Hatch-Waxman amendment: a Hobson’s choice

US Senator Orrin Hatch, co-author of the original Hatch-Waxman Act of 1984, has introduced a new bill seeking to dramatically change the current course of Hatch-Waxman litigation. On June 13, Hatch introduced an amendment, the Hatch-Waxman Integrity Act of 2018, that is designed “to restore the careful balance the Hatch-Waxman Act struck to incentivise generic drug development”.

Already registered?

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk

More on this story

Americas

AIPPI 2018: Eli Lilly talks IPRs and biosimilar litigation

26 September 2018 The inter partes review process has had a huge impact on biosimilar litigation, but it isn’t truly fulfilling its goal of being an alternative to district court litigation.

Big Pharma

Fed Circuit spurns bid to review Hatch-Waxman Act venue limits

27 January 2021 The US Court of Appeals for the Federal Circuit has dismissed an attempt by Valeant Pharmaceuticals to overturn a ruling that restricted where Hatch-Waxman Act patent lawsuits can be filed.

Americas

Hatch-Waxman can’t offer ‘safe harbour’ defence in gene therapy case

6 January 2022 Sarepta Therapeutics won’t be able to rely on a “safe harbour” provision to protect its gene therapy invention from a patent infringement suit from biotech Regenxbio and the University of Pennsylvania, a Delaware court has ruled.

More on this story

Americas

AIPPI 2018: Eli Lilly talks IPRs and biosimilar litigation

26 September 2018 The inter partes review process has had a huge impact on biosimilar litigation, but it isn’t truly fulfilling its goal of being an alternative to district court litigation.

Big Pharma

Fed Circuit spurns bid to review Hatch-Waxman Act venue limits

Americas

Hatch-Waxman can’t offer ‘safe harbour’ defence in gene therapy case

More on this story

Americas

AIPPI 2018: Eli Lilly talks IPRs and biosimilar litigation

26 September 2018 The inter partes review process has had a huge impact on biosimilar litigation, but it isn’t truly fulfilling its goal of being an alternative to district court litigation.

Big Pharma

Fed Circuit spurns bid to review Hatch-Waxman Act venue limits

Americas

Hatch-Waxman can’t offer ‘safe harbour’ defence in gene therapy case