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Enoxaparin Generic Saga Continues: Momenta's Manufacturing Patent Invalid

Executive Summary

Jury verdict comes seven years after Momenta/Sandoz launched generic version of Lovenox; firms sought treble damages from Amphastar for willful infringement of manufacturing process patent.

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Insider Trading By Ex-FDA Official Puts Spotlight On Agency Practices

After Office of Generic Drugs Deputy Director Gordon Johnston left FDA, he joined GPhA and 'tricked' a former colleague into sharing info on generic Lovenox on behalf of a hedge fund he was secretly working for, SEC says.

Manufacturing Patents In Peril After Court Extends Hatch-Waxman “Safe Harbor”

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.”

Lovenox Generics: FDA’s Split Opinion On ANDA Approval Fully Supported By Court

The decision will give FDA ammunition for future battles over biosimilar approvals as Sanofi’s suit against the agency is tossed out. The court notes there was a split within FDA over its five-pronged test for active ingredient sameness, which the judge sees as evidence that the issues were carefully weighed.

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