DMF filings by Indian companies-April 2025 and BMS vs Zydus- Nivolumab Case- Delhi HC.

Contents

DMF filings by Indian companies-April 2025

General information

Linus Health Announces Expansion of AI-Powered Early Cognitive Decline Detection Platform

FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs

Intellectual Property

BMS vs Zydus- Nivolumab Case

DMF filings by Indian companies- April 2025

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 April 2025. A total of 89 DMFs were filed in April 2025, with 32 filed by Indian companies and 37 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.

Below are some of our other observations about DMFs filed by Indian companies.

General information

Linus Health Announces Expansion of AI-Powered Early Cognitive Decline Detection Platform

Companies across the pharma industry are exploring ways to implement AI-based technology. One area where many believe the technology has shown promise is in early detection. By being able to identify patterns that humans would struggle to notice, the technology has the potential to provide doctors with early warnings of conditions and diseases before the symptoms begin to truly manifest and cause serious, and potentially long-lasting, damage to the patient. News here

FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs

The FDA is investigating the root cause of benzene contamination in certain drugs and informing drug manufacturers about the risks associated with benzene contamination from drug components and other potential factors. News here

Intellectual Property

BMS vs Zydus- Nivolumab Case

Today’s write-up discusses a judgment by the High Court of Delhi in a case between E.R. Squibb and Sons, LLC & ORS (Plaintiffs) and Zydus Lifesciences Limited (Defendant) regarding the infringement of Indian Patent No. IN 340060, related to the drug Nivolumab. The court rules in favour of the plaintiffs, granting an interim injunction against the defendant. Background The plaintiffs (E. R. Squibb/BMS) hold the patent for Nivolumab, a monoclonal antibody used in cancer treatment. E.R. Squibb & Sons is now a subsidiary of Bristol Myers Squibb (BMS) The defendant (Zydus) is developing a biosimilar version of Nivolumab. BMS filed suit seeking a permanent injunction to prevent Zydus from infringing its patent. The court is considering BMS’s application for interim relief to restrain Zydus pending the outcome of the suit. Plaintiff’s (BMS) Arguments

1. The suit patent is valid and subsisting.
2. Zydus, in its response dated 17th May 2022, stated that Zydus was only conducting clinical trials and defended the Bolar Exemption under Section 107A of the Patents Act. As a result, the BMS took no further action. Subsequently, after receiving certain information in April/May 2024 regarding Zydus’s proposed commercial launch of a biosimilar of Nivolumab, BMS filed the present suit.
3. Irreparable harm would be caused to BMS if an injunction is not granted.
4. The defendant, Zydus, never officially requested to procure Nivolumab from BMS.
5. Zydus’ sister concern company filed a post-grant opposition against the patent.
6. Zydus filed a patent application for a process to purify anti-PD-1 antibody, with Nivolumab being the preferred anti-PD-1.
7. The claims of the suit patent cover Nivolumab.
8. The plaintiffs, ie BMS, have mapped the sequence identifier of Nivolumab to the suit patent.

Defendant's (Zydus) Arguments

1. The patent is invalid due to a lack of novelty, inventive step, and being non-patentable.
2. Nivolumab was already claimed in patent family WO 2004/004771.
3. The process for making Nivolumab is known in the art.
4. The monoclonal antibody is a natural phenomenon.
5. The plaintiffs (BMS) have admitted to developing the Nivolumab antibody by practicing the invention described in prior art U.S. patents.
6. The defendant's (Zydus) product, ZRC-3276, is biosimilar but does not infringe because biosimilarity does not prove infringement, which requires a claim to product mapping.
7. The claim scope is limited to antibodies binding to PD-1 with no binding to other receptors; the defendant's product does not fulfil this.

Court's Analysis and Findings

1. Delay: The court rejects the defendant's (Zydus) argument of delay in filing the suit, as the cause of action arose when the plaintiffs (BMS) became aware of the defendant's intent to commercially launch the product.
2. Validity of Suit Patent: The court finds that the defendant (Zydus) has failed to raise a credible challenge to the validity of the suit patent. The prior art cited by Zydus does not disclose the specific sequences of the antibody claimed in the suit patent. The Controller of Patents previously rejected pre-grant oppositions, upholding the novelty of the patent in suit.
3. The Opposition Board Recommendation ("OBR") issued on 31st January, 2023, is consultative, and the matter is sub-judice in the High Court of Madras.
4. Inventive Step: The court finds that creating the artificial monoclonal antibody (Nivolumab) involves an inventive step.
5. Patent Claims: The plaintiffs (BMS) assert that claim mapping has been done to the Nivolumab INN.
6. Similar Biologics: In biosimilar drugs, the amino acid sequencing is also similar; however, chemically, the said drugs would be different.
7. Infringement: The court finds that both Opdivo® and ZRC-3276 are anti-PD-1 antibodies that bind with PD-1 with high specificity than the other CD-28 family receptors.

Decision

1. The court concludes that the plaintiffs (BMS) have established a prima facie case in their favour, the balance of convenience lies in their favour, and they would suffer irreparable harm if an injunction is not granted. The court grants an interim injunction restraining the defendant (Zydus) from manufacturing, using, selling, offering for sale, importing, exporting, advertising, or dealing in any biosimilar/similar biologic of Nivolumab during the pendency of the suit. The defendant, Zydus, is also directed to file an affidavit disclosing the quantity of its manufactured biosimilar product within four weeks.
2. The Court clarified that the observations made in this case are only prima facie in nature and are intended to inform the decision on the application for an interim injunction. Nothing contained herein shall be construed as an expression on the merits of the case, which shall be decided after trial, independent of any observations made herein.
3. The case is scheduled to be listed before the Roster Bench on August 8th, 2025, when a decision on merit will be made. We will monitor the case and keep the readers updated.

Decision here