Recent ANDAs P-IV filings and EirGen Pharma Ltd Vs DSM Nutritional Products AG
Contents
Recent P-IV filings
General information
Local division Mannheim imposes over €1.7 million penalty against Kodak
FDA Releases Draft Guidance on Registering Pharmaceuticals for Human Use
Intellectual Property
EirGen Pharma Ltd Vs DSM Nutritional Products AG
Recent P-IV filings
We follow P-IV filings on the FDA website. The recent update was on January 05, 2026. ANDAs with P-IV filing were recently filed for two products. Details are as follows.
General information
Local division Mannheim imposes over €1.7 million penalty against Kodak
The local division Mannheim has ruled that Kodak has not complied with the conditions of a first-instance injunction in its printing plate dispute with FujiFilm. The US company must pay a substantial penalty, although the court rejected automatic enforcement by the UPC in non-EU countries such as the UK. News hereFDA Releases Draft Guidance on Registering Pharmaceuticals for Human Use
- M4Q(R2) is a globally harmonized framework for structuring quality information in medicinal product registration applications.
- The guidance organizes information into Module 2.3 (Quality Overview) and Module 3 (Body of Data) for comprehensive regulatory assessment.
- The DMCS model standardizes the structure of quality information, facilitating digitalization and efficient regulatory analysis.
- Emphasizes a holistic control strategy and accommodates emerging technologies for product lifecycle management and post-approval changes.
News here
Intellectual Property
EirGen Pharma Ltd Vs DSM Nutritional Products AG
This write-up details the decision of the Technical Board of Appeal of the European Patent Office, issued on November 24, 2025. The case, T 0180/24, concerns an appeal by EirGen Pharma Ltd. (Patent Proprietor/Appellant) against the Opposition Division's (1st instance) decision to revoke European patent EP 3650016. The opponent in the proceedings is DSM Nutritional Products AG (Respondent). The patent's title is "STABILIZED MODIFIED RELEASE VITAMIN D FORMULATION AND METHOD OF ADMINISTERING SAME." This decision would be interesting from the perspective of European patent practice, where the patent office is very strict about broadening the claimed scope beyond the application as originally filed. Present granted claim: 1. A stabilized formulation for sustained release of a vitamin D compound, the formulation comprising a mixture of: one or both of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3; and a stabilizing agent comprising a material selected from the group consisting of: cellulose compounds, poloxamers, poly(ethylene oxide) polymers, povidones, fumed silicas, and combinations thereof, wherein the stabilizing agent is present in an amount of at least about 5% of the formulation, based on the total weight of the formulation excluding any additional coatings or shells (wt%), which is effective to maintain a difference of less than 30% between the amount of vitamin D compound released at any given time point after four hours during in vitro dissolution after two months exposure to storage conditions of 25°C and 60% relative humidity and the amount released at the same dissolution time point during in vitro dissolution conducted prior to exposing the formulation to the storage conditions. Background of the Opposition Division's Decision: The Opposition Division had revoked European patent No. 3650016. This revocation was based on the conclusion that the patent as granted (Main Request) contained subject-matter extending beyond the content of the earliest application as filed, a violation of Article 100(c) EPC (which references Article 123(2) for patents, or Article 76(1) for divisional applications like this one). Furthermore, 21 auxiliary requests were found to also add subject matter (Article 76(1) EPC), and auxiliary request 22 (which later became Auxiliary Request 3 in the appeal) was deemed to extend the protection conferred by the patent as granted (Article 123(3) EPC). Auxiliary request 22 A sustained release dosage form in the form of a capsule, tablet, sachet, dragee, or suppository comprising a stabilized formulation for sustained release of a vitamin D compound, the formulation comprising a mixture of: 2. one or both of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3; and a stabilizing agent comprising hydroxypropyl methylcellulose, wherein the stabilizing agent is present in an amount of at least about 5% of the formulation, based on the total weight of the formulation excluding any additional coatings or shells (wt%), which is effective to maintain a difference of less than 30% between the amount of vitamin D compound released at any given time point after four hours during in vitro dissolution after two months exposure to storage conditions of 25°C and 60% relative humidity and the amount released at the same dissolution time point during in vitro dissolution conducted prior to exposing the formulation to the storage conditions.
