1.) ANDA approvals in August 2025 AND 2.) Amgen Inc. Vs Sandoz Inc
Contents
ANDA approvals in August 2025
General information
Lilly Chooses Virginia Site for $5B API Manufacturing Facility, with ADCs in Mind
GSK commits $30 billion to US research and development, factory expansion, as Trump visits UK
Intellectual Property
Amgen Inc. Vs Sandoz Inc
ANDA approvals in August 2025
We follow ANDA approvals. In August, a total of 63 ANDA approvals were issued, 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 sought more than 2 ANDA approvals (including tentative) were as follows.
Some of our observations are as follows.
General information
Lilly Chooses Virginia Site for $5B API Manufacturing Facility, with ADCs in Mind
Elli Lilly said it has chosen a location near Richmond, VA, for its planned $5 billion manufacturing plant that will be the first-ever dedicated, fully integrated active pharmaceutical ingredient (API) and drug product facility for the pharma giant’s bioconjugate platform and monoclonal antibody portfolio. News hereGSK commits $30 billion to US research and development, factory expansion, as Trump visits UK
- GSK plans $30 billion investment in U.S. over next five years
- Investment includes new factory in Pennsylvania for cancer drugs
- Investment would create thousands of jobs, boost US drug making
Intellectual Property
Amgen Inc. Vs Sandoz Inc.
US discovery process in the patent litigation: The U.S. patent litigation discovery process is a broad, crucial phase where both parties exchange information relevant to the case, aiming to prevent surprises at trial. Governed by the Federal Rules of Civil Procedure and sometimes by local patent rules that supplement them, this process is known for its extensive scope. It employs several key mechanisms, including document requests, which compel the production of all relevant tangible and electronically stored information, from technical specifications to internal emails and financial data. Another primary tool is the use of interrogatories, written questions that the opposing party must answer under oath. Additionally, parties conduct depositions, where witnesses and experts provide sworn, out-of-court testimony that's transcribed and can be used for gathering facts or for preparing for trial. The discovery phase also requires parties to make initial disclosures of key witnesses, documents, and a computation of damages without waiting for formal requests. Due to its comprehensive nature, discovery in patent cases is often the most time-consuming and expensive part of the litigation. In this specific case, Amgen Inc. filed a second application seeking an order authorising discovery for use in a foreign proceeding. Sandoz, Inc. opposed this application. The case revolves around Amgen's biologic drug products, Prolia and XGEVA, which are used to treat bone conditions and contain the active ingredient denosumab. Sandoz had announced in February 2023 that the FDA had accepted its biologics license application (BLA) for denosumab biosimilars. The Underlying Dispute: Amgen and Sandoz engaged in information exchange under the Biologics Price Competition and Innovation Act (BPCIA), which led to Amgen filing a patent infringement suit against Sandoz in the District of New Jersey. In that suit, Amgen asserted patents, including United States Patent No. 11,098,079. Amgen's current application aims to obtain discovery for anticipated preliminary injunction proceedings in Austria and Slovenia against Sandoz GmbH and Lek Pharmaceuticals d.d. (Lek). Amgen sought discovery not only from Sandoz but also from Sandoz GmbH, Lek, and Novartis AG (Novartis). Sandoz GmbH and Lek are sister entities of Sandoz, all indirect subsidiaries of Sandoz Group AG. Before October 4, 2023, Sandoz Group AG was a subsidiary of Novartis and served as Novartis' generic pharmaceutical and biosimilar division. After this date, Novartis spun off Sandoz Group AG (including subsidiaries Sandoz, Sandoz GmbH, and Lek) as a separate corporate organisation. Prior Litigation and Applications: Amgen previously filed a first application in May 2023, seeking discovery from Sandoz for the anticipated European preliminary injunction proceeding, which was granted in September 2023. Sandoz produced over 250,000 pages of documents in response to Amgen's requests. Amgen filed the instant case on January 17, 2024, and the application relates to two subpoenas Amgen served on Sandoz, seeking additional discovery regarding Sandoz's denosumab biosimilars, including in-line product samples. Amgen believed that Sandoz GmbH and Lek were manufacturing a generic denosumab biosimilar for Sandoz, which Sandoz intended to market in the United States and elsewhere. Amgen also thought that this foreign manufacturing would infringe its European Patent No. EP 3334747 B1 ("EP 747"). Key Issues and Arguments: The central question before the court was whether to grant Amgen's application for discovery from Sandoz and related entities. A key issue revolved around whether Sandoz has "control" over documents in the possession of Novartis, Sandoz GmbH, and Lek. Amgen argued that Sandoz has "control" due to its relationship with these entities. In contrast, Sandoz argued that it does not, particularly since the spin-off of Sandoz Group AG from Novartis. Court's Analysis and Ruling: The court first analysed whether the statutory requirements were met, finding that they were. However, the court then focused on the discretionary Intel factors, particularly whether Sandoz had control over the documents sought from Novartis, Sandoz GmbH, and Lek. Novartis: The court concluded that Amgen did not demonstrate that Sandoz has "control" over documents in Novartis' possession. Sandoz provided evidence that, following the spin-off, Novartis was no longer a corporate affiliate and that any documents at issue were now in Novartis' physical possession, not Sandoz's. Amgen failed to prove that Sandoz had the legal right or ability to obtain the documents from Novartis upon demand. Sandoz GmbH and Lek: The court similarly concluded that Amgen did not demonstrate that Sandoz had "control" over documents in the possession of Sandoz GmbH and Lek. The court analysed whether Sandoz was "litigating on behalf" of these entities. The court found that Amgen did not provide sufficient evidence that Sandoz GmbH or Lek were directing the course of Sandoz's litigation or making critical strategic decisions on Sandoz's behalf. The Court's Conclusion: Based on its analysis, the court DENIED the unresolved portions of Amgen's application for discovery. The court found that Amgen had not met its burden to demonstrate that Sandoz had control over the documents sought from Novartis, Sandoz GmbH, and Lek. The court recognised that the stakes of this dispute might be less significant as Amgen was currently suing Sandoz GmbH in Austria, where it could obtain some or all of the documents it was seeking here. The court ordered the release of a redacted version of its Memorandum Opinion to protect confidential information and allowed the parties time to propose a jointly redacted version. Decision here
