IN THE HIGH COURT OF JUDICATURE AT MADRAS Dated: 02.12.2008 Coram: The Hon’ble Mr.A.K.GANGULY, CHIEF JUSTICE and The Hon’ble Mr.Justice F.M.IBRAHIM KALIFULLA Writ Petition No. 24904 of 2008 and M.P.Nos. 2 & 3 of 2008 1. Indian Network for People living with HIV/AIDS, Rep. by its President, Flat No.6, Kash Towers, 93, South West Boag Road, T.Nagar, Chennai – 17. 2. Tamil Nadu Networking People with HIV/AIDS, Rep. by its President, No.391/30, 8th Street, K.K.Nagar, Near Mahatma Montessori School, Madurai – 625 020. … Petitioners Vs. 1. Union of India, Rep. by the Secretary, Department of Industrial Policy and Promotion, Ministry of Industry and Commerce, Udyog Bhavan, New Delhi – 110 011. 2. Controller General of Patents & Designs, and Trade Marks Bhoudhik Sampada Bhavan, S.M.Road, Near Antop Hill Head Post Office, Antop Hill, Mumbai – 400 037. 3. Assistant Controller of Patents & Designs & Trade Marks, Intellectual Property Office, G.S.T.Road, Guindy, Chennai – 600 032. 4. F.Hoffmann-La Roche AG, 124, Grenzacherstrasse CH 4200, Basle, Switzerland. …. Respondents https://hcservices.ecourts.gov.in/hcservices/ Petition filed under Article 226 of the Constitution of India praying for the issue of a Writ of Certiorarified Mandamus calling for the records of Patent Application No.959/MAS/1995 and Patent No.207232 and after going through the same, quash patent No.207232 granted by the office of Respondent Nos. 2 & 3 in Patent Application No.959/MAS/1995 filed by Respondent No.4 and consequently direct the Respondent Nos. 2 and 3 to consider Patent Application No.959/MAS/1995 after hearing the Petitioners as per Section 25 of the Patents Act, 1970 read with Rule 55 of the Patent Rules and award costs. For Petitioner ::: Mr.Anand Grover, Senior Counsel for Ms.R.Vaigai. For Respondents 1 to 3 ::: Mr.Haja Mohideen Gisthi For Respondent 4 ::: Mr.A.L.Somayaji, Senior Counsel for M/s.T.K.Baskar O R D E R THE HON’BLE CHIEF JUSTICE Both the petitioners in this writ petition are registered societies under the Tamil Nadu Societies Registration Act, 1975 and they are providing support to people living with HIV/AIDS (herein after referred to as “PLHIV”). The petitioners try to lend support to PLHIV in critical areas such as access to medicine and treatment and also for removal of discrimination facing PLHIV in Indian society. Members of the petitioner organizations are citizens of India. 2. F.Hoffmann-La Roche AG, the 4th respondent herein, is a pharmaceutical company registered in Switzerland having its office at 124, Grenzacherstrasse CH 4200, Basle, Switzerland. It filed a Patent Application titled “2-(2-Amino-1, 6-Dihydro-6-oxo- purin-9-yl)-methoxy-1,3-propanediol Derivative”, which was allocated No.959/MAS/1995, for a patent relating to Valganciclovir, which is a drug used to treat CMC retinitis. The 4th respondent’s Patent Application No.959/MAS/1995 was filed on 27.07.1995, and the 2nd respondent published the said application on 25.02.2005 in Issue No.06/2005 in the Official Journal of the Patent Office. 3. Thereafter, on 12.07.2006 the petitioners filed a representation by way of opposition at a pre-grant stage to the Patent Application of the 4th respondent under Section 25(1) of https://hcservices.ecourts.gov.in/hcservices/ the Patents Act, 1970 (herein after referred to as the “said Act). In the said application it was contended by the petitioners that the Indian Patents (Amendment) Act, 2005 was passed to make the said Act compliant with the obligations under TRIPS. TRIPS, signed in 1995, required India to effect a product patent regime after ten years. From 1995, it became clear that India would adopt a product patent regime by 2005. Prior to the Patents (Amendment) Act, 2005 the said Act only granted patents for processes but not for products. Therefore, the petitioners’ contention is that all inventions relating to products that were disclosed prior to 1995 were in the public domain, and remains so even today, even after the passing of the said Amendment Act. The petitioners objected that any product patent application in respect of an invention which was in public domain prior to 1995 must therefore be rejected on the grounds that the subject matter of invention lacks novelty. 4. Inter alia on the basis of the aforesaid contentions, the petitioners filed their representation opposing the grant of patent to the 4th respondent under the provisions of Section 25(1) (f) and 25(1)(h) of the said Act. In the said representation, which is filed by the petitioners by way of opposition, they gave grounds of opposition and specifically demanded hearing under Rule 55(1) of the Patents Rules, 2003 (herein after referred to as the “said Rules”). 