter referred to as the Rules). The response to the First Examination Report and to this notice was filed by the appellants on 6-4-2009 and 14-4-2009 respectively. The respondent No. 4 finally appointed a hearing on the said pre-grant representation, on 6 May 2009. The respondent No. 4 passed the impugned order dated 24 July 2009 refusing the application of the appellant on the grounds of lack of novelty, obviousness and lack of inventive step. Being aggrieved by the said order, the appellants herein preferred the said appeal before this Appellate Board. The Registry of this Board sought clarification from the appellant as to how the order passed under section 25(1) of Act is admissible/appealable before the Hon'ble Appellate Board as it is very clear that any decision issued under section 25(1) of the Act, by the Controller is not appealable under section 117(A)(2) of the Act. The appellant's counsel replied that this appeal was preferred inter alia under section 117 read with section 15 of the Act, enclosing therewith the certified copy of the order of the Controller issued under section 25(1) of the Act together with a condonation of delay application for the period of delay of 6 months from the date of the impugned order. The appellant's counsel also replied that this present appeal is maintainable as the representation made in a pre-grant opposition under section 25(1) of the Act when allowed would amount to a refusal of the subject application under section 15 of the Act. The matter was therefore listed before the Bench for maintainability on 2nd August, 2010.

4. The appellant was represented by Mr. S.C Aggarwall Sr. advocate. The appellant's counsel submitted that the section 25(1) hearing was conducted on 6 May, 2009 and the decision was issued on 24 July 2009. But the counsel submitted that they had the time for appeal when the aggrieved applicant (the appellant herein) makes within three months from the date of the Hon'ble Delhi Court order dated 8.2.2010 and he said that they had made it on 23 April 2010 within the stipulated time.

5. The counsel for the appellant referred to the recent Delhi High Court judgment dated 8 February 2010 in W.P (C) No. 332 of 2010 and submitted that it was held by the Hon'ble Delhi High Court, that the decision of the Controller under section 25(1) is in fact relatable to and should be understood as if an order has been issued by the Controller under section 15 of the Act. Further, the counsel quoted extensively from the recent Delhi High Court judgment and also referred to the judgment delivered in Ucb Farchim Sa… v. Cipla Ltd. & Ors.…) No. 332 of 2010and said that this impugned order should be treated as an order under section 15 of the Act which is appealable before this Board.

6. The counsel also submitted that the legislative logic has been recognized by the Hon'ble Supreme Court in J. Mitra and Co. v. Assistant Controller of Patents (2008) 10 SCC 368, where the Supreme Court has held that an order rejecting a representation of a pre-grant opposition proceeding is not appealable since the opponent aggrieved has the option of filing a post-grant opposition under section 25(2) of the Act. Had section 25(1) been mentioned in section 117(A) (2) of the Act, it would have had the result of allowing an appeal before this Board by a person whose representation for pre-grant opposition has been rejected. The Counsel continued that, on the other hand, since the refusal of a patent application pursuant to a pre-grant opposition would be treated as a refusal order under section 15 of the Act which is appealable before this Board, there was no need for the legislature to include the section 25(1) in Section 117(A)(2) to cover the cases where a patent application has been refused pursuant to a representation in a pre-grant opposition. The counsel also emphasized, that, the pre-grant opposition is only an aid to the examination process of a patent application, by the examiner with the assistance of a third party and also referred to the rule 55(6) of the Rules, which clearly stipulates that in case the representation of the opposing party in a pre-grant opposition proceeding is allowed, it has the result of refusal of the patent application and consequently such refusal of the patent application would fall only under an order of refusal as per section 15 of the Act.

7. We have heard the arguments of the counsel and his submission in this regard. It is very clearly noticeable that this is an appeal against the order of the respondent No. 4 issued under section 25(1) of the Act, wherein a third party intervening opponent M/s. Natco Pharma Ltd. made a 3 party pre-grant opposition to the grant of patent to M/s. Millenium Pharmaceuticals Inc. (the appellant herein).

