Central Information Commission
Kewal Krishan Nangia vs Chief Commissioner Of Customs And ... on 1 July, 2024
केन्द्रीय सूचना आयोग
Central Information Commission
बाबा गंगनाथ मागग, मनु नरका
Baba Gangnath Marg, Munirka
नई दिल्ली, New Delhi - 110067
File No : CIC/CECHZ/A/2023/114457
Kewal Krishan Nangia .....अपीलकर्ाग/Appellant
VERSUS
बनाम
PIO,
Office of the Dy. Commissioner
of Customs, Air Cargo Complex,
Customs Commissionerate,
Shamshabad, Hyderabad - 500409 ....प्रनर्वािीगण /Respondent
Date of Hearing : 31.05.2024
Date of Decision : 26.06.2024
INFORMATION COMMISSIONER : Vinod Kumar Tiwari
Relevant facts emerging from appeal:
RTI application filed on : 30.07.2022
CPIO replied on : 12.08.2022
First appeal filed on : 04.11.2022
First Appellate Authority's order : 21.12.2022
2nd Appeal/Complaint dated : 22.03.2023
Information sought:
The Appellant filed an RTI application dated 30.07.2022 seeking the following information:
"The present application is being filed on behalf of Regeneron Pharmaceutical Inc. and Bayer Intellectual Property GMBH who have the rights and interest in the drug Aflibercept/Eylea, also protected by patents in India. Accordingly, this Page 1 of 25 application under the Right to Information Act, 2005 is being filed to seek the following information:
Q1. Please confirm whether Cliantha Research Limited has imported/exported the solution for injection Aflibercept or Aflibercept/Eylea in any other form into India or from India.
a. If the answer to Q1. is yes, please provide the following:
(i) All shipment documents including the bills of lading relating, declaration and description of product to the import/export of solution for injection of Aflibercept or Aflibercept/Eylea in any other form into India or from India by Cliantha Research Limited.
To the best of my knowledge all of the above information is within the public domain and does not fall within the restrictions contained in Section 8 and 9 of the RTI Act and requires to be disclosed in the interest of public health and welfare particularly when the application is for biosimilar wherein, safety and efficacy is of paramount interest of public health and welfare. As per Government Guidelines, any study/trial in relation to biosimilar involves an element of public interest considering that safety and efficacy is of utmost importance.
In case I am required to pay certain extra fees for the photocopies requested by me, please do inform me and I shall arrange for it at the earliest."
The CPIO furnished a reply to the Appellant on 12.08.2022 stating as under:
"As the details pertains to the 3rd Party. Your Application is rejected Under Section 8(1) of Right to Information Act, 2005.
The Indian Postal Order No.53H-219530 for an amount of Rs.100/- & Postal Order No.53H-219531 for an amount of Rs.100/- is returned back."
Being dissatisfied, the appellant filed a First Appeal dated 04.11.2022. The FAA vide its order dated 21.12.2022, upheld the reply of CPIO.
Feeling aggrieved and dissatisfied, appellant approached the Commission with the instant Second Appeal.
Relevant Facts emerged during Hearing:
The following were present:-Page 2 of 25
Appellant: Shri Siddhant Sharma, Advocate along with Shri Abhay Tandon, Advocate and authorized representative of Appellant present in person. Respondent: Shri Anupam Paliwal, Dy. Commissioner (Customs) & CPIO present through Video-Conference.
Third party: Shri Ashish Verma and Shri Rituraj Shahi, Advocates and authorized representatives of third party present in person.
The Rep. of the Appellant raised his arguments in the instant Appeal on the following lines:
The Rep. of the Appellant submitted that the Appellant is an Indian citizen and is the duly authorized representative of Regeneron Pharmaceuticals, Inc. and Bayer Intellectual Property GMBH, who have rights and interest in the drug Aflibercept/Eylea', which is also protected by patents in India. That the Appellant had filed an RTI application dated 30.07.2022 under the Right to Information Act, 2005 on behalf of the concerned entities seeking information relating to import/export of the drug 'Aflibercept/Eylea'. He submitted that on bare perusal of Section 3 and Section 6 of the RTI Act, it is evident that although the right of all citizens to receive information is statutorily recognized under Section 3 of the Act yet Section 6 is wider in a sense as it gives the right to any Person to obtain information under the Act. The said position has also been crystallized by the Hon'ble Supreme Court in the judgment of Chief Information Commissioner & Anr. Vs. State of Manipur & Anr (AIR 20L2 SC 864). The relevant paragraph of the judgment is extracted herein below:
"22. It is quite interesting to note that though under Section 3 of the Act right of all citizens, to receive information, is statutorily recognized but Section 6 gives the said right to any person. Therefore, Section 6, in a sense, is wider in its ambit than Section 3." (emphasis added) The above position has been followed by the Hon'ble High Court of Delhi in its recent judgment of A. S. Rawat vs. Dawa Tashi (2023/DHC/0 01799). The relevant paragraph of the judgment is extracted herein below: "48. Restricting the Right to Information to only citizens in the light of both terms i.e., citizens and persons being used in the RTI Act without any discernible distinction could be contrary to spirit of the Constitution as well as to the RTI Act.Page 3 of 25
Xxxxxxxxxxx"
The Rep. of the Appellant further submitted that Section 3 of the RTI Act would have to be read as positive recognition of the right in favour of citizens but not as a prohibition against noncitizens. In the present case, the Ld. FAA ignored the fact that the Appellant is an Indian citizen and is a duly authorized representative of the concerned entities through Power of Attorney(s) dated 13.06.2022 and 14.03.2022. The mere fact that the information has been requested by the concerned entities does not disentitle the Appellant from requesting for information under the Act. Therefore, so long as the RTI application is signed by individual who is a citizen of India, then, notwithstanding the capacity in which such application is filed, it shall be valid.