5. In November, 2006 the General Secretary of the 1st petitioner received a letter dated 15th November, 2006 from the office of the 3rd respondent to the effect that on the basis of the opposition filed by the petitioners, notice has been given to the agent of the 4th respondent to file statement and evidence if any in support of the patent application within three months from the date of the said notice under Rule 55(4) of the said Rules. 6. Pursuant thereto, a reply was filed by the 4th respondent on 30th November, 2006 against the grounds raised by the petitioners in their patent application. The petitioners were not informed of anything about the fate of their objection, nor were they informed of the date of hearing in respect of their objection, though they made a specific request for such a hearing. From page – 7 of the typed set filed by the 4th respondent it appears that the 3rd respondent addressed a communication to the 4th respondent on 12th April, 2007 to the following effect: “Your above said application for patent has been found in order for grant. However, patent will be granted after disposal of pre-grant https://hcservices.ecourts.gov.in/hcservices/ opposition by way of third party representation, if any, under Section 25(1) of the Act and found in favour of the application. In this connection, you may note that you can initiate infringement proceedings only after grant.” 7. It appears that the 3rd respondent unilaterally took a decision for grant of patent in favour of the 4th respondent though the objections filed by the petitioners were not disposed of till then. Thereafter, the Patent Office granted the patent to the 4th respondent and the same was published in the Official Journal of the Patent Office on 29.06.2007. Immediately after coming to know of the same the petitioners issued a legal notice dated 29.10.2007 complaining of the fact that the petitioners’ right of hearing in respect of their opposition under Section 25(1) of the said Act read with Rule 55(1) of the said Rules was denied and the petitioners did not receive any communication from the Patent Office intimating the date of hearing or any intimation that their objections have been rejected. As such, the said legal notice prayed that the patent granted should be withdrawn or cancelled, failing which appropriate proceedings would be initiated. 8. To the said legal notice of the petitioners, a reply was sent from the 3rd respondent – Patent Office on 12th November, 2007 informing that the grounds of objections raised by the petitioners in their representation under Section 25(1) of the said Act were considered and it was found that the objections raised by the petitioners were met by the 4th respondent. The exact text of the said letter is set out herein below. “With reference to your letter dated 01/11/2007, I would like to bring it to your notice that the two grounds of opposition by way of representation under Section 25(1) of the Patents Act, 1970, as amended, have been carefully considered and found that the said issues have been met by the applicant. Having the objections, raised by you, were met and by applying my mind, I came to the conclusion to expedite the prosecution of application for patent in question. However, if you are interested, you may file Post-Grant Opposition under Section 25(2) of the Patents Act, 1970, as amended, as your request to withdraw/cancel the grant of patent is not permissible under the provisions of the Patents Act, 1970, as amended.” https://hcservices.ecourts.gov.in/hcservices/ 9. Thereafter, on behalf of the petitioners a further legal notice was sent on 28th November, 2007 to the 3rd respondent – Patent Office praying for furnishing them the following documents: “(a) Copy of all documents submitted by the Patent Applicant or their agent to your letter dated 16th November 2006 intimating the Patent Applicant of the representation by way of opposition filed by our clients; (b) Copy of the file notings pertaining to the opposition by way of opposition filed by our clients; and (c) Copy of the decision disposing of the representation by way of opposition filed by our clients and the grant of patent.” 10. But, no reply to the said letter dated 28th November, 2007 was given by the 3rd respondent. Thereafter, this writ petition has been filed on 15.10.2008 with the following prayer: “For the reasons mentioned in the accompanying affidavit, it is prayed that this Hon’ble Court may be pleased to issue any appropriate writ, order or direction and in particular, a writ in the nature of Certiorarified Mandamus calling for the records of Patent Application No.959/MAS/1995 and Patent No.207232 and after going through the same, quash Patent No.207232 granted by the office of the Respondent Nos.2 and 3 in Patent Application No.959/MAS/1995 filed by Respondent No.4 and consequently, direct the Respondent Nos.2 and 3 to consider Patent Application No.959/MAS/1995 after hearing the petitioners as per Section 25 of the Patents Act, 1970 read with Rule 55 of the Patent Rules, award costs and pass such other orders or directions as are necessary and proper to meet the ends of justice.” 