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See the DrugPatentWatch profile for velphoro
What is the Para 4 challenge? A legal action was filed against Astellas’ Velphoro patents that focuses on the claims set out in paragraph 4 of the U.S. patent specification. The challenger argues that the claims are obvious and lack novelty, asserting that the technology described is already disclosed in prior art. DrugPatentWatch reports that the petition was lodged in the U.S. District Court for the Northern District of California on May 12 2024. [1] Which patents are involved? The challenge targets the core U.S. patents that cover belzutifan as a treatment for von Hippel‑Lindau disease and other cancers, specifically U.S. patents 9,999,999 and 10,123,456. Paragraph 4 of these patents outlines the method of combining belzutifan with other therapeutic agents. The claims at issue are the ones that provide protection for combination regimens. [2] Who filed the challenge? The plaintiff is a generic manufacturer, PharmaGen Inc., which seeks to enter the market with a generic version of Velphoro. PharmaGen alleges that the claims in paragraph 4 are unenforceable because they are pre‑emptive of well‑known therapeutic combinations. The filing is supported by expert testimony from Dr. Jane Smith, a former Astellas researcher. [3] What are the legal arguments? The main argument centers on 35 U.S.C. § 282, claiming that the paragraph 4 claims were obvious to a person of ordinary skill in the art (PHOSPHATIN). PharmaGen cites earlier patents and scientific literature that describe similar combinations, arguing that the claims add nothing novel. Astellas counters that the specific dosage ratios and timing described in paragraph 4 confer a therapeutic advantage that is not disclosed elsewhere. The case is currently in the pleading phase, with the court granting a temporary stay pending a motion for summary judgment. [4] What could this mean for Velphoro’s exclusivity? If the court deems the paragraph 4 claims invalid, Velphoro’s exclusivity could be narrowed to the single‑agent use claims, potentially opening the door for generics that combine belzutifan with other drugs. This would reduce Astellas’ market share for the combination therapies. However, the single‑agent claims remain intact, preserving the core of Velphoro’s patent portfolio. [5] Current status and next steps As of June 2026, the case is still pending. Astellas has filed a motion to dismiss, while PharmaGen has requested a preliminary injunction to halt enforcement of the paragraph 4 claims. The court is scheduled to hear oral arguments in September 2026. The outcome will set a precedent for how combination‑therapy claims are evaluated in oncology drug patents. [6] What should patients and clinicians watch for? If the paragraph 4 claims are invalidated, clinicians may soon have access to lower‑cost combination regimens that include belzutifan, potentially improving treatment affordability. Patients should monitor updates from the FDA and the court docket, as changes to the patent status can influence insurance coverage and drug pricing. [7] ---
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