Victory for Access: Nexus Crushes Patent Barrier for Essential Cancer Drug

Nexus Pharmaceuticals has triumphed in a high-stakes patent dispute over injectable cyclophosphamide, a crucial cancer medication.
A federal court invalidated Ingenus Pharmaceuticals' patent (U.S. Patent No. 9,952,xxx), citing a fatal flaw: the undefined term "stable."
This landmark decision on May 9, 2025, clears the way for Nexus to introduce a more accessible generic alternative for patients.

In a decisive blow to patent ambiguity, Nexus Pharmaceuticals has emerged victorious from a fierce legal battle, paving the way for its generic injectable cyclophosphamide to reach cancer patients. The fight centered on Ingenus Pharmaceuticals' U.S. Patent No. 9,952,xxx, listed in the FDA’s Orange Book for cyclophosphamide injection (NDA No. 212501), which Nexus boldly challenged with a Paragraph IV certification as part of its Abbreviated New Drug Application (ANDA)^{3, 7}.

Cyclophosphamide, a cornerstone chemotherapy agent used since 1959 for various cancers^{2, 5}, became the subject of litigation when Ingenus sued Nexus for patent infringement. However, a federal judge in the Northern District of Illinois delivered a stunning rebuke, finding all claims in Ingenus’s patent invalid due to indefiniteness^{1, 8}. The lynchpin of the ruling? The patent's repeated use of the word “stable” without a clear, workable definition. This, the judge declared, created an "impermissible ‘zone of uncertainty’," rendering the patent unenforceable¹. The court’s finding underscores the critical importance of precise claim language, especially for complex drug formulations where defining stability can be challenging⁴.

"We are pleased that the district court judge issued a thoughtful opinion concluding that Ingenus’s patent was invalid," stated Usman Ahmed, Chief Executive Officer and President of Nexus. "Nexus appreciates the judgment, and we look forward to helping patients access generic alternatives for injectable cyclophosphamide."

This final judgment in Nexus’s favor dismantles a significant barrier, promising increased access to a life-saving treatment. Nexus Pharmaceuticals, dedicated to making difficult-to-manufacture drugs more accessible, can now move forward, offering a vital generic option where it's needed most.

Victory for Access: Nexus Crushes Patent Barrier for Essential Cancer Drug

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