Generic Drug Program Activity Report FY 2025 by US FDA and Case: Ipsen Biopharm Ltd vs Sandoz AG et al

Contents

Generic Drug Program Activity Report FY 2025 by US FDA.

General information

Novartis settles with Henrietta Lacks’ estate over use of her ’stolen’ cells to advance medicine

Can Pharma Companies Reverse String of Judicial Defeats at SCOTUS?

Intellectual Property

Ipsen Biopharm Ltd vs Sandoz AG et al

Generic Drug Program Activity Report FY 2025 by US FDA.

FDA publishes Generic Drugs Program Activities Report. The FY 2025 report was recently published. The details can be found here.

The FDA’s Fiscal Year 2025 Generic Drugs Program Activities Report reveals a highly active year for regulatory submissions, totalling 600 original Abbreviated New Drug Application (ANDA) receipts. Activity peaked significantly in September 2025, which saw 114 ANDA submissions—nearly double the monthly average. Beyond original applications, the program managed a massive volume of supplemental filings, including 11,715 total supplements and 2,087 amendments.

* = Original Receipts are reported as raw receipts (versus filed receipts). ** = PAS Supplements do not include REMS PAS supplements. *** = Controls count only those requests deemed appropriate for a control.

The industry also sought extensive technical guidance, submitting 3,916 requests for controlled correspondence, the majority of which were categorised as Level 1 inquiries.

On the output side, the FDA oversaw 689 total approvals and 250 tentative approvals throughout the fiscal year. Notable achievements in timely access included 92 first-time generic approvals and 137 applications that reached approval within their first review cycle. However, the process remained rigorous, as evidenced by the issuance of 1,281 complete responses and 18 Refuse-to-Receive actions for original ANDAs. Additionally, the agency completed 462 Drug Master File (DMF) completeness assessments to support the generic manufacturing pipeline.

General information

Novartis settles with Henrietta Lacks’ estate over use of her ’stolen’ cells to advance medicine

Novartis has settled a lawsuit by the estate of Henrietta Lacks that alleged the pharmaceutical giant unjustly profited off her cells, which were taken from her tumor without her knowledge in 1951 and reproduced in labs to enable major medical advancements, including the polio vaccine News here

Can Pharma Companies Reverse String of Judicial Defeats at SCOTUS?

Following the passage of the Inflation Reduction Act’s (IRA) provision granting Medicare the authority to negotiate drug prices, pharmaceutical companies and allied organisations have brought a dozen lawsuits challenging the legality of the negotiation program. While this program annually saves billions of dollars for taxpayers through Medicare savings and for patients through reduced out-of-pocket costs, the program threatens pharmaceutical companies’ unilateral price-setting ability and will reduce their revenue by an estimated $100 billion over the next decade. News here

Intellectual Property

Ipsen Biopharm Ltd vs Sandoz AG et al

Case background

• Patent: European patent No. 3 266 456, titled “Combinations of liposomal irinotecan, 5 FU and leucovorin for the treatment of pancreatic cancer” (divisional of EP application 13731230.2 / WO 2013/188586).
• Patent proprietor: Ipsen Biopharm Ltd.; opponents: Sandoz AG, Teva, Generics [UK] Ltd.
• Claims: Claim 1 (as granted) defined a use claim for irinotecan sucrose octasulfate salt liposome injection co administered with 5 FU and leucovorin for treating pancreatic cancer after gemcitabine failure; it specified order and durations (irinotecan IV over 90 minutes, leucovorin IV over 30 minutes, 5 FU IV over 46 hours). Dependent claim 6 specified dosage regimens including leucovorin at 200 mg/m2 (or 400 mg/m2 racemate / 200 mg/m2 levo) and irinotecan dosing adjusted by UGT1A1*28 status. (The UGT1A1*28 status refers to a specific genetic polymorphism (variation) in the UGT1A1 gene that causes reduced enzyme activity. It is primarily used to predict the risk of severe toxicity (neutropenia and diarrhea) in patients receiving irinotecan chemotherapy)
• Opposition: Three oppositions raised a lack of novelty/inventive step, insufficiency, and added subject matter (Articles 100(a),(b),(c) EPC). The Opposition Division revoked the patent (decision posted 16 Nov 2023). The proprietor appealed.