11. In the background of these facts, the question which arises is whether the petitioners, who filed their pre-grant opposition and who have been given under Section 25(1)(k) of the said Act read with Rule 55(6) of the said Rules a right of https://hcservices.ecourts.gov.in/hcservices/ hearing, if such hearing is requested, and admittedly such a request has been made, can be denied the right of hearing by the third respondent in violation of the statute. In other words, the precise question is whether by denying the petitioners their statutory right of hearing under Section 25(1)(k) of the said Act read with Rule 55(6) of the said Rules, which are also statutory in nature, the Controller can purport to reject the petitioners objections to the grant of patent at a pre-grant stage and a patent, which has been granted in violation of the aforesaid statutory provisions is valid in the eye of law. 12. Under the amended provisions of the said Act, which has been brought about by Patents (Amendment) Act, 2005, it is provided in Section 25(1) of the said Act where an application for patent has been published, but the patent has not been granted, any person may in writing represent by way of opposition to the Controller against the grant of patent on certain grounds enumerated under Section 25(1) (a to k) of the said Act. Since in this writ petition we are not concerned with the merits of the order granting patent to the 4th respondent we need not go into those grounds. Section 25(1) of the said Act is as follows: - “Where an application for a patent has been published but a patent has not been granted, any person may, in writing represent by way of opposition to the Controller against the grant of patent on the ground: -“ (underlined for emphasis) 13. Here the expression “such person” would mean any person, who has given the right to oppose the grant in writing under Section 25(1) of the said Act. Under Section 25(1)(k) of the said Act, it is provided as follows: - “the Controller shall, if requested by such person for being heard, hear him and dispose of such representation in such manner and within such period as may be prescribed.” (underlined for emphasis) 14. Here the expression ”manner as prescribed” has been explained under Section 2(u)(C) of the said Act as prescribed by the Rules made under this Act. 15. Under Section 159 of the said Act Rules have been framed and the relevant rule is Rules 55(1) to (6), which would apply in respect of right of objection to pre-grant of patent as https://hcservices.ecourts.gov.in/hcservices/ given under sub-section (1) of Section 25. Those Rules are set out below: - “ Rule 55. Opposition to the Patent. (1) Representation for opposition under sub-section (1) of Section 25 shall be filed at the appropriate office and shall include a statement and evidence, if any, in support of the representation and a request for hearing if so desired. (2) The Controller shall consider such representation only when a request for examination of the application has been filed. (3) On consideration of the representation if the Controller is of the opinion that application for patent shall be refused or the complete specification requires amendment, he shall give a notice to the application to that effect along with a copy of such representation. (4) On receiving the notice under sub-rule (3), the applicant shall, if he so desires, file his statement and evidence, if any, in support of his application within three months from the date of the notice. (5) On consideration of the statement and evidence filed by the applicant, the Controller may either refuse to grant a patent on the application or require the complete specification to be amended to his satisfaction before the patent is granted. (6) After considering the representation and submission made during the hearing if so requested, the Controller shall proceed further simultaneously either rejecting the representation and granting the patent or accepting the representation and refusing the grant of patent on that application, ordinarily, within one month from the completion of above proceedings.” (underlined for emphasis) https://hcservices.ecourts.gov.in/hcservices/ 16. A perusal of the Rules will show that on consideration of the representation from the objectors, if the Controller is of the opinion that the application for patent shall be refused or the complete specification requires amendment, under Rule 55(4), he shall give notice to the applicant to that effect along with the copy of such representation. In the instant case, the 3rd respondent gave such notice to the 4th respondent. So it cannot be said that the grounds of objection raised by the petitioners are frivolous. Thereafter, under Rule 