It is submitted that there cannot subsist any copyright over the information requested by the Appellant. The mere fact that copyright subsists in a literary or artistic work does not mean that its disclosure under the RTI Act would lead to its infringement. In the present case, none of the information as requested in the Appellants' RTI Application dated 30.07.2022 relates to any original literary or artistic work of Cliantha Research Limited. The information sought is required to be furnished by every entity under Chapter VII (Clearance of Imported Goods and Exported Goods) of the Customs Act, 1962. He further submitted that the Ld. FAA has wrongly interpreted and applied Section 9 of the Act and the impugned order is liable to be set aside. He further submitted that 'Aflibercept/Eylea' is a vascular endothelial growth factor ("VEGF") inhibitor formulated as an injection for the eye, for use in the treatment of retinal vascular diseases which are a major cause of visual impairment and blindness. 'Aflibercept/Eylea' is used in the treatment for both Age-related Macular Degeneration ("AMD"), which affects the elderly population, and Diabetic Macular Edema ('DME"), which affects diabetic persons. He stated that India is estimated to have the second highest number of diabetes cases in the world with 77 million cases, a figure that is projected to rise to more than 100 million cases by 2030.
The Rep. of Appellant further reiterated the contents of their written submissions which are taken on record and relevant extracts of the same is reproduced hereinbelow:Page 4 of 25
"2.1. The impugned order suffers from grave error of law as the Ld. CPIO has passed a non-speaking order without even specifying under which sub-clause of Section 8(1) of the Act has the information been denied.
2.2. The exercise of powers and passing of the orders concerned under the provisions of the RTI Act cannot be arbitrary. Application of mind and passing of reasoned orders are inbuilt into the scheme of the RTI Act and cannot be overlooked.
2.3. It is judicially settled that it is the duty of every adjudicatory authority to provide the reasons in support of its decisions. The reasons, enable higher authorities, before whom an order is challenged, to test the veracity and correctness of an impugned order. Reliance is placed on:
Namit Sharma Vs. Union of India (MANU/SC/0744/2012) - Paragraph 97 2.4. However, in the present case, the Ld. CPIO has erred it providing justification for applicability of Section 8(1) of the Act to the information sought by the Appellant in the application. Therefore, the impugned order is liable to be set aside as it is vague and devoid of proper reasoning.
3. Provisions of Section 8(1) of the RTI Act do not contemplate an absolute exemption:
3.1. It is submitted that whether information relating to the commercial confidence, trade secrets or intellectual property or not and whether disclosure thereof would harm the competitive position of the third party, can be determined by the Ld. CPIO only after issuing notice to the said third party as mandated under Section 11 of the Act.
3.2. Unless the nature of such harm is placed before the Ld. CPIO by the third party, the Ld. CPIO cannot arrive at a conclusion whether larger public interest would outweigh the said harm or not.
3.3. Nonetheless, the proviso to Section 11(1) of the Act states that information, otherwise treated as confidential by a third party, can be disclosed if the public interest in disclosure outweighs the possible harm and injury to the interest of such a third party. Reliance is placed on:
CPIO, Supreme Court of India vs. Subash Chandra Agarwal (MANU/SC/1561/2019) - Paragraph 60 3.4. In the present case, the information sought for by the Appellant is of vital importance and in the public interest considering that the drug in question is a patented biologic drug and the export/ import of any substandard biosimilars therein would cause grave harm to the public (as detailed below). Therefore, Page 5 of 25 the Ld. CPIO ought to have disclosed the information taking into consideration the larger public interest.
4. Information requested ought to be provided in larger public interest:
4.1. It is pertinent to mention that 'Aflibercept/Eylea' is formulated as an injection for the eye for the treatment of retinal vascular diseases a major cause of visual impairment and blindness.
4.2. It is submitted that one of the most significant safety concerns with biosimilars is the potential risk of immune-based adverse reactions. Thus, compared to a chemical generic drug, there is a bigger need for strict vigilance and approval studies.
4.3. The Ld. CPIO has discounted the fact that, as per Government guidelines, any study/ trial in relation to a biosimilar involves an element of public interest, considering that safety and efficacy is of utmost importance and does not fall within the exemption given in Section 8(1) of the Act. Reliance is placed on:
Guidelines on Similar Biologics: Regulatory Requirements for Marketing - Section 6 4.4. Further, the Ld. CPIO failed to appreciate that despite exemptions under Section 8 of the Act, there are inbuilt exceptions where the Commission may call upon the authority to furnish information in larger public interest.
Bihar Public Service Commission Vs. Saiyed Hussain Abbas Rizwi & Ors. (MANU/SC/1103/2012) - Paragraph 23 4.5. The information sought for by the Appellant is justifiable on the grounds of public interest and ought to have been provided by the Ld. CPIO.
5. Information sought is not confidential in nature 5.1. The Appellant has requested for "All shipment documents including the bills of lading, declaration and description of product to the import/export of solution for injection of Aflibercept or Aflibercept/Eylea in any other form into India or from by Cliantha Research Limited."
5.2. It is submitted that if Government authorities refuse to disclose documents, the very purpose of the Act will be frustrated. Rather disclosure of such information shall be in public interest, inasmuch as it will show the transparency in the activities of the Government. Reliance is placed on:
Sunflag Iron & Steel Company Ltd. Nagpur Vs. State Information Commission, Nagpur & Ors. (2014 SCC OnLine Bom 1763) - Paragraph 26 CPIO, Supreme Court of India Vs. Subhash Chandra Agarwal (MANU/SC/1561/2019) - Paragraph 60 Page 6 of 25 5.3. In the present case, the disclosure of documents (bills of lading, shipping documents, etc.), sought for by the Appellant, cannot be considered as information including commercial confidence or trade secret, as the said documents have been filed before the Air Cargo Complex, Customs Department, Hyderabad and the concerned third party does not have exclusive possession thereof.
