1.) DMFs filed in August 2025 2.) Arkema France vs Central Glass Company
Contents
DMFs filed in August 2025
General information
Relief Therapeutics Announces Positive Results from Pivotal Bioequivalence Study of RLF-OD032
AI-Driven Organ-on-Chip Platforms Are Changing the Game in Bio/Pharma R&D
Intellectual Property
Arkema France vs Central Glass Company
DMFs filed in August 2025
The FDA publishes a list of DMF filings each quarter. The third-quarter list was recently released. Last week, we analysed DMFs filed in July; this week, we will cover those filed in August 2025. 81 DMFs were filed in August 2025. Chinese companies submitted 42 DMFs, while Indian companies filed 33 DMFs. However, one Chinese company, Suzhou Ryway Biotech Co Ltd, filed 12 DMFs for different iodine-based imaging agents. The list of other companies that have filed more than 2 DMFs in August 2025 is shown below.
General information
Relief Therapeutics Announces Positive Results from Pivotal Bioequivalence Study of RLF-OD032
Relief, a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced positive results from its pivotal bioequivalence clinical study evaluating RLF-OD032, Relief's innovative and highly concentrated liquid formulation of sapropterin dihydrochloride, for the treatment of phenylketonuria (PKU). News hereAI-Driven Organ-on-Chip Platforms Are Changing the Game in Bio/Pharma R&D
Silvia Scaglione, PhD, director of research at the National Research Council in Italy and founder of React4Life, an Italy-based biotech company specializing in organ-on-chip technology, spoke with the Pharmaceutical Technology® group during CPHI Frankfurt about the advancement of organ-on-chip platforms in bio/pharmaceutical R&D. Her insights reveal a transformational period in translational research and drug development, with the potential to reshape preclinical testing and personalized medicine globally. In particular, organ-on-chip technology (such as React4Life’s platform) facilitates growth and analysis of patient-derived tissue samples. This capability enables researchers topotentially drastically reduce time, cost, and failure rates typically associated with traditional preclinical studies, Dr. Scaglione emphasizes. News hereIntellectual Property
Arkema France vs Central Glass Company
This is a write-up about an interesting decision T 1671/23 of the Technical Board of Appeal 3.3.10 of the European Patent Office (EPO), issued on August 21, 2025. The case involved an appeal by the Opponent, ARKEMA FRANCE, against the Interlocutory decision of the Opposition Division to maintain European Patent No. 3 404 006 in amended form. The Patent Proprietor was Central Glass Company, Limited. The subject of the invention is a "METHOD FOR PRODUCING TRANS-1-CHLORO-3, 3, 3-TRIFLUOROPROPENE". Trans-1-chloro-3,3,3-trifluoropropene is a chemical compound used as a refrigerant, foam blowing agent, and solvent due to its low environmental impact, specifically low global warming and ozone depletion potentials. Arkema France produces and markets trans-1-chloro-3,3,3-trifluoropropene, a chemical also known as R-1233zd(E), under its Forane brand. Central Glass Company is also a supplier of trans-1-chloro-3,3,3-trifluoropropene. The Board ultimately decided to set aside the decision under appeal and revoke the patent issued to Central Glass Company, Limited. This is a sizable market. Recent research estimates the European market for trans-1-chloro-3,3,3-trifluoropropene (R-1233zd(E)) to be around $300 million in 2024, expected to reach $600 million by 2033. This highlights the significance of this patent for both parties. Main Request: Novelty (Article 54 EPC) The Board first addressed the novelty of Claim 1 of the Main Request (the patent as maintained by the Opposition Division) in view of document D2 (GB 2313118 A). Claim 1 of the Main Request describes a method for producing trans-1-chloro-3,3,3-trifluoropropene (1233zd) by reacting a halogenated C-3 hydrocarbon compound of formula (1) with hydrogen fluoride (HF) in a gas phase, in the presence of a solid catalyst and chlorine. It specifies that the solid catalyst is a metal fluoride containing a metal from a defined list, and the molar ratio of the C3 hydrocarbon compound to chlorine is in the range of 1/0.01 to 1/0.05. The Board found that some features of Claim 1 were disclosed in D2:- D2 discloses the conversion of a compound of formula (1), 1,1,1,3,3-pentachloropropane (240fa), to the final product 1233zd by catalytic fluorination with HF.
- D2 discloses that it may be advantageous to operate with a small amount of oxygen or chlorine and that the amount of oxygen or chlorine used with respect to 240fa feeding can vary between 0.1 and 5 molar %. The Board noted that this range (1/0.001 to 1/0.05) overlaps with and completely encompasses the claimed molar ratio range of 1/0.01 to 1/0.05. Therefore, the specific molar ratio range does not contribute to novelty in combination with the presence of chlorine.
- The key differentiating feature identified by the Board was the metal fluoride catalyst. D2 discloses that, while all catalysts are activated by fluorination with HF, which can convert metal oxides to metal fluorides, it also teaches that this does not necessarily convert them entirely to a metal fluoride, potentially leaving partially fluorinated metal oxides. Since Claim 1 explicitly requires a metal fluoride catalyst, a catalyst had to be selected from the disclosure of D2.
The Board concluded that the combination of selecting chlorine gas and selecting a metal fluoride catalyst results in a method that is novel over the method disclosed in D2. Thus, the Main Request meets the requirements of Article 54 EPC. Inventive Step (Article 56 EPC) The Board considered D2 as the closest prior art. The method of Claim 1 of the Main Request differs from D2 in that it requires selecting a solid metal fluoride catalyst and the presence of chlorine during the reaction. The Board accepted the Respondent's argument that the presence of chlorine addressed a technical problem by maintaining the catalytic activity longer, resulting in an overall increase in the production (yield) of 1233zd. This was demonstrated by the patent's Comparative Example 1 and Examples 5 and 6. The resulting technical problem was the provision of an improved production method for 1233zd. The Board also noted that no particular technical effect was shown for the specific metal fluoride catalyst. The Board then assessed the obviousness of the claimed solution, which it reduced to a production method characterised by the presence of chlorine.
- D2 explicitly discloses that operating in the presence of oxygen or chlorine, in an amount according to the claim, improves the lifetime of the catalyst.
- The Board found that a skilled person, looking for a method to solve the technical problem of providing an improved production method for 1233zd, would be expected to use chlorine in the claimed amount, following the suggestion in D2 to improve catalyst lifetime.
- The Appellant's argument that D2 dissuaded the use of chlorine because of potential selectivity disadvantages was not convincing. The Board noted that D2 merely suggested using the gases with care and in specified small amounts, which were those claimed, but did not suggest completely avoiding them.
Consequently, the Board concluded that the method according to Claim 1 of the Main Request does not involve an inventive step over D2, the closest prior art. The Main Request was therefore found not allowable (Article 56 EPC). Similarly, auxiliary requests were also not allowed. Since the Main Request failed due to lack of inventive step (Article 56 EPC), Auxiliary Requests 1 to 3, 1a, 2a, and 3a were not admitted, and Auxiliary Request 4 failed for added subject-matter (Article 123(2) EPC), the patent could not be maintained on any basis. Therefore, the patent was revoked. Details here
