Recent 505 (b) (2) filings (October 2025) and Discovery process in US litigations: OptraSCAN, Inc. v. Morphle Labs

Contents

Recent 505 (b) (2) filings

General information

Building Resilience in Pharma: Our Top 10 Questions from CPHI Frankfurt

Biologics Market Surges Toward $680B as FDA Accelerates Approval Pathways

Intellectual Property

Discovery process in US litigations: OptraSCAN, Inc. v. Morphle Labs

Recent 505 (b) (2) filings

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)). For more details on 505(b)(2) FDA approvals, please visit this link. The details of October 2025, 505 (b) (2)/NDA approvals are as follows:

General information

Building Resilience in Pharma: Our Top 10 Questions from CPHI Frankfurt

Exclusive interviews revealed that digital transformation, data integrity protocols, and a regionalized supply chain are crucial strategies for optimizing drug development and manufacturing efficiency. News here

Biologics Market Surges Toward $680B as FDA Accelerates Approval Pathways

The global biologics industry is experiencing unprecedented expansion as the market surges toward $679.56 billion by 2030 driven by precision therapeutics and accelerated regulatory frameworks, while complementary advances in drug delivery systems launched at major industry events are streamlining paths to market for complex biological treatments News here

Intellectual Property

Discovery process in US litigations: OptraSCAN, Inc. v. Morphle Labs

The discovery process in U.S. patent litigation is a crucial, costly, and often contentious pre-trial phase where opposing parties formally exchange all non-privileged information and evidence relevant to the claims or defences in the lawsuit. Governed by the Federal Rules of Civil Procedure, this process is notably broader in scope compared to many other international jurisdictions, and it is designed to prevent "trial by ambush." The core activities include document production, especially the costly and extensive review of electronically stored information (e-discovery), sworn depositions of witnesses taken outside of court, written interrogatories to gather factual and contention-based information, and requests for admissions to narrow the issues for trial. Due to the technical complexity of patent cases and the enormous volume of documents—often involving millions of emails and files—the discovery phase alone can cost a party millions of dollars, with the expenses through the completion of discovery frequently constituting a majority of the total litigation cost. Here is an example of an Opinion and Order from the United States District Court for the District of Delaware regarding a discovery dispute in the case of OptraSCAN, Inc. v. Morphle Labs. The case concerns patent infringement under 35 U.S.C. § 271. Key Issues and Background The central issue before the Court is whether certain employees of Morphle Labs, based in India, should be required to travel to Delaware for in-person depositions. The employees in question are: 1. Mr. Rohit Hiwale, Chief Executive Officer 2. Mr. Akash Abhishek, Vice President of Mechanical Design 3. Mr. Ashish Manmode, Vice President of Software 4. Mr. Sunnel Daniel, Vice President of Sales and Marketing During a discovery conference held on October 9, 2025, the parties agreed that Mr Manmode and Mr Daniel would be deposed via video conference. Thus, the Court's order focuses on whether Mr Hiwale and Mr Abhishek must travel to Delaware for in-person depositions. Arguments Presented OptraSCAN argued that all four employees, as officers of Morphle, should be compelled to travel to Delaware for their depositions, citing the Scheduling Order. Morphle Labs contests this, particularly regarding Mr Abhishek, claiming he is not an officer and that requiring travel from India would impose an undue burden on the company. Court’s Analysis and Reasoning: The Court refers to the Scheduling Order, which generally requires officers or representatives of a party filing a civil action in the District Court to submit to depositions within the District. Exceptions can be made by court order or agreement between the parties. The Court recognises Morphle’s argument that Mr Abhishek does not possess the most "superior knowledge" compared to Mr Hiwale. However, the Court determines that Mr Abhishek's role and knowledge establish him as an essential witness and a corporate officer with a relevant understanding of the technology in dispute. Morphle Labs cited out-of-district cases to support its argument that even if Mr Abhishek is an officer, an exception should be made because Morphle's counterclaims are compulsory. Compulsory counterclaimants may be exempt from travelling to the forum for depositions. A compulsory counterclaim is a claim that a party (usually the defendant) must assert against an opposing party (usually the plaintiff) in the current lawsuit, or they will be forever barred from asserting it in any future, separate action. Morphle Labs is a Bangalore-based company that develops robotic automation for digital pathology, including AI-powered whole slide scanners and other medical devices for cancer diagnostics. Morphle Labs reported revenue of ₹14.2 Cr ($11.8M) for the financial year ending March 31, 2024. The Court addressed Morphle's argument that requiring Mr Abhishek to travel from India to the United States would impose an undue burden, considering Morphle's small size (20 employees) and upcoming product launch. OptraSCAN countered that in-person depositions are necessary to observe nonverbal cues and facilitate testimony regarding mechanical technology. Court’s Order: The Court ordered that Mr Ashish Manmode and Mr Sunnel Daniel shall appear for deposition by video conference, as previously agreed upon by the parties. The Court orders that Mr Rohit Hiwale and Mr Akash Abhishek shall appear for in-person depositions within the United States at a time and location agreed upon by the Parties. The Court specifies that these depositions do not need to occur in Delaware but can be at any mutually convenient location within the United States. Decision here