55, the applicant filed its statement in support of the application within the time specified under sub-rule(4) of Rule 55. Under sub-rule (5) of Rule 55, it is provided that on consideration of the statement and evidence filed by the applicant, the Controller may either refuse to grant the patent on the application or require the complete specification to be amended to his satisfaction before the patent is granted. Under sub-rule (6) of Rule 55, it is provided that after considering the representation and submission made during the hearing, if so requested, the Controller shall proceed further simultaneously either rejecting the representation and granting the patent or accepting the representation and refusing the grant of patent on that application, ordinarily, within one month from the completion of such proceedings. 17. Here, admittedly, the Controller has not given the petitioner any chance of hearing even though the petitioner admittedly requested for the same. Therefore, concededly the petitioner’s statutory right of making ‘submission during hearing’ was denied. But the patent was granted to the 4th respondent by denying the petitioner any chance to make submission on his representation. The petitioner was not informed of the grant of patent to the 4th respondent till the petitioner came to see the publication of the patent in the Patent Journal. 18.In the background of the aforesaid statutory provisions, to justify the grant of patent, it has been argued by the learned counsel for the 4th respondent that the proceedings before the Controller at the pre-grant stage are not quasi-judicial and the Controller merely acts in an administrative capacity and in such a situation he does not decide any ‘lis’. The hearing is optional even if it is requested and the words “Controller shall hear” used in Section 25(1)(k) of the said Act are to be construed directory and similarly, the requirement of hearing under Rule 55(6) should also be treated directory. https://hcservices.ecourts.gov.in/hcservices/ 19. It has also been argued on behalf of the fourth respondent that by a mere denial of hearing, even though statutorily provided, the resultant decision does not become bad, unless the person who have been denied such hearing proves that he has suffered a prejudice and in this case the petitioners did not suffer any prejudice. Since the petitioner did not suffer any prejudice, the order granting the patent cannot be invalidated. Apart from that it has been stated that the petitioners have a liberty of challenging the grant even at a post-grant stage under Section 25(2) of the said Act. It has also been stated that the Delhi Network of the Positive People has actually filed an opposition at the post-grant stage. However, it may be mentioned that the Delhi Network of Positive People are not parties to this writ petition. Learned counsel for the 4th respondent also stated that the 4th respondent filed a suit, being Suit No.2869 of 2008, before the Bombay High Court against Cipla Limited alleging infringement, and in that suit an impleading petition has been filed by the present writ petitioners. Therefore, they have an alternative remedy, which remedy they are pursuing. It has been stated that in view of that the present writ petition should not be entertained. 20. It has further been stated that there is a delay on the part of the petitioners in approaching this writ Court, and on the ground of delay, which has not been explained, this writ petition should be dismissed. 21. This Court is unable to accept the aforesaid submissions for various reasons. Section 77 of the said Act makes it clear that subject to any rules made, the Controller in any proceedings before him under the Act shall have the powers of a Civil Court while trying a suit under the Code of Civil Procedure, 1908 in respect of certain matters. Those matters are as follows: - “(a) summoning and enforcing the attendance of any person and examining him on oath; (b) requiring the discovery and production of any document; (c) receiving evidence on affidavits; (d) issuing commissions for the examination of witnesses or documents; (e) awarding costs; (f) reviewing his own decision on application made within the prescribed time and in the prescribed manner; https://hcservices.ecourts.gov.in/hcservices/ (g) setting aside an order passed ex parte on application made within the prescribed time and in the prescribed manner; (h) any other manner which may be prescribed.” 22. Learned counsel for the 4th respondent has however argued that those provisions of Section 77 of the said Act would only apply to proceedings before the Controller at the post grant stage. 