5.4. Therefore, if such information is available with the concerned authority and such information is in exclusive custody of the concerned authority, the question of seeking any opinion from the third party on such issues cannot arise, especially, when they are public documents. Further, by disclosure of such information, no privilege or business interests of the third-party are affected.
6. Errors committed by the Ld. FAA in its order dated 21.12.2022: It is submitted that the Ld. FAA prospectively introduced new grounds of rejection of the Appellant's RTI application, which is not permissible at an appellate stage. However, without prejudice to the Appellant's submissions herein above, the Appellant has dealt with the same hereinbelow.
6.1. The Appellant is an Indian Citizen: The Ld. FAA ignored the fact that the Appellant is an Indian citizen and is a duly authorized representative of the concerned entities aide Power of Attorney(s) dated 13.06.2022 and 14.03.2022. The mere fact that the information has been requested by the concerned entities does not disentitle the Appellant from requesting for information under the Act. Therefore, so long as the RTI application is signed by an individual who is a citizen of India, then, notwithstanding the capacity in which such application is filed, it shall be valid. Reliance is placed on:
Chief Information Commissioner & Anr. vs. State of Manipur & Anr. (AIR 2012 SC 864) - Paragraph 22 A.S. Rawat vs. Dawa Tashi (2023/DHC/001799) - Paragraph 48 No copyright subsists in shipping documents: The Ld. FAA refused the Appellant's request for information by stating that" It appears that the information sought falls under Section 9 of the RTI Act, 2005". It is submitted that the mere fact that copyright subsists in a literary or artistic work does not mean that its disclosure under the RTI Act would lead to its infringement. In the present case, the information sought for by the Appellant is required to be furnished by every entity under Chapter VII (Clearance of Imported Goods and Exported Goods) of the Customs Act, 1962 - See Sections 46 and 50. Therefore, furnishing of the same would not ipso facto amount to infringement of the copyright as the nature of these documents is not such that the mere access to Page 7 of 25 such information itself would breach a copyright. Thus, the Ld. FAA has wrongly interpreted and applied Section 9 of the Act.
7. In view of the foregoing submissions and case laws advanced, the Ld. Information Commissioner may be pleased set aside the impugned order dated 12.08.2022 and direct the Ld. CPIO to furnish, full, complete, and correct information as sough for in the Appellant's RTI application bearing no. ETT/1489/36 dated 30.07.2022.
Written submissions filed by the Rep. Appellant after hearing is over is taken on record and relevant extracts of the same is reproduced hereinbelow:
"We would like to highlight that the Appellant was not informed by the Ld. CPIO that a notice under Section 11 of the RTI Act had been given to the Third- Party, Cliantha Research Limited. Further, the Appellant was neither served a copy of the written submissions and/or case laws filed by the Third-Party in the present matter, if any, nor informed by the Ld. CPIO about the fact that the Third-Party would be attending to the hearing before the Ld. Information Commissioner on 31.05.2024.
In view of the same, the Appellant is now making the following additional submissions to counter the additional arguments and case laws submitted by the Third-Party during the hearing dated 31.05.2024.
1. Objection on maintainability of the RTI Application and the Appeal filed by the Appellant under Section 3 of the RTI Act:
1.1. During the hearing, it was objected by the Respondent as well as the Third-
Party, Cliantha Research Limited, that the Appellant is merely an agent of the foreign companies, Regeneron Pharmaceutical Inc. and Bayer Intellectual Property GMBH, to whom the provisions of the RTI Act, 2005 do not apply. It was further argued on behalf of the Respondent and Third-Party that the provisions of the Act apply only to citizens and since the present RTI application has been filed on behalf of foreign corporations, the same is not maintainable under the Act.
1.2. In this regard, it is submitted that such contention is completely misconceived and misplaced. The relationship of the Appellant with the foreign companies is irrelevant for the purpose of ascertaining the maintainability of the Appellant's RTI Application dated 30.07.2022. The Appellant is an Indian citizen and as such entitled to seek the information as sought for in the RTI Application dated 30.07.2022 under Section 3 of the RTI Act. There is no judicial Page 8 of 25 precedent whatsoever which debars an Indian citizen to seek information under the RTI Act, 2005 solely on the ground that the seeker of the information is a power of attorney holder of foreign corporations. If such practice is to be followed then every Indian citizen, being office bearer or power of attorney holder of a foreign corporation, would lose his/her statutory right to information under the RTI Act, 2005.
Further, reliance is placed on the order dated 09.02.2023 passed by this Hon'ble Commission in the case of UPPL Projects Private Limited vs CPIO, File no. CIC/IBBIN/A/2022/126256. It is pertinent to mention that this Hon'ble Commission in the UPPL Projects case dismissed the appeal for the reason that the Appellant failed to adduce details of any individual/representative in whose capacity the RTI application was filed. However, this Hon'ble Commission did observe that "...if the RTI application is filed by an office bearer of any legal entity, indicating his/her name and citizenship, in such cases information can be supplied to him / her on the presumption that a citizen has sought the information."
In the present case since the Appellant has already furnished his bona fide information by placing on record the power of attorney, the information sought for by the Appellant should be supplied to him on the presumption that a citizen has sought the information.
1.3. It is further submitted that Section 6(2) of the RTI Act specifically bars the requirement of giving reasons for the requesting an information under the Act. In view of this statutory bar, the Ld. Information Commissioner ought not to dismiss the Appellant's RTI Application dated 30.07.2022 solely on an apprehension or some future eventuality. It is submitted that de hors the statutory protection afforded to the Appellant under Section 6(2) of the RTI Act, the Appellant has bona fidely furnished his background for seeking information in his RTI Application dated 30.07.2022, which ought not to be used against him to challenge his locus standi under Section 3 of the Act. 1.4. Thus, the mere fact that the information has been requested on behalf of the concerned entities does not disentitle the Appellant from requesting for information under the RTI Act, 2005 so long as the RTI application is filed in the name of an individual who is a citizen of India. It is submitted that the Appellant has already furnished sufficient proof to show that he is a citizen of India and a valid power of attorney holder of the corporations. In view of the same, the objection as to the maintainability of the Appellant's RTI Application dated 30.07.2022 is liable to be rejected.
