patent_istock-643607264_warchi-
warchi / iStockphoto.com
8 August 2018AmericasJanine Carlan

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?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

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
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.
Big Pharma
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
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.

More on this story

Americas
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.
Big Pharma
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
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.

More on this story

Americas
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.
Big Pharma
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
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.