Delhi High Court Rules Against Roche in Pertuzumab Patent Disclosure Case, Clarifies Section 104A Requirements for Biologics
核心洞察
The Delhi High Court denied F. Hoffmann-La Roche's request to access Zydus Lifesciences' manufacturing process for their Pertuzumab biosimilar, ruling that Roche failed to meet mandatory requirements under Section 104A of the Patents Act.
The court established that Section 104A can be invoked at interim stages of patent litigation and prevails over general discovery provisions under the Commercial Courts Act.
The ruling clarifies that "identical product" requirements under Section 104A cannot be diluted for biological drugs, even though absolute replication is scientifically difficult.
The Delhi High Court has delivered a significant ruling in the patent dispute between F. Hoffmann-La Roche AG and Zydus Lifesciences Limited, denying Roche's application to access confidential manufacturing information for Zydus's Pertuzumab biosimilar through a confidentiality club. Justice Amit Bansal held that Roche failed to meet the mandatory requirements under Section 104A of the Patents Act, 1970, while establishing important precedents for biological drug patent litigation in India.
Patent Dispute Background
The case centers on two Indian patents held by the Roche Group: Indian Patent No. IN 268632, titled "Pharmaceutical Formulation Comprising HER2 (搜索) Antibody," covering an aqueous pharmaceutical formulation of Pertuzumab with specific excipients including sucrose, histidine acetate buffer, and polysorbate with pH maintained between 5.5 and 6.5; and Indian Patent No. IN 464646, titled "Pertuzumab Variants and Evaluation Thereof," a process patent detailing manufacturing methods for Pertuzumab and its variants.
Pertuzumab, marketed as Perjeta, is a prescription medicine for treating patients with early-stage breast cancer (搜索) and metastatic breast cancer (搜索), approved by regulatory authorities in several countries. Zydus Lifesciences, an Indian pharmaceutical company, had filed an application with the Central Drugs Standard Control Organisation (CDSCO) for permission to manufacture a biosimilar formulation and was conducting clinical trials for their product ZRC-3277.
Court's Analysis of Section 104A
The court addressed several critical questions regarding the scope and interpretation of Section 104A of the Patents Act. Justice Bansal ruled that Section 104A can be invoked at interim stages of patent litigation, stating there was "nothing in the Section to suggest that Section 104A of the Act cannot be invoked at an earlier stage and may be invoked only at the stage of final adjudication."
The court determined that Section 104A applies to disclosure of manufacturing processes, noting that "disclosure of its manufacturing process by Zydus is the key mandate under Section 104A of the Act." The language of Section 104A(2) specifically uses the term 'disclose' in relation to confidential aspects of the defendant's process.
Patents Act Prevails Over Commercial Courts Act
In a significant ruling for patent law practitioners, the court held that Section 104A of the Patents Act prevails over discovery provisions under the Commercial Courts Act, 2015. Applying the principle of lex specialis derogat legi generali, Justice Bansal stated that "the Patents Act, 1970 is a specialised legislation dealing with patent infringement whereas the Commercial Courts Act, 2015 is a general legislation dealing with all commercial disputes."
Biologics and Identical Product Requirements
The court rejected Roche's contention that Section 104A should not apply to biological drugs because they cannot be identical by nature. Justice Bansal held that "the threshold of identicality cannot be diluted in biologic cases merely because absolute replication is scientifically difficult. The statutory use of the term 'identical' reflects the legislature's conscious choice, and to read the same in a lower threshold would amount to judicial dilution of the requirement."
Failure to Meet Section 104A Requirements
The court found that Roche failed to demonstrate that Zydus's product was identical to the product obtained from their patented process. The analysis revealed that Pertuzumab was already known in prior art, and the end product of process patent IN 646 was "a distinct composition comprising Pertuzumab and one or more variants." The court noted that Zydus's reference to Perjeta in its CDSCO application was not to the product obtained from the patented process IN 646.
Claim mapping showed formulation differences between the products, with Zydus using arginine citrate versus Roche's histidine acetate buffer. The court emphasized that "reference to a branded biologic in regulatory filings does not imply process infringement."
Legal Precedents Established
The ruling establishes several important precedents for patent litigation in India. The court clarified that Section 104A governs disclosure in process patent cases and applies at all litigation stages. Plaintiffs must prove product identity before invoking Section 104A, and the Patents Act prevails over general laws like the Commercial Courts Act. The decision also establishes that "similar biologic" is not equivalent to "identical product" under patent law.
Impact on Biosimilar Industry
The decision has significant implications for India's growing biosimilar market, particularly in oncology where multiple companies are developing alternatives to expensive branded biologics. The ruling provides clarity on disclosure requirements while protecting defendants from overly broad discovery requests that lack proper legal foundation.
The court dismissed Roche's application (I.A. 5827/2024) for constitution of a confidentiality club, while clarifying that the ruling was limited to this specific application and would not affect the suit's final outcome. The case continues as CS(COMM) 159/2024 in the Delhi High Court.