Page 9 of 25Reliance is also placed on the following decisions:
• Chief Information Commissioner & Anr. vs. State of Manipur & Anr. (AIR 2012 SC 864); Paragraphs 22-25 • A.S. Rawat vs. Dawa Tashi (2023/DHC/001799); Paragraphs 36-50 • Meera Murali vs. BSNL (CIC/BSNLD/A/2017/176199); Paragraph 8
2. Objection under Section 9 of the RTI Act:
2.1. During the hearing, it was objected by the Respondent as well as the Third-
Party, Cliantha Research Limited, that copyright subsists in the information sought for by the Appellant and therefore the information ought not to be provided to the Appellant. It is submitted that such contention is completely wrong and misconceived. No copyright can subsist in a bill of lading, which contains nothing but details of the shipment and serves merely as a document to establish title of the goods. It is a trite law that filling up of general information on a form, without a minimum of original creativity, cannot be protected by copyright. The Respondent as well as the Third-Party wrongly mixed the issue of copyright and patents in the present matter. Reliance is placed on the contents of the 2nd Appeal filed by the Appellant as well as the written submissions dated 23.05.2024 and the same are not being repeated herein for the sake of brevity.
3. Objection under Section 8(1)(d) of the RTI Act:
3.1. It is submitted that the information sought by the Appellant in the first question of his RTI Application dated 30.07.2022 is a simple polar interrogative, answer to which could either be "Yes" or "No". Such information cannot be considered to be "information including commercial confidence, trade secrets or intellectual property" which would be barred under Section 8(1)(d) of the RTI Act.
Therefore, there is no bar for the Ld. CPIO to furnish the information as sought by the Appellant in the first question of his RTI Application dated 30.07.2022, which is reproduced below for ready reference of the Ld. Information Commissioner.
"Q.1. Please confirm whether Cliantha Research Limited has imported/exported the solution for injection Aflibercept or Aflibercept/Eylea in any other form into India or from India."
In view of the above, it is submitted that any answer to Q.1. above cannot, in any likelihood, harm the competitive position of the Third-Party. Therefore, we humbly request the Ld. Information Commissioner to direct the Ld. CPIO to Page 10 of 25 furnish the information sought by the Appellant in Q.1. of his RTI Application dated 30.07.2022.
3.2. Additionally, it is submitted that the information requested by the Appellant in Q.2. of his RTI Application dated 30.07.2022 also cannot be considered to be "information including commercial confidence, trade secrets or intellectual property" which would be barred under Section 8(1)(d) of the RTI Act.
During the hearing it was objected by the Third-Party that providing information relating to "all shipment documents" would harm its competitive position as the same would include various commercially confidential information. In this regard, the Appellant humbly limits its request under Q.2 of his RTI Application dated 30.07.2022 only to bills of lading relating to the product Aflibercept or Aflibercept/Eylea and the description of such product as mentioned therein. The Appellant humbly submits that furnishing such limited information would not be prejudicial to the Third-Party as the same is not confidential and already submitted to the Customs Authorities. It is submitted that a bill of lading contains details of the shipment and serves as a document to establish title of the goods. Such bill of lading does not include any information which is of commercial confidence, or trade secrets or intellectual property. In view of the same, we humbly request the Ld. Information Commissioner to direct the Ld. CPIO to furnish the limited information as now sought by the Appellant in Q.2. of his RTI Application dated 30.07.2022."
Written submissions of Respondent dated 27.05.2024 is taken on record and the relevant extracts are reproduced hereinbelow:
"Comments on the written submissions dated 23.05.2024 filed by the appellant:
Point No 1 &2 The appellant has sought information relating to import/export of a product by M/s Cliantha Research Limited which is clearly trade information pertaining to their rival/competitor and same was rightly rejected in terms of Section 8(1) of RTI Act 2015 by the CPIO. The copy of the order was also supplied to the Appellant.
Point No 3 & 4 Page 11 of 25 The appellant has sought all shipment related documents including bill of lading, declaration and description of product ete being imported exported by the third party. These documents will invariably contain information such as details of supplier/recipient, rate quoted, terms and conditions quoted as mentioned in the purchase order etc. This information is nothing but trade secrets of any exporter importer and sharing this information will put them at a disadvantage vis a vis their competitors. As far as apprehension of appellant of any substandard product is concerned, the same can be addressed by bringing the same to the notice of concerned authority by the appellant and seeking third party trade secrets on this ground is not justified. Hence. CPIO has rightly rejected the information under Section 8(1) of RTI Act 2015.
It is submitted that the facts and circumstances of the case laws referred by the appellant are not similar to this case and hence not relevant Point No 5 & 6.
The shipping documents sought by the applicant contain the information about supplier/ recipient of the goods, value, terms and conditions as mentioned in the purchase order etc and disclosure of the same to rival businesses will harm the competitive position of any importer/ exporter and hence same cannot be supplied in terms of Section 8(1) of RTI Act. The appellant are not public organization/ public litigants and hence claim of larger public interest is not justifiable. Moreover, the issue involves copyright/ patent issue and the same cannot be supplied under Section 9 of the RTI Act.
The appellant has sought information on behalf of foreign companies. As they are not Indian citizens as required in terms of the Rule 3 of RTI Act, 2005, the information can not be provided to them. section It is submitted that case laws referred by the appellant are not relevant to this case as facts and circumstances are different".
