API and IP Newsletter: DMF filings in February 2025 and Nicotin tablet/FERTIN PHARMA decision by EPO, -Article 123(2) and (3) EPC
Contents
Recent DMF filings- February 2025
General information
Lilly sues four compounders over copies of weight-loss drugs
Liquidia Corp files patent infringement suit against United Therapeutics
Intellectual Property
T 1330/23 (Nicotin tablet/FERTIN) 20-02-2025
Recent DMF filings- February 2025
We track DMFs filed each month. The FDA publishes the list of DMF filings quarterly. The first quarter DMF filing list was released in the first week of April, and this month we are analysing DMFs filed in February 2025.
A total of 57 DMFs were filed in January 2025. The top DMF filers are listed below.
About 18 DMFs were filed by Chinese companies, and about 24 DMFs were filed by Indian companies. After a long time, we are noticing that Indian companies have submitted a greater number of DMFs than Chinese companies. This month, perhaps due to the Chinese New Year holidays, the number of DMFs filed by Chinese companies is lower than that of Indian companies.
Some of our other observations are as follows.
General information
Lilly sues four compounders over copies of weight-loss drugs
Lilly's lawsuits, to be filed in California, name Mochi Health Corp, Fella Health and Delilah, Willow Health Services, and Henry Meds, accusing them of selling tirzepatide knockoffs — including versions with additives or in oral form — without clinical evidence of safety or effectiveness.
News here
Liquidia Corp files patent infringement suit against United Therapeutics
The action, filed on Monday, April 21, 2025, in the United States District Court for the Middle District of North Carolina, alleges that United Therapeutics infringed on U.S. Patent No. 10,898,494. The patent in question pertains to a dry powder formulation of treprostinil, a drug used for the treatment of pulmonary hypertension.
News here
Intellectual Property
T 1330/23 (Nicotin tablet/FERTIN) 20-02-2025
Background of the Appeal
The document presents a decision from the Boards of Appeal of the European Patent Office (EPO) concerning a patent dispute over a nicotine tablet designed for oral disintegration. The core issue revolves around an appeal filed by Fertin Pharma A/S ("the Appellant" or "Patent Proprietor") against a prior decision by the Opposition Division of the EPO.
Our Pharma readers might not know much about Fertin Pharma, a company known for making nicotine gum. In 2021, it was taken over by Philip Morris International Inc for ~ USD 800 mio.
Now, back to the case: The Opposition Division had initially revoked European Patent No. 3720418. This revocation was based on the finding that the claims within the patent application, specifically claim 1 of the main request and several auxiliary requests, contained added subject matter that was not originally disclosed in the initial filing.
Furthermore, the Opposition Division determined that claim 1 of auxiliary request 2 broadened the scope of protection beyond what was initially granted.
In response to the revocation, Fertin Pharma A/S initiated an appeal, submitting eleven sets of claims, including a main request and ten auxiliary requests. The Appellant Fertin Pharma also presented documents D25 and D26 as evidence of prior art, intending to demonstrate the common general knowledge regarding polyols, a key ingredient in the nicotine tablet formulation.
Prior Art documents
Article 123(2) and Article 123(3)
Article 123(2) of the European Patent Convention (EPC) prohibits amending a European patent application or patent to include subject matter beyond what was disclosed in the original application as filed.
Article 123(3) prohibits amending a European patent to extend the protection it confers.
In European patent practice, this is referred to as an inescapable trap. In this regard, EP patent practice is much stricter than that of the US or India.
This isn't very easy to understand, but very simplistically, once a European patent is granted, it cannot be amended to extend the protection it confers. This is Article 123(3) EPC.
The practical consequence of this is that if a limiting amendment introduced during prosecution is found, post-grant (e.g., in Opposition proceedings), to add matter in contravention of Article 123(2) EPC, it may not be possible to save the patent because deleting the limiting feature would broaden the scope of the claim and thus violate Article 123(3).
The Fertin Pharma case is one example of a case related to Articles 123(2) and 123(3).
The Core Dispute: Claim 1 and Added Subject Matter
The central point of contention is the validity of Claim 1 in the main request, which is identical to the initially granted Claim 1.
This claim describes an orally disintegrating nicotine tablet designed to relieve nicotine cravings. The tablet comprises a pressed powder formulation that disintegrates within 60 seconds upon oral administration. The formulation includes:
• Nicotine
• A pH regulating agent
• At least one polyol (comprising more than 40% of the tablet's weight)
• A disintegrant (present in an amount of 1-10% of the tablet's weight)
The claim specifies that the polyol must be selected from a list of sugar alcohols (sorbitol, erythritol, xylitol, maltitol, mannitol, lactitol, and isomalt), the disintegrant must be cross-linked polyvinylpyrrolidone, and the pH regulating agent must be an alkaline buffering agent.
