Recent ANDA approvals and British-American Tobacco (Investments) Limited vs Swedish Match North Europe AB
Contents
Recent ANDA approvals General information
Tharimmune Receives Positive FDA Feedback for TH104 Prophylaxis Program Against Respiratory Depression from Fentanyl and Ultrapotent Opioids
InterDigital accelerate battle against Amazon in Europe, Brazil and the US
Intellectual Property
British-American Tobacco (Investments) Limited vs Swedish Match North Europe AB
Recent ANDA approvals
We follow ANDA approvals. In October 2025, the USFDA issued a total of 69 ANDA approvals, of which 19 were tentative. A tentative approval is a formal notification from the USFDA indicating that a generic drug application has met all scientific and regulatory requirements for safety, efficacy, and quality, but cannot be granted final marketing approval due to unexpired patents or market exclusivities held by the original brand-name drug. The companies that could seek more than two ANDA approvals (including tentative ones) in October were as follows.
General information
Tharimmune Receives Positive FDA Feedback for TH104 Prophylaxis Program Against Respiratory Depression from Fentanyl and Ultrapotent Opioids
Tharimmune, Inc. a digital asset treasury company with a clinical-stage biotechnology function, today announced an update from the biotechnology side of the business. Its lead clinical asset, TH104 (nalmefene buccal film), received positive feedback from the U.S. Food and Drug Administration (FDA) on the Company's submitted simulation modeling plan. The FDA's feedback further de-risks the TH104 program and aligns with Tharimmune's development strategy for the planned 505(b)(2) New Drug Application (NDA) submission. News hereInterDigital accelerate battle against Amazon in Europe, Brazil and the US
InterDigital announced yesterday that it has initiated litigation against Amazon over alleged ongoing infringement of its intellectual property. The company filed cases with the US Federal District Court in Delaware, the Rio de Janeiro State Court, the Munich Regional Court and the UPC local division of Mannheim. In total, InterDigital asserted the infringement of ten patents News hereIntellectual Property
British-American Tobacco (Investments) Limited vs Swedish Match North Europe AB
This write-up details the decision of the Technical Board of Appeal of the European Patent Office concerning European Patent No. 2649888. The decision, dated 3 November 2025, addresses an appeal filed by British-American Tobacco (Investments) Limited (Opponent) against an interlocutory decision of the Opposition Division. The Patent Proprietor is Swedish Match North Europe AB. Background: The Opposition Division had previously found that, based on Auxiliary Request 1 (which was the main request in the appeal proceedings), the patent met the requirements of the European Patent Convention (EPC), specifically regarding inventive step. The Opponent requested that this decision be set aside and the patent be revoked. The Patent Proprietor requested the appeal be dismissed, maintaining the patent under Auxiliary Request 1 or, alternatively, under Auxiliary Requests 9-15. The core of the dispute revolved around the inventive step of the claimed subject matter, particularly in light of prior art documents D2 (WO 2011/127182 A1) and D5 (WO 2012/019025 A2). Main Request (Auxiliary Request 1 in Opposition Proceedings): The main request contained two independent claims:- Claim 1 (Product Claim): A smokeless tobacco composition for oral use comprising at least one type of non-tobacco fibers having an average length-to-width (L/W) ratio of 3.5:1 to 15:1, where the fiber content is 2 to 10 wt% (dry weight), and the non-tobacco fibers originate from bamboo.
- Claim 11 (Method Claim): A method for manufacturing the composition of claim 1, including steps of providing tobacco material, processing it with non-tobacco fibers added either prior to, during, or after processing to form a homogeneous blend, and optionally packing.
The Board assessed inventive step starting from D2, which discloses a smokeless tobacco product for oral use comprising non-tobacco fibres. The Board identified three differing features of claim 1 compared to D2: • Average L/W ratio of non-tobacco fibers: 3.5:1 to 15:1. • Content of non-tobacco fibers: 2 to 10 wt%. • Type of non-tobacco fiber: bamboo. Inventive Step Assessment for Claim 1 (Main Request):
- Average L/W Ratio: The Board agreed with the Opposition Division that D2 itself did not disclose a particular L/W ratio for "Just Fibre bamboo," nor was it common general knowledge. The Board also found that D3 and D4 (cited by the appellant) as proof of implicit L/W ratio or common general knowledge were new in appeal and provisionally deemed inadmissible. Furthermore, the Board noted that while D2's examples 5 and 6 used sugar beet fibres with an L/W ratio (3.3) just outside the claimed range, D2 itself proposed bamboo (claim 9 and page 10), implying it would be obvious to use bamboo as a substitute. However, the Board found no particular advantageous effect in terms of density for the claimed L/W range. Even if bamboo BAF 200 (mentioned in the patent's table 3) had an L/W ratio of 8.6 (within the claimed range), the Board considered using it as a mere alternative, thus not contributing to inventive step.
- Content of non-tobacco fibres (2 to 10 wt%): D2 disclosed at least 20 wt% non-tobacco fibres, a higher percentage than claimed. The Board considered whether a skilled person would combine D2 with D5, which proposes various structural fibres, including bamboo, at 0.5 to 10 wt% (e.g., 1 to 7 wt%).
- The Respondent argued against combining D2 and D5, citing differences in product type (pouched vs. fabric strip), user experience, and the "deliberately chosen" starting points for fibre content.
- The Board, however, maintained that D2 and D5 are in the same technical field (oral tobacco products) and that a skilled person, seeking an alternative composition, would combine their teachings. The Board did not find the Respondent's arguments convincing that the differing delivery formats or chosen weight percentages would deter a skilled person from considering D5's teachings for alternative fibre compositions or content. The Board concluded that the combination of D2 and D5 would lead to a composition comprising bamboo with a wt% of non-tobacco fibres within the claimed range, thus anticipating this feature and rendering it non-inventive.
Conclusion for Main Request: Since the Board found that the features of L/W ratio and the content of non-tobacco fibres (when combined with D2 and D5) did not contribute to an inventive step, both independent claim 1 and, consequently, independent claim 11 (which depends on claim 1 and specifies a homogeneous blend, a feature already disclosed in D2) were deemed to lack an inventive step. Auxiliary Requests 9 to 13: These requests aimed to provide more detailed definitions of the average L/W ratio to address potential clarity issues. The Board found them inadmissible or not allowable, stating that while they might improve clarity, they wouldn't change the patent's overall disclosure regarding sufficiency, and clarity itself is not an opposition ground. Moreover, these requests would not overcome the lack of inventive step already identified for Auxiliary Request 1. Claim 1 of Auxiliary Request 9 was also deemed to lack clarity (Article 84 EPC) due to an unspecific reference. Auxiliary Requests 14 and 15: These requests were method claims, similar to claim 11, incorporating elements from Auxiliary Request 1 and 9, respectively. The Board found that they also lacked inventive step for the same reasons as claim 11 of the main request. Auxiliary Request 15 was additionally found to lack clarity due to incorporating the unclear wording of Auxiliary Request 9. Final Order: The Board found that the Opposition Division was incorrect in concluding that the subject matter of claims 1 and 11 of Auxiliary Request 1 involved an inventive step. As none of the lower-ranked auxiliary requests were found allowable, the Board decided to: 1. Set aside the decision under appeal. 2. Revoke the patent. Decision here