Written submissions on behalf of Cliantha Research Limited is taken on record and relevant extracts are reproduced hereinbelow:
"At the very outset we wish to state that the instant appeal is an abuse of the process of law and is liable to be dismissed. The order dated 12.08.2022 by the Deputy Commissioner of Customs, as well as the order dated 21.12.22 passed by the First Appellate Authority/ Additional Commissioner Customs Commissionerate Hyderabad, have been passed on due appreciation of facts and law and do not warrant any interference.
The application has been filed seeking third party arty information of Cliantha Research Limited. Cliantha Research, a full-service Clinical Research Page 12 of 25 Organization (CRO), is a leading provider of Clinical research services, based in Ahmedabad, India. Cliantha's motto is Science with Integrity. Cliantha has fifteen years of impeccable regulatory history with USFDA, WHO, MHRA, Health Canada, AGES, AEMPS, MCC, MOI, ANSM, MOPH, ANVISA, CAP, and NABL The instant submissions are being filed by Cliantha, being directly affected by the outcome of the instant appeal.
APPLICATION WAS NOT MAINTAINABLE.
Upon a perusal of the application as well as the instant appeal, it is evident that the same has been filed on behalf of Regeneron Pharmaceuticals Inc. and Bayer Intellectual Property GMBH. Both the said entities are foreign companies. In light of the provisions contained in Section 3 of the Right to Information Act, all citizens of India have the right to information. Both the said entities do not qualify as citizens of India and hence access to information under the said Act cannot be sought by them.
Upon perusal of the application, it is evident that Mr. Kewal Krishan Nangia has only signed the same on behalf of the aforementioned foreign companies. As the application had been filed by the entities not entitled to seek information in terms of the Act, the same was liable to be dismissed at the outset.
Without prejudice, to the aforestated contention regarding non- maintainability of the application as well as the appeal we would like to state further as under:-
The information is exempt under Sections 8(1)(d), 8(1)(e), and Section 9 of the Act.
The information/record pertaining to Cliantha specified in Annexure I to the said Notice and disclosure of which has been sought by Regeneron Pharmaceutical Inc. and Bayer Intellectual Property GMBH "Applicants") by way of application(s) dated 30 July 2022, is exempted under the provisions contained in Sections 8(1)(d), 8(1)(e), and Section 9 of the Act.
Cliantha's objections to disclosure of the information sought in the Request is tabulated below:
Notice/ Request Information/ Record Sought in Objection to Disclosure the Request Notice bearing no. Z- Copy of the application in form We object to the disclosure of 28020/585/2022-DC dated 5 CT-04/CT-05/form 44 this information under 8(1)(d), Sept, 2022 including study reports for sections 8(1)(e), and 9 of the each trial phase, Act.
Bioavailability/Bioequivalence
Page 13 of 25
studies Pharmacokinectics
absorption, disruption,
metabolism, excretion
Pharmacodynamics/early
measurement of drug activity
filed by Cliantha Research
Limited while seeking
permission to conduct clinical
trial for biosimilar / similar
biologic of Aflibercept/Eylea.
Copy of dossier/documents filed We object to the disclosure of
by Cliantha Research Limited this information under 8(1)(d),
along with the application sections 8(1)(e), and 9 of the
seeking permission to conduct Act.
clinical trial for biosimilar/
similar biologic of
Aflibercept/Eylea,
Investigational Product Dossier,
including, Medicinal systemic
toxicity studies, Clinical Data
and Study Protocol.
Details provided by Cliantha We object to the disclosure of
Research Limited in support of this information under 8(1)(d),
seeking exemption of clinical sections 8(1)(e), and 9 of the
trial on the ground of unmet Act.
medical need in the country (of
IMP/trial proposal) with respect
to for biosimilar/similar biologic
of Aflibercept/Eylea.
The purported contention of the appellant that the information is being sought in larger public interest, interest of justice, equity and good moral sense, public at large will suffer irreparable loss, prejudice and injury, is grossly incorrect. As aforestated the applicants Regeneron Pharmaceutical Inc, and Bayer Intellectual Property GMBH are not a public organisation/public litigants. On the contrary the applicants are foreign Companies and their actions are infact actuated by malice and with an intent to obstruct competition.
The said information was disclosed under commercial confidence, and constituted trade secrets and intellectual property of Cliantha Research Limited and was exempt in terms of Section 8, 9 and 11 of the Right to Information Act The information sought by the applicant is in the nature of commercial confidence and includes vital commercial trade secrets and intellectual property of Cliantha. The said information/record was provided to the office of the Drugs Controller General of India ("DCGI") as part of a fiduciary relationship.Page 14 of 25
There is no larger public interest warranting disclosure of information and therefore, it is exempt from disclosure in view of Section 8(1)(d) of the Act particularly since the information sought was inter alia in respect of Cliantha Research Limited's application seeking permission to conduct clinical trial for biosimilar/similar biologic of Aflibercept/Eylea, including, Investigational Medicinal Product Dossier, systemic toxicity studies, Clinical Data and Study Protocol.
The use of the words "person" in section 8(1)(e) shows that the holder of the information in a fiduciary relationship need not only be a 'public authority' as the word 'person' is of much wider import than the word 'public authority'. Therefore the exemption under Section 8(1)(e) is available not only in regard to information that is held by a public authority (in this case the examining body) in a fiduciary capacity, but also to any information that is given or made available by a public authority to anyone else for being held in a fiduciary relationship. In other words, anything given and taken in confidence expecting confidentiality to be maintained will be information available to a person in fiduciary relationship, The information sought by the applicant had been filed before the DCGI as a part of the application process under the Drugs and Cosmetics Act, 1940 and the Rules promulgated thereunder including the New Drugs and Clinical Trial Rules, 2019 for the purpose of scientific and medical evaluation by statutorily recognized authorities/persons who are trained professionals. The disclosure of such information is not permissible in terms of the Act.
