API and IP News 29 March 2026: Abrocitinib P-IV Filings, Oral Semaglutide, and EPO Patent Decisions
The Future of Pharma: Key Insights from the March 2026 API and IP Newsletter Summary for this blog post: Staying ahead in the pharmaceutical industry requires a keen eye on Paragraph IV (P-IV) filings, intellectual property litigation, and regulatory shifts. This latest update covers significant developments in atopic dermatitis treatments, oral semaglutide legal battles, and landmark patent office decisions. Abrocitinib: The Next Big Frontier in Paragraph IV Filings The landscape for Abrocitinib (Pfizer’s Cibinqo) is shifting rapidly following recent FDA updates. As a selective JAK1 inhibitor indicated for refractory, moderate-to-severe atopic dermatitis, it represents a high-stakes market with 2025 US sales reaching approximately $115 million. Key Market Insights:
- NCE-1 Date: January 14, 2026.
- ANDA Activity: Three Abrocitinib ANDAs with P-IV certificates have been submitted to the FDA.
- Indian Market: Glenmark Pharmaceuticals recently launched the drug in India as Jabryus in partnership with Pfizer.
- Pricing: In the US, a 30-day supply costs between $5,000 and $11,000, highlighting why generic entry is so critical.
Patent No. Expiration Date Use/Type 9035074 01/14/2036 Drug Substance/Product 9545405 02/19/2034 Drug Substance/Product 9549929 02/19/2034 Use Code U-3195
While the legal battle is just beginning, a generic launch before 2036 remains a significant challenge for filers.
EPO Ruling: EirGen Pharma Ltd vs. DSM Nutritional Products
A major decision from the European Patent Office (EPO) Technical Board of Appeal has provided a significant victory for EirGen Pharma. The case centred on a stabilised, controlled-release Vitamin D formulation.
What Changed?
Below are more details
- Broader Protection: The Board maintained the patent based on Auxiliary Request 1, which offers broader protection than the more restrictive "wax matrix" limitation previously suggested.
- Novelty & Inventive Step: The Board ruled that adding at least 5 wt% of a cellulose ether provided an inventive step by improving the stability of the dissolution profile, a solution not suggested in prior art.
- Clinical Clarification: The patent now specifically targets treatment for secondary hyperparathyroidism in patients with chronic kidney disease (CKD).
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Contents
Recent Paragraph IV filings
General information
No luck for Broadcom as Netflix and Quinn Emanuel succeed in another nullity claim
OPINION | Legal battle over IP covering oral semaglutide is not yet over
Intellectual Property
EirGen Pharma Ltd vs DSM Nutritional Products AG
Recent Paragraph IV filings
We follow an ANDA filed with P-IV certificates. On 19 March, the FDA published the list of recent P-IV filings, and only an ANDA with a P-IV certificate was filed, i.e., abrocitinib.
Abrocitinib is marketed by Pfizer under the brand name Cibinqo. It is a selective JAK1 inhibitor specifically indicated for refractory, moderate-to-severe atopic dermatitis. US sales totalled approximately $115 million, contributing to global revenue of roughly $284 million in 2025.
Abrocitinib is marketed by Pfizer under the brand name Cibinqo. It is a selective JAK1 inhibitor specifically indicated for refractory, moderate-to-severe atopic dermatitis. US sales totalled approximately $115 million, contributing to global revenue of roughly $284 million in 2025.
The NCE-1 date was 14 January 2026
Three ANDAs with P-IV certificates were submitted to the FDA.
The OB listed patents are as follows.
Three ANDAs with P-IV certificates were submitted to the FDA.
The OB listed patents are as follows.
General information
No luck for Broadcom as Netflix and Quinn Emanuel succeed in another nullity claim
Broadcom has suffered a further defeat in the long-running case against Netflix over video streaming technology. The Federal Court of Justice has declared another patent invalid. Now, only one case is pending in this extensive series of proceedings in Germany. News hereOPINION | Legal battle over IP covering oral semaglutide is not yet over
Torrent Pharmaceuticals marks a new frontier, making the drug more accessible without the need for injections. Torrent had received a favourable DCGI recommendation for oral semaglutide tablets across multiple strengths, making it the first oral generic entry into the Indian market. Rather than a full injunction being granted, the matter was resolved at least on an interim basis through a consent arrangement. Both parties agreed that Torrent would manufacture its oral semaglutide tablets — sold under the brand names Semalix and Sembolic in strengths of 3 mg, 7 mg, and 14 mg — with SNAC at 0.53 mmol, and would not breach the range of 0.6 to 2.1 mmol claimed under claim 1 of patent IN 325669, for both domestic and export purposes. Torrent also agreed to hand over samples of all three tablet strengths to Novo Nordisk's counsel by 10:30 a.m. the following morning. This interim arrangement was made expressly without prejudice to the rights and contentions of either party, and the matter was listed for further hearing on 24 April, with Torrent directed to file its written statement within two weeks. News hereIntellectual Property
EirGen Pharma Ltd vs DSM Nutritional Products AG
On 26 February 2026, the Technical Board of Appeal of the European Patent Office issued a decision regarding European Patent No. 2968172, titled "Stabilised Modified Release Vitamin D Formulation and Method of Administering Same". The case involved cross-appeals from the patent proprietor, EirGen Pharma Ltd., and the opponent, DSM Nutritional Products AG, following an interlocutory decision by the Opposition Division that the patent could be maintained only in the form of auxiliary request 3. Background and Requests The patent concerns controlled-release oral formulations of 25-hydroxyvitamin D2 and/or D3. The main request (the patent as granted) included independent claims for a formulation comprising a matrix—specifically a cellulose ether present in an amount of at least 5 wt%. The appellant-proprietor sought to maintain the patent as granted or through various auxiliary requests. The appellant-opponent sought the total revocation of the patent. Procedural Issues: Admittance and Witnesses The Board addressed several procedural challenges:- Admittance of Grounds and Evidence: The Board rejected the proprietor’s request to exclude the Article 100(c) EPC (added subject-matter) ground and document D79. Because these had been admitted and discussed in the first-instance proceedings, they were automatically part of the appeal.