Procedural issues / filed requests

• On appeal, the proprietor filed a new main request and three auxiliaries (the main request essentially recombining the features of granted claims 1 and 6). They also filed document A36 (NCCN Guidelines 2013) with the statement of grounds.
• The Board issued a preliminary communication indicating that A36 should not be admitted and that the appeal should likely be dismissed (Art. 15(1) RPBA). Oral proceedings were held 27 Jan 2026.

Admittance of A36

• The proprietor argued A36 was late but a justified reaction to the Opposition Division’s finding that Figure 7 of the parent application erroneously showed leucovorin 200 mg/m2 and that A36 proved common general knowledge supporting 200 mg/m2 as suitable.
• Board’s decision: A36 was not admitted under Art. 12(6) RPBA because the core objection (that Figure 7’s 200 mg/m2 is erroneous and not shown in combination with other claim features) had been raised early in opposition proceedings and maintained thereafter. Thus, A36 should have been filed already before the Opposition Division.

Substantive issue: Article 76(1) EPC (added subject matter from parent)

• Central question: whether claim 1 of the main request (and auxiliaries) is directly and unambiguously derivable from the parent application as filed (Art. 76(1) EPC). The contested feature was the leucovorin dose of 200 mg/m2 as part of the specified triple therapy (including MM 398 IV over 90 minutes, and patients progressed after gemcitabine). MM-398 is the liposomal irinotecan formulation — specifically, irinotecan sucrose octasulfate salt liposome injection (i.e., liposomal irinotecan). The decision notes MM-398 as the same agent used in the described combination therapy and in Example 7/Figure 7
• Relevant disclosure in the parent: general embodiments and “Administration” and “Patient Populations” passages disclose order, durations and that MM 398 can be given IV over 90 minutes; general dosage references specify leucovorin either as 200 mg/m2 levo leucovorin or 400 mg/m2 racemic. Example 7 describes a Phase 3 study design with Arm C matching the claimed triple therapy, and the description consistently describes Arm C as using 400 mg/m2 racemic or 200 mg/m2 levo.
• Problem: Figure 7 (the study design flowchart, reproduced in the decision) shows Arm C with leucovorin 200 mg/m2. The Board found an inconsistency: Example 7 and other textual passages indicate leucovorin doses as either 400 mg/m2 racemate or 200 mg/m2 levo, but Figure 7 lists 200 mg/m2 without specifying racemate/enantiomer. Figure 7 is explicitly described in the parent as “illustrating the study design of Example 7”, so the discrepancy creates ambiguity.

Board’s analysis and conclusions on Article 76(1)

• Interpretation: The Board accepted that, in the absence of a contrary specification in the claim wording, a mention of “200 mg/m2 leucovorin” would be understood by the skilled person to mean 200 mg/m2 of the racemic mixture. The proprietor did not adequately counter this during the appeal; accordingly, the claim can be read as requiring 200 mg/m2 racemic leucovorin.
• Ambiguity: Since the parent consistently teaches racemic = 400 mg/m2 or levo = 200 mg/m2 in Example 7, but Figure 7 lists 200 mg/m2 without qualification, the Board considered the disclosure ambiguous and inconsistent. Because of that ambiguity, it is not possible to directly and unambiguously derive from the parent that a 200 mg/m2 leucovorin dose (interpreted as racemate) forms part of the specific triple therapy regimen for gemcitabine progressed metastatic pancreatic cancer with MM 398 IV over 90 minutes.
• The Board rejected the proprietor’s attempts to rely on common general knowledge or external documents (D1, D19, D29) to cure the ambiguity: such evidence does not resolve the internal inconsistency between Example 7 and Figure 7 (section 2.6). Case law cited during the proceedings does not require a different outcome here because the issue is ambiguity, not merely an isolated erroneous figure.

Auxiliary requests and outcome

• Auxiliary requests 1–3 include the same contested leucovorin dose feature; therefore, they fail for the same Article 76(1) reasons.
• Order: Appeal dismissed; the Opposition Division’s revocation is upheld (final order at end of decision).

Decision here