The applicant's success in the clinical trials is infact in public interest as it would result in the availability of formulations for treatment of ailments. The information as is being sought in the application rather than being in public interest is contrary to the same, Disclosure of information would harm the competitive position of Cliantha, such information, if disclosed, would compromise, jeopardize and irreparably harm the competitive position of Cliantha, its affiliates and partners in the market.
It is submitted that the information has been requested in furtherance of the Applicants' private commercial interest namely the purported rights and interests of the Applicants in Aflibercept/ Eylca. The same is also evident upon a perusal of the application. It is respectfully submitted that it is not the object of Page 15 of 25 the Act to further the commercial interests of any person by disclosure of commercial confidential information/trade secrets/intellectual property.
The applicant's in the instant case have been known to be indulging in anti- competitive activities in order to thwart any competition in the Biosimilar market. The instant application has also been filed with such malafide objectives in minds. Furthermore, the appellants' contention of having patent on certain products is no ground and or justification for seeking the information as has been sought in the application. The said statement infact makes it evident that the information is being sought for commercial reasons and not for any public good.
It is respectfully submitted that we are following all provisions of the Drug and Cosmetics Act, 1940 and the Rules issued thereunder. Cliantha submits that the Act does not contemplate or permit applications for information that is in the nature of a roving and fishing enquiry, and each Request is liable to be disallowed because it fails to identify information with the degree of specificity required under the Act. Upon a perusal of the application it is evident that the commercial intent behind the application seems to be ascertain whether Cliantha Research Limited was conducting clinical trial for biosimilar/similar biologic of Aflibercept/Eylea"
Third party further refers to various decisions of the Commission regarding denial of information under Section 8(1)(d) of the RTI Act in support of his arguments.
Decision:
The Commission after adverting to the facts and circumstances of the case, hearing all the parties at length and perusal of the records, observes that the Appellant Shri Kewal Krishan Nangia has filed this RTI application on behalf of two foreign companies M/s Regeneron Pharmaceuticals, Inc, New York, USA and M/s Bayer Intellectual Property GMBH, Germany as mentioned by him in his RTI application itself and these two foreign companies have given power of attorney to Shri Kewal Krishan Nangia to obtain information under the RTI Act. It is also noted that the Power of Attorney filed by the Appellant has, instead of the usual term 'resident of' or 'residing at' has used an unusual term 'available at' and similarly the RTI application has used 'communication address'. As the Appellant himself disclosed in his RTI application in the opening para that he is Page 16 of 25 the authorized representative of the said foreign companies for seeking information on their behalf. The relevant para is reproduced hereinbelow:
"the present application is being filed on behalf of Regeneron Pharmaceutical lnc and Bayer Intellectual Property GMBH who have the rights and interest in the drug Aflibercept/Eylea, also protected by patents in India. Accordingly, this application under the Right to Information Act, 2005 is being filed to seek the following information:"
It clearly means that said foreign companies are seeking information under the RTI Act using the identity of an Indian national. In other words, M/s Regeneron Pharmaceuticals, Inc, New York, USA and M/s Bayer Intellectual Property GMBH, Germany are not Indian Citizens as required in terms of Section 3 of RTI Act, 2005 to obtain the information.
It may be noted that Section 3 of the RTI Act provides for that "subject to the provisions of this Act, all citizens shall have the right to information" and not a legal entity which in this case are foreign Companies.
The Commission referred to the decision of Hon'ble High Court of Madras in K K C Balaganesan Vs. Managing Director, Tamil Nadu Generation and Distribution Corporation Limited & Ors. in W.P. No. 19811 of 2013 dated 31.01.2023, wherein the Hon'ble Court held as:
"15. The term "person" has not been defined under the Act. However, Section 3 of the Act empowers all "citizens" to have the right to information. The preamble of the Act also is very categorical that the citizens requires to be informed in view that the democracy requires transparency of information which is vital to the functioning and to contain corruption and hold Government and their instrumentalities accountable. Viewing in that angle, the term a "person" in Section 6(1) of the Act will have to be given a restricted meaning viz., a "citizen" of India who is entitled to information....
20.In the light of the aforesaid observations and findings of the Hon'ble Apex Court in the same judgment, the observations in paragraph No.25 (extracted supra) relied upon by the learned counsel for the petitioner will have to https://www.mhc.tn.gov.in/judis be understood that the Page 17 of 25 provisions of the Act would only enable a citizen of India to receive the information. The reason that I arrive at, to such a conclusion is on the touchstone of Article 19 of the Constitution of India. Article 19 of the Constitution of India is available to only the citizens.
22.Further, if the contention of the learned counsel for the petitioner that the application under Section 6 of the Act cannot be restricted only to the citizens as adumbrated in Section 3, then would render Section 3 of the Act otiose/redundant. It is the cardinal principles of interpretation of statutes that while reading a statute, a provision of the statute cannot be made otiose or redundant. I am fortified to come to the aforesaid conclusion by placing reliance of the very same judgment (AIR 2012 SCC
864). The relevant paragraph in the aforesaid judgment is extracted hereunder: "It is well known that the legislature does not waste words or say anything in vain or for no purpose. Thus, a construction which leads to redundancy of a portion of the statute cannot be accepted in the absence of compelling reasons. In the instant case there is no compelling reason to accept the construction put forward by the respondents."
23.Hence, the contention raised by the learned counsel for the petitioner that even a non citizen would be entitled to information under the Act, in my view, is untenable. It is the duty of the Court to ascertain the intention of the statute and to whose benefit such a statute has been enacted. The statute could be enacted for a class of persons for their benefit. In the present case, the Act has been enacted to provide information to a citizen alone. Any other person, who is not a citizen of India, cannot invoke the provisions of the Act and seek information."
