Q1 2026 Global Pharma Insights: USFDA DMF Filing Trends and the Landmark EPO Revocation of Biogen’s Dimethyl Fumarate Patent

Q1 2026 API & IP Insights: DMF Filings, GLP-1 Litigation, and Major Patent Revocations

The first quarter of 2026 has seen a significant shift in the pharmaceutical landscape, with 379 new Type II DMFs filed at the USFDA. While Indian and Chinese companies continue to dominate the volume of filings, the focus has moved sharply toward Complex APIs and New Oncology molecules, such as Fruquintinib and Tirzepatide. For industry professionals, these filings represent the first clear roadmap for generic competition in the coming decade.

1. Q1 2026 DMF Filing Trends: India and China Lead the Charge

The USFDA recently released the DMF filing list for the first quarter of 2026, revealing a total of 379 Type II DMFs submitted. The data shows a clear dominance by Indian and Chinese manufacturers, particularly in the "New APIs" and "Speciality" categories.  

Breakdown by Category:  

  • New APIs / Speciality: ~160 DMFs from India; ~136 from China.  
  • Complex APIs: 18 filings from India; 11 from China.  
  • Vanilla Generics: Minimal activity (1 DMF each across major regions), signalling a shift toward higher-value molecules.  

Top DMF Filers:  

The MSN Group remains the clear leader with 35 combined filings (MSN Laboratories and Maithri Laboratories), followed by Dr. Reddy’s Laboratories (11) and Shandong Loncom (10). 

2. Key DMF Analysis filed by MSN: 

The Next Generic Frontier

The following molecules are seeing significant DMF activity, representing massive future opportunities and complex litigation hurdles:  

  1. Tirzepatide (Mounjaro/Zepbound): Despite high technical barriers and patents active until 2036+, several filers have entered. Global sales reached a staggering $36.5 billion in 2025.  
  2. Dapagliflozin (Farxiga): A blockbuster with 2026 generic expectations; multiple ANDAs, including MSN’s, were approved in April 2026.  
  3. Deutetrabenazine (Austedo): A specialised deuterated molecule. MSN filed its DMF in March 2026, just five days after the first ANDA was submitted.  
  4. Ensifentrine (Ohtuvayre): A first-in-class COPD treatment. Early filings suggest manufacturers are positioning themselves for a post-2036 launch. 

3. Intellectual Property Watch: Biogen’s DMF Patent Revoked

In a landmark decision (T 1462/24), the European Patent Office (EPO) revoked Biogen’s patent (EP 2,653,873) for Dimethyl fumarate (DMF).  

  1. The Issue: The Board ruled that the specific combination of a 480 mg dose for Multiple Sclerosis (MS) was an "unallowable selection" that was not directly disclosed in the original parent application.  
  2. The Result: The patent was revoked in its entirety.  
  3. Procedural Note: The Board took the rare step of ordering the patent proprietor to pay the costs for all 14 opponents due to "unprofessional" and "bad faith" procedural objections.

------------XX-------------XX--------------

Contents

Recent DMF filings

General information

FDA panel rejects risk-benefit profile of AstraZeneca cancer drug

Judge dismisses part of Eli Lilly's GLP-1 lawsuit against Houston's Empower Pharmacy

Intellectual Property

T 1462/24 (Dimethyl fumarate/BIOGEN)


Recent DMF filings

DMF filings in Q1 2026

We follow DMF filings. The USFDA recently published the list of DMF filings for 1Q 2026. A total of 379 DMFs (Type II) were filed. 

We attempted to analyse DMF filings by categorising them and defining different categories. 

The list of top DMF filers is as follows.


We analyse DMFs filed by top Indian companies. Below is a summary of MSN's important DMF filings.



General information

FDA panel rejects risk-benefit profile of AstraZeneca cancer drug

The FDA's Oncologic Drugs Advisory Committee voted 3 to 6 against AstraZeneca's experimental oral drug camizestrant, which is being developed as a first-line treatment for a type of breast cancer whose ⁠tumors have a specific mutation.
News here


Judge dismisses part of Eli Lilly's GLP-1 lawsuit against Houston's Empower Pharmacy

A federal judge on Wednesday dismissed part of Eli Lilly's lawsuit against the Houston-based Empower Pharmacy — the latest development in the pharmaceutical giant's bid to curb sales of cheaper, less-regulated versions of their blockbuster GLP-1 weight loss drug. 
The lawsuit is significant because millions of Americans have gained access to GLP-1s through compounding pharmacies like Empower, which make customized versions of drugs without going through the U.S. Food and Drug Administration review process. Empower describes itself as the largest and most advanced compounding pharmacy in the country. 

