DMF filings by Indian companies in May 2025 and F-Hoffmann-La Roche AG Vs Zydus Lifesciences Limited- Delhi High Court decision

Contents

DMF filings by Indian companies

General information

The Central Drugs Standard Control Organisation(CDSCO) issued a circular for Nitrosamines in Ranitidine

Novo Nordisk files 14 new lawsuits against unapproved semaglutide drugs

Intellectual Property

            F-Hoffmann-La Roche AG Vs Zydus Lifesciences Limited- Delhi High Court

DMF filings by Indian companies

We monitor DMF filings each quarter. The USFDA recently published the list of DMF filings for the second quarter of 2025. This week, we will review the DMFs filed in May 2025. A total of 82 DMFs were filed in May 2025, with 29 filed by Indian companies and 41 by Chinese companies.

Not many Indian companies are at the top of the DMF filing list. Chinese companies have long overtaken Indian companies in the DMF filing race. Now, Chinese companies consistently file more DMFs than Indian companies each quarter.

General information

The Central Drugs Standard Control Organisation(CDSCO) issued a circular for Nitrosamines in Ranitidine

The CDSCO issued a circular on July 12, 2025. The circular can be found here. The circular addresses concerns about NDMA impurity in Ranitidine. It informs State/UT Drug Controllers of recommendations from the Drugs Technical Advisory Board (DTAB), following a report by an expert committee. News here

Novo Nordisk files 14 new lawsuits against unapproved semaglutide drugs

Novo Nordisk announced the filing of 14 new lawsuits to safeguard patients from unsafe and unapproved compounded drugs claiming to contain "semaglutide." The defendants named in these lawsuits employ tactics that deceive patients into believing compounded products have been reviewed and approved by FDA or have equivalent safety or effectiveness as Novo Nordisk's approved semaglutide medicines. News here

Intellectual Property

F-Hoffmann-La Roche AG Vs Zydus Lifesciences Limited- Delhi High Court

This write-up is about a case involving F-Hoffmann-La Roche AG & ANR. (Plaintiffs) and Zydus Lifesciences Limited (Defendant). The present suit has been filed inter alia seeking relief of permanent injunction restraining infringement of the following two Indian patents.

1. Indian patent no. IN 268632, titled ‘PHARMACEUTICAL FORMULATION COMPRISING HER2 ANTIBODY’ (hereinafter ‘IN’632’), is a product patent related to an aqueous pharmaceutical formulation containing Pertuzumab and excipients such as sucrose, histidine acetate buffer, and polysorbate, with a pH between 5.5 and 6.5.
2. Indian patent no. IN 464646 titled as ‘PERTUZUMAB VARIANTS AND EVALUATION THEREOF’ (hereinafter ‘IN’646’) is a process patent which relates to the method for making a composition comprising Pertuzumab and one or more variants.

Justice Amit Bansal delivered the judgment on July 23, 2025. The main issue concerns allegations of patent infringement related to the two Indian patents mentioned above for Pertuzumab, a cancer treatment drug. The plaintiffs sought to access the defendant's manufacturing process to ascertain if it infringes their patents. The court ultimately dismissed the plaintiffs' application, finding they did not meet the mandatory requirements of Section 104A of the Patents Act, 1970. In simple words, if Company A meets the requirements of Section 104A, and in a lawsuit filed by Company A against Company B for patent infringement, the court, under Section 104A, may direct Company B to prove that their process of obtaining the identical product is different from Company A's patented process. Background of the Case

1. The plaintiffs, F-Hoffmann-La Roche AG and its subsidiary, filed the suit seeking a permanent injunction against Zydus Lifesciences Limited, alleging infringement of their Indian patents IN 268632 and IN 464646, which pertain to pharmaceutical formulations comprising HER2 antibody (Pertuzumab) and methods for making compositions comprising Pertuzumab variants. The plaintiffs contended that Zydus Lifesciences was attempting to manufacture and market a similar biologic of Pertuzumab, potentially infringing their patents. They argued that Zydus's application to the Central Drugs Standard Control Organisation (CDSCO) for permission to manufacture Pertuzumab, along with clinical trials for their product ZRC-3277, indicated an imminent threat of infringement.
2. Zydus Lifesciences countered that their product does not infringe the plaintiffs' patents, and that Pertuzumab per se cannot be patented in India. They argued that the plaintiffs' product claim for Pertuzumab was deleted by amendment during prosecution of IN’632, implying acknowledgement that Pertuzumab and its variants were already known.
3. Patent IN 632 will expire in October 2025, while the more critical patent for Plaintiff F-Hoffmann-La Roche AG, IN 646, can be enforced until April 2034.
   

