DMF filings in June 2025 and L'OREAL Vs Henkel AG

Contents

DMF filings by Indian companies

General information

Lexaria's GLP-1 Breakthrough: A Paradigm Shift in Oral Drug Delivery and Market Leadership Potential

Texas suit claims Lilly bribed providers to prescribe drugs

Intellectual Property

L'OREAL Vs Henkel AG

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 June 2025. A total of 107 DMFs were filed in June 2025, with 35 filed by Indian companies and 60 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

Lexaria's GLP-1 Breakthrough: A Paradigm Shift in Oral Drug Delivery and Market Leadership Potential

GLP-1 drugs, such as semaglutide (Ozempic, Wegovy) and liraglutide (Saxenda, Victoza), have revolutionized diabetes and obesity treatment. However, their reliance on injections and gastrointestinal side effects (e.g., nausea, vomiting) remain significant barriers to patient adherence. Industry data reveals that up to 75% of patients discontinue GLP-1 therapies due to tolerability issues. Lexaria's DehydraTECH platform addresses these challenges head-on. By enabling oral delivery of GLP-1 drugs with reduced side effects and comparable efficacy to injectables, the technology could redefine the standard of care. News here

Texas suit claims Lilly bribed providers to prescribe drugs

Eli Lilly has been accused of giving illegal inducements to encourage medical providers in Texas to prescribe its medicines in a new lawsuit backed by state Attorney General Ken Paxton. News here

Intellectual Property

L'OREAL Vs Henkel AG

The decision from the Boards of Appeal of the European Patent Office, dated June 17, 2025, concerns patent number EP 2830584, which the Opposition Division initially revoked. Case Details
  1. Case Number: T 0585/23 - 3.3.10
  2. Invention Title: "composition comprising (2,5-diaminophenyl)ethanol and a cellulose polymer or carboxylic anionic polymer in a medium rich in fatty substances, dyeing process and device"
  3. Patent Proprietor (Appellant): L'OREAL
  4. Opponent (Respondent): Henkel AG & Co. KGaA
Background L'OREAL appealed the decision to revoke its patent. The opposition was based on grounds including a lack of inventive step. The main issue concerns the composition of a hair dye containing (2,5-diaminophenyl)ethanol, a cellulose polymer, and fatty substances. Granted Claim: 1 . Cosmetic composition comprising: a) one or more fatty substances; b) one or more cellulose polymer(s) and/or one or more carboxylic anionic polymer(s); c) one or more oxidation base(s) chosen from (2,5-diaminophenyl)ethanol and also acid salts thereof or solvates thereof such as hydrates; d) optionally one or more coupler(s); e) optionally one or more basifying agent(s); f) one or more chemical oxidizing agent(s), preferably hydrogen peroxide; and the fatty substance content representing in total at least 10%, in particular at least 15% by weight, more particularly at least 20% by weight and more preferentially at least 25% even more particularly at least 30% by weight, more preferentially at least 40% by weight and even more preferentially at least 50 % by weight relative to the weight of the composition. Market information It appears that the Patent covers Majirel, a brand marketed by L’Oréal. Majirel is L’Oréal Professionnel’s iconic colouring product. Invented back in 1978. The brand was recently relaunched, and according to publicly available information, the product contains 2,5-diaminophenylethanol. Arguments Appellant (L'OREAL): Argued that the claimed composition was inventive because it provided an improved dyeing composition with less selectivity and greater resistance to shampooing and light compared to the closest prior art (Document D16). They contended that the specific oxidation base used in their composition (2,5-diaminophenyl)ethanol made it non-obvious. Respondent (Henkel): Argued that the claimed solution was obvious to a skilled person based on the prior art, particularly D16 in combination with D11 or D12. They claimed that a skilled person would have been motivated to use (2,5-diaminophenyl)ethanol based on the teachings of these documents.
Prior art cited during opposition

Board's Reasoning
  1. Closest Prior Art: The Board agreed that D16 was the closest prior art.
  2. Problem and Solution: The Board acknowledged that the problem underlying the invention was to provide a cosmetic composition with less selective dyeing and greater resistance to light and shampooing. The claimed solution was the specific composition containing (2,5-diaminophenyl)ethanol.
  3. Obviousness: The Board found that a skilled person, seeking to improve upon D16, would have been led to consider the teachings of D11 or D12, which disclose the benefits of (2,5-diaminophenyl)ethanol for homogeneous colouring and other desirable properties.
  4. Auxiliary Requests: The appellant filed auxiliary requests (variations of the claims) that included specific couplers and defined an alkaline pH value. The Board refused to admit auxiliary requests, stating that the appellant did not adequately explain how the amendments in these requests would overcome the objections of lack of inventive step. They noted that it was not apparent that the additional elements in the auxiliary requests should render the claimed subject-matter inventive if the higher-ranked requests were not allowed.
 Decision The Board dismissed the appeal, upholding the revocation of the patent. The Board concluded that the claimed composition was not inventive (Article 56 EPC) and that auxiliary request was not allowable. The decision was based on the reasoning that the claimed invention would have been obvious to a skilled person in light of the prior art. Decision here




Location: Mumbai, Maharashtra, India

Popular posts from this blog

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic and Trademark case for J&J's ORS-L brand (Delhi HC decision)

Image
  Contents List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic General information Unicycive Therapeutics, Inc. Announces the Publication of Oxylanthanum Carbonate Pivotal Trial Data in Clinical Journal of the American Society of Nephrology Weak regulation causing deaths due to contaminated medicines, WHO says Intellectual Property Delhi HC Trademark decision registered marks for ORS-L and ORSL List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic The FDA maintains a list of approved new drug applications (NDAs) that are no longer under patent or exclusivity and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA. The list is updated every six months (in June and December) to enhance transparency and promote the development and submission of ANDAs in markets with limited competition. The June list was published recently and can be found here . Some oral dosage formulations for which the ...
Read more

API and IP Newsletter- Recent ANDA approvals and Roxadustat decision by EPO: T 0072/23

Image
Contents Recent ANDA approvals General information Jazz pays $145m to resolve Xyrem antitrust disputes Bristol Myers Freed From Blood Cancer Drug Antitrust Litigation Intellectual Property Roxadustat decision: T 0072/23 (Photostable roxadustat formulation/FIBROGEN) Recent ANDA approvals We track ANDA approvals monthly. This report discusses the ANDA approvals obtained by generic companies in March 2025. There are approximately 86 ANDA approvals for March 2025, of which 23 are tentative approvals. Interestingly, out of the total 86 approvals, 47 were received by Indian companies.  Below is the list of top ANDA approvals. Some of our observations for the approved products are as follows. General information Jazz pays $145m to resolve Xyrem antitrust disputes Jazz Pharma has agreed to pay $145 million to settle lawsuits claiming it illegally acted to prevent generic versions of its narcolepsy therapy Xyrem from entering the US market. The lawsuits – which date back to 2020...
Read more

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

Image
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 ...
Read more