In a landmark judgment in the case of F-Hoffmann-La Roche AG & Anr. vs Zydus Lifesciences Limited (IA 5827/2024), involving the interpretation of Section 104A of the Patents Act 1970, the Delhi High Court dismissed Roche's interlocutory application for seeking Zydus' confidential process for the cancer drug Sigrima. The Court slammed Roche for shifting stand on invoking Section 104A and retracting its stand to the extent that the provision is not applicable at this stage of trial. The Court ruled that Roche's request to seek access to Zydus' proprietary information on the manufacturing process cannot be permitted without Roche meeting the patent law threshold as stipulated under Section 104A.
Roche also attempted to seek discovery/disclosure of the defendant's process under the provisions of Order XI Rules 1(7), 1(12), and 5 of the CPC. Roche argued that the discovery of the Zydus process was essential for infringement claim mapping and that no prima facie case was required for such discovery. The Court interpreted provisions under Section 104A of the Patent Act and provisions of Order XI Rules 1(7), 1(12), and 5 of the CPC and ruled that it cannot bypass Section 104A by invoking general discovery provisions under CPC and stated that:
“5. The Patents Act is a specialized legislation dealing with cases relating to patents including patent infringement cases, whereas the Commercial Courts Act, 2015 is a general legislation dealing with all commercial disputes. It is a settled position of law that provisions of a special statute would always prevail over the provisions of general law. Therefore, Section 104A of the Act would prevail over the discovery provisions under the CPC as amended by the Commercial Courts Act, 2015.”
Factual Matrix
The present suit bearing the case title: F-Hoffmann-La Roche AG & Anr. vs Zydus Lifesciences Limited (CS(COMM) 159/2024) was filed as a quia timet action in view of the apprehension that the defendant would launch its biologic/biosimilar product ZRC-3277, similar to the plaintiff's Pertuzumab, covered under Indian Patent No. IN 268632 titled as ‘Pharmaceutical Formulation Comprising Her2 Antibody' (hereinafter ‘IN'632').
It is a product patent that relates to an aqueous pharmaceutical formulation comprising Pertuzumab and excipients such as sucrose, histidine acetate buffer, and polysorbate, such that the pH of the formulation is between 5.5 and 6.5. and other IN 464646 titled as ‘Pertuzumab Variants And Evaluation Thereof' (hereinafter ‘IN'646'), a process patent which relates to the method for making a composition comprising Pertuzumab and one or more variants. In a series of legal developments relating to the grant of a preliminary injunction, the filing of a writ, and so on, the present position is that there is no interim injunction in favour of the plaintiffs as of the date.
Application Seeking Disclosure of the Defendant's Manufacturing Process
The present application, I.A. 5827/2024, sought disclosure of the defendant's manufacturing process for manufacturing its product ‘Sigrima', which was filed by the defendant on March 22, 2024, in a sealed cover to the members of the confidentiality club. The plaintiff contended that Section 104A of the Act is concerned with the burden of proof and not with discovery. The said burden must be established during the course of trial and not at an interim stage wherein discovery of the defendant's process is sought by the plaintiffs. Thus, Section 104A of the Act may be invoked only at the stage of final arguments and not at this stage.
The plaintiff argued that since no methodology for producing the defendant's similar biologic has been disclosed, the process employed by the defendant is identical to that of Perjeta and thus infringes the registered patent IN'646. The plaintiff further submitted that discovery/disclosure of the defendant's process also ought to be granted under the provisions of Order XI Rules 1(7), 1(12), and 5 of the CPC as amended by the Commercial Courts Act, 2015.
Additionally, the plaintiff argued that mere filing of the manufacturing process by the defendant in a sealed cover will serve no purpose, as the question whether the process employed by the defendant for making its similar biologic was identical to the plaintiff's process cannot be ascertained until the defendant's process is disclosed to the plaintiff. Relying on F-Hoffmann-La Roche vs Drugs Controller General of India [2025 SCC OnLine Del 934] judgment of this bench, the plaintiff asserted that no prima facie case was required to be established by the plaintiff for being permitted discovery of the defendant's manufacturing process.
