Summary
This case involved process patent claims on Pertuzumab, a breast cancer biologic. Roche alleged Zydus’s biosimilar infringed its patent and sought disclosure of Zydus’s manufacturing process. The Court held that the statutory condition under Section 104A—identity of the two products—was not satisfied. Since Sigrima (Zydus’s product) was only a similar biologic and not identical to Perjeta (Roche’s product), the Court refused disclosure.
Background & Facts
Roche holds two Indian patents covering its breast cancer drug Pertuzumab, sold under the brand name Perjeta. IN 268632 claims a formulation. IN 464646 claims a process for making Pertuzumab with specific variants.
In January 2024, Roche discovered that Zydus had applied to the drug regulator to market Sigrima, a biosimilar of Pertuzumab. It filed suit for patent infringement as a quia timet action and sought an interim direction to compel Zydus to disclose its manufacturing process, invoking Section 104A.
Zydus had earlier described Perjeta as the reference biologic in its filings, which Roche argued showed that the products were identical.
Issues for the Court
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- Can Roche compel Zydus to disclose its process under Section 104A without first showing the two products are identical?
- Does a biosimilar qualify as an “identical product” under Section 104A?
- Should Zydus’s sealed disclosure be shared with Roche’s representatives in a confidentiality club?
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Key Arguments
Roche argued that:
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- Section 104A does not require proof of identity at the interim stage; it only shifts the burden of proof during trial.
- Zydus’s use of Perjeta as a reference biologic in regulatory filings supports a strong presumption of identity.
- Similar biologics are, by definition, close enough to be treated as functionally equivalent.
- Disclosure is needed for claim mapping, and confidentiality measures can safeguard Zydus’s trade secrets.
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Zydus argued that:
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- Its product is a similar biologic, not identical to Perjeta.
- Section 104A applies only if the two products are identical, as per statutory language and case law.
- Roche cannot invoke Section 104A unless it proves identity first.
- Process disclosure at this stage would unfairly reveal proprietary information.
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Court’s Analysis
The Court held that Section 104A creates a limited exception to the normal rule that the plaintiff must prove infringement. It shifts the burden of proof only if:
a) the patent covers a process for making a product, and
b) the plaintiff first proves that the defendant’s product is identical to the one made by the patented process.
The Court distinguished “identical” from “similar,” citing dictionaries and precedent:
“The word used is ‘identical’ and not ‘similar’… ‘Similar’ means having a resemblance… but not identical.” [¶25]
As per the Court, Roche’s patent IN 646 covered not just Pertuzumab but also specific variants. Sigrima, according to the Court, did not contain those variants. So the two products were not identical.
The Court also rejected Roche’s argument that biologics should be treated differently due to their complex nature. It stated that even biosimilars must satisfy the legal threshold of identity under Section 104A before the burden of proof can shift.
Because Roche had not shown identity, the Court refused to order Zydus to share its process details with the confidentiality club.
Findings & Order
The Court held:
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- Section 104A does not apply unless the plaintiff proves product identity.
- A similar biologic is not the same as an identical product.
- Roche had not shown that Sigrima and Perjeta were identical.
- Therefore, the Court would not compel Zydus to disclose its manufacturing process.
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Relevant Paragraphs
“The word used is ‘identical’ and not ‘similar’… The meaning of the word ‘identical’ means being the same, exactly equal and alike… ‘Similar’ means having a resemblance… but not identical.” [¶25]
“Unless the two products are identical, Section 104A is not attracted. The products being identical is sine qua non for applicability of Section 104A.” [¶70]
“A similar biologic can never be an exact replica… Nonetheless, a similar biologic is nearly identical to its reference biologic… Therefore, the requirement of identity is not satisfied.” [¶16.4]
Disclaimer
This case note has been prepared based on the author’s understanding, views, and conclusions. Opinions of others may differ.
Citation: F-Hoffmann-La Roche AG & Anr. v. Zydus Lifesciences Ltd., CS(COMM) 159/2024, 2025 SCC OnLine Del 2347, https://indiankanoon.org/doc/103228643/ (last visited July 24, 2025).