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Biosimilar Launch Notification: Solicitor General Backs Pre-FDA Approval Notice

Executive Summary

Government urges Supreme Court to take up Sandoz’s Zarxio petition challenging Federal Circuit’s interpretation of the biosimilars statue; says it should also review Amgen’s challenge of ruling on patent dance.

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Supreme Court Jumps Into Biosimilars Battle Over Launch Notification, Patent Dance

Following advice of Solicitor General, high court grants both Sandoz and Amgen Zarxio petitions challenging Federal Circuit’s interpretation of the biosimilars statute.

Supreme Court Jumps Into Biosimilars Battle Over Launch Notification, Patent Dance

Following advice of Solicitor General, high court grants both Sandoz and Amgen Zarxio petitions challenging Federal Circuit’s interpretation of the biosimilars statute.

Supreme Court And Patents: What’s Not Happening

High court denies petition by Mylan to limit patent litigation venue and petition by Merck KGAA to address whether “on sale” bar to obtaining patent applies to non-public sales; Zarxio case to go to conference Friday.

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