In the matter of Genentech Inc and others v Drugs Controller General of India and others, CS(OS) 3284 of 2015 (Suit), the Learned Single Judge of the Delhi High Court (Court) has passed an order dated 2 March 2020 (decision) allowing an in-house expert of the Plaintiffs (defined hereinafter) to the Suit to form part of the Confidentiality Club for inspection of confidential documents produced by one of the Defendants viz. Reliance Life (defined hereinafter).

Factual Background

In 2015, Genentech Inc and others (Plaintiffs) filed the Suit against Drug Controller General of India (DCGI), Department of Biotechnology, Government of India and Reliance Life Sciences Private Limited (Reliance Life) inter alia challenging the approval given by DCGI to a drug proposed to be launched by Reliance Life under the brand name 'TrastuRel' (Impugned Drug) claiming it to be biosimilar to the Plaintiffs' drug 'Trastuzumab' sold under brand names 'Herceptin', 'Herclon', and 'Biceltis' (Plaintiffs' Drug). The Plaintiffs claimed that Reliance Life failed to conduct the necessary pre-clinical and clinical tests to establish the biosimilarity of the Impugned Drug with the Plaintiffs' Drug, in compliance of the provisions of Drugs and Cosmetics Act 1940, Drugs and Cosmetics Rules 1945 and Biosimilar Guidelines 2012, and therefore, the approval granted by DCGI was bad in law.

To support its case, Reliance Life filed an application under Section 151 of the Code of Civil Procedure 1908 (CPC) for filing of documents relating to the pre-clinical and clinical tests conducted by it in relation to the Impugned Drug, in a sealed cover with an exemption from serving a copy thereof upon the Plaintiffs. Relying upon the order dated 25 April 2016 passed in Roche Products (India) Private Limited and others v DCGI and others (CS(OS) 355/2014), the Court vide its order dated 25 April 2016 (2016 Order), dismissed the above application filed by Reliance Life. However, in order to strike a balance between the parties, the Court permitted Reliance Life to file the documents in a sealed cover and directed that the documents could be inspected by a Confidentiality Club comprising two advocates and an expert on behalf of the Plaintiffs. At this time, the Court also permitted the Plaintiffs to amend the pleadings post inspection of documents, if required. Accordingly, the Plaintiffs filed a list of two advocates and its in-house expert for inspection of documents.

Thus, Reliance Life filed another application under Section 151 of the CPC (said application) inter alia seeking a direction that for the purposes of inspection, the Plaintiffs should provide the details of an independent expert, and not an in-house expert of the Plaintiffs.

Rival contentions

Reliance Life contended that the documents relating to pre-clinical and clinical tests conducted in relation to the Impugned Drug, were generated for the purposes of the DCGI to analyse and approve the Impugned Drug, and the same were confidential qua any other competitor including the Plaintiffs. Reliance Life relied upon the Delhi High Court (Original Side) Rules 2018 (Original Side Rules) which provides for a model Confidentiality Club for inspection of confidential documents by lawyers and external experts. Reliance Life also relied upon various orders passed by the Court in the patent matters relating to Standard Essential Patents (SEPs) where the Court had constituted Confidentiality Clubs consisting of lawyers and external experts for inspection of documents.

In response, the Plaintiffs inter alia contended that the Reliance Life was essentially seeking a modification of the 2016 Order passed by the Court whereby the Confidentiality Club was constituted and an expert on behalf of the Plaintiffs was made a part of it and it was the intention of the parties that the expert will include in-house expert. The Plaintiffs further contended that the Court vide the 2016 Order had permitted the Plaintiffs to amend the plaint, which could only be possible if the Plaintiffs were permitted inspection of the documents produced by Reliance Life.

Findings and decision

The Court observed that the 2016 Order (which was carried in appeal before a Division Bench of the Court but not pressed) did not limit the expert to be an external expert only. The Court further observed that since liberty had been granted to the Plaintiffs to amend the pleadings post inspection, the same was only possible if the Plaintiffs were represented by an internal expert. As regards the model Confidentiality Club provided under the Original Side Rules, the Court observed that the same was applicable only to commercial suits and since the present Suit was not being filed as a commercial suit, the Original Side Rules are not applicable. The Court further observed that in any case, the principles akin to the model Confidentiality Club provided under the Original Side Rules were made applicable in the present case vide the 2016 Order. Further, Reliance Life's reliance on the orders passed by the Court in other matters, were considered to be distinguishable from the present case by the Court. In view of the same, the Court dismissed the said application filed by Reliance Life and permitted an in-house expert of the Plaintiffs to form part of the Confidentiality Club.

Comment

The Confidentiality Club has come across as a significant development to protect the sanctity and confidentiality of confidential documents and trade secrets, particularly useful in IP matters. The Confidentiality Club acts as a balance between a party's proprietary rights in confidential documents and counter-party's rights to have limited access to the same to effectively defend its case, under the supervision of the Court.

The decision deviates from the earlier orders on the Confidentiality Clubs which comprised of advocates and external experts only. Although, the decision has been passed in peculiar facts and its applicability on the other matters remains to be seen, this will certainly act as a guide for the Courts to mould the structure of Confidentiality Clubs. The decision will also help prevent unwanted withholding of documents by a party under the garb of them being confidential.

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