Momenta’s Generic Lovenox Suit Is Harbinger Of Biosimilar Battles Over Manufacturing
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At least nine complaints have been filed against the agency since March, most involving market exclusivity claims; lawyers expect innovators will be pursuing more cases as patents expire and biosimilars emerge.
In a dispute related to Amphastar/Watson’s generic enoxaparin, a Federal Circuit panel takes an expansive view of the “Bolar Amendment” and finds that certain post-approval activities are protected from infringement claims, including quality control batch testing of commercial product. The decision draws a blistering dissent from the appeals court’s chief judge, who warns the ruling will “render manufacturing method patents worthless.”
Without offering a timeline for release, CDER’s Rachel Sherman says the documents will also address exclusivity issues, as well as specifying what constitutes “publicly available” information regarding FDA’s previous determination of safety, purity and potency.