Further, the applicability of ratio of decisions, the arguments tendered by the Rep. of Appellant in support of his contention are rendered inconsequential. As the interpretation of judgments by Rep. of the Appellant are not in consonance with the present case. Furthermore, the judgments as referred by the Rep. of Appellant are context specific and are not generally applicable to every case.
Even if, a liberal view is accorded in the matter, the Commission upon a perusal of records and perusal of nature of the information sought by the Appellant on point No. 1 of the RTI application, the Appellant appears to have misinterpreted the scope and ambit of the RTI Act or appears largely not well acquainted with the technicalities of the Act in terms of what to ask, how to Page 18 of 25 ask and most importantly, what to expect from the CPIO(s) & FAA in exercise of his right to information. In other words, the information sought on point No. 1 of the RTI application do not strictly even conform to the provision of Section 2(f) of the RTI Act as the Appellant has raised queries or statements that are in the form of conjecture, seeking answers to "whether" questions or requires the CPIO to form an opinion based on records or interpret the records. Further, the period to which the query pertains is also not specified by the Appellant. The query involves employing certain degree of outside expertise by the CPIO and FAA to decipher 'any other form' of solution for injection Aflibercept or Aflibercept/Eylea.
The Appellant shall note that outstretching the interpretation of Section 2(f) of the RTI Act to include deductions and inferences to be drawn by the CPIO is unwarranted as it casts immense pressure on the CPIOs to ensure that they provide the correct deduction/inference to avoid being subject to penal provisions under the RTI Act. For the sake of clarity, the provision of Section 2(f) of the RTI Act is reproduced hereunder:
"2. Definitions.--In this Act, unless the context otherwise requires,-- 2(f) "information" means any material in any form, including records, documents, memos, e-mails, opinions, advices, press releases, circulars, orders, logbooks, contracts, reports, papers, samples, models, data material held in any electronic form and information relating to any private body which can be accessed by a public authority under any other law for the time being in force;.."
In this regard, the Appellant's attention is drawn towards a judgment of the Hon'ble Supreme Court on the scope and ambit of Section 2(f) of RTI Act in the matter of CBSE vs. Aditya Bandopadhyay & Ors.[CIVIL APPEAL NO.6454 of 2011]wherein it was held as under:
"35. At this juncture, it is necessary to clear some misconceptions about the RTI Act. The RTI Act provides access to all information that is available and existing.........A public authority is also not required to furnish information which require drawing of inferences and/or making of assumptions. It is also not required to provide `advice' or `opinion' to an applicant, nor required to obtain and furnish any `opinion' or `advice' to an applicant. The reference to `opinion' or `advice' in the definition of `information' in section 2(f) of the Act, only refers to such material Page 19 of 25 available in the records of the public authority. Many public authorities have, as a public relation exercise, provide advice, guidance and opinion to the citizens. But that is purely voluntary and should not be confused with any obligation under the RTI Act." (Emphasis Supplied) Similarly, in the matter of Khanapuram Gandaiah vs Administrative Officer &Ors. [SLP (CIVIL) NO.34868 OF 2009], the Hon'ble Supreme Court held as under:
"7....Public Information Officer is not supposed to have any material which is not before him; or any information he could have obtained under law. Under Section 6 of the RTI Act, an applicant is entitled to get only such information which can be accessed by the "public authority"
under any other law for the time being in force. The answers sought by the petitioner in the application could not have been with the public authority nor could he have had access to this information and Respondent No. 4 was not obliged to give any reasons as to why he had taken such a decision in the matter which was before him...." (Emphasis Supplied) In the matter of Dr. Celsa Pinto, Ex-Officio Joint Secretary, (School Education) vs. The Goa State Information Commission [2008 (110) Bom L R 1238], the Hon'ble Bombay High Court held as under:
"..... In the first place, the Commission ought to have noticed that the Act confers on the citizen the right to information. Information has been defined by Section 2(f) as follows. Section 2(f) -Information means any material in any form, including records, documents, memos e-mails, opinions, advices, press releases, circulars, orders, logbooks, contracts, reports, papers, samples, models, data material held in any electronic form and information relating to any private body which can be accessed by a public authority under any other law for the time being in force; The definition cannot include within its fold answers to the question why which would be the same thing as asking the reason for a justification for a particular thing. The Public Information Authorities cannot expect to communicate to the citizen the reason why a certain thing was done or not done in the sense of a justification because the citizen makes a requisition about information. Justifications are matter within the Page 20 of 25 domain of adjudicating authorities and cannot properly be classified as information." (Emphasis Supplied) With respect to point No. 1 (a) (i) of the RTI application, there is no larger public interest warranting disclosure of information, as the Appellant has not established larger public interest either in his RTI application or second appeal. The Commission further noted that the information sought by the Appellant "whether Cliantha Research Limited has imported/exported the solution for injection Aflibercept or Aflibercept/Eylea in any other form into India or from India". It signifies that the appellant company wants to know both 'import or export' which obviously is designed to keep a tab on the activity of a competitor using the RTI Act. The Commission further observes that the Appellant instead of seeking generic details of import/export of injection Aflibercept or Aflibercept/Eylea, has sought third party namely Cliantha Research Ltd. specific data. This amounts to targeted fishing aimed at preventing competition. Further, the Appellant in his RTI application himself stated that:
"the present application is being filed on behalf of Regeneron Pharmaceutical lnc and Bayer Intellectual Property GMBH who have the rights and interest in the drug Aflibercept/Eylea, also protected by patents in India. Accordingly, this application under the Right to Information Act, 2005.is being filed to seek the following information:"
Therefore, the information sought is exempted from disclosure in view of Section 8(1)(d) of the Act particularly since the information sought was in respect of specifications/description of products, bills, etc. which were all information in the nature of commercial confidence, trade secrets and intellectual property of third party i.e. Cliantha Research. Similarly, the information that is shared by Cliantha Research with the Respondent Public Authority, was done in compliance of the regulatory regime and were shared with a view to comply with the statutory requirements involving trust regarding confidentiality of the same. Moreover, Cliantha Research is not a Public Authority within the meaning of Section 2(h) of the Act, and the information sought was vague and a fishing and roving exercise to misuse the provision of the Act under the guise and ruse of public interest. Upon being queried by the Commission, the Appellant contended that the information sought by him is in larger public interest. On further query, it revealed that of the claimed number of diabetic persons in India only a few of Page 21 of 25 them have their eyesight affected adversely and further administering the injection does not require hospitalization as it is done in OPD with two or three dosages of the same over a period of time. Each dose of the injection cost around Rs. 40,000-50,000 in India. Being an OPD treatment, the insurance does not generally cover such costs. That means it is to be borne out of pocket. There will be very few people who can afford such cost of treatment. Public interest will thus lie in making more such drugs available in the market and not restrict their entry.
