Recent DCGI approvals and Case law: Honeywell International Inc. Vs ARKEMA FRANCE.

Contents

Recent DCGI approvals

Erdafitinib Tablets 3 mg, 4 mg and 5 mg. Vorasidenib Tablets 10 mg/ 40 mg

General information

FDA Conditionally Approves Drug to Treat New World Screwworm in Dogs Novo Nordisk Submits NDA to FDA for CagriSema

Intellectual Property

Honeywell International Inc. Vs ARKEMA FRANCE.

Recent DCGI approvals

We follow the approvals of the Drugs Controller General of India (DCGI). DCGI serves as the head of the Central Drugs Standard Control Organisation (CDSCO) and is the regulatory authority for approving new medicines, vaccines, and medical devices in India. In October 2025, there are two approvals for drug products.

Erdafitinib Tablets 3 mg, 4 mg and 5 mg.

Approval Approval date: 01.10.2025 The DCGI granted approval to Natco Pharma Limited for the treatment of locally advanced or metastatic urothelial carcinoma. The decision was reached during technical committee meetings, where the committee recognised an unmet medical need for this indication. In its recommendation, the DCGI committee granted a waiver for local Phase III clinical trials. However, it stipulated that the firm must conduct a Phase IV clinical trial and submit the protocol within three months. Erdafitinib is a first-in-class FGFR kinase inhibitor designed to target specific genetic alterations in patients whose cancer has progressed after prior therapies. Patent situation in India The compound is protected in India under patent number IN-325020. It will be valid till April 2031. Any launch activities before the expiration of IN-325020 could be considered as a launch at risk.

SIDVIM’s analysis and market assessment Incidence in India: Roughly 22,500 new cases of bladder cancer are diagnosed in India annually. Genetic Eligibility: Clinical data suggest that approximately 15–20% of these patients harbour the specific FGFR3/2 genetic alterations that Erdafitinib targets. Second-Line Market: Erdafitinib is primarily used for patients whose cancer has progressed after initial chemotherapy or immunotherapy. This narrows the immediate target pool to roughly 1,500 to 2,000 patients per year in India who are both genetically eligible and have reached the metastatic/second-line stage. We found this through a simple Google search; we don’t have any direct market information or our own market research. Pricing and Probable Market Strategy Innovator Price: The innovator brand, Balversa, has been sold by distributors in India at prices exceeding Rs. 3,00,000 per pack. Generic Disruption: Natco is known for its aggressive volume-over-margin strategy in oncology (similar to their success with gRevlimid and Sorafenib). By manufacturing the Bulk Drug (API) in-house, Natco can likely offer the drug at a 60–80% discount compared to the innovator. DCGI also approved the API on the same date. Estimated Price Point: A monthly treatment cost of Rs. 40,000 to Rs. 60,000 would make it accessible to a significantly wider portion of the Indian middle class and government procurement schemes. This is an educated guess. Estimated Sales for Natco. For the domestic formulation business, even a conservative estimate of 500–700 patients annually at the estimated generic price point could generate Rs. 35-Rs. 50 crore in annual revenue from this single molecule within the first 24 months. However, noticing the IP situation, an immediate launch in the Indian market could trigger litigation.

