API and IP Newsletter 1.) Recent 505 (b) (2) approvals 2.) Dapagliflozin formulation patent decision by the Boards of Appeal at the EPO

 Contents

Recent 505 (b) (2) approvals

General information

Beijing IP Court Releases 2024 Annual Cases

Hawaiʻi Secures $700 Million Settlement In Pharmaceutical Lawsuit

Intellectual Property

Dapagliflozin formulation patent decision by the Boards of Appeal at the EPO

Recent 505 (b) (2) approvals

We follow 505 (b) (2) approvals every month.

Generally, 505(b)(2) NDAs pertain to changes in comparison to previously approved drugs, such as indication, active ingredient, fixed-combination, dosage form, route of administration, dosing regimen, strength, and formulation (not approvable under section 505(j)). More details on 505(b)(2) FDA approvals can be found here. 

The details of May 2025, 505 (b) (2)/NDA  approvals are as follows:

General information

Beijing IP Court Releases 2024 Annual Cases

On April 30, 2025, the Beijing IP Court (BIPC) released their list of 2024 annual cases including 7 IP-related cases and 1 antitrust case. The Court explained that the cases “cover the four major intellectual property trial areas of patents, trademarks, copyrights, and competition and monopoly, involving innovative achievements in emerging industries in key areas such as medicine, communications, seed industry, platform economy and data. These cases reflect five major characteristics: increasing efforts to protect industrial innovation in key areas, cracking down on intellectual property infringements, helping to build a high-level socialist market economic system, serving the development of the intellectual property rule of law, and contributing Chinese wisdom to world intellectual property governance.”

News here 

Hawaiʻi Secures $700 Million Settlement In Pharmaceutical Lawsuit

In a significant win for the state, Governor Josh Green, M.D., and Attorney General Anne Lopez announced a landmark $700 million settlement with pharmaceutical companies Bristol-Myers Squibb (BMS) and three subsidiaries of Sanofi. The case, titled State of Hawaiʻi ex. rel. Anne E. Lopez, Attorney General v. Bristol-Myers Squibb Company et al., marks the end of nearly 12 years of litigation.

The settlement agreement divides the total amount of $700 million equally between BMS and Sanofi, with the funds expected to be transferred by June 9, 2025.

News here

Intellectual Property 

Dapagliflozin formulation patent decision by the Boards of Appeal at the EPO

This write-up is for a decision by the Boards of Appeal of the European Patent Office regarding case T 1041/23, concerning a patent for pharmaceutical formulations containing dapagliflozin propylene glycol hydrate. The decision was made on April 10, 2025.

Key Parties

1. Patent Proprietor/Appellant: AstraZeneca AB
2. Opponents/Respondents: Zentiva, k.s.; Galenicum Health S.L.U.; Generics (UK) Limited; Stada-Arzneimittel Aktiengesellschaft; Gedeon Richter Plc.; Kraus & Lederer PartGmbB

Background 

Six oppositions were filed against patent EP2139494, claiming it lacked novelty, inventive step, sufficient disclosure, and extended beyond the original application. The patent proprietor appealed the opposition division's decision to revoke the patent.

Subject Matter of the Patent 

The patent concerns an immediate-release pharmaceutical formulation in the form of a stock granulation containing dapagliflozin propylene glycol hydrate.

An immediate release pharmaceutical formulation in the form of a stock granulation for loading in capsules or forming tablets, or in the form of a capsule or a tablet containing the stock granulation, the stock granulation comprising:

a) dapagliflozin propylene glycol hydrate having the formula

 

b) one or more bulking agents;

c) one or more binders;

d) one or more disintegrants;

e) optionally one or more glidants and/or anti-adherents; and

f) optionally one or more lubricants.

Decision Under Appeal The European Patent Office's Opposition Division decided on March 16, 2023, to revoke EP 2139494.