Defendant's Plea of Invoking Section 104A Safeguard
The defendant invoked Section 104A to seek protection from disclosure, arguing that the pre-requisite of Section 104A of the Act has not been satisfied, as it requires the products of the parties to be identical. In contrast, the defendant's product is only a similar biologic of the plaintiff's product. The defendant contended that the present application does not establish any grounds for disclosure of the defendant's proprietary process, as the plaintiffs have failed to establish a prima facie case of patent infringement against the defendant. The bald assertions made by the plaintiff in reply to statements that the grounds for invoking Section 104A of the Act are satisfied are not sufficient to invoke Section 104A reversal of burden of proof.
Contrary to their earlier stance on invoking Section 104 during the oral arguments, the plaintiffs argued that Section 104A is not attracted at the stage of constituting the confidentiality club and is only relevant at the final adjudication stage. The plaintiff's aforesaid stance is contrary to the statute as well as their own pleaded case. The defendant asserted that the satisfaction of the pre-requisites prescribed under Section 104A of the Act is mandatory prior to directing the defendant to disclose its process to the members of the confidentiality club. The purpose of invoking Section 104A is to seek disclosure from the defendant in a proceeding where a plaintiff has discharged its initial onus. Thus, Section 104A cannot be ignored at the time of seeking disclosures from the defendant.
Court Analysis and Findings
The Court observed that the present application concerns enabling the confidentiality club and permitting its members to access the process used by the defendant. The Court observed that, in infringement of the process patent, the provisions of Section 104A apply. As both parties contested its applicability, one of the key issues in deciding the present application would be to determine the scope and interpretation of Section 104A. One of Roche's patents in suit, IN464646, claims a process for making a composition comprising Pertuzumab. Roche had sought disclosure, on a confidential basis, of Zydus' manufacturing process for Sigrima®.
Roche invoked Section 104A of India's Patents Act, 1970, under which a defendant may carry the burden of proving non-infringement of a patent that claims a process for producing a product, if the defendant's product is shown to be “identical” to one produced by the patented process. The Court found that Roche had not proved that Sigrima® was “identical” to the product of the patented process. The only evidence Roche could give was the use of Perjeta® by Zydus as the reference drug for Sigrima. The Court observed that this evidence may be sufficient to prove that Sigrima met the regulatory guidelines on biosimilars, but it does not prove that it was “identical” to Perjeta®. It remains open to Roche to prove the products are identical by other means in the substantive trial.
On Interpretation of Section 104A
According to the Court, “Section 104A of the Act represents a calibrated departure from the general evidentiary principle that the burden of proof lies upon the party asserting a fact. It carves out a statutory exception only in suits involving infringement of process patents, where the patentee is often handicapped in proving the infringing process due to its inherently concealed nature. However, this exception is neither automatic nor routine. Section 104A applies only when the plaintiff discharges the following threshold requirements:
“1. The defendant's product is identical to the product directly obtained by the patented process; and
2. The subject matter of the process patent is for obtaining a new product or there is a substantial likelihood that the identical product is made by the said process, and it is difficult for the plaintiff to determine the process used by the defendant.
3. If the plaintiff is able to satisfy both the aforesaid conditions, the Court has the discretion to direct the defendant to prove that the process adopted by it to obtain its product is different from the patented process.
4. In order to protect the legitimate commercial interests of the defendant, sub-section (2) of Section 104A of the Act provides that a defendant would not be required to disclose any manufacturing or commercial secrets if it appears to the Court that the same is unreasonable to do so.”
