This case revolves around biosimilar drug approvals and allegations of regulatory non-compliance in granting approvals to biosimilar versions of Roche’s patented cancer drugs. The plaintiffs, including F. Hoffmann-La Roche Ltd., challenged the approvals granted by the Drugs Controller General of India (DCGI) to Hetero Drugs Limited and Cadila Healthcare Limited, alleging that these approvals were obtained through inadequate testing and a lack of compliance with the Biosimilar Guidelines, 2012.The case raises significant issues regarding data exclusivity, regulatory oversight, and the role of the judiciary in pharmaceutical patent disputes after the expiration of a patent.

Factual Background

The Plaintiffs and Their Patented Drugs

• Roche, along with its subsidiaries, developed two key biological cancer drugs:
  • Bevacizumab (marketed as AVASTIN®) – Used for treating colorectal cancer.
  • Trastuzumab (marketed as HERCEPTIN®, HERCLON™, and BICELTIS®) – Used for breast and gastric cancers.
• These drugs underwent extensive clinical trials since the late 1990s and received regulatory approvals in India between 2005-2010.

The Defendants and Their Biosimilar Approvals

• Defendant No. 1: Drugs Controller General of India (DCGI) – The regulatory body that granted approvals for biosimilar versions of Roche’s drugs.
• Defendant No. 3: Hetero Drugs Limited – Obtained DCGI approval on May 13, 2016, for biosimilar Bevacizumab.
• Defendant No. 2: Cadila Healthcare Limited – Obtained DCGI approval on October 28, 2015, for biosimilar Trastuzumab.
• Both defendants launched their drugs in India shortly after approval.

Procedural Background

Roche’s Opposition to Biosimilar Approvals

• Roche filed two separate suits in 2016 challenging the approvals granted to Hetero and Cadila.
• Sought injunctions to stop the marketing of biosimilar versions of its drugs.
• Alleged non-compliance with clinical trial protocols required under the Drugs and Cosmetics Act, 1940, and the Biosimilar Guidelines, 2012.

Interim Injunction and Regulatory Review

• The court initially granted temporary relief but allowed Cadila and Hetero to market their drugs with conditions.
• The DCGI and expert committees reviewed the approvals but upheld their decisions, claiming proper testing procedures were followed.

Discovery Applications Filed by Roche (2022)

• Roche sought disclosure of regulatory documents from DCGI, Cadila, and Hetero under Order XI Rules 12 and 14 CPC.
• Argued that key documents regarding bioequivalence and safety testing were not provided.

High Court’s Decision on Discovery Applications (2025)

• The court allowed Roche’s discovery applications, directing the defendants to submit all regulatory documents for judicial scrutiny.

Issues Involved

• Whether the approvals granted by DCGI to biosimilar versions of Bevacizumab and Trastuzumab complied with the regulatory framework?
• Whether Roche had a right to access regulatory documents under discovery proceedings?
• Whether the defendants’ biosimilars were sufficiently tested to establish bioequivalence with Roche’s drugs?
• Whether granting approvals without complete clinical trials constituted regulatory misconduct?
• Whether Roche could claim exclusivity over the test data used to approve biosimilars?

Plaintiffs (Roche’s Arguments)

Non-Compliance with Biosimilar Guidelines

• Argued that the defendants’ drugs were not properly tested to establish bioequivalence with Roche’s products.
• The clinical trial phases were incomplete and approval was granted prematurely.

Data Exclusivity & Regulatory Secrecy

• The defendants failed to submit independent test data and instead relied on Roche’s publicly available data without due process.

Regulatory Irregularities in DCGI Approvals

• Alleged that the approval process violated Section 122E of the Drugs and Cosmetics Rules, 1945, which mandates stringent testing for new drugs.

Judicial Precedents Supporting Document Disclosure

• Cited Genentech v. Drugs Controller General of India, 2016 SCC OnLine Del 2572, where the court allowed disclosure of biosimilar approval documents.
• Cited Roche India v. Drugs Controller General of India, 2016 SCC OnLine Del 2358, where the court found irregularities in biosimilar approvals.

Defendants’ (DCGI, Cadila, Hetero) Arguments

Regulatory Compliance Ensured

• The approvals were granted after following due process, including:
  • Preclinical studies.
  • Comparative clinical trials with Roche’s drugs.
  • Expert committee approvals.

Data is Confidential and Proprietary

• Argued that disclosing regulatory dossiers would give Roche unfair access to competitors’ business secrets.

Patent Expiry Eliminates Monopoly

• Roche’s patents for these drugs expired in 2013, and it cannot block biosimilars based on regulatory concerns.

Judicial Review Not Required for Regulatory Decisions

• Courts should not interfere in regulatory approvals unless there is a gross violation of law.

Judgment and Analysis

Discovery of Regulatory Documents Permitted

• The court relied on M.L. Sethi v. R.P. Kapoor (1972) 2 SCC 427, holding that discovery should be allowed if documents are relevant to the case.
• Held that Roche had a right to examine all documents used to approve biosimilars.

No Prima Facie Finding of Misconduct by DCGI

• The court did not find immediate regulatory misconduct but allowed Roche to scrutinize documents to prove its claims.

Balance Between Public Interest and Regulatory Compliance

• While acknowledging public access to cheaper biosimilars, the court emphasized the importance of strict regulatory adherence in the pharmaceutical sector.

Final Decision

• DCGI, Cadila, and Hetero were directed to submit all regulatory documents in a sealed cover.
• Confidentiality Club formed: Only legal representatives and experts could access sensitive data.
• Court upheld the validity of Roche’s discovery application but did not stay biosimilar approvals.
• Matter to proceed for trial on regulatory violations and unfair competition claims.

Key Legal Takeaways from the Case

• Pharmaceutical companies have a right to scrutinize regulatory approvals through discovery proceedings.
• Patent expiration does not eliminate a company’s right to challenge biosimilar regulatory compliance.

Case Title:F. Hoffmann-La Roche Ltd. & Others Vs. Drugs Controller General of India & Ors.
Date of Order:February 18, 2025
Case No.:CS(COMM) 540/2016 
Neutral Citation:2025:DHC:997
High Court of Delhi
Judge:Hon’ble Mr. Justice Amit Bansal

Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor - Patent and Trademark Attorney
Email: ajayamitabhsuman@gmail.com, Ph no: 9990389539