8. Looking at the sequence of patent grant procedure, the Controller of Patents does the examination of the patent applications for the grant of patents under section 12 of the Act (under chapter 4) which deals with, mainly regarding the publication and examination of applications for patent leading to the grant of patent. This chapter 4 also deals with the applications filed, regarding its publication in the patent journal, and as to when the applicant has to make a request for examination, which is subsequently followed by the detailed technical examination by the patent office considering the patentability criteria. Also there is dealt with the procedure and action as to when the Controller can refuse to grant the patent keeping in view of the stipulated time given in the first examination report issued subsequent to the technical examination of the patent application. Here in the proceeding, before the Controller, it is seen that there are only two parties, namely, the Controller and the applicant for patent and there is no 3 party present. Consequently, when the Controller issues the examination report, it is directed towards the applicant for patent and either he has to comply with the requirements raised therein within the stipulated time given or if he does not agree with the directions for amendment or any correction, he may seek an opportunity of hearing as well, in case, the Controller proceeds to make a decision adverse to the applicant. Subsequent to this action, in chapter 5 under a different heading “Opposition proceedings to grant of patents” under section 25 another party enters the proceedings, by way of pre-grant opposition, if and when the patent has not been granted, by way of opposition sending the representation directly to the Controller on any of the grounds specified therein. The procedure as to how this pre-grant opposition is to be carried out or effected is given under rule 55 in chapter 6 of the Rules. This shows very clearly, that it is a next stage after the examination of the patent application showing that it is a separate proceeding, but, ofcourse, subsequent to the proceeding which took place between the Controller and the applicant. Therefore it is very clear based on the objections raised by the Controller either the applicant has to comply with the technical objections by making necessary amendments in the specification or make necessary observations to satisfy the Controller that he deserves to get the patent granted based on the disclosure in the specification already made. Here again if the Controller is not satisfied with the observations of the applicant, he may offer an opportunity of hearing to the applicant for patent and allow and direct the applicant to amend the specification to his satisfaction and in the event that the applicant does not comply with the same, the Controller may refuse to proceed with the application under section 15 of the Act. This refusal gives the power of appeal against the decision of the Controller under section 117 (A) (2) whereas in pre-grant opposition as clearly given in the statute, the second party or as worded in the statute, the third party enters into the proceeding, mainly with the intention of opposition to the grant of patent and he submits the representation to the Controller directly. The Controller of Patents then forwards this representation to the applicant calling for his observations and reply if any, together with the evidence thereof. Finally, the Controller may decide the issue by offering an opportunity of hearing to both the parties namely (it's a bipartite proceeding) the applicant and the intervening 3 party opponent and decide the issue (1) allow the pre-grant opposition and reject the patent (2) dismiss the pre-grant opposition and grant the patent.

9. Here in this first category, it is very clear and known to all parties in the proceeding that the opponent who comes to enter the proceeding by way of pre-grant opposition has a remedy under section 25(2) of the Act as post grant opposition or under section 64 by way of revocation of patent before this Board. Also it is known to the parties in the proceeding that if the pre-grant opposition is allowed and the patent is refused there is no remedy provided to the applicant under the law in an explicit manner in the statute. That is, the applicant for patent cannot appeal against the order of the Controller under section 25(1) before this Appellate Board. As the Controller's decision issued under section 25(1) is not explicitly provided or mentioned under section 117(A)(2) for appealing against, it is a clear fact that the applicant for patent has no remedy except by way of judicial review to the Court. But this order of the Controller can never be taken as if it is an order issued under section 15 of the Act. Further neither it is equivalent to nor relatable to the provisions contained in section 15 of the Act, nor the pre-grant opposition proceeding is an extension or assistance to the examination process of a patent application. The intention of the third party entering the pre-grant opposition is very clear, that the patent should not be granted under the grounds specified therein and that is why he makes the opposition under section 25(1). Whereas, in an examination process, the intention of the patent office or the patent examiner or the Controller of patents is to technically examine the patent application and make the patent specification a worthwhile document under chapter IV before it is made open to public by granting a patent simultaneously, if the invention claimed has met the patentability criteria as mentioned in the statute. So this action of the third party can never be taken as an action in aid of the examination of the patent application. That is why the legislature has very clearly brought this proceeding under a different heading called “an opposition proceeding” simultaneously keeping a check that if the third party opponent is not an interested person, then, he cannot proceed for appeal or for a further proceeding namely post grant opposition under section 25(2) or a revocation proceeding under section 64 of the Act. The intention of the legislature is very clear that the patent monopoly right being the negative right, a provision of third party intervening opposition as a pre-grant opposition has been brought in, to check no worthless patents has been granted by the Controller. So, these two proceedings are not relatable to each other and the decision issued under section 25(1) cannot be deemed to have been given under section 15 of the Act. However, we also agree that there should be a remedy by way of appeal to the applicant whose patent has been refused due to the intervention of the third party in a pre-grant opposition proceeding and also in the interest of natural justice when such a remedy for the aggrieved applicant is available, he would be able to prefer an appeal against the order of the Controller in case the Controller takes an adverse decision against the applicant. The Hon'ble Delhi High Court W.P(C) Nos. 322 of 2010 and 13295, 12006, 8393, 8392 and 8389 of 2009 has given the ruling and interpretation that an aggrieved applicant in a 3 party pre-grant opposition proceeding under section 25(1) of the Act, may prefer an appeal before this Appellate Board. Therefore taking into consideration the law of natural justice and the recent ruling and interpretation by the Hon'ble Delhi High Court, we hereby allow the application and direct the Registry to number this appeal if in order.

Disclaimer: This order is being published for present information and should not be taken as a certified copy issued by the Board.