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Amgen files IPR petitions on two Humira patents

On Friday, June 26, 2015 Amgen Inc. filed IPR petitions (IPR2015-01514 and IPR2015-01517) against two Humira (adalimumab) patents owned by AbbVie Inc., in an effort to clear the way for its Humira biosimilar, ABP 501.  The patents, 8,916,157 and 8,916,158, are directed to improved formulations of Humira, which Amgen argues are…

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UK Patents Court Invalidates Genentech Herceptin Patent

On June 24, 2015, the UK’s High Court of Justice Patents Court invalidated a Genentech patent (EP 1037926 (“the ’926 patent”)) for the combined use of Herceptin (trastuzumab) in combination with the chemotherapeutic taxane for treatment of HER2-positive breast cancer.  Hospira brought this action as part of a series of patent…

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AbbVie Petitions FDA On Biosimilar Labeling

AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose three labeling requirements on biosimilar applicants. “Biosimilars are not generic drugs and should not be labeled like generic drugs” AbbVie stated, and demanded that the FDA require biosimilars to contain various statements in their labels to distinguish…

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