In order to look deeper into the application of Section 104A in the present case, the Court relied on the decisions of the High Court of Karnataka in Natural Remedies Pvt. Ltd. vs Indian Herbs Research and Supply Co. Ltd. [2011 SCC OnLine Kar 4561], and the High Court of Andhra Pradesh in Bristol-Myers Squibb Holdings Ireland vs Mylan Laboratories Limited [2014 SCC OnLine Hyd 1511] and noted that from a reading of the aforesaid judgments, the following legal principles emerge with regard to the scope and ambit of Section 104A of the Act:
“1. Only when the plaintiff proves that the plaintiff's product and the defendant's product are identical, the Court may direct the defendant to disclose its process to show that the same is different from the patented process.
2. The products of the plaintiff and the defendant being identical is a sine qua non for the applicability of Section 104A of the Act. Mere similarity between the two products would not suffice.
3. While directing the defendant to disclose its process, the Court would protect the trade and commercial secrets of the defendant.
4. Where the products are found to be identical and the defendant nonetheless refuses to furnish the particulars of its process, the Court may draw adverse inference and invoke Section 104A of the Act.”
Decision
Agreeing with the position of law as elucidated by the aforesaid judgments, the Court noted and clarified that:
“The intent behind Section 104A of the Act is to shift the onus of proof from the plaintiff to the defendant in cases involving infringement of process patents. This is premised on the fact that the process adopted by a defendant in manufacturing its product would be known only to the defendant and would be difficult for the plaintiff to determine. However, this is subject to certain pre-conditions, one of which is that the plaintiff has to show that the product of the defendant is identical to the product that is directly obtained from the process patent of the plaintiff."
The Court Agreed with Zydus
Agreeing with Zydus, the Court ruled that Section 104A does apply at the interlocutory stage when disclosure is sought and stated that:
“From a plain reading of Section 104A of the Act, there is nothing to suggest that Section 104A cannot be invoked at an earlier stage, particularly when the plaintiffs are seeking disclosure of the defendant's process by way of an interlocutory application."
On Relaxed Interpretation for Biosimilars
When Roche's counsel contended that biosimilar cases warrant a relaxed interpretation, the Court rejected this argument and stated that:
“There is nothing in the language of Section 104A of the Act to suggest that it would not apply in cases pertaining to infringement of biological drugs. ………“While the Biosimilar Guidelines use the term ‘similar' as sufficient for regulatory approval, the legal burden under Section 104A remains one of proving identity in substance and composition, as held in Natural Remedies (supra). This threshold 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.
Therefore, the plaintiff's contention with respect to the inapplicability of Section 104A of the Act in cases involving biological drugs is devoid of merit.
The Court dismissed Roche's application (IA 5827/2024), stating that “I do not see any merit in the present application” and noted that:
"Based on the aforesaid discussion, in my considered view, the plaintiffs have, therefore, no direction can be issued to the defendant to disclose its manufacturing process filed in a sealed cover.
As a caution, the Court also clarified that observations made in this judgment are limited to the present suit and will not affect the final adjudication of the suit.
Conclusion
It is clear from this judgment that Section 104A of the Patents Act represents a calibrated departure from the general evidentiary principle that the burden of proof lies upon the party asserting a fact. The Patents Act is a specialised legislation dealing with patents, including patent infringement disputes, and the Commercial Courts Act, 2015, is a general legislation dealing with all commercial disputes. It is a settled position of law that provisions of a special statute would always prevail over the provisions of general law. Therefore, Section 104A of the Act would prevail over the discovery provisions under the CPC as amended by the Commercial Courts Act, 2015.
For seeking disclosure under Section 104A, all thresholds as set therein should be satisfied. There cannot be a relaxed provision of Section 104A for biosimilar cases to warrant a relaxed interpretation, as there is nothing in the language of Section 104A of the Act to suggest that it would not apply in cases pertaining to infringement of biological drugs. This case is a quick reminder of the safeguards built relating to the reversal of burden of proof under Section 104A under the Indian Patent Law as amended in 2005.
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