The opposition division determined that the subject matter of the main request and of each auxiliary request lacked novelty compared to the public prior use in the clinical study NCT00263276 presented in D1. According to the decision, the tablet formulations distributed to the study participants were publicly available and could be analysed by placing them in an aqueous physiological medium to separate the excipients from the insoluble 1:1:1 dapagliflozin propylene glycol hydrate.

The objection of lack of novelty over the clinical trial reported in D1 was initially raised by the opponent in their notice of opposition. Regarding the possibility of analysing the medication administered in this clinical trial, the opponent mentioned various analytical techniques, such as HPLC/MS and XRPD, that would allow for the determination of the active ingredient as containing propylene glycol and the fact that it was in crystalline form, i.e., in the form of the propylene glycol solvate. 

Appellant's (AstraZeneca ) Arguments

1. The decision of the Opposition Division was based on new reasoning (specifically, how a skilled person could isolate and analyse the crystalline form of dapagliflozin) that the appellant didn't have the opportunity to comment on, violating their right to be heard.
2. The respondents persisted in requesting oral proceedings despite knowing about the violation of Article 113(1) EPC, justifying a different apportionment of costs.
3. The Article 113 (1) states the decisions of the European Patent Office may only be based on grounds or evidence on which the parties concerned have had an opportunity to present their comments. 

Respondents' Arguments

1. The opposition division had expressed the preliminary view that a skilled person could analyse the dosage form and discover all technical features. The appellant didn't react to this position early enough.
2. The appellant's request for apportionment of costs was late and unjustified.

Board's Decision The Board of Appeal decided the following:

Procedural Violation:

1. The Board agreed that the decision was based on a specific method for isolating the solvate that hadn't been discussed in prior proceedings.
2. This violated Article 113(1) EPC, as the appellant didn't have the opportunity to comment on this essential reasoning.

Remittal and Reimbursement:

1. The case was remitted to the opposition division for further prosecution due to the substantial procedural violation.
2. The appeal fee was to be reimbursed.

Admission of Documents:

1. The Board decided not to rule on the admission of documents D53-D56, D60, and D61, stating that it was for the opposition division to assess this during further prosecution.

Apportionment of Costs:

1. The appellant's request for a different apportionment of costs was rejected.
2. The Board found no special circumstances to justify departing from the principle that each party bears its own costs.

Reasons for the Decision 

1. Procedural Violation: The core of the decision rested on the specific method by which a skilled person could isolate the solvate from the medication. This specific method was not previously discussed, thereby infringing upon the appellant's right to be heard as enshrined in Article 113(1) EPC. The Board emphasised that decisions by the EPO must be based on evidence and arguments on which all parties have had the chance to comment.
2. Remittal and Reimbursement: As the procedural violation constituted a fundamental deficiency, the Board remitted the case to the Opposition Division for further examination. This decision aligns with established practices under Article 11 RPBA, which dictates that a case should be sent back to the original department if critical procedural errors are identified. Simultaneously, the reimbursement of the appeal fee was deemed equitable under Rule 103(1)(a) EPC due to the procedural deficiencies.
3. Admission of Documents: The Board opted not to make a judgment on the admittance of new documents (D53-D56, D60, D61). The rationale behind this decision was that the primary task of assessing the evidence falls under the purview of the Opposition Division, especially since the case was being remitted for further prosecution. Making a decision on the documents would preempt the Opposition Division’s comprehensive examination.
4. Apportionment of Costs: The request for an alternative apportionment of costs was scrutinized under Article 104(1) EPC and Article 16(1) RPBA, which generally require each party to bear their own costs unless equitable reasons suggest otherwise. The appellant's argument was that the respondents prolonged the oral proceedings despite being aware of the procedural violation. However, the Board found no abusive conduct or breach of duty of care.

Conclusion

The Board of Appeal sided with the appellant, finding a procedural violation in the initial decision. The case was remitted to the opposition division for further prosecution, and the appeal fee was reimbursed. The request for a different apportionment of costs was rejected. 

Decision here