Appellant's Appeal and Requests: EirGen Pharma Ltd. filed an appeal against this decision, submitting claims for a Main Request and 36 Auxiliary Requests. The Main Request and Auxiliary Requests 1 to 12 were essentially identical to some of the requests previously considered by the Opposition Division, while Auxiliary Requests 13 to 36 were new. Analysis of the Main Request: The appellant argued that Claim 1 of the Main Request, which was identical to Claim 1 as granted, did not add subject matter. They contended that all technical information was disclosed in the earliest application (WO 2014/143941 A1). Specifically, they argued that the requirement in paragraph [0144] of the earliest application—that the formulation be suitable for "controlled release of a vitamin D compound in the gastrointestinal tract of a subject which ingests the formulation"—was either not a strict limitation or was implicitly covered by the claim. The Board of Appeal, applying the "gold standard" for assessing added subject-matter (what a skilled person would directly and unambiguously derive from the entire application), disagreed. The Board highlighted two main differences:
- Claim 1 of the Main Request referred to "sustained release," while paragraph [0144] specifically mentioned "controlled release."
- Claim 1 did not explicitly state that the vitamin D compound's release was intended for the gastrointestinal tract of a subject who ingests the formulation.
The Board ruled that "ingestion" necessarily implied oral administration, and since Claim 1 was broader (not explicitly limited to oral administration), paragraph [0144] could not serve as a direct basis. Additionally, the Board found that paragraph [0036], another basis cited by the appellant, was too ambiguous and its stability example was merely illustrative, not generally applicable to support the specific combination of features in Claim 1. Consequently, the Board concluded that Claim 1 of the Main Request added subject-matter under Article 76(1) EPC.
Analysis of Auxiliary Requests 1 and 2: The Board applied similar reasoning to Auxiliary Request 1, concluding that it also added subject-matter. For Auxiliary Request 2, which included various dosage forms (capsule, tablet, sachet, dragee, or suppository), the Board found that while the appellant argued implicit suitability for gastrointestinal release via ingestion, this was not technically sound for all listed forms (e.g., suppositories). Therefore, Claim 1 of Auxiliary Request 2 was also found to add subject-matter under Article 76(1) EPC.
Analysis of Auxiliary Request 3: This request, previously Auxiliary Request 22, had been considered by the Opposition Division as not adding subject matter but to extend patent protection. The Board's review focused on the Article 123(3) EPC criterion (no extension of protection). Claim 1 of Auxiliary Request 3 detailed a sustained-release dosage form for "controlled release" of a vitamin D compound, featuring a highly specific composition including mineral oil, paraffin, glycerol monostearate, lauroyl macrogolglycerides, and HPMC.
The Board addressed two main concerns regarding extended protection:
- "Controlled release" versus "Sustained release": The Board agreed with the appellant (EirGen Pharma Ltd ) that, given the specific excipient combination and the required in vitro dissolution profile (extending over at least four hours), the "controlled release" described in Auxiliary Request 3 was inherently "sustained release." Thus, this wording did not broaden the scope of protection beyond that of the granted patent.
- Stabilising agent amount: The original patent required the stabilising agent to be present at "at least about 5% of the formulation." Auxiliary Request 3 specified HPMC (a known stabilising agent) at 10-15 wt.%. The Board clarified that the 5 wt.% threshold applied to the total stabilising agent, not each component. Since the HPMC content satisfied this, no extension of protection was identified.
Based on these findings, the Board concluded that Claim 1 of Auxiliary Request 3 met the requirements of Article 123(3) EPC.
Remittal of the Case: Auxiliary Request 3 was introduced late in the original opposition proceedings. The Opposition Division's preliminary opinion had been based on broader claims. Given that Auxiliary Request 3 was significantly more limited and aligned with the patent's examples, and because the issues of sufficiency, novelty, and inventive step for this specific request had not been thoroughly addressed by the Opposition Division or adequately argued by the parties during the appeal, the Board found "special reasons" to remit the case. This decision ensures that the appellant receives a decision on all grounds of opposition from two instances.
Final Order: The Board of Appeal set aside the Opposition Division's decision and remitted the case to the Opposition Division for further prosecution based on Auxiliary Request 3.
Decision here