Vorasidenib Tablets 10 mg/ 40 mg

Approval Approval date: 15.10.2025 The DCGI approval for Vorasidenib Tablets (10 mg and 40 mg) was granted to Servier India Private Limited, a subsidiary of the French pharmaceutical group Servier. This landmark approval allows marketing of the drug under the brand name Voranigo for the treatment of Grade 2 IDH-mutant gliomas, including astrocytoma and oligodendroglioma. The therapy is specifically indicated for adult and paediatric patients aged 12 years and older following surgical procedures like biopsy or resection. Recognising the significant unmet medical need and the drug's orphan drug status in other major markets, the DCGI committee granted a waiver for local Phase III clinical trials. However, as a condition of this approval, Servier India is required to conduct a Phase IV clinical trial on Indian patients. It must submit the study protocol to the CDSCO within three months. Vorasidenib is the first targeted therapy of its kind, offering a precision medicine approach that specifically inhibits mutant IDH enzymes to delay tumour progression while preserving the patient’s quality of life. Patent situation in India IN 387852 was issued to Agios and will be protected till July 2034. Any generic launch before July 2034 could be challenging and would be considered a launch-at-risk. Servier acquired Agios Pharmaceuticals’ commercial, clinical, and research-stage oncology portfolio for up to $2 billion plus royalties in 2021. Vorasidenib must be among them. SIDVIM’s analysis and market assessment The total glioma treatment market in India is valued at approximately USD 95.3 million in 2022. As a first-in-class therapy for a niche (orphan) indication, Vorasidenib is expected to capture a significant portion of the premium oncology segment. This is a Brand product. Once the product is launched in India, we will provide a more detailed assessment of the market after about a year. General information

FDA Conditionally Approves Drug to Treat New World Screwworm in Dogs

U.S. Food and Drug Administration conditionally approved Credelio Quattro-CA1 (lotilaner, moxidectin, praziquantel, pyrantel) chewable tablets for the treatment of infestations caused by New World screwworm (NWS) larvae (myiasis) in dogs and puppies at least eight weeks of age and weighing at least 3.3 pounds. News here

Novo Nordisk Submits NDA to FDA for CagriSema

1. CagriSema combines cagrilintide and semaglutide, potentially becoming the first FDA-approved GLP-1 receptor agonist and amylin analogue combination treatment.
2. Redefine 1 trial showed CagriSema led to significant weight loss, with 91.9% achieving ≥5% body weight reduction, compared to 31.5% in the placebo group.

News here

Intellectual Property

Honeywell International Inc. Vs ARKEMA FRANCE.

This document details the decision of the Boards of Appeal of the European Patent Office (Case Number: T 1940/23) regarding the European Patent Number EP3269698 held by Honeywell International Inc., opposed by ARKEMA FRANCE. The decision, dated October 17, 2025, primarily concerns the inventive step of the claimed method for manufacturing fluorinated olefins. Background: The patent relates to a method for producing fluorinated organic compounds, specifically 2,3,3,3-tetrafluoropropene (HFO-1234yf), addressing issues like catalyst collapse and byproduct formation. The method claims to convert pentafluoropropene into a final product stream containing at least one compound of formula (II) with a concentration of 3,3,3-trifluoropropene (HFO-1243zf) limited to less than 20 parts per million. CHX=CZCF3     (II) Key steps include: (a) Reacting pentafluoropropene to obtain a first product stream with pentafluoropropane and a compound of formula (I) (e.g., HFC-254eb). (b) Separating compound (I) from the first product stream. (c) Reacting the second reaction stream (with reduced compound (I)) to produce compound (II). Step (a) is typically a hydrogenation, and step (c) a dehydrofluorination.         CH2XCHZCF3     (I) HFO-1234yf (2,3,3,3-Tetrafluoropropene) is primarily used as a low Global Warming Potential (GWP) refrigerant in automobile air conditioning (MAC) systems, replacing the older HFC-134a, and is also used in heat pumps and some stationary refrigeration due to its excellent climate performance.

It is a growing market segment. The HFO-1234yf market is experiencing strong growth, projected to increase from around $1.04 billion in 2024 to $1.71 billion by 2029, driven by strict F-gas regulations, the phase-out of older refrigerants like HFC-134a, and the automotive industry's demand for low-Global Warming Potential (GWP) solutions, especially in North America and Europe.

The leading companies in the HFO-1234yf market, a key low-GWP refrigerant, are led by Honeywell International (Solstice yf) and The Chemours Company (Opteon YF). Arkema holds a significant market share, making it one of the top players worldwide in this sector.

