Discovery of documents is essential for fair adjudication in disputes over bio-similar drugs, and confidentiality claims cannot obstruct this process.

JUDGMENT :

AMIT BANSAL, J.

I.A. 5639/2022 in CS(COMM) 540/2016 (under Order XI Rule 12 and 14 of CPC)

I.A. 2912/2022 in CS(COMM) 1119/2016 (under Order XI Rule 12 and 14 of CPC)

1. By way of present judgment, I shall decide the above captioned applications filed on behalf of the plaintiffs under Order XI Rules 12 and 14 of the Code of Civil Procedure, 1908 (hereinafter the ‘CPC’) seeking disclosure and production of certain documents by the defendants in connected suits being CS(COMM) 540/2016 and CS(COMM) 1119/2016.

2. CS(COMM) 540/2016 (hereinafter the ‘Hetero Suit’) has been filed by the plaintiffs seeking relief of permanent injunction restraining defendant no.3 (Hetero Drugs Limited; hereinafter ‘Hetero’) from launching, selling, marketing and/or distributing any purported bio-similar version of the plaintiffs’ approved drug ‘bevacizumab’, decree of declaration that the approval granted by the Drug Controller General of India (hereinafter the ‘DCGI’) to the Hetero’s drug is invalid, along with other ancillary reliefs. The other suit, being CS(COMM)1119/2016 (hereinafter the ‘Cadila Suit’), has been filed by the plaintiffs seeking similar relief against defendant no.1 (Cadila Healthcare Limited; hereinafter ‘Cadila’), in respect of their drug ‘trastuzumab’.

3. The documents of which production is sought by the plaintiffs in the Hetero Suit are detailed in paragraph 11 of I.A. 5639/2022, and the documents of which production is sought by the plaintiffs in the Cadila Suit are detailed in paragraph 8 of I.A. 2912/2022.

4. Since both the aforesaid applications raise common issues, they are being decided by way of a common judgment.

BRIEF FACTS

5. The plaintiffs, a group of affiliate companies, are the innovators and developers of biological drugs used for cancer treatment. The plaintiffs are the innovators of the biological drug ‘bevacizumab’, marketed under the brand name ‘AVASTIN’, which is the subject matter of the Hetero Suit. Similarly, the plaintiffs are the innovators of the biological drug ‘trastuzumab’, marketed under the brand names ‘HERCEPTIN’, ‘HERCLON’, and ‘BICELTIS’, which is the subject matter of the Cadila suit.

6. In Hetero Suit, the plaintiff no.3 [Genentech Inc.], a company organised and existing under laws of USA, is the innovator of drug ‘bevacizumab’, the plaintiff no.1 [F. Hoffmann-La Roche Ltd.], a company organised and existing under laws of Switzerland, is its manufacturer, and the plaintiff no. 2 [Roche Products (India) Private Limited], an Indian Company, is responsible for its import and marketing in India.

6.1. Extensive clinical trials for ‘bevacizumab’ began in 1997, and the drug was approved by the United States Food and Drug Administration (hereinafter the ‘FDA’) in 2004. It was launched in India in 2005 and had gained approvals in over 100 countries by 2016.

6.2. The defendant no.1, DCGI, granted approval to defendant no.3 [Hetero], to manufacture and market a bio-similar version of ‘bevacizumab’ under the brand name ‘HETERO’ on 13^th May 2016 for anti-angiogenesis treatment of metastatic colorectal cancer.

6.3. On June 27, 2016, Hetero launched its alleged bio-similar variant of the plaintiffs’ ‘bevacizumab’ under the name of ‘bevacizumab injection’ in the Indian market.

7. In Cadila Suit, the plaintiff no.3 [Genentech Inc] is the innovator of the drug ‘trastuzumab’, the plaintiff no.2 [F. Hoffmann-La Roche AG] is its manufacturer, and the plaintiff no.1 [Roche Products (India) Privat