- Witness Testimony: The proprietor requested that Charles W. Bishop and Colm Nulty be summoned as witnesses. The Board refused this, noting that the proprietor failed to indicate specific factual details to be proved. Furthermore, the Board found that their previous contributions related to claim interpretation and novelty rather than personal knowledge of past events.
Added Subject-Matter (Article 123(2) EPC)
The Board found the main request invalid due to the added subject matter in claim 16. The claim referred to treating patients with chronic kidney disease (CKD) without specifying "secondary hyperparathyroidism," which was present in the original claims. The Board agreed with the opponent that the description did not provide a basis for this omission without also including a limitation regarding "vitamin D supplementation," which was missing from the claim.
Auxiliary request 1 overcame this by reinserting "secondary hyperparathyroidism" and deleting problematic claims 19 and 20.
Novelty (Article 54 EPC)
The opponent argued that the subject-matter lacked novelty over several documents (D26, D7-D9, D24, D27, and D28). Their argument relied on combining specific examples (often using different vitamin D forms or different excipients) with general descriptions of alternative components within the same document.
The Board disagreed, emphasising the "disclosure test": novelty requires a direct and unambiguous disclosure of the claimed features in combination. It ruled that one cannot simply swap components in a specific example with alternatives from a general list unless the document specifically suggests that combination. Consequently, auxiliary request 1 was deemed novel.
Inventive Step (Article 56 EPC)
The assessment centred on D3 as the closest prior art, which disclosed controlled-release vitamin D formulations using waxy carriers. The distinguishing feature in the patent was the inclusion of at least 5 wt% of a cellulose ether.
- Technical Problem: The Board identified the technical effect as improved stability of the dissolution release profile during storage, rather than the chemical stability of the active ingredient itself.
- Obviousness: The Board reviewed several documents (D5, D9, D22, D66, D79) to see if this solution was obvious. It found that while HPMC was known generally as a stabiliser, the prior art did not suggest it would stabilise the dissolution profile of these specific vitamin D formulations. For instance, D22’s teaching on stable dissolution was limited to tramadol and required a "curing" step rather than the mere presence of cellulose ether.
The Board concluded that the claimed invention involved an inventive step.
Decision
The Board set aside the original decision and remitted the case to the Opposition Division, ordering maintenance of the patent based on auxiliary request 1 with an appropriately adapted description.
Based on the Board’s decision, the primary differences between Auxiliary Request 1 and Auxiliary Request 3 involve the scope of the pharmaceutical matrix and the specific clinical indications defined in the claims.
Matrix Composition
Auxiliary Request 1: This request maintains a broader definition of the formulation. It encompasses a controlled-release oral formulation comprising a matrix that "releasably binds and controllably releases" the vitamin D compound.
Auxiliary Request 3: This request is more restrictive. Claim 1 was specifically limited to a "wax matrix". The Opposition Division initially found that this specific "wax matrix" feature was what established novelty over prior art document D26.
Clinical Indications and Added Subject-Matter
Auxiliary Request 1: This request specifically addressed the "added subject-matter" objection that defeated the Main Request. It clarified that the treatment for patients with chronic kidney disease (CKD) must specifically be for secondary hyperparathyroidism. It also involved the deletion of claims 19 and 20 to comply with Article 123(2) EPC.
Auxiliary Request 3: While this request also met the requirements of Article 123(2) EPC, it was the version the Opposition Division originally deemed maintainable before the Board's broader ruling.
Outcome of the Appeal
The Board ultimately found that the broader Auxiliary Request 1 was both novel and inventive. Consequently, it set aside the lower decision and ordered the patent to be maintained on the basis of Auxiliary Request 1, which provides the proprietor with broader protection than the "wax matrix" limitation of Request 3.
Decision here