News here


Intellectual Property 

T 1462/24 (Dimethyl fumarate/BIOGEN)

In a decision dated 26 November 2025, the Technical Board of Appeal of the European Patent Office (EPO) set aside an interlocutory decision of the Opposition Division and revoked European Patent EP 2,653,873. The case centred on whether the combination of a specific dosage and a specific medical indication for Multiple Sclerosis (MS) extended beyond the original disclosure of the parent application. The Board also addressed significant procedural objections and issued a rare order apportioning costs against the patent proprietor.

1. Substantive Issue: Extension of Subject-Matter
The primary dispute concerned claim 5 of the main request, which specified the use of dimethyl fumarate (DMF) or monomethyl fumarate (MMF) for treating Multiple Sclerosis at a daily oral dose of 480 mg.

The Gold Standard Analysis
The Board applied the gold standard for assessing added matter: whether the skilled person would derive the subject-matter directly and unambiguously from the earlier application as filed.
  • Dosage Disclosure: The Board found that paragraph [0116] of the parent application was the only passage disclosing the 480 mg dose. However, this paragraph listed several dosage options, and the Board concluded it implicitly preferred 720 mg/day over 480 mg/day.
  • Lack of Link to MS: Although MS was mentioned elsewhere in the application, paragraph [0116] did not mention any specific disease. The Board determined that the dosages in paragraph [0116] were presented in general terms for various neurodegenerative diseases, rather than being specifically linked to MS.
  • Failed Pointers: The patent proprietor argued that MS was the "predominant" disease mentioned in the application, creating a pointer. The Board disagreed, noting that the application also discussed other conditions like ALS and Parkinson's on an equal footing.
  • Consequently, the combination of a 480 mg dose and the treatment of MS was deemed an unallowable selection that extended beyond the original disclosure. All auxiliary requests (1–39) failed for similar reasons.
2. Request for Referral to the Enlarged Board
The patent proprietor requested a referral to the Enlarged Board of Appeal, questioning whether selections from "lists of some length" necessarily lead to added matter. The Board rejected this request, asserting that its decision relied on the established "gold standard" rather than a formalistic "selection from lists" approach.

3. Procedural Objections (Rule 106 EPC)
The patent proprietor filed objections under Rule 106 EPC, alleging a fundamental violation of its right to be heard.
  • Case Reallocation: The proprietor objected to the transfer of the case from Board 3.3.08 to Board 3.3.04.
  • Board's Ruling: The Board dismissed these objections, clarifying that the allocation of cases is an internal organisational matter. Parties have no legal right to influence which Board hears their case, nor do they have a right to oral proceedings regarding case management decisions.
  • Timing: The Board noted that the proprietor waited until the end of the oral proceedings to raise these objections, despite the transfer occurring months earlier. This was deemed inconsistent with the purpose of Rule 106 EPC, which is to allow the Board to rectify defects immediately.

4. Apportionment of Costs
  • In a notable move, the Board ordered the patent proprietor to bear the costs of all 14 opponents for the second day of oral proceedings.
  • Reasoning: The Board found the proprietor’s procedural objections were filed in bad faith and at an improper time. The proprietor insisted on pursuing "unfounded legal and factual constructs" regarding the case transfer despite clear instructions from the Board.
  • Conduct: The proprietor’s conduct was described as "unprofessional and even disrespectful," as it continued to accuse the Board of acting unlawfully without a valid legal basis. The late filing of these unsubstantiated objections required an additional day of discussion, justifying bearing the cost.

Final Decision
The Board set aside the previous decision and revoked European Patent No. EP 2,653,873 in its entirety


Decision here



#Pharmaceuticals, #DMF, #IntellectualProperty, #GenericDrugs, #USFDA, #EPO, #PharmaIP, #API, #Tirzepatide, #PatentLitigation, #PharmaNews, #RegulatoryAffairs


Location: Mumbai, Maharashtra, India

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