23. This Court is unable to accept the said contention in view of the clear provisions of the said Act and the Rules framed there under. Rule 55(6) of the said Rules, which is confined only to a pre-grant stage clearly characterize the pre-grant exercise by the Controller as “proceedings”. The word “proceedings” have not been defined in the definition clause, namely, Rule 2 of the said Rules. But under Rule 2(g), it has been stated that the words and expressions used, but not defined in these rules, shall have the meanings respectively assigned to them in the Act. Therefore, the word “proceedings” in Rule 55(6) of the said Rule will have the same meaning as the expression “proceedings” occurring in Section 77 of the said Act. Section 77 of the said Act also makes it clear that the said Section will apply to any proceedings before the Controller under the Act. Any would include all. Thus, the pre- grant opposition proceedings come within the sweep of “any proceedings” under Section 77 of the said Act. 24. The Controller, before whom the proceedings takes place, is endowed with some of the powers of a Civil Court, and whose order or costs are executable as a decree of a Civil Court, is thus having the trappings of a Civil Court. Proceeding before such an authority are obviously a quasi-judicial proceedings. In a pre-grant stage, the Controller is also deciding a controversy, which is raised by the objector opposing the grant of patent and the applicant who applies for the grant. 25. From the statutory provisions discussed above, it is clear that if the pre-grant opposition is upheld, the patent will be refused, which is clear from the provisions of Rule 55(5) and Rule 55(6). Therefore the Controller will have to take a decision of either refusing to grant the patent by accepting the pre-grant opposition or grant the patent by rejecting the opposition. So he has to decide this controversy between the applicant’s right to get the patent and the objector’s right to defeat the claim of patent. The objector may not be a rival in trade of the person claiming the patent. But the objector can raise his objection on much wider grounds of public policy and public interest. That is why the right to raise pre-grant objection has been advisedly given to “any person”. The Hon’ble Supreme Court construing the pre-grant and post-grant proceedings https://hcservices.ecourts.gov.in/hcservices/ under the said Act held in J.Mitra & Co. Pvt. Ltd. Vs. Assistant Controller of Patents & Design (2008 (11) SCALE 524) held that the provision of pre-grant under Section 25(1) is wider than the provisions of post-grant under Section 25(2). So, the concept of lis has to be construed in the context of wider right given to the objector. Such objection may not stem from any business or commercial interest, but such objection can be raised on a wider concept of public health and nutrition and the issue of affordability of medicine at a reasonable rate to those persons who are affected by disease. Therefore, it cannot be said that a person opposing the grant has no interest. 26. The word “lis’ has been defined in Black’s Law Dictionary (8th Edition) as “a piece of litigation, a controversy or dispute”. In a judgment of the Court of Appeal rendered in the case of B.Johnson & Co. (Builders) Ltd., v. Minister of Health reported in 1947 All.E.R 395), it has been held by Lord Greene, the Master of Rolls, as follows: - “Lis, of course, implies the conception of an issue joined between two parties. The decision of a lis, in the ordinary use of legal language, is the decision of that issue” 27. The same principles have been laid down by the Hon’ble Supreme Court in its Constitution Bench Judgment in Kihoto Hollohan v. Zachillhu, 1992 Supp. (2) SCC 651. At paragraph-99 (page 707 of the report), Justice M.N.Venkatachaliah, (as His Lordship then was), speaking for the majority held: “Where there is a lis – an affirmation by one party and denial by another – and the dispute necessarily involves a decision on the rights and obligations of the parties to it and the authority is called upon to decide it, there is an exercise of judicial power. That authority is called a Tribunal, if it does not have all the trappings of a Court” 28. Following the aforesaid test, as we must, this Court holds that the third respondent functions as a quasi- judicial tribunal and has to decide the lis namely, the right of the objector raised on a wider perspective as against the claim of patent by the fourth respondent. 29. The present structure of the pre-grant and post- grant procedure vide Sections 25(1) and 25(2) of the said Act has been brought about by the Patent Amendment Act, 2005 (hereinafter referred to as the ‘said Amendment’). A perusal of the Statement of Objects and Reasons of the said amended Act would clarify the legislative intent of giving right of objection to ‘any person’, https://hcservices.ecourts.gov.in/hcservices/ whereas prior to the said amendment such right of opposition at a pre-grant stage was only given to any person interested. The