The Hon'ble Supreme Court in the matter of Bihar Public Service Commission vs. Saiyed Hussain Abbas Rizwi & Anr. [CIVIL APPEAL NO.9052 OF 2012] observed as under:
"23. The expression 'public interest' has to be understood in its true connotation so as to give complete meaning to the relevant provisions of the Act. The expression 'public interest' must be viewed in its strict sense with all its exceptions so as to justify denial of a statutory exemption in terms of the Act. In its common parlance, the expression 'public interest', like 'public purpose', is not capable of any precise definition. It does not have a rigid meaning, is elastic and takes its colour from the statute in which it occurs, the concept varying with time and state of society and its needs. [State of Bihar v. Kameshwar Singh (AIR 1952 SC 252)]. It also means the general welfare of the public that warrants recommendation and protection; something in which the public as a whole has a stake [Black's Law Dictionary (Eighth Edition)]. Emphasis Supplied "24. The satisfaction has to be arrived at by the authorities objectively and the consequences of such disclosure have to be weighed with regard to circumstances of a given case. The decision has to be based on objective satisfaction recorded for ensuring that larger public interest outweighs unwarranted invasion of privacy or other factors stated in the provision. Certain matters, particularly in relation to appointment, are required to be dealt with great confidentiality."
".... Similarly, there may be cases where the disclosure has no relationship to any public activity or interest or it may even cause unwarranted invasion of privacy of the individual. All these protections have to be given their due implementation as they spring from statutory exemptions. It is not a decision simpliciter between private interest and public interest. It is a matter where a constitutional protection is available to a person with regard to the right to privacy. Thus, the Page 22 of 25 public interest has to be construed while keeping in mind the balance factor between right to privacy and right to information with the purpose sought to be achieved and the purpose that would be served in the larger public interest, particularly when both these rights emerge from the constitutional values under the Constitution of India."
Emphasis Supplied Therefore, the information sought by the Appellant relates to the personal information of third party, which is exempted from disclosure under Section 8(1)(j) of the RTI Act and also held by the Respondent Public Authority in trust.
The same can be garnered from a bare perusal of the text of Section 8(1)(j) of the RTI Act as under:
"8. Exemption from disclosure of information.--
(1) Notwithstanding anything contained in this Act, there shall be no obligation to give any citizen, xxxx
(j) information which relates to personal information the disclosure of which has no relationship to any public activity or interest, or which would cause unwarranted invasion of the privacy of the individual unless the Central Public Information Officer or the State Public Information Officer or the appellate authority, as the case may be, is satisfied that the larger public interest justifies the disclosure of such information;.."
Further, the information sought is commercially sensitive information. In the context of non-disclosure of information under Section 8(1)(d) of the RTI Act, 2005, the decision in Naresh Trehan vs Rakesh Kumar Gupta (W.P(C) 85/2010) decided on 24.11.2014, was referred to, wherein it was held as under:
14. "....Such information would clearly disclose the pricing policy of the assessee and public disclosure of this information may clearly jeopardise the bargaining power available to the assessee since the data as to costs would be available to all agencies dealing with the assessee. It is, thus, essential that information relating to business affairs, which is considered to be confidential by an assessee must remain so, unless it is Page 23 of 25 necessary in larger public interest to disclose the same. If the nature of information is such that disclosure of which may have the propensity of harming one's competitive interests, it would not be necessary to specifically show as to how disclosure of such information would, in fact, harm the competitive interest of a third party. In order to test the applicability of Section 8(1)(d) of the Act it is necessary to first and foremost determine the nature of information and if the nature of information is confidential information relating to the affairs of a private entity that is not obliged to be placed in public domain, then it is necessary to consider whether its disclosure can possibly have an adverse effect on third parties."
In this regard, the Commission finds no infirmity in the reply and as a sequel to it further clarifications tendered by the CPIO during hearing as the same was found to be in consonance with the provisions of RTI Act.
The Commission is of the considered opinion that RTI Act is meant to promote transparency, it was not intended to cause an invasion of the privacy of third party or to disclose their financial information/commercially confidential information, etc. Neither in the application nor in the appeal has the Appellant brought out any overriding public interest that will be served with the disclosure of the information.
No intervention of the Commission is required in the matter.
The appeal is disposed of accordingly.
Vinod Kumar Tiwari (विनोद कुमार तििारी) Information Commissioner (सूचना आयुक्ि) Authenticated true copy (अभिप्रमाणणर् सत्यापपर् प्रनर्) (S. Anantharaman) Dy. Registrar 011- 26181927 Date Page 24 of 25 Copy To:
The FAA, Office of the Principal Commissioner Of Customs, Hyderabad Customs Commissionerate, L.B. Stadium Road, Basheerbagh, Hyderabad - 500004 Page 25 of 25 Recomendation(s) to PA under section 25(5) of the RTI Act, 2005:-
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