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31 May 2022AmericasSarah Speight

J&J units launch prostate cancer drug suit

Johnson & Johnson subsidiaries Aragon Pharmaceuticals and Janssen Biotech have sued three pharma companies for alleged infringement of five patents relating to prostate cancer treatment Erleada (apalutamide).

Aragon and Janssen, along with the governing board of the University of California and the Sloan-Kettering Institute for Cancer Research, filed the complaint in the US District Court for the District of New Jersey on Thursday, May 26.

The defendants—Eugia Pharma, its parent company Aurobindo Pharma, and AuroMedics Pharma—proposed a generic version of the drug and notified the plaintiffs in April that they had submitted their Abbreviated New Drug Application (ANDA) to the Food and Drug Administration (FDA).

The pharma trio claimed in the letter that the proposed product would not infringe one of the patents because it does not contain the crystalline Form B of apalutamide, the active ingredient in Erleada—a claim which the court found to be unsubstantiated.

The defendants subsequently failed to respond to a letter from the plaintiffs requesting technical information regarding the proposed generic.

Elements omitted

The court stated that the defendants’ notice letter omitted certain compulsory elements, such as the requirement to cite a section of the Federal Food, Drug, and Cosmetic Act.

The letter also failed to include a “detailed and supported statement of allegations of invalidity, unenforceability, or non-infringement” for one of the patent claims.

The plaintiffs, whose five patents-in-suit were registered between 2013 and 2018, claimed that they “will be irreparably harmed by these infringing activities unless those activities are enjoined by this court”.

And in January 2021, Covis Pharma alleged that Eugia had infringed two patents for an injectable treatment for reducing the risk of premature birth.

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