McNeil AB ("the Respondent" or "Opponent") opposed the appeal, requesting its dismissal and the upholding of the Opposition Division's revocation decision.
McNeil AB develops nicotine replacement therapy products that include gums, patches, inhalers, microtabs, lozenges, mouth sprays, and nasal sprays.
McNeil AB submitted document D27 as further evidence of prior art knowledge concerning polyols. The Respondent, McNeil AB argued that Claim 1 was not adequately supported by the original application as filed, asserting that the Appellant Fertin Pharma had arbitrarily selected certain features from a broader range of possibilities without a sufficient basis.
Appellant's (Fertin Pharma) Arguments
The Appellant Fertin Pharma argued that the subject matter of Claim 1 was directly and unambiguously disclosed in the original application. Claims 1, 19, 25, 26, and 29 are linked by their dependencies.
Fertin Pharma contended that the features not explicitly disclosed in these claims—namely, the specific preferred polyols and the limitation of the pH regulating agent to an alkaline buffering agent—were disclosed as preferred embodiments within the application's description.
The Appellant, Fertin Pharma, specifically pointed to a passage on page 32, lines 16-19, as disclosing the preferred polyols and argued that this passage was generally applicable to the invention, rather than limited to specific examples. They also contended that the disclosure of polyols as bulk sweeteners implied their significance as a major ingredient in the tablet. Regarding the alkaline buffering agent, the Appellant cited passages on pages 22 and 34, arguing that the general teaching of the application, including the examples, indicated a preference for alkaline over acidic buffering agents.
McNeil AB’s Arguments
McNeil AB countered that Claim 1 was not supported by the original application, arguing that the application contained a "reservoir of features" from which Fertin Pharma had selectively combined elements without a clear link or basis. McNeil AB argued that there was no inherent connection between the chosen disintegrant (cross-linked polyvinylpyrrolidone) and the specified amount (1-10 wt.%). Similarly, it is argued that there was no link between the polyol content (more than 40 wt.%) and the specific list of sugar alcohols.
McNeil AB further argued that the polyols were described as having different functions in different parts of the application (disintegration rate vs. bulk sweeteners) and that the passage on page 32 was limited to specific examples and could not be generalised.
Finally, McNeil AB argued that the application disclosed both acidic and alkaline buffering agents without expressing a preference, making the limitation to alkaline agents an unallowable generalisation.
Board's Analysis and Reasoning
The Board of Appeal focused its analysis on whether the subject matter of Claim 1 met the requirements of Article 123(2) EPC, which prohibits adding subject matter to a patent application after its initial filing. The Board considered whether the combination of features in Claim 1 was directly and unambiguously disclosed in the original application.
The Board agreed that Claims 1, 19, 25, 26, and 29 were linked by their dependencies and that Claim 19's specification of at least one polyol at a concentration of at least 40% by weight was a preferred feature supported by multiple points in the description.
The Board also found that the requirement for a disintegrant in Claim 25 was a preferred embodiment, given the tablet's intended rapid disintegration. The Board further agreed that the specification of cross-linked polyvinylpyrrolidone as the disintegrant was also a preferred embodiment, as it was the only disintegrant mentioned in the claims.
Regarding the specific polyols, the Board found that the passage on page 32, lines 16-18, which described sugarless sweeteners including the listed sugar alcohols, was directly and unambiguously disclosed in combination with the other features in Claims 1, 19, 25, 26, and 29. The Board rejected McNeil AB’s argument that the polyols had different functions in different parts of the application, noting that formulation excipients often serve multiple roles.
With respect to the alkaline buffering agent, the Board acknowledged that the application disclosed both acidic and alkaline agents. However, the Board found that the common general knowledge that nicotine absorption requires an alkaline pH, combined with the fact that the examples in the application used alkaline buffering agents, pointed towards a preference for alkaline agents.
The Board disagreed with McNeil AB’s argument that selecting certain preferred embodiments was arbitrary. The Board stated that Claim 1 was limited by incorporating the most preferred embodiment of each feature, and the application did not disclose embodiments of the same feature with equal or higher preference.
Decision and Order
Based on its analysis, the Board concluded that the subject matter of Claim 1 of the main request met the requirements of Article 123(2) EPC. The Board then considered both parties' requests regarding the outcome of the appeal. Both parties had requested that, if the Board found that one of the claim requests met the requirements of Article 123(2) and (3) EPC, the case should be remitted to the Opposition Division for further prosecution.
Considering these requests and that the initial decision under appeal dealt only with the ground of added subject matter (ie Article 123), the Board found that special reasons existed to remit the case to the Opposition Division per Article 111(1) EPC.
Therefore, the Board issued the following order:
1. The decision under appeal was set aside.
2. The case was remitted to the Opposition Division for further prosecution.
The Board also decided to admit documents D25 to D27 into the proceedings, finding that they were relevant to the issue of common general knowledge regarding polyols.
Decision here
