1.) Recent 505 (b) (2) filings 2.) Patent decision by EPO for a patent related to assaying vitamin D
Contents
Recent 505 (b) (2) filings
General information
BioNTech and Pfizer strike back against GSK in London
US FDA stepping up enforcement of pharma ad rules, sends letters to companies
Intellectual Property
N.V. Nederlandsch Octrooibureau vs Diazyme Laboratories, Inc.
Recent 505 (b) (2) filings
We follow 505 (b) (2) approvals every month. Generally, 505(b)(2) NDAs pertain to changes in comparison to previously approved drugs, such as indication, active ingredient, fixed-combination, dosage form, route of administration, dosing regimen, strength, and formulation (not approvable under section 505(j)). For more details on 505(b)(2) FDA approvals, please visit this link. The details of August 2025, 505 (b) (2)/NDA approvals are as follows:
General information
BioNTech and Pfizer strike back against GSK in London
The backlash from BioNTech and Pfizer was not long coming. After GSK sued the two manufacturers of the COVID-19 vaccine Comirnaty at the UPC and in Ireland, Pfizer and BioNTech are now seeking revocation of the related GSK patent at the UK High Court. News hereUS FDA stepping up enforcement of pharma ad rules, sends letters to companies
• Trump signs presidential memorandum on drug ad transparency • Administration seeks to enforce regulations on misleading drug ads • FDA to issue 100 cease-and-desist notices for non-compliant ads • Industry says direct-to-consumer ads help patients News hereIntellectual Property
N.V. Nederlandsch Octrooibureau vs Diazyme Laboratories, Inc.
This is a summary of a decision from the Boards of Appeal of the European Patent Office regarding an appeal against the opposition division's decision concerning European patent EP 3491392, which relates to methods and compositions for assaying vitamin D. The appeal was lodged by the opponent, N.V. Nederlandsch Octrooibureau, against the patent held by Diazyme Laboratories, Inc. Key Dates 1. Date of Decision: September 2, 2025 2. Opposition Division Decision: July 3, 2023 Grounds for Opposition The opposition was based on the following grounds: 1. Novelty (Article 54 EPC) 2. Inventive Step (Article 56 EPC) 3. Article 100(b) and (c) EPC Claim A method for assaying a vitamin D moiety in a sample, which method comprises: a) contacting a sample containing or suspected of containing a vitamin D moiety with a buffer of acidic pH in the range from 2.5 to 6.9, and at least two antibodies that are separately conjugated to particles, wherein at least one of said antibodies or the first antibody has a specific binding affinity towards the vitamin D moiety, and at least another said antibody or the second antibody has a specific binding affinity towards the complex formed between the first antibody and the vitamin D moiety; and b) assessing binding between said antibodies and said vitamin D moiety to determine the presence, absence and/or amount of said vitamin D moiety in said sample, wherein said method is conducted as a homogeneous assay. Other claims, i.e., claim 11, 13, 15, can be found here. Appellant's Arguments (N.V. Nederlandsch Octrooibureau) The appellant N.V. Nederlandsch Octrooibureau (NLO), a major European intellectual property (IP) firm , challenged the novelty and inventive step of the patent, arguing that the claims lacked sufficient disclosure and basis in the application as filed. They contended that the claimed subject matter was obvious in view of prior art, especially document D6. The strawman had filed this opposition. A strawman filing of an opposition involves a person, the "straw man," filing an opposition to a patent in their own name but on behalf of an anonymous third party, often a competitor or business partner. This is a legally accepted tactic in the European Patent Office. Respondent's Position (Diazyme Laboratories Inc) The patent proprietor (respondent) maintained that the patent should be upheld as granted, asserting that the claims were novel and inventive. They argued that the appellant's objections were unfounded and that the claimed invention was not obvious in light of the prior art. Diazyme Laboratories Inc., a leader in innovative diagnostic solutions. Prior art documents
Decision-Making Process The board initially scheduled oral proceedings but later cancelled them when the appellant indicated they would not attend. The decision was thus made in written proceedings. Key Issues and Analysis
- Homogeneous Assay Definition: The parties disagreed on the meaning of "homogeneous assay" as used in claim 1. The appellant relied on a Wikipedia definition, while the respondent argued that this definition was inaccurate and that a homogeneous assay meant an assay performed in a single phase without separating the analyte from other assay reagents. The board sided with the respondent (patentee), noting that the appellant's definition was inconsistent with the patent's description and prior art.
- Novelty: The appellant argued that claims 1 to 11, 13, and 15 lacked novelty over document D6. The board disagreed, finding that D6 did not disclose all the features of claim 1, particularly the use of at least two antibodies separately conjugated to particles. Similarly, the board found claims 9 and 13 to be novel over D6 because D6 did not disclose the specific features recited in those claims. Claim 15 was also deemed novel because D6 did not disclose the feature of antibodies attached to a solid surface.
- Inventive Step: The appellant raised several inventive step objections, arguing that the claimed subject matter was obvious in light of various combinations of prior art documents (D7, D8, D11, D12, and D17). However, the board found that many of these objections were raised for the first time on appeal and thus constituted an amendment to the appellant's case, which was not admissible. The board considered the inventive step of claims 1 to 8 and 15 based on the combination of document D7 with document D8. The board found that the lateral flow immunoassay disclosed in D7 was not a "homogeneous assay" and that combining the teachings of D7 with the use of antibodies conjugated to latex particles (as disclosed in D8) would not have led the skilled person to the claimed invention.
- Added Subject-Matter and Insufficiency of Disclosure: The appellant argued that the subject matter of the main request extended beyond the content of the application as filed and was insufficiently disclosed. However, the board found that the appellant had not adequately substantiated these arguments in the grounds of appeal. Thus, there was no reason to depart from the opposition division's decision on these points.