The claim of IN 646 A method for making a composition comprising Pertuzumab and one or more variants wherein the Pertuzumab and variant(s) each comprise the variable light and variable heavy amino acid sequences in SEQ ID NOs. 7 and 8, respectively, and the method comprises: a. expressing Pertuzumab and the variant(s) from a recombinant Chinese Hamster Ovary (CHO) cell at manufacturing scale and purifying the composition comprising the Pertuzumab and the variant(s); and b. subjecting the purified composition to an analytical assay to evaluate the amount of the variant(s) therein, wherein: i. the variant(s) comprise an unpaired cysteine variant comprising Cys23/Cys88 unpaired cysteines in one or both variable domains of Pertuzumab in an amount ≤25% as measured by hydrophobic interaction chromatography (HIC) of the intact antibody; ii. the variant(s) comprise both a low-molecular-weight-species (LMWS) and high-molecular-weight-species (HMWS), wherein the amount of LMWS is ≤1.6% of the composition as measured by size-exclusion high performance liquid chromatography (SE-HPLC), and the amount of HMWS is ≤1.7% of the composition as measured by size-exclusion high performance liquid chromatography (SE-HPLC); iii. the variant(s) comprise an afucoslated variant in the range from > 2% to 4.1% as measured by capillary electrophoresis-laser-induced fluorescence (CE-LIF); or iv. the variant(s) comprise Pertuzumab Peak 1 fragment in an amount of ≤ 0.5% or Pertuzumab Peak 2 fragment in an amount of ≤1.0% as measured by reduced capilliary electrophoresis sodium dodecyl sulphate (R-CESDS). Key Arguments and Contentions Plaintiffs' Arguments: The plaintiffs sought the constitution of a confidentiality club to gain access to the defendant's manufacturing process, arguing it was essential for mapping the defendant's formulation and process to determine infringement. They contended that Zydus's use of Perjeta (the plaintiffs' brand of Pertuzumab) as a reference drug in their CDSCO application implied that Zydus was manufacturing a similar biologic, potentially infringing patent IN'646. The plaintiffs invoked provisions of Order XI Rules 1(7), 1(12), and 5 of the CPC, as amended by the Commercial Courts Act, 2015, to support their demand for discovery and disclosure of the defendant's process. Defendant's Arguments: The defendant argued that the plaintiffs had not established a prima facie case of patent infringement and were using the confidentiality club application as an afterthought to access their proprietary process. They contended that the plaintiffs were required to conduct claim mapping only for product patent IN'632, not process patent IN'646, and that the information for IN'632 was already publicly available. The defendant emphasised that Section 104A of the Patents Act requires the products of the plaintiff and defendant to be identical, and since their product was only a similar biologic, Section 104A did not apply. The defendant also argued that the plaintiffs were changing their stance by initially asserting compliance with Section 104A and later arguing it was not applicable at the stage of constituting a confidentiality club. Confidentiality club In patent litigation, a confidentiality club is a tool used to control the sharing of sensitive commercial information between parties during legal proceedings. It limits access to this information to a select group of people, usually including lawyers and outside experts, to balance transparency in legal processes with protecting confidential business interests. Court's Analysis and Findings Justice Bansal thoroughly analysed the arguments and relevant legal provisions, particularly Section 104A of the Patents Act. The Court emphasised that Section 104A represents a departure from the general evidentiary principle and applies only when the plaintiff meets specific threshold requirements:

1. The defendant's product is identical to the product directly obtained by the patented process.
2. The subject matter of the process patent is for obtaining a new product, or there is a substantial likelihood that the said process makes the identical product, and it is difficult for the plaintiff to determine the process used by the defendant.
   

The Court referred to several precedents, including Natural Remedies Pvt. Ltd. v. Indian Herbs Research and Supply Co. Ltd. and Bristol-Myers Squibb Holdings Ireland v. Mylan Laboratories Limited, which underscored that the products of the plaintiff and defendant must be identical for Section 104A to apply. The Court also addressed the plaintiffs' reliance on the Commercial Courts Act, 2015, noting that the Patents Act is a specialised legislation that prevails over general laws. Additionally, the Court considered the argument that Section 104A does not apply to biological drugs, acknowledging that biological drugs cannot be perfectly replicated. However, the Court stated that the legal burden under Section 104A remains one of proving identity in substance and composition and cannot be diluted merely because absolute replication is scientifically difficult. The Court found that the plaintiffs had failed to fulfil the mandatory requirements of Section 104A. Specifically, the Court concluded that the plaintiffs did not adequately demonstrate that the defendant's product was identical to the plaintiffs' product directly obtained from the patented process. The Court observed that the defendant's reference to Pertuzumab (Perjeta®) in its CDSCO application did not establish identity, as Perjeta was known in the prior art, and the product of the process patent IN'646 was a distinct composition comprising Pertuzumab and one or more variants. Judgment and Conclusion Based on the analysis, Justice Amit Bansal dismissed the plaintiffs' application for the constitution of a confidentiality club. The Court held that no direction could be issued to the defendant to disclose its manufacturing process filed in a sealed cover, as the plaintiffs had not met the requirements of Section 104A of the Patents Act. The Court clarified that any observations made in the judgment were solely to decide the present application and would not affect the final adjudication of the suit. The case was directed to be listed before the Joint Registrar on September 23, 2025. We will monitor the case and inform readers about the next developments. Key Takeaways

1. Section 104A Requirements: The judgment reinforces the strict interpretation of Section 104A of the Patents Act, emphasising the requirement of product identity between the plaintiff's and defendant's products before the burden of proof shifts to the defendant to prove their process is non-infringing.
2. Specialised vs. General Laws: The judgment affirms that the Patents Act, as a specialised law, prevails over the general provisions of the Commercial Courts Act, 2015, regarding discovery.
3. Burden of Proof: The plaintiffs failed to adequately demonstrate that the defendant's product was identical to the product directly obtained from their patented process and did not fulfil the mandatory requirements of Section 104A of the Act.
4. Biosimilarity vs. Identity: Similarity in biologics is not equivalent to identity, and the regulatory approval pathway for biosimilars does not diminish the legal burden of proving identity for patent infringement purposes.
5. Relevance of Claim Mapping: In this specific case, the claim mapping filed by the plaintiffs was considered insufficient because it related to a product patent rather than the process patent at issue.

In essence, the judgment underscores the importance of adhering to the stringent requirements of Section 104A when seeking access to a defendant's manufacturing process in patent infringement cases, particularly those involving biological drugs. Decision here