Patented Biologics and Section 104A: No Process Disclosure Without Proving Product Identity

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Roche sued Zydus for infringing its process patent on Pertuzumab. The Delhi High Court held that Roche had not shown Zydus’s biosimilar was identical to its product. Without identity, Section 104A did not apply, and the Court refused to compel Zydus to disclose its manufacturing process.

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