In short, like pharmaceutical drugs, these products also have significant markets in Europe, and patents are litigated with equal vigour. Prior Art

Opposition Division's Decision (Initial): The Opposition Division found the patent (in amended form) allowable, concluding that the main request involved an inventive step. They identified documents D3 or D6 as the closest prior art, noting that the distinguishing feature was the concentration of 3,3,3-trifluoropropene in the final product stream (less than 20 ppm). The problem addressed was providing an improved method that avoided purification difficulties, and the solution was deemed non-obvious. Appellant's (Opponent's) Argument on Inventive Step: The appellant argued that the claimed method lacked an inventive step. They contended that the separation of the by-product HFC-254eb, corresponding to step (b), was not a distinguishing feature because D3 itself indicated the need to remove such by-products to prevent the formation of 3,3,3-trifluoropropene (HFO-1243zf). They also stated that no specific technical effect had been shown for the low concentration of 3,3,3-trifluoropropene. Therefore, the problem to be solved was merely the provision of an alternative method, and the claimed method was obvious in light of D3. Respondent's (Patent Proprietor's) Argument on Inventive Step: The respondent maintained that the method in claim 1 had an inventive step, considering D3 as the closest prior art. They highlighted that their method differed from D3 (specifically example 3) by including the separation step (b) and achieving the specific low concentration of 3,3,3-trifluoropropene. This, they argued, led to an improved process with less yield loss for the target compound. The prior art, according to the respondent, did not provide an incentive for a skilled person to introduce an additional intermediate separation step, making the claimed solution inventive. The Board of Appeal's Analysis of Inventive Step:

1. Closest Prior Art: The Board agreed that D3 was a suitable starting point, describing a process for HFO-1234yf that included similar hydrogenation (step a) and dehydrohalogenation (step c) steps.
2. Differing Features:

1. The Board confirmed that D3 (claim 1 and example 3) disclosed steps (a) and (c) of the main request.
2. However, D3 did not explicitly disclose the claimed separation step (b) of compound (I) (e.g., HFC-254eb) in combination with steps (a) and (c). Example 3 of D3, in particular, used the effluent directly without such separation.
3. D3 also did not explicitly disclose the feature of limiting 3,3,3-trifluoropropene to less than 20 ppm in the final product stream.

1. Technical Problem: In favour of the respondent, the Board assumed the objective technical problem was to provide an improved method with lower yield losses.
2. Obviousness of the Solution:
1. The Board noted that D3 clearly stated that HFC-254eb (a byproduct of step a) could lead to the formation of 3,3,3-trifluoropropene (HFO-1243zf) if present in the feed for dehydrofluorination (step c).
2. D3 also mentioned that pentafluoropropane (HFC-245eb) could be separated from by-products, for example, by distillation, before dehydrofluorination (page 7, lines 1-4).
3. Given this, the Board concluded that a skilled person, aware of the problem of HFO-1243zf formation from HFC-254eb, would find it obvious to separate HFC-254eb before step (c) to limit the formation of 3,3,3-trifluoropropene. This would not require inventive skills.
4. Regarding the "less than 20 ppm" limit for 3,3,3-trifluoropropene, the Board considered that seeking a high level of purity is a common objective for a skilled person, dependent on the intended use and economic balance. The respondent demonstrated no technical effect beyond this obvious advantage.
5. Thus, even assuming the more ambitious problem of an improved method with lower yield losses, the claimed solution was considered obvious.

Conclusion for Main Request: The Board found that the method of claim 1 of the main request lacked an inventive step under Article 56 EPC. Therefore, the main request was not allowable.

Auxiliary Requests 1-11: These requests were either identical to the main request or contained additional features specifying particular compounds or a minimum removal percentage (at least 50%) of compound (I). The respondent did not provide further inventive step arguments for these requests. The Board found no particular technical effect demonstrated for these additional features that would alter the inventive step assessment. Consequently, Auxiliary Requests 1-11 were also deemed to lack an inventive step and were not allowable. Auxiliary Requests 12-31: These requests were filed late (on July 14, 2025). The Board, exercising its discretion, did not admit them into the appeal proceedings because the respondent's arguments did not sufficiently demonstrate their suitability to overcome the existing inventive step issues. Final Decision: As neither the main request nor any of the auxiliary requests met the requirements of Article 56 EPC, and the late-filed auxiliary requests were not admitted, the Board set aside the decision under appeal and revoked the patent. Decision here