Recent ANDA approvals by USFDA and Case BioNTech vs Withers & Rogers LLP

Contents

Content

Recent ANDA approvals

General information

ScinoPharm Secures U.S. FDA Approval for Glatiramer Acetate Injection for the Treatment of Multiple Sclerosis

Q1 2026: 5 FDA Decisions to Watch in the Realm of Oncology

Intellectual Property

BioNTech vs Withers & Rogers LLP

Recent ANDA approvals

We follow ANDA approvals. In December 2025, the USFDA issued 61 ANDA approvals, of which 12 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 November were as follows.

Some of our other comments about a few ANDA approvals sought by Indian companies are listed below.

General information

ScinoPharm Secures U.S. FDA Approval for Glatiramer Acetate Injection for the Treatment of Multiple Sclerosis

Even today, only a handful of companies worldwide possess the scientific and manufacturing capabilities required to produce and commercialize Glatiramer Acetate. Leveraging its integrated strengths in R&D, manufacturing, and advanced analytical capabilities, ScinoPharm has taken the lead in Taiwan by successfully obtaining U.S. FDA approval for this product. News here

Q1 2026: 5 FDA Decisions to Watch in the Realm of Oncology

1. Tabelecleucel shows promise for EBV-positive PTLD, with FDA priority review granted after resolving manufacturing issues, potentially becoming the first approved therapy for this condition.
2. Pembrolizumab plus chemotherapy, with or without bevacizumab, demonstrates significant survival benefits in platinum-resistant recurrent ovarian cancer, marking a potential first for immunotherapy in this setting.
3. Decitabine/cedazuridine plus venetoclax offers a fully oral treatment option for newly diagnosed AML patients ineligible for intensive chemotherapy, showing promising response rates.
4. Piflufolastat F 18 and gallium-68 edotreotide are new imaging agents under FDA review, aiming to enhance diagnostic accuracy and patient management in prostate cancer and neuroendocrine tumors, respectively.

News here

Intellectual Property

BioNTech vs Withers & Rogers LLP

This decision, T 1909/23, concerns an appeal against the rejection of an opposition to European Patent No. EP 3 473 267, granted to BioNTech SE and TRON for "Individualised vaccines for cancer." The primary grounds for opposition included lack of novelty (Article 54 EPC) and lack of inventive step (Article 56 EPC). This decision is very lengthy, and in this write-up, we will cover the essence of the inventive step discussion. In summary, the Board of Appeal ultimately dismissed the appeal, affirming the patent's inventive step. The Patented Invention Claim 1 of the patent defines an individualised cancer vaccine for use in treating a cancer patient. The method involves: (A) Providing the vaccine by: (a) Identifying cancer-specific somatic mutations in a tumour specimen to provide a cancer mutation signature, by sequencing genomic DNA/RNA of tumour and normal cells and comparing them. (b) Providing an RNA vaccine featuring this signature, where the RNA encodes a recombinant polyepitopic polypeptide comprising mutation-based neo-epitopes. (B) Administering the individualised cancer vaccine to the patient. Prior Art Cited

Inventive Step Discussions The core of the inventive step discussion revolved around whether the claimed invention, particularly the individualised RNA vaccine comprising a polyepitopic polypeptide encoding mutation-based neo-epitopes, would have been obvious to a skilled person based on the prior art, primarily document D1 and other cited documents. Appellant's Arguments (Opponent) The appellant contended that the subject matter lacked inventive step, arguing that:

1. D1 as a starting point: Document D1 (Rammensee et al., 2009) clearly suggested mRNA as the preferred compound class for designing individualised cancer vaccines based on a patient's tumour mutation pattern.
2. Common General Knowledge: There was no inventive merit as it was common general knowledge to pursue personalised approaches, use mRNA for tumour vaccination, and employ poly(neo)epitopic constructs for cancer therapy, as evidenced by D2-D5 and D7. Epitopes are the part of an antigen molecule to which an antibody attaches itself.
3. Lack of Unexpected Effects: The patent did not demonstrate any unexpected or superior effects compared to prior art, such as peptide-based vaccines or vaccines with distinct RNA molecules encoding neo-epitopes (D13). Neoepitopes are unique, mutated protein fragments from cancer cells that the immune system recognises as foreign, serving as targets for T cells to attack the tumour and making them crucial for personalised cancer immunotherapies, such as vaccines, as they are specific to a patient's cancer and less likely to trigger autoimmunity.
4. Obvious Alternatives: Prior art documents D3, D6, and D8 could serve as alternative starting points, leading to an obvious alternative for prior art peptide-based vaccines. D6 showed experimental evidence for an mRNA-based anti-cancer vaccine. D8 taught multiepitopic polypeptides.

Respondents' Arguments (Patent Proprietor) The respondents maintained that the invention involved an inventive step:

1. D1's Disclosure: D1 was a review article describing an "ideal cancer vaccine" and lacked an enabling disclosure for the claimed individualised RNA cancer vaccine. Its suggestions were purely speculative, without experimental data.
2. Distinguishing Features: D1 did not disclose a polyepitopic polypeptide, let alone an RNA encoding such a polypeptide for treating cancer. The claimed invention involved specific steps (aa), (bb), and (cc) that were not present in D1.
3. Objective Technical Problem: The objective technical problem was to provide a personalised RNA cancer vaccine with therapeutic efficacy.
4. Lack of Incentive/Enabling Disclosure in Prior Art Combinations: Neither common general knowledge nor combinations of D1 with other documents (D2-D5, D7, D8, D24-D27) would have rendered the invention obvious. D1 aimed to include the broadest possible range of epitopes, which diverged from the specific selection of a limited number of neo-epitopes in a polyepitopic RNA format as claimed. D3 and D8 did not target individualised cancer therapy.

Board's Decision on Inventive Step The Board conducted its assessment starting from document D1, recognizing it as a review article summarizing steps toward an "ideal therapeutic cancer vaccine." Differences from D1:

1. Step (a) (identifying mutations): D1 conceptually discloses this step and the initial part of step (b) (providing an RNA vaccine).
2. Crucial Difference: D1 does not disclose the specific feature of the claimed invention where "the RNA vaccine comprises RNA encoding a recombinant polyepitopic polypeptide comprising mutation-based neo-epitopes." D1's statements about multi-epitope RNA/DNA vaccines were predictive and speculative, not an enabling disclosure. They did not specify how multi-epitopes would be encoded (e.g., on separate molecules versus a single polyepitopic polypeptide)
3. Neo-epitopes: D1 broadly refers to "tumour-associated/specific structures" but does not explicitly specify "neo-epitopes" as a subset of mutations presented by MHC molecules, which is critical to the patient.
4. Therapeutic Effect: The Board found D1 did not credibly achieve a therapeutic effect; its descriptions were hypothetical.

Objective Technical Problem: The Board agreed with the respondents that the objective technical problem was to provide a personalised RNA cancer vaccine with therapeutic efficacy. Obviousness from D1: The Board concluded that D1 did not provide an incentive for a skilled person to arrive at the claimed invention. To reach the claimed solution from D1, a skilled person would need to make several non-obvious selections and modifications, each fraught with uncertainty. For instance, D1 focused on total RNA libraries comprising multiple epitopes on separate molecules, not a single RNA encoding a polyepitopic polypeptide. It also did not suggest identifying neo-epitopes specifically among tumour-specific mutations and presenting them as a polyepitopic RNA. Obviousness from other cited documents (D2-D8): The Board then analysed each additional document cited by the appellant and found that none, individually or in combination, made the claimed invention obvious: D2, D3, D4, D5, D7, D8: While discussing aspects like somatic mutations, multi-epitope vaccines, or mRNA for tumour vaccination, these documents either lacked the specific combination of features (e.g., polyepitopic RNA encoding neo-epitopes), did not aim for an individualised approach, or highlighted significant technical difficulties that would deter a skilled person from pursuing them. For example, D6 discussed tumour mRNA libraries. Still, it did not disclose encoding a polyepitopic polypeptide comprising neo-epitopes, nor did it provide a reason to change the format from an RNA library to a polyepitopic one. Conclusion: The Board concluded that none of the cited documents, alone or in combination, would have led a skilled person to the claimed invention in an obvious manner, nor would they have provided a reasonable expectation of achieving a therapeutic effect for an individualised RNA vaccine as claimed. Therefore, the claimed subject-matter involves an inventive step (Article 56 EPC). The